carelink€¦ · medtronic gmbh geschäftsbereich diabetes telefon: +49 2159 8149-370 telefax: +49...

CareLink™

Software for Professional CGM Systems

User Guide

M10552423-021_A

MMT-7340

© 2019 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third

party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.iPro™, CareLink™, and Envision™ are trademarks of Medtronic MiniMed, Inc.

Microsoft™*

Windows™*

Access™*

Excel™*

Internet Explorer™*

Mozilla™*

Firefox™*

Apple™*

Mac™*

Mac OS™*

Safari™*

Adobe™*

Reader™*

Java™*

JavaScript™*

USBGEAR™*

Google™*

Ascensia, the Ascensia Diabetes Care logo, CONTOUR, and BREEZE are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

Contacts: Africa:Medtronic South Africa and Southern AfricaOffice Reception Tel: +27(0) 11 260 9300Diabetes: 24/7 Helpline: 0800 633 7867Sub-Sahara 24/7 Helpline: +27(0) 11 260 9490

Albania:Net Electronics AlbaniaTel: +355 697070121

Argentina:Corpomedica S.A.Tel: +(11) 4 814 1333Medtronic Directo 24/7:+0800 333 0752

Armenia:Exiol LLCTel: +374 98 92 00 11or +374 94 38 38 52

Australia:Medtronic Australasia Pty. Ltd.Tel: 1800 668 670

Bangladesh:Sonargaon Healthcare Pvt Ltd.Mobile: (+91)-9903995417or (+880)-1714217131

Belarus:Zarga MedicaTel: +375 29 625 07 77or +375 44 733 30 99Helpline: +74995830400

België/Belgique:N.V. Medtronic Belgium S.A.Tel: 0800-90805

Bosnia and Herzegovina:"Novopharm“ d.o.o. SarajevoTel: +387 33 476 444Helpline: 0800 222 33Epsilon Research Intern. d.o.o.Tel: +387 51 251 037Helpline: 0800 222 33

Brasil:Medtronic Comercial Ltda.Tel: +(11) 2182-9200Medtronic Directo 24/7:+0800 773 9200

Bulgaria:RSR EOODTel: +359 888993083Helpline: +359 884504344

Canada:Medtronic of Canada Ltd.Tel: 1-800-284-4416 (toll free/sans-frais)

Chile:Medtronic ChileTel: +(9) 66 29 7126Medtronic Directo 24/7:+1 230 020 9750Medtronic Directo 24/7 (From Santiago): +(2) 595 2942

China:Medtronic (Shanghai) Ltd.24 Hour Help (Cell):+86 400-820-198124 Hour Help (Land):+86 800-820-1981

Colombia:Medtronic Latin America Inc. Sucursal ColombiaTel: +(1) 742 7300Medtronic Directo 24/7 (Landline):+01 800 710 2170Medtronic Directo 24/7 (Cellular):+1 381 4902

Croatia:Mediligo d.o.o.Tel: +385 1 6454 295Helpline: +385 1 4881144Medtronic Adriatic d.o.o.Helpline: +385 1 4881120

Danmark:Medtronic Danmark A/STel: +45 32 48 18 00

Deutschland:Medtronic GmbHGeschäftsbereich DiabetesTelefon: +49 2159 8149-370Telefax: +49 2159 8149-11024-Stdn-Hotline: 0800 6464633

Eire:Accu-Science LTD.Tel: +353 45 433000

España:Medtronic Ibérica S.A.Tel: +34 91 625 05 42Fax: +34 91 625 03 9024 horas: +34 900 120 330

Estonia:AB Medical Group Estonia LtdTel: +372 6552310Helpline: +372 5140694

Europe:Medtronic Europe S.A. Europe, Middle East and Africa HQTel: +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:Medtronic International Ltd.Tel: +852 2919-1300To order supplies:+852 2919-132224-hour helpline: +852 2919-6441

India:India Medtronic Pvt. Ltd.Tel: (+91)-80-22112245 / 32972359Mobile: (+91)-9611633007Patient Care Helpline:1800 209 6777

Indonesia:Medtronic International Ltd.Tel: +65 6436 5090or +65 6436 5000

Israel:MedtronicTel. (orders):+9729972440, option 3 + option 1Tel. (product support):+9729972440, option 2Helpline (17:00 – 08:00

daily/weekends – Israel time):1-800-611-888

Italia:Medtronic Italia S.p.A.Tel: +39 02 24137 261Fax: +39 02 24138 210Servizio assistenza tecnica:Nº verde: 800 60 11 22

Japan:Medtronic Japan Co. Ltd.Tel: +81-3-6776-001924 Hr. Support Line: 0120-56-32-56

Kazakhstan:Medtronic BV in KazakhstanTel: +7 727 311 05 80 (Almaty)Tel: +7 717 224 48 11 (Astana)Круглосуточная линия поддержки:8 800 080 5001

Kosovo:Yess PharmaTel: +377 44 999 900Helpline: +37745888388

Latin America:Medtronic, Inc.Tel: 1(305) 500-9328Fax: 1(786) 709-4244

Latvija:RAL SIATel: +371 67316372Helpline (9am to 6pm):+371 29611419

Lithuania:Monameda UABTel: +370 68405322Helpline: +370 68494254

Macedonia:Alkaloid Kons DooelTel: +389 23204438

Magyarország:Medtronic Hungária Kft.Tel: +36 1 889 0688

Malaysia:Medtronic International Ltd.Tel: +603 7946 9000

Middle East and North Africa:Regional OfficeTel: +961-1-370 670

Montenegro:Glosarij d.o.o.Tel: +382 20642495

México:Medtronic Servicios S. de R. L. de C.V.Tel (México DF): +(11) 029 058Tel (Interior): +01 800 000 7867Medtronic Directo 24/7 (from México DF): +(55) 36 869 787Medtronic Directo 24/7:+01 800 681 1845

Nederland, Luxembourg:Medtronic B.V.Tel: +31 (0) 45-566-8291Gratis: 0800-3422338

New Zealand:Medica PacificaPhone: 64 9 414 0318Free Phone: 0800 106 100

Norge:Medtronic Norge A/STel: +47 67 10 32 00Fax: +47 67 10 32 10

Philippines:Medtronic International Ltd.Tel: +65 6436 5090or +65 6436 5000

Poccия:ООО «Медтроник»Tel: +7 495 580 73 77Круглосуточная линия поддержки:8 800 200 76 36

Polska:Medtronic Poland Sp. z o.o.Tel: +48 22 465 6934

Portugal:Medtronic Portugal LdaTel: +351 21 7245100Fax: +351 21 7245199

Puerto Rico:Medtronic Puerto RicoTel: 787-753-5270

Republic of Korea:Medtronic Korea, Co., Ltd.Tel: +82.2.3404.3600

Romania:Medtronic Romania S.R.LTel: +40372188017Helpline: +40 726677171

Schweiz:Medtronic (Schweiz) AGTel: +41 (0)31 868 016024-Stunden-Hotline: 0800 633333Fax Allgemein: +41 (0)318680199

Serbia:Epsilon Research International d.o.o.Tel: +381 113115554Medtronic Serbia D.o.oHelpline: +381 112095900

