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Health Management System

Software and

User’s Guide

Version 4.2.1

Health Management System

Version 4.2.1

User’s Guide

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Table of Contents

Contents

Preface ..........................................................................................................................v

Overview of the FreeStyle CoPilot Health Management System................................. v

Intended Use and Application ................................................................................................. v

Purpose and Scope .....................................................................................................................vi

Software Availability ..................................................................................................................vi

Computer Requirements ..........................................................................................................vi

Technical Support and Customer Care ................................................................................vi

1 Introduction ..............................................................................................................1

1.1 Modes of Operation .............................................................................................................1

1.2 Overview of Home User Activities ..................................................................................1

1.3 Overview of HCP User Activities ......................................................................................2

1.4 FreeStyle CoPilot System Terminology .........................................................................2

1.5 Organization and Topics in this Guide ..........................................................................3

1.6 Warning, Caution and Important Messages in this Guide ...................................4

1.7 Getting Around - The FreeStyle CoPilot System Home Page .................................4

1.7.1 The FreeStyle CoPilot System Home Page ..........................................................5

1.7.2 Menu Bar ........................................................................................................................5

1.7.3 Shortcut Keys ................................................................................................................6

1.7.4 Select User, Select HCP, and Select Patient Lists ...............................................6

1.7.5 Small Icons .....................................................................................................................7

1.7.6 Large Buttons ...............................................................................................................8

1.7.7 Resource Links ..............................................................................................................9

1.7.8 FreeStyle CoPilot System Help ...............................................................................9

1.7.9 Pictures of the FreeStyle CoPilot System Screens .............................................9

2 FreeStyle CoPilot System Installation ....................................................................10

2.1 FreeStyle CoPilot System Installation Overview ......................................................10

2.2 Standard Installation Procedure ....................................................................................10

2.2.1 Install the FreeStyle CoPilot System ....................................................................11

2.2.2 Select Application Mode ........................................................................................12

3 HCP and Home User Profiles ...................................................................................13

3.1 Home User - Profile Setup ................................................................................................13

3.1.1 What is a Home User Profile? .................................................................................13

3.1.2 Health Profile Tab ......................................................................................................16

3.1.3 Data Entry Preferences Tab ....................................................................................17

3.1.4 Glucose Targets Tab ..................................................................................................18

3.1.5 Options Tab .................................................................................................................21

3.2 Home User: Managing Your User Profile .....................................................................22

3.2.1 Changing or Updating Your User Profile ...........................................................22

3.2.2 Adding a User Profile ...............................................................................................22

3.2.3 Removing a User Profile ..........................................................................................22

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Table of Contents

3.2.4 Adding an HCP Profile ..............................................................................................24

3.2.5 Editing an HCP Profile ..............................................................................................26

3.2.6 Removing an HCP Profile .......................................................................................26

3.3 HCP - Setting Up Your User Profile ................................................................................27

3.3.1 What is an HCP Profile? ............................................................................................27

3.3.2 HCP Profile Setup ......................................................................................................28

3.3.3 Automatic Report Printing .....................................................................................29

3.3.4 Glucose Targets Tab ..................................................................................................30

3.3.5 Options Tab .................................................................................................................33

3.4 HCP - Managing the HCP Profile ....................................................................................34

3.4.1 Changing or Adding to Your HCP Profile ...........................................................34

3.4.2 Adding a Patient Profile ...........................................................................................34

3.4.3 Editing a Patient Profile ..........................................................................................36

3.4.4 Removing a Patient Profile ....................................................................................36

3.5 Managing HCP Profiles .....................................................................................................37

3.5.1 Adding an HCP Profile ..............................................................................................37

3.5.2 Assigning an HCP .....................................................................................................37

3.5.3 Editing an HCP Profile ..............................................................................................38

3.5.4 Removing an HCP Profile ........................................................................................38

4 Entering Data Into the FreeStyle CoPilot System ..................................................40

4.1 Uploading Data from a Device .......................................................................................40

4.1.1 Connecting a Device to Your Computer ............................................................40

4.1.2 Uploading from a Device and Saving to a Profile ...........................................41

4.1.3 Undoing a Device Upload ......................................................................................43

4.1.4 Data Transfer between Patient Profiles (HCPs Only) ......................................43

4.1.5 Quick Print ...................................................................................................................45

4.2 Manual Data Entry ..............................................................................................................46

4.2.1 Entering a Glucose Reading ...................................................................................48

4.2.2 Recording an Insulin Dose .....................................................................................49

4.2.3 Recording a Meal .......................................................................................................50

4.2.4 Recording Exercise Activity ....................................................................................52

4.2.5 Recording State of Health ......................................................................................53

4.2.6 Recording a Medication Event ..............................................................................54

4.2.7 Recording a Medical Exam/Doctor Visit ............................................................55

4.2.8 Recording a Lab Test Result ...................................................................................56

4.2.9 Recording a Ketone Reading .................................................................................57

4.2.10 Recording a Note (or Miscellaneous Event) ...................................................58

4.3 Customizing Data Lists .....................................................................................................59

4.3.1 Customizing Data Entry Lists.................................................................................59

4.4 Importing Data from Database Files ............................................................................61

4.4.1 Importing a Database ..............................................................................................61

4.4.2 Importing a Supported Database .......................................................................61

4.4.3 Importing Data from a File .....................................................................................62

4.5 Exporting Data ....................................................................................................................63

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Table of Contents

5 Viewing and Printing Reports .................................................................................64

5.1 Viewing Reports ..................................................................................................................65

5.1.1 Date Range ..................................................................................................................66

5.1.2 Data Symbols .............................................................................................................67

5.1.3 Target Range Colors ..................................................................................................67

5.2 Printing and Sending Reports .......................................................................................68

5.3 Personalizing Report Settings ........................................................................................69

5.3.1 Report Options (User or HCP Profile) ..................................................................69

5.3.2 Data Filters ...................................................................................................................70

5.3.3 Display Features ........................................................................................................71

5.4 Glucose Target Modes .......................................................................................................73

5.5 Definition of a Day ..............................................................................................................73

5.6 Descriptions of Reports ....................................................................................................74

5.6.1 Two Week Glucose Summary with Logbook ....................................................74

5.6.2 Two Week Glucose Summary ................................................................................76

5.6.3 Diary List .......................................................................................................................77

5.6.4 Glucose Modal Day Report ....................................................................................81

5.6.5 Glucose Line Report .................................................................................................83

5.6.6 Glucose Average Report .........................................................................................84

5.6.7 Glucose Histogram Report .....................................................................................86

5.6.8 Glucose Pie Chart ......................................................................................................87

5.6.9 Logbook Report .........................................................................................................88

5.6.10 Lab and Exam Record Report .............................................................................89

5.6.11 Statistics Report ......................................................................................................89

5.6.12 Daily Combination View Report ........................................................................97

5.6.13 Weekly Pump View Report ................................................................................100

5.6.14 HCP Group Analysis Report ..............................................................................102

6 Prescribed Plan ......................................................................................................105

6.1 Prescribed Plan .................................................................................................................105

6.2 Filling-in a Prescribed Plan ...........................................................................................106

7 Database Management ........................................................................................107

7.1 Archiving Data ..................................................................................................................107

7.2 Viewing Archived Data ..................................................................................................109

7.3 Restoring Archived Data ...............................................................................................109

7.4 Backing Up the Database ..............................................................................................110

7.4.1 Automatic Database Backup ..............................................................................110

7.4.2 Manual Database Backup ....................................................................................111

7.5 Restoring a Database Backup ......................................................................................112

7.5.1 Restoring a Database Backup File .....................................................................112

7.5.2 Viewing the Restore Log ......................................................................................112

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Table of Contents

8 Security ..................................................................................................................113

8.1 System Administrator Profile .......................................................................................113

8.2 Password Protection .......................................................................................................113

8.2.1 The Logon to System Screen ..............................................................................114

8.3 Defining User Rights .......................................................................................................115

8.3.1 User Rights Options for HCP and Home Users ..............................................115

8.3.2 Assigning Your Own User Rights - HCP and Home User ............................116

8.3.3 Home User - Assigning User Rights to Other Home Users ........................117

8.3.4 HCP - Assigning User Rights to Other HCPs ...................................................118

Appendix A: Contact Customer Care .......................................................................119

Appendix B: Troubleshooting ..................................................................................120

Device Connection Problems .............................................................................................120

Data Import Problems ...........................................................................................................120

Printing Problems ...................................................................................................................121

PDF Attachments ....................................................................................................................121

Access Violation Errors ...........................................................................................................121

Appendix C: Supported Devices And Databases ....................................................122

Appendix D: Warning, Caution and Important Messages ......................................125

WARNING Messages ...............................................................................................................125

CAUTION Messages ................................................................................................................126

IMPORTANT Messages ...........................................................................................................128

Appendix E: FreeStyle CoPilot System Network Installation .................................129

About FreeStyle CoPilot System Network Installation ...............................................129

Installing the FreeStyle CoPilot System Server .............................................................129

Installing the FreeStyle CoPilot Server Client Application ........................................130

Restarting the Client ..............................................................................................................131

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Preface

Preface

Overview of the FreeStyle CoPilot Health Management System

The FreeStyle 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 FreeStyle 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.

The FreeStyle CoPilot Health Management System (“FreeStyle CoPilot system”) allows you to upload recorded test results from supported Abbott Diabetes Care blood glucose monitoring systems. The FreeStyle CoPilot system also allows you to record information about insulin, ketones, medications, meals, exercise, state of health, medical exams, lab results, as well as general notes.

The FreeStyle CoPilot system displays trends and patterns in glucose readings, carbohydrate intake, insulin dosage, and other diabetes-related factors.

Please note: The Unit of Measure in the FreeStyle CoPilot system is locked and cannot be changed. However, the Unit of Measure that is illustrated in some of the figures in this User’s

Guide may be different. The FreeStyle CoPilot system will display results only in the Unit of

Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

The FreeStyle CoPilot system can be installed in one of two modes or, versions. The Home User version is for people with diabetes, or their caregivers. The HCP version is for healthcare professionals (HCPs). When you install and use the FreeStyle CoPilot system for the first time, you must specify which version you use. Both versions provide the same tools to record, track, view and analyze individualized health information. When needed, this guide provides instructions specifically for each version and type of user.

To allow multiple home users (such as a family) and multiple HCPs (such as in a clinic) to share the use of the FreeStyle CoPilot system, each user has a Profile. The information for each profile can be made secure with a unique password.

Intended Use and Application

The FreeStyle CoPilot Health Management System is intended for use in home and clinical settings by patients and healthcare professionals. It is intended to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of information such as historical blood glucose test results, insulin dosages, carbohydrate intake, and exercise data in support of an effective diabetes health management program. It can be used with supported Abbott

Diabetes Care blood glucose monitoring systems (as listed in Appendix C: Supported Devices and

Databases), where data is uploaded, saved, analyzed, displayed as charts, graphs and reports, printed, and shared.

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Preface

Users should be aware that the FreeStyle CoPilot Health Management System is merely an information management tool - it does not itself provide diagnostic information, nor does it give advice on 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 their diabetes management.

Purpose and Scope

This User’s Guide provides computer requirements, installation steps and configuration options. It provides instructions and procedures for setting up user profiles, for uploading, recording and importing data, and for viewing reports . This guide also provides instruction for managing system security and data integrity by using logon profiles and passwords, and for managing user rights. Finally, information is provided for troubleshooting and obtaining technical support.

Software Availability

To obtain the FreeStyle CoPilot system installation software, contact your local Abbott Diabetes

Care office. For a list of worldwide offices, visit www.AbbottDiabetesCare.com.

Computer Requirements

The following are minimum requirements for FreeStyle CoPilot system operation:

• Microsoft Windows XP (32-bit), Windows Vista (32-bit or 64-bit), or Windows 7 (32-bit or

64-bit)

(The FreeStyle CoPilot system does not run on Apple computers.)

• RS-232 Serial port, or USB port

The following components are needed or recommended for optimal use of FreeStyle CoPilot system features: Internet connection, email account, 1024 x 768 resolution monitor, CD-ROM drive, color printer, fax software.

Technical Support and Customer Care

To obtain support, please contact your local Abbott Diabetes Care office. For a list of worldwide offices, visit www.AbbottDiabetesCare.com.

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Section 1: Introduction

1 Introduction

The FreeStyle CoPilot

Health Management System (“the FreeStyle CoPilot system”) 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 FreeStyle CoPilot system tracks health information and provides graphs, charts and reports that can help people with diabetes and healthcare professionals evaluate needs and options for a diabetes health management program.

This section introduces and explains the FreeStyle CoPilot system features, installation options, user roles and activities, terminology, day-to-day procedures, and on-screen navigation for both home users and healthcare professionals.

All users should read this section to understand key features and capabilities and different ways that you can use the FreeStyle CoPilot system.

1.1 Modes of Operation

The FreeStyle CoPilot system can be installed in one of two modes, or versions. The Home User version is for people with diabetes, or their caregivers. The HCP version is for healthcare professionals. When you install and use the FreeStyle CoPilot system for the first time, you must specify which version you use.

Both versions appear and operate in very similar ways. Both provide the same tools to record, track, view and analyze individualized healthcare information. Each version displays slightly different menus, screens and configuration options to accommodate both the home user and

HCP. This guide provides instructions as needed for each version and type of user.

1.2 Overview of Home User Activities

The FreeStyle CoPilot system allows you to upload, record, store, analyze and share important information about your glucose readings, insulin, exercise, medication and other health information.

The following is an overview of typical, routine use of the FreeStyle CoPilot system for home users:

• Install the FreeStyle CoPilot system and set up your profile using easy-to-follow forms, to specify personal and health information, your glucose targets, and much more.

• Set up user preferences so that the system works best for you.

• Upload test results from your blood glucose meter to the FreeStyle CoPilot system.

• Record your carbohydrate intake, insulin, exercise, state of health, medical exams, medications, ketones, lab results, and general notes. Keep as much or as little information as you and your HCP find helpful.

• View and print many types of graphs, charts and reports that will help you understand and track the progress of your diabetes health management plan.

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Section 1: Introduction

1.3 Overview of HCP User Activities

As a healthcare professional, you can use the FreeStyle CoPilot system to observe trends and patterns in your patients’ glucose readings, and to review exercise, medication and other health information.

The following is an overview of typical, routine use of the FreeStyle CoPilot system for healthcare professionals:

• Install the FreeStyle CoPilot system and set up your HCP profile using easy-to-follow forms.

• Set up user preferences and system options.

• Set up a patient profile for each patient with a supported device.

• View and print charts, graphs and reports.

• View a Group Analysis Report for a summary of all patient data.

• Configure multiple HCP profiles and groups of patients.

1.4 FreeStyle CoPilot System Terminology

The following terms are used in the FreeStyle CoPilot Health Management System and this

User’s Guide:

Healthcare Professional - A healthcare professional (HCP) is a physician, nurse practitioner, certified diabetes educator (CDE), or other healthcare professional authorized to provide care to patients with diabetes; a healthcare group or entity such as a clinic; or case manager.

Home User - A home user is a person with diabetes, or their caregiver. (In the HCP version, a home user is called a “patient.”)

Profile - Each home user and HCP creates a profile. The home user profile is a collection of personal information, and the FreeStyle CoPilot system preferences, permissions and options.

The HCP profile is a collection of professional identification, health management preferences, and the FreeStyle CoPilot system options.

Data - Information recorded by any supported medical device and uploaded to the FreeStyle

CoPilot system. See Appendix C for a list of supported devices, and the data collected and uploaded.

Health Information - Personal and medical information recorded by (or for) a patient.

Information categories include: Glucose Readings, Insulin Doses, Meals, Exercise, State of

Health, Medications, Medical Exams, Lab Results, Ketone Readings, and General Notes.

Reports - Reports are charts, graphs, and tables generated by the FreeStyle CoPilot system.

There are at least 13 types of reports. You can use powerful filters to select the types of data, date ranges, etc., that you would like to view. You can also save, print, email and Fax (with installed Fax software) any report that you generate.

Database - All the FreeStyle CoPilot system information is stored in a database file. Database information can be archived, exported and imported. Database files can be backed-up, copied and stored to ensure data integrity and safekeeping.

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Section 1: Introduction

1.5 Organization and Topics in this Guide

The table below provides an overview of sections and topics.

Note: When needed, this guide provides instructions specifically for the home user or HCP. If no specification is indicated, the instructions are the same for both.

