Medtronic CareLink Pro software User Guide

Medtronic CareLink Pro software User Guide
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Below you will find brief information for software CareLink Pro. The software helps you to acquire, store and report patient treatment and diagnostic data. You can also use it to access pump, meter and sensor-based glucose data your patients have uploaded to CareLink Personal, a web-based therapy management system that works with CareLink Pro.

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CareLink Pro User Guide | Manualzz

T H E R A P Y M A N A G E M E N T S O F T WA R E F O R D I A B E T E S

User Guide

6025179-024_a

REF MMT-7335

© 2010 Medtronic MiniMed, Inc. All rights reserved.

Paradigm® Veo™ is a trademark of Medtronic MiniMed, Inc.

Paradigm®, Paradigm Link®, Guardian REAL-Time®, CareLink®, and Bolus Wizard® are registered trademarks of Medtronic MiniMed.

BD Logic® is a registered trademark of Becton, Dickinson and Company.

LifeScan®, OneTouch® UltraLink®, OneTouch® Profile®, OneTouch® Ultra®, OneTouch® UltraSmart®, OneTouch® Basic®, OneTouch® FastTake®, OneTouch® SureStep®, OneTouch® Ultra®

2, OneTouch® UltraMini®, and OneTouch® UltraEasy® are registered trademarks of LifeScan, Inc.

Bayer CONTOUR® LINK, Ascensia®, Glucometer®, Ascensia® DEX®, Glucometer® DEX®, Ascensia® DEX® 2, Glucometer® DEX® 2, Ascensia® DEXTER-Z® II, Glucometer® DEXTER-Z®, Ascensia®

ESPRIT® 2, Glucometer® ESPRIT®, Glucometer® ESPRIT® 2,Ascensia ELITE® XL, Glucometer ELITE® XL, Bayer BREEZE™, Bayer BREEZE™ 2, and Bayer CONTOUR® are registered trademarks of Bayer Corporation, Diagnostics Division.

Precision Xtra™, Optium Xceed™, Precision Xceed™, Therasense FreeStyle®, FreeStyle® Flash, FreeStyle Mini®, and FreeStyle Papillon™ mini are trademarks of Abbott Laboratories, Inc.

ACCU-CHEK® Active, ACCU-CHEK® Aviva, ACCU-CHEK® Compact, and ACCU-CHEK® Compact Plus are registered trademarks of a member of the Roche Group.

Java™ is a trademark of Sun Microsystems, Inc.

Microsoft® and Windows® are registered trademarks of Microsoft Corporation.

Adobe® and Acrobat® Reader® are registered trademarks of Adobe Systems, Incorporated.

Contacts:

Africa:

Medtronic Africa (Pty) Ltd.

Tel: +27 (0) 11 677 4800

Australia:

Medtronic Australasia Pty. Ltd.

Tel: 1800 668 670 (product orders)

Tel: 1800 777 808 (customer help)

Bangladesh

Sonargaon Healthcare Pvt Ltd

Mobile: (+91)-9903995417 or (+880)-1714217131

België/Belgique:

N.V. Medtronic Belgium S.A.

Tel: 0800-90805

Brasil:

Medtronic Comercial Ltda.

Tel: +(11) 3707-3707

Canada:

Medtronic of Canada Ltd.

Tel: 1-800-284-4416 (toll free/sans-frais)

China:

Medtronic (Shanghai) Ltd.

Tel: +86 40 0820 1981 or 80 0820 1981

Croatia

Medtronic Adriatic

Tel: +385 1 488 11 20

Fax: +385 1 484 40 60

Danmark:

Medtronic Danmark A/S

Tel: +45 32 48 18 00

Deutschland:

Medtronic GmbH

Geschäftsbereich Diabetes

Telefon: +49 2159 8149-370

Telefax: +49 2159 8149-110

24-Stdn-Hotline: 0800 6464633

Eire:

Accu-Science LTD.

Tel: +353 45 433000

España:

Medtronic Ibérica S.A.

Tel: +34 91 625 05 42

Fax: +34 91 625 03 90

24 horas: +34 901 120 335

Europe:

Medtronic Europe S.A. Europe, Middle East and Africa

Headquarters

Tel: +41 (0) 21-802-7000

France:

Medtronic France S.A.S.

Tel: +33 (0) 1 55 38 17 00

Hellas:

Medtronic Hellas S.A.

Tel: +30 210677-9099

Hong Kong:

Celki International Ltd.

Tel: +852 2332-3366

India:

India Medtronic Pvt. Ltd

Tel: (+91)-80-22112245 / 32972359

Mobile: (+91)-9611633007

Italia:

Medtronic Italia S.p.A.

Tel: +39 02 24137 261

Fax: +39 02 24138 210

Servizio assistenza tecnica: Nº verde

24h: 800 712 712

Japan:

Medtronic Japan Co. Ltd.

Tel: +81-3-6430-2019

Latin America:

Medtronic, Inc.

Tel: 1(305) 500-9328

Fax: 1(786) 709-4244

Latvija:

Ravemma Ltd.

Tel: +371 7273780

Magyarország:

Medtronic Hungária Kft.

Tel: +36 1 889 0697

Malaysia:

Medtronic International Ltd.

Tel: +60-3 7953 4800

Middle East and North Africa:

Regional Office

Tel: +961-1-370 670

Nederland, Luxembourg:

Medtronic B.V.

Tel: +31 (0) 45-566-8291

Toll Free: 0800-3422338

New Zealand:

Medica Pacifica

Tel: +0800 106 100

24-hr After-Hours:

+0800 633 487

Norge:

Medtronic Norge A/S

Tel: +47 67 10 32 00

Fax: +47 67 10 32 10

POCCИЯ:

Medtronic B. V.

Tel: (+7-495) 5807377 x1165

24h: 8-800-200-76-36

Polska:

Medtronic Poland Sp. Z.o.o.

Tel: +48 22 465 6934

Portugal:

Medtronic Portugal Lda

Tel: +351 21 7245100

Fax: +351 21 7245199

Puerto Rico:

Medtronic Puerto Rico

Tel: 787-753-5270

Republic of Korea:

Medtronic Korea, Co., Ltd.

Tel: +82.2.3404.3600

Schweiz:

Medtronic (Schweiz) AG

Tel: +41 (0)31 868 0160

24-Stunden-Hotline: 0800 633333

Fax Allgemein: +41 (0)318680199

Serbia & Montenegro:

Epsilon

Tel: +381 11 311 8883

Singapore:

Medtronic International Ltd.

Tel: +65 6436-5097 or +65 6436-5090

Slovenija:

Zaloker & Zaloker d.o.o.

Tel: +386 1 542 51 11

Fax: +386 1 542 43 32

Slovenská republika:

Medtronic Slovakia O.Z.

Tel: +421 268 206 944

Fax: +421 268 206 999

Sri Lanka

Swiss Biogenics Ltd.

Mobile: (+91)-9003077499 or (+94)-777256760

Suomi:

Medtronic Finland Oy

Tel: +358 20 7281 232

Help line: +358 20 7281 200

Sverige:

Medtronic AB

Tel: +46 8 568 585 10

Fax: +46 8 568 585 11

Taiwan:

Medtronic-Taiwan Ltd.

Tel: +886.2.2183.6093

Fax: +886.2.2501.7680

Toll Free: 0800.082.999

Thailand:

Medtronic (Thailand) Ltd.

Tel: +66 2 232 7400 ext 1

Turkiye:

Medtronic Medikal Teknoloji

Ticaret Ltd. Sirketi.

Tel: +90 216 4694330

USA:

Medtronic Diabetes Global Headquarters

Tel: +1-800-826-2099

24 Hour HelpLine: +1-818-576-5555

To order supplies: +1-800-843-6687

United Kingdom:

Medtronic Ltd.

Tel: +44 1923-205167

Yisrael:

Agentek

Tel: +972 3649 3111

Österreich:

Medtronic Österreich GmbH

Tel: +43 (0) 1 240 44-0

24 – Stunden – Hotline: 0820 820 190

Česká republika:

Medtronic Czechia s.r.o.

Tel: (+420-233) 059401

Contents

Chapter 1

Chapter 2

4

5

5

2

2

2

2

1

1

Introduction

Features

Security

Related documents

Assistance

Supported devices

Ordering

How to use this guide

User safety

7

7

13

13

13

14

10

10

11

11

14

14

15

15

15

9

9

8

9

8

8

7

8

Getting started

Before you begin

Primary system tasks

Navigating the system

Opening CareLink Pro

Workspaces

Toolbar

Patient tabs

The Guide Me feature

Turning Guide Me on and off

Opening patient records

Closing patient records

Setting system preferences

General preferences

Patient profile preferences

Choosing data fields

Adding a custom field

Changing the order of data fields

Finalizing patient profile preferences

Patient Lookup preferences

Choosing data to display

Changing the column order

Finalizing patient lookup preferences

CareLink Pro User Guide Contents v

Chapter 3

Chapter 4

Chapter 5

Chapter 6

Chapter 7

15

16

17

17

Report Generation preferences

Choosing data to display

Changing the column order

Finalizing report generation preferences

18 Profile workspace

18 Before you begin

19

19

19

20

Adding new profiles

Editing patient profiles

Deleting patient data from the system

Linking to CareLink Personal

23 Hardware setup

23 Connecting devices

27

29

32

33

26 Devices workspace

27 Before you begin

27 Adding a device

Adding a Medtronic pump or Guardian monitor

Adding a meter

Making a device active or inactive

Reading device data

42

42

42

43

41

41

42

42

37

38

39

40

36

36

36

37

35 Reports workspace

35 Before you begin

36 Creating reports

Opening the Reports workspace

Selecting the reporting period

Data calendar

Selecting source data to include

Checking for device data

Getting additional device data

Verifying report settings

Selecting report types and inclusion dates

Generating reports

About reports

Adherence Report

Sensor and Meter Overview Report

Logbook Report

Device Settings Snapshot

Daily Detail Report

Exporting data

44 System administration

44 Applying software updates

45

45

Turning off automatic updates

Manually checking for updates

CareLink Pro User Guide Contents vi

Chapter 8

Chapter 9

Appendix A

Glossary

Index

45

45

46

46

Backing up and restoring the database

Backing up the database

Restoring the database

When the system is unavailable

47 Troubleshooting

47 General application use errors

47

48

48

49

49

49

Not connected to the database

Forgot the clinic password for CareLink Pro

Device read errors

Report creation errors

Backup and restore errors

Uninstalling the software

55

58

51 Icon table

52 CSV data

52 Column data definitions

53

54

More about CSV files exported by CareLink Pro

If data is not displaying as expected

CareLink Pro User Guide Contents vii

CareLink Pro User Guide Contents viii

1

Introduction

Thank you for choosing Medtronic Diabetes as your partner in helping you and your patients better manage diabetes therapy. We believe you will benefit from CareLink® Pro software’s leading edge technology and simple, menu-driven user interface.

CareLink Pro allows you to acquire, store and report patient treatment and diagnostic data.

You can also use it to access pump, meter, and sensor-based glucose data your patients have uploaded to CareLink® Personal, a web-based therapy management system that works with

CareLink Pro.

Features

CareLink Pro is a diabetes therapy management software for a personal computer (PC). It includes these features:

• Patient records can be created to store data gathered from a patient’s device as well as therapy data from their CareLink Personal account.

• Data from insulin pumps, monitors, and blood glucose meters can be sent to the system, stored, and then used to generate reports.