Singapore:Medtronic International Ltd.Tel: +65 6436 5090or +65 6436 5000

Slovenija:Zaloker & Zaloker d.o.o.Tel: +386 1 542 51 1124-urna tehnična pomoč:+386 51316560

Slovenská republika:Medtronic Slovakia, s.r.o.Tel: +421 26820 6942HelpLine: +421 26820 6986

Sri Lanka:Swiss Biogenics Ltd.Mobile: (+91)-9003077499or (+94)-777256760

Suomi:Medtronic Finland OyTel: +358 20 7281 200Help line: +358 400 100 313

Sverige:Medtronic ABTel: +46 8 568 585 20Fax: +46 8 568 585 11

Taiwan:Medtronic (Taiwan) Ltd.Tel: 02-21836000Toll free: +886-800-005285

Thailand:Medtronic (Thailand) Ltd.Tel: +662 232 7400

Türkiye:Medtronic Medikal TeknolojiTicaret Ltd. Sirketi.Tel: +90 216 4694330

USA:Medtronic Diabetes Global Headquarters24 Hour HelpLine: +1-800-646-4633To order supplies: +1-800-843-6687

Ukraine:Med Ek Service TOVTel: +380 50 3311898or +380 50 4344346Лінія цілодобової підтримки:0 800 508 300

United Kingdom:Medtronic Ltd.Tel: +44 1923-205167

Österreich:Medtronic Österreich GmbHTel: +43 (0) 1 240 44-024 – Stunden – Hotline: 0820 820 190

Česká republika:Medtronic Czechia s.r.o.Tel: +420 233 059 111Non-stop helpLine (24/7):+420 233 059 059Zákaznický servis (8:00 - 17:00):+420 233 059 950

Contents

Chapter 1 1 Introduction2 CareLink Software for Professional CGM Systems2 Indication for Use2 Contraindications2 Storage and Transportation information2 Disposal information2 Computer system requirements3 Assistance

Chapter 2 4 One-time software and computer setup5 Register clinic and create administrative user5 Create multiple user accounts6 Set clinic report settings7 General Report Settings7 Analysis Reports Settings8 Required settings for Windows users9 Required Internet browser settings9 Enable JavaScript9 Secure Browsing9 Download and print resources10 Print clinic information10 User security advisory

Chapter 3 12 Using CareLink software with Envision Pro CGMsystem

13 Patient evaluation status14 Confirm the information in the patient record14 Force Close Evaluation14 Enter patient log sheet data14 Open the Logbook15 Add and review events15 Edit events15 Remove events

CareLink Software — User Guide Contents vi

16 Exclude events16 Sort events

Chapter 4 17 Using CareLink software with iPro2 recorders18 Computer setup for iPro2 recorder upload19 Open the patient record20 Setup to upload your meter on Mac21 Setup of LifeScan meters on Mac21 Setup for all other meters or ComLink on Mac22 Upload blood glucose meter data23 Enter patient log sheet data23 Open the Logbook23 Add events24 Exclude BG meter readings24 Edit events24 Remove events25 Sort events

Chapter 5 26 CareLink reports27 View and print patient reports27 About reports28 Area under the curve (AUC)28 Patient Report Settings29 Modify patient report settings29 Restore the default report settings30 Generate a Data Table report30 Export data to character-separated values (CSV) file

Chapter 6 31 Pattern Snapshot report32 Overview of the Pattern Snapshot report32 General statistics33 Observed patterns and some possible causes33 Observed patterns35 Some possible causes44 Sensor data graph

Chapter 7 45 CareLink software ongoing use46 User tasks46 Print more log sheets and other forms46 Change your password or other user information46 Edit patient information46 Move a patient evaluation47 Modify clinic information47 Administrator tasks47 Modify user accounts48 Delete user accounts

CareLink Software — User Guide Contents vii

Appendix A 49 Troubleshooting49 Troubleshooting Envision Pro reference table50 Troubleshooting iPro2 reference table51 CareLink uploader messages with iPro2

Glossary 54

Index 56

CareLink Software — User Guide Contents viii

1

Introduction

Welcome to CareLink Software for Professional Continuous Glucose Monitoring (CGM)Systems

Thank you for your trust in Medtronic products and services.

• This user guide provides the information that you need for setting up and using the CareLink

Software for Professional CGM Systems.

• You will find a page like this at the beginning of each chapter. This page provides a basic

overview of that chapter, and the steps to take to complete each task.

CareLink Software — User Guide Introduction 1

CareLink Software for Professional CGM Systems

CareLink Software for Professional CGM Systems, MMT-7340 (CareLink software), is a web-based

system designed to generate reports and store data.

Indication for Use

The CareLink software is intended for use by healthcare professionals, for the purpose of

analyzing and displaying uploaded data. This information is intended to supplement, not

replace, blood glucose information obtained using standard home glucose monitoring devices.

The information may allow identification of patterns of glucose-level excursions above and below

a desired range, facilitating therapy adjustments, which may minimize these excursions.

Contraindications

None known.

Storage and Transportation information

Not applicable.

Disposal information

Not applicable.

Computer system requirements

Computers that run CareLink software must have the following software installed:

• Operating system:

- Microsoft Windows 7 Ultimate, 32-bit or 64-bit

- Microsoft Windows 8 Enterprise, 32-bit or 64-bit, from the desktop only

- Microsoft Windows 8.1 Enterprise, 32-bit or 64-bit, from the desktop only

- Microsoft Windows 10, 32-bit or 64-bit, from the desktop only

- Mac OS 10.10 (Yosemite)

- Mac OS 10.11 (El Capitan)

- Mac OS 10.12 (Sierra)

- Mac OS 10.13 (High Sierra)

- Mac OS 10.14 (Mojave)

• Internet browser:

NOTE: On Windows 8 and 8.1, from the Start screen, click the Desktop tile and makesure you are viewing the desktop before you open your browser.

- On Windows only: Microsoft Internet Explorer 8, 9, 10, or 11, 32-bit or 64-bit

- Mozilla Firefox 38

- On Mac OS only: Apple Safari 8, 9, 10, 11, or 12

• Adobe Reader 5.0 or greater


• Display: 1024x768 resolution (minimum) For CareLink software with iPro2:

• On Windows only: Universal Serial Bus (USB) device drivers for meters that use a USB cable

to connect to the computer to upload data. For more information, see the instructions

provided by the meter manufacturer.

NOTE: Some meter manufacturers may not provide a USB device driver for uploading toWindows 7, 8, 8.1, and 10 (32-bit and 64-bit). If your computer is running one of these

operating systems, you may need to use the manufacturer's serial cable.

Depending on the brand and model of blood glucose meter you have, you may need a

serial (COM) port for the CareLink uploader to communicate with the meter.

CareLink software does not support USB uploads for all meters.

• On Mac OS only: Serial port driver for uploading blood glucose meters. For details, see Setup

to upload your meter on Mac on page 20. Computers that run CareLink software must also be compliant with IEC 60950-1 or an equivalent

safety standard.

Assistance

For residents in countries outside the United States, contact your local representative or

helpline. See the contacts listed in the beginning of this user guide, or access the following URL

for international contact information:

http://www.medtronicdiabetes.com/customer-support/international-contacts


http://www.medtronicdiabetes.com/customer-support/international-contacts

2

One-time software and computer setup

Key Notes:

• Usernames for CareLink software must be unique among all clinics in the system, not just

your clinic.