Section

Preface

1. Introduction

Topics

FreeStyle CoPilot System Overview; Intended Use; Purpose and Scope; Computer

Requirements; Technical Support and Customer Care

Modes of Operation; Home User Activities; HCP User Activities; FreeStyle CoPilot System

Terminology; Warning, Caution and Important Messages; FreeStyle CoPilot System Screen

Navigation; Using Help

Installation Options; FreeStyle CoPilot System Installation; User Mode

2. FreeStyle

CoPilot System

Installation

3. HCP and Home

User Profiles

4. Entering Data

Into the FreeStyle

CoPilot System

What is a Home User Profile?; Edit Home User Profile; Add, Delete and Edit Home User

Profiles; Add, Delete and Edit HCP List; Manage Multiple Home Profiles; What is an HCP

Profile? Edit HCP Profile; Manage HCP Profiles; Manage Patient Profiles; Add, Delete and

Edit HCP Profiles

Uploading Data; Connecting a Device; Undoing a Device Upload; Manual Data Entry --

Glucose Reading, Insulin Dose, Meal, Exercise, Health, Medication, Exam, Lab Test, Ketone

Reading, Note; Customizing Lists; Importing a Database; Importing Data; Exporting Data

5. Viewing and

Printing Reports

Opening, Viewing a Report; Printing and Sending Reports; Personalizing Reports;

Glucose Target Modes; Definition of a Day; Descriptions of Reports; HCP Group Analysis

Report

6. Prescribed Plan

Prescribed Plan (for record-keeping only)

7. Managing

Databases

8. Security

Database Management; Archive Data; View Archived Data; Restore Archived Data; Back

Up the Database; Restore a Database; Restore Log

System Administrator Profile; Password Protection; Defining User Rights; User Rights

Options; Assigning Your Own User Rights; Home User Assigning User Rights; HCP

Assigning User Rights

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Section 1: Introduction

1.6 Warning, Caution and Important Messages in this Guide

Warning, Caution, and Important messages are included throughout this User’s Guide. These messages warn you to pay careful attention to specific instructions and guidelines for using the

FreeStyle CoPilot system.

Before using the FreeStyle CoPilot system, read each message included in the FreeStyle CoPilot system User’s Guide. (See Appendix D: Warning, Caution and Important Messages, for a list of all messages.) Always seek the advice of a healthcare professional before making any change in your lifestyle or use of medication.

Warning, Caution and Important messages have a very specific meaning. The following list explains the meaning and purpose of each:

WARNING:

• WARNING indicates possible hazards that, if not avoided, could result in serious injury or death.

CAUTION:

CAUTION to yourself, or to your patients.

indicates that inconvenience to you (such as loss of text entries or saved settings) may result if you do not follow instructions.

1.7 Getting Around - The FreeStyle CoPilot System Home Page

The FreeStyle CoPilot system uses menus, buttons, icons, tabs, drop-down lists, “mouse-button

clicks”, check boxes, text fields (that you can type in), and other common Windows screen elements for operation and navigation. This guide assumes that all FreeStyle CoPilot system users have a clear understanding of how to use these software controls.

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Section 1: Introduction

1.7.1 The FreeStyle CoPilot System Home Page

In this User’s Guide, certain terms are used to describe how (or, where to click) to perform procedures -- such as icon, button, menu and user list. These are explained below.

Tip: To return to the Home page from any other screen, click the “Home” icon.

Figure 1. The FreeStyle CoPilot System Home Page (Home User)

1.7.2 Menu Bar

The menu bar provides commands for the FreeStyle CoPilot system features and operations

(including the features that you can use by clicking buttons and icons.)

The following are two examples of how instructions are written for using commands on the

menu bar.

• Click File > Database Maintenance > Archive to export data to an archive file.

• Click Reports on the main menu, and select Diary List.

Also, an instruction may direct you to use an icon or button.

• Click the Read Device button to upload data from your device.

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Section 1: Introduction

1.7.3 Shortcut Keys

Menu commands, buttons and icons often provide a keyboard shortcut.

Many menu items have shortcut keys, such as Ctrl+P to print.

Many icons have a “popup” (which appears when you hold the mouse pointer over the icon) that indicates the shortcut key, such as Ctrl+6 to enter a medication event.

1.7.4 Select User, Select HCP, and Select Patient Lists

You can search for a User/Patient by entering the first few characters of the Last name, First name, or ID in the search field, and clicking the Start Search button or pressing Enter. Clicking the Start Search button without any search criteria will display all Users/Patients. Click the

Clear Search button to clear the current search.

For Home Users

The Select User list is displayed in the Home page in the home user version. The list includes the system administrator, and at least one home user profile.

Note: If you have more than one home user profile on your system, verify that you select the correct home user before you upload data, record health information, or change profile settings.

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Section 1: Introduction

For HCPs

The Select HCP and Select Patient lists are displayed on the Home page in the HCP version.

Note: Verify that you select the correct patient before you upload data, record health information, or change profile settings.

1.7.5 Small Icons

Small icons are displayed on the Home page under the menu bar. In this User’s Guide, these are referred to as Icons. For example: Click the Home Icon to return to the Home page.

In addition to icons on the Home page, several other screens display icons. You can use these icons as described in procedures.

Home User Icons

Home User Tip: Select UserProfile > User Profile > Options > Show Button Captions to see button captions.

HCP Icons

HCP Tip: Select UserProfile > HCP Profile > Options > Show Button Captions to see button captions.

Icons and Associated Actions

Home - Return to the FreeStyle CoPilot system home page.

Read Device - Upload data from a blood glucose meter or other device.

Quick Print - Upload data and automatically print selected Favorite Reports without saving the data to a user (or patient) profile.

Manual Entry - Record health information events; open the Data Entry screen.

View Reports - Open the Report screen to the default report you select in Options.

User Profile/Patient Profile - Open the home user (or patient) profile to view, or to edit information.

Help - Open this User’s Guide to the appropriate section for help.

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Section 1: Introduction

1.7.6 Large Buttons

Large Buttons on the Home page provide shortcuts to commonly used actions.

Home User Buttons

HCP Buttons

Buttons and Associated Actions

User List (Home User) - Open the User List to add, edit or delete home users.

Patient List (HCP) - Open the Patient List to add, edit or delete patients.

Read Device - Upload data from a blood glucose meter or other device.

Quick Print - Upload data and automatically print selected Favorite Reports without saving the data to a user (or patient) profile.

Manual Entry - Record health information events; open the Data Entry screen.

View Report - Open the Report screen to the default report you select in Options.

User Profile (Home User) - Open the profile of the home user selected in the Select User list to view or edit information.

Patient Profile (HCP) - Open the profile of the patient selected in the Select Patient list to view or edit information.

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Section 1: Introduction

1.7.7 Resource Links

If you installed extensions or plug-ins for other devices, additional options appear under

Resource Links. Refer to the documentation provided with your device for more information about using these links.

1.7.8 FreeStyle CoPilot System Help

Use the help feature in the FreeStyle CoPilot system from virtually any screen or window. There are two options:

• Click Help > Contents on the menu bar to open the help feature.

• The context-sensitive help option is available in many screens and dialog boxes. Click

Help or the question mark icon, to open the help feature at the appropriate section.

1.7.9 Pictures of the FreeStyle CoPilot System Screens

• In this guide, pictures of the FreeStyle CoPilot system screens may be from either the home version or HCP version. If the information or procedure is specific to a particular version of the FreeStyle CoPilot system, the image used is from the relevant version.

• The figures within this guide are intended to serve only as examples.

Please note: The Unit of Measure in the FreeStyle CoPilot system is locked and cannot be changed. However, the Unit of Measure that is illustrated in some of the figures in this User’s

Guide may be different. The FreeStyle CoPilot system will display results only in the Unit of

Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

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Section 2: FreeStyle

CoPilot Installation

2 FreeStyle CoPilot System Installation

This section provides detailed installation instructions for the FreeStyle CoPilot Health

Management System.

2.1 FreeStyle CoPilot System Installation Overview

Select an Application Mode

When you install the FreeStyle CoPilot system and start the application for the first time, the FreeStyle CoPilot system asks you to specify if you are a home user, or healthcare professional. When you make your selection, the FreeStyle CoPilot system completes the final installation step and enables the version appropriate for you.

Both versions operate and look almost identical. Home users and HCPs use the same features and follow many of the same procedures. However, there are differences, and these require separate instructions in this User’s Guide. Separate instructions are clearly identified for the home user or HCP. Where applicable, be sure to read the correct instructions.

Note: It is very important to select the right option.

FreeStyle CoPilot System Network Installation

To allow multiple users to work from more than one computer, and to share one database, you can perform the FreeStyle CoPilot system network installation. This is recommended only for HCPs who work in a clinical setting with other HCPs. See Appendix

E: FreeStyle CoPilot System Network Installation, for more information.

Upgrading from a Previous Version of the FreeStyle CoPilot System

If you are installing an upgrade to a previous version of the FreeStyle CoPilot system, your data is automatically migrated when installing the new version. You will also be prompted during the upgrade to allow the installer to automatically uninstall the previous version prior to installing the upgrade.

2.2 Standard Installation Procedure

When you start the FreeStyle CoPilot system for the first time, the application asks you to specify if you are a home user, or healthcare professional.

This step is a part of the installation procedure.

Before You Install the FreeStyle CoPilot System

• Verify computer requirements as listed in the Preface.

• Save all information and close all running applications.

Note: Please have your glucose meter or other supported device available during installation.

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Section 2: FreeStyle

CoPilot Installation

2.2.1 Install the FreeStyle CoPilot System

These steps correspond to the FreeStyle CoPilot system installer screens, which provide additional instructions. Screen names are in Italic.

1. Start the installer.

• Insert the CD-ROM into the drive. (Most computers start installation automatically.)

–OR–

• Double-click the FreeStyle CoPilot system installer file (CoPilot_Setup.exe).

2. Installation Language - Select the Installation Language, and click OK.

3. Welcome Page - Read the welcome page and click Next to continue or Cancel to quit.

4. License Agreement - The End User Agreement is displayed. Read it, and select I Agree and then click Next to continue or click Cancel to stop the installation.

5. Confirmation - Click I Confirm to continue. Click I Do Not Confirm to return to the license agreement.

6. Installation Destination - Verify the installation folder. We recommend that you keep the preselected folder. (If required, click Browse to select another folder.) Click Next.

7. Start Installation - The installer is ready to begin. Click Next to proceed. Alternatively, 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. You may need to install additional software if you use certain devices. Click Finish.

10. The FreeStyle CoPilot system icon is placed on your desktop, and in your Start Menu.

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Section 2: FreeStyle

CoPilot Installation

2.2.2 Select Application Mode

To complete installation, you must launch the FreeStyle CoPilot system and choose the

Application Mode.

1. Double-click the FreeStyle CoPilot system icon on the desktop to launch the FreeStyle

CoPilot system.

2. Initial User Setup - Select the Application Mode, either:

Home User

Health Care Professional

Note: If you are a home user, you cannot change this selection after you click OK. If you select the wrong option, you will need to reinstall the FreeStyle CoPilot system. Contact

Customer Care for assistance.

Figure 2. Initial User Setup

3. Enter your Name, a User ID and Password then click OK.

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Section 3: HCP and Home User Profiles

3 HCP and Home User Profiles

If you are a home user, read Section 3.1, Home User - Profile Setup.

If you are an HCP, read Section 3.3: HCP - Setting Up Your User Profile.

3.1 Home User - Profile Setup

This section explains how to create and use profiles. It describes the five parts of the home user profile (called Tabs): User Information, Health Profile, Data Entry Preferences, Glucose

Targets, and Options. Each tab is a form that you fill out using open text fields, drop-down lists, and check boxes.

This section describes how to:

• Choose settings, preferences and options to customize reports, data entry, printing, and much more.

• Set up and manage other home user profiles.

• Create and manage HCP profiles in the HCP list.

3.1.1 What is a Home User Profile?

Every home user can set up a home user profile. A profile contains personal information and a brief medical history. A profile also allows you to select options and preferences that you can use to specify glucose targets, daily time periods (meals, sleep, etc.), how reports are displayed, and items that you want to see listed when you record important health in formation - such as your medications, exercise, and insulin doses.

Use your profile to specify:

• Your contact information, age, health, weight, type of diabetes, year of diagnosis, other medical conditions, etc.

• Your glucose targets and daily time periods (meals, sleep, etc.) - which change how some charts, graphs and reports are displayed.

• Categories you would like to use when entering health information events, such as ketones, exercise, lab results, and exams.

• Items in health information events that you want to see listed when you record patient health information - such as medications, exercise, and insulin doses.

• Whether to automatically print your favorite report(s) when you upload glucose meter or other device readings.

• The default date-range you would like to see in your reports such as seven days, one month, or three months.

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Section 3: HCP and Home User Profiles

Note: Preferences and settings in your profile affect your use of the manual entry and reports features in the FreeStyle CoPilot system. For more information that will help you complete your profile, read Section 4: Entering Data into the FreeStyle CoPilot System, and

Section 5: Viewing and Printing Reports

1. Click the User Profile button (or click UserProfile > User Profile.)

Figure 3. The FreeStyle CoPilot System Home Page: User Profile Menu

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Section 3: HCP and Home User Profiles

2. The screen displays with the User Information tab selected.

User

Information

Tab

Figure 4. User Information

3. Fill in the information you would like to provide. Fields marked with an asterisk (*) must be filled in to create a profile.

Add information by selecting items from drop-down boxes or by typing information.

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Section 3: HCP and Home User Profiles

3.1.2 Health Profile Tab

1. Click the Health Profile tab and fill in the items listed under General.

Figure 5. Health Profile Information

4. Add another condition, if needed.

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Section 3: HCP and Home User Profiles

3.1.3 Data Entry Preferences Tab

You can save time in manually entering data by setting up your Data Entry Preferences. For example, if you regularly take a certain type of insulin at a particular dose, you can en ter it here.

The same is true for your regular exercise routines and other medications you may take. The information you enter here is listed for you when you go to make manual entries.

Figure 6. Data Entry Preferences

1. To enter your preferences, select the Data Entry Preferences tab and fill in Exercise

Preferences (type, duration, intensity); Insulin Preferences (insulin name/type, dosage, type); and Medication Preferences (medication name, dosage, number of pills).

• You can type in a new entry that will be added to the list, or select one of the listed entries.

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Section 3: HCP and Home User Profiles

3.1.4 Glucose Targets Tab

1. Click the Glucose Targets tab to enter your target glucose ranges. If you don’t know what to fill in, ask the HCP who helps you manage your glucose levels. The target ranges you set here are displayed in the graph, as well as in many FreeStyle CoPilot system reports. The ranges are displayed in unique colors for easy viewing.

Figure 7. Glucose Target Ranges Page

2. You may view the graph in three modes. Select the desired mode from the Mode list:

Standard: The glucose target ranges you set apply to all glucose readings, regardless of when the glucose reading is taken. (For example, target ranges are the same for pre-meal readings as for post-meal readings, bedtime readings, etc.)

Pre/Post Meal: The glucose target ranges you set for all pre-meal readings can be different from the target ranges for all post-meal readings.

All Time Periods: The glucose target ranges you set can be different for each time period listed: Pre-Bkfst, Post-Bkfst, Pre-Lunch, Post-Lunch, Pre-Dinner, Post-Dinner,

Bed, and Sleep.

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Section 3: HCP and Home User Profiles

Figure 8. Glucose Targets, Mode Selection

You should set glucose targets in all three modes to take best advantage of the reports the

FreeStyle CoPilot system creates. For a table of the reports that use glucose targets and the modes they use, see Section 5.4: Glucose Target Modes.

Note: The glucose targets mode you select here will become the default and will display in all the reports that use glucose targets. To change the mode, return to the Glucose

Targets screen and select another mode from the Mode list. This will become the default until you change it.

3. Click on the up/down arrows for High and Low to set your glucose targets. To restore

Glucose Target Ranges to the default ranges, click Restore Defaults.

Note: Clicking Restore Defaults also restores the mode to Standard Mode and un-checks the Use Hypo/Hyper Values box.

Figure 9. Pre/Post Meal Mode with Hypo/Hyper Checked (left); All Time Periods Mode (right)

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Section 3: HCP and Home User Profiles

4. Check the Use Hypo/Hyper Values box to activate the Very Low and Very High data fields.

Figure 10. Hypo/Hyper Values Check Box

5. Click the up/down arrows for Very Low and Very High to change these values.

6. To customize the Time Periods to your normal daily schedule, click the up/down arrows next to a time period (for example, Pre-Bkfst, Post-Bkfst, Sleep, etc.) to change the time.

To restore all Time Periods to the times shown here (the defaults), click Restore Defaults.

IMPORTANT: Please customize your Time Periods before entering data into the FreeStyle

CoPilot system. If the Display Time Periods setting is turned on for the

Glucose Modal Day Report, changing the Time Periods after data has been entered will result in the data appearing based on the Time Periods. This may result in data not corresponding to the event times.

Figure 11. Time Periods

Note: The FreeStyle CoPilot system will not allow you to enter a normal daily schedule that exceeds 24 hours. If you try, you will receive an error message. Readjust the time periods to equal 24 hours.

Figure 12. Time Period Error Message

7. Click Apply to save your settings.

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3.1.5 Options Tab

1. Click the Options tab.

Section 3: HCP and Home User Profiles

Figure 13. Profile and System Options

Note: For additional information on Data Entry Options see Section 4: Entering Data into the

FreeStyle CoPilot System. For additional information on Report Options and Favorite

Report Options see Section 5: Viewing and Printing Reports. After reading these sections, be sure to select only the options that apply to your diabetes management. This will simplify your use, entry, and viewing of data/events.