• As an option, it interfaces with the CareLink Personal system, allowing access to device data patients have stored there. This is ideal for creating current reports between office visits, and may make the need to read device data during office visits unnecessary.

• Different treatment reports can be created from device data stored in the patient’s record.

Reports facilitate answers to therapy concerns such as patient adherence, patterns and exceptions.

• The system alerts you when software updates are available to be downloaded and installed.

This ensures you have access to the latest features.

• There is a Guide Me feature to help users who are new to CareLink Pro. It gives hints and tips about the tasks they are performing.

• An integrated help system is available throughout the software to provide information on specific areas of interest.

CareLink Pro User Guide Introduction 1

Security

• CareLink Pro can be password protected.

• Transmission of patient data from CareLink Personal is encrypted using industry-standard

Secure Sockets Layer (SSL) technology.

Related documents

Each of these Medtronic MiniMed documents has device-specific information that is not covered in detail in this user guide.

NOTE: For meters from other companies, see the instructions the manufacturer included with the meter.

• Paradigm Insulin Pump User Guide

• Guardian REAL-Time Monitor User Guide

• Sensor Features User Guide

• ComLink User Guide

• CareLink USB User Guide

Assistance

If you need further help with this system, contact your local country representative. Access the following web site for international contact information: http://www.medtronicdiabetes.com/help/contact/locations.html

Supported devices

CareLink Pro gets data from the following devices.

NOTE: Some devices supported by this software may not be available in all countries where this software is approved for use.

Medtronic MiniMed pumps:

Guardian REAL-Time monitors:

Insulin pumps/Glucose monitors

508

Medtronic MiniMed Paradigm® series pumps:

511, 512, 712, 515, 715, 522, 722, 522K, 722K,

Paradigm® Veo™ (554, 754)

CSS-7100

CSS-7100K

CareLink Pro User Guide Introduction 2

Manufacturer

Medtronic Diabetes partner devices:

LifeScan:

Bayer:

BD:

Bayer Ascensia® DEX® family, including these compatible meters:

Bayer Ascensia ELITE™ family, including these compatible meters:

Abbott:

Roche:

Blood glucose meters

Bayer CONTOUR® LINK

BD Paradigm Link® Blood Glucose Monitor

OneTouch® UltraSmart®

OneTouch® Profile®

OneTouch® Ultra®

OneTouch® Basic®

OneTouch® FastTake®

OneTouch® SureStep®

OneTouch® Ultra® 2

OneTouch® UltraMini®

OneTouch® UltraEasy®

Ascensia BREEZE®

BREEZE® 2

CONTOUR®

Logic®

Ascensia® DEX®

Ascensia® DEX® 2

Ascensia® DEXTER-Z® II

Glucometer® DEXTER-Z®

Ascensia® ESPRIT® 2

Glucometer® ESPRIT®

Glucometer® ESPRIT® 2

Ascensia ® ELITE™

Glucometer ELITE® XL

FreeStyle®

FreeStyle® Lite®

FreeStyle® Freedom®

FreeStyle® Freedom Lite®

Precision Xtra™

TheraSense FreeStyle®

FreeStyle® Flash®

FreeStyle® Papillon™ mini

FreeStyle® Mini®

Optium Xceed™

Precision Xceed™

Accu-Chek® Aviva

Accu-Chek® CompactPlus

Accu-Chek® Compact

Accu-Chek® Active

CareLink Pro User Guide Introduction 3

Com-Station

ComLink

Paradigm Link® Blood Glucose Monitor

CareLink® USB

Data communications cable

Communication devices

For use with the Medtronic MiniMed 508 Pump.

(See the Com-Station User Guide for details about the required hardware.)

For use with the MiniMed Paradigm Pump and

Guardian REAL-Time Monitor. (See the ComLink

User Guide for details about the required hardware.)

For use with a MiniMed Paradigm Pump or

Guardian REAL-Time Monitor. (See the Paradigm

Link® Blood Glucose Monitor User Guide for details about the required hardware.)

For use with the MiniMed Paradigm-series insulin pump and Guardian REAL-Time Monitor.

For use with third-party blood glucose meters.

Each meter manufacturer supplies a data communications cable.

Note: If a meter manufacturer provides a USB cable instead of a serial cable for uploading data, you must install the software driver provided by that manufacturer.

Also, check with the meter manufacturer to ensure that the USB driver is compatible with your operating system. Some USB drivers may not be available for 64-bit operating systems.

Equivalent devices

When you add a device to the system, you select its make and model from a list. If a device make and model is not on the list, refer to the following table to find an equivalent one to use.

If your patient uses one of these devices

Bayer Ascensia® DEX® 2

Bayer Ascensia® DEXTER-Z® II

Bayer Glucometer® DEXTER-Z®

Bayer Ascensia® ESPRIT® 2

Bayer Glucometer® ESPRIT®

Bayer Glucometer® ESPRIT® 2

Bayer Glucometer ELITE® XL

Precision Xceed™

Select this device

Bayer Ascensia® DEX®

Bayer Ascensia ELITE™

Optium Xceed™

Ordering

To order Medtronic Diabetes products, contact your local country representative. Access the following URL for international contact information: http://www.medtronicdiabetes.com/help/contact/locations.html

NOTE: Meters can be ordered from their respective companies.

CareLink Pro User Guide Introduction 4

How to use this guide

NOTE: This user guide shows samples of the software screens. The screens of the actual software may be slightly different.

Refer to the Glossary for definitions of terms and functions. The conventions used in this guide are defined in the following table.

Term/style

Click

Double-click

Right-click

Bold text

NOTE:

CAUTION:

WARNING:

Meaning

Press the left mouse button over an object on the screen to select it

Press the left mouse button twice over an object on the screen to open it

Press the right mouse button over an object on the screen to display another window or menu

Used for a button, screen name, field name, or menu option. For example: Patient > New

Patient

Provides additional information for a procedure or step.

Alerts you of a potential hazard which, if not avoided, may result in minor or moderate damage to the software program or equipment.

Notifies you of a potential hazard which, if not avoided, could result in death or a serious injury.

It may also describe potential serious adverse reactions and safety hazards.

User safety

Indications for use

The CareLink Pro system is intended for use as a tool to help manage diabetes. The purpose of this system is to take information transmitted from insulin pumps, glucose meters and continuous glucose monitoring systems, and turn it into CareLink Pro reports. The reports provide information that can be used to identify trends and track daily activities—such as carbohydrates consumed, meal times, insulin delivery, and glucose readings.

Warnings

• This system is intended to be used by a healthcare professional familiar with the management of diabetes.

• System results are not intended to produce medical advice and should not be relied upon for such purpose.

• This product should only be used with the supported devices listed in this document. (See

Supported devices on page 2

.)

• Patients should be advised to monitor their blood glucose levels at least 4 – 6 times a day.

CareLink Pro User Guide Introduction 5

• Patients should be advised not to make any changes to their treatment without consulting their healthcare professional.

• Patients should be advised to make treatment decisions based on healthcare professional guidelines and meter BG results, not glucose sensor results.

Contraindications

This software should not be used with devices that are not listed in

Supported devices on page 2

. Nor should this product be used for the treatment of medical conditions other than

diabetes.

Before opening this software, close any of the following software that is currently running on your computer:

• CGMS

®

System Solutions™ Software (7310)

• Solutions

®

Pumps & Meters Software (7311)

• Guardian

®

Solutions

®

Software (7315)

• ParadigmPAL™ (7330)

• CareLink® Personal software (7333)

• Solutions

®

Software for CGMS

®

iPro (7319)

CareLink Pro User Guide Introduction 6

2

Getting started

The following information will guide you through starting the CareLink Pro software, opening and closing patient records, and setting preferences that apply to all patients in the system.

Before you begin

If this is the first time you are using CareLink Pro, you should be sure to set the General preferences (see

General preferences on page 11

). These preferences determine how certain items display in the software and in reports, and how you want the system to communicate with the Internet.

Preferences can be set at any time. You may want to wait until you are familiar with the

CareLink Pro software to set the other preferences.

Primary system tasks

The following table outlines the main tasks you will want to perform when first setting up and using CareLink Pro. It also tells you which part of this user guide discusses each task.

Step

Familiarize yourself with the CareLink Pro user interface.

Define the global system options your clinic will use.

Create profiles for each of your patients.

Link to your patients' CareLink Personal accounts.

Add your patient's pump and meters to their profile.

Read data from your patient's pump and meters.

Set up and generate reports for each of your patients.

Regularly back up the CareLink Pro database.

Update the CareLink Pro software.

Location

Navigating the system on page 8

Setting system preferences on page 11

Adding new profiles on page 19

Linking to CareLink Personal on page 20

Adding a device on page 27

Reading device data on page 33

Creating reports on page 36

Backing up the database on page 45

Applying software updates on page 44

CareLink Pro User Guide Getting started 7

Navigating the system

Before working with the CareLink Pro software, you should get acquainted with the user interface. The user interface includes menus, a toolbar, a navigation bar, workspaces, and a

Guide Me window.

Opening CareLink Pro

1

Double-click the CareLink Pro icon on your computer desktop, or select Medtronic

CareLink Pro from the Programs list on your Windows Start menu.

If your clinic requires you to enter a password, the login screen is displayed.

a. Type your password into the Password field.

NOTE: Requiring a password is an optional feature that is set during the installation process.

b. Click LOGIN.

The startup screen is displayed.

2

To start a new patient record, click New Patient. To open a patient record from a list of patients in the system, click Open Patient.

Workspaces

If you have a patient’s record open, you can click one of the buttons on the navigation bar to display the corresponding workspace. Use these workspaces to enter or select information to perform CareLink Pro tasks for that patient.

Profile: Allows you to maintain such patient information stored as name and date of birth.

This workspace also allows you to link to a patient’s CareLink Personal account.

Devices: Allows you to store information required to read a patient’s devices.

Reports: Allows you to select parameters and choose reports to be generated for the patient.

Until a profile is added and saved for a patient, only the Profile workspace is accessible for that patient. Until devices are added for a patient, only the Profile and Devices workspaces are accessible for that patient.

Toolbar

The CareLink Pro toolbar provides quick access to frequently used features. The toolbar contains the following buttons.

CareLink Pro User Guide Getting started 8

Button

Add Patient

Name

Open Patient

Guide Me

Functionality

Opens a Profile workspace so you can add a new patient record to the system.

Opens the Patient Lookup table where you can choose an existing patient’s record to view.

Displays or hides the Guide Me window. Click for context-aware system hints.

Patient tabs

Once you open a patient record, a tab is displayed along the toolbar with the patient’s name on it. When a tab is active, it means that patient record and workspace are active, and you can perform CareLink Pro tasks for the patient.

To make a patient record active so that you can work with it, click on the tab for that patient.

To close a patient record, click the Close button on the tab.

The Guide Me feature

A Guide Me feature is provided throughout CareLink Pro. It opens a window with contextaware hints and tips for actions you might take from the part of system that is active. Guide

Me windows might also include >>learn more links. When clicked, these links take you to the relevant section in the online help for more details. The Guide Me feature is enabled by default. However, you can turn it off at any time.

Turning Guide Me on and off

To turn Guide Me on or off, do one of the following:

CareLink Pro User Guide Getting started 9

• Click the Guide Me button.

• Select Help > Guide Me.

Opening patient records

As many as six patient records can be open at one time. If you have not yet created any patient profiles, see

Adding new profiles on page 19

.

1

Select File > Open Patient, or click the Open Patient button. A patient list similar to the following is displayed.