• Choose at least two people to be administrative users. One of them should complete the

CareLink software setup for the clinic.

• Use either http://envisionpro.medtronic.com or http://ipro.medtronic.com to log into the

Medtronic CareLink software.

CareLink Software — User Guide One-time software and computer setup 4

Register clinic and create administrative user

When you access CareLink software for the first time, you are guided through a process to

register your clinic and create an administrative user. The administrative user is the person who

creates, adds, and deletes user accounts for the rest of the clinic's staff.

NOTE: Initially, choose one person to be the first administrator for your clinic, and registeryour clinic only once using the Register Clinic link. After the initial registration, giveadministrative privileges to at least two users to ensure an administrative user can access

the system at all times.

CAUTION: Do not create more than one clinic account for your clinic. If each user registersanother clinic, then the patient records divide into separate clinic accounts and are not

accessible to all users.

1 On the computer, open your Internet browser and go to http://envisionpro.medtronic.com.

NOTE: On Windows 8 and 8.1, from the Start screen, click the Desktop tile and make

sure you are viewing the desktop before you open your browser.

If you cannot access the CareLink software, check your web browser settings to verify that

JavaScript and Transport Layer Security (TLS) protocol 1.2 are enabled. See Required Internet

browser settings on page 9 for additional information. If you still cannot access the

website, check with your network administrator to find out if your Internet access is

restricted.

2 If necessary, click Change country/language, and follow the on-screen instructions.

3 Click the Register Clinic link near the bottom of the screen and follow the on-screen

instructions.

4 Sign into the CareLink software.

5 To sign out of CareLink software, click Sign out near the top right corner of your screen.

Create multiple user accounts

For administrator tasks, modifying user accounts or deleting user accounts, see Administrator

tasks on page 47.


An administrator has administrative privileges that allow them to add and delete user accounts

and also change the password or other information in the account.

Set up an account for each individual user and delete accounts for individuals who no longer

need access.

1 Sign into CareLink software.

2 In the Clinic Settings tab, click Users. The existing user accounts are displayed.

Only an administrator can see the Users tab.

3 Click the Create new user button.

4 Enter the required information about the user.

5 To make the user an administrator, check the Administrative Privileges check box.

Important: Always have at least two individuals with administrative privileges. If anadministrator is no longer available, add a new one to ensure an administrator can

access the system at all times.

6 Click Save.

NOTE: Usernames for CareLink software must be unique among all clinics in the system,not just your clinic. If the username you entered is not available, the system informs

you to try a different username.

7 Record the username and password to provide them to the user. The user needs this

information to sign in and select a new password.

Repeat this procedure for each user account that you need to create.

Set clinic report settings

The clinic report settings are the default settings for each new patient record. They are like a

template for new patient records.

xxxxxxx xxxxx xxxxxx xxxxxxx xxxxx

xxxx

xxxx

xxxx xxxx xxxxxx xxxx xxxxxxx

xxxxxxx xxxxx xxxxxx xxxxx xxxxx xxxx

xxxx

xxxx

xxxx xxxx xxxxxx xxxx

xxx

xxx

xxx xxx xxx xx xxxxxx

xxxxxxxx xxxx xx xxx xxx xxxxx xxx xxxx xxx x

xxxx xxx xxx


xxxx xxx xxx


NOTE: Changes to the clinic report settings do not affect the reports for any existingpatient.

If a patient has unique needs, you can customize these settings later for individual patients.

1 Click the Clinic Settings tab. The Report Settings for the clinic appear.


If the Clinic Settings tab does not appear, click the Home tab. The Clinic Settings tab

should now appear.

2 In Report Settings, set the General Report Settings and the Analysis Reports Settings.

For more information about these settings, see the following two sections, or click the help

icon in CareLink software for each section.

3 When you are finished, click Save.

The clinic settings take effect for all new patients added to the system after you change the

settings. Previously added patients and previously generated reports are not affected.

However, changes to Glucose Units and Time Display will apply to all patients in the system.

For more details about how to set different report settings for a particular patient, see Patient

Report Settings on page 28.

General Report Settings

The General Report Settings determine how glucose and time information will be displayed in

patient reports.

• Glucose Target Range fields: Select a glucose target range to use in the reports.

- For High Value: Enter the glucose value that represents the upper limit of the glucose

target range for this patient. The system uses the High value in reports to show the

range that is above the glucose target range.

- For Low Value: Enter the glucose value that represents the lower limit of the glucose

target range for this patient. The system uses the Low value in reports to show the

range that is below the glucose target range.

• Glucose Limits fields: Select a glucose value to use in the reports.

- For Highest Limit: Enter the glucose value that represents the highest limit for this

patient. CareLink software uses the highest limit in reports to show glucose excursions

that are above the Highest Limit.

- For Lowest Limit: Enter the glucose value that represents the lowest limit for this

patient. CareLink software uses the lowest limit in reports to show the glucose

excursions that are below the Lowest Limit.

• Glucose Units: Select the appropriate units to display glucose amounts in the system and

reports (mmol/L or mg/dL).

• Time Display: Select 12 hour or 24 hour time display format.

Analysis Reports Settings

The Glucose Target Range fields specify a Before meal and After meal glucose target range for

each of the three meal periods. The overnight periods of Evening and Sleeping contain a single

target range. Enter a high glucose value and low glucose value for a target range according to

the following rules.

• When selecting mmol/L as the glucose units:


- The format to enter the Low glucose value for the target range is x.x mmol/L (for

example, 5.6 mmol/L).

The low glucose value must be at least 0.6 mmol/L greater than the Lowest Limit and

cannot be higher than 7.8 mmol/L.

- The format to enter the High glucose value for the target range is xx.x mmol/L (for

example, 12.3 mmol/L).

The High glucose value must be at least 4.4 mmol/L and must always be 1.1 mmol/L

lower than the Highest Limit.

• When selecting mg/dL as the glucose units:

- The format to enter the Low glucose value for the target range is xxx mg/dL (for

example, 123 mg/dL).

The Low glucose value must be at least 10 mg/dL greater than the Lowest Limit and

cannot be higher than 140 mg/dL.

- The format to enter the High glucose value for the target range is xxx mg/dL (for

example, 123 mg/dL).

The High glucose value must be at least 80 mg/dL and must always be 20 mg/dL lower

than the Highest Limit. Time periods are used to identify which meal to associate with each meal marker. For

example, if the breakfast time period is set from 06:00 to 10:00 and lunch is set from 10:00 to

15:00, then a meal marker entered for 09:30 would be interpreted as a breakfast marker, and a

meal marker entered for 12:30 would be interpreted as a lunch marker.

The duration of each period must be at least 0.5 hours. The end time of a period can be different

from the start time of the next period, so gaps between periods may exist. The one exception

to this rule is that the end of Evening must be the same as the start of Sleeping.

A post-meal analysis is used to generate statistics from data collected after a meal. The Post-

Meal Analysis window can extend up to 4.0 hours after a meal event. The duration of the analysis

window must be at least 0.5 hours. The start time can range from 0.0 to 3.5 hours and the end

time can range from 0.5 to 4.0 hours.

Required settings for Windows users

When running the Windows operating system, follow these additional steps to prepare your

computer for uploading device data.

