Professional Documents
Culture Documents
Version 2.0
©2008 Abbott
ART13564 Rev. A 01/08
CoPilot for FreeStyle Navigator
User’s Guide
Contents
Contents................................................................................................................................... 1
Preface...................................................................................................................................... 3
Intended Use and Application .............................................................................................................. 3
Purpose and Scope ................................................................................................................................... 3
Installation Software................................................................................................................................. 4
Versions ......................................................................................................................................................... 4
Related Documentation.......................................................................................................................... 4
Technical Support and Customer Care.............................................................................................. 4
1 Introduction 5
1.1 CoPilot System for FreeStyle Navigator and Bluetooth Technology .............................. 5
1.2 Product Names ................................................................................................................................... 5
1.3 Warning and Caution Messages ................................................................................................... 6
2 CoPilot System for FreeStyle Navigator Installation 7
2.1 Pre-Installation Requirements ...................................................................................................... 7
2.1.1 Computer Requirements .................................................................................................... 7
2.1.2 Bluetooth Adapter Requirements ................................................................................... 7
2.1.3 FreeStyle Navigator System............................................................................................... 7
2.2 Installation Procedure...................................................................................................................... 8
2.2.1 Bluetooth Adapter Installation ......................................................................................... 8
2.2.2 CoPilot Health Management System Installation...................................................... 9
2.2.3 CoPilot System for FreeStyle Navigator Installation ................................................. 9
2.2.4 Verify Installation................................................................................................................... 9
2.2.5 To Uninstall the CoPilot System for FreeStyle Navigator..................................... 10
2.3 To Uninstall a Bluetooth Adapter ............................................................................................... 10
3 Uploading Data into the CoPilot System 11
3.1 Important Considerations ........................................................................................................... 11
3.2 Read Device Button - Default Device ...................................................................................... 12
3.3 Data Upload Procedure................................................................................................................ 13
3.4 Additional Messages During Data Upload ............................................................................ 15
3.4.1 New Device/Data Source Message .............................................................................. 15
3.4.2 Select FreeStyle Navigator Message............................................................................ 16
3.4.3 Assigned to Another User Message............................................................................. 17
3.4.4 Device Timeout Messages............................................................................................... 17
4 Reports for Continuous Monitoring 18
4.1 Size Warning Message .................................................................................................................. 18
4.2 Glucose Data Type Symbols ....................................................................................................... 19
4.3 Scope of this Section and Additional Information ............................................................. 19
1
Contents
4.4 Diary List............................................................................................................................................. 19
4.5 Glucose Modal Day Report.......................................................................................................... 21
4.5.1 Zoom In or Out .................................................................................................................... 21
4.5.2 Viewing Trends in Glucose Levels ................................................................................ 22
4.6 Glucose Line Report....................................................................................................................... 23
4.7 Statistics Report............................................................................................................................... 24
4.8 Daily Combination Report........................................................................................................... 25
Appendix A: Troubleshooting ................................................................................... 26
Installation and Uninstallation Problems....................................................................................... 26
Communication Problems .................................................................................................................. 26
Data-Related Problems......................................................................................................................... 28
Appendix B: Warning and Caution Messages ......................................................... 29
WARNING Messages .............................................................................................................................. 29
CAUTION Messages................................................................................................................................ 29
Index....................................................................................................................................... 30
2
Preface
Preface
This guide is provided for home users and healthcare providers who wish to use the CoPilot Health
Management System for FreeStyle Navigator Continuous Glucose Monitoring System. This
software allows you to transfer data collected and stored in your Freestyle Navigator Receiver
(“FreeStyle Navigator”) to the CoPilot Health Management System ("CoPilot system"). The
CoPilot™ Health Management System is a versatile tool that allows people with diabetes, their
caregivers, and healthcare professionals to take a more informed role in managing diabetes by
acting as a data management tool. The CoPilot system tracks diabetes-related health information,
and provides graphs, charts and reports that can help both patients and healthcare professionals
evaluate needs and options for a diabetes health management program.
Users should be aware that the CoPilot system is merely an information management tool - it does
not provide diagnostic information, nor does it give advice on the management of diabetes, and it
is therefore not intended to substitute for the support of a healthcare professional. Home users
should always consult their healthcare professional if they have any queries or concerns about
diabetes management.