NOTE: If you receive a message that you have too many patient records open, click

OK, close a record, and continue.

2

Locate the patient’s listing by typing some or all of their name in the Find a Patient field.

When the patient’s listing is highlighted, click OPEN, double-click the listing, or press ENTER.

You can also navigate the list by using the up and down arrows on your keyboard.

The patient’s Devices (if devices have not yet been added) or Reports workspace is displayed.

3

To see the patient’s Profile workspace, click the Profile button on the navigation bar.

Closing patient records

1

Make sure the patient record you want to close is active (the tab is highlighted).

2

Do one of the following:

a. Select File > Close Patient.

CareLink Pro User Guide Getting started 10

b. Click the Close button on the patient tab.

c. Press Ctrl+F4.

Setting system preferences

These preferences apply to all patients in the system. For preferences that affect only individual patients, see

Verifying report settings on page 39

.

Preferences are displayed in the following groups:

• General

Glucose units

Carbohydrate units

Communications

Troubleshooting

• Patient Profile

Select and arrange data fields on patient profiles.

• Patient Lookup

Modify and change the order of fields displayed when you choose Open Patient to view a list of patients.

• Report Generation

Choose the data fields you want to display when selecting Daily Detail report input from the Data table.

General preferences

Use the General tab to define how the software displays certain types of information, and to establish your external communication preferences.

1

If it is not active already, click the General tab.

CareLink Pro User Guide Getting started 11

2

Select Tools > Options. The following window is displayed.

3

Click to select the option button for the value you want:

Glucose Units: mg/dL or mmol/L

Carbohydrate Units: grams or Exchanges

a. If you selected Exchanges for Carbohydrate Units, type the appropriate number in the

grams are equal to 1 Exchange field.

4

Click to select or clear the check box in the Chart Options > Overview Report section. If the check box is selected, the application will connect the BG readings on the Meter Glucose

Overlay chart with lines. (This is a chart that appears in the Sensor and Meter Overview

Report.)

5

For the following Communications preferences, click to select the check box (enable), or to clear the check box (disable):

NOTE: Make sure you follow the guidelines of your clinic or IT department when setting communication preferences.

Automatically check for software updates: if selected, a notification will be sent to each system running CareLink Pro whenever a software update is available. The active user will then have the opportunity to download and install the updates. To prevent this from occurring and institute a controlled distribution of software updates, you can clear this check box.

Synchronize with Medtronic CareLink® Personal: If you want the system to automatically synchronize your patients' CareLink Personal data each time you open their profile, select this check box. If you clear this check box, you will have to manually synchronize the CareLink Personal data for each patient.

6

Click to select or clear the check box in the Troubleshooting section. If the check box is selected, the application will save a record of device reads for troubleshooting purposes.

CareLink Pro User Guide Getting started 12

7

Click OK to save the General preferences.

Patient profile preferences

This is a global setting that defines the content of your profiles. You can customize fields in the Profiles workspace to include information that is most important to your clinic. You can add or remove fields, create your own custom fields, and determine the order in which the fields will appear in the window.

1

Select Tools > Options.

2

Click the Patient Profile tab. The following window is displayed.

NOTE: Use the check boxes to choose the fields you want on the profile. Use the up and down arrows to put the fields in order.

Choosing data fields

1

Use the check boxes to add the fields you want.

NOTE: First and Last Name cannot be removed.

2

To remove a field from the profile, clear its check box.

3

To make a field required, select the check box in the Required column. Any field that is required must be filled in before a profile can be created.

Adding a custom field

1

Select the check box to the left of an empty custom field.

2

Enter text to name the field (for example, Emergency Contact). This is the field name that will display on the patient profile.

CareLink Pro User Guide Getting started 13

3

To make the field required, select the check box in the Required column.

NOTE: To remove a custom field from the profile, clear the check box next to the field(s) you want to remove.

Changing the order of data fields

Select the field you want to move, and click the up or down arrow to move it. (The arrows at the top and bottom move a field all the way to the top or bottom of the list.)

Finalizing patient profile preferences

When the Field Order list has all the fields you want in the correct order, click OK.

Patient profiles now have the fields and field order you just selected.

Patient Lookup preferences

The Patient Lookup table is used to search for and open a patient record. The table includes every patient in your database and provides identifying information from the patient's profile.

You have the option of customizing what information is displayed in this table, and the order in which the columns appear. To customize the Patient Lookup table, complete the following steps:

1

Select Tools > Options.

2

Click the Patient Lookup tab. The following window is displayed.

NOTE: Use the check boxes to choose the data you want on the Patient Lookup table.

Use the up and down arrows to put the columns in order.

CareLink Pro User Guide Getting started 14

Choosing data to display

Use the check boxes to select the type of data you want to display, or to clear data you do not want to display on the Patient Lookup table.

Changing the column order

To change the order of columns on the Patient Lookup table, select the column to move, and click the up or down arrows. (The arrows at the top and bottom move a data column all the way to the top or bottom of the list.)

The data column at the top of the Column Display Order list will display in the first column of the Patient Lookup table. The data column at the bottom will be displayed in the last column of the table.

Finalizing patient lookup preferences

When the Column Display Order list has all the data you want in the correct order, click OK.

The Patient Lookup table will now have the data and column order you just selected.

Report Generation preferences

The Data Table appears in the Select and Generate Reports window. This table is used during reporting. It contains daily information derived from your patient’s devices and, if applicable, their CareLink Personal software account. The data provided in this table helps you determine which days require a Daily Detail report. It also helps you decide which of the other reports you should run.

Your clinic can customize the data that displays in this table, including the order in which it's presented, to reflect that which is of most relevance to your practice.

NOTE: To see how these preferences apply to the Data Table during report creation, see

Selecting report types and inclusion dates on page 40.

1

Select Tools > Options.

CareLink Pro User Guide Getting started 15

2

Click the Report Generation tab. The following window is displayed.

Choosing data to display

Use the check boxes to select the type of data you want to display or clear data you do not want to display on the Data Table.

The following information is available for inclusion in the Data Table.

Column Name

№ of Meter Readings

Meter Readings Average

Sensor Duration

Sensor Average

Highest Reading

Lowest Reading

Avg AUC Below Target

Avg AUC Above Target

Total Carbs

Definition

The amount of readings for the specified date that were recorded by the included devices.

The average of the glucose readings recorded by the included devices.

The amount of time within the specified date for which sensor date was recorded. Values are --

(none), 0:05 - 24:00.

The average of sensor readings recorded in the specified date.

The highest glucose reading (derived from a sensor or meter) for the date.

The lowest glucose reading (derived from a sensor or meter) for the date.

Avg Area Under the Curve below the patient's target range.

Avg Area Under the Curve above the patient's target range.

The sum of all carbohydrate amounts (rounded to the nearest gram or the nearest 0.1 exchange, depending on the unit of measure used) reported during the day through Bolus Wizard events or carbohydrate markers on the pump or Guardian monitor.

CareLink Pro User Guide Getting started 16

Column Name

Suspend Duration

№ of Rewinds

№ of Primes (or Fills)

Prime (or Fill) Volume (U)

Total Insulin (U)

Total Basal (U)

Total Bolus (U)

Basal %

Bolus %

№ of Boluses

Bolus Wizard Events

Bolus Wizard Overrides

№ of Meal Boluses

№ of Correction Boluses

№ of Manual Boluses

Definition

The amount of time the pump was suspended on the specified date. Values are -- (no data), 0:01 - 24:

00.

The number of rewind events for the specified date.

The number of prime events (or fill events) recorded for the specified date.

The total volume of insulin used for prime events

(or fill events) on the specified date.

The total volume of insulin given during the specified date, as recorded by the pump.

The total volume of basal insulin given during the specified date (the total insulin given, less the sum of all boluses given).

The total volume of insulin given in boluses during the specified date, as recorded by the pump.

Shows the ratio (in whole % values) of basal insulin to total insulin.

Shows the ratio (in whole % values) of bolus insulin to total insulin.

The number of bolus events recorded for the specified date.

The total number of bolus wizard events recorded on the specified date.

The number of bolus wizard events where the amount of insulin delivered is different than the amount recommended.

The number of bolus wizard events with carbohydrate amounts greater than zero that were recorded on the specified date.

The number of bolus wizard events with correction amounts greater than zero that were recorded on the specified date.

The number of bolus events recorded during the date, which were not bolus wizard events.

Changing the column order

To change the order of columns on the Data Table, select the column to move, and click the up or down arrow. (The top and bottom arrows move a data column all the way to the top or bottom of the list.)

NOTE: Items at the top of the Column Order list will display in the first column of the Data

Table. Items at the bottom will be displayed in the last column of the Data Table.

Finalizing report generation preferences

When the Column Order list has all the data you want in the correct order, click OK.

The Data Table will now have the data and column order you just selected.

CareLink Pro User Guide Getting started 17

3

Profile workspace

A profile is similar to the cover page of a medical chart. It stores patient data such as name and date of birth. A profile is required before device data can be gathered and used for therapy reports.

The Profile workspace also allows you set up a link to a patient’s CareLink Personal account.

Once the link is established, you can retrieve patient data stored on CareLink Personal anytime

—without the need to have the patient present.

Before you begin

You may want to customize your patient profiles so they contain only the type of information

you want to collect. To learn more, see

Patient profile preferences on page 13

.

Also, a username and password is required when you set up the link to a patient’s CareLink

Personal account. The patient must be present to supply this data.

CareLink Pro User Guide Profile workspace 18

Adding new profiles

Each time you add a patient to the CareLink Pro system, you must start by filling out a profile for them.

1

Select File > New Patient, or click the Add Patient button.

The Profile workspace is displayed.

NOTE: To add or change fields on the patient profile, click customize fields. See

Patient profile preferences on page 13.

2

Fill in the fields in the Patient Profile section.

3

Click SAVE.

The new patient profile is added to the CareLink Pro database. A message is displayed that confirms the profile was saved.

Completing required fields

1

If a required field is not complete when you save a patient profile, a message is displayed next to that field. You will not be allowed to save the profile until you make an entry in the field.

2

Complete the field.

3

Click SAVE.

4

When the confirmation message displays, click OK.

Editing patient profiles

1

Make sure the patient’s Profile workspace is open.

2

Click EDIT.

3

Edit the data in the Patient Profile section as needed.

4

Click SAVE.

A message is displayed that confirms the profile was saved.

Deleting patient data from the system

1

Make sure the patient’s Profile workspace is open.

2

Verify that this is the patient you want to delete. Deleting a patient profile also removes all of their data from the CareLink Pro database and cannot be undone.

3

Click >> delete patient record above the synchronization section of the profile.

A message is displayed to alert you that all of the patient’s data will be erased when you delete the record.

CareLink Pro User Guide Profile workspace 19

4

Click Yes to delete the patient’s record.

Linking to CareLink Personal

If your patient permits it, you can set up a link to their CareLink Personal account. This Webbased tool allows patients to upload and store device-derived data, and to run various therapy reports.

Once you link to the patient’s CareLink Personal account, you can retrieve the device data they store there. This is ideal for creating CareLink Pro therapy reports between office visits. It also reduces the need to read the patient’s device in the office.

If a patient does not yet have a CareLink Personal account, you can send them an e-mail inviting them to establish one.

Linking to an existing account

NOTE: The patient must be present to complete these steps.

1

Make sure you are connected to the Internet.

2

Open the patient’s Profile workspace.

3

Make sure all required fields in the Patient Profile section are filled in.