3. Click to save your selections.

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Section 3: HCP and Home User Profiles

3.2 Home User: Managing Your User Profile

3.2.1 Changing or Updating Your User Profile

1. Click on the Home Page.

2. Click the tab you want (User Information, Health Profile, etc.) and change or add information as described in Section 3.1: Home User - Profile Setup. Be sure to click Apply to save your new or changed data.

3.2.2 Adding a User Profile

Some households may have more than one home user managing glucose levels. To add another home user:

1. On the Home Page, select Add User from the File menu.

Figure 14. File Menu: Add User

2. The Profile for: screen displays with the User Information tab selected. Fill in information as described in Section 3: HCP and Home User Profiles.

3.2.3 Removing a User Profile

1. Click . The User List screen displays.

Figure 15. User List

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Section 3: HCP and Home User Profiles

2. Highlight the name of the user you wish to remove.

3. Click (or select Remove User from the File menu on the User List screen). The system will ask you to confirm. If you select Yes, the user is removed.

Note: You cannot delete your own user profile. If you try, the FreeStyle CoPilot system displays the following error message:

Figure 16. Error Message

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Section 3: HCP and Home User Profiles

3.2.4 Adding an HCP Profile

You can create as many HCP profiles as you want. This is often a good way to store names, addresses, and other information about your doctors, clinics, etc.

To add an HCP:

1. From the File menu on the menu bar, select Add HCP.

Figure 17. File Menu: Add HCP Command

2. The Profile for: screen displays.

Figure 18. HCP Profile

3. Select a description of the HCP from the HCP Type list.

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Section 3: HCP and Home User Profiles

Figure 19. HCP Type List

• Select the type of HCP from the list.

• If you don’t see the one you want, type in a description

(for example, Case Manager).

4. If you know it, fill in the rest of the information for the HCP.

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3.2.5 Editing an HCP Profile

Section 3: HCP and Home User Profiles

Figure 20. UserProfile Menu: HCP List Command

2. The HCP List screen displays. Highlight the name of the HCP User.

Figure 21. HCP List

3. Click (or select Edit HCP Profile from the File menu). The Profile for: screen for the

HCP User displays.

4. Make your edits on the screen. When done, click OK.

3.2.6 Removing an HCP Profile

UserProfile > HCP List.

2. Highlight the name of the HCP User on the HCP List screen.

3. Click (or select Remove HCP from the File menu). The FreeStyle CoPilot system will ask you to confirm. If you select Yes, the HCP User is removed.

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Section 3: HCP and Home User Profiles

3.3 HCP - Setting Up Your User Profile

This section explains how to create and use HCP profiles. It describes the three parts of the HCP profile (called Tabs): User Information, Glucose Targets, and Options. Each tab is a form that you fill out using open text fields, drop-down lists, and check boxes. This sec tion describes how the settings, preferences and options you choose affect how the FreeStyle CoPilot system works and the appearance of reports you use.

This section also explains how to set up and manage other HCP profiles, as well as patient profiles.

Note: The home user profile is displayed (labeled) in the home user version of the FreeStyle

CoPilot system as User Profile. The home user profile is displayed (labeled) in the HCP version as Patient Profile.

3.3.1 What is an HCP Profile?

Each HCP should set up and use an individual HCP profile. The HCP profile allows you to set options and preferences, to customize how you would like to work with patient informa tion, reports, and other application features.

You can use your profile to specify the following, and more:

• Categories you would like to use when entering patient health information events, such as blood ketones, exercise, lab tests, and exams.

• Items that you want to see listed when you record patient health information - such as medications, exercise, and insulin doses.

• Glucose targets which change how some charts, graphs and reports are displayed.

• Whether to automatically print your favorite report(s) when you upload glucose meter or other device readings.

• The default date-range you would like to see in reports such as last seven days, one month, or three months.

Note: Preferences and settings in the HCP profile affect your use of the Manual Entry and

Reports features in the FreeStyle CoPilot system. For more information, read Section 4:

Entering Data into the FreeStyle CoPilot System, and Section 5: Viewing and Printing

Reports.

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3.3.2 HCP Profile Setup

Section 3: HCP and Home User Profiles

Select

Patient List

Select

HCP List

Figure 22. HCP Home Page

Figure 23. HCP: UserProfile Menu

3. Fill in the information you would like to provide.

• Add information by selecting items from drop-down boxes or typing information.

• Fields marked with an asterisk (*) must be filled in to create a profile.

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Section 3: HCP and Home User Profiles

Figure 24. HCP User Information Page

4. If you don’t see your HCP type in the HCP Type list, you can type a description.

5. Click to save the information you filled in, or click OK to save the information.

3.3.3 Automatic Report Printing

When you fill in information for a new profile and click Apply, the FreeStyle CoPilot system asks if you would like to enable automatic printing of reports for all devices after data upload using

Read Device.

• Click Yes or No.

Figure 25. Automatic Printing Option

Note: You can enable this option at any time, in the Options tab of your profile.

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Section 3: HCP and Home User Profiles

3.3.4 Glucose Targets Tab

1. Use the Glucose Targets tab to customize glucose target ranges. The glucose targets you set here change the display of tables, charts and graphs. See Section 5.4: Glucose Target

Modes, for a list of reports that use glucose targets, the modes they use, and ones that you can change.

Figure 26. Glucose Targets Page: Standard Mode

2. You may view the graph in three modes. Select the desired mode from the Mode list.

Figure 27. Glucose Targets Mode List

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Section 3: HCP and Home User Profiles

You should set glucose targets in all three modes to take best advantage of the reports the FreeStyle CoPilot system creates.

Standard: The glucose target ranges you set apply to all glucose readings, regardless of when the glucose reading is taken. (For example, target ranges are the same for pre-meal readings as for post-meal readings, bedtime readings, etc.)

Pre/Post Meal: The glucose target ranges you set for all pre-meal readings can be different from the target ranges for all post-meal readings.

All Time Periods: The glucose target ranges you set can be different for each time period listed: Pre-Bkfst, Post-Bkfst, Pre-Lunch, Post-Lunch, Pre-Dinner, Post-Dinner, Bed, and

Sleep.

3. Click the up/down arrows for High and Low to set glucose targets. Click Restore Defaults to restore Glucose Target Ranges to default settings.

Note: The glucose targets mode you select here will become the default and will display in all the reports that use glucose targets. To change the mode, return to the Glucose

Targets screen and select another mode from the Mode list. This will become the default until you change it.

Figure 28. Pre/Post Meal Mode

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Section 3: HCP and Home User Profiles

Figure 29. All Time Periods Mode

4. To display Hypo (low) and Hyper (high) glucose values, check Use Hypo/Hyper Values.

Optionally, adjust Very Low and Very High values.

Figure 30. Hypo/Hyper Values

Restore Defaults to restore default glucose target range values, including Hypo/

Hyper values.

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3.3.5 Options Tab

1. Select the Options tab.

Section 3: HCP and Home User Profiles

Figure 31. HCP Profile Options Page

Note: For additional information on Data Entry Options see Section 4: Entering Data into the

FreeStyle CoPilot System. For additional information on Report Options and Favorite

Report Options see Section 5: Viewing and Printing Reports. Setting these options can save time when patients arrive for clinic visits. For example, your preferred reports can be set to print whenever a device is uploaded to the FreeStyle CoPilot system.

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Section 3: HCP and Home User Profiles

3.4 HCP - Managing the HCP Profile

3.4.1 Changing or Adding to Your HCP Profile

1. From the Home page, select HCP Profile from the UserProfile menu.

Figure 32. HCP: UserProfile List

2. On the HCP Profile for: screen, select the tab you want (User Information, Glucose Targets,

Options) and change or add information as described in Section 3.3: HCP - Setting Up Your

User Profile. Be sure to click Apply to save your new or changed data.

3.4.2 Adding a Patient Profile

1. Click . The Patient List screen displays.

Figure 33. Patient List

2. Click . The Patient Profile for: screen displays. The form is similar to the form you filled in to set up your HCP profile.

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Section 3: HCP and Home User Profiles

Figure 34. Patient Profile Page

3. Fill in the information you can provide on the Patient Information tab.

• Add information by selecting items from drop-down boxes or typing information.

• Fields marked with an asterisk (*) must be filled in to create a profile.

4.

Click

Apply to save the information you filled in.

Health Profile Tab

Click the Health Profile tab. Fill out the Health Profile screen as described in Section 3.1.2:

Health Profile Tab.

Data Entry Preferences Tab

You can save time in manually entering data by setting up your patient’s Data Entry

Preferences (if you know them). For example, if a patient regularly takes a certain type of in sulin at a particular dose, you can enter it here. The same is true for their regular exercise routines and other medications they may take. The information you enter here is listed for you when you go to make manual entries.

Click the Data Entry Preferences tab. Fill out the preferences for the patient as described in

Section 3.1.3: Data Entry Preferences Tab.

Glucose Targets Tab

Click the Glucose Targets tab. Fill out the glucose targets for the patient as described in Section

3.1.4: Glucose Targets Tab. The glucose targets that you define in your own (HCP) profile are used as parameters in the reports, charts and graphs that you view. The glucose targets that you define in a patient profile are reflected in reports, charts and graphs that your patient sees when they use the FreeStyle CoPilot system.

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Section 3: HCP and Home User Profiles

3.4.3 Editing a Patient Profile

1. Click . The Patient List screen displays. Highlight the name of the patient.

Figure 35. Patient List

2. Click (or select Edit Patient Profile from the File menu on the Patient List screen).

3. The Patient Profile for: screen for that patient displays. Make your edits on the screen.

3.4.4 Removing a Patient Profile

1. Click . The Patient List screen displays.

2. Highlight the name of the patient you wish to remove.

3. Click (or select Remove Patient from the File menu on the Patient List screen). The system will ask you to confirm. If you select Yes, the patient is removed.

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3.5 Managing HCP Profiles

3.5.1 Adding an HCP Profile

Section 3: HCP and Home User Profiles

Figure 36. File Menu, Add HCP Command

3. Fill in the fields as described in Section 3.3: HCP—Setting Up Your User Profile.

3.5.2 Assigning an HCP

1. Click . The Patient List screen displays.

2. Click .

3. On the next screen, click Assign Patients to: and select the HCP from the list.

Figure 37. Assign Patients Drop-down List

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Section 3: HCP and Home User Profiles

4. Highlight the name of the patient you want to assign to this HCP and select the Access

Level (None, Read Only, Full, Owner) for the HCP.

Figure 38. Access Levels

Note: For more information about Access Levels, see Section 8: Security.

3.5.3 Editing an HCP Profile

Figure 39. HCP List

2. Highlight the name of the HCP User.

3. Click (or select Edit HCP Profile from the File menu on the HCP List screen).

4. Make your edits on the HCP Profile for: screen. Click Apply

,

then OK.

3.5.4 Removing an HCP Profile

2. Highlight the name of the HCP User you wish to remove.

3. Click (or select Remove HCP from the File menu on the HCP List screen).

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Section 3: HCP and Home User Profiles

4. The FreeStyle CoPilot system will ask you to confirm. Click Yes to remove the HCP.

5. If local patients are assigned to this HCP, the FreeStyle CoPilot system prompts you to reassign the patients to another HCP on the local computer:

Figure 40. Reassign Local Patients Message

OK. Select the HCP you are attempting to remove from the HCP Select List on the

Home Page and reassign the HCP’s patients to another HCP as described in

Section 3.5.2: Assigning an HCP.

7. After reassigning the patients, follow Steps 1 through 4 (above) to remove the HCP.

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Section 4: Entering Data Into the FreeStyle CoPilot System

4 Entering Data Into the FreeStyle

CoPilot System

There are three ways to enter events (data) into the FreeStyle CoPilot system. Each of these methods is explained in the corresponding section, below.

• Uploading Data from a Device

• Manual Data Entry

• Importing Data from Database Files

This section also explains how to export data.

CAUTION:

The FreeStyle CoPilot system assumes a single glucose calibration type, either plasma or whole blood.

4.1 Uploading Data from a Device

Use the FreeStyle CoPilot system to upload data from all supported Abbott Diabetes Care blood glucose monitoring systems. For a list of supported devices, see Appendix C: Supported Devices

and Databases.

Data from the Deltec Cozmo Insulin Pump and the FreeStyle Navigator System can be directly uploaded to the FreeStyle CoPilot system by installing the appropriate software for these devices where available. For more information, view the User’s Guide provided with each device.

You can also import data from CoZmanager, the software program for storing CozMore System data where available. For more information, see Section 4.4: Importing Data from Database Files.

IMPORTANT: To avoid losing data, upload data from your device often. Most devices hold only a limited number of historical records.

4.1.1 Connecting a Device to Your Computer

Before uploading, you must connect the device to an available COM port or USB port on your computer using an approved data cable for that device.

• One end of the data cable attaches to the device; the other end attaches to the computer.

• The connectors on the data cable will fit only into the appropriate ports on the PC and monitoring device.

WARNING:

• To avoid the possibility of electrical shock, never perform a blood glucose test while the meter is connected to the computer.

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Section 4: Entering Data Into the FreeStyle CoPilot System

CAUTION:

Ensure that the time and date are set correctly on your personal computer and other devices.

IMPORTANT: Always refer to the user’s guide that came with your device or pump for complete instructions on its use.

4.1.2 Uploading from a Device and Saving to a Profile

To upload and print reports without saving to a profile, see Section 4.1.5: Quick Print.

IMPORTANT: Any data you previously uploaded from a device will not be overwritten when you upload again from that same device. Only the new data will be added to your file.

Connect the device to the computer.

1. On the Home page, select the user whose data is being uploaded from the device.

DataEntry on the menu bar; and select Read Abbott BG Meter. (Or, click the Read

Device button on the Home page.)

Figure 41. DataEntry Menu: Read Abbott BG Meter

CAUTION:

When uploading glucose data from a device, the FreeStyle CoPilot system does not differentiate between devices that are whole-blood or plasma calibrated.

The FreeStyle CoPilot system merely uploads the data with no calculations made. Because there are slight differences between the two calibrations, you should not mix data from devices that use different calibration references. It is possible to enter duplicate data entries into the FreeStyle CoPilot Health

Management System.

The FreeStyle CoPilot system does not check the accuracy of the data the user provides. For example, a user of the Deltec Cozmo insulin pump might record the carbohydrates for a meal (for example, 25 g) and enter it into the Deltec

Cozmo software. When the user uploads the data from the pump, a meal entry

(25 g) will be created in your FreeStyle CoPilot system. If the user also manually enters a meal entry (25 g) for that same meal in the FreeStyle CoPilot Software, two meal entries would result (at slightly different times), thereby accidentally recording a total of 50 g for the meal. The user must take reasonable precautions to prevent duplication errors. For example, choose one location for recording certain data types (i.e., on a single device or in a particular software program).

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Section 4: Entering Data Into the FreeStyle CoPilot System

Note: When a device has been detected but cannot be identified as belonging to a specific user, the FreeStyle CoPilot system will prompt you to assign the device to an existing user or to add a new user:

Figure 42. Assign Device Dialog Box

CAUTION:

Do not upload data from any device that has recorded data for more than one person. The FreeStyle CoPilot system cannot identify if data on a device has ever been recorded for more than one person. All data stored on a device is uploaded to the database for the person associated with the device in the FreeStyle CoPilot system.

3. The data from the device is uploaded to your PC. A fully filled progress bar indicates when the upload is complete. A summary of the upload displays in a pop-up window. Press OK to continue.

Figure 43. Upload Summary

Note: If you receive an error message, check the device connection. Also, click DataEntry >

Assign Default Device to verify the device setting. After the first upload from a device, the FreeStyle CoPilot system will identify that device and associate it with the assigned user.

Note: More than one device may be associated with a single user.

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.1.3 Undoing a Device Upload

You can delete (undo) the data uploaded from the most recent device that was newly assigned to a user as long as you have not selected another user, closed the application, or performed a

Quick Print (see Section 4.1.5: Quick Print).

Figure 44. DataEntry Menu: Undo Upload

2. The FreeStyle CoPilot system will undo your last upload from a newly assigned device.

Note: If Undo Upload is grey, you cannot undo the last upload.

4.1.4 Data Transfer between Patient Profiles (HCPs Only)

If data was uploaded from a device into an incorrect patient profile, you can transfer the data associated with that device into the correct patient profile. The device association will also be reassigned to the correct patient profile.

Transferring Data between Patient Profiles:

1. On the Home page, select the HCP and Patient from which to transfer data (the Patient

Profile selected here is referred to as the Source Profile).

3. The selected patient profile from the Home page is highlighted. To select a different Source

Profile, click on the patient name to highlight it.