1 Make sure that User Account Control is enabled. By default, User Account Control is already

enabled, so it is likely that you do not have to enable it. For details, please see the Microsoft

documentation.

2 Close Internet Explorer.

3 When using the Windows 7 operating system:

a. Navigate to Start > All Programs.

b. Right-click on the Internet Explorer menu item.


When using the Windows 8 or Windows 8.1 operating system:

a. From the Start screen, click the Desktop tile and make sure you are viewing the desktop.

b. Right-click on the Internet Explorer icon in the task bar.

c. In the menu that appears, right-click again on Internet Explorer.

When using the Windows 10 operating system:

a. Navigate to Start > All Apps > Windows Accessories.b. Right-click on the Internet Explorer menu item.

4 Select Run as Administrator.

5 When the User Account Control window is displayed, click Allow or Yes.

NOTE: If you are not logged in as an administrator on your computer, you may be

asked to enter an administrator user's password.

Required Internet browser settings

On all computers where you plan to use CareLink software, your Internet browser must have the

following settings enabled:

• JavaScript

• Transport Layer Security (TLS) protocol version 1.2

• Cookies

• ActiveX

Enable JavaScript

The software uses JavaScript to perform some of its functions. JavaScript is enabled by default

for most Internet browsers. If the JavaScript setting for your Internet browser is disabled, you

need to enable this setting to use the system.

Secure Browsing

To keep your therapy management information private, always remember to log off of the

system by clicking the Sign out hyperlink.

Download and print resources

When finished setting up CareLink software for the clinic, click the Resources hyperlink in

CareLink software to download document resources such as patient log sheets and other useful

materials.

For example, you can download a sample Patient Consent Form in Microsoft Word format. This

form allows you to easily create Patient Consent Forms that are appropriate for your office.


Medtronic provides these resources free of charge. Medtronic may occasionally update these

resources based on feedback from users like you.

Print clinic information

The Clinic Information tab displays the Quick Response (QR) code and clinic identification (ID).

The system generates a random clinic ID. When using the CareLink software with the Envision

Pro CGM system, the Envision Pro app scans the QR code and populates the Clinic ID field.

To print the clinic Information to scan the QR code for future Envision Pro evaluations, from the

Clinic information tab, click Print.

User security advisory

Your safety and the privacy of your information are of highest importance to Medtronic. To help

us ensure that our CareLink software products work correctly and securely, please consider these

good practices and precautions to help keep your computer system safe and secure:

• Use a supported operating system and browser. Even though CareLink software may let you

proceed with an operating system or browser that is not validated, it is better to use one

of the fully supported configurations.

• Keep your computer system up-to-date by using the most current versions of your operating

system, browser, plug-ins, and Java run-time environment. Updates are sent to respond to

possible security issues.

• Use a strong password. The most important factors are length and to avoid common

spellings of words. Some password vaults offer the ability to create very strong passwords

and provide them on demand.

• Do not disclose your password to anybody.

• Do not reply to an email that requests you to disclose your password. Contact your local

representative or helpline immediately and do not reply to the email. Medtronic never asks

for your password. If a Medtronic representative requests your password, ask to speak to a

manager immediately.

• Change your password immediately if you think your password has been compromised.

• Change your password every 3–6 months.

• If you suspect someone might have accessed the account, contact your local representative

or helpline immediately.

• Use reputable security software, including firewall features on your computer that provides

protection against viruses, adware and other forms of malicious software (also known as

malware).

• Consult with your Internet service provider regarding security for your access point (typically

your modem) and router.


• Be careful when you open email from someone you don't know, or when you visit websites

from links in emails. Many websites and emails are malicious and are designed to

compromise your computer system.

• To guard against accidental contact with malicious software, use the strongest settings on

your computer security software.


3

Using CareLink software with EnvisionPro CGM system

Key Notes:

• The Envision Pro app creates a patient record. Sensor data stored in the recorder is available

automatically in CareLink software as soon as the evaluation ends. Use the CareLink software

to confirm the patient record, enter events, and access reports.

• There are two modes for the Envision Pro app, the Patient mode and the Healthcare

Professional (HCP) mode:

1 Patient Mode: when performing the evaluation, events upload automatically into

CareLink software and appear on the reports.

2 Healthcare Professional (HCP) Mode: when performing the evaluation, the app does not

capture or upload events into CareLink software. HCPs can enter events manually into

CareLink software from the patient's paper log sheet. If manually entered, events appear

in the reports.

CareLink Software — User Guide Using CareLink software with Envision Pro CGM system 12

Patient evaluation status

Patient evaluations generated through the app appear in the Home page. If this is a new

patient, the evaluation is in bold. The clinic name and clinic ID are at the top of the Home page

screen. Your clinic’s patient list is in the middle of the screen, showing one sample patient record.

Evaluation Start Date column and Status column on the Home page apply only when the

software is being used with the Envision Pro CGM system:

The Evaluation Start Date column indicates the date when the evaluation started. While the

evaluation is underway, this column indicates how many days passed since the evaluation

started. Once the evaluation completes, it tells how many days of data are included in the report.

The Status column indicates the status of the evaluation:

• When the evaluation starts, it says Active Evaluation.

• After seven days, when the status changes to Data Upload Needed, upload the data using

the Envision Pro app.

- If the patient uses the app, the app notifies the patient that the evaluation is

complete. To end the evaluation and upload the data, the patient must follow the app

instructions.

- If the evaluation starts in HCP mode, instruct the patient to return the recorder and

completed paper log sheet. Open the app in HCP mode and ensure the recorder is

within close range. To end the evaluation and upload the data, follow the app

instructions.

• Once the evaluation ends, the final data is uploaded to CareLink software, reports are

generated, and the status changes to Report Ready. An * after Report Ready means there

are no events logged. You can open the CareLink software logbook and add events if

needed.

• If the status changes to Force Close Needed, the evaluation did not end properly before the

Envision recorder battery depleted.

- Use the CareLink software to force close the evaluation.

- To close the evaluation, open the patient record and follow the instructions in the

CareLink software.

- After the evaluation closes, all uploaded data is visible in the CareLink software and can

be used to generate reports.

NOTE: If the patient evaluation starts in HCP or Patient mode and the data did not

upload, no reports or data are available.

• If there is no evaluation data in the patient record or if this is not an Envision Pro evaluation

(as in the case of an iPro2 evaluation), the evaluation status shows "---". The status also

changes to "---" four weeks after the evaluation ends.


Confirm the information in the patient record

For a new patient record or a returning patient with updated patient information, confirm the

information is correct.

1 Select the patient whose name appears in bold and click the Open patient button. You can

also double-click the patient in the list.

2 If any information is incorrect, edit as needed. Click Confirm when complete. (These steps

do not apply to returning patients with unchanged information)

To modify the patient information, click the Edit Patient Information link on the patient’s

record.

Force Close Evaluation

If “Force Close Needed” appears in the Patient List, open the patient record. If the Force CloseEvaluation button appears on the patient record, the evaluation did not end properly before

the Envision recorder battery depleted. The evaluation must be forced closed. If data is

available, the system generates reports after you close the evaluation.

The Force Close Evaluation button is available if an evaluation is still active or when data needs

to be uploaded. Do not click the Force Close Evaluation button unless there is no way to

retrieve data from the recorder, for example, if the recorder is lost. If data is available, reports

generate after the evaluation is force closed.