4

Click LINK TO EXISTING ACCOUNT.

The CareLink Personal Log In screen is displayed.

5

Have the patient do the following:

a. Type in their Username and Password.

b. Click Sign In.

A Grant Access page is displayed, based on the patient’s enrollment settings for language and region.

6

Have the patient do the following:

a. Read the Terms of Use.

b. Click to check the box next to I agree to the Terms of Use above...

c. Click Grant Access.

d. Let you know when the Thank You page is displayed.

7

If needed, print the Terms of Use for the patient by clicking the Print button. You are now linked to the patient's CareLink Personal account.

Sending an e-mail invitation

To send an e-mail inviting a patient to establish a CareLink Personal account, follow these steps:

1

Open the patient’s Profile workspace.

2

Make sure all required fields in the Patient Profile section are filled in.

CareLink Pro User Guide Profile workspace 20

3

Click SEND E-MAIL INVITATION TO PATIENT.

4

Make sure Patient Name, Email Address and Language are filled in correctly.

5

Click SEND.

The patient’s profile status area confirms the e-mail was sent.

Getting data from a linked account

If you are linked to a patient’s CareLink Personal account, any new data from this account is automatically sent each time you open their patient profile in CareLink Pro.

NOTE: To ensure this happens, go to Tools > Options > General, and make sure there is a check next to “Synchronize with CareLink Personal.”

Follow these steps to get a patient’s CareLink Personal data any time after you have opened their patient profile:

1

Make sure the patient’s Profile workspace is open, and that you are connected to the

Internet.

2

Select Tools > Synchronize Patient Data.

The sync icon on the patient’s tab rotates. When the icon stops, the process is complete.

NOTE: If the patient no longer wants to share their CareLink Personal data, a message displays to let you know.

3

Any additional data retrieved from CareLink Personal will show up in the patient’s reports.

CareLink Pro User Guide Profile workspace 21

Unlinking a patient’s CareLink Personal account from CareLink Pro

You can unlink a patient’s CareLink Personal account from CareLink Pro. This option is only available after a patient has been linked. It prevents CareLink Pro from continuing to retrieve data from the patient's CareLink Personal account. It does not affect the patient's personal usage of their CareLink Personal account.

1

Open the patient's record and access the Profile workspace.

2

Click UNLINK ACCOUNT.

3

Click Yes at the confirmation message. The patient's personal profile is no longer linked to

CareLink Pro.

The status is changed to Not linked, and the LINK TO EXISTING ACCOUNT and SEND E-

MAIL INVITATION TO PATIENT buttons are now displayed.

CareLink Pro User Guide Profile workspace 22

4

Hardware setup

To read data directly from a device, you must have the patient's device, and any cables or communications devices required to transfer the data to your computer.

Alternatively, if the patient has uploaded their device data to their CareLink Personal account, you can obtain the data by linking to their account. To link to a patient's CareLink Personal

account, see

Linking to CareLink Personal on page 20

.

Connecting devices

Review the overview diagram to get a general idea of how devices should be set up to communicate with the computer. The diagrams that follow illustrate specific aspects of device communication.

For more details, follow the instructions CareLink Pro displays as you are reading devices.

CareLink Pro User Guide Hardware setup 23

Overview of hardware setup

The following example shows the CareLink USB being used to communicate between the pump and the computer.

Serial and USB cable connection examples:

CareLink Pro User Guide Hardware setup 24

Optional ComLink for use with the Paradigm series pump:

Optional Com-Station for use with the Medtronic MiniMed 508 pump

CareLink Pro User Guide Hardware setup 25

5

Devices workspace

Information that you will need to read a patient’s device, such as the make, model and serial number, is stored in The Devices workspace. Thus, you do not have to supply it each time you read data from the device.

Devices on the Devices workspace are stored in one of two lists—Active Devices or Inactive

Devices. When you add a device, it is automatically placed on the Active Devices list. You can only read data from devices displayed in the Active Devices list. These will likely be the devices your patient currently uses.

Other devices that belong to the patient, but are not currently used, can be stored in the

Inactive Devices list. This keeps the information on file. These devices can be made active at any time.

CareLink Pro User Guide Devices workspace 26

Before you begin

Before you can open the Devices workspace for a patient, they must have a profile saved in the system. See

Adding new profiles on page 19

.

To add a device or read data directly from it, the device must be communicating with the computer. See

Connecting devices on page 23

to learn how to set up devices to communicate with the computer.

Adding a device

You can get data from the patient’s CareLink Personal account for a device not yet added.

Such devices will automatically be added when data is synchronized between CareLink

Personal and CareLink Pro.

NOTE: There can only be one active pump per patient. Adding a new pump will move the existing one to the inactive list.

Adding a Medtronic pump or Guardian monitor

1

Make sure the device you are adding is set up to communicate with the computer. (See

Connecting devices on page 23

for connection steps.)

2

Click the patient’s tab or double-click their name on the Patient Lookup table.

3

Click Devices to access the patient’s Devices workspace.

4

Click ADD DEVICE.

5

Select Medtronic Pump/Guardian. The Add Medtronic Pump/Guardian Wizard is displayed.

NOTE: The pump model is listed on the back of the pump or on the pump status screen.

CareLink Pro User Guide Devices workspace 27

6

Select the option button to specify the device you are adding.

If you selected the MiniMed 508 pump option, go to Step 9.

7

Click NEXT. The Serial Number page is displayed.

NOTE: An error message is displayed if you do not enter the correct serial number.

Check the examples on this page, and verify that you are entering the correct characters from the back of the pump. If necessary, re-type the six characters.

8

Use the examples on this page to help locate the six-character serial number on the device you are adding. (If you need more help in locating it, click >>learn more.) Type the six characters in the Device Serial Number field.

9

Click NEXT. A Communication Options page similar to the following is displayed.

10 Click the Choose Port drop-down menu, and select the port that the ComLink, Paradigm

Link

®

, CareLink USB, or Com-Station connects to on your computer. If you are not sure which port to choose, select Auto Detect (or USB).

CareLink Pro User Guide Devices workspace 28

11 Click NEXT. The Test Connection page similar to the following is displayed.

12 Follow any device instructions, and click TEST.

A message displays to let you know if the connection was successful. If it was, go to the next step.

NOTE: This Test does not read pump data, but verifies correct communications between the pump and the computer.

If not, make sure the hardware between the device and the computer is connected properly.

Also, click BACK on the pages of the wizard to make sure the device data you have entered is correct.

13 Click DONE.

The device is added to the patient’s Active Devices list.

Adding a meter

1

Click the patient’s tab or double-click their name on the Patient Lookup table.

2

Make sure the meter you are adding is in communication with the computer. (See

Connecting devices on page 23

for connection steps.)

3

Click the Devices button to access the patient’s Devices workspace.

4

Click the ADD DEVICE button.

CareLink Pro User Guide Devices workspace 29

5

Select Blood Glucose Meter. The Add Blood Glucose Meter Wizard is displayed.

6

Click the option button to select the correct brand of meter.

7

Click NEXT. The Meter Model page is displayed (this page differs depending on the meter manufacturer).

8

Click to select the meter model you are adding.

CareLink Pro User Guide Devices workspace 30

9

Click NEXT. The Communication Options page is displayed.

NOTE: Only those choices that are valid for the meter you are adding are available for selection.

10 Click the Choose Port drop-down menu, and select the port that the ComLink, Paradigm

Link, or CareLink USB connects to on your computer. If you are not sure which port to choose, select Auto Detect (or USB).

11 Click NEXT. The Test Connection page is displayed.

12 Follow the instructions given for the meter, and click TEST.

A message displays to let you know if the connection was successful. If it was, go to the next step.

CareLink Pro User Guide Devices workspace 31

If not, make sure the hardware between the device and the computer is connected properly.

Also, click BACK on the wizard to make sure the data you have entered is correct.

13 Click DONE.

The meter is added to the patient’s Active Devices list.

Making a device active or inactive

Patient devices can be moved between the Active Devices list and the Inactive Devices list as needed. A device must be active in order to read data from it.

You can have as many meters as you want on the Active Devices list, but only one pump.

Make sure you want to inactivate the current active pump before you add a new one.

Inactivating a device

1

Click the patient’s tab or double-click their name on the Patient Lookup table.

2

Click the Devices button to access the patient’s Devices workspace. Devices may be listed under an equivalent device name. See

Supported devices on page 2

.

3

Click >> make this device inactive under the device you want to make inactive. The device moves to the Inactive Devices list.

Re-activating a device

1

Click the patient’s tab or double-click their name on the Patient Lookup table.

2

Click the Devices button. The patient’s Devices workspace is displayed.

Devices may be listed under an equivalent device name. See

Supported devices on page 2

.

3

Click >> activate this device under the device you want to make active.

The device moves to the Active Devices list.

Deleting a device

These steps will delete a device and its data from the Devices workspace and the CareLink Pro system:

1

Click the patient’s tab or double-click their name on the Patient Lookup table.

2

Click the Devices button to access the patient’s Devices workspace.

Devices may be listed under an equivalent device name. See

Supported devices on page 2

.

3

Make sure the device is on the Inactive Devices list. If it is not, click >> Inactivate this

device under its current listing.

4

Click >> delete this device under the device you want to delete. A message is displayed to alert you that the device and all of its data will be removed from the patient’s record.

5

Click YES to delete the device.

The device and its data is removed from the Devices workspace and from the CareLink Pro system. Data from this device is no longer available for use in reports.

CareLink Pro User Guide Devices workspace 32

Reading device data

One way to get device data is to link to the patient’s existing CareLink Personal account. (See

Linking to CareLink Personal on page 20

.) Another way is to read it directly from their device, as

described here.

Data from your patient’s device can be read by CareLink Pro if the device is on the Active

Devices list and it is in communication with the computer. Once you get this data, you can use

it to create reports that help assess the patient’s therapy management. See

About reports on page 41

for a brief description of the available reports.

CareLink Pro can gather the following data from an insulin pump:

• Various settings on the pump, such as the alert mode, the beep volume and the time display

• Basal insulin amounts delivered

• Bolus events and amounts delivered

• Bolus Wizard entries

• Priming amounts

• Suspend periods

• Sensor glucose readings over a period of time, on pumps with sensor capabilities

The system can also gather data from a Guardian REAL-Time system including:

• Sensor Glucose (SG) readings

• Sensor coefficient values

• Sensor calibration factors

• Meal markers

• Insulin injections

Additionally, various information stored in a blood glucose meter can be uploaded to the system during a device read.

WARNING: Please cancel or finish any temp basals or active boluses, and clear any active alarms. The pump will be suspended for reading. Once the read is complete, please verify the pump has resumed.

CAUTION: Do not use the pump remote when the pump is being read. If the pump battery is low, the pump will not send data to the PC. Replace the battery if the status indicates battery power is low.

1

Click the patient’s tab or double-click their name on the Patient Lookup table.

2

Make sure the patient’s device is in communication with the computer. (See

Connecting devices on page 23

.)

3

Click the Devices button to access the patient’s Devices workspace.

CareLink Pro User Guide Devices workspace 33

Devices may be listed under an equivalent device name. See

Supported devices on page 2

.

4

Find the device you want to get data from on the Active Devices list, and make sure the

Choose port data is correct.

For pumps, click the Amount of Data drop-down menu and select how much pump data you want CareLink Pro to read.

5

Click the associated READ DEVICE button.

6

Follow device-specific instructions, and click OK.