4. Click the Transfer Data Between Patients button.

Figure 45. Patient List: Data Transfer

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Section 4: Entering Data Into the FreeStyle CoPilot System

5. In the Transfer From list, select the device that was uploaded to an incorrect patient profile.

6. In the Transfer To list, select the Patient to transfer the data to (the Patient Profile selected here is referred to as the Target Profile). Note: The Data Transfer can only be performed between patient profiles assigned to the same HCP.

Figure 46. Data Transfer Confirmation

8. A confirmation message will appear asking you to confirm the data transfer. Click OK to continue.

9. If the data transfer was successful, a message will appear indicating that the data transfer had completed successfully.

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.1.5 Quick Print

Quick Print will upload your device data and automatically print the selected Favorite Reports without having to create a new user/patient profile. See Section 5.3.1: Report Options (User or

HCP Profile) for instructions to select your Favorite Reports to print.

Note: If you had an earlier version of the FreeStyle CoPilot system (version 4.1 or earlier) installed, the Favorite Reports that you had previously selected may need to be selected again.

Note: Any data you upload using Quick Print will not be permanently saved to a profile. The uploaded data will only be temporarily stored in a Guest profile until one of the following events occurs:

• Uploading data from a device

• Switching to a different user/patient profile

• Logging off or closing the FreeStyle CoPilot system

In addition, any reports that are open on the screen will be immediately closed when you use

Quick Print.

To upload and save data to a profile, see Section 4.1.2: Uploading from a Device and Saving to a

Profile.

To use Quick Print:

Connect the device to the computer.

1. On the Home page, click the Quick Print button. (Or, click DataEntry > Quick

Print Abbott BG Meter from the menu bar.)

Note: To use Quick Print for other supported Abbott Diabetes Care blood glucose monitoring systems that require the installation of additional software for those devices (e.g.

FreeStyle Navigator System), you must click the corresponding DataEntry > Quick

Print <device> from the menu bar.

2. As the data from the device is uploaded, a screen appears indicating the data upload progress and print status. When the reports have completed printing, the Home page will be displayed.

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2 Manual Data Entry

The FreeStyle CoPilot system allows you to add, edit, hide, and unhide manually entered information. When manually recorded events are hidden, they are omitted from views and reports but are not removed from your database.

WARNING:

• Be sure to enter and check all values carefully. The FreeStyle 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.

CAUTION:

It is possible to enter duplicate data entries into the FreeStyle CoPilot Health

Management System. The FreeStyle CoPilot system does not check the accuracy of the data the user provides. For example, a user of the Deltec Cozmo insulin pump might record the carbohydrates for a meal (for example, 25 g) and enter it into the Deltec Cozmo software. When the user uploads the data from the pump, a meal entry (25 g) will be created in your FreeStyle CoPilot system. If the user also manually enters a meal entry (25 g) for that same meal in the FreeStyle

CoPilot system Software, two meal entries would result (at slightly different times), thereby accidentally recording a total of 50 g for the meal. The user must take reasonable precautions to prevent duplication errors. For example, choose one location for recording certain data types (i.e., on a single device or in a particular software program).

Manually recordable events include the categories listed below. Their icons are pictured with them. These icons are displayed in the Diary List to represent the type of event on the list; see

Section 5.6.3: Diary List.

Icon Event

Glucose reading

Glucose Control reading

Bolus Insulin

Meal

Exercise

State of health

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Medication

Medical exam

Lab Test Result

Ketones (blood)

Ketone Control readings

Notes (miscellaneous events, etc.)

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2.1 Entering a Glucose Reading

1. Click the large Manual Entry button

Glucose Reading displays.

. The Data Entry screen for entering a

Figure 47. Glucose Reading Data Entry

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

2. If the date, time, and time period of the glucose reading is different from the current display, adjust the Date, Time, and Time Period.

3. Record the value of your glucose reading in the Glucose Value field. Optionally:

• In the Sample Site field, select the site from which the reading was taken (finger,

forearm, etc.).

• In the Hours Since Last Meal field, select the time of your last meal.

• If you wish, enter the calibration code or lot number from your glucose monitor in the

Calibration Code field.

• If this is a Control Solution reading from your glucose monitor, check the Control

Reading box.

• Enter any comments you may have about the reading in the Comment field.

4. Because you are entering data at the keyboard, the Data Source is set to Manual.

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2.2 Recording an Insulin Dose

CAUTION:

Contact your healthcare professional for guidance on determining and using your insulin dosages, insulin-to-carbohydrate ratios, and insulin sensitivities.

1. Click the Insulin icon on the Data Entry screen. The Bolus Insulin data entry screen displays.

Figure 48. Insulin Data Entry

2. Adjust the Date, Time, and Time Period fields for the insulin dose you are recording.

3. Click directly under the Insulin Name/Type column, and select or type in the name of your insulin.

Note: To add items to the Insulin list, refer to Section 3.1.3: Data Entry Preferences Tab. Also, to add or hide items, see Section 4.3: Customizing Data Lists.

4. Enter the correct dosage in the Dosage (Units) column.

5. In the Injection Type list, select the correct injection type: bolus, injection, meal,

correction, combination, dual wave, or square wave.

Note: Verify that the box is checked

next to the entry. Otherwise, the data will not be recorded and will not appear on your Diary List.

6. Optionally, add a comment in the Comment box.

8. The entry is added to the Diary List.

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2.3 Recording a Meal

CAUTION:

Contact your healthcare professional for guidance on determining and using your prescribed carbohydrate intake.

Note: See Section 4.3: Customizing Data Lists to make changes to the Meals list.

1. Click the Meal icon on the Data Entry screen. The Meal data entry screen displays.

Figure 49. Meal Data Entry

2. Adjust the Date, Time, and Meal fields for the meal you are entering.

3. Enter an item in the Food Item list. If your meal includes more than one item (drink, main

course, fruit, etc.), list each item in the Food Item list.

Note: You will need to know the serving size and the carbohydrates per serving.

Svgs: Select the number of servings.

Carbs (g): Enter the grams of carbohydrates per serving.

Total Carbs (g): Total grams of carbohydrates.

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Total

Carbohydrates for a multi-item meal

Figure 50. Multi-Item Meal with Total Carbohydrates Shown

4. Check the Use Only Favorite Foods to display your list of favorite foods.

Note: To customize items in the Food Item list, see Section 4.3: Customizing Data Lists .

5. Enter any comments in the Comment box (optional).

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2.4 Recording Exercise Activity

1. Click the Exercise icon screen displays.

on the Data Entry screen. The Exercise data entry

Figure 51. Exercise Data Entry

2. Adjust the Date, Time, and Time Period fields for the exercise activity you are entering.

3. Enter or select an activity in the Type list.

Note: To customize (add or hide) items in the Exercise list, refer to instructions for the Section

3.1.3: Data Entry Preferences Tab. Also, see Section 4.3: Customizing Data Lists.

4. Select the Duration, and Intensity of the activity.

Duration: Length of activity (in minutes and hours: 0:30, 1:15, etc.). You can select from the list or type in the duration of the activity.

Intensity: Intensity of the activity (none, low, medium, or high).

Note: Confirm that the box

next to the entry is checked. Otherwise, the data will not be recorded and will not appear on your Diary List.

5. Enter any comments in the Comment box (optional).

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4.2.5 Recording State of Health

1. From the Data Entry screen, click the Health icon screen displays.

Section 4: Entering Data Into the FreeStyle CoPilot System

. The State of Health data entry

Figure 52. State of Health Data Entry

2. Adjust the Date and Time fields for the health condition you are recording.

3. Type in or select the State of Health event.

4. Use the Comment box to further describe your condition (optional).

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2.6 Recording a Medication Event

1. Click the Medication icon displays.

on the Data Entry screen. The Medication data entry screen

IMPORTANT: Medication Event refers to all medications you take except insulin.

Figure 53. Medication Data Entry

2. Adjust the Date, Time, and Time Period fields for the medication event you are recording.

3. Type in or select the name of your medication in the Medication list.

Note: To customize (add or hide) items in the Medication list, refer to instructions for Section

3.1.3: Data Entry Preferences Tab. Also, see Section 4.3: Customizing Data Lists .

4. Type in the dosage (for example, 2 mg) in the Dosage column. If you don’t know the dosage, check the medication bottle or ask your HCP.

5. Select the number of pills you take from the # of Pills list.

Note: Confirm that the box next to the entry is checked. Otherwise, the data will not be recorded and will not appear on your Diary List.

6. Enter any comments in the Comment box (optional).

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2.7 Recording a Medical Exam/Doctor Visit

1. Click the Exam icon displays.

on the Data Entry screen. The Medical Exam data entry screen

Figure 54. Medical Exam Data Entry

2. If necessary, adjust the Date for the medical exam you are recording.

3. Type in the exam type in the Exam Type list.

Note: To customize items in the Medical Exam list, see Section 4.3: Customizing Data Lists .

4. If you know it, type the name of the HCP into the Examined By field.

5. Enter any comments in the Comment box (optional).

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2.8 Recording a Lab Test Result

1. Click the Lab icon displays.

on the Data Entry screen. The Lab Test Result data entry screen

Figure 55. Lab Test Result Data Entry

2. If necessary, adjust the Date for the lab test result you are recording.

3. In the Test Type field, enter or select the lab test you had (for example, Cholesterol LDL).

Note: To customize items in the Lab Test Result list, see Section 4.3: Customizing Data Lists.

4. If you know the Result Value, the Units, and the Reference Range for the lab test you had, type the information into the appropriate fields.

IMPORTANT: Be careful to type numbers only into the Result Value field. For example, if your A1C test result is 7.6%, type 7.6 in the Result Value field and type % in the Units field. If you type the units in the Result Value field, the entry for this lab test will not be displayed correctly in the reports you generate.

5. Enter any comments in the Comment box (optional).

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2.9 Recording a Ketone Reading

1. Click the Ketones icon in the Data Entry screen. The Ketones (Blood) data entry screen displays.

Figure 56. Ketones (Blood) Data Entry

2. If necessary, adjust the Date, Time, and Time Period fields for the ketone reading you are recording.

3. Enter the result of the ketone reading in the Value (mmol/L) field.

4. From the Sample Site list, select the sample site.

5. Type in the ketone Lot Number, if you know it.

6. Check the Control Reading box if this is a control reading.

7. Enter any comments in the Comment box (optional).

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.2.10 Recording a Note (or Miscellaneous Event)

1. Click the Note icon in the Data Entry screen. The Notes data entry screen displays.

Figure 57. Notes Data Entry

2. If necessary, adjust the Date, Time, and Time Period fields for the information you are recording.

3. Type your note or information about a miscellaneous event in the Comment box.

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4.3 Customizing Data Lists

To make manual data entry faster and easier, you can customize items in the lists. You can:

• Add new items to lists

• Hide items that you want keep in a list but do not want to see

• Designate favorite food items

Items you add to a list are marked with the User Entry icon . Items provided by the

FreeStyle CoPilot system are marked with .

4.3.1 Customizing Data Entry Lists

Figure 58. Customize Data Entry Lists

Customize Data Entry Lists screen displays. Select Test Types (or other desired list) from the Select List to Customize list.

Figure 59. Select List to Customize List

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Section 4: Entering Data Into the FreeStyle CoPilot System

3. Add an item to the list. Type the name of the test under the Item heading (for example,

Serum theophylline level). The User Entry icon

appears next to the new entry.

Figure 60. Test Types List

4. Check the Hide box for items that you don’t want to see listed when you record a test result.

For the Food Item list you can also mark an item as a favorite.

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Section 4: Entering Data Into the FreeStyle CoPilot System

4.4 Importing Data from Database Files

You can import some databases from other programs into your FreeStyle CoPilot system using the Import function.

4.4.1 Importing a Database

Some databases can be imported directly into the FreeStyle CoPilot system. They include databases created by:

• Precision Link Diabetes Data Management System (V. 2.5 or higher)

• FreeStyle Connect Data Management System

• CoZmanager System

Databases from these programs are detected by the FreeStyle CoPilot system as long as the software for the programs that created them are installed on your PC. Otherwise, you may need to browse for the database to import by selecting DataEntry > Import > Browse for File on the menu bar.

Note: The CoZmanager System software must be Rev. D or higher. The internal Deltec Cozmo pump software must be Rev. F or higher. The FreeStyle CoPilot system detects the software revisions and will not allow the import if it detects the wrong revision(s).

WARNING:

• Imports from the CoZmanager System include data only from full days (24 hours), not partial days. This is so that CoZmanager can provide daily totals.

4.4.2 Importing a Supported Database

1.

From the menu bar, select DataEntry > Import, then select the database file you want to import.

Figure 61. DataEntry Menu; and Import Menu

2. If the database is detected, you will be asked to confirm the import operation. Otherwise, if the database is not detected, the file browser window will open to allow you to select the database file to import.

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4.4.3 Importing Data from a File

You can import a *.tab or *.xml file after the file is specially formatted for the FreeStyle CoPilot system by following the instructions provided in the Importing TAB and XML Data manual. For a copy of this manual, contact your local Abbott Diabetes Care office, or visit our web site at

www.AbbottDiabetesCare.com and look for your country contact information.

Perform the following steps to import a *.tab or *.xml file:

1. Select the profile that you want to import data into.

2. From the menu bar, select DataEntry > Import > Import Events From File.

Figure 62. Import Menu: Import Events From File

3. When the file browser window opens, select the file type (*.tab or *.xml) and the file to import, then click Open.

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4.5 Exporting Data

Exporting data in the FreeStyle CoPilot system is similar to archiving data (see Section 7.1:

Archiving Data) except that the exported data is not removed from the FreeStyle CoPilot system’s database.

To export data:

Figure 63. Reports Menu

3. Adjust the date to include the data you want to export.

Figure 64. Diary List: Date Adjustment

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

Export from the File menu on the Home page. When the file browser window opens, select the folder where you want to save the file that is exported.

5. Select the file type (*.tab or *.xml) in the Save as type field.

6. Enter the name of the file in the File name field. Click Save.

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Section 5: Viewing and Printing Reports

5 Viewing and Printing Reports

With the FreeStyle CoPilot system, data entered manually or uploaded from a device can be displayed on the screen in a variety of ways. Statistical and other calculations are automatically performed on the data, and the results are put into tables and graphs. A report is one or a set of these tables and graphs.

Reports

Toolbar

Figure 65. Glucose Modal Day Report

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

Any report can be customized to your preferences. Many variables can be adjusted in real time as you view the report. These are described in Section 5.3: Personalizing Report Settings.

Data cannot be changed in any reports except the Diary

List. Corrections or additions to manually entered data can be made by accessing the Data Entry screen for the event. Refer to the individual report sections for instructions on calling up the Diary

List

entry for past events.

The changes display immediately on any affected report.

Once opened, a report remains open until you close it. Any number of reports can be open at

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Section 5: Viewing and Printing Reports

the same time; only one is visible. Each open report shows as a tab at the top of the screen.

All open reports apply the same active date range, data filter options, and display features.

Changing these settings in any report changes them for all other open reports.

CAUTION:

For glucose and insulin entries, if the Time Period is changed manually, all reports will still be displayed as defined by the Time Period setting in the User

Profile.

Note: Any decimal calculations that are 0.4 or less are rounded to 0. Any decimal calculations that are 0.5 or greater are rounded to 1.

5.1 Viewing Reports

See Section 5.3.1: Report Options (User or HCP Profile) for instructions to select your default report and date range interval.

1. To open your default report, click the View

Report button on the Home page.

2. To open another report, click any report listed in the Reports menu. The first report remains open but hidden, except for its tab. The new report displays with the same date range, active data filters, and display features.

Figure 66. Reports Menu

3. To display a report, click the desired tab on the reports tab bar.

Figure 67. Reports Tab Bar

4. To close the active report, click the Close

Report icon on the reports tab bar.

When you view reports, you can select the date or Date Range for information to view, and you can use interactive Data Symbols to see more detailed information.

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5.1.1 Date Range

Use controls on the Reports Toolbar to select the date range (time period) for the information that you want to view in one or more reports. You can select a pre-selected time period, and you can also select custom dates and date-range intervals.

Figure 68. Reports Toolbar

To select the date or date range for information you want to view, use one or more of the following tools:

Custom Date Range List - Select any time period (such as Last 1 Month or Last 3

Months) in the Custom Date Range List. The dates for your selected date range are automatically entered in the Calendar Date Selection Tool.

Figure 69. Custom Date Range, Calendar Date Selection, and Arrow Tools

Calendar Date Selection Tool - To select a specific date range, enter dates in the calendar range selection tool. You can type in the date(s) in the format: mm/dd/yyyy (or dd/mm/ yyyy depending on your operating system), or you can use the down arrows to open the calendar. Use the left and right arrows above the calendar to select the month and year.

Highlight any day in the calendar.

Previous and Next Arrows - After you have selected a date range, use the previous and next arrows to “jump” or “scroll” back or forward in time. For example, if you have selected the Last 7 days date range (such as from May 1 to May 7), you can click the previous arrow to change the date range seven days earlier. The same effect occurs forward and backward for any date range interval, whether days or months.