To start a new evaluation for the same patient, force close the evaluation to clear the patient's

previous evaluation and then start a new evaluation.

Enter patient log sheet data

When the evaluation is done in HCP mode and the patient is not using the app, the HCP must

enter events manually into the software.

In the Logbook screen, manually enter events that the patient recorded on the paper log

sheet, such as meals, medication, exercise, or other. You can include details of an event, such as

the intensity of the exercise or the size of the meal.

NOTE: Enter event time and date accurately as this impacts the CareLink reports.

Open the Logbook

To open the Logbook, click the Open Logbook button found on the patient record screen.


Add and review events

Events upload automatically when the evaluation is done in Patient mode. This is where

patients log events on their mobile device. Events uploaded in Patient mode can be viewed

and edited. In the Logbook screen, you can review and add events manually. To see additional

details, hover over certain icons with the mouse. For example, when hovering over a meal

icon, you can see if the meal was:

• small, medium, or large

• unknown size, if meal size was not indicated

When adding Sleep information, enter the bedtime in the primary "Time" area located at the

top of the window, click the "Wake-Up" box in the Sleep icon area to activate and enter the

wake-up time. The bedtime and wake-up time need to be entered to log a sleep event.

1 Click the Add button. A small window appears to enter an event in the Logbook.

2 Enter the date and time. Select the appropriate check box or button for the event. If the

patient recorded more than one event at the same time, such as a meal and exercise, you

must enter them both in one event.

NOTE: If a daylight saving time change occurred during the evaluation, or after theevaluation but before you are entering the data, enter all log sheet events that

occurred before the time change according to the old time.

3 Click Enter. The information goes into the Logbook, but a new empty data event window

stays open and is ready for the next event.

4 When you are finished adding Logbook events, click the X in the upper right corner of the

data event window to close it.

5 When finished using the Logbook, click Done to return to the patient record screen.

Edit events

You can edit Logbook events that have been entered manually.

1 In the patient’s Logbook screen, click on a Logbook event to highlight it, then click the Edit

button. The Logbook event opens in a small window.

2 Edit the information as needed, and click Enter.

3 When finished using the Logbook, click Done to return to the patient record screen. The

reports regenerate automatically.

Remove events

You can remove events from the Logbook so that they do not appear on the patient‘s reports.

You can remove both the events you entered manually or uploaded with the Envision Pro

app.

1 In the patient's Logbook screen, click on a Logbook event to highlight it, then click the

Remove button.


2 A small window appears, asking you to confirm that you want to remove the event. Click

Remove. The event no longer appears in the Logbook. When you view the patient‘s

reports, the events that you removed do not appear on the reports.

3 When finished using the Logbook, click Done to return to the patient record screen. The

reports regenerate automatically.

Exclude events

To exclude an event from the reports, follow these steps.

1 From the Logbook screen, check the box of a specific event in the Exclude column.

2 Click the Done button in the lower right corner. The event does not appear in the report.

To add an excluded event back into the reports, uncheck the box in the Exclude column.

Sort events

To sort the events in the Logbook, click on a column heading. This helps you find events in

the Logbook. Sorting events does not affect how patient data appears on reports.

Click the column heading twice to reverse the sort order.


4

Using CareLink software with iPro2recorders

Key Notes:

• Create a new record or verify that a record already exists for that patient. Use the Internet

browser to upload the iPro2 recorder data for that patient.

• BG readings are essential for iPro2 reports. Manually enter BG readings and other events

from the patient's paper log sheet in CareLink Software.

• You can upload patient meter data directly into CareLink software. The meter data adds

automatically into the CareLink Logbook. Do not change the time or date on the meter

before uploading.

• Enter any additional data that a patient has recorded on their paper log sheet into the

CareLink Logbook. You can exclude BG meter readings or remove manually entered patient

events from the Logbook.

CareLink Software — User Guide Using CareLink software with iPro2 recorders 17

Computer setup for iPro2 recorder upload

CareLink software needs the CareLink uploader application (uploader) to be installed first. The

uploader includes the installation of hardware drivers to upload patient data from the iPro2

recorder.

Before beginning computer setup, note the following requirements:

• Some operating systems require administrative privileges for each computer to upload the

installer and meters. Ask a user with administrative privileges, such as your network

administrator, to sign in to each computer to allow the software to install.

• Install the uploader on each computer that is used to upload sensor data from an iPro2

recorder.

• If the computer runs Windows 7, 8, 8.1, or 10, see Required settings for Windows users on

page 8 before completing this procedure.

• When you use a Mac computer, you might need a new cable to install a software driver to

upload data from the blood glucose meter. For details, see Setup to upload your meter on

Mac on page 20.

CAUTION: Do not connect the Dock to the computer until specifically told to do so whenreviewing the on-screen instructions. If you connect the Dock before the CareLink uploader

is installed, you may see the Microsoft Windows installation wizard for new hardware. Closethe wizard screen or cancel the procedure and do not follow the instructions in the wizard.The wizard can prevent the Dock driver from proper installation.

1 Sign in to CareLink software.

2 On the Home screen, a Patient list is displayed. Click to select a patient from the PatientList.

Choose the Sample M. Patient when installing the CareLink uploader for the first time on

each computer. If you already have a list of patients, type Sample Patient in the Search

box to find the sample patient in the Patient List, and click on the sample patient to select

it.

3 Click the Open patient button at the bottom of the screen. The patient record is displayed

on the Patient screen.

4 Click the Upload iPro2 button to be directed to the required link.


NOTE: When a message asks to upload another evaluation for the sample patient, clickYes. This dialogue prevents multiple evaluation uploads for the same patient on the

same day. This dialogue is not relevant when installing the CareLink uploader.

5 After 20 seconds, when the "CareLink uploader installation needed" dialogue box appears,

click the Download CareLink Uploader Installer link. Install the CareLink uploader once on

each computer.

6 Choose the installation language, and click OK.

7 When prompted to allow the CareLink uploader to install, follow the on-screen instructions

to set up the CareLink uploader.

a. Allow time for the installation process.

b. Read the license agreement.

c. Click "I accept the agreement".

Important: When prompted, disconnect any medical devices from the computer.

d. Confirm all medical devices are disconnected.

e. Click OK.

Allow time for the installation process to complete.

8 When the installation is complete, click Finish.

9 When the installation dialogue box appears, click the red X in the top right corner to close

this page.

10 Choose the Sample M. Patient record and click the Upload iPro2 button to launch the

CareLink uploader.

NOTE: If you see a message asking you to upload another study for the patient, clickYes.

11 When a message appears, confirm that you want to start the CareLink uploader.

NOTE: The message varies depending on your browser. To stop the security message

from appearing every time the CareLink uploader launches, click Upload iPro2.

12 After you confirm the CareLink uploader launched successfully, click the Home tab to close

the sample patient record. The computer is now ready for you to upload patient data.

13 Repeat this process on each computer used to upload sensor data from an iPro2 recorder.

14 All computers used to open and view reports must have Adobe Reader installed. If Adobe

Reader is not installed, go to http://www.adobe.com/reader.

Open the patient record

1 On the computer, open your Internet browser and go to http://envisionpro.medtronic.com.

2 Sign in to CareLink software using your username and password.

If you are already signed in, click the Home tab.