7

CareLink Pro displays a progress bar that updates to show how much of the device read has been completed.

If you click CANCEL as the device is being read, a message is displayed to alert you that cancelling the action may result in the loss of all of the data read so far. You will need to click the READ DEVICE button to restart the upload.

To cancel, click YES.

To continue reading device data, click NO.

When the system finishes reading data from the device, you will see a message that confirms the device read is complete.

8

Click OK.

For pumps, follow the instructions for taking it out of suspend mode.

If CareLink Pro is unable to get data from the device, see Troubleshooting for further guidance.

CareLink Pro User Guide Devices workspace 34

6

Reports workspace

CareLink Pro software provides a variety of reports to help you better manage your patients' diabetes treatment. The information contained in each report is based on data you obtain from a patient's devices and their CareLink Personal software account.

Reports can be generated on screen, sent directly to a printer, or saved as TIFF or PDF files that you can attach to an Electronic Medical Record (EMR). You can generate several report types through a single operation.

The data displayed through these reports is captured from the patient’s devices, from their

CareLink Personal account, or from both.

NOTE: More details about the report components, as well as sample reports are contained in the Report Reference Guide. You can access the Report Reference Guide through the

CareLink Pro software by going to Help>View Report Reference Guide (PDF), and selecting the appropriate language.

Before you begin

If you have a period of time you want reflected in a report, you must have a patient’s device data for that time period. You may also need to have the patient’s device connected to the computer to get current data before running reports.

CareLink Pro User Guide Reports workspace 35

Be sure to take a close look at the Verify Report Settings step before running a report. This is where you can fine tune a report to capture the patient data you want.

Creating reports

The following sections will help you better understand the reports that are available to you, and the process you use to generate them.

If you are familiar with the reporting process and know what reports you would like to run, you can begin generating reports.

Opening the Reports workspace

Click the patient’s tab or click the Open Patient button and double-click the patient’s name.

The Reports workspace is displayed.

NOTE: To make sure you have the latest device data from the patient’s CareLink Personal account, click SYNC DATA.

Selecting the reporting period

1

To change how much time is reflected in the report(s), click the Duration drop-down menu and select the amount of time. (The maximum duration is 12 weeks.)

2

From and through dates are automatically set, unless you choose the custom date range option.

NOTE: If you select a date range longer than allowed, you get an error message.

Adjust the duration or dates.

If you want a custom date range, click the From or Through drop-down menus and select the desired month, date or year.

Data calendar

The data calendar area of the Reports workspace shows a three-month window of reporting information.

CareLink Pro User Guide Reports workspace 36

The blue bars represent device data. The orange bar represents the reporting period that you selected. Overlap in the device data and reporting period means you have data for some or all of the displayed reporting period.

The data calendar area initially displays the most current three months. To see other months, click the arrow buttons on either end of the months.

Selecting source data to include

1

If the patient uses a BG meter that links to their pump, click to choose one of the following options for reporting meter BG data:

In the pump: Advantages of this selection include that you only have to read data from the patient’s pump, BG readings are time stamped by the pump, and the readings are tied directly to any Bolus Wizard calculations used. A disadvantage is that if there are communication difficulties between the pump and the linked meter, BG readings during that time may not get reported. Also, for MiniMed Paradigm pumps prior to the 522/722, any BG readings from Bolus Wizard calculations that are not acted on do not get reported.

In the link meter(s): The advantage of this selection is that all readings stored in the linked meter are reported. The disadvantage is that to correlate meter and pump data, you must have made sure that the pump and meter clocks were synchronized with one another. You must also read data from the pump and the linked meter separately.

2

To add device data to reports, select the check box next to the relevant device.

You cannot add devices that were excluded due to your selection in step 1. To change this, select the other linked meter option.

3

To exclude device data from reports, clear the check box next to the relevant device.

You cannot clear check marks related to the option you selected in step 1. To change these, select the other linked meter option.

Checking for device data

1

Look at the data calendar in the Reports workspace to see if the orange bar representing the reporting period overlaps with the blue bars representing device data.

2

If the bars overlap for the entire reporting period, you have data for your report(s). You can click NEXT and go to

Verifying report settings on page 39

.

3

If the bars do not overlap, or there is not enough overlap, you have a few choices:

CareLink Pro User Guide Reports workspace 37

Adjust the reporting period.

Get additional device data.

Getting additional device data

1

To get more data from a device, click the READ DEVICE button associated with the device.

The Read Device bar is displayed.

WARNING: Please cancel or finish any temp basals or active boluses, and clear any active alarms. The pump will be suspended for reading. Once the read is complete, please verify the pump has resumed.

CAUTION: Do not use the pump remote when the pump is being read. If the pump battery is low, the pump will not send data to the PC. Replace the battery if the device status screen indicates battery power is low.

2

Verify that the data in the Choose port field is correct for this device.

To change this setting, click the drop-down menu for the field and select a different setting.

3

Make sure the device is connected to your computer.

4

If the device is a pump, you can specify how much data to get from it. Click the Amount of

Data drop-down menu and select an amount.

NOTE: If you select All available data, the system reads all data in the pump. This

overwrites any existing duplicate data in the system.

5

Click READ DEVICE. Be sure to read the message that is displayed carefully because it provides specific instructions for reading the pump.

6

Follow the instructions and click OK.

The read device progress bar is displayed.

You can choose to cancel the read at any time by clicking CANCEL.

A message is displayed to confirm that the read is complete.

7

Click OK.

Device data is now visible within the data calendar.

8

Click NEXT at the top of the Reports workspace.

CareLink Pro User Guide Reports workspace 38

The Verify Report Settings step is displayed. This allows you to make sure the settings for this patient are correct before you run the report(s).

Verifying report settings

1

Make sure the Glucose Target settings are at the desired values. Type in these values, or click the up or down arrows in the Low and High fields to raise or lower the values.

NOTE: Meter reading markers (|| |) are displayed on the wake-up and bedtime timeline, as well as on the meal markers timeline. Because some of the reports are based on data found within defined meal times, wake-up or bedtime hours, it is important that a patient's Bolus Wizard event and meter reading markers are grouped appropriately.

2

To add a new meal period, click ADD MEAL. To edit an existing meal period, click anywhere within one of the meal periods along the timeline.

The Meal Period editor, located below the timeline, becomes active.

NOTE: You can have as many as five meal periods. The defaults are breakfast, lunch and dinner.

3

Enter text or click arrows to select the settings you want.

If you only want to use these settings for this meal, clear the check box Use these

parameters for all of this patient's meals.

Meal Name: name you want to assign to the meal period.

Meal Time Period: hours between which the meal occurs.

Pre-Meal BG Target (mg/dL or mmol/L): low and high ends of the patient’s beforemeal glucose target range.

Pre-Meal Analysis Period: time period that glucose will be analyzed prior to the start of a meal. The glucose readings captured during this time are used in a detailed report analysis.

Post-Meal BG Target (mg/dL or mmol/L): low and high ends of the patient’s post-meal glucose target range.

Post-Meal Analysis Period: time period that glucose will be analyzed after a meal. The glucose readings captured during this time are used in a detailed report analysis.

You can change the length of an existing meal period or the wake-up and bedtime period by clicking on the start or end handles, and dragging and dropping them along the timeline.

NOTE: Meal periods cannot overlap, but start and end lines can border one another.

Meal periods must be at least 60 minutes in length.

CareLink Pro User Guide Reports workspace 39

4

To use the settings from this meal for all of the patient’s other meals, make sure the check box next to Use these parameters for all of this patient’s meals is selected.

5

After you finish creating or editing a meal period, click SAVE.

6

To remove a meal period, click DELETE MEAL. Click DELETE when asked to confirm.

7

CareLink Pro can remember these settings for this patient the next time you run a report for them. To save them for this patient, click SAVE SETTINGS.

8

Click NEXT at the top of the Reports workspace.

This is the Select and Generate Reports step of the process. It provides a list of report types as well as a Data Table that helps you choose to include or exclude certain days of data from the Daily Detail report(s).

NOTE: To modify the Data Table display, click >>customize columns. See Report

Generation preferences on page 15.

9

To print the screen, click the PRINT icon .

Selecting report types and inclusion dates

1

Select the check box next to the report(s) you want to include in the report set.

2

If data has been read from a pump or Guardian monitor more than once during this reporting period, there may be multiple device snapshots:

CareLink Pro User Guide Reports workspace 40

a. Make sure the check box is selected next to Device Settings Snapshot.

b. Click the drop-down arrow and select a snapshot date and time.

Pumps: Select a snapshot from the patient’s pump.

Guardian: Select a snapshot from the patient’s Guardian monitor.

If either field is dimmed, there are no snapshots available during the reporting period.

3

Scroll though the Data Table to review the available Daily Detail report information.

You can sort the data in each column. Click the column heading to sort the data in ascending order. Click the heading again to sort the data in descending order.

NOTE: If there is no data for a certain date, that date cannot be selected.

4

Select the check box in the Data Table rows for any date for which you want a Daily Detail report.

To include or exclude all Daily Detail report dates with one click, select the check box at the top of the Data Table check box column.

Generating reports

1

After you verify your report selections, click GENERATE REPORTS at the top of the Reports workspace.

A list of options is displayed.

2

Select an option to preview, print, or save the report(s).

If you selected Preview, the Preview window is displayed.

3

Click the arrow buttons to navigate through multi-page reports.

4

Click one of the other buttons at the top of the Preview window to save or print the report(s).

5

To close this window, click the Close button in the upper right corner of the window.

About reports

This topic provides a description of each report. More details about the report components, as well as sample reports are contained in the Report Reference Guide. You can access the

Report Reference Guide through the CareLink Pro software:

1 Help > View Report Reference Guide (PDF).

2

Select a language for the Report Reference Guide.

The CareLink Pro reports share these common elements:

Report header — The report header contains identifying information, such as the name of the report, the patient's name, and the source of the data.

CareLink Pro User Guide Reports workspace 41

Carbohydrates and blood glucose levels — Within the graphs and charts, carbohydrate units are displayed in italics and blood glucose levels are displayed in bold.

Weekend data — Weekend days are in bold so you can easily identify them.

Legends — A legend of symbols appears at the bottom of each report. While a symbol may be used in multiple reports, the legends are unique to each report.

Adherence Report

The Adherence Report presents data that describes how insulin pumps and sensors are used and the patient’s behavior relevant to their therapy. It answers the question, “Was there enough data to provide an accurate picture of how the patient uses their insulin pump and sensor, if applicable” It also answers the question, “Do patients adhere to the therapy as instructed?” It also indicates whether you may need to speak to your patient about the way they are managing their diabetes.

Sensor and Meter Overview Report

The Sensor and Meter Overview Report provides a graphical representation of the patient's daily sensor and meter-derived glucose levels and averages, including hourly breakdowns over 24 hours and as they relate to their meals and sleep patterns. Statistics on the patient's glucose readings and insulin usage are also included.

A similar analysis of sensor data is generated as the first page of this report if sensor data is available. When no sensor data is available, the meter data analysis page will be generated as the first page.

The final page(s) of the report shows the day-to-day level and quality of your patient’s glycemic, carbohydrate, and insulin control. Each page shows how that control varies during each day across the entire reporting period up to a 14 day maximum per page.

Logbook Report

The Logbook Report provides meter glucose, carbohydrate, and insulin data for each day in the reporting period. It provides a diary of events recorded hourly, as well as daily averages and totals. Each page contains up to 14 days. If the reporting period exceeds 14 days, extra pages are generated.