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5.1.2 Data Symbols

You can use the symbols used in reports to link to related or more complete information.

Interactive data symbols include data points on a graph, regions on a chart, and cells in a table.

Your pointer becomes the hand icon when it is hovering over an interactive data symbol. For example, by hovering the pointer over a triangle (meter blood glucose reading data symbol), you can display the value, date, and time of the reading in a pop-up field. To go to the Glucose

Reading event in the Diary List, double-click the triangle.

On the Daily Combination and Weekly Pump reports:

• Carbohydrate events are represented by dark yellow circles; the size of each circle is proportional to the carbohydrate value.

• Insulin data is represented by light green, dark green, and dark red bars.

On all reports (except for the Diary List):

• Glucose readings are represented by squares (manual entries), triangles (meter blood glucose readings), and circles (continuous glucose readings) which can be linked by a line.

5.1.3 Target Range Colors

Glucose readings are separated into target ranges, which are represented on graphs and tables either in distinctive colors or in distinctive patterns for black-and-white printing.

You can display the data in three ranges (High, Within, and Low) or five ranges (Very High, High,

Within, Low, and Very Low). These choices can be changed at any time on the Miscellaneous tab of the Report Configuration form by checking or un-checking the Show Hypo/Hyper box.

Each target range is associated with a unique color: Very High (turquoise), High (purple), Within

(green), Low (yellow), and Very Low (red).

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Section 5: Viewing and Printing Reports

5.2 Printing and Sending Reports

To view a menu of options for printing and sending a report, click the down arrow next to the

Print icon

on the Reports toolbar.

Figure 70. Print Menu

• To print the report in its currently displayed configuration (format), select Print. The report prints on your printer.

• To verify or change the page setup options (margins, paper size, etc.), click Page Setup.

Review or make changes to the Page Setup form.

• To preview the report before printing it, click Print Preview.

• To print one copy of each of your favorites on the default printer, click Print Favorite

Reports for..., then select the device type you want to print the reports for.

• To save the open report in the Adobe Acrobat (PDF) file format, click Save as PDF file.

Select this option if the E-Mail Report to option (below) does not automatically create a

*.pdf file. Or select this option if you have a printing problem and want to print from

Adobe Acrobat. (The Adobe Acrobat Reader program must be installed on your computer. Go to www.Adobe.com for instructions on downloading this program.)

• To e-mail the report as an attachment, click E-Mail Report to. The report is attached to the e-mail message as a *.pdf file. (You do not have to Save as PDF file first.)

Note: The E-Mail Report to option is designed to access your e-mail account and open a new e-mail message screen. If your e-mail account is not detected automatically, you will need to e-mail the report manually. To do so:

• With the desired report open, select the Save as PDF file option from the Print drop-down box on the Reports toolbar. Then manually attach the *.pdf file to an e-mail.

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5.3 Personalizing Report Settings

Reports can be personalized to your preferences by making choices for Report Options on the

Profile for: screen and by activating data filters and display features on the Report Configuration screen.

5.3.1 Report Options (User or HCP Profile)

On the Profile page, click the Options tab.

Report

Options

Figure 71. User Profile Screen with Options Tab Active

The Report Options are on the right. The Default Report is the report you want to display when you select on the Home page.

• Select your preferred default report in the Default Report Type list.

• Select your preferred default date range interval for the default report from the Default

Report Date Range list.

• Select Print Using Adobe Acrobat to enable the PDF printer option. Use this option if a report does not print correctly on your printer.

• Select whether to attach a Statistics Summary list whenever a report is printed.

• Select the number of characters at the end of the User (or Patient) ID to display on report headers. Select 0 (zero) if the ID is not to be displayed on report headers.

• To select your Favorite Reports, check any report or set of reports you prefer to print when you select Print Favorite Reports After Device Upload (using Read Device) or when you use Quick Print (see Section 4.1.5: Quick Print). You may select a different set of

Favorite Reports for each type of device installed by selecting the appropriate device tab (if applicable). For each report, complete the Date Range. Selected date ranges may be different for different reports.

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Note: A separate Statistics Summary does not automatically print with your Favorite

Reports even if Include Statistics Summary With Each Report Printout is selected.

Note: The Statistics Summary is not attached to reports you email. It also does not display when you select Print Preview even though it will be printed with the report.

5.3.2 Data Filters

Data filters are tools for selecting the types of data you want to include in a report. You select the data filters you want by clicking the Report

Configuration

icon on the Reports toolbar and choosing items from the Event

Types, Time Periods, and Week Days sections on the

Data

Filter tab. Click Apply to save any changes. Click OK to save changes and return to the report.

Figure 72. Report Configuration: Data Filter Tab

Data filters and display features (Section 5.3.3) apply to all reports except the HCP Group

Analysis Report. Changing data filter or display settings in any report changes them for all other open reports. Not all filters are configurable in all reports.

Event Types

There are two types of Glucose events: Glucose (BG) refers to results from a blood glucose meter. Glucose (CM) refers to results from a continuous glucose monitoring system.

Time Periods - If you de-select the Pre-Breakfast, Pre-Lunch, or Pre-Dinner options on the

Data Filter tab, the carbohydrates for the corresponding meal (breakfast, lunch, or dinner), if entered manually or uploaded into the FreeStyle CoPilot system, will not be displayed on the reports that would ordinarily show this information.

Week Days - Week Days filters do not apply to the Daily Combination View Report.

Several data filters can be applied together. For example, you could uncheck Exercise events in the Event Types filter and check only Tuesday and Friday in the Week Days filter.

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5.3.3 Display Features

Some display features are configured on the Miscellaneous tab of the Report Configuration screen.

Figure 73. Report Configuration: Miscellaneous Tab

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GENERAL ITEMS

Display Time Periods

Show Hypo/Hyper

Show Glucose Targets

Show Hidden Data

Show Text on Graphs in Daily

Combination Report

Show Legend

Color

Devices

Select to display time periods on the report.

Deselect to display glucose readings in three target ranges: and

Low

.

Select to display glucose readings in five target ranges:

High

,

Within

,

Very High

,

High

,

Within

,

Low

, and

Very Low

.

Note: If you select to display glucose data in three target ranges (the

Show

Hypo/Hyper

box is not checked),

Very High

readings display as

High readings (purple) and

Very Low

readings display as

Low

readings (yellow).

Select to display glucose readings data in their unique color or pattern (black and white display).

Select to view all entries in the

Diary List

, including those you marked

Hide

.

Select to view numerical values of glucose readings.

Select to display the legend in all applicable reports. Displaying the legend will help you understand the report.

Select to display glucose target ranges in their unique colors. See Section

3.1.4: Glucose Targets Tab for information about glucose target ranges.

Deselect to display glucose target ranges in their distinctive patterns for black-and-white printing.

This list includes all installed meters and other supported devices. See

Appendix C: Supported Devices and Databases.

If you have installed only one device, you cannot deselect the device (to filter out the data). If you have two or more devices installed, one device must always be selected.

Figure 74.

Black-and-White Display Patterns (Screen Detail)

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5.4 Glucose Target Modes

The following is a table of the reports that use glucose targets, and the modes they use:

Report

Diary List

Glucose Modal Day

Glucose Line

Glucose Average

Glucose Histogram

Glucose Pie Chart

Logbook

Lab and Exam Record

Statistics

Daily Combination View

Weekly Pump View

HCP Group Analysis

Home User Version

Glucose Target Mode

User’s choice

User’s choice

Standard Mode

Standard Mode

Standard Mode

User’s choice

User’s choice

Not applicable

User’s choice

User’s choice

Standard Mode

Not applicable

HCP Version

Glucose Target Mode

HCP’s choice

HCP’s choice

Standard Mode

Standard Mode

Standard Mode

HCP’s choice

HCP’s choice

Not applicable

HCP’s choice

HCP’s choice

Standard Mode

Standard Mode

5.5 Definition of a Day

Depending on the report, a day (24 hours) is calculated from midnight to midnight or pre-breakfast to pre-breakfast. The various reports define a day as follows:

Report

Diary List

Glucose Modal Day

Glucose Line

Glucose Average

Glucose Histogram

Glucose Pie Chart

Logbook

Lab and Exam Record

Statistics

Daily Combination View

Weekly Pump View

HCP Group Analysis

Definition of a Day

Midnight to Midnight

Pre-breakfast to Pre-breakfast

Midnight to Midnight

Pre-breakfast to Pre-breakfast

Midnight to Midnight

Pre-breakfast to Pre-breakfast

Pre-breakfast to Pre-breakfast

Midnight to Midnight

Pre-breakfast to Pre-breakfast

Midnight to Midnight

Midnight to Midnight

Midnight to Midnight

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5.6 Descriptions of Reports

Carefully review the earlier sections in this section before reading these descriptions. The earlier material provides important overall guidelines for viewing, navigating, and personalizing reports.

WARNING:

• Have your healthcare professional review and confirm your entries before using this data. Serious effects on your health could result from relying on or using incorrect entries.

CAUTION:

If any event data is Hidden, a comment will appear at the top of the report indicating the number of Hidden events. Hidden data will not be displayed or included in the calculations for that report.

5.6.1 Two Week Glucose Summary with Logbook

The Two Week Glucose Summary with Logbook provides a consolidated view of the following individual reports in a single summary report for a specified 2-week date range:

Glucose Modal Day (see Section 5.6.4)

Glucose Pie (see Section 5.6.8)

Statistics (see Section 5.6.11)

Logbook (see Section 5.6.9)

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• To select the 2-week date range for the data you want to view, use the date field on the right to select the last date you want to see.

• The number of pages that will print is dependent on the number of glucose entries in the

Logbook within the specified 2-week date range.

Note: If there are a large number of glucose entries within the specified 2-week date range (e.g. when uploading data from a continuous glucose monitoring device), it is highly recommended that the Two Week Glucose Summary report be selected instead which does not include the Logbook in order to minimize the number of printed pages.

To maximize legibility in this consolidated summary report format, there are minor formatting adjustments in addition to the following differences from the individual reports:

• The Statistics section is limited to the following statistics: # Readings, Highest, Lowest,

Average, Standard Deviation, and Within %.

• The Logbook section is limited to displaying glucose values only. The insulin and carbohydrate columns do not appear.

• The glucose values in the Logbook section that are not within range (i.e. Low or High glucose values) are in bold italic instead of being in distinctive colors.

• The timestamps have been removed for the individual glucose values in the Logbook section. Instead, the user-specified Time Periods (pre-meal and post-meal) appear under the column headings for each meal.

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Section 5: Viewing and Printing Reports

5.6.2 Two Week Glucose Summary

The Two Week Glucose Summary, similar to the Two Week Glucose Summary with Logbook above, provides a consolidated view of the following individual reports in a single summary report for a specified 2-week date range:

Glucose Modal Day (see Section 5.6.4)

Glucose Pie (see Section 5.6.8)

Statistics (see Section 5.6.11)

If there are a large number of glucose entries within the specified 2-week date range (e.g. when uploading data from a continuous glucose monitoring device), it is highly recommended that the Two Week Glucose Summary report be selected which does not include the Logbook in order to minimize the number of printed pages.

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5.6.3 Diary List

The Diary

List is a table of all data entries made over the specified date range. Each row corresponds to one event.

Figure 75. Diary List

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

• A day (24 hours) is defined as midnight to midnight.

• The glucose target mode is your choice.

• Columns are for data categories. The Value column displays the value in units appropriate to the event type. For Glucose

Reading

events, the Value cell is shaded with the unique color for the glucose target range.

• To open the original Data Entry screen for a specific event, double-click any cell in the row.

• Data that was entered manually can be edited. Some fields in uploads from devices can be edited.

WARNING:

• Some Deltec Cozmo Insulin Pump events such as disconnect, reconnect and cancelled boluses are not included.

Note: When uploading data from a device, or when importing data from Precision Link System

(version 2.5 or higher), glucose readings greater than 500 are displayed as “501”, and readings less than 20 are displayed as “19”.

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Section 5: Viewing and Printing Reports

Hide/Un-Hide Events

By default, the Diary List contains a Hidden column (far-left). Entries you have chosen to hide will display in the Hidden column.

Hidden column

Figure 76. Diary List with Hidden Column Displayed

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

Figure 77. Reports: Context Menu

• To Hide an event, select the row, and right-click. Click Hide Data on the context menu.

When prompted to confirm, click Yes to hide the data. Pump Insulin data cannot be hidden.

• To Un-Hide an event, click any cell in a row that displays in the Hidden column.

Next, right-click and select Un-Hide Data from the context menu. The event is no longer hidden.

• The Diary List displays Hidden data and the Hidden column by default. To not display

Hidden data on the Diary List:

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Section 5: Viewing and Printing Reports

• Click

on the Reports toolbar. Click the Miscellaneous tab and uncheck the box to

Show Hidden Data. Click OK. The Diary List will no longer display Hidden data and the

Hidden column.

Hidden column and hidden data are not displayed

Figure 78. Diary List: Hidden Column and Hidden Data Not Displayed

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

• Only the Diary List can display Hidden data. In all other reports, Hidden events are not displayed or included in the calculations even if you checked the box to Show Hidden

Data on the Miscellaneous tab.

• The Hidden column must be displayed in order to Un-Hide events. It is recommended to always display Hidden data.

Columns

You can customize the columns in the Diary List by changing the order of events in a column, adding and removing columns, and resizing columns. These changes are saved when you close the Diary List or exit the FreeStyle CoPilot system.

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Section 5: Viewing and Printing Reports

Change Order of Events

To change the order of the events in the Diary List, click any of the following column heads:

Hidden

Type

Date

Time

Time Period

Value

Description

Other Info

Comment

Hidden entries display in descending order (latest date at the top).

Click to display all hidden entries at the top. Click again to display all hidden entries at the bottom.

Events are grouped by Event Type. Click to reverse the order.

Events display in ascending order (earliest date at the top) or descending order (latest date at the top). Click to reverse the order.

The events display in chronological order. Click to group entries by time of day.

Time periods are arranged in chronological order. Click to list the time periods in alphabetical order.

Click to display the values in alphanumeric order. Click again to reverse the alphanumeric order.

Events are displayed in ascending alphabetical order. Click to reverse the order.

Click to reverse the order.

Events with Comments display in ascending alphabetical order.

Events with no comments display first. Click to reverse the order.

Remove/Add Columns

• To remove a column from the report, drag-and-drop the column head cell off the table.

• To add a column to the report, right-click anywhere on the table to call up the context menu. Select Customize Columns. The Customization list displays. From the list, select the column head you want to add. Drag-and-drop it to the preferred position in the column-head row. Two green arrows display to help you position the column.

Figure 79. Customization List

Move/Resize Columns

• To move columns left or right in the table, drag-and-drop the column-head cell to the preferred position in the column head row.

• To adjust the width of any column, use the sizing tool that becomes active when you hover your pointer over the right margin of the column-head cell.

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Section 5: Viewing and Printing Reports

5.6.4 Glucose Modal Day Report

The Glucose Modal Day Report shows the daily pattern of glucose levels over the specified date range. A line linking the readings for a specific date can be displayed or hidden.

List of all days in date range

Figure 80. Glucose Modal Day Report

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

• The horizontal axis is a 24-hour timeline. All readings for all dates display on the same timeline. The vertical axis plots the glucose level.

• A day (24 hours) is defined as pre-breakfast to pre-breakfast.

• The glucose target mode is your choice.

• Each data symbol represents one glucose reading. For the date, time, and value of the reading, hover the pointer over the data symbol.

HI/LO indicates a reading outside the working range of the meter.

• A list of all days in the date range displays to the right of the graph.

• To link all the readings for a single day with a line, click the date of interest in the list of all days in the date range. All the data symbols for that date change color and a line is drawn linking them. Click any data symbol or in the line to cancel the line.

• To zoom in on (magnify) an area of the graph, place the mouse in the upper left of the graph, press and hold the left mouse button, and drag to the lower right corner of the graph. Repeat this action to further magnify the area of interest. To return the graph to its original state, place the mouse in the lower right of the graph, press and hold the left mouse button, and drag to the upper left corner.

• To go to the Glucose Reading entry in the Diary List, double-click the data symbol.

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Section 5: Viewing and Printing Reports

IMPORTANT: Please customize your Time Periods before entering data into the FreeStyle

CoPilot system. If the Display Time Periods setting is turned on for the

Glucose Modal Day Report, changing the Time Periods after data has been entered will result in the data appearing based on the Time Periods. This may result in data not corresponding to the event times.

CAUTION:

If the user reconfigures the Glucose Modal Day report by turning Display Time

Periods OFF, the Glucose Modal Day report will go back to plotting the data point based on the user-configured time period and remove the Time Period labels across the top of the graph. This can result in a data point for any glucose reading, where a user manually assigned the time period, being displayed in a different location on the Glucose Modal Day graph. When the Display Time

Periods is ON, the glucose reading that has a manually assigned time period will be displayed on the graph in the middle of the time period assigned.