3 Type any of the following into the Search box to find the patient record:

- First name

- Last name

- Patient ID or Management ID

- Date of birth or Patient Creation Date

As you type, the Patient List displays matching patient records from previous evaluations.

NOTE: Depending on the CareLink settings in your country, you may not be allowed toenter personal information.

4 To open the patient record, choose the patient from the list using one of these methods:

- Click Open patient.

- Double-click the patient name.

For the patient using iPro2, the Evaluation Start Date and Status columns display "---".

5 To add the patient manually:

a. Click New patient.

The Create New Patient screen appears.

b. Enter the identifying information for the patient.

The patient’s name or patient ID that you enter appears on reports.

c. Click Save when you are finished.

CAUTION: Make sure to thoroughly search for the patient in CareLink software beforeadding a new patient record. If your clinic has already conducted an evaluation for the

patient, open the existing patient record. Avoid creating multiple records for onepatient, as this will make the patient's data more difficult to find in the software.

6 To modify the patient information, click the Edit Patient Information link on the patient's

record.

Setup to upload your meter on Mac

To upload a supported Ascensia meter (BREEZE, CONTOUR, or CONTOUR NEXT family of

products) that has a USB connector on a Mac computer, select your meter and complete the

upload procedure. No additional setup is needed.

To upload any other blood glucose meter on a Mac computer, please follow the instructions in

this section for your meter and operating system version. After you have set up your computer

for uploading your meter, you do not need to complete these steps again.

NOTE: Medtronic Diabetes cannot guarantee the availability of cables, adapters, and

software drivers from other manufacturers. Websites of other manufacturers may change.

Setup of LifeScan meters on Mac

Setup for all other meters or ComLink on Mac


Setup of LifeScan meters on Mac

1 Get a serial cable from the meter manufacturer. You will need a serial cable because at the

time of this publication, the USB cable from LifeScan does not work with Mac OS.

2 Get a USB-to-serial adapter that is compatible with your Mac operating system, such as the

USBGEAR RS-232 Serial Adapter DB-9 Male. You need a USB-to-serial adapter because Mac

computers do not have serial ports.

Important: If you have a different adapter, install the driver provided by the adaptermanufacturer. Do not continue with the instructions in this section.

3 When you use the USBGEAR RS-232 Serial Adapter, click the following hyperlink to install

the software driver:

http://www.ftdichip.com/Drivers/VCP/MacOSX/FTDIUSBSerialDriver_v2_2_18.dmg.

NOTE: This website is in English only.

Select the driver called FTDIUSBSerialDriver_10_4_10_5_10_6_10_7 and follow the on-screen

instructions.

4 When prompted, enter your Mac username and password. The username you enter must

have administrative privileges on your computer.

5 When prompted, restart the computer.

Setup for all other meters or ComLink on Mac

1 Get a serial cable from the meter manufacturer. You need a serial cable because most meter

manufacturers that provide USB cables do not provide support for Mac computers.

2 Get a USB-to-serial adapter that is compatible with your Mac operating system, such as the

USBGEAR RS-232 Serial Adapter DB-9 Male. You need a USB-to-serial adapter because Mac

computers do not have serial ports.

Important: If you have a different adapter, install the driver provided by the adapter

manufacturer. Do not continue with the instructions in this section.

3 When you use the USBGEAR RS-232 Serial Adapter, click the following hyperlink to install

the software driver:

http://www.ftdichip.com/Drivers/VCP/MacOSX/FTDIUSBSerialDriver_v2_2_18.dmg.

NOTE: This website is in English only.

Select the driver called FTDIUSBSerialDriver_10_4_10_5_10_6_10_7 and follow the on-screen

instructions.

4 When prompted, enter your Mac username and password. The username you enter must

have administrative privileges on your computer.

5 When prompted, restart the computer.


http://www.usbgear.com/USBG-232MINI.html

http://www.usbgear.com/USBG-232MINI.html

http://www.ftdichip.com/Drivers/VCP/MacOSX/FTDIUSBSerialDriver_v2_2_18.dmg

Upload blood glucose meter data

To upload data to CareLink software from several blood glucose meters, obtain a meter cable

from the meter manufacturer. Meter cables are not supplied as part of the iPro2 recorder.

When you use a meter that is not compatible with CareLink software, manually enter the BG

meter readings into CareLink software. For a list of compatible meters see

http://ipro.medtronic.com.

CareLink software will compare the time and date of the computer to the time and date of

the meter. If the meter time is incorrect, CareLink software uses the computer's time to

automatically correct the BG meter reading times. Do not change the time or date on the

meter before uploading.

NOTE: If you uploaded an evaluation from an iPro2 recorder and there was a time changeon the computer, contact your local representative or helpline for assistance in uploading

the meter.

If the patient's meter is not supported, enter BG meter readings manually. See Enter patient log

sheet data on page 23 for instructions.

NOTE: You can upload only one meter per evaluation.

1 When the CareLink uploader successfully uploads the data, the message The upload hassuccessfully completed appears, click OK. The page updates and displays the new data.

Click the Upload iPro2 button.

When the message Evaluation Incomplete appears, choose the appropriate option to enter

data:

- Upload BG Meter- Add Logbook Data

You can also choose to enter BG meter readings manually using the Logbook. For details,

see Enter patient log sheet data on page 23.

2 Click Upload BG Meter button to relaunch the CareLink uploader to upload the BG readings

from the meter.

3 Follow the on-screen instructions.

4 When prompted, connect the meter to the computer using the appropriate cable (supplied

by the meter manufacturer).


CareLink software tells you when the upload is successfully completed.

5 Disconnect the meter from the computer.

Enter patient log sheet data

The Logbook screen in CareLink software allows you to manually enter BG meter readings and

other events that the patient recorded on the paper log sheet, such as meals, medication,

exercise, or other. You are able to include details of an event, such as the intensity of the exercise

or the size of the meal.

You can exclude BG meter readings from being used for sensor calibration, and update or remove

manually entered events from the patient data if necessary.

Xxxxxx

XxxxxxxxXxxxx

Xxxxxx

Xxxxxx

XxxxxxxxXxxxx

Xxxxxxxxxxxx

Xxxxxx

Xxxxxxxxxx

Xxxxxx

Xxxxxxxx

Xxxxx

Xxxxxxxx

Xxxxxx

xxxx

Xxxxx Xxxxxxxxxxx

Xxxxxx

Xxxxxxxxxxx

Xxxxxxx

Xxxxxxx

XxxxxxxxXxxxxx

Open the Logbook

To open the Logbook, click the Open Logbook button found on the patient record screen.

Add events

CareLink software calibrates the sensor glucose data using the patient’s BG meter readings

that are uploaded from a meter or entered manually. If you cannot upload data from the

patient’s meter, then you must enter BG meter readings manually in the Logbook.

1 Click the Add button. A small window appears where a new event can be entered in the

Logbook.

2 Enter the date and time. If the event is a BG meter reading, enter the BG value. If it is a

different event, select the appropriate check box or button for the event.

If the patient recorded more than one event at the same time, such as a meal and a BG

meter reading, you must enter them both in one event.

NOTE: If a daylight saving time change occurred during the evaluation, or after theevaluation but before you are entering the data, enter all log sheet events that

occurred before the time change according to the new time.