Device Settings Snapshot

The Device Settings Snapshot Report presents a snapshot of the settings for the patient's pump or Guardian REAL-Time monitor for a specific date and time. This can help you understand other reports or can simply document your patients' settings.

The pump or monitor settings are recorded only when the device is read. If the device was not read during the reporting period, no settings will be available.

Daily Detail Report

The Daily Detail Report shows glucose data, carb amounts, and the patient’s insulin usage for the selected day. A separate report is generated for each day you select from the Data Table.

CareLink Pro User Guide Reports workspace 42

The Daily Detail Report provides a detailed look at each day you select. It allows you to focus on a particular day if you feel something of interest to the patient’s therapy was occurring.

Exporting data

You can export device data that is acquired and stored by CareLink Pro. This gives you all of a patient’s device data to use for statistics or the creation of specialized reports or charts.

The .csv file can be imported into Microsoft Excel or certain clinical statistics programs where you can further manipulate the data.

The .csv file contains data recording the actions of the device. For example, it lists the recording of meter readings, the pump receiving the meter reading value, or change in basal rate.

NOTE: This is an advanced feature, and requires you to be familiar with the raw device data. It also requires proficiency with any software into which you import the .csv file.

Follow these steps to use the CareLink Pro export feature:

1

Click the patient’s tab or click the Open Patient button and double click the patient’s name.

2

Make sure the Reports workspace is displayed.

3

Use the Duration or From/Through fields to set the dates and length of the report.

The maximum duration you can select is 12 weeks.

4

Click the export selected data link.

The Export Data to CSV File dialog box is displayed.

5

Navigate to the location where you want to store the .csv file on your computer. If you want to change the name of the file, type it into the File name box.

6

Click SAVE.

NOTE: For more information about the data displayed in CSV files, see the CSV data appendix.

The .csv file is now saved on your computer in the location you selected. You can now choose to import it into any program that supports this file type.

CareLink Pro User Guide Reports workspace 43

7

System administration

It is important that you regularly back up the CareLink Pro database. The database stores all system data that has accumulated in your patient’s records, including profile information, device-derived data, and report settings.

It is also important that you have the latest version of CareLink Pro. Updated versions are available periodically, and may contain important enhancements. You can choose to search for updates or to be notified when they are available.

Applying software updates

There will be occasional updates to the CareLink Pro software. When notice of an update is displayed, take the following steps to download the latest software release.

NOTE: The database should be backed up before a software update is applied. See Backing up the database on page 45.

1

Make sure an Internet connection is available and active on your computer.

2

The CareLink Pro Update message is displayed when there is an update to CareLink Pro. It gives you the option to download the update.

3

Click DOWNLOAD. (If you click CANCEL, the update notice will close. You can download the update at a later time.)

A warning message is displayed that recommends backing up your database.

4

Click YES to create a backup of your database (see

Backing up the database on page 45

for this procedure). Click NO if you have already backed up your data.

A message is displayed to confirm that the new version of CareLink Pro has been downloaded.

5

To begin using the latest version of CareLink Pro, click YES to close and re-open the software application. Click NO if you would prefer to wait before re-starting CareLink Pro.

CareLink Pro User Guide System administration 44

Turning off automatic updates

If you do not want to receive automatic notification of CareLink Pro updates, follow these steps:

1

Select Tools > Options.

2

Click the General tab.

3

Under the Communications section, clear the check box next to Automatically check for

software updates.

Manually checking for updates

You can manually check for CareLink Pro updates at any time.

NOTE: The database should be backed up before a software update is applied. See Backing up the database on page 45.

1

Make sure an Internet connection is available and active on your computer.

2

Select Tools > Check for Software Updates.

3

You will receive a message if no updates are currently available. If an update is available, a

CareLink Pro Update message is displayed.

4

Follow the procedure in

Applying software updates on page 44

.

Backing up and restoring the database

It is a good idea to establish a regular schedule by which to perform database backups. This will help ensure that it is done regularly, and will minimize the risk of data loss.

If you are backing up or restoring the database, the system displays an alert message if there are active users of the software on other computers.

Backing up the database

The following steps let you back up the current database to the location you select.

1

Make sure all patient records are closed.

2

Select Tools > Backup Database.

NOTE: Database backups can be saved on a network drive, or to removable storage

(such as a DVD, CD, or USB drive).

3

Navigate to the location on your computer where you want to save the backup file. If you want to change the name of the backup file, type it into the File name box.

4

Click Save. A progress bar is displayed while the database is saved.

A message is displayed when the backup is complete.

CareLink Pro User Guide System administration 45

5

Click OK to close the message.

Restoring the database

The current database may need to be replaced if it can no longer be accessed or used. The more current your backup, the less data you will lose if you replace the database.

CAUTION: When you restore the database with a backup copy, you lose all the new data created in the current database since the selected backup copy was made.

The following steps let you select a backup copy to replace the current database.

1

Make sure all patient records are closed.

2

Select Tools > Restore Database.

3

Select the backup file you want to use to replace the current database (usually the most recent).

4

Click Open. A warning message is displayed to remind you about the data that may be lost if you continue the database restore.

5

To continue, click OK. A progress bar is displayed while the database is being restored.

A message is displayed when the database is restored.

6

Click OK to close the message.

When the system is unavailable

If you attempt to start the system while another user is performing a backup or restore, you will receive a message notifying you that the system is not available. You will not be able to access the system until the task is complete.

Do one of the following:

• Wait for the process to complete and for the system to become available.

• Click CANCEL to exit and try again later.

CareLink Pro User Guide System administration 46

8

Troubleshooting

This topic is designed to help you solve issues that may occur while using CareLink Pro software. It also contains instructions for uninstalling the CareLink Pro software if necessary.

General application use errors

If you try to download a software upgrade over the Internet, you may receive the message that you do not have sufficient privileges to do so. You must have administrative privileges to download CareLink Pro software upgrades.

1

Close the CareLink Pro software application, and restart your computer system.

2

Have someone with administrative privileges log in to the computer.

3

Follow the instructions in

Applying software updates on page 44

.

Not connected to the database

An error message stating that you are not connected to the database indicates one of the following:

• The database has been moved. The database must be located in the same place that was selected during installation of the CareLink Pro software. If it has been moved, it must be moved back to the location selected during installation.

• You are not connected to the network drive where the database is located. If the database is located on a network drive, the network may occasionally experience problems that prevent you from accessing the drive. Contact your computer support department for help in reconnecting to the network drive where the database is located.

CareLink Pro User Guide Troubleshooting 47

Forgot the clinic password for CareLink Pro

If no one can remember the password your clinic uses to log in to CareLink Pro, the CareLink

Pro software must be re-installed, and a new database created. Once you re-install the software, you will not be able to access any patient information that was in the previous database. Store the password that you created during the new installation somewhere in the office so that you will not lose future data.

Device read errors

Error

The selected serial port could not be opened. Another operation might be in progress on that port. Please wait until the port is available, or select another port.

Auto Detect could not find the device on any available port. Please check the cable connection, device battery

& status and try again, or try specifying a serial port.

Device not found at selected serial port. Please check the cable connection, device battery & status and try again, try selecting a different port, or try to Auto

Detect the device.

Unable to communicate with the device. Please ensure you’ve attached and selected the correct device, check the cable connection, device battery and status, and try again.

Unexpected response... retrying (n%)

The link device was found, but the device (<serial #>) is not responding. Please verify the device’s serial number, place the device closer to the link device to minimize signal interference, check device battery and status.

This pump is delivering a temp basal. Please cancel the temp basal or wait until it completes, and then try again.

This device has active errors or alarms. Please clear the alarms and try again.

Explanation

Please verify that the com port selected is not in use by another program, or select a different port.

Try rebooting the computer you are using and then try the device read again. The hardware (such as the cable) connected to the port or the port itself may be bad. Connect the hardware to another port and try the device read again to help determine the problem.

Check the connection between the cable and the

PC, and verify that the device battery status is fine.

If so, try specifying the PC serial port to which the cable is connected, rather than selecting Auto

Detect.

Check the connection between the cable and the

PC, and verify that the device battery status is fine.

If so, try either selecting a different PC serial port number, or choose the Auto Detect option.

Verify all settings selected for the device read, including device name, serial number and type of connection. Also check to make sure that the device, cable and PC are connected properly. Verify the battery and alarm status of the device is okay.

Try the read again.

An unexpected value was read from the device. The system retries communication until you cancel or communication succeeds.

Verify that the correct serial number was entered.

If not, re-enter the correct serial number. If the serial number is correct, try moving the link device closer to the communication device. Move the link device and communication device away from possible interference (such as other RF devices).

Check the device's battery strength and if uploading an insulin pump, check the pump delivery status.

The pump you are attempting to read is delivering a Temp basal. Either wait until the Temp basal completes to read the pump, or cancel the Temp basal and then read the pump.

There are active alarms on the pump which prevent it from being read. Read the alarm instructions for clearing the alarm. Clear the alarm and try the pump read again.

CareLink Pro User Guide Troubleshooting 48

Error

This pump is delivering a bolus. Please cancel the bolus or wait until it completes, and then try again.

The device returned invalid entries; all data read will be discarded.

Explanation

The pump you are attempting to read is delivering a bolus. Either wait until the bolus completes to read the pump, or cancel the bolus and then read the pump.

Contact your local country representative (see

Assistance on page 2

).

Report creation errors

Multiple data entries for the same date

If multiple data entries exist for the same date and time for the same device, the system considers this to be a conflict that it cannot resolve. Reports created using this device data will omit the portion of data that overlaps.

You can try to adjust the reporting period to miss the overlapping data. Or, you can remove the device from the system and then add it back again to clear the previous readings.

System is going to ignore data

If the time on a device has been changed causing overlaps or gaps in data of three hours or longer, the system does not include that portion of data when creating reports.

Backup and restore errors

The database cannot be locked

This means that you are using the system in a multi-user environment, and other users are logged in. The system will not allow a database backup to be performed while other users are potentially performing tasks that may affect the database. Once all other users exit CareLink

Pro, you can perform the database backup.

A database backup or restore is not completing

Other users cannot log in and the backup or restore cannot complete. Please contact your local country representative (see

Assistance on page 2

).

A restore database fails

The database backup file you are attempting to use in the restore process is corrupt. Try restoring with a different backup file.

Uninstalling the software

If you need to uninstall CareLink Pro, complete the following steps:

1

Open the Control Panel through your Windows Start menu.

2

Select Add or Remove Programs.The Windows Add or Remove Programs window is displayed.

CareLink Pro User Guide Troubleshooting 49

3

Scroll down to Medtronic CareLink Pro and click on it.

4

Click Remove. The Install Shield Wizard is displayed.

5

Click Next. A message is displayed asking you to confirm that you want to remove the application.

6

Click Yes. The uninstall program runs and removes the program and all of its files from your computer. When it is done, a message displays on the wizard screen confirming the uninstall.

7

Click Finish.

CareLink Pro User Guide Troubleshooting 50

9

Icon table

The icons and symbols on the packaging labels and the equipment are described in the following table:

Description

One per container/package

CD enclosed

Attention: Read all warnings and precautions in instructions for use.

Date of manufacture (Year)

Catalogue number

Conformité Européene (European Conformity). This symbol means that the device fully complies with MDD

93/42/EEC and R&TTE Directive 1999/5/EC.