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Section 5: Viewing and Printing Reports

5.6.5 Glucose Line Report

The Glucose Line Report is useful for seeing trends in glucose levels. It plots each glucose reading over the specified date range.

Figure 81. Glucose Line Report (Show Line Is Activated)

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

• The horizontal axis is a timeline of the entire date range. The vertical axis plots the glucose level.

• A day (24 hours) is defined as midnight to midnight.

• The glucose target mode is Standard.

• Each data symbol represents one reading; a solid line connecting them can be displayed or hidden. To hide the line, point to any data symbol, and right-click. Click Show/Hide

Line on the context menu.

• For the date, time, and value of the glucose reading, hover the pointer over the data symbol.

• To zoom in on (magnify) an area of the graph, place the mouse in the upper left of the graph, press and hold the left mouse button, and drag to the lower right corner of the graph. Repeat this action to further magnify the area of interest. To return the graph to its original state, place the mouse in the lower right of the graph, press and hold the left mouse button, and drag to the upper left corner.

• To go to the event data in the Diary List, double-click the data symbol.

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Section 5: Viewing and Printing Reports

5.6.6 Glucose Average Report

The Glucose Average Report may help identify times of the day that may need more testing or improved control. The report separates all glucose readings over the specified date range into pre-meal (yellow bars) and post-meal (blue bars) groupings and averages the values for each group.

For convenience, there are two graphs. One shows pre-meal and post-meal glucose averages over the date range by meal. The other shows overall pre-meal and post-meal averages by day over the date range.

Figure 82. Glucose Average Report: By Meal

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

• The asterisk (*) next to the title indicates that the report does not include sleep or bedtime data.

• The glucose target mode is Standard.

• The horizontal axis is a timeline showing the time periods (pre-meal and post-meal) and the average for all meals. The vertical axis plots the glucose level.

• Each bar shows the average value of all glucose readings over the date range for the specific time period (for example, the average value of all pre-breakfast readings).

• A day (24 hours) is defined as pre-breakfast to pre-breakfast.

• Double-click any bar to call up the Diary List entries for these events.

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Section 5: Viewing and Printing Reports

Figure 83. Glucose Average Report: By Day

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

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Section 5: Viewing and Printing Reports

5.6.7 Glucose Histogram Report

The Glucose Histogram Report separates all glucose readings over the specified date range into the default target ranges and displays the data as a histogram (bar chart) with its bar height proportional to the number of readings in each glucose target range.

Figure 84. Glucose Histogram Report

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

• The glucose target mode is Standard.

• The horizontal axis shows the default glucose target ranges (not the user-defined glucose target ranges). The vertical axis plots the Number of Readings.

• A day (24 hours) is defined as midnight to midnight.

• The color of the bar corresponds to the unique color for the glucose target range. The height of the bar is proportional to the number of readings in that range; that is, the bar for a range in which there are 20 readings is twice as high as the bar for a range with 10 readings. The percentage of readings in the range is shown at the top of the bar.

• Double-click the bar to call up the Diary List entries that make up that bar.

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Section 5: Viewing and Printing Reports

5.6.8 Glucose Pie Chart

The

Glucose Pie Chart separates glucose readings over the date range into the default glucose target ranges and averages the values within each range. These averages are displayed in a series of pie charts. Each segment (wedge) displays in the unique color of its glucose target range.

Figure 85. Glucose Pie Chart Report: Total Readings Pie Chart

Figure 86. Glucose Pie Chart Report: Summary Pie Charts

• A maximum of 10 individual pie charts (2 rows of 5) and 1 total pie chart summarizing the glucose readings for all configured time periods over the date range are displayed.

• A day (24 hours) is defined as pre-breakfast to pre-breakfast on Total Readings pie chart.

• The glucose target mode is your choice.

• Double-click a wedge on any of the pie charts to call up the Diary List entries that make up that wedge.

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Section 5: Viewing and Printing Reports

5.6.9 Logbook Report

The Logbook Report is a table of glucose, carbohydrate, and insulin values associated with each time period over the specified date range.

WARNING:

• Some Deltec Cozmo Insulin Pump events such as disconnect, reconnect and cancelled boluses are not included.

CAUTION:

If any event data is Hidden, a comment will appear at the top of the report indicating the number of Hidden events. Hidden data will not be displayed or included in the calculations for this report.

Figure 87. Logbook Report

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

• Insulin, carbohydrate, and pre-meal, post-meal, bedtime, and sleep glucose reading values are displayed in columns under each time period (Breakfast, Lunch, Dinner, Bed

& Sleep) for each day over the date range.

• A day (24 hours) is defined as pre-breakfast to pre-breakfast.

• The glucose target mode is your choice.

• To call up the entry in the Diary List, double-click any cell in the row.

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Section 5: Viewing and Printing Reports

5.6.10 Lab and Exam Record Report

The Lab and Exam Record Report is a table of data from all Medical Exam and Lab Test Result data entry screens over the specified date range.

CAUTION:

If any event data is Hidden, a comment will appear at the top of the report indicating the number of Hidden events. Hidden data will not be displayed or included in the calculations for this report.

Figure 88. Lab & Exam Record Report

• The screen shows a table of lab test data on the top and the exam data below. Each event is shown in one row.

• A day (24 hours) is defined as midnight to midnight.

• Double-click any cell in a row to go to the Diary List entry for the event.

5.6.11 Statistics Report

The Statistics Report provides an overview of glucose, carbohydrate, and insulin data

(including insulin pump data) over the date range and displays it in a series of tables. You can attach the Statistics Report to any other report by enabling from User Profile/Options tab.

Figure 89. Statistics Report: Glucose Statistics

• A day (24 hours) is defined as pre-breakfast to pre-breakfast.

• The glucose target mode is your choice.

• Double-click any cell to see the entries from the Diary List that are included in the data set for a particular statistical calculation.

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Section 5: Viewing and Printing Reports

Glucose Statistics Table

The Glucose Statistics Table shows data regarding the number of readings per day, the values of the highest and lowest readings in each time period, and the results of some automatic calculations (averages and standard deviation) within and across time periods.

CAUTION:

If any event data is Hidden, a comment will appear at the top of the report indicating the number of Hidden events. Hidden data will not be displayed or included in the calculations for this report.

# Readings

# Days w/

Readings

By Time Period: Reports the number of readings recorded during the Time

Period specified for each day of the selected Date Range.

Total/Summary: Reports the number of readings recorded during the selected

Date Range.

By Time Period: Reports the number of days within the selected Date Range where one or more readings are recorded during the specified Time Period.

Total/Summary: Reports the number of days within the selected Date Range where one or more readings are recorded.

Avg #

Readings/Day

By Time Period: Reports the number of readings recorded during the Time

Period specified for each day of the selected Date Range divided by the number of days in the selected Date Range regardless of whether a glucose reading was recorded or not.

Total/Summary: Reports the number of readings recorded during the selected

Date Range divided by the number of days in the selected Date Range regardless of whether a glucose reading was recorded or not.

Highest

Lowest

Average

By Time Period: Reports the highest reading recorded during the Time Period specified within the selected Date Range.

Total/Summary: Reports the highest reading recorded during the selected

Date Range.

By Time Period: Reports the lowest reading recorded during the Time Period specified within the selected Date Range.

Total/Summary: Reports the lowest reading recorded during the selected Date

Range.

By Time Period: Reports the sum of the readings recorded during the selected

Date Range that fall within the specified Time Period divided by the number of readings recorded during the selected Date Range that fall within the specified

Time Period.

Total/Summary: Reports the sum of the readings recorded during the selected

Date Range divided by the number of readings recorded during the selected

Date Range.

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Standard

Deviation

Above %

Within %

Below %

Section 5: Viewing and Printing Reports

By Time Period: Reports the standard deviation* of the readings recorded during the Time Period specified within the selected Date Range.

Total/Summary: Reports the standard deviation* of the readings recorded during the selected Date Range.

Note: N/A is displayed where fewer than three readings are recorded.

*Standard deviation is a statistical calculation that tells how close a set of values is clustered around the average of those values. It is a measure of dispersal or variation of the patient’s average glucose level. For example, a small number

(less than half the average) indicate that most of the glucose readings during the day are close to the average value and that the patient is maintaining glucose levels near that value. A large number (more than half the average) indicates that many glucose levels during the day vary considerably from the average and that the patient is not maintaining glucose levels near the average value.

By Time Period: Reports the number of readings recorded above the patient’s defined normal glucose limits during the Time Period specified within the selected Date Range divided by the total number of readings recorded during the Time Period specified within the selected Date Range** and multiplied by

100.

Total/Summary: Reports the total number of readings recorded above the patient’s defined normal glucose limits during the selected Date Range divided by the total number of readings recorded during the selected Date Range** and multiplied by 100.

By Time Period: Reports the number of readings recorded within the patient’s defined normal glucose limits during the Time Period specified within the selected Date Range divided by the total number of readings recorded during the Time Period specified within the selected Date Range and multiplied by 100.

Total/Summary: Reports the total number of readings recorded within the patient’s defined normal glucose limits during the selected Date Range divided by the total number of readings recorded during the selected Date Range and multiplied by 100.

By Time Period: Reports the number of readings recorded below the patient’s defined normal glucose limits during the Time Period specified within the selected Date Range divided by the total number of readings recorded during the Time Period specified within the selected Date Range** and multiplied by

100.

Total/Summary: Reports the total number of readings recorded below the patient’s defined normal glucose limits during the selected Date Range divided by the total number of readings recorded during the selected Date Range** and multiplied by 100.

** Available when three target zones are being reported: Show Hypo/Hyper not selected.

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Very High %

Section 5: Viewing and Printing Reports

By Time Period: Reports the number of readings recorded as hyperglycemic events during the Time Period specified within the selected Date Range divided by the total number of readings recorded during the Time Period specified within the selected Date Range*** and multiplied by 100.

Total/Summary: Reports the total number of readings recorded as hyperglycemic events during the selected Date Range divided by the total number of readings recorded during the selected Date Range*** and multiplied by 100.

High %

By Time Period: Reports the number of readings recorded above the patient’s defined normal glucose limits and below the limits of a hyperglycemic event during the Time Period specified within the selected Date Range divided by the total number of readings recorded during the Time Period specified within the selected Date Range*** and multiplied by 100.

Total/Summary: Reports the total number of readings recorded above the patient’s defined normal glucose limits and below the limits of a hyper event during the selected Date Range divided by the total number of readings recorded during the selected Date Range*** and multiplied by 100.

Low %

By Time Period: Reports the number of readings recorded below the patient’s defined normal glucose limits and above the limits of a hypo event during the

Time Period specified within the selected Date Range divided by the total number of readings recorded during the Time Period specified within the selected Date Range*** and multiplied by 100.

Total/Summary: Reports the total number of readings recorded below the patient’s defined normal glucose limits and above the limits of a hypo event during the selected Date Range divided by the total number of readings recorded during the selected Date Range*** and multiplied by 100.

Very Low %

By Time Period: Reports the number of readings recorded as hypo events during the Time Period specified within the selected Date Range divided by the total number of readings recorded during the Time Period specified within the selected Date Range*** and multiplied by 100.

Total/Summary: Reports the total number of readings recorded as hypo events during the selected Date Range divided by the total number of readings recorded during the selected Date Range*** and multiplied by 100.

*** Available when five target zones are being reported: Show Hypo/Hyper selected.

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Insulin Statistics Table

The Insulin Statistics table shows average insulin dosages over the date range (calculated from insulin data).

Figure 90. Statistics Report: Insulin and Carbohydrates Statistics Tables

Avg/Day

(Insulin Name)

Avg/Day Total

Insulin

By Time Period: Reports the sum of the units of Insulin delivered during the Time Period specified for the selected Date Range divided by the number of days in the selected Date Range where that particular type of Insulin was recorded during that Time Period.

Total/Summary: Reports the sum of the units of Insulin delivered during the selected Date Range divided by the number of days in the selected Date Range where that particular type of Insulin was recorded.

Note: Separate entries exist for each type of Insulin recorded.

By Time Period: Reports the sum of the units of all Insulin delivered during the Time Period specified for the selected Date Range divided by the number of days in the selected Date Range where any type of

Insulin was recorded during that Time Period.

Total/Summary: Reports the sum of the units of all Insulin delivered during the selected Date Range divided by the number of days in the selected Date Range where any type of Insulin was recorded.

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Pump Statistics Table

If your insulin is administered by pump, the table will say Pump Statistics (instead of Insulin

Statistics) and display the following information:

Figure 91.

Statistics Report: Pump and Carbohydrates Statistics Tables

Avg/Day Meal

Bolus

By Time Period: Reports the sum of all Meal Bolus Insulin recorded during the specified Time Period for the selected Date Range divided by the number of days in the selected Date Range where Meal Bolus

Insulin entries were recorded during that Time Period.

Total/Summary: Reports the sum of all Meal Bolus Insulin recorded during the selected Date Range divided by the number of days in the selected Date Range where Meal Bolus Insulin entries were recorded.

Note: Meal Bolus is defined as the sum of all insulin entries (from pump uploads and manual entries) of the following injection types:

Injection, Bolus, Meal Bolus, Combination Bolus, Dual Wave Bolus,

and Square Wave Bolus.

Avg/Day

Correction

Bolus

Avg/Day Total

Bolus

By Time Period: Reports the sum of all Correction Bolus Insulin recorded during the specified Time Period for the selected Date Range divided by the number of days in the selected Date Range where

Correction Bolus Insulin entries were recorded during that Time

Period.

Total/Summary: Reports the sum of all Correction Bolus Insulin recorded during the selected Date Range divided by the number of days in the selected Date Range where Correction Bolus Insulin entries were recorded.

By Time Period: Reports the sum of all Meal and Correction Bolus

Insulin entries recorded during the specified Time Period for the selected Date Range divided by the number of days in the selected

Date Range where Meal and Correction Bolus Insulin entries were recorded during that Time Period.

Total/Summary: Reports the sum of all Meal and Correction Bolus

Insulin entries recorded during the selected Date Range divided by the number of days in the selected Date Range where Meal and Correction

Bolus Insulin entries were recorded.

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Avg/Day Basal By Time Period: Reports the sum of the Basal Insulin delivered during the Time Period specified for the selected Date Range divided by the number of days in the selected Date Range where Basal Insulin was recorded for that Time Period.

Total/Summary: Reports the sum of the Basal Insulin delivered during the selected Date Range divided by the number of days in the selected

Date Range where Basal Insulin was recorded.

Avg/Day Total

Insulin

By Time Period: Reports the sum of the Total Bolus and Basal Insulin doses delivered during the Time Period specified for the selected Date

Range divided by the number of days in the selected Date Range where Insulin entries were recorded for that Time Period.

Total/Summary: Reports the sum of the Total Bolus and Basal Insulin doses delivered during the selected Date Range divided by the number of days in the selected Date Range where Insulin entries were recorded.

Note: Days where no Insulin entries were recorded during the specified Time Period will not be included in the By Time Period calculation. Days where no Insulin entries were recorded will not be included in the Total calculation.

WARNING:

• Imports from the CoZmanager System (pump) include data only from full days

(24 hours), not partial days. This is so that CoZmanager can provide daily totals.

WARNING:

• Some Deltec Cozmo Insulin Pump events such as disconnect, reconnect and cancelled boluses are not included.

CAUTION:

Total Insulin statistics based on data from the CoZmanager System (pump) may differ from the sum of the individual insulin fields that make up the total. This is because CoZmanager may record the amount of a cancelled bolus. The Total

Insulin statistic on any FreeStyle CoPilot system report displays only the insulin delivered, not the cancelled bolus.

CAUTION:

Total Insulin statistics may appear to vary from report to report. This is usually due to how the report defines a day.

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Carbohydrate Statistics Table

The Carbohydrates Statistics table shows average carbohydrates over the date range

(calculated from carbohydrates data).

Figure 92. Statistics Report-Carbohydrates Statistics Table

Avg/Day Carbs

By Time Period: Reports the sum of the meal Carbohydrate intake for the Time Period specified during the selected Date

Range divided by the number of days within the selected Date

Range where meal Carbohydrate entries were recorded during the Time Period specified.

Total/Summary: Reports the sum of the meal Carbohydrate intake during the selected Date Range divided by the number of days within the selected Date Range where meal Carbohydrate entries were recorded.

Note: Days where no Meal entries were recorded during the specified Time Period will not be included in the By Time Period average. Days where no Meal entries were recorded will not be included in the Total average.

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Section 5: Viewing and Printing Reports

5.6.12 Daily Combination View Report

The Daily Combination View Report summarizes glucose, carbohydrate, and insulin data

(including pump data) for a single day and displays it in both graphic and table formats.

• To select the day for the data you want to see, use the date field on the right.

Select day you want to view in this date field.

Figure 93. Date Field for Selecting Date

• A day (24 hours) is defined as midnight to midnight.

• The glucose target mode is your choice.

Note: Week Days filters do not apply to the Daily Combination View Report. See Section

5.3.2: Data Filters.