3 Click Enter. The information goes into the Logbook, but a new empty data event window

stays open and is ready for the next event.

4 When you are finished adding Logbook events, click the X in the upper right corner of the

data event window to close it.


5 When you are finished using the Logbook, click Done to return to the patient record screen.

NOTE: Only BG meter readings between 2.2 and 22.2 mmol/L (40 and 400 mg/dL) are

used for calibration.

Exclude BG meter readings

You can tell CareLink software to exclude a BG meter reading so that it is not used to

calibrate the sensor glucose data and is not included in the reports.

For example, if the patient allowed a different person to use the meter, or if a control solution

was used but the BG meter reading was not marked as a control reading in the meter, you

would not want these BG meter readings to be used to calibrate the sensor glucose data.

1 In the patient’s Logbook screen, click the Exclude check box for each BG event that you

want to exclude from the calibration.

2 When you are finished using the Logbook, click Done to return to the patient record

screen. The reports regenerate automatically.

When you view the patient’s reports, the excluded BG meter readings do not appear, and

they do not affect the sensor information in the reports.

Edit events

You can edit Logbook events that have been entered manually. Events that were uploaded

from a meter cannot be edited but can be excluded. Calibration does not use the BG values

marked as excluded in the Logbook screen. In addition, excluded events do not appear in the

reports. For more information about a specific event, hover over the event icon.

1 In the patient’s Logbook screen, click on a Logbook event to highlight it, and then click the

Edit button. The Logbook event opens in a small window.

2 Edit the information as needed, and click Enter.



Remove events

You can remove events from the Logbook so that they do not show up on the patient’s

reports. You can remove Logbook events that have been entered manually. Events that were

uploaded from a meter cannot be removed. They can only be excluded from calibration and

reports.

1 In the patient’s Logbook screen, click on a Logbook event to highlight it, and then click the

Remove button.

2 A small window appears, which asks you to confirm that you want to remove the event.

Click Remove. The event no longer appears in the Logbook. When you view the patient’s

reports, the events that you removed will not show on the reports.




Sort events

To sort the events in the Logbook, click on a column heading. This helps you find events in

the Logbook. It does not affect how patient data appears on reports.

Click the column heading twice to reverse the sort order.


5

CareLink reports

Key Notes:

• You can modify a patient's Report Settings, such as the glucose target range and meal

periods, and regenerate reports from an evaluation.

• Reports show up to seven 24-hour periods of evaluation data that can span up to eight

calendar days.

• The Portable Document Format (PDF) reports easily print and store electronically.

CareLink Software — User Guide CareLink reports 26

View and print patient reports

After you upload and enter all of a patient’s evaluation data into CareLink software, you have

two options to view the patient’s reports:

• View and print the reports individually

• Print all reports

1 From the Home tab, use the Search box to find the patient record.

For more instructions on how to find a patient record, see Open the patient record on page 19.

2 On the patient record screen, you can find the dates for all of the evaluations conducted

for this patient. The most recent evaluation is displayed first. You can scroll down to find

older evaluations.

3 Select the evaluation and click the name of the report. To print all of the main reports, click

Print all reports.

4 To print, use the print functions that are set up on the computer. For example, you may

need to click a printer icon, or you may need to select File > Print.

About reports

CareLink reports show up to seven 24-hour periods of evaluation data that may span eight

calendar days. The reports are created in PDF format, so they can easily be stored electronically

or printed. The five main reports are:

• Daily Overlay (one page) - provides an overlay of the sensor traces for each day on a single

24-hour graph, so that you can look for trends or excursions that occur around the same

time each day. This report also provides daily statistical information, including an Excursion

Summary of highs and lows, and Duration Distribution pie charts. The Duration Distribution

pie charts show what percent of each day the patient spent above, below, and within the

target range.

• Overlay by Meal (two pages) - provides an overlay of the sensor traces from each day of the

evaluation, broken down into meal and overnight periods. The meal overlay graphs are only

created if meal events are entered into the CareLink Logbook. The patient's Report

Settings, if different from the clinic Report Settings, determine what the periods are. The

sensor traces for each day are overlaid, so that you can look for trends at certain times

related to meal or overnight periods. This report lines up glucose sensor traces before and

after each meal and is especially useful if patients eat meals at varying times each day.

• Daily Summary (two pages) - provides a summary of each full or partial 24-hour period of

the evaluation, including both the sensor trace and events such as meals, medication, and

exercise. The report includes details of the events, for example the intensity of the exercise

or the size of the meal.


• Pattern Snapshot (one page) - provides a summary of daily glucose information and up to

three observed patterns. This report has three sections consisting of general statistics,

observed patterns and some possible causes, and an overlay graph.

• Patient Notes - provides a summary of the event markers recorded in the system. This report

includes a chronological listing of all patient events for a given time period. Each event is

represented by a corresponding icon and includes event details.

Area under the curve (AUC)

AUC information appears in the Excursion Summary on the Daily Overlay report. AUC provides

more insight into how much time the patient's glucose was high or low, in addition to the

severity of excursions outside of the target range. A high AUC indicates more excursions or more

severe excursions. The closer the AUC is to zero, the more the patient's glucose stayed within

the target range.

AUC calculations are reported in mmol/L per day (mg/dL per day). The Daily Overlay report

provides two AUC amounts for each day: AUC Above Limit and AUC Below Limit.

• AUC Above Limit: this statistic provides a relative indication of the overall extent and

duration of high glucose excursions over the entire day. The calculation is dependent on

the patient Glucose Target Range High setting. The High limit value is subtracted from each

individual sensor glucose value that exceeds the limit. The differences are added together

and the sum total is divided by the total number of sensor glucose values that exist for the

day.

• AUC Below Limit: this statistic provides a relative indication of the overall extent and

duration of low glucose excursions over the entire day. The calculation is dependent on the

patient Glucose Target Range Low setting. Each individual sensor glucose value that exceeds

the limit is subtracted from the Low limit value. The differences are added together and the

sum total is divided by the total number of sensor glucose values that exist for the day.

Patient Report Settings

When you first add a patient into CareLink software, the patient's Report Settings are set based

on the current clinic report settings that are defined on the Clinic Settings tab. The clinic report

settings are like a template for creating the Report Settings for each new patient. After a patient

record has been created, you can change the Report Settings for that patient's reports.

For example, the patient’s meal periods may not match the default meal periods, which were

defined for your clinic in the clinic report settings. Or, the target glucose range for the patient

may be different from the default range set in the clinic report settings.

You can modify a patient’s report settings manually, in these cases:

• If you change the Patient Report Settings before generating reports, future reports will be

generated based on the changes you made.


• If you change the Report Settings after generating reports, you must choose whether you

want to apply the new settings to the most recent reports. You can also apply the new

settings to older evaluations. Existing reports do not update automatically based on the new

settings. After you view the first reports you generate for a patient, you may decide to modify the Patient

Report Settings, and then generate the reports again based on the new settings.

Modify patient report settings

1 Click the Edit link in the Patient Report Settings section of the patient record screen.

The patient’s General Report Settings and Analysis Reports Settings are displayed.

2 Change the settings as needed. For more information about the General Report Settings and

Analysis Reports Settings, see General Report Settings on page 7 or Analysis Reports Settings

on page 7.

3 Click Save. A small window appears, asking if you want to apply these report settings to

the most recent set of reports.