Icon

(1X)

CareLink Pro User Guide Icon table 51

A

CSV data

When you export report data from the CareLink Pro software, it is exported into a .csv file. This file can then be imported into a spreadsheet application, such as Microsoft Excel. See the CSV file column definitions for a complete listing of the data that can be contained in a CSV file.

The CSV file contains the name and Patient ID for the patient, the reporting period, and identifies each device included in the report.

Column data definitions

Column heading

Index

Date

Time

New Device Time

BG Reading (mg/dL or mmol/L)

Linked BG Meter ID

Basal Rate (U/h)

Temp Basal Amount

Temp Basal Type

Temp Basal Duration (m)

Bolus Type

Bolus Volume Selected (U)

Definition

The order in which data was recorded in the device.

The date data was recorded in the device.

The time data was recorded in the device.

The new date and time if this was changed in the device.

The blood glucose reading recorded by the meter,

Guardian or pump. If the data is from a pump or

Guardian, this column reflects manual BGs and BGs received from a Link meter.

The serial number for the meter that sent a particular blood glucose reading to the device.

The active basal insulin delivery rate in units per hour.

If a temp basal was applied on the pump, this value is the temp basal amount.

The type of temporary basal adjustment (insulin rate or percent of basal).

The length of time in minutes for the temporary basal insulin delivery (see type above).

The bolus insulin delivery type [Normal, Square, Dual

(normal part), or Dual (square part)].

The number of units of insulin selected to be delivered during the bolus insulin delivery.

CareLink Pro User Guide CSV data 52

Column heading

Bolus Volume Delivered (U)

Programmed Bolus Duration (h)

Prime Type

Prime Volume Delivered (U)

Alarm

Suspend

Rewind

BWZ Estimate (U)

BWZ Target High BG (mg/dL or mmol/L)

BWZ Target Low BG (mg/dL or mmol/L)

BWZ Carb Ratio

BWZ Insulin Sensitivity

BWZ Carb Input

BWZ BG Input (mg/dL or mmol/L)

BWZ Correction Estimate (U)

BWZ Food Estimate (U)

BWZ Active Insulin (U)

Sensor Calibration BG (mg/dL or mmol/L)

Sensor Glucose (mg/dL or mmol/L)

ISIG value

Definition

The number of insulin units actually delivered during the bolus insulin delivery.

Duration of a square bolus or the square portion of a dual wave bolus.

Manual or fixed. Manual is used just after a rewind, to fill the infusion set tubing with insulin before inserting it. Fixed is used after infusion set insertion to fill the soft cannula with insulin after removing the introducer needle.

The number of units of insulin actually delivered for the prime

The name of the alarm that occurred.

Identifies the suspended state of the pump.

Date and time the device was rewound.

The bolus insulin estimate calculated by the Bolus

Wizard feature on the Paradigm pump.

The setting for the high end of the blood glucose target range, used by the Bolus Wizard feature.

The setting for the low end of the the blood glucose target range, used by the Bolus Wizard feature.

The setting for insulin-to-carbohydrate ratio. If grams are used as the units, the ratio is the number of grams covered by one unit of insulin. If exchanges are used for units, the ratio is the number of insulin units used to cover one exchange.

The setting for insulin sensitivity. Insulin sensitivity is the amount the blood glucose level is reduced by one unit of insulin. This is used by the Bolus Wizard feature.

Amount of carbohydrates entered into the Bolus

Wizard and used to estimate a bolus.

Blood glucose reading when entered into the Bolus

Wizard and used to estimate a bolus.

Units of bolus insulin to give for blood glucose level correction, as calculated by the Bolus Wizard feature.

The estimated units of bolus insulin to give to cover the expected amount of carbohydrate consumption, as calculated through the Bolus Wizard feature.

The amount of active insulin calculated to be left in the body from prior bolus insulin deliveries when determining the estimated bolus amount through the Bolus Wizard feature.

The BG value used for calibrating the sensor in mg/ dL or mmol/L).

The sensor glucose value.

Input signals (ISIG), being read from the sensor, measured in nanoamperes (nA).

More about CSV files exported by CareLink Pro

The title at the top of CSV file includes the following:

CareLink Pro User Guide CSV data 53

• patient’s name

• a list of selected devices and their serial numbers

• selected date range

Each block of columns has a title that includes the following:

• name of the device to which the block of data applies

• serial number of that device

If data is not displaying as expected

There are a number of different factors that can cause the CSV data to display differently than expected.

• Date or time changes on the device can change the sequence or cause records outside the selected date range to be shown.

• If there is a large gap between device reads, data for that device may be displayed in multiple blocks.

CareLink Pro User Guide CSV data 54

Glossary

A1C - Glycosylated hemoglobin

A1C Test - Hemoglobin A1C test, used to interpret blood glucose level over a period of time.

Area Under the Curve (AUC) - Indicates the amount in high and low excursions as determined by preset values. Excursion data indicates the frequency of highs or lows. AUC indicates the magnitude of events by showing how far out of range and for how long.

Audio bolus - The pump can be programmed so the user hears a beep when they select a bolus insulin amount (0.5 or 1.0 units) to be delivered. This is useful for situations when it is difficult to see the buttons on the pump.

Basal insulin - An hourly, continuous infusion of insulin delivered automatically by an insulin pump based on preprogrammed profiles and personalized rates set in the pump. The pump delivers a daily infusion of insulin that typically covers background insulin needs during periods of fasting

(such as overnight and between meals).

Basal patterns - The user can program up to three different basal rate patterns into their pump for the delivery of basal insulin: Standard, A, and B. For each pattern there is the option of setting up to 48 basal rates.

Basal profile - A basal rate with a start and stop time. The user can program several different profiles into their pump, each with a different basal rate, during a 24 hour period of time to achieve better glucose control.

Basal rate - The pump setting that provides a continuous infusion of insulin to keep the blood glucose stable between meals and during the night. Basal insulin mimics pancreatic insulin delivery— which meets all the body's non-food related insulin needs.

BG - Abbreviation for Blood Glucose

Bolus insulin - A dose of insulin given to cover an expected rise in blood glucose (such as the rise after a meal or a snack) or to lower a high blood glucose down to target range.

Cal Reminder - The pump will trigger a Meter BG By HH:MM alarm automatically every 12 hours, signaling that the current calibration value is no longer valid. The value of the Cal Reminder is the amount of time before the current calibration value expires by which the user wants to be reminded to calibrate. For example, if the Cal Reminder is set to 2 hours, the Meter BG By HH:MM alarm will occur 2 hours before calibration is required.

Carb ratio (carbohydrate ratio) - The amount of carbohydrates covered by one unit of insulin. (Also see exch ratio.)

Carb units - The food entry when using the Bolus Wizard. Entered as (carbohydrate) grams or exchanges.

CareLink

®

Personal - An online service that allows management of diabetes data via the Internet.

CareLink Pro User Guide Glossary 55

CH - Carbohydrate

ComLink - A radio frequency (RF) transceiver device used to download Paradigm pump data to the computer.

Com-Station - A device used to download MiniMed 508 pump and pass-through third-party meter data to the computer.

Correction bolus - The amount of insulin needed to return a high blood glucose level back down to target range.

Correction bolus factor - How much 1.0 unit of insulin will lower your blood glucose. This factor is used to calculate a correction bolus amount when your blood sugar is high. (BG level) - (BG target)

= X. X ÷ (correction bolus factor) = correction bolus amount

Dual Wave

®

bolus - Combination of a Normal bolus that is delivered immediately, then followed by a Square Wave bolus. The Square Wave portion is delivered evenly over a period of time.

Easy Bolus™ - Method of delivery for a Normal bolus by using the Easy Bolus button on the pump.

Exch ratio (exchange ratio) - The amount of insulin required to cover one (1) carbohydrate exchange.

(Also see carb ratio.)

Express bolus - Method of delivery for any bolus type using the express bolus button on the pump.

Food bolus - A dose of insulin given to cover the expected rise in blood glucose that occurs after eating.

HbA1c - Glycosylated hemoglobin

HbA1c Test - Hemoglobin A1C test, used to interpret blood glucose control or average of levels over a 2- to 3-month period of time.

High Glucose - The pump will alarm if the sensor indicates that the user’s sensor glucose is at or above this value. You have the option to turn this feature on or off.

Hyperglycemic - Elevated blood glucose as seen by monitoring blood glucose levels with or without any or all of the following symptoms: nausea, vomiting, blurred vision, headache, gastric distress, frequent urination of large amounts, and lethargy.

Hypoglycemic - Low blood glucose as seen by monitoring blood glucose levels, with or without any or all of the following symptoms: excessive hunger, shaking or tremors, perspiration, dancing visions, light-headedness, headache, blurred speech, sudden mood swings or personality change.

Infusion set - The apparatus used for inserting and securing a cannula below the skin and transporting insulin to the insertion site via tubing from the pump.

Insulin concentration - The strength or type of insulin the doctor has prescribed for the user. This affects the rate of insulin the pump delivers. If the user’s insulin concentration changes, the basal patterns and the maximum basal and bolus rates must be reprogrammed in the pump.

Insulin sensitivity - The amount of mg/dL (or mmol/L) that your blood glucose (BG) level is reduced by one unit of insulin. (Bolus Wizard data.)

ISIG - Sensor values that indicate whether the transmitter electronics in a sensor-augmented system are working properly. If you see an ISIG value that is less than 24.00 nA or more than 29.00 nA, call for product assistance. It may be time to replace your transmitter.

Ketone test - Ketone is a waste product that is produced when the body is forced to burn body fat instead of glucose for energy. It may be a sign of lack of insulin in the body. The Ketone test measures the amount of ketone concentrated in the blood or urine.

Link

(1) To turn on and setup the meter option that allows the pump to receive BG readings from a meter that communicates with your pump.

(2) It is also used in this system to refer to hypertext links. When clicked on, hypertext links take you to another place in the system or to another Web site.

Low Glucose - The pump will alarm if the sensor indicates that the user’s sensor glucose is at or below this value. You have the option to turn this feature on or off.

CareLink Pro User Guide Glossary 56

Low reservoir warning - Programmable warning that notifies you with an alert when either a specified number of units remain in the reservoir of your pump, or a specified amount of time remains before the reservoir will be empty.

Manual bolus - Optional item available in the BOLUS MENU when the Bolus Wizard is active. One method of programming a bolus without the Bolus Wizard.

Max basal insulin - The maximum amount of basal insulin that the pump will deliver at one time.

(Set by the user).

Max bolus - The maximum amount of bolus insulin that the pump will deliver at one time. (Set by the user).

Mean Absolute Difference % (MAD%) - Represents the level of accuracy in calibration of the sensor to BG meter readings. The lower this number, the greater the calibration accuracy. MAD% is calculated by taking the difference between closely occurring pairs of sensor glucose and BG meter readings, dividing by the BG meter reading and then averaging across all pairs.

Meter - a medical device for determining the approximate concentration of glucose in the blood. A small drop of blood is placed on a disposable test strip, which the meter reads and uses to calculate the blood glucose level. The meter then displays the level in mg/dL or mmol/L.

Meter option - Feature that allows the pump to receive BG readings from a linked BG meter.

Normal bolus - An immediate delivery of a specified unit amount of insulin.

Pattern feature - Extended pump feature that allows you to program optional basals (Pattern A,

Pattern B) that support activities or glucose patterns that are not a part of your day-to-day routine, but are usual in your lifestyle. Such activities could be a sport that you do once a week, a change in your sleep pattern over the weekend, or hormonal changes during a menstrual cycle.