CAUTION:

If any event data is Hidden, a comment will appear at the top of the report indicating the number of Hidden events. Hidden data will not be displayed or included in the calculations for this report.

Figure 94. Daily Combination View: Glucose Line and Carbohydrates Graphs

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

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Section 5: Viewing and Printing Reports

Glucose Line Graph

The Glucose Line graph plots glucose readings by hour of day.

• The horizontal axis is a 24-hour timeline. The vertical axis plots the glucose level.

• Each data symbol represents one reading. Hover the cursor over the data symbol to see the glucose value, date, and time of that reading.

• Double-click a data symbol to view this entry in the Diary List.

• To display or hide the solid line connecting the data symbols, right-click a data symbol, and select Toggle Glucose Line from the context menu.

Carbohydrates Graph

The Carbohydrates Graph plots carbohydrate events by hour of day.

• The carbohydrate data symbol represents one carbohydrate event. The size of the circle is proportional to the carbohydrate value. Its position along the horizontal axis corresponds to the time (hour) of the meal.

• Double-Click to view this entry in the Diary List.

Figure 95. Daily Combination View Report: Insulin Summary and Data Table

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Section 5: Viewing and Printing Reports

Insulin Summary

The Insulin Summary graph plots insulin events by hour of day.

• The horizontal axis is a 24-hour timeline. The vertical axis is units of insulin.

• Basal insulin data (light green shaded area) can be imported into the FreeStyle CoPilot system only from CoZmanager software.

• Each dark green bar represents one meal bolus insulin event. Its position along the horizontal axis corresponds to the time (hour) of the insulin event. Its height correlates with dosage. Double-click to view this entry in the Diary List.

• Each red bar represents one correction bolus insulin event. Its position along the horizontal axis corresponds to the time (hour) of the insulin event. Its height correlates with dosage. Double-click to view this entry in the Diary List.

• If pump data has not been imported into the FreeStyle CoPilot system from CoZmanager software, manually entered meal bolus and correction bolus will not appear separately.

Instead, a green bar will indicate all manually entered bolus events. Its position along the horizontal axis corresponds to the time (hour) of the insulin event. Its height correlates with dosage. Double-click to view this entry in the Diary List.

Data Table

The Data Table tracks glucose, carbohydrates, and insulin values hourly.

• Each column represents 1 hour.

• Each event type is one row.

• Each event is one cell. The value associated with the event displays in the cell.

Double-click the cell to view this event in the Diary List.

Note: The symbol “...” indicates that the full value does not fit in the space provided. To call up the full entry in the Diary List, double-click “...”.

WARNING:

• Imports from the CoZmanager System (pump) include data only from full days

(24 hours), not partial days. This is so that CoZmanager can provide daily totals.

WARNING:

• Some Deltec Cozmo Insulin Pump events such as disconnect, reconnect and cancelled boluses are not included.

CAUTION:

Total Insulin statistics based on data from the CoZmanager System (pump) may differ from the sum of the individual insulin fields that make up the total. This is because CoZmanager may record the amount of a cancelled bolus. The Total

Insulin statistic on any FreeStyle CoPilot system report displays only the insulin delivered, not the cancelled bolus.

CAUTION:

Total Insulin statistics may appear to vary from report to report. This is usually due to how the report defines a day.

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Section 5: Viewing and Printing Reports

5.6.13 Weekly Pump View Report

The Weekly Pump View Report shows the components of insulin doses for each day in a seven-day period in bar graph and pie chart formats.

CAUTION:

If any event data is Hidden, a comment will appear at the top of the report indicating the number of Hidden events. Hidden data will not be displayed or included in the calculations for this report.

To select the week (7 days) for the data you want to view:

• Using the date field on the right, select the last date in the week you want to see

(17/03/2007, for example).

Set to last date in week.

Figure 96. Date Field for Selecting Date

• A day (24 hours) is defined as midnight to midnight.

• The glucose target mode is Standard.

Figure 97. Weekly Pump View Report: Bar Graph

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Section 5: Viewing and Printing Reports

Figure 98. Weekly Pump View Report: Pie Charts and Glucose Statistics Table

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

• Double-click any cell to view this entry in the Diary List.

• Basal insulin data (light green shaded area) is imported into the FreeStyle CoPilot system only from CoZmanager System software.

• A Glucose Statistics table summarizes the glucose readings for the week displayed.

WARNING:

• Imports from the CoZmanager System (pump) include data only from full days

(24 hours), not partial days. This is so that CoZmanager can provide daily totals.

CAUTION:

Total Insulin statistics based on data from the CoZmanager System (pump) may differ from the sum of the individual insulin fields that make up the total. This is because CoZmanager may record the amount of a cancelled bolus. The Total

Insulin statistic on any FreeStyle CoPilot system report displays only the insulin delivered, not the cancelled bolus.

CAUTION:

Total Insulin statistics may appear to vary from report to report. This is usually due to how the report defines a day.

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Section 5: Viewing and Printing Reports

5.6.14 HCP Group Analysis Report

The HCP Group Analysis Report is available to HCP Users only. This report is a userconfigurable view of all FreeStyle CoPilot system data for all patients of the HCP. The HCP can display data for any patient he/she manages. This includes all device data uploaded during a patient visit, and all data entered manually. This report facilitates viewing and comparing of data for all patients of the HCP or clinic.

Figure 99. HCP Group Analysis Report

• By default, the report displays with column heads for Patient ID, Last Name, First

Name, and for a number of event-related data fields.

• Data for each patient displays in one row. Each glucose value displays in a cell shaded the unique color of its target range.

• The glucose target mode is Standard.

• A day (24 hours) is defined as midnight to midnight.

Columns

You can customize the columns in the HCP Group Analysis Report by changing the order of events in a column, adding and removing columns, and resizing columns.

Change Order of Events

• To reverse the order of items in any column, click the column heading, and click the little arrow that appears to the right of the heading. Do the same to change the order back to its original sequence.

Add/Remove Columns

• To remove a column from the report, drag-and-drop the column head cell off the table.

• To add a column to the report, right-click anywhere on the table to call up a context menu. Click Customize Columns.

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Section 5: Viewing and Printing Reports

Figure 100. Context Menu

The Customization list displays. From the list, select the column head you want to add. Next, drag-and-drop it to the preferred position in the column-head row. Two green arrows display to help you position the column.

Figure 101. Customization List

Move/Resize Columns

• To move columns left or right in the table, drag-and-drop the column-head cell to the preferred position in the column head row.

• To adjust the width of any column, use the sizing tool that becomes active when you hover your pointer over the right margin of the column-head cell.

Note: The Insulin column contains the Insulin Type entered in the Prescribed Plan. The

Medication column contains the Medication Type, entered in the Prescribed Plan.

Data Filter

For most column-heads in the table, you can configure a data filter using the selection list. To display the selection list for any column, click the down-arrow on the right.

• To display data for all patients, with any or no entry in the corresponding data field, click All.

• To customize the data filter, click Customize. Complete the Filter Builder dialog box.

• To save your custom changes:

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Section 5: Viewing and Printing Reports

1. Click Customize (bottom right of screen). The Filter Builder screen displays.

2. Click Save As. Enter a filename. Next, click Save.

Figure 102. Filter Builder Tool

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Section 6: Prescribed Plan

6 Prescribed Plan

The FreeStyle CoPilot system provides an additional utility, called the Prescribed Plan. This utility stores guidelines which have been given by your Healthcare Professional.

6.1 Prescribed Plan

You can use the Prescribed Plan to store and review prescribed guidelines from your HCP, for the following information:

• Insulin type, dosage, and time of day

• Insulin sensitivity

• Medication type, dosage, and time of day

• Carbohydrates for each individual meal time

• Ratio of amount of insulin per grams of carbohydrate

You can add information for each of the items listed above, for breakfast, lunch, dinner, bedtime and a snack. You can also add comments or notes that you would like to keep.

Figure 103. Prescribed Plan

Note: The FreeStyle CoPilot system will display results only in the Unit of Measure that is specific to your version of the software (either mg/dL only or mmol/L only).

Sensitivity

Sensitivity is your insulin sensitivity factor. It is based on the amount of blood glucose lowered by 1 (one) unit of insulin within a specific time frame. This is also called your insulin correction

factor. Your insulin sensitivity factor is determined by your HCP.

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Section 6: Prescribed Plan

Ratio

Ratio is the insulin-to-carbohydrate ratio. It is used to determine how much insulin to administer per grams of carbohydrates eaten. Your insulin-to-carbohydrate ratio is determined by your HCP.

WARNING:

• Do not change your medication unless advised by your healthcare professional.

WARNING:

• Be sure to enter and check all values carefully. The FreeStyle 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.

CAUTION:

Contact your healthcare professional for guidance on determining and using your insulin dosages, insulin-to-carbohydrate ratios, and insulin sensitivities.

CAUTION:

Contact your healthcare professional for guidance on determining and using your prescribed carbohydrate intake.

CAUTION:

The FreeStyle CoPilot system does not calculate your insulin sensitivity or your insulin-to-carbohydrate ratio. These should always be determined by your healthcare professional.

6.2 Filling-in a Prescribed Plan

To fill in a Prescribed Plan:

1. Click Plan on the menu bar. The Prescribed Plan screen displays.

2. Select an entry type from the Type list: Insulin or Medication.

• Select Insulin to record an insulin type.

• Select Medication to record a medication type.

3. Enter the name of the Insulin or the Medication in the Item field.

4. Enter the Dosage Amount for each of the breakfast through snack meals.

Grams of Carbs to record the optimum carbohydrate intake. Enter the desired number of grams of carbohydrate for each meal field.

8. Enter any comments in the Comments field (optional).

9. Click Plan window. (Or, to clear all data entered into the plan, click Reset.)

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Section 7: Database Management

7 Database Management

The FreeStyle CoPilot system can create and alternately use more that one database. When you start the FreeStyle CoPilot system, it uses the same database that was used when the application was closed the last time. The FreeStyle CoPilot system changes databases only when you select a different database.

To ensure that your information remains accurate, the FreeStyle CoPilot system allows you to perform database maintenance. You can use the Database Maintenance feature to:

Archive: Remove old data from the database and save it in a file.

Backup: Save a copy of your current database in a backup file.

Restore: Restore data from the last database backup or other database file.

7.1 Archiving Data

When you archive data, the data being archived is removed from the FreeStyle CoPilot system database and stored in an XML file format. (To restore archived data, see Section 7.3: Restoring

Archived Data.)

To create an archive data file:

Figure 104. Database Archive Command

2. In the Archive Data window, select the last date of the data to be included in the archive and click OK.

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Section 7: Database Management

Figure 105. Select Archive Event Date

3. When the file browser window opens, enter the filename to save the archived data and click Save.

4. A confirmation message is displayed when the process is complete.

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Section 7: Database Management

7.2 Viewing Archived Data

You can open and view archived data at any time. The location of the archived data file (*.xml) depends on which operating system you are using.

For Windows XP, this location is in:

C:\Documents and Settings\All Users\Application Data\AbbottDiabetesCare\CoPilot\Archives

For Windows Vista and Windows 7, this location is in:

C:\ProgramData\AbbottDiabetesCare\CoPilot\Archives

7.3 Restoring Archived Data

You can import archived data back into the FreeStyle CoPilot system database at any time.

Note: It is a good idea to create a database backup before you import data. (See Section 7.4.2: Manual

Database Backup.)

Figure 106. Restore Archive Data (Import Events from File)

2. When the file browser window opens, select the archived data file (*.xml) and click Open.

3. The archived data will begin importing and a status message will indicate the progress.

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Section 7: Database Management

7.4 Backing Up the Database

7.4.1 Automatic Database Backup

When the FreeStyle CoPilot system closes, it automatically creates a database backup file with the filename format of “AUTO_<database>.bak”, where <database> is the filename of the database that was just closed. To ensure that your data is safely stored, be sure to exit the FreeStyle CoPilot system when you are finished.

If you have a large database, an hourglass will appear until the automatic backup is complete.

The location of the automatic database backup file (*.bak) depends on which operating system you are using.

For Windows XP, this location is in:

C:\Documents and Settings\All Users\Application Data\AbbottDiabetesCare\CoPilot\Backups

For Windows Vista and Windows 7, this location is in:

C:\ProgramData\AbbottDiabetesCare\CoPilot\Backups

An automatic database backup file (*.bak) can be used to restore the last opened database file if the FreeStyle CoPilot system is unable to open the database when it starts. This situation may occur if the FreeStyle CoPilot system is unable to locate the database file (*.cpd) due to corruption, manual deletion by a user, or other unexpected conditions.

If an error message appears indicating that the FreeStyle CoPilot system is unable to connect to the database when it starts and you want to restore the last opened database: from the backup, or create a new database.

Figure 107. Error Opening Database Message

3. A confirmation message will appear indicating that the Restore will overwrite the current database with the backup copy. Click Yes to complete the operation.

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Section 7: Database Management

7.4.2 Manual Database Backup

You can create a manual backup of your database at any time. A manual database backup

(*.cpb) can be restored by selecting File > Database Maintenance > Restore. (See Section 7.5:

Restoring a Database Backup.)

Note: For added security, the manual database backup file may be copied onto an external media (such as a CD or DVD disk) or other storage location.

To create a manual database backup:

2. When the file browser window opens, enter the filename to save the database backup file and click Save.

IMPORTANT: As a precaution, you should make a full backup of your FreeStyle CoPilot system database before upgrading your operating system.

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Section 7: Database Management

7.5 Restoring a Database Backup

A manual database backup can be restored at any time.

7.5.1 Restoring a Database Backup File

To restore a manual database backup:

1. Select File > Database Maintenance > Restore. A message will appear asking you to confirm the operation.

Figure 108. Confirmation Message

3. When the file browser window opens, select the database backup file (*.cpb) to restore and click Open.

4. The selected database is restored and a message will appear asking if you would like to view the restore log file.

7.5.2 Viewing the Restore Log

You can open and view the Restore Log at any time. The location of the Restore Log file depends on which operating system you are using.

For Windows XP, this location is in:

C:\Documents and Settings\All Users\Application Data\AbbottDiabetesCare\CoPilot\Logs

For Windows Vista and Windows 7, this location is in:

C:\ProgramData\AbbottDiabetesCare\CoPilot\Logs

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Section 8: Security

8 Security

This section explains how to set up and use User IDs and Passwords. It also explains how to set

User Rights, the feature that allows an HCP or home user to define access rights for their own profile, and/or for other profiles (users) that share the system.

When you set user rights, you define the ability to create or edit other profiles, to define user rights for others, and to configure the FreeStyle CoPilot system settings.

8.1 System Administrator Profile

In the FreeStyle CoPilot system, there is a built-in user profile for the FreeStyle CoPilot System

Administrator. You cannot use the system administrator profile to upload data or enter information. This profile is used generally for configuring security (user rights). It cannot be deleted, and system administrator user rights cannot be revoked. If you like, you can set or change the system administrator’s password using the procedure below.

The default password for the system administrator is Admin. Follow procedures below to enable password protection.

8.2 Password Protection

Each user has a user ID (the name used for the profile). Defining a user ID is a required step in creating a profile. You can set the FreeStyle CoPilot system to request a user ID and password each time the FreeStyle CoPilot system starts, or each time a different user is selected in the

Select User list (home user version) or Select HCP list (HCP version).

To turn on password protection:

2. In the System Setting window, select Require User Logon.

Note: If File > System Settings is grey, you do not have the user rights to turn on password protection. See Section 8.3: Defining User Rights.

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Section 8: Security

8.2.1 The Logon to System Screen

To log on to the FreeStyle CoPilot system, enter your user ID and password.

Figure 109. System Logon Screen

1. Type in your User ID and Password.

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Section 8: Security

8.3 Defining User Rights

Any HCP or home user can define user rights for their own profile, or for other profiles. (But only if they already have been granted permission to change user rights.)

The system administrator (in either the HCP or home user version) can set or revoke the user rights for any other profile.

If user rights are granted to a user (profile) to allow editing of user rights for others, HCPs and home users can set user rights as follows:

• HCPs can define user rights for their own profile, or for other HCP profiles.

• Home users can define user rights for their own profile, or for other home user profiles.

Note: User rights cannot be defined for the Guest profile that is used with Quick Print (see

Section 4.1.5: Quick Print).

8.3.1 User Rights Options for HCP and Home Users

User Rights Option

Edit Data

Description

Select to allow the user to edit events and user profiles.

Without this right, the user cannot change or hide events, nor delete or change another user’s profile. The user can, however, edit his/her own profile, add another user, or enter (add) data by manual entry, device upload, or import.

Assign User Rights

Configure System Settings

Select to allow any user to change user rights of other users.

Deselect to allow the user to view but not change user rights (for others or their own.)

Select to allow the user to change System Settings. If the user does not have this right, the System Settings option is greyed out.

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Section 8: Security

8.3.2 Assigning Your Own User Rights - HCP and Home User

If you are the initial HCP or home user, you are automatically granted full user rights. With this status, you can change your own user rights and assign rights for other profiles.