The CoPilot Health Management System for FreeStyle Navigator Continuous Glucose Monitoring
System (CoPilot system for FreeStyle Navigator) allows data to be uploaded from the FreeStyle
Navigator System to the CoPilot System, where it can be saved, analyzed, displayed as reports,
charts and graphs, printed and shared.
3
Preface
Installation Software
CoPilot system for FreeStyle Navigator installation software is available as a download from
www.abbottdiabetescare.com. The installation software includes the following:
Versions
This guide provides instructions for CoPilot system for FreeStyle Navigator, version 2.0. This version
is recommended for use with the CoPilot Health Management System, version 4.0.
Related Documentation
Before you install the CoPilot system for FreeStyle Navigator it is recommended that you become
thoroughly familiar with the CoPilot system, as well as with your FreeStyle Navigator Continuous
Glucose Monitoring System. For information about these products, see the following
documentation:
4
Section 1 Introduction
1 Introduction
1.1 CoPilot System for FreeStyle Navigator and Bluetooth Technology
CoPilot system for FreeStyle Navigator is software that allows you to wirelessly transfer continuous
glucose monitoring data and other events from your FreeStyle Navigator Receiver to the CoPilot
Health Management System.
To enable wireless communication, CoPilot system for FreeStyle Navigator uses a technology called
Bluetooth. The FreeStyle Navigator Receiver has a built-in Bluetooth adapter. To support wireless
data transfer to your computer, you need to install a Bluetooth adapter -- a small device that plugs
in to a USB port. See Section 2, CoPilot System for FreeStyle Navigator Installation, for information
about installing and using a Bluetooth adapter.
Figure 1. Wireless Connection Between FreeStyle Navigator and the CoPilot System
5
Section 1 Introduction
1.3 Warning and Caution Messages
Warning and Caution messages included in this guide advise you to pay careful attention to
specific instructions or guidelines for using the CoPilot system for FreeStyle Navigator. The
following paragraphs explain the meaning and display the format of each type of message:
WARNING
• Indicates possible hazards that, if not avoided, could result in serious injury or death.
CAUTION: Indicates possible hazards that can cause harm to yourself, or to your patients.
6
Section 2 CoPilot System for FreeStyle
Navigator Installation
Before you install the CoPilot system for FreeStyle Navigator, verify the following:
7
Section 2 CoPilot System for FreeStyle
Navigator Installation
2.2 Installation Procedure
Install components in the following order:
8
Section 2 CoPilot System for FreeStyle
Navigator Installation
2.2.2 CoPilot Health Management System Installation
To install and prepare the CoPilot system to upload data from FreeStyle Navigator:
1. Read the CoPilot Health Management System User’s Guide for system requirements and
installation instructions.
• If you have downloaded the installation software, double-click the CoPilot system for
FreeStyle Navigator installer file (CPNavigator_Web.exe).
3. A message appears if you try to install the CoPilot system for FreeStyle Navigator before you
install the CoPilot system.
4. Welcome Page - Read the welcome page and click Next to continue or Cancel to quit.
5. License Agreement - The End User License Agreement is displayed. Read it and select I Agree,
then click Next to continue or click Cancel to stop the installation.
6. Confirmation - Click I Confirm to continue. Click I Do Not Confirm to return to the license
agreement.
7. Start Installation - The installer is ready to begin. Click Next to proceed, click Back to make
changes in previous screens, or click Cancel to stop the installation.
8. Installation Progress - A screen shows installation progress.
9. Success Message - Installation is complete. Click Finish.
9
Section 2 CoPilot System for FreeStyle
Navigator Installation
2.2.5 To Uninstall the CoPilot System for FreeStyle Navigator
When the CoPilot system for FreeStyle Navigator is installed, it is an integrated part of the CoPilot
system. To uninstall the CoPilot system for FreeStyle Navigator only, follow these steps:
10
Section 3 Uploading Data into the
CoPilot System
3 Uploading Data into the
CoPilot System
This section provides instructions to upload data from your FreeStyle Navigator Receiver to the
CoPilot system. Be sure to read all instructions before you connect your receiver and upload data.
