Abbott Diabetes Care TX111004 Diabetes Monitor Transmitter User Manual ART05005 REV 4

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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. It is intended for
everyday use in the home to aid people with diabetes, and for use in clinical settings
to aid healthcare professionals in evaluating glucose control. It is intended for
prescription use only.
CAUTION: Read all the instructions provided in this User’s Guide before using the
System. Glucose management (therapy adjustment) should be done only under the
guidance of your healthcare team.
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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.
System-Related Warnings and Cautions
•
WARNING: Keep the System and its components away from young children, as
there are small parts that may be dangerous if swallowed. The caps are choking
hazards. The Test Strip cap or vial may contain a drying agent that could be
harmful if inhaled or swallowed and may cause skin and eye irritation.
•
WARNING: Never point the pre-cocked Sensor Inserter toward the eyes, face,
or any other body part where Sensor insertion is not desired.
•
Changes or modifications not expressly approved by Abbott Diabetes Care could
void the user's authority to operate the equipment.
•
The System should not be used in an oxygen-rich environment or one related to
anesthetic gas.
•
To reduce the chance of infection, do NOT leave a Sensor inserted for more than
3 days.
•
Once the Locking Pin has been removed from the Sensor Delivery Unit, the
Sensor will be released if the button is pressed (see page 48). Do NOT press the
button until you are ready to insert the Sensor.
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•
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. When the Transmitter is underwater,
the Transmitter/Receiver connection will be broken and you will not receive
continuous glucose readings.
•
Do NOT immerse the Receiver in water or any other liquid. Avoid getting
water or any other liquid in the Receiver’s Test Strip Port.
•
The Transmitter should be removed from the Sensor Support Mount and cleaned
(see page 141) each time you remove a used Sensor (every 3 days).
•
If the Sensor Support Mount fails to adhere to the skin, the Sensor will not work
and you will need to insert a new Sensor.
•
Do NOT drop the Receiver.
•
When using the System in the Blood Glucose Mode, use only FreeStyle Test
Strips and FreeStyle Control Solution. Other brands of test strips or control
solution can give you inaccurate results.
•
Do NOT use FreeStyle Control Solution for calibration.
•
If you get a Control Solution test result that falls outside the range printed on the
Test Strip vial, repeat the test with a new Test Strip. If the test result is still
outside the range on the vial, the System may not be working properly. Do NOT
use the System to test your glucose levels unless you get a Control Solution test
result within the range printed on the Test Strip vial.
Health-Related Information
•
The System is intended to assist you in better managing your diabetes by
allowing you to know your glucose levels throughout the day.
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•
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.
•
If your results do not reflect how you feel, wait at least 1 minute and review
the new data from the Continuous Monitoring Mode or test your glucose using
the Blood Glucose Mode.
•
If you get results below 60 mg/dL (3.3 mmol/L) or above 300 mg/dL (16.7
mmol/L) and do not have symptoms of hypoglycemia or hyperglycemia, wait
at least 1 minute and review the new data from the Continuous Monitoring
Mode or test your glucose using the Blood Glucose Mode.
•
If you have symptoms of hypoglycemia or hyperglycemia, or continue to get
results below 60 mg/dL (3.3 mmol/L) or above 300 mg/dL (16.7 mmol/L),
consult your healthcare team.
•
If you are experiencing symptoms that are not consistent with your glucose
test results, consult your healthcare team.
•
When testing your glucose levels in the Blood Glucose Mode, differences in
the blood circulation in your finger or palm at the base of your thumb* and
other test sites (forearm, upper arm, hand, thigh, calf) may result in different
glucose readings. Differences in blood glucose readings between your finger
or palm and other test sites may be observed after eating, taking insulin
medication, or exercising.
* Palm testing at the base of your thumb is the same as finger testing; see Appendix A.
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•
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. Do you often get blood glucose readings below 55 mg/dL (3.1
mmol/L) without any of the usual symptoms of hypoglycemia
(sweating, tremors, rapid heartbeat, nervousness, extreme hunger)?
2. Have you had episodes of impaired thinking?
3. Have there been times when other people told you that you appeared
pale, tired, confused, or acted as if in "slow motion?"
4. Have you been irritable or forgetful, even though you physically felt
fine?
5. Have you had difficulty managing a hypoglycemic episode alone, and
needed others to help you?
6. Have you ever had a seizure or loss of consciousness without any
warning signs?
7. Do you try to maintain a very tightly controlled blood glucose level
(often running below 90 mg/dL [5 mmol/L])?
8. Have you had frequent episodes of hypoglycemia?
9. Have you had diabetes for more than 20 years?
10. Have you had a recent episode of severe hypoglycemia?
If you answered Yes to any of these questions, consult your healthcare team.
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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.
•
Physiologic differences between interstitial fluid (used to determine glucose
levels in the Continuous Monitoring Mode) and capillary blood (used to determine
glucose levels in the Blood Glucose Mode) may result in different glucose
readings. These differences may be seen after eating, taking insulin, or
exercising. This is a normal physiologic difference and does not reflect on the
accuracy of the System.
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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……...............................................................................13
How to Use This Guide ..................................................................14
Where to Get Help .........................................................................14
SECTION 1: THE SYSTEM
Components ..................................................................................17
Continuous Monitoring Mode vs Blood Glucose Mode ..................18
Daily Living ....................................................................................20
SECTION 2: GETTING STARTED
The Receiver: Initial Set-up.........................................................27
Installing the Batteries.........................................................28
Turning the Receiver Display Screen On ............................29
Setting the Date and Time ..................................................30
Performing a Control Solution Test .....................................32
The Sensor ...................................................................................41
When to Insert the Sensor ..................................................43
What You’ll Need to Insert the Sensor ................................43
Selecting the Insertion Site .................................................44
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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............................................................................55
Installing the Transmitter Battery.........................................56
Attaching the Transmitter to the Sensor..............................57
The Receiver: Calibration and the Blood Glucose Mode .........61
Entering the Sensor Code Into the Receiver .......................61
Calibrating the Receiver and Using the Blood Glucose
Mode ...................................................................................63
When to Calibrate ..........................................................63
Supplies Needed ...........................................................65
Switching to Blood Glucose Mode .................................66
Testing Sites ..................................................................66
Calibrating......................................................................67
SECTION 3: USING THE RECEIVER
The Glucose (Initial) Display Screen………………………………….79
Trend Arrows…………………………………………………………….80
Main Menu……………………………………………………………….81
Icons………………………………………………………………………83
SECTION 4: MAINTAINING THE TRANSMITTER/RECEIVER CONNECTION
Maintaining the Connection ...........................................................87
Reconnecting Automatically...........................................................89
Reconnecting Manually..................................................................89
Linking the Receiver to a New Transmitter ....................................90
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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......104
Setting Data Loss Alarms..................................................108
Setting System Alarms......................................................109
Setting Progress Tones.....................................................111
Muting Audible Alarms ......................................................112
Reports.. .....................................................................................117
Setting Glucose Targets....................................................117
Line Graphs ......................................................................118
Statistics............................................................................119
Event Histories ..................................................................122
Uploading Data .................................................................124
System... .....................................................................................127
Status Information .............................................................127
Removed Sensor .........................................................128
System Status..............................................................129
Receiver Status ...........................................................130
Transmitter Status .......................................................131
Continuous Monitoring (CM) Status.............................132
Calibration BG .............................................................132
Add Event ...................................................................................135
Meal Event ........................................................................136
Insulin Event .....................................................................137
Exercise Event ..................................................................137
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State of Health Event ........................................................138
Generic Event ...................................................................138
SECTION 6: MAINTENANCE ................................................................141
Cleaning the Transmitter..............................................................141
Cleaning the Receiver..................................................................141
Changing the Transmitter Battery ................................................142
Changing the Receiver Batteries .................................................142
Disposal of Components..............................................................143
SECTION 7: ALARMS, ERROR CODES, AND
TROUBLESHOOTING ...........................................................................147
Alarms………………. ...................................................................151
Error Codes .................................................................................163
Troubleshooting ...........................................................................167
APPENDICES ........................................................................................171
Appendix A: Palm and Finger Testing .........................................173
Appendix B: Performance Characteristics ...................................174
Appendix C: Specifications ..........................................................177
GLOSSARY……………………….. .........................................................185
INDEX………………………………… ......................................................197
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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.
By having access to more frequent glucose measurements, you can monitor your
glucose levels and gain an understanding of glucose trends. This will help you and
your healthcare team see how diet, insulin, exercise, and medication affect your
glucose levels, and to adjust your treatment plan accordingly.
In addition to its ability to provide continuous glucose readings, the System has a
number of other helpful features, including alarms to alert you to low or high glucose
levels (hypoglycemia or hyperglycemia), and reports that show your glucose
information in easy-to-understand ways. The System is intended for everyday use in
the home and is available by prescription only. It is also intended for use in clinical
settings to help healthcare professionals evaluate glucose test results.
CAUTION: Read the entire User’s Guide before using the System. Adjustments to
your treatment plan should be done under the guidance of your healthcare team.
The System includes:
•
A FreeStyle Navigator Sensor that you insert under your skin. Each inserted
Sensor is intended to remain in place and provide a continuous glucose
reading for up to 3 days.
•
A wireless FreeStyle Navigator Transmitter, a small electronic device that
makes an electrical connection to the portion of the Sensor that extends
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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.
The Receiver should always be kept with you on a belt, in a pocket, or in a
purse.
How to Use This Guide
Although you should read this entire User’s Guide before using your System, it is
also designed to serve as an easy-to-use reference manual. Sections 1 –4 (The
System, Getting Started, Using the Receiver, and Maintaining the
Transmitter/Receiver Connection) provide the information you need to get your
System up and running. Section 5 (Advanced Features) can help you get the most
out of your System. Sections 6 and 7 (Maintenance, Alarms, Error Codes and
Troubleshooting) can be of help if you have any problems. Finally, a Glossary and
Index are included to help you understand unfamiliar words and locate the
information you need.
Where to Get Help
Help is available 24 hours a day, 7 days a week.
If you have any questions about your System, call the Clinical Trial Support Line at
1-888-971-4766.
If you have any questions about your glucose levels, glucose target goals, treatment
plan, or diabetes management, consult your healthcare team.
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1. THE SYSTEM
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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.