Pattern, standard - Your normal basal that supports your usual day-to-day activity. When the

Patterns feature is off, the pump uses your standard (basal) pattern.

RF - Radio frequency (RF).

Square Wave

®

bolus - Bolus delivered evenly over a specified time period (30 minutes to 8 hours).

Square Wave portion - (Sq) The second part of a Dual Wave bolus. The Square Wave portion delivers evenly over a period of time after the NOW portion delivers.

Step - Measurement of insulin that you set and use for Easy Bolus delivery.

Suspend - Function on the pump that stops all insulin delivery. Any current bolus and/or prime deliveries are canceled. The basal delivery is paused until restarted.

Temp - Temporary

Temp basal (tmp basal) - Temporary one-time basal insulin with a specified amount and duration.

Used to support insulin needs for special activities or conditions that are not part of the normal daily routine.

Transmtr ID - The serial number of the transmitter currently in use.

Upload - The process for transferring pump or meter data to the CareLink® Personal server.

CareLink Pro User Guide Glossary 57

Index

A

about reports 41

Adherence report 42

Daily Detail report 42

Device Settings Snapshot 42

Logbook report 42

Sensor & Meter Overview report 42

activating devices 32

adding a device to the system 27 adding a Guardian monitor to the system 27

adding a meter to the system 29

equivalent meter names to choose 4

adding a patient 19

adding a patient’s device to the system

Guardian monitor 27

meters 29

pumps 27 adding a pump to the system 27

Adherence report

about 42

B

backing up the database 45

basic CareLink Pro tasks 7

Bayer Ascensia® DEX®

devices equivalent to 4

Bayer Ascensia ELITE™ XL

devices equivalent to 4

buttons on the toolbar 8

C

cables for connecting devices to computer

serial 24

USB 24

CareLink Personal

getting data 21

linking to an account 20 email invitation 20 existing account 20

checking

for device data for reports 37

closing patient profiles 10

ComLink 4, 25

communication devices supported by

CareLink Pro 4

communications devices supported 2

Com-Station 4

connecting devices to computer 23

cables 24 computer connections 24 serial 24

USB 24

meter options 23

optional components 25

ComLink 25

connecting devices to your computer

computer connections 24 serial 24

USB 24 overview 24

contraindications 5

copying the database for backup 45

creating patient profiles 19

creating reports 36

checking for device data 37

getting new device data 38

making your own report 43

opening the reports workspace 36

previewing 41 printing 41 saving 41

selecting devices 37

selecting report types and inclusion

dates 40

selecting the reporting period 36

verifying report settings 39

CSV files

exporting device data to 43

D

Daily Detail report

about 42

CareLink Pro User Guide Index 58

data communications cable 4 data communications cable supported 4

database

copying for backup 45

restoring with backup copy 46

deleting a patient’s device from the system 32

device data

getting data from CareLink Personal 21

getting it from a patient’s device 33

linking to CareLink Personal 20 email invitation 20 existing account 20

Device Settings Snapshot

about 42

devices

activating 32

adding to the system 27, 29

Guardian monitor 27

meters 29

pumps 27

checking for data for reports 37

connecting to computer 23, 24, 25

computer connections, serial 24

optional components, ComLink 25

connecting to your computer 24 computer connections, serial 24 overview 24

deleting 32 deleting from the system 32

exporting data 43

getting data 33, 38 new data for reports 38

inactivating 32

ordering 4

selecting for reports 37

storing in the system 32 inactivating 32 making active 32

supported 2, 3, 4

ComLink 4

Com-Station 4

glucose meters 3

insulin pumps 2

meter data communications cable 4

supported by CareLink Pro 2

devices workspace

adding devices 27, 29

Guardian monitor 27

meters 29

pumps 27

deleting devices 32

getting device data 33

storing devices 32 inactivating 32 making active 32

documents related to this user guide 2

downloading software updates 44

E

editing patient profiles 19

email invitation to set up a CareLink Personal

account 20

equivalent devices

alternative meter names to choose 4

existing CareLink Personal account

linking to 20

exporting device data 43

F

features of CareLink Pro 1

security 2

G

general preferences

setting 11

generating reports 41 previewing 41 printing 41 saving 41

getting a patient’s device data 33

getting device data

from CareLink Personal 21

linking to CareLink Personal 20 email invitation 20 existing account 20

new data for reports 38

global system preferences

setting 11, 13, 14, 15, 16, 17

general preferences 11

open patient preferences, choosing

data 15

patient lookup preferences 14

patient lookup preferences, changing

column order 15

patient profile preferences 13

patient profile preferences, adding a

custom field 13

patient profile preferences, changing

field order 14

patient profile preferences, choosing

data fields 13

report generation preferences,

changing column order 17

report generation preferences,

choosing data 16

understanding 11

glucose meters supported 2

glucose meters supported by CareLink Pro 3

Guardian monitor

adding to the system 27

Guardian monitors

inactivating 32

Guide Me feature 9

CareLink Pro User Guide Index 59

H

hardware connections 23

cables 24 computer connections 24 serial 24

USB 24

meter options 23

optional components 25

ComLink 25

overview 24

USB 24

HelpLine, contacting 2

how to use this user guide 5

I

icons 51

inactivating devices 32

inclusion dates

selecting for reports 40

indications for use 5

insulin pumps supported 2 insulin pumps supported by CareLink Pro 2

K

key features of CareLink Pro 1

L

linking to CareLink Personal accounts 20 email invitation 20 existing account 20

getting data 21

Logbook report

about 42

logging in

to CareLink Pro 8

M

Medtronic MiniMed products

ordering 4 meter cable 4

meter data communications cable

supported 4

meter name

equivalent devices 4

meters

activating 32

adding to the system 29

connecting to computer 23, 24, 25

computer connections, serial 24 computer connections, USB 24

optional components, ComLink 25

connecting to your computer 24 computer connections, serial 24 computer connections, USB 24

deleting 32

getting data 33

inactivating 32

options for communicating with

computer 23

ordering 4

supported 3

N

navigating

workspaces 8 navigating the CareLink Pro GUI 8

navigation bar

workspaces 8

notification of software updates 44

O

online device data

getting the data 21

linking to CareLink Personal 20 email invitation 20 existing account 20

open patient preferences

setting 15 choosing data 15

opening

reports workspace 36

opening CareLink Pro 8 entering your password 8 logging in 8

opening patient profiles 10

optional devices for communicating with

computer 25

ordering

devices 4

Medtronic MiniMed products 4 meters 4

Paradigm Link 4 pumps 4

overview of CareLink Pro 1

P

Paradigm Link

ordering 4

password

entering for CareLink Pro 8

patient lookup preferences

setting 15 changing column order 15

CareLink Pro User Guide Index 60

patient profile preferences

setting 13, 14

adding a custom field 13

changing field order 14

choosing data fields 13

patient profiles

closing 10

creating 19 editing 19

opening 10

PC

connecting devices 23, 24 computer connections, serial 24 computer connections, USB 24

connecting devices to it 24, 25

computer connections, serial 24 computer connections, USB 24

optional components, ComLink 25

overview 24

preferences

system 11, 13, 14, 15, 16, 17

setting 11 setting, general preferences 11

setting, open patient preferences,

choosing data 15

setting, patient lookup preferences 14

setting, patient lookup preferences,

changing column order 15

setting, patient profile preferences 13

setting, patient profile preferences,

adding a custom field 13

setting, patient profile preferences,

changing field order 14

setting, patient profile preferences,

choosing data fields 13

setting, report generation

preferences 15

setting, report generation preferences, changing column

order 17

setting, report generation

preferences, choosing data 16

understanding 11

previewing

reports 41

primary CareLink Pro tasks 7

printing

reports 41

product

overview 1

profiles

closing 10

creating 19 editing 19

opening 10

pumps

activating 32

adding to the system 27

communicating with the computer 33, 38 guidelines 33, 38

connecting to computer 23, 24, 25

computer connections, serial 24 computer connections, USB 24

optional components, ComLink 25

connecting to your computer 24 computer connections, serial 24 computer connections, USB 24 example 24

deleting 32

getting data 33

inactivating 32

ordering 4

supported 2

R

related documents 2

report generation preferences

setting 15, 16, 17

changing column order 17

choosing data 16

report settings

verifying 39

report types

selecting for reports 40

reporting period

selecting 36

reports

about 42

Adherence report 42

Daily Detail report 42

Device Settings Snapshot 42

Logbook report 42

Sensor & Meter Overview report 42

creating 36, 37, 38, 39, 40, 41

checking for device data 37

getting new device data 38

opening the reports workspace 36

previewing 41 printing 41 saving 41

selecting devices 37

selecting report types and inclusion

dates 40

selecting the reporting period 36

verifying settings 39

creating your own 43

previewing 41 printing 41 saving 41 understanding 41

reports screen

overview 35

restoring the database 46

S

safety 5

saving

reports 41

CareLink Pro User Guide Index 61

security features of CareLink Pro 2

selecting

devices for reports 37

report types and inclusion dates 40

the reporting period 36

Sensor & Meter Overview report

about 42

serial connections 24

settings

verifying for reports 39

software updates 44

starting the software 8 entering your password 8 logging in 8

storing a patient’s device on the system 32 inactivating 32 making active 32

supported communications devices 2 supported devices 2

ComLink 4 communication devices 4

Com-Station 4 glucose meters 3, 4 equivalent devices 4

insulin pumps 2

meter communications cable 4

supported meters 2 supported pumps 2

symbols 51

system preferences

setting 11, 13, 14, 15, 16, 17

general preferences 11

open patient preferences, choosing

data 15

patient lookup preferences 14

patient lookup preferences, changing

column order 15

patient profile preferences 13

patient profile preferences, adding a

custom field 13

patient profile preferences, changing

field order 14

patient profile preferences, choosing

data fields 13

report generation preferences 15

report generation preferences,

changing column order 17

report generation preferences,

choosing data 16

understanding 11

T

toolbar for CareLink Pro

buttons 8

troubleshooting 47

U

understanding reports 41

Adherence report 42

Daily Detail report 42

Device Settings Snapshot 42

Logbook report 42

Sensor & Meter Overview report 42

updating software 44

USB connections 24

user guide

conventions 5

related documents 2

user interface

Guide Me 9

navigating 8 toolbar 8

user safety

contraindications 5 indications for use 5 warnings 5

V

verifying report settings 39

W

warnings 5

workspaces 8

CareLink Pro User Guide Index 62

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Key Features

  • Store patient treatment and diagnostic data
  • Access pump, meter and sensor-based glucose data
  • Generate reports
  • Interface with CareLink Personal
  • Password protected
  • Encrypted transmission
  • Automatic software updates
  • Guide Me feature
  • Integrated help system

Frequently Answers and Questions

What devices are supported by CareLink Pro?
CareLink Pro supports a variety of devices, including insulin pumps, glucose monitors, and blood glucose meters from Medtronic MiniMed and other manufacturers.
How do I connect a device to CareLink Pro?
You can connect a device to CareLink Pro by using a ComLink or CareLink USB cable, or by linking to the patient’s CareLink Personal account.
What types of reports can I generate with CareLink Pro?
CareLink Pro can generate a variety of reports, including adherence reports, sensor and meter overview reports, logbook reports, device settings snapshots, and daily detail reports.
How do I update CareLink Pro?
CareLink Pro will automatically notify you when a software update is available. You can also manually check for updates.
How do I back up my CareLink Pro database?
You can back up your CareLink Pro database by selecting Tools > Options > System Administration > Back Up Database.

Related manuals

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