Carefully review the following guidelines and considerations to help ensure trouble-free
connections and data upload.
• Time and Date Settings - Verify that your receiver and computer have the correct (same)
time and date setting. You must have the correct time and date setting when you perform
any testing, record continuous data, and upload data. If the time and date setting is
incorrect in either your receiver or computer, data may not upload, or data may upload with
the incorrect date and time.
• Distance - The maximum distance that you can keep between your receiver and computer
depends on your Bluetooth adapter. Bluetooth adapters are designed for short range
communication only. For best results, place your receiver within ten feet of your computer
during data upload.
• Battery - You may not be able to complete data upload if your receiver battery is less than
20% full. See the FreeStyle Navigator User’s Guide for more information about battery life
and replacement.
• Time to Upload - Depending on the quantity of data stored in your receiver, it can take up
to 12 minutes to upload your data.
• Device Association - The CoPilot system uniquely identifies any supported device when
the device is connected, using a built-in electronic identification number. Since the data in
each FreeStyle Navigator Receiver belongs to an individual user, each receiver uploaded to
the CoPilot system must be associated with a specific user profile. When you upload a
specific receiver for the first time, the CoPilot system prompts you to assign the receiver to a
user. Once made, you cannot change the association between the receiver and user profile.
• Other Receivers Nearby - Because it is a wireless communication, the CoPilot system for
FreeStyle Navigator will be able to upload other receivers that are nearby. Look for the NAV
number that is located on the back of your receiver to ensure you are uploading the
appropriate receiver.
11
Section 3 Uploading Data into the
CoPilot System
3.2 Read Device Button - Default Device
There are two options that you can use to start the process to upload data:
12
Section 3 Uploading Data into the
CoPilot System
3.3 Data Upload Procedure
Before you upload data from a receiver, you must use the Select User or Patient list to select the
correct profile for the receiver you are using. If you do not have a user profile for the device user,
create a profile before you upload data.
Note: The data upload procedure includes steps to use the CoPilot system and your receiver at the
same time.
2. Click the Read Device button. (Or, click DataEntry > Read FreeStyle Navigator.)
3. The CoPilot system displays a message to prompt you to set your FreeStyle Navigator
Receiver to Upload Mode.
Note: Do not click OK until you are instructed to do so.
13
Section 3 Uploading Data into the
CoPilot System
6. Click OK in the CoPilot message.
7. During the time that it takes to establish a connection and upload all data, the CoPilot
system displays a series of “Connection Status” messages.
8. When a connection is established, your receiver beeps (or vibrates, depending on your
settings). Your receiver displays a message indicating the data upload is in progress.
9. When data upload is complete, both the CoPilot system and your receiver display
messages. If the time difference between the PC and receiver is more than 10 minutes the
CoPilot system displays two messages. The first message is a reminder to check the time in
your receiver.
10. Click OK.
11. The CoPilot system then displays a status report with a summary of all event types and the
number of records transferred.
Note: Check the last line for errors. If you see errors, try the upload again. If errors persist, see
Appendix A: Troubleshooting.
14
Section 3 Uploading Data into the
CoPilot System
3.4 Additional Messages During Data Upload
There are several other messages that you may see while connecting your receiver or uploading
data:
Using the identification number, the CoPilot system assigns each device to a specific user profile.
The reason for assigning each device to a specific profile is to prevent the uploading of data from a
device used by one person, to the profile database of another person.
When you connect a specific device to the CoPilot system, the CoPilot system checks the
identification number. If the device is new to the CoPilot system, the CoPilot system displays a New
Device/Data Source message.
15
Section 3 Uploading Data into the
CoPilot System
This message prompts you to assign the device to a specific user, the name of the current user, or to
add a new user. When you see this message, you have three options:
A.) To associate the device with the current profile, select Assign this device to {current user}
and click OK. The CoPilot system assigns the device to this profile, and closes the message. In
the future, select the correct user profile in the Select User (or Patient) list before you connect
and upload data.
B.) To add a new user and associate the device with a new profile, select Add a new user and
click OK. The CoPilot system opens a new profile for you to fill in required information. When
you save the new profile, the device is associated and the data upload process is completed.