The System Kit contains:
•
One FreeStyle Navigator™ Receiver
•
Two AAA alkaline batteries for the Receiver
•
One FreeStyle Navigator™ Transmitter
•
One 357 (silver oxide) battery for the Transmitter
•
One protective carrying case for the Receiver (with belt clip)
•
One FreeStyle Lancing Device
•
One finger cap (for lancing device)
•
One User’s Guide
•
One Getting Started Guide
The Sensor Kit contains:
•
Ten Sterile Sensor Delivery Units (each containing a Sensor)
•
One vial of 50 FreeStyle Test Strips
•
One vial of FreeStyle Control Solution
•
Thirty sterile lancets
•
Ten adhesive remover application pads
•
Ten IV Prep wipes
•
One 357 (silver oxide) replacement battery for the Transmitter
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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. It continuously displays the glucose level in your interstitial fluid
(the fluid in the tiny spaces between your tissues). This glucose reading comes from
the Sensor you will place just beneath your skin and is updated every minute. In the
Blood Glucose Mode, you can perform traditional blood glucose testing manually,
using a FreeStyle Test Strip and a drop of blood. Although you can use the Blood
Glucose Mode whenever you wish, its main use is for calibrating the System.
IMPORTANT: Blood glucose testing is REQUIRED for calibration each time you
insert a new Sensor. You will be prompted to perform a blood glucose test for
calibration at approximately 1, 3, and 24 hours after Sensor insertion. If you do not
perform these calibrations within the allowable time period, the Continuous
Monitoring Mode will not operate, your glucose readings will not be displayed, and
alarms will not be active.
Table 1.1 highlights some of the differences between the Continuous Monitoring
Mode and the Blood Glucose Mode.
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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.
Uses a Sensor to measure glucose
Uses a FreeStyle Test Strip to measure
levels. A Transmitter sends the glucose blood glucose levels.
reading to the Receiver.
Should only be used with FreeStyle
Should only be used with FreeStyle
NavigatorTM Transmitters and Sensors.
Test Strips and FreeStyle Control
Solution.
The System automatically works in the Continuous Monitoring Mode. To switch to
the Blood Glucose Mode, simply insert a FreeStyle Test Strip into the Receiver’s
Test Strip Port. Use only FreeStyle Test Strips. When the Test Strip is removed, the
Receiver will automatically switch back to the Continuous Monitoring Mode.
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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. As you get ready to go to sleep, you should place the Receiver
close by (within 10 feet) in order to maintain the Transmitter/Receiver connection
(see page 87).
•
Bathing—You can bathe or shower while wearing the Sensor/Transmitter. Do not
wear the Receiver while bathing or allow it to get wet.
•
Swimming—You can swim while wearing the Sensor/Transmitter. Do not go
deeper than 1 meter (roughly 3 feet) or the Sensor gasket might leak, causing
the Transmitter to stop working properly. The Transmitter/Receiver connection is
not maintained when the Transmitter is underwater and thus you will not receive
continuous glucose readings during this period. As soon as you take the
Sensor/Transmitter out of the water, continuous glucose readings will resume.
•
Traveling by Plane—Federal Aviation Administration (FAA) regulations may
prohibit the use of the Transmitter on commercial aircraft (visit www.faa.gov for
the most up-to-date information). Since signals from the Transmitter may
interfere with aircraft communications, you may not be able to wear the Sensor
and Transmitter during flight. However, you can check your blood glucose levels
manually in the Blood Glucose Mode except during takeoff and landing.
Before going through airport security, you should:
1. Remove your Sensor and disconnect the Transmitter from the Sensor
Support Mount (see page 51).
2. Remove and discard the Transmitter battery (see page 142).
3. Unlink the Transmitter and Receiver (see page 92) to stop the Receiver
from sending or receiving signals. Alarms associated with the Continuous
Monitoring Mode will also be turned off.
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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).
Now that you know a little more about the System, it’s time to start using it!
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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
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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. However, unlike traditional blood glucose meters, the Receiver can
provide you with continuous glucose readings from the Sensor. The Receiver also has a
built-in FreeStyle Blood Glucose Meter that works as a traditional blood glucose meter
when a FreeStyle Test Strip is inserted into the Test Strip Port. You can wear the
Receiver on your belt or carry it in your pocket or purse.
The Receiver (Front)
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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.
CAUTION: Use only AAA alkaline batteries. Do NOT use lithium, nickel cadmium
(NiCad), nickel hydride (NiMH), carbon zinc (heavy duty), or rechargeable batteries.
They will not power the Receiver properly and the Receiver will not show the correct
remaining battery life.
NOTE: To avoid draining the batteries, be careful not to accidentally press and hold
the Receiver’s buttons for a long period of time. When changing batteries, be sure to
finish within 10 minutes to preserve your date/time settings.
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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. This alarm means you have
approximately 1 week of battery power remaining. Because you must insert a new
Sensor after each battery replacement, you should replace the batteries just before
you insert a new Sensor. If your batteries are low and you fail to replace them, they
may run out and the Receiver will not display your glucose levels or sound alarms.
Turning the Receiver Display Screen On
To turn the Receiver display screen on, press the Right Option Button (see below).
The Receiver display screen automatically turns off after 12 seconds to save battery
power. You cannot turn the screen off manually. In addition, the Receiver cannot be
turned off because it runs continuously (unless you remove the batteries).
The Receiver has a backlight that can be used to light up the screen (for use in the
dark). Once the backlight is turned on, it will stay on as long as the display screen is
in use. It will turn off automatically when the screen goes blank after 12 seconds of
no activity.
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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. Press the Right Option Button once to turn the Receiver on. Press it again to see
the Main Menu.
3. Use the Up/Down Arrow Buttons to highlight System. Press the Right Option
Button to Select.
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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).
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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.
Performing a Control Solution Test
FreeStyle Control Solution is a red liquid that contains a fixed amount of glucose and
can be used:
•
To ensure that your Receiver and Test Strips are working properly prior to
calibration or blood glucose testing.
•
To check that you are following the correct testing procedure.
•
To practice Blood Glucose Mode testing without having to use your own blood.
The best way to check your Receiver is to perform a test using FreeStyle Control
Solution. A Control Solution test follows the same procedure as a blood glucose test,
except that you use a sample of Control Solution instead of a drop of blood. If the
Receiver reading is within the Control Solution acceptable range, the Receiver is
working properly.
You’ll want to perform a Control Solution test:
•
When you first get your Receiver, before performing a calibration.
•
When you open and begin using a new vial of Test Strips.
•
When you suspect that your Receiver or Test Strips are not working properly.
•
When you think your glucose test results are not accurate, or if your test results
are not consistent with how you feel.
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•
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. For example, if you open
the Control Solution on January 15th, count forward 3 months to April 15th. This is the
discard date that you record on the bottle.
Ensuring accurate Control Solution results:
•
Use only FreeStyle Control Solution with your Test Strips. The use of other
brands of Control Solution may produce inaccurate results.
•
Replace the cap on the Control Solution bottle immediately after using.
•
Do NOT use Control Solution past the expiration date or you may get inaccurate
results.
•
Do NOT add water or any liquid to Control Solution.
•
Control Solution tests are specified to be accurate only when performed between
59° and 104°F (15° and 40°C).
CAUTION: Results from Control Solution tests do NOT reflect your blood glucose
level.
The Control Solution test results should fall within the range printed on the Test Strip
vial label. If Control Solution test results are out of this range, repeat the test. Outof-range Control Solution test results may be caused by:
•
Expired or bad Control Solution.
•
Expired or bad Test Strips.
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•
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. Do NOT use the System
to test your glucose levels. Call the Clinical Trial Support Line at 1-888-971-4766.
Important Test Strip Information:
•
The System has an operating range of 40 to 104 F (5 to 40 C).
•
Use the Test Strips only within the System operating temperature range.
•
Store the Test Strip package in a cool, dry place between 37 to 86F (3 to 30 C).
•
Keep Test Strip package away from direct sunlight and heat.
•
Store your Test Strips in their original vial only; never transfer them to another
vial or any other container or carrying case.
•
Never store individual Test Strips outside the vial.
•
After removing a Test Strip from the vial, immediately replace the vial cap and
close tightly.
•
With clean, dry hands, you may gently touch the Test Strip anywhere when
removing it from the vial or inserting it into the Receiver.
•
Do NOT use Test Strips beyond the expiration date printed on the package as
this may cause inaccurate results.
•
Do not bend, cut, or alter Test Strips in any way.
For detailed storage and usage information, refer to the FreeStyle Test Strip
package insert.
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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. The code number on the Receiver display screen should match the code number
on the side of your Test Strip vial (see below). They must always match or your
results will be inaccurate. 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. Once the code on the screen matches the code on
the Test Strip vial, press the Right Option Button to select Set.
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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. The Receiver will prompt you to Apply Sample (see below).
4. Gently touch only one edge of the Test Strip to the Control Solution. Specifically,
apply the Control Solution to the Test Strip edge next to one of the dark-colored
half-circles. If Progress Tones are turned on (see page 111), the Receiver will
beep once to indicate that enough Control Solution was applied.
IMPORTANT: Do NOT apply Control Solution to both edges of the Test Strip.
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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.
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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
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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 Delivery Unit has 2 parts packaged together: the Sensor Inserter with preinstalled Sensor (which puts the tip of the Sensor under your skin) and the Sensor
Support Mount (which stays on your skin to hold the Sensor in place and also
attaches the Sensor to the Transmitter; see below).
The Sensor
The Sensor Delivery Unit
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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. Do not remove the Locking Pin
until the Sensor Support Mount is adhered to the skin.
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
inserter from the Support Mount after the Sensor is inserted into the skin. The
Adhesive Protective Liner surrounding the Sensor Support Mount is designed to hold
the Support Mount and Transmitter onto the body for up to 3 days of normal use.
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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. In addition, because you will need to calibrate at
approximately 1, 3, and 24 hours after Sensor insertion, it is best not to insert the
Sensor just before you go to bed.
What You’ll Need to Insert the Sensor
•
Soap and water
•
IV Prep wipes
•
Sensor Delivery Unit (in its unopened package)
•
Transmitter (reusable)
•
Receiver (reusable)
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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. Insertion of a Sensor on the abdomen or back of
upper arm are the only sites studied in clinical trials.
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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. If the area is not clean, an
infection may occur. If the area is not dry, the Sensor Support Mount adhesive may
not stick.
Inserting the Sensor
1. Remove the Sensor Delivery Unit from its sterile package. Save this package; it
contains the Sensor code number. Later, you will need to enter this code
number into the Receiver.
NOTE: Do NOT use the Sensor Delivery Unit if the sterile package has been opened
or otherwise damaged.
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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). If inserting the Sensor on the back of your
arm, place the Sensor Support Mount lengthwise down your arm with the top of
the Sensor Support Mount facing up. Having the top of the Sensor Support
Mount facing up will allow fluids to drain away from the Sensor Contact Points
(for example, when you bathe). If inserting the Sensor on your abdomen, position
the Sensor Support Mount horizontally. The top of the Sensor Support Mount
MUST be pointing to your left to allow fluids to drain away from the Sensor
Contact Points.
Top of Sensor Support Mount
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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. Press the button on the top of the Sensor Inserter (see below). You will feel a
slight pinch as the Sensor is placed just under your skin.
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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). On your abdomen,
the top of the mount should always point to your left. The Sensor should be
visible, with its tip inserted into your skin. A small drop of blood may be visible.
Top of Sensor Support Mount
NOTE: If there is more than a small drop of blood at the Sensor insertion site, it may
interfere with the Transmitter connection and you will not receive continuous glucose
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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. You should change your
Sensor if you notice ANY irritation or discomfort at the Sensor insertion site, or if the
Receiver reports a problem with the inserted Sensor. Taking action at the first sign of
irritation or discomfort will keep small issues from turning into larger or ongoing
ones.
It is recommended that you do not change your Sensor at the same time you change
your insulin pump infusion set, as you will not get continuous glucose readings for at
least 1 hour after Sensor insertion (until after the first calibration).
Site Rotation
To prevent discomfort, irritation, bruising, skin rashes, or sensitivity to adhesives, it is
important to rotate across several sites and to insert Sensors only in the abdomen or
back of the upper arm. Always change the insertion site each time a new Sensor is
used.
Rotating the sites in a predictable pattern may help you remember to rotate them
evenly. For example, you may want to start in the upper-right corner of your
abdomen, and then move one inch to the left when you insert a new Sensor,
continuing in a circular direction. Or, start on the right arm at a high position, move to
a low position on the right arm, then repeat on the left arm.
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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. A variety
of such bandages are available at your local pharmacy. Ask your healthcare
team which type of bandage is best for you.
•
Adhesive Enhancers—If you’re having trouble getting the Sensor Support Mount
to stick to your skin, you may want to try an adhesive enhancer, which will help
the adhesive pad on the Sensor Support Mount stick to your skin better. IV Prep
wipes are adhesive enhancers included in your Sensor Kit. After applying this
type of product, be sure that the Sensor insertion site is thoroughly dry before
placing the Sensor Support Mount on your skin. Ask your healthcare team which
adhesive enhancer is best for you.
•
Skin Barriers—If you experience sensitivity to adhesives, there are products that
may help prevent irritation or sensitivity by placing a barrier between your skin
and the Sensor Support Mount’s adhesive pad. These products may also help
the adhesive stick better. Be sure to allow the skin to dry thoroughly before
inserting the Sensor or applying another tape or dressing. Ask your healthcare
team which skin barrier product is best for you.
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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).
End nearest
Sensor
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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. If necessary, use an adhesive remover, baby oil, or a wet, soapy washcloth to
remove any adhesive residue left on your skin.
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The Transmitter
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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. When you first receive your System, the Transmitter
and Receiver will already be linked—that is, the Receiver will be preset to receive
glucose information from the specific Transmitter included with your System.
The Transmitter (Front)
Transmitter Tabs—Provide a
secure connection to the Sensor
Support Mount
The Transmitter (Back)
Sensor Support Mount
Latch—Secures the Transmitter
to the Sensor Support Mount
Battery
Contact Points—Connect
the Transmitter to the Sensor
Support Mount.
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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). Be sure the
battery door is closed securely to create a seal.
NOTE: When changing the battery, always insert a new battery into the Transmitter.
If you insert an old battery, the battery life timer will not be accurate and the battery
may stop working without warning.
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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). The Transmitter Tabs
slide into the Sensor Support Mount Guides for a tight connection. Check that
there is no space between the Sensor Support Mount and the Transmitter.
NOTE: Because of differences in skin type, exercise, weather, and other factors,
adhesion of the Sensor/Transmitter unit may vary. You may want to use an overbandage in certain conditions (see page 49).
Once the Transmitter is attached to the Sensor, it will begin transmitting data to the
Receiver. After entering the Sensor code and performing the first calibration (see
next sub-section) you will be receiving continuous glucose readings.
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The Receiver: Calibration and the Blood
Glucose Mode
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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. Press the Right
Option Button once to turn the Receiver display on. The following message will
appear on the screen: “New Sensor Detected. Have you recently inserted a new
Sensor?” (see below). Select Yes by pressing the Right Option Button.
NOTE: If at any time you get this message and you have not just connected a
Transmitter to a newly inserted Sensor, select No. You may get this message, for
example, during the cleaning of the Transmitter or if the Transmitter is bumped while
connected to the Sensor.
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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.
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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.
When to Calibrate
Blood glucose testing is required for calibration each time you insert a new Sensor.
You will be prompted to perform a blood glucose test approximately 1, 3, and 24
hours after Sensor insertion.
NOTE: You must perform all 3 calibration tests. If you do not complete all 3
calibration tests in the allowed time periods, your glucose readings will not be
displayed, and alarms will be inactive. See Table 2.1 for details regarding each
calibration test. If a calibration failure occurs, see Table 7.2 on page 152 for detailed
instructions.
IMPORTANT: Your blood glucose level must be between 60 and 400 mg/dL (3.3
and 22.2 mmol/L) to be able to perform calibration tests. If your blood glucose level
is outside this range or if it is changing rapidly, the System will not be calibrated,
continuous glucose readings will not be available, and alarms will not function.
Under such conditions, the System may not ask you to calibrate; instead, it will delay
its request until conditions are acceptable.
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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.
Between 2 and 4
Continuous
hours after the first glucose levels will
successful
no longer be
calibration
displayed and
(approximately 3 to alarms will not
5 hours after
function. The
Sensor insertion).
Receiver display
screen will show
An alarm will sound “Do BG Test—
and the Receiver
Alarms Inactive”.
display screen will
show “Do BG Test”.
A blood drop icon
will also appear.
What to do if
Calibration is Missed
Between 21 and 29
hours after the
second calibration
(approximately 24
to 32 hours after
Sensor insertion).
Do the calibration test
as soon as possible
(even if more than 29
hours have passed);
continuous glucose
levels will then be
displayed and alarms
will resume.
An alarm will sound
and the Receiver
display screen will
show “Do BG Test”.
A blood drop icon
will also appear.
Continuous
glucose levels will
no longer be
displayed and
alarms will not
function. The
Receiver display
screen will show
“Do BG Test—
Alarms Inactive”.
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Do the calibration test
as soon as possible;
continuous glucose
levels will then begin
to be displayed and
alarms will function.
Do the calibration test
as soon as possible
(even if more than 4
hours have passed);
continuous glucose
levels will then be
displayed and alarms
will resume.
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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).
11:00 AM: Perform Second Calibration (2 hours after first successful
calibration).
Day 2
8:00 AM: Perform Third Calibration (21 hours after second successful calibration).
Supplies Needed for Calibration
Before performing a blood glucose test for calibration, be sure you have the
following materials nearby:
•
Soap, water, towel
•
FreeStyle lancing device
•
Sterile lancets
•
FreeStyle Test Strip
•
Receiver
•
Sharps container or other puncture-proof container with lid
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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. Or, if you do not touch any
buttons on the Receiver for 12 seconds, the screen will go blank, and when you turn
the Receiver on, you will be back in the Continuous Monitoring Mode.
Blood Glucose Testing Sites
To calibrate the System, only use a blood sample from your finger or forearm. You
can use a blood sample taken from a number of different areas on your body to
check your blood glucose levels in the Blood Glucose Mode. You may take a blood
sample from your forearm, upper arm, hand, thigh, or calf, as well as from your
fingers or your palm at the base of your thumb (see below). When blood glucose is
changing rapidly, blood from the fingertips or palm may show these changes sooner
than blood from other sites. When selecting a site, be sure to avoid moles, veins,
bones, and tendons.
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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. Push until the Test Strip stops.
NOTE: If you do not start the test within 2 minutes of inserting the Test Strip, the
Receiver will display an “Er4” message. To start the test again, simply remove the
old Test Strip and insert an unused Test Strip.
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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.
NOTE: If you do not change or set the Test Strip code number within 3 seconds, the
Receiver will accept a blood sample using the existing Test Strip code number and
automatically move on to the next step. 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 3.
NOTE: To ensure accurate test results, MAKE SURE the code number on the
Receiver matches the code number on the Test Strip vial.
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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.
Lancing Device
Cocking Handle
Depth Settings Dial
Depth Indicator Window
Release Button
Clear Cap
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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. Hold the lancet firmly in place with one hand and use
your other hand to twist off the rounded top.
V. Replace the cap until it snaps or clicks into place. Be
careful not to touch the exposed needle on the lancet.
IMPORTANT: Use the grey cap for finger tests. Lancing with the clear cap may be
completed at the following sites: forearm, upper arm, hand, thigh, and calf.
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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 forearm, upper arm, hand, thigh, or calf:
a. Bring fresh blood to the surface by rubbing the test
site vigorously for a few seconds until you feel it
getting warm.
b. Hold the clear cap down against the top of your test
site. Depress the release button. Do not lift up.
c. Continue to hold the lancing device and gradually increase pressure for
several seconds. While holding the lancing device on your test site, look
through the clear cap; the blood sample should be about the size of a
pinhead (example:
).
d. Lift the lancing device straight up; be careful not to smear the blood
sample on your test site.
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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. When you have finished testing, snap off the cap from
the lancing device. Hold the lancet over a sharps
container or other puncture-proof container with a lid.
Pinch the white clip that holds the lancet until the lancet
falls out.
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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.
•
Do NOT apply blood to the Test Strip when the Test Strip is out of the Receiver.
•
Do NOT apply blood to both edges of the Test Strip.
•
Do NOT put blood or foreign objects into the Receiver’s Test Strip Port.
IMPORTANT: Test Strips may be used only once. Discard used Test Strips.
7. A Stopwatch Icon will appear while the Receiver is measuring the blood glucose
level. If Progress Tones are turned on (see page 111), the Receiver will beep
once to let you know enough blood was used. The Receiver will beep twice when
the blood glucose result appears. Blood glucose levels take about 7 seconds to
calculate. The higher the blood glucose level, the longer the calculation time.
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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 (1.1 mmol/L), “LO” appears on the Receiver
display screen. This indicates that you may be experiencing severe hypoglycemia
(low blood glucose levels).
•
If you get a “LO” reading and have symptoms such as weakness, sweating,
nervousness, headache, or confusion, follow your healthcare team’s
recommendations for treating hypoglycemia.
•
If you have a “LO” reading but have no low blood glucose level symptoms, retest
with a new Test Strip.
•
If you still get a “LO” reading with a repeated test, follow your healthcare team’s
recommendations for treating hypoglycemia.