To change user rights in your own profile:

1. Open your profile

Figure 110. User Rights: Home User (left) and HCP User (right)

4. Check the rights that you want to grant to yourself. Uncheck the rights that you want to revoke.

Note: If you cannot change your own user rights, select System Administrator in the Select

User list or Select HCP list. The system administrator can change user rights for any profile.

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Section 8: Security

8.3.3 Home User - Assigning User Rights to Other Home Users

If you have set up more than one home user profile, you can follow this procedure to set user rights for another profile.

to display the User List.

Figure 111. User List

2. Select a user in the list.

3. Click to open the User Rights screen.

4. Check the rights that you want to grant. Uncheck the rights that you want to revoke.

Note: Edit Data allows the user to edit data/events and delete user profiles.

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Section 8: Security

8.3.4 HCP - Assigning User Rights to Other HCPs

If you have set up more than one HCP profile, you can follow this procedure to set user rights for another profile.

Figure 112. HCP List

2. Select a user in the list.

3. Click to open the User Rights screen.

4. Check the rights that you want to grant. Uncheck the rights that you want to revoke.

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Appendix A

Appendix A: Contact Customer Care

If you have questions after reading this User’s Guide, or for technical assistance, please contact your local Abbott Diabetes Care office. For a list of worldwide offices, visit

www.AbbottDiabetesCare.com.

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Appendix B

Appendix B: Troubleshooting

If you continue to experience a problem after completing troubleshooting steps listed in this section, please see Appendix A: Contact Customer Care to request further assistance.

Device Connection Problems

Devices

Abbott Diabetes Care

Blood Glucose

Monitoring Devices

Troubleshooting

• Check your connection at the meter and the computer.

• Reset the device by turning off and on.

• Disconnect and reconnect the cable.

• Check the device user instructions.

• Other programs may be attempting to use the COM port. In this case, close all programs but the FreeStyle CoPilot system and see if it corrects the problem.

• Review the settings on a switchbox if you are using one.

• COM port may not have been released by another program (e.g.,

PDA programs). PDAs tend to cause problems by occupying COM ports. Consider dedicating a COM port to your PDA and dedicating a different COM port to data uploads from other devices.

Data Import Problems

Not all database imports will populate all the available fields in the Diary List. Appendix C:

Supported Devices and Databases lists all the events and data that the FreeStyle CoPilot system is able to import from these databases. No HCP Profile information is ever imported. Importing a file imports patient data only, one patient at a time.

Source

CoZmanager Software

Precision Link System

Troubleshooting

• CoZmanager software must be Rev. D or higher.

• Cozmo pump software must be Rev. F or higher.

• Precision Link system Versions 2.4 and lower are not supported.

FreeStyle Connect System • COM port may not be released by another program (e.g., PDA programs). PDAs tend to cause problems by occupying COM ports.

Consider dedicating a COM port to your PDA and dedicating a different COM port to data uploads from other devices.

XML Files

TAB Files

• Imports from a file (*.tab or *.xml) must be specially formatted for the FreeStyle CoPilot system. For a copy of the Importing TAB and

XML Data manual that contains instructions on creating these files, contact your local Abbott Diabetes Care office, or visit our web site at www.AbbottDiabetesCare.com and look for your country contact information.

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Appendix B

Printing Problems

You should download the latest printer driver from the manufacturer of your printer. If you change the orientation of the page (portrait, landscape) or change page size, view the page using Print Preview before printing to check formatting.

Problem

Unclear Printing

(Greyscale)

Blacked out Regions in the

Printout

Blank Regions in the

Printout

Information is Missing on the Printout

Extraneous Lines in the

Printout

PDF Attachments

Problem

E-Mail Report to: PDF File

Not Attached

Troubleshooting

• Reports are clearest when printed on a color printer. For greyscale or black-and-white printing, display the report with distinctive patterns in black and white rather than color. See Section 5.3.3:

Display Features.

• Certain combinations of operating systems, printers, and printer drivers may result in printouts that contain blank regions, black regions, or missing information. An alternate printing method has been provided in the program: You can save any report as a .pdf file and open the file in Adobe Acrobat Reader and print it from that application. Go to www.Adobe.com for instructions on downloading this application.

Troubleshooting

• The E-Mail Report to option is designed to access your e-mail account and open a new e-mail message screen. The report is attached to the message as a *.pdf file. If your e-mail account is not detected automatically, you will need to e-mail the report manually. To do so: With the desired report open, select the Save

as PDF file option from the File menu. Attach the *.pdf file to an e-mail manually.

Access Violation Errors

If you receive an access violation error message, you should close the program and reopen it, even if the program allows you to continue. If you do not close and reopen the program, you may get further access violation error messages.

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Appendix C

Appendix C: Supported Devices

And Databases

The FreeStyle CoPilot Health Management System supports many types of blood glucose monitoring devices and databases.

This appendix provides a list of supported devices and databases along with the types of data and information that can be uploaded to the FreeStyle CoPilot system.

In addition, different devices may require different steps to upload data:

• Some devices upload all collected data to the FreeStyle CoPilot system, using the

DataEntry > Read Abbott BG Meter command.

If your device is not listed below, please contact Abbott Diabetes Care, Customer Care to determine if your device is supported.

Supported Devices and Databases

FreeStyle Precision, FreeStyle Optium, FreeStyle Xido, FreeStyle Precision H, FreeStyle

Optium H, Precision Xtra, Optium, Precision Easy, Optium Easy, EasySense, TrueSense,

Precision Xceed, Optium Xceed Meter Interface

Glucose Event Data

• Date/time of event

• Data source (to distinguish manual or device)

• Glucose value

• Device ID (serial number)

Ketone Event Data

• Date/time of event

• Data source (to distinguish manual or device)

• Ketone value

• Device ID (serial number)

FreeStyle family of meters and Optium Mini Meter Interface

Glucose Event Data

• Date/time of event

• Data source (to distinguish manual or device)

• Glucose value

• Device ID (serial number)

• Status flag

• Cal code

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Appendix C

CoZmanager Interface

User Contact Information

• First name

• Last name

Glucose Event Data

• Date/time of event

• Data source (to distinguish manual or device)

• Glucose value

• Device ID (serial number)

Correction Bolus Event Data

• Date/time of event

• Dosage

• Administration type (correction, meal, general)

Meal Bolus Event Data

• Date/time of event

• Dosage

• Administration type (meal, general)

Basal Rate Event Data

• Date/time of event

• Rate

• Administration type (programmed, temporary)

Temp Basal Rate Event Data

• Date/time of event

• Rate

• Administration type (programmed, temporary)

Carbohydrate Event Data

• Date/time of event

• Carbohydrates

Daily Basal Insulin Sum Data

• Date

• Basal insulin daily total

Daily Meal Bolus Sum Data

• Date

• Meal bolus insulin daily total

Daily Correction Bolus Sum Data

• Date

• Correction bolus insulin daily total

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Appendix C

Precision Link System v2.5 and Higher Interface

Glucose Event Data

• Date/time of event

• Data source (to distinguish manual or device)

• Glucose value

Ketone Event Data

• Date/time of event

• Data source (to distinguish manual or device)

• Ketone value

User Contact Information

• First name

• Last name

Glucose Targets

• High value

• Low value

Time Periods

• Time periods

FreeStyle Connect Interface

User Contact Info

• Patient last name

• Patient first name

Glucose Targets

• High value

• Low value

Time Periods

• Time Periods

Glucose Event Data

• Date/time of event

• Data source (to distinguish manual or device)

• Glucose value

• Device ID (serial number)

• Status flag

• Cal code

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Appendix D

Appendix D: Warning, Caution and

Important Messages

For reference, Warning, Caution and Important messages included in this guide are listed below.

WARNING Messages

The following WARNING messages are included in this User’s Guide.

Section 4

• To avoid the possibility of electrical shock, never perform a blood glucose test while the meter is connected to the computer.

• Be sure to enter and check all values carefully. The FreeStyle 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.

• Imports from the CoZmanager System include data only from full days (24 hours), not partial days. This is so that CoZmanager can provide daily totals.

Section 5

• Have your healthcare professional review and confirm your entries before using this data. Serious effects on your health could result from relying on or using incorrect entries.

• Imports from the CoZmanager System (pump) include data only from full days

(24 hours), not partial days. This is so that CoZmanager can provide daily totals.

• Some Deltec Cozmo Insulin Pump events such as disconnect, reconnect and cancelled boluses are not included.

Section 6

• Do not change your medication unless advised by your healthcare professional.

• Be sure to enter and check all values carefully. The FreeStyle 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.

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Appendix D

CAUTION Messages

The following CAUTION messages are included in this User’s Guide.

Section 4

• The FreeStyle CoPilot system assumes a single glucose calibration type, either plasma or whole blood.

• Ensure that the time and date are set correctly on your personal computer and other devices.

• When uploading glucose data from a device, the FreeStyle CoPilot system does not differentiate between devices that are whole-blood or plasma calibrated. The FreeStyle

CoPilot system merely uploads the data with no calculations made. Because there are slight differences between the two calibrations, you should not mix data from devices that use different calibration references. It is possible to enter duplicate data entries into the FreeStyle CoPilot Health Management System.

The FreeStyle CoPilot system does not check the accuracy of the data the user provides.

For example, a user of the Deltec Cozmo insulin pump might record the carbohydrates for a meal (for example, 25 g) and enter it into the Deltec Cozmo software. When the user uploads the data from the pump, a meal entry (25 g) will be created in your FreeStyle

CoPilot system. If the user also manually enters a meal entry (25 g) for that same meal in the FreeStyle CoPilot Software, two meal entries would result (at slightly different times), thereby accidentally recording a total of 50 g for the meal. The user must take reasonable precautions to prevent duplication errors. For example, choose one location for recording certain data types (i.e., on a single device or in a particular software program).

• Do not upload data from any device that has recorded data for more than one person.

The FreeStyle CoPilot system cannot identify if data on a device has ever been recorded for more than one person. All data stored on a device is uploaded to the database for the person associated with the device in the FreeStyle CoPilot system.

• It is possible to enter duplicate data entries into the FreeStyle CoPilot Health

Management System. The FreeStyle CoPilot system does not check the accuracy of the data the user provides. For example, a user of the Deltec Cozmo insulin pump might record the carbohydrates for a meal (for example, 25 g) and enter it into the Deltec

Cozmo software. When the user uploads the data from the pump, a meal entry (25 g) will be created in your FreeStyle CoPilot system. If the user also manually enters a meal entry

(25 g) for that same meal in the FreeStyle CoPilot system Software, two meal entries would result (at slightly different times), thereby accidentally recording a total of 50 g for the meal. The user must take reasonable precautions to prevent duplication errors. For example, choose one location for recording certain data types (i.e., on a single device or in a particular software program).

• Contact your healthcare professional for guidance on determining and using your insulin dosages, insulin-to-carbohydrate ratios, and insulin sensitivities.

• Contact your healthcare professional for guidance on determining and using your prescribed carbohydrate intake.

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Appendix D

Section 5

• For glucose and insulin entries, if the Time Period is changed manually, all reports will still be displayed as defined by the Time Period setting in the User Profile.

• If any event data is Hidden, a comment will appear at the top of the report indicating the number of Hidden events. Hidden data will not be displayed or included in the calculations for this report.

• If the user reconfigures the Glucose Modal Day report by turning Display Time Periods

OFF, the Glucose Modal Day report will go back to plotting the data point based on the user-configured time period and remove the Time Period labels across the top of the graph. This can result in a data point for any glucose reading, where a user manually assigned the time period, being displayed in a different location on the Glucose Modal

Day graph. When the Display Time Periods is ON, the glucose reading that has a manually assigned time period will be displayed on the graph in the middle of the time period assigned.

• Total Insulin statistics based on data from the CoZmanager System (pump) may differ from the sum of the individual insulin fields that make up the total. This is because

CoZmanager may record the amount of a cancelled bolus. The Total Insulin statistic on any FreeStyle CoPilot system report displays only the insulin delivered, not the cancelled bolus.

• Total Insulin statistics may appear to vary from report to report. This is usually due to how the report defines a day.

Section 6

• Contact your healthcare professional for guidance on determining and using your insulin dosages, insulin-to-carbohydrate ratios, and insulin sensitivities.

• Contact your healthcare professional for guidance on determining and using your prescribed carbohydrate intake.

• The FreeStyle CoPilot system does not calculate your insulin sensitivity or your insulin-to-carbohydrate ratio. These should always be determined by your healthcare professional.

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Appendix D

IMPORTANT Messages

Section 4

• To avoid losing data, upload data from your device often. Most devices hold only a limited number of historical records.

• Always refer to the user’s guide that came with your device or pump for complete instructions on its use.

• Any data you previously uploaded from a device will not be overwritten when you upload again from that same device. Only the new data will be added to your file.

• Medication Event refers to all medications you take except insulin.

• Be careful to type numbers only into the Result Value field. For example, if your A1C test result is 7.6%, type 7.6 in the Result Value field and type % in the Units field. If you type the units in the Result Value field, the entry for this lab test will not be displayed correctly in the reports you generate.

Section 5

• Please customize your Time Periods before entering data into the FreeStyle CoPilot system. If the Display Time Periods setting is turned on for the Glucose Modal Day

Report, changing the Time Periods after data has been entered will result in the data appearing based on the Time Periods. This may result in data not corresponding to the event times.

Section 7

• As a precaution, you should make a full backup of your FreeStyle CoPilot system database before upgrading your operating system.

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Appendix E

Appendix E: FreeStyle CoPilot System

Network Installation

About FreeStyle CoPilot System Network Installation

This appendix provides instructions for setting up a network installation for the FreeStyle

CoPilot Health Management System. The instructions assume that the user is setting up a

FreeStyle CoPilot system database on a central computer (server) that will provide data access for one or more FreeStyle CoPilot system installations (clients) residing on other machines in a common network. The user setting up the network installation must have a working knowledge of Windows and basic networking terminology.

Installing the FreeStyle CoPilot System Server

Note: If the FreeStyle CoPilot system client application was previously installed, it will need to be uninstalled prior to installing the server.

1. Place the FreeStyle CoPilot system installation CD into the CD/DVD drive of the server. Or, to find out if the FreeStyle CoPilot LAN Database Installer is available for download, contact your local Abbott Diabetes Care office. For a list of worldwide offices, visit our web site at

www.AbbottDiabetesCare.com.

Note: With the CD, do not install the FreeStyle CoPilot Health Management System program, which starts automatically. Instead, open the contents of the CD and locate the LAN

Server folder.

2. Open the LAN Server folder.

3. Install the FreeStyle CoPilot system server on the host server by running the

CoPilotServerSetup.exe setup file from the CD. (Or, if you had downloaded the LAN

Database Installer, double-click the setup file that was downloaded to run the server setup program.)

4. When the installation is complete, go to the Windows Control Panel and open the Firebird

2.0 Server Manager applet. Make sure it is configured like this:

Start button

Figure 113. Firebird 2.0 Server Manager

Note: Be sure to click the Start button to run the Firebird Server application.

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Appendix E

Installing the FreeStyle CoPilot Server Client Application

1. Install the FreeStyle CoPilot system client application (CoPilot_Setup.exe) on a client computer with network connectivity to the host server.

2. Run the client application. Select System Settings from the File menu.

Figure 114. File Menu, System Settings Command

Figure 115. System Settings

5. For the Server Name, enter the computer name of the server. This is the name that the computer is identified by on the local network.

6. For the Database Name, enter the complete path and filename of the server database (for example, C:\Program Files\CoPilot Server\Database\CoPilot.cpd). DO NOT use the full path specification that includes \ComputerName\C\...

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Appendix E

Restarting the Client

1. Restart the FreeStyle CoPilot system on the client. You may need to set up the user again (as either a Home User or a Health Care Professional) even if you did so in the past. This will establish the server database as either a Home or HCP system. All subsequent clients that attach to the server database will use the established Home or HCP selection.

2. The lower left corner of the client should indicate the name of the current database

(CoPilot.cpd, unless you have created and named your own FreeStyle CoPilot client database).

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FreeStyle CoPilot System User’s Guide

©2007-2011 Abbott. All rights reserved.

Manufacturer: www.AbbottDiabetesCare.com

ART23867-101 Rev. A 08/13

Published in USA

Disclaimers and Limitations of Liability

The information contained in this Guide, including but not limited to any product specifications, is subject to change without notice.

Abbott Diabetes Care makes no representations or warranties of any kind concerning the contents of this Guide. Under no circumstances will Abbott Diabetes Care be held liable for any loss or other damages pertaining to the use of this Guide.

Copyright and Trademarks

This document is the property of Abbott Diabetes Care Inc. and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of Systems without the express written consent of Abbott Diabetes Care Inc.

Permission is granted to print copies of this document for use solely by the FreeStyle CoPilot system user.

FreeStyle and other brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions.

Other trademarks are the property of their respective owners.

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Recycle

CE Mark

Authorized Representative in the

European Community

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