C.) To associate the device with another user who already has a profile, click Cancel and follow
these steps:
• Return to the CoPilot system home page.
• Select the person to assign the device to, in the Select User or Patient list.
• Restart the data upload procedure.
• When data upload is complete, the CoPilot system displays the same message. Select
Assign this device to {name of current user} and click OK.
Follow instructions in the message to identify your receiver and click Connect.
16
Section 3 Uploading Data into the
CoPilot System
3.4.3 Assigned to Another User Message
If you attempt to upload data from an identified device to the profile of a user who is not associated
with the device, the CoPilot system prevents the data upload and displays a message.
To upload data from this device, select the correct user profile in the Select User or Patient list and
restart the data upload procedure.
1. If you see a status message indicating the device is being read, the CoPilot system is trying to
connect to a blood glucose meter that connects to your computer with a wire to a COM
port. This error occurs if you use the Read Device button or icon, and the button is not set to
access a FreeStyle Navigator via the Bluetooth adapter. To fix this issue, see Section
3.2: Read Device Button - Default Device.
2. A timeout message is displayed if the CoPilot system fails to connect with your receiver.
Check your receiver battery, the Bluetooth adapter, menu settings and procedures in your
receiver, and the distance between your computer and receiver. For more troubleshooting
information, see Appendix A: Troubleshooting.
17
Section 4 Reports for Continuous Monitoring
4 Reports for Continuous Monitoring
The CoPilot Health Management system automatically performs statistical and other calculations
on data that you upload from a device or that you enter manually.
The CoPilot system displays data in several types of reports designed to present information helpful
for health management by acting as a data management tool. Reports contain various types of
tables, charts, and graphs that can help you see trends and find historical details about your blood
glucose, insulin, diet, medication and more.
When you view reports that contain continuous glucose data, the date range you select may
contain more than 5000 events. If there are more than 5000 events in the date range you have
selected, the CoPilot system displays the following warning message before opening the report.
18
Section 4 Reports for Continuous Monitoring
4.2 Glucose Data Type Symbols
The following key is included on reports to help you remember symbols used for various types of
data. Blood glucose (BG) readings are represented in reports as follows:
19
Section 4 Reports for Continuous Monitoring
• Continuous glucose data is shown in the Type column with the Continuous Monitoring
symbol (CM).
• In the Value column, each CM event is displayed with a TRU™ directional glucose trend
arrow.
WARNING
• Be sure to enter and check all values carefully. The CoPilot system cannot check that
the entries you make are correct for your personal needs. Serious effects on your
health could result from relying on or using improper or incomplete entries. Discuss
the data entry options available with your HCP so you are both clear on the amount
and types of information for therapy analysis.
WARNING
• Have your HCP review and confirm your entries before using this data. Serious effects
on your health could result from relying on, or using, incorrect entries.
CAUTION: Any data that is edited on the FreeStyle Navigator Receiver after that data has been
uploaded will not be altered during subsequent uploads.
20
Section 4 Reports for Continuous Monitoring
4.5 Glucose Modal Day Report
The Glucose Modal Day Report shows the daily pattern of glucose levels from blood glucose
testing and continuous glucose monitoring. Daily glucose data is displayed as symbols, connected
by a line. These symbols help you easily recognize the different types of data on the report.
To zoom out, left-click and drag your mouse from the bottom right to the top left of the
desired area.
WARNING
• The line connecting glucose symbols helps you view daily patterns in your data. It is
not meant to represent actual glucose values. Only the symbols represent your actual
glucose readings.
Daily glucose readings are displayed on the Glucose Modal Day Report under headings for specific
time periods: Pre- and Post-Bkfst, Pre- and Post-Lunch, Pre- and Post-Dinner, Bed, and Sleep. A line
links the daily readings. Each day is represented by a line with a unique color; if you choose to view
more than seven days, the colors repeat.
21
Section 4 Reports for Continuous Monitoring
4.5.2 Viewing Trends in Glucose Levels
Use the Glucose Modal Day Report to view trends in your glucose levels. For example, you might
want to examine your breakfast glucose levels for the last several days. If the timing of breakfast is
consistent over the date range that you select, it is easy to identify patterns.