You may want to check for low blood glucose levels when you:
•
Are feeling symptoms such as weakness, sweating, nervousness, headache, or
confusion.
•
Have delayed a meal after taking insulin.
•
Have been advised to test by your healthcare team.
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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.
•
If you still get a “HI” reading with a repeated test, follow your healthcare team’s
recommendations for treating hyperglycemia.
8. Once your blood glucose result is displayed, the Receiver will ask if the result is
from a Control Solution test (see below). Press the Right Option Button to select
No. (For more information about Control Solution tests, see page 32.) If you
ignore this prompt, the System will default to No.
9. Remove and discard the Test Strip.
You are now ready to start using your System!
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3. USING THE RECEIVER
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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).
Glucose Trend Arrows let you know the direction that your glucose levels are
moving—whether they are stable, increasing, or decreasing—and how quickly they
are changing. There are 5 types of Glucose Trend Arrows (Table 3.1).
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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]).
Moderate Fall
A Glucose Trend Arrow angled downward means your glucose is
decreasing 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]).
Rapid Rise
A Glucose Trend Arrow pointing straight up means your glucose is
increasing rapidly (at a rate of greater than 120 mg/dL/hr [6.7
mmol/L/hr]).
Rapid Fall
A Glucose Trend Arrow pointing straight down means your
glucose is decreasing rapidly (at a rate of more than 120 mg/dL/hr
[6.7 mmol/L/hr]).
The letters CM in the display screen’s upper left corner indicate the Receiver is
operating in the Continuous Monitoring Mode. This means the glucose reading that
you see comes from the Sensor inserted under your skin, not from a drop of blood
on a Test Strip.
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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. Press the Right Option Button once to turn the Receiver on.
2. Press the Right Option Button again and the Main Menu will appear.
3. Use the Up/Down Arrow Buttons to find and highlight the option you want.
4. Press the Right Option Button to Select the option you want and advance to the
next screen.
Table 3.2 contains a list of Main Menu options; each of these options is explained in
detail in Section 5 (page 97).
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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.
Add Event
Allows you to record the time, date and other information for
specific activities and events. Activities and events that you may
want to add (or your healthcare team may ask you to add)
including insulin doses, meals, exercise, illness, and low blood
glucose symptoms.
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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. Calibration
needs to be done approximately 1, 3, and 24 hours after inserting a
new Sensor. For more information on calibration, see page 61.
An hourglass icon appears when the System is waiting. For example,
it will appear for the first hour after a new Sensor has been inserted,
while the System is waiting to do the first calibration. You don’t need
to do anything when you see this icon.
The connection icon appears where there is a problem with the
Transmitter/Receiver connection. For more information about
maintaining or restoring this connection, see page 88.
The battery icon means it is time to replace the batteries in the
Receiver. New batteries should be installed just before a new Sensor
is inserted. For more information on replacing the Receiver batteries,
see page 142.
For other information on Receiver options and functions not discussed in the section,
see “Getting Started” (Section 2) or “Advanced Features” (Section 5).
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4. MAINTAINING THE
TRANSMITTER/RECEIVER CONNECTION
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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. An alarm will sound to remind you to keep the
Receiver and the Transmitter within 10 feet of each other (Table 4.1).
Table 4.1. Breaking the Transmitter/Receiver Connection
Amount of Time
Connection Has
Been Broken
3 Minutes
What Will Happen
The System will no longer show glucose readings and
you will not receive glucose alarms.
5 Minutes
The Receiver will sound an alarm. You will also see an
alert on the screen (see below).
8 or More Minutes
The Receiver will sound a more urgent, repeating alarm.
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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. For example, having the Transmitter on
your abdomen and the Receiver in your back pocket may result in a broken
connection.
•
Nearby Objects—Large metal objects (for example, filing cabinets) and large
containers of water (for example, waterbeds) can sometimes interfere with the
connection.
•
Interfering Signals—The System is designed to work in the presence of most
electronics (for example, cell phones and computers). Electronics that produce
radio frequencies (for example, some computers and computer displays) may
cause the connection to be broken.
Tips for Maintaining the Connection
Follow these tips to help maintain the Transmitter/Receiver connection:
•
Keep the Receiver with you at all times. If you leave it somewhere and walk
away, the Transmitter/Receiver connection will be broken.
•
When you sleep, place the Receiver on a high headboard or nearby dresser,
rather than in bed or clipped to your clothing.
•
If a Connection Alarm sounds, adjust the placement of the Transmitter and/or
Receiver to restore the connection.
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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. Bring the Receiver to within 10 feet of the Transmitter.
2. Press the Receiver’s Right Option Button once to turn the Receiver on. Press it
again to see the Main Menu.
3. Use the Up/Down Arrow Buttons to highlight System. Press the Right Option
Button to Select.
4. Use the Up/Down Arrow Buttons to highlight Reconnect (see below). Press the
Right Option Button to Select.
5. Wait for the Transmitter to automatically send a signal to reconnect with the
Receiver. The Receiver will beep twice if reconnection is successful. It will beep
3 times if the reconnection is unsuccessful. If the reconnection is unsuccessful,
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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. If you link a new Transmitter to your Receiver while a Sensor is
inserted, you will need to insert a new Sensor.
To link to a new Transmitter, follow these steps:
1. Place the Receiver within 10 feet of the new Transmitter.
2. Press the Receiver’s Right Option Button once to turn the Receiver on. Press it
again to see the Main Menu.
3. Use the Up/Down Arrow Buttons to highlight System. Press the Right Option
Button to Select.
4. Use the Up/Down Arrow Buttons to highlight Link (see below). Press the Right
Option Button to Select.
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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.
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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.
Unlinking the Transmitter and Receiver
You can unlink the Transmitter and Receiver to stop the Receiver from sending or
receiving signals and to turn off all alarms associated with the Continuous Monitoring
Mode (for example, if you will be flying on a commercial aircraft). Note that you will
NOT receive continuous glucose data while the Transmitter and Receiver are
unlinked.
Follow these steps to unlink the Transmitter and Receiver:
1. Press the Receiver’s Right Option Button once to turn the Receiver on. Press it
again to see the Main Menu.
2. Use the Up/Down Arrow Buttons to highlight System. Press the Right Option
Button to Select.
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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. Use the Up/Down Arrow Buttons to highlight System. Press the Right Option
Button to Select.
4. Use the Up/Down Arrow Buttons to highlight Link. Press the Right Option Button
to Select.
5. Wait for the Receiver to detect the Transmitter and display the Transmitter serial
number (ID; see below). This may take up to 70 seconds.
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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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5. ADVANCED FEATURES
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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
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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).
Projected Low
Provides an early warning when you are approaching your low
glucose threshold.
Projected High
Provides an early warning when you are approaching your high
glucose threshold.
Data Loss
Notifies you when your glucose data will be lost and the alarms will
not be working. Data Loss Alarms sound when the
Transmitter/Receiver connection is broken or when you are overdue
to change the Sensor.
System
Non-urgent System notifications. Examples include low battery life
and time for calibration.
Progress Tones Communicate progress, errors, and successful completion of System
activities such as Blood Glucose Mode Testing.
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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. Or, if you’ve made changes but changed your mind, before you
pressed Select, you can wait 12 seconds and allow the Receiver screen to go blank,
and the changes will be cleared or cancelled.
NOTE: Be careful to avoid making unintentional changes to System settings when
setting or turning off Alarms.
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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).
CAUTION: 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).
NOTE: High and Low Glucose Alarms are DIFFERENT from your Glucose Targets.
For information about Glucose Targets, see page 117.
From the Low/High Glucose Alarm screens you can:
•
Turn the Glucose Alarms on or off.
•
Set your low and high glucose thresholds.
•
Select Alarm types (low, medium, or high beep or short, medium, or long
vibration).
To change Low or High Glucose Alarms:
1. Select Low Glucose or High Glucose from the Alarms Menu (see below).
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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.
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 Projected Low and Projected High Glucose Alarms
Projected Low and Projected High Alarms are early warning alarms that tell you your
glucose is changing and is approaching your low or high glucose threshold. Both the
level of your glucose thresholds and how fast your glucose is changing will affect
when your Projected Alarms are triggered. You can select the sensitivity of the early
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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 5.2 and/or consult your healthcare
team to determine which sensitivity level is best for you).
•
Select alarm type (low, medium, or high beep or short, medium, or long
vibration).
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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.
Medium
20 minutes
If you want a little bit of advanced warning
when your glucose level approaches your
high or low glucose threshold, set the
sensitivity to Medium and you will be
warned approximately 20 minutes ahead
of when the System thinks you will reach
the threshold.
Low
10 minutes
If you want to be warned just before your
glucose level reaches your high or low
glucose threshold, set the sensitivity to
Low and you will be warned 10 minutes
ahead of when the System thinks you will
reach the threshold.
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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. Press Set (Right Option Button) to accept the settings and return to the Alarms
Menu.
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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.
•
Select alarm type (low, medium, or high beep or short, medium, or long
vibration).
IMPORTANT: If you want to turn off your Data Loss Alarms, you will also need to
turn off all of your Glucose Alarms.
To set or change Data Loss Alarm:
1. Select Data Loss from the Alarms Menu (see below).
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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.
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 System Alarms
System Alarms notify you when:
•
The Receiver batteries are low.
•
The Transmitter batteries are low.
•
A Blood Glucose Mode Test is needed for calibration.
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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.
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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. 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 Progress Tones
Routine System activities such as Blood Glucose Mode testing use sounds to notify
you of errors, results, and successful completion of steps. These sounds are known
as Progress Tones.
From the Progress Tones Screen you can:
•
Turn Progress Tones on or off.
•
Select Progress Tone volume (low or high).
To set or change Progress Tones:
1. Select Progress Tones from the Alarms Menu (see below).
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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.
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.
Muting Audible Alarms
The Mute Alarms feature allows you to turn off all audible alarms for 1 hour. Even
when alarms are muted, you will still get vibration and visual alarms. After 1 hour,
alarms will sound again. If you want to turn off alarms for extended periods of time,
you should turn off each alarm individually.
NOTE: When alarms are muted, you will not be able to hear any alarms and will
need to rely on vibrations and visual displays only.
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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
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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. Your healthcare
team can help you determine your Glucose Targets.
NOTE: Glucose Targets are DIFFERENT from High and Low Glucose Alarms. For
information about High and Low Glucose Alarms, see page 103.
To set Glucose Targets:
1. Select Reports from the Main Menu. Then select Glucose Targets.
2. Enter Low and High Glucose Targets using the Up/Down Arrow Buttons.
Default values are 80 mg/dL (4.4 mmol/L; low) and 180 mg/dL (10 mmol/L;
high).
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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. Glucose levels (in mg/dL) are plotted on
the vertical axis. Line Graph Reports display both continuous readings (a continuous
line graph) and blood glucose readings (plotted as “+” symbols on the line graph).
NOTE: The line graph scale does not go below 20 mg/dL (1.1 mmol/L) or above 350
mg/dL (19.4 mmol/L). If any of your glucose values fall below 20 mg/dL (1.1
mmol/L), they will be plotted as 20 mg/dL (1.1 mmol/L). If any of your glucose values
fall above 350 mg/dL (19.4 mmol/L), they will be plotted as 350 mg/dL (19.4
mmol/L).
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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).
You can view Statistical Reports for 1-, 3-, 7-, 14-, 21-, or 28-day time periods.
Viewing this sort of information may help you see patterns in your glucose levels.
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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.
Available Statistical Reports are outlined in Table 5.3.
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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. For example, a
small number indicates that most of your glucose readings during the
day are close to the average value and that you are maintaining your
glucose levels near that value. A large number indicates that many of
your glucose levels during the day vary considerably from the average
value and that you are not maintaining your levels near the average
value.
Above Target
The percentage of readings over the selected time period that are
above your High Glucose Target.
Within Target
The percentage of readings over the selected time period that are
within your Glucose Targets (between the high and low glucose
targets).
Below Target
The percentage of readings over the selected time period that are
below your Low Glucose Target.
Low/Day
The average number of Low Glucose Alarm events per day for the
selected time period.
High/Day
The average number of High Glucose Alarm events per day for the
selected time period.
Proj Low/Day
The average number of Projected Low Alarm (early warning) events
per day for the selected time period.
Proj High/Day
The average number of Projected High Alarm (early warning) events
per day for the selected time period.
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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.
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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. Each CM 10 reading is
displayed on a single screen with its date/time. This
is the most frequent glucose data available.
BG
Recorded Blood Glucose (BG) readings. Each BG
reading is displayed on a single screen with its
date/time. All BG readings are displayed. A check
mark appears next to BG readings that were marked
as control.
Insulin
Recorded Insulin Events. Each Insulin Event entered
is displayed on a single screen with type (rapid,
intermediate, basal, or mixed), dosage (in units), and
date/time.
Meals
Recorded Meal Events. Each Meal Event entered is
displayed on a single screen with its carbohydrate
value (in grams) and date/time.
Exercise
Recorded Exercise Events. Each Exercise Event
entered is displayed on a single screen with its
description (running, swimming, walking, biking, for
example), duration (hours and minutes), intensity,
and date/time.
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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.
User Events
Recorded User Events. Each User Event (includes
Insulin, Meal, Exercise, State of Health, and Generic
Events, described above) is displayed with its
description and date/time.
Uploading Data
The System is designed to allow your healthcare team to upload data to a computer
in the clinic. To upload data, your healthcare team will select System from your
Receiver’s Main Menu and then select Data Upload from the System Menu.
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System
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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.
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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.
Transmitter ID
Shows the Transmitter’s serial number. You may need to verify the
serial number after linking to a new Transmitter. This unique value is
used by the Receiver to accept data from only your Transmitter. It
also shows battery life remaining.
CM Status
Stores recent error codes related to the Continuous Monitoring Mode
(may be useful when calling Clinical Trial Support).
Calibration BG
Allows you to add a new blood glucose reading used for calibration.
Use this selection ONLY at the request of a Clinical Trial Support
representative.
Removed Sensor
Removed Sensor is an optional feature that can be activated when you manually
remove a Sensor. Activating the Removed Sensor feature:
•
Keeps the Data Loss Alarm from sounding when you remove the Sensor.
•
Electronically records the time and date of Sensor removal.
To activate the Removed Sensor feature:
1. Select System from the Main Menu.
2. Select Status from the System Menu.
3. Select Removed Sensor from the Status Menu. Press the Right Option
Button to activate.
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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. Select System Status from the Status Menu.
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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.
Shows the charge that remains in the Receiver’s battery. During
typical use of the Receiver, the batteries should last about 3 months.
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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. This unique value is
used by the Receiver to accept data only from your Transmitter.
TX Battery
Shows the life that remains in the Transmitter’s battery. During typical
use of the Transmitter, the battery should last about 30 days.
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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.
Stores a code for the most recent delayed calibration.
Stores a code for the most recent unsuccessful calibration.
Stores a code for the most recent Sensor error.
Calibration BG
Calibration BG allows you to add a new blood glucose measurement to the average
used for Sensor calibration. Use this feature only under the direction of a Clinical
Trial Support representative.
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Add Event
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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).
•
Events may also be uploaded to a valid software application by your healthcare
team.
For many events, you can simply record the time and date. Or, you can take
additional steps to record events in more detail. Pressing the Right Option Button
completes the entry of your event regardless of how much detail you have provided.
Events are listed in Table 5.10.
NOTE: The date and time are automatically recorded when you enter an event. If
you enter the event at a later time, you must enter the date and time the event
occurred.
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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 Events are always
recorded with a time and date notation and may also include
type of insulin and dose amount (units).
Exercise Event
Records the time and date and a description of many popular
forms of exercise. You may also specify the intensity and
duration of each exercise event.
State of Health
Records events, symptoms, and other observations that may
Event
aid in recognizing glucose patterns.
Generic Event
Records any other event you and your healthcare team decide
is useful in evaluating glucose patterns. You may assign up to
eight Generic Events for observations of your choosing.
To add Events:
1. Select Add Event from the Main Menu.
2. Select the Event you wish to enter. Then, follow the instructions for that Event
(see below).
Meal Event
1. Use the Left Option Button to select which item to enter (Date, Time,
Carbohydrate Grams) 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 Meal Event.
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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.
2. Use the Up/Down Arrow Buttons to select each item.
3. When you are done, press the Right Option Button to Save the Exercise
Event.
NOTE: Your type of Exercise choices are Aerobics, Walking, Jogging, Running,
Swimming, Biking, Weights, or Other. Duration can be increased or decreased by
15-minute increments. Your Intensity choices are None, Low, Medium, or High. You
can record each Exercise Event in 15-minute segments, up to 2.5 hours.
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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. There are eight Generic Event numbers that you and/or your healthcare team
can assign to specific events (for example, #1 can to refer to “Dining Out”, #2
to “Shopping”, #3 to “Inactive Day”, #4 to “Party”, etc.). Decide what you want
your Generic Event numbers to represent (you don’t have to assign meanings
to all of the numbers at once), and write down your choices.
2. Use the Left Option Button to select which item to change (Date, Time,
Generic Event) and to move from one item to the next.
3. Use the Up/Down Arrow Buttons to change each item (including choosing the
number that corresponds to the Generic Event you are recording).
4. When you are done, press the Right Option Button to Save the Generic
Event.
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6. MAINTENANCE
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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. Contact your healthcare
team if you need to replace your Transmitter or Receiver.
Cleaning the Transmitter
You should clean the Transmitter each time you change the Sensor. Follow these
steps:
1. Wash the Transmitter with mild soap and water.
2. Rinse the Transmitter thoroughly under running water.
3. Shake any water out of the Transmitter Contact Points.
4. Dry the Transmitter thoroughly using a clean, soft, lint-free cloth. Make sure that
the Contact Points are dry.
Cleaning the Receiver
CAUTION: Do NOT immerse the Receiver in water or any other liquid. Avoid getting
water or any other liquid into the Test Strip Port.
To clean the Receiver, wipe the outside with a cloth dampened with either mild
soapy water or 70% isopropyl alcohol.
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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.
NOTE: One Transmitter battery comes with each Sensor Kit.
Changing the Receiver Batteries
The Receiver is designed to operate for approximately 90 days with 2 AAA batteries.
When the Receiver Batteries run low, the Receiver will sound an alarm and display
the “Replace Receiver Battery within 1 week” message 1 week before the Receiver
batteries need to be changed. A battery icon will also appear on the Receiver.
IMPORTANT: After the Receiver Battery Alarm sounds, wait to replace the
Receiver’s batteries until just before the next time you insert a new Sensor.
For instructions on installing the Receiver’s batteries, see page 28.
NOTE: Once you take the old batteries out, you have 10 minutes to install the new
batteries. If you do not install the new batteries within this 10-minute time frame, you
may have to reset the date and time (see page 30).
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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. Alarms, Error Codes, and Troubleshooting
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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
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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. This type of alarm can be muted (see
page 112), and will be turned off when you acknowledge
the alert.
Intermediate Urgency
A series of three short beeps. These beeps will repeat
every 6 seconds for 1 minute or until you activate the
display. If the alarm is not acknowledged and the
condition remains the same, it will sound again in 5
minutes. The Intermediate Urgency Alarm will not sound
again after 5 minutes if the alarm is acknowledged, or if
the situation is fixed (for example, moving the Transmitter
and Receiver closer if the alarm is connection-related). It
will stop completely after an hour. The Intermediate
Urgency Alarm can be muted (see page 112).
Medium Urgency
A series of three short beeps. These beeps will repeat
every 6 seconds for 1 minute or until you activate the
display. The alarm will repeat every 5 minutes until the
situation is fixed, except when it is acknowledged—then
it will repeat every 15 minutes until the situation is fixed.
The Medium Urgency Alarm can be muted (see page
112).
High Urgency
The High Urgency alarm is the same as the Medium
Urgency alarm except that it cannot be muted.
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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
A Blood Glucose Mode
Perform a Blood Glucose
test is needed for
Mode test (see page 63).
calibration. The Receiver
will prompt you to perform
this test approximately 1,
3, and 24 hours after a
new Sensor is inserted.
Calibration failed because Bring the Receiver to room
Cal Failed:
the Receiver was too
temperature, and then
Receiver
warm or too cold.
perform another Blood
Temp
Glucose Mode test. If
Redo BG
calibration fails 3 times,
Later
remove the Sensor and
insert a new one (see page
43).
Calibration result was very Perform another Blood
Cal Failed
different from the previous Glucose Mode test.
Redo BG
calibration. Another Blood
Test
Glucose Mode test is
needed.
Cool Down
Calibration failed because Cool the skin at the
Skin
your skin temperature is
insertion site. Perform
Redo BG
too high.
another Blood Glucose
Later
Mode test. If calibration
fails 3 times, remove the
Sensor and insert a new
one (see page 43).
* Urgency is defined as: L = Low, I = Intermediate, M = Medium, H = High
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Alarm
Message
Do BG Test
Alarms
Inactive
Urgency*
What It Means
What To Do
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
Cal Failed:
Low BG
Redo BG
Later
Cal Failed:
Redo BG in 1
HR
Cal Failed:
Redo BG
Later
Calibration was not
performed within the
required time; therefore,
readings will not be
displayed and the alarms
are not working.
Calibration failed because
the Blood Glucose Mode
test reading was too high.
The System needs a
blood glucose level
between 60 and 400
mg/dL (3.3 and 22.2
mmol/L) for proper
calibration.
Calibration failed because
the Blood Glucose Mode
test reading was too low.
The System needs a
blood glucose level
between 60 and 400
mg/dL (3.3 and 22.2
mmol/L) for proper
calibration.
The Blood Glucose Mode
test showed the Sensor
may not be working
properly.
Calibration failed.
Warm Up
Skin
Redo BG
Later
* Urgency is defined as:
Perform another Blood
Glucose Mode test. If your
glucose level is still high,
follow your healthcare
professional’s advice for a
high glucose
(hyperglycemic) episode.
Perform another Blood
Glucose Mode test. If your
glucose level is still low,
follow your healthcare
professional’s advice for a
low glucose
(hypoglycemic) episode.
Wait 1 hour and try again.
Perform another Blood
Glucose Mode test. If
calibration fails three times,
remove the Sensor and
insert a new one (see page
43).
Calibration failed because Warm the skin at the
your skin temperature is
insertion site. Perform
too low.
another Blood Glucose
Mode test. If calibration
fails 3 times, remove the
Sensor and insert a new
one (see page 43).
L = Low, I = Intermediate, M = Medium, H = High
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Alarm
Message
Cool Down
Skin
Urgency*
What It Means
What To Do
Warm Up
Skin
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. The
Receiver is either too far
from the Transmitter or
there are materials or
signals causing
interference.
The Receiver is not linked
to the Transmitter. The
link is necessary for the
System to operate in the
Continuous Monitoring
Mode.
Be sure the Receiver and
Transmitter are within 10
feet of one another. If the
alarm persists, select
System from the Main
Menu, then select
Reconnect (see page 89).
Connection
Alarms
Reconnect
Alarms
Inactive
Link
Reconnect
* Urgency is defined as:
Place the Receiver within
10 feet of the Transmitter.
Select System from the
Receiver’s Main Menu,
then select Link. If the
Transmitter ID that appears
on the display screen is
correct, select Yes (see
page 92).
Be sure the Receiver and
Transmitter are within 10
feet of one another. If the
Alarm persists, select
System from the Main
Menu, then select
Reconnect (see page 89).
The Receiver has not
been receiving signals
sent by the Transmitter for
5 minutes. Two minutes of
data have been lost. The
Receiver is either too far
from the Transmitter or
there are materials or
signals causing
interference.
L = Low, I = Intermediate, M = Medium, H = High
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Alarm
Message
Glucose
Level Alarms
———
Urgency*
What It Means
N/A
•
Low Glucose
High Glucose
* 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.
Sensor is expired.
•
If you see this alarm
message more than 3
hours after a new
Sensor is inserted and
the Receiver does not
request a blood glucose
measurement, the
Sensor is not
functioning correctly.
Remove the Sensor
and insert a new one
(see page 43).
•
If you see this alarm
message after you have
•
been getting continuous
glucose results, check
the
•
Transmitter/Receiver
connection.
•
Check the insertion site
to make sure the
adhesive is holding the
Sensor in your skin. If
the Sensor is no longer
in your skin, insert a
new Sensor.
Your glucose has reached Follow the
your preset low glucose
recommendation of your
threshold.
healthcare team for
treating a low glucose
(hypoglycemic) episode.
Your glucose has reached Follow the
your preset high glucose
recommendations of your
threshold.
healthcare team for
treating a high glucose
(hyperglycemic) episode.
L = Low, I = Intermediate, M = Medium, H = High
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Alarm
Message
Projected
High Glucose
Urgency*
What It Means
What To Do
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.
When set to Medium
sensitivity, you probably
have about 20 minutes
before reaching your high
glucose threshold.
* Urgency is defined as:
When set to Low
sensitivity, you probably
have about 10 minutes
before reaching your high
glucose threshold.
L = Low, I = Intermediate, M = Medium, H = High
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ART05005 REV 4
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Alarm
Message
Projected
Low Glucose
Urgency*
What It Means
What To Do
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.
When set to Medium
sensitivity, you probably
have about 20 minutes
before reaching your Low
Glucose Threshold.
When set to Low
sensitivity, you probably
have about 10 minutes
before reaching your Low
Glucose Threshold.
Receiverrelated
Alarms
Alarms
Inactive
Replace
Receiver
Receiver
Error
Alarms
Inactive
Log Cleared
Receiver malfunction.
Problem has persisted for
1 hr.
Call the Clinical Trial
Support.
Receiver error.
Wait 50 minutes for the
problem to go away. If
problem persists, call
Clinical Trial Support.
Acknowledge the alarm.
* Urgency is defined as:
History log has been
successfully cleared.
L = Low, I = Intermediate, M = Medium, H = High
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Alarm
Message
Log
Corrupted
Some Data
Lost
Urgency*
What It Means
What To Do
History log is corrupt.
Preferences
Lost
Reconfigure
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.
The batteries in your
Replace the Receiver
Receiver will lose power in batteries (see page
approximately 1 week.
28)before you insert a new
Sensor. Then reset the
time and date (see page
30). Replacing the
batteries before a Sensor
has expired will require you
to insert a new Sensor.
The Transmitter battery
Replace the Transmitter
monitor indicates there are battery prior to inserting the
only 4 days of battery
next Sensor. Be sure to
power left.
reconnect the Transmitter
and Receiver.
Transmitter battery power Remove Sensor, replace
loss is imminent.
Transmitter battery,
reconnect Transmitter and
Receiver, and insert a new
Sensor.
Replace
Receiver
Battery Within
1 Week
Replace TX
Battery With
Next Sensor
TX Battery
Exhausted
Replace
Battery
Sensorrelated
Alarms
Alarms
Inactive
Insert New
Sensor
* Urgency is defined as:
Alarms are not operating
because the 3-day life of
the Sensor has ended.
Remove the Sensor and
insert a new one (see page
43).
L = Low, I = Intermediate, M = Medium, H = High
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Alarm
Message
Alarms
Inactive
Replace
Sensor
Urgency*
What It Means
What To Do
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
Remove Any
Sensor
Alarms
Inactive
Did You
Remove the
Sensor?
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. Condition has
been persistent for up to
60 minutes. The alarms
are not working.
Alarms are not operating.
Remove the Sensor and
The Receiver thought the
insert a new one (see page
Sensor was inserted when 43). Ignore the message if
the Receiver was reset.
there is no Sensor
inserted.
If you just removed the
• The System has
Sensor, select Yes.
detected that the
Sensor was just
If you did not just remove
removed.
the Sensor, select No.
• If this message
If the alarm persists, the Sensor may
appears and you did
not remove the Sensor, have failed. Remove the
Sensor and insert a new
there may be a faulty
one (see page 43).
connection between
the Sensor and the
Transmitter.
New Sensor
Detected.
Did you
recently Insert
new Sensor?
* Urgency is defined as:
•
The System has
detected a new
Sensor.
•
If you just inserted a new
Sensor, select Yes.
If you did not insert a new
Sensor, select No. If the
alarm persists, the Sensor
may have failed. Remove
the Sensor and insert a
new one (see page 43).
If this message
appears and you did
not insert a new
Sensor, there may be
a faulty connection
between the Sensor
and the Transmitter.
L = Low, I = Intermediate, M = Medium, H = High
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Alarm
Message
Replace
Sensor Soon
Transmitterrelated
Alarms
Transmitter
Error Alarms
Inactive
Urgency*
What It Means
What To Do
The Sensor will reach the
end of its life within 2
hours.
Replace the Sensor within
the next 2 hours (see page
43).
Transmitter problem.
Alarms are not working.
Alarms
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.”
Transmitter problem for an Replace the Transmitter,
hour. Alarms are not
and insert a new Sensor.
working.
L = Low, I = Intermediate, M = Medium, H = High
Clinical Trial Support Line: 1-888-971-4766
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Error Codes
Clinical Trial Support Line: 1-888-971-4766
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Clinical Trial Support Line: 1-888-971-4766
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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]).
•
High Control
Solution applied
when temperature is
too cold. (This
applies only to
Control Solution
labeled High.)
Clinical Trial Support Line: 1-888-971-4766
ART05005-REV-4
What To Do
• If you have symptoms such as
weakness, sweating,
nervousness, headache, or
confusion, follow your healthcare
team’s advice for treating a low
glucose level (hypoglycemic)
episode.
•
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.
If you have symptoms such as
thirst, fatigue, excess urination, or
blurry vision, follow your
healthcare team’s advice for
treating a high glucose level
(hyperglycemic) episode.
•
•
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.
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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.
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.
•
Problem with the Test
Strip.
•
Problem with the
Receiver.
•
•
Problem with Test
Strip.
•
•
Problem with
Receiver.
•
Er5
Er6
N/A
Button on Receiver was
pressed while you were
applying blood or Control
Solution.
If Control Solution Test does not
work or error code persists, call
Clinical Trial Support.
This error code not currently in use.
Retest using a new Test Strip. Do NOT
touch the Right Option Button while
applying blood or Control Solution to the
Test Strip. If error code persists, call
Clinical Trial Support.
Clinical Trial Support Line: 1-888-971-4766
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Troubleshooting
Clinical Trial Support Line: 1-888-971-4766
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Clinical Trial Support Line: 1-888-971-4766
ART05005 REV 4
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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).
• Make sure batteries
are oriented correctly
(see page 142).
•
If batteries were
installed incorrectly or
removed, reset the
time and date (see
page 30).
•
Whenever the
batteries are taken
out and put back in,
you will also need to
insert a new Sensor
and reconnect the
Transmitter (see page
89).
Always insert the Test
Strip end with the
dark rectangle (see
page 67).
•
•
•
•
•
Defective Receiver or
Test Strips.
Defective Receiver.
•
•
Make sure “FreeStyle”
is facing up.
Repeat test with a
new Test Strip.
Call Clinical Trial
Support.
Blood or foreign
object in Test Strip
Port.
Clinical Trial Support Line: 1-888-971-4766
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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. Apply
sample when Apply
Sample appears on
the display.
• Call Clinical Trial
Support.
• Change batteries,
then reset time and
date (see page 30).
•
Make sure batteries
are oriented correctly
(see page 142). If
batteries were
installed incorrectly or
removed, reset the
time and date (see
page 30).
•
Whenever the
batteries are taken
out and put back in,
you will also need to
insert a new Sensor
and reconnect the
Transmitter (see
pages 89).
If the unusual or
unexpected screen
appearance
continues, call Clinical
Trial Support.
At next insertion rub
the Sensor insertion
site with ice before
inserting Sensor.
•
Damaged or defective •
screen.
•
Sensitivity to pain.
•
•
Clinical Trial Support Line: 1-888-971-4766
ART05005 REV 4
Call Clinical Trial
Support if problem
persists.
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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.
Place an overbandage over the
Transmitter after
connecting the
Transmitter to the
Sensor Support
Mount.
If irritation is around
the edges of the
adhesive or tape, lift
the edges slightly all
around the dressing.
•
Your skin or activity
level may require
more adhesive than
that provided on the
Sensor Support
Mount.
•
•
Sensitivity to the
Sensor adhesive.
•
•
Friction from the
Sensor.
Clinical Trial Support Line: 1-888-971-4766
ART05005-REV-4
•
If irritation is wherever
the adhesive touches
skin, you may be
sensitive to the tape’s
adhesive or material.
•
Avoid wearing seams
or waistbands over
the site.
•
Consult your
healthcare team to
identify the best
solution.
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Clinical Trial Support Line: 1-888-971-4766
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APPENDICES
Clinical Trial Support Line: 1-888-971-4766
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Clinical Trial Support Line: 1-888-971-4766
ART05005 REV 4
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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. The differences between readings from the finger and palm at
the base of the thumb sites for all glucose levels and for low glucose levels are
summarized below.
Table A.1. Clinical Trial Glucose Readings
Range
Number of
Test Pairs
Average
Difference
Standard
Deviation
-2.1%
12.7%
All Tests
43-477 mg/dL
(2.4-26.5 mmol/L)
1309
Low Glucose
43-69 mg/dL
(2.4-3.8 mmol/L)
72
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1.9 mg/dL
(0.3 mmol/L)
9.0 mg/dL
(0.5 mmol/L)
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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.
In Vivo Performance
The in vivo performance of the system was evaluated in a multi-center clinical trial
that involved 85 subjects who used the system at home for an average of 17.8 days.
Each subject used an average of 12 Sensors. Subjects took an average of 8 blood
glucose measurements each day using the built-in FreeStyle blood glucose meter.
System performance was assessed by comparing the Blood Glucose Mode readings
with the Continuous Monitoring Mode readings. The data from the study were used
to calculate the mean difference, mean absolute difference (MAD), and absolute
relative error (ARE) between the Continuous Monitoring Mode and Blood Glucose
Mode test results.
Estimated Mean Difference
The mean difference and mean percent difference were estimated using a mixed
model repeated measures ANOVA (ANalysis Of VAriance). The mean difference
between the glucose Sensor and the reference Receiver was 7.2 mg/dL (0.4
mmol/L)(std err = 0.78) at glucose concentrations <100 mg/dL (5.6 mmol/L) and the
mean percent difference was −1.72% (std err = 0.36%) at glucose concentrations =
100 mg/dL (5.6 mmol/L).
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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 25.8 mmol/L):
y = 0.943x + 6.8
Slope = 0.943
Intercept = 6.8
r = 0.893
Accuracy
Accuracy of the System was evaluated in a clinical study (N = 28) by comparing
System readings to the glucose concentration of venous samples collected every 15
minutes for 72 hours and measured using a Yellow Springs Instruments (YSI)
Glucose Analyzer. This testing yielded the following results over a glucose range of
20 to 500 mg/dL (1.1 to 27.8 mmol/L):
y = 1.00x + 5.7
Slope = 1.00
Intercept = 5.7
r = 0.914
Clinical Trial Support Line: 1-888-971-4766
ART05005-REV-4
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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
7865
70.7
70.7
3056
27.5
98.2
36
0.3
98.5
165
1.5
100.0
0.0
100.0
Interfererents
In vitro and in vivo testing suggests that usual pharmacologic levels of ascorbic acid
have no effect on the function of the System but salicylic acid has minimal effect. In
vitro testing suggests that normal physiologic levels of uric acid, lipids, and bilirubin
do not affect System function. The impact of oral hypoglycemic agents and other
potential interfering substances has not been studied.
Limitations
Inaccuracy in glucose values obtained using the BG mode during calibration of the
System will affect the accuracy of the System.
Clinical Trial Support Line: 1-888-971-4766
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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 27.8 mmol/L)
Glucose assay method
Wired enzyme
Power source
Transmitter: One silver oxide 357 battery (small coin cell
battery), replaceable (battery life is ~ 30 days)
Receiver: Two AAA alkaline batteries, replaceable
(battery life is ~ 3 months)
Transmitter size
Height 2.05 in. (5.2 cm)
Width 1.23 in. (3.1 cm)
Transmitter weight
.48 oz
Transmitter battery life
Up to 30 days
Receiver size
Height 2.50 in. (6.3 cm)
Width 3.25 in. (8.1 cm)
Depth 0.88 in. (2.2 cm)
Receiver weight
3.5 oz. (including batteries; 99.2 grams)
Receiver battery life
Up to 3 months
Automatic shutoff
Built-in blood glucose meter: 2 minutes after last user
action
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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. Data
CANNOT begin to be calculated until this first
calibration is done.
•
Second Calibration: This must be done between 2
and 4 hours after the first calibration or glucose will
no longer be calculated. The second calibration can
still be performed after 4 hours, and glucose
calculation will then resume.
•
Third Calibration: This must be done between 21 and
29 hours after the second calibration or glucose will
no longer be calculated. The third calibration can still
be performed after 29 hours, and glucose calculation
will then resume.
Blood glucose test time
Average of 7 seconds
Blood glucose assay method
Coulometric electrochemical sensor
Blood sample type
Whole blood, capillary
Hematocrit
15% to 65%.
Classification
The Transmitter and Receiver are classified as follows:
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•
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. Operation is subject to the
following two conditions:
•
This device may not cause harmful interference.
•
This device must accept any interference received, including interference that
may cause undesired operation.
NOTE: This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
•
Reorient or locate the receiving antenna.
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•
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. Operation is subject to the
following two conditions:
•
This device may not cause harmful interference.
•
This device must accept any interference received, including interference that
may cause undesired operation.
NOTE: This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
•
Reorient or locate the receiving antenna.
•
Increase the separation between the equipment and Receiver.
•
Consult the dealer or an experienced radio/TV technician for help.
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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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Clinical Trial Support Line: 1-888-971-4766
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GLOSSARY
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Clinical Trial Support Line: 1-888-971-4766
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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. The higher the sensitivity, the sooner
the alarm will sound.
Alarm Type—Refers to the sound or vibration of the alarm. Alarm types include low,
medium, or high beeps and short, medium, or long vibrations.
Antiseptics—Products that can be used at the Sensor insertion site if you tend to
develop infections.
Backlighting—A light inside the Receiver that lets you see the display screen in the
dark (at night, for example).
Blood Glucose Mode—One of two modes in which the System functions (the other is
Continuous Monitoring Mode). In the Blood Glucose Mode, you can perform
traditional blood glucose testing manually using a FreeStyle Test Strip and a drop of
blood. Although you can use the Blood Glucose Mode whenever you wish, its main
use is for calibrating the System.
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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.
Calibration BG—Allows you to add a new blood glucose measurement to the
average used for Sensor calibration. Use this feature only under the direction of a
Clinical Trial Support representative.
Capillary Blood—Blood from the tiny blood vessels in your body (such as in the tip of
your finger or alternate sites) used to measure glucose levels in the Blood Glucose
Mode. Capillary blood is also used for measuring glucose levels with traditional
glucose meters.
CM Status—Lets you view recent error codes related to the Continuous Monitoring
Mode. These codes appear only when the System is not functioning properly. Use
this option only under the direction of a Clinical Trial Support representative.
Continuous Monitoring Mode—One of two modes in which the System functions (the
other is Blood Glucose Mode). This is the mode you will use 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.
Control Solution Test—A test done with FreeStyle Control Solution in the Blood
Glucose Mode using the built-in FreeStyle Blood Glucose Meter to ensure that the
System is working properly.
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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.
Events—Activities and observations that can affect your glucose levels that you
record in your System. Reviewing Events may help you see patterns in your glucose
levels and how you manage your diabetes. Once entered into the System, Events
may be viewed in several ways, including Event History Reports or Line Graph
Reports.
Event History Reports—A type of report that incorporates the Event information you
enter (for example, histories of recent glucose results, insulin doses, carbohydrate
content of meals, exercise, state of health, etc.).
Exercise Event—A record of many popular forms of exercise. You may also specify
the intensity and duration of each Exercise Event.
FreeStyle Control Solution—A solution containing a known amount of glucose. Used
to perform Control Solution tests to make sure the System is working properly.
FreeStyle NavigatorTM Continuous Glucose Monitoring System—Also referred to as
the “System”, this device is designed to give people with diabetes a continual
reading of their glucose levels in real time.
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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. Glucose Targets are separate
from—and independent of—the levels you may be using for High and Low Glucose
Alarms.
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 are at 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. You and your healthcare team choose the level that is right for you, and you
set in the System. The high glucose threshold is used by the High Glucose Alarm
and the Projected High Glucose Alarm.
Icons—Simple graphic symbols that appear on the Receiver display screen to alert
you to non-urgent System conditions or actions required.
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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.
In vitro—The measuring of something out of the body, for example, in a test tube.
Lancet—A tiny, sharp-pointed, disposable component used with the lancing device
to obtain a drop of blood for a Blood Glucose Mode test.
Lancing Device—A handheld piece of equipment that is used with a lancet to obtain
a drop of blood for a Blood Glucose Mode test.
Lancing Device Cocking Handle—A part of the lancing device that you pull to
position the lancet for pricking the test site.
Lancing Device Depth Setting—A part of the lancing device that lets you to adjust
how deep the lancet pricks your skin.
Lancing Device Depth Indicator Window—A window on the lancing device that
shows you the depth setting you have chosen.
Lancing Device Lancet Cup Holder—A part of the lancing device that holds the
lancet in place when pricking your skin.
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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).
Low Glucose Threshold—The level that you do not want your glucose level to fall
below. You and your healthcare team choose the level that is right for you, and you
set it in the System. The low glucose threshold is used by the Low Glucose Alarm
and the Projected Low Glucose Alarm.
Main Menu—Displays a list of options that allow you to perform many functions and
view specific information.
Meal Event—A record of a meal and snack that you enter in the System to help you
see patterns in your glucose levels. The time and date are always recorded. You
may also record carbohydrate grams to help you count carbohydrates or determine
insulin/carbohydrate ratios.
Multi-day Statistics—A type of Statistical Report that shows a summary of glucose
results in relation to your Glucose Targets over a specified number of days. You can
choose 3-, 7-, 14-, 21-, or 28-day time periods.
Projected High Alarm—Provides an early warning when you are approaching
your high glucose threshold.
Projected Low Alarm— Provides an early warning when you are approaching
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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.
The Receiver also has a built-in FreeStyle Blood Glucose Meter that works as a
traditional blood glucose meter when a FreeStyle Test Strip is inserted into the Test
Strip Port. You can wear the Receiver on your belt or carry it in your pocket or purse.
Receiver Display Screen—The rectangular window on the center of the Receiver
that displays glucose levels and other important information.
Receiver Status—Provides you with information regarding the Receiver, including
serial number, software version, and battery life remaining.
Receiver Test Strip Port—The slot on the lower left edge of the Receiver where you
insert the FreeStyle Test Strips to calibrate the System or perform Blood Glucose
Mode tests.
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 3 days.
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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. The
Sensor Delivery Unit has 2 parts assembled and packaged together: the Sensor
Inserter with pre-installed Sensor (which puts the tip of the Sensor under your skin)
and the Sensor Support Mount (which stays on your skin to hold the Sensor in place
and also attaches the Sensor to the Transmitter).
Sensor Inserter—The Sensor Inserter is a cylindrical-shaped, plastic-cased device.
A pre-cocked, coiled spring is connected to a stainless steel 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. Do not remove
the Locking Pin until the Sensor Support Mount is adhered to the skin.
Sensor Insertion Button—With a single push of the Insertion Button, the needle
guides the Sensor into the skin and is quickly withdrawn from the skin.
Sensor Insertion Site—The place on your body where you insert a Sensor, either on
the abdomen or the back of the upper arm. Always change the Sensor insertion site
each time a new Sensor is used. The Sensor should be inserted at least 1 inch from
the previous site.
Sensor Locking Pin—A pin on the Sensor Delivery Unit that was designed to prevent
accidental release of the Sensor. This must be removed before the Sensor can be
inserted.
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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. The Adhesive Protective Liner surrounding the
Sensor Support Mount is designed to hold the Support Mount and Transmitter onto
the body for up to 3 days of normal use.
Sharps Container—A safe place for disposal of Sensor Inserters and lancets.
Single-day Statistics—A type of Statistical Report that shows a summary of glucose
results in relation to your Glucose Targets over a one-day period.
Site Rotation—The practice of using a different location on the body each time you
insert a new Sensor. The new Sensor should be inserted at least 1 inch from the
previous site.
Skin Barriers—Products that can help prevent irritation or sensitivity problems at the
Sensor insertion site.
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
time periods. Viewing this kind of information can help you see patterns in your
glucose levels.
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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—A small electronic device that makes an electrical connection to the
portion of the Sensor that extends 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.
Transmitter Contact Points—Conductive points that connect the Transmitter to the
Sensor Support Mount.
Transmitter/Receiver Connection—The wireless connection needed for the System
to function. The Transmitter and the Receiver must be within 10 feet of each other
for the connection to be valid.
Transmitter Sensor Support Mount Latch—A connector that helps secure the
Transmitter to the Sensor Support Mount.
Transmitter Status—Allows you to view the Transmitter serial ID number and battery
life remaining.
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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.
adhesive enhancers: 17, 45, 50, 169, 185,
187
Alarms: 2, 7, 13, 18, 20, 29, 63, 64, 82, 8788, 92, 101-113, 151, 152, 154, 155,
159-160
Alarms Menu: 102, 103, 104, 107, 108,
109, 110, 111, 112, 185
Alarm sensitivity: 104-107, 156-157, 185
Alarm type: 103, 105, 107, 108, 109, 110,
111, 185
antiseptics: 50, 185
backlighting: 29-30, 185
Blood Glucose Mode: 4, 5, 7, 17, 18-19,
20, 32, 61, 63, 65, 66, 83, 93, 109, 111,
120, 147, 152, 153, 155, 163, 174, 175,
185, 186, 188, 189, 191
Calibration: 4, 18, 32, 33, 43, 49, 57, 61,
63-75, 83, 109, 110, 128, 132, 152-154,
155, 176, 178, 186, 192
Calibration BG: 128, 132, 186
cleaning: 61, 141
Continuous Monitoring Mode: 5, 7, 17, 1819, 20, 63, 66, 80, 91, 128, 132, 152,
154, 174, 175, 185, 186
Continuous Monitoring (CM) Status: 132
Control Solution Test: 4, 27, 32-38
Data Loss Alarms: 101, 108-109, 128, 187
Data Upload: 124, 187
display screen: 29-30, 79, 80, 81, 185, 188,
191
disposal of components: 143
dressings and skins: 47, 49, 50, 57, 169,
187
error codes: 128, 132, 163-164, 186
Events: 82, 117, 122-124, 135-138, 187,
188, 189, 190, 193
Event History: 117, 122-124, 135, 187
Exercise Event: 123, 136, 137, 187
FreeStyle Control Solution: 4, 17, 19, 27,
32, 33, 34, 36, 37, 38, 75, 83, 141, 163,
164, 186
FreeStyle Test Strips: 4, 17, 19, 73, 188,
191
Generic Event: 124, 136, 138, 188
glucose (initial) display screen: 79, 83
glucose levels: 2, 4, 5, 6,7, 13, 14, 18-19,
20, 29, 34, 41, 43, 63, 64, 65, 66, 73,
74, 75, 79, 103, 117, 118, 119, 121,
135, 173, 174, 186, 187, 188, 189, 190,
191, 193
Glucose Targets: 103, 117, 119, 121, 188,
190, 193
Glucose Trend Arrows: 79, 80, 188
High Glucose Alarm: 7, 103, 104, 105, 121,
155, 185, 188
High Glucose Threshold: 101, 103, 104,
105, 155, 156, 188, 190
icons: 83, 188
Insulin Event: 123, 136, 137, 189
interstitial fluid: 2, 7, 13, 18, 19, 63, 186,
189
lancet: 17, 65, 70, 72, 143, 189, 193
lancing a test site: 5-6, 69-72, 189
lancing device: 17, 65, 69, 70, 71, 72, 189
Line Graphs: 17, 118, 119
linking Transmitter and Receiver: 90-92,
131, 154, 155
Low Glucose Alarm: 7, 103, 106, 117, 121,
188, 190
Low Glucose Threshold: 101, 106, 155,
157, 190, 191
Main Menu: 10, 30, 81, 82, 83, 90, 92, 93,
97, 102, 108, 117, 119, 120, 122, 124,
127, 128, 129, 130, 131, 136, 154, 185,
190, 194
Meal Event: 123, 136, 190
Multi-day Statistics: 190
muting Alarms: 112
performance characteristics: 174
Progress Tones: 36, 73, 101, 111-112, 191
Projected High Glucose Alarm: 101, 104108, 124, 156, 188, 190
Projected Low Glucose Alarm: 104-108,
121, 157, 190
Receiver: 3, 4, 14, 17, 19, 20, 21, 27-38,
43, 45, 55, 57, 61-75, 79-83, 87-94, 101,
102, 104, 108, 109, 111, 112, 117, 119,
130, 131, 141, 142, 143, 151, 152, 155,
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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
reconnecting (Transmitter and Receiver):
88, 89, 127, 154, 158, 167, 168
relinking (Transmitter and Receiver): 21,
91, 92, 93
reports: 13, 32, 49, 82, 97, 117-124, 135,
158, 187, 188, 190, 191, 193
Sensor: 3, 4, 13, 14, 17, 18, 19, 20, 21, 27,
29, 38, 39-52, 57, 61, 62, 63, 64, 65, 67,
79, 80, 83, 90, 101, 108, 110, 128, 132,
141, 142, 143, 152, 153, 155, 158-160,
167, 168, 169, 174, 177, 178, 185, 186,
187, 191, 192, 193, 194, 195
Sensor code number: 45, 62, 192
Sensor Delivery Unit: 3, 17, 41, 43, 45, 62,
192, 193
Sensor Inserter: 3, 41, 42, 47, 48, 49, 143,
192, 193
Sensor Insertion button: 42, 192
Sensor Insertion site: 4, 44, 45, 46, 48, 49,
50, 152-154, 155, 159, 168, 169, 185,
192, 193
Sensor Locking Pin: 3, 42, 47, 48, 192
Sensor Release Tabs: 42, 48, 193
Sensor removal: 4, 20, 49, 51-52, 128, 152,
153, 155, 158, 159
Sensor Support Mount: 4, 20, 41, 42, 45,
46, 47, 48, 50, 51, 52, 57, 169, 185,
187, 192, 193, 194, 195
sharps container: 49, 65, 72, 143, 193
Single-day Statistics: 193
site rotation: 49, 193
site maintenance: 50
site preparation: 45, 50, 169
skin barriers: 50, 193
State of Health Event: 128, 136, 138, 187,
193
statistics: 32, 117, 119-121, 190, 193
Status Information: 127-128, 194
Status Menu: 128, 129, 130, 131
System Alarms: 109-110, 194
System Status: 128, 129
Target Glucose: see Glucose Targets
testing sites (Blood Glucose Mode): 66
Test Strip Port: 19, 27, 66, 67, 73, 141,
167, 191
Transmitter: 3, 4, 13, 14, 17, 19, 20, 21,
29, 41, 42, 43, 44, 48, 50, 51, 52, 55-57,
61, 66, 79, 83, 87, 88, 89, 90, 91, 92,
93, 94, 101, 108, 109, 128, 129, 131,
141, 142, 143, 151, 154, 155, 158, 159,
160, 167, 168, 169, 177, 179, 180, 187,
192, 193, 194, 195
Transmitter battery: 20, 56-57, 142, 158,
177
Transmitter Contact Points: 141, 194
Transmitter/Receiver connection: 4, 14, 20,
29, 66, 83, 88-94, 101, 108, 129, 155,
187, 194
Transmitter Sensor Support Mount latch:
52, 194
Transmitter Status: 131, 194
Transmitter Tabs: 55, 57, 195
troubleshooting: 167-169
unlinking (Transmitter and Receiver): 20,
29, 90, 91, 92-93
uploading data: 124, 127, 135, 187 (see
also Data Upload)
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Modify Date                     : 2004:11:17 10:07:00-08:00
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Creator Tool                    : PScript5.dll Version 5.2
Document ID                     : uuid:56ffd155-c475-443d-90c4-36fdb9f8f333
Format                          : application/pdf
Creator                         : MosierDA
Title                           : Microsoft Word - ART05005-REV-4.doc
Author                          : MosierDA

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