- To apply the settings to the most recent reports, click Yes. The report settings screen

closes, and the patient record screen appears, where you can view and print the updated

reports.

The new Report Settings have been applied to the most recent evaluation. You can then

click any of the reports for the most recent evaluation to view and print one of them,

or click Print all reports to print all of the reports.

- To save the Report Settings for the patient but not apply them to an evaluation, click No.

To apply the new Report Settings for the patient to one or more evaluation, find the

evaluation on the patient record screen and select Regenerate reports from the OtherOptions drop-down list. The reports regenerate using the new Reports Settings.

Restore the default report settings

To set a patient’s report settings to the current default settings for your clinic, go to the Patient

Report Settings. You will then have the option to choose to which evaluations you want to apply

the newly changed report settings.

1 Click the Edit link in the Patient Report Settings section of the patient record screen.

The patient’s General Report Settings and Analysis Reports Settings are displayed.

2 Click the Restore defaults button on the patient’s report settings screen.

3 Click Save. A small window appears, asking if you want to apply these report settings to

the most recent set of reports.

- To apply the settings to the most recent reports, click Yes. The report settings screen

closes, and the patient record screen appears, where you can view and print the updated

reports.


The new Report Settings have been applied to the most recent evaluation. You can then

click any of the reports for the most recent evaluation to view and print one of them,

or click Print all reports to print all of the reports.

- To save the Report Settings for the patient but not apply them to any evaluation yet,

click No.

To apply the new Report Settings for the patient to one or more evaluation, find the

evaluation on the patient record screen and select Regenerate reports from the Other

Options drop-down list. The reports regenerate using the new Reports Settings.

Generate a Data Table report

If necessary, you can generate a Data Table report (approximately 40 pages for a complete seven-

day evaluation). This report lets you view detailed sensor glucose readings, and events that are

recorded in the Logbook. The Data Table is used by Medtronic employees for troubleshooting

purposes. Most of the time, you do not need it in order to understand an evaluation.

1 In the patient record screen, select Generate Data Table from the Other Options drop-

down list.

After a few moments, a new Data Table PDF link appears.

2 Click the link to view the report. The report opens in a new browser window or tab.

Or, click Print to print the report without viewing it first.

Export data to character-separated values (CSV) file

If necessary, you can export report data as a CSV file for further analysis. A CSV export is raw

data, typically for clinical evaluation use. Additional information in the data is used by Medtronic

employees for troubleshooting purposes. Most of the time, you do not need it to understand

an evaluation.

1 In the patient record screen, select Export data from the Other Options drop-down list.

After a few moments, a dialog box opens, allowing you to save the file on the computer.

2 Save the file on your computer or network. You can now open the file directly, for

example, in Microsoft Excel or Access.


6

Pattern Snapshot report

Key Notes:

• The Pattern Snapshot report displays general statistics, observed patterns and some possible

causes, and an overlay graph.

• General statistics include Average Sensor Glucose (Avg SG), Estimated A1C, and Time in

range.

• The Pattern Snapshot report displays up to three observed patterns.

• The Overlay graph displays information gathered from the evaluation period.

CareLink Software — User Guide Pattern Snapshot report 31

Overview of the Pattern Snapshot report

The Pattern Snapshot report displays general statistics, observed patterns and some possible

causes, and an overlay graph.

-

X

X X

1 23

General statistics

This section of the Pattern Snapshot report shows general statistics, including Avg SG (average

sensor glucose value), Estimated A1C (glycosylated hemoglobin), and Time in range.


Item Description

Avg SGAvg SG is the average of all SG values during the current evaluation. If this patienthas a previous evaluation in CareLink software, the most recent previous Avg SG willalso be displayed.

Estimated A1C

Estimated A1C is an estimated measurement of glycosylated hemoglobin. EstimatedA1C does not replace the lab measurement of A1C and is calculated from limited SGdata, from the current evaluation.

Formula:

A1C% = (Avg SG + 46.7) / 28.7

A1C mmol/mol = (10.93* A1C) - 23.5

Time in range Time in range displays the percentage of time the patient is above, below, or withinthe high or low thresholds set in clinic settings, during the evaluation.

Observed patterns and some possible causes

Observed patterns

The Pattern Snapshot report displays up to three observed patterns. The pattern title consists of

glycemic issues and an analysis period in which the issue was observed.

NOTE: Time periods in between the selected time ranges will not be analyzed.

During an evaluation, if there are at least two days with meal markers occurring in a meal

period, pre-meal and post-meal analysis is performed, otherwise an analysis is performed for the

time period. When pre-breakfast analysis cannot be performed because there are not at least

two meal markers during the Breakfast period, then the Fasting period is used for analysis in

addition to Breakfast time period.

• Post-meal analysis period is based on patient settings.

• Pre-meal analysis period is fixed and it is the hour immediately prior to the meal marker.


21 3

some possiblecauses

pattern heading

line 1line 2line 3

prioritynumber

Data elements displayed

Priority number The priority number corresponds to the priority of the pattern and its location on theSG graph. Up to three patterns may be shown.

Pattern heading

The pattern heading displays the SG pattern and corresponding time period. SGpatterns will be High, Low, Variable with Low, or Variable. Time periods are definedby meal times, such as Breakfast, Lunch, and Dinner. For more information on timeperiods, see Analysis Reports Settings on page 7.

NOTE: Overnight time is the combination of Evening and Sleepingtime periods.

Line 1

For High SG and Low SG patterns, Line 1 displays the number of days out of thenumber of evaluation days, when an excursion was observed. For example, High SGduring the fasting period might be seen only on two days out of the three-dayevaluation.

For Variable SG and Variable SG with Low SG patterns, Line 1 displays the number ofexcursions per day that occurred.

Line 2

For High SG and Low SG patterns, Line 2 displays the number of days whenexcursions occurred between Lowest Limit and the Low value or between the Highvalue and the Highest Limit.

For Variable SG and Variable SG with Low SG patterns, Line 2 displays the number ofexcursions per day that occurred below the Lowest Limit.

Line 3

For High SG and Low SG patterns, Line 3 displays the number of days whenexcursions occurred below the Lowest Limit or above the Highest Limit.

For Variable SG and Variable SG with Low SG patterns, Line 3 displays the number ofexcursions per day that occurred above the high limit.

Some possible causes For a list of some possible causes, see Some possible causes on page 35.


Some possible causes

The tables in this section list the causes that will be shown with each SG pattern observed.

NOTE: The causes listed are not a complete list of all possible causes and some causes maynot apply. Healthcare professionals should use best judgment on other causes that might be

relevant.

Low SG – Overnight

Oral medication(s) too high or incorrectly timed?

Basal insulin injection in evening(s) too high?

Insulin to carbohydrate ratio not optimal in prior evening(s)?

Less food intake in prior evening(s)?

More exercise in prior evening(s)?

Alcohol consumed in prior evening(s)?

High SG – Overnight

Oral medication(s) missed, too low, or incorrectly timed?

Basal insulin injection in evening(s) too low?

Insulin to carbohydrate ratio not optimal in prior evening(s)?

High calorie or high fat foods in prior evening(s)?

Late evening snack?

Variable SG – Overnight

Inconsistent food intake day before?

Inconsistent exercise schedule day before?

Inconsistent sleep pattern?

Oral medication(