CAUTION: In the FreeStyle Navigator clinical trials, the sensor signal sometimes temporarily
decreased from the true value. This typically happened during sleep, and recovered rapidly when
the user moved or was awakened.
Depending on the size of the decrease and your alarm settings, a false low-glucose alarm or false
projected low-glucose alarm may sound. When viewing CoPilot system reports, you may see
artificially low glucose readings at these times.
22
Section 4 Reports for Continuous Monitoring
4.6 Glucose Line Report
The Glucose Line Report displays all glucose readings for the selected date range connected by
one continuous line. You can quickly and easily see patterns in your glucose levels over the date
range. To see more detail, zoom in on specific areas.
CAUTION: When you zoom in or out, you may change the scale on the Y-axis (vertical). When you
compare two or more separate line graphs for different date ranges, verify that the scale on the Y-
axis is the same on all graphs. Otherwise, changes in your glucose levels may be interpreted
incorrectly.
23
Section 4 Reports for Continuous Monitoring
4.7 Statistics Report
The Statistics Report includes tables for glucose, insulin, and carbohydrate statistics. The glucose
statistics table includes detailed glucose meter information such as total number of readings;
highest, lowest and average readings; above, below and within target percentages.
CAUTION: Including both Glucose (CM) and Glucose (BG) blood glucose readings may alter the
Statistics Report and other reports.
CAUTION: The CoPilot system uses a minimum of three data points to determine standard
deviation. FreeStyle Navigator uses a minimum of two data points to determine standard deviation.
There may be a slight difference if you are comparing the two statistics.
24
Section 4 Reports for Continuous Monitoring
4.8 Daily Combination Report
The Daily Combination Report summarizes glucose, carbohydrate, and insulin data for a single
day. It displays the data in both graphic and table formats.
You can view the glucose graph in this report with or without text. The text shows the numerical
value of each glucose reading. Due to the large number of glucose readings, the numbers may be
difficult to read. Open the Diary List to view the numerical value of specific glucose readings.
25
Appendix A: Troubleshooting
Appendix A: Troubleshooting
If you have questions after reading this User’s Guide, or for technical assistance, please contact
Abbott Diabetes Care, Customer Care.
To obtain support, please contact the person you received the software from, or your local Abbott
Diabetes Care office. For a list of worldwide offices, visit www.abbottdiabetescare.com and click
Worldwide Locations. On the Worldwide Locations page, click the link for your country or a
country near you.
Should you still have a problem after completing the suggested corrections listed in this section,
please contact Customer Care.
Bluetooth Installation
• You must use an ADC-recommended Bluetooth adapter when using the CoPilot system
for FreeStyle Navigator. Contact Customer Care for other Bluetooth adapter brands recom-
mended by Abbott Diabetes Care.
• During an uninstall, the CoPilot system for FreeStyle Navigator software will be removed from
the CoPilot Health Management System folder on your computer.
Communication Problems
General Information
• For any problems with data transfer from FreeStyle Navigator to the CoPilot system, contact
Customer Care.
26
Appendix A: Troubleshooting
Bluetooth Communication Error
• If you remove the Bluetooth adapter from your PC, you may get the following error message
during the next upload.
• Reconnect the Bluetooth adapter to your PC. Then try the data upload again.
It should be successful.
• Move the receiver closer to the PC. Then try the data upload again. It should be successful.
• If the FreeStyle Navigator Receiver is not working properly, see the FreeStyle Navigator User’s
Guide.
FreeStyle Navigator Receiver Data Upload Error
• If communication is broken between your PC and the FreeStyle Navigator Receiver, some data
may be lost. You may get a message indicating there was a data upload error.
• Try the data upload again. It should be successful.
• Contact Customer Care if you continue to get this error message.
27
Appendix A: Troubleshooting
FreeStyle Navigator Receiver Battery Low
• If the FreeStyle Navigator Receiver battery is less than 20% full, you may get a message
indicating the battery is too low for data transfer.
• Replace the batteries in the FreeStyle Navigator Receiver. You will not be able to complete the
data upload until you do so. See the FreeStyle Navigator User’s Guide for information on battery
life and replacement.
Data-Related Problems
General Information
• For any problems with data you uploaded from FreeStyle Navigator, contact Customer Care.
Missing Data
• If you notice that data is missing when using the CoPilot system for FreeStyle Navigator, verify
which data filters are active. Also verify that the data is not hidden. For more information, see
“Data Filters” and “Display Features” in the CoPilot Health Management System User’s Guide.
• If you have recently archived your the CoPilot system data, the data is not gone. You can restore
the data by importing it. For more information, see “Archiving Data” and “Importing a Data-
base” in the CoPilot Health Management System User’s Guide.
28
Appendix B: Warning and
Caution Messages
WARNING Messages
The following WARNING messages are included in this User’s Guide.
Section 4
• Be sure to enter and check all values carefully. The CoPilot system cannot check that the
entries you make are correct for your personal needs. Serious effects on your health could
result from relying on or using improper or incomplete entries. Discuss the data entry options
available with your HCP so you are both clear on the amount and types of information for
therapy analysis.
• Have your HCP review and confirm your entries before using this data. Serious effects on your
health could result from relying on, or using, incorrect entries.
• The line connecting glucose symbols helps you view daily patterns in your data. It is not
meant to represent actual glucose values. Only the symbols represent your actual glucose
readings.
CAUTION Messages
The following CAUTION messages are included in this User’s Guide.
Section 4
• Any data that is edited on the FreeStyle Navigator Receiver after that data has been uploaded
will not be altered during subsequent uploads.
• In the FreeStyle Navigator clinical trials, the sensor signal sometimes temporarily decreased
from the true value. This typically happened during sleep, and recovered rapidly when the user
moved or was awakened. Depending on the size of the decrease and your alarm settings, a false
low-glucose alarm or false projected low-glucose alarm may sound. When viewing CoPilot
system reports, you may see artificially low glucose readings at these times.
• When you zoom in or out, you may change the scale on the Y-axis (vertical). When you
compare two or more separate line graphs for different date ranges, verify that the scale on
the Y-axis is the same on all graphs. Otherwise, changes in your glucose levels may be
interpreted incorrectly.
• Including both Glucose (CM) and Glucose (BG) blood glucose readings may alter the Statistics
Report and other reports.
• The CoPilot system uses a minimum of three data points to determine standard deviation.
FreeStyle Navigator uses a minimum of two data points to determine standard deviation. There
may be a slight difference if you are comparing the two statistics.
29
Index
Index G
glucose (BG) 24
glucose (CM) 24
A glucose data symbols 19
archived data 28 glucose levels
viewing trends 22
B
Glucose Line Report 23
battery low 28
Y-axis scale 23
Bluetooth
Glucose Modal Day Report 21
communication error 27
glucose trend arrows 20
installation problems 26
Bluetooth adapter 5, 7 H
hidden data 28
C
Caution 6 I
communication error importing data 28
Bluetooth 27 installation 4, 7
FreeStyle Navigator Receiver 27 intended use 3
communication problems 26 L
computer requirements 7 low battery 28
continuous glucose data 20
continuous glucose symbol 19
M
CoPilot Health Management System 3 missing data 28
CoPilot Health Management System for FreeStyle P
Navigator 5 preinstallation requirements 7
customer care 4 R
D read device button 12, 13
Daily Combination Report 25 Reports
view graph with text 25 overview 18
view graph without text 25 reports 18
data upload 13 S
data upload error
size warning message 18
FreeStyle Navigator Receiver 27
Statistics Report 24
data upload messages 15
date range 22 T
Diary List 19 technical support 4
E troubleshooting 26
battery low 28
event types summary 14
Bluetooth adapter 26
F communications 26
FreeStyle Navigator data upload 27
upload duration 11 install and uninstall 26
FreeStyle Navigator Continuous Glucose Monitoring missing data 28
System 3 U
FreeStyle Navigator Receiver
upload data 11
battery 11
upload summary 14
communication error 27
low battery 28 W
upload error 27 Warning and Caution messages 29
warning and caution messages 6
30
Index
wireless communication 5 Glucose Line Report 23
Y Z
Y-axis scale zoom in or out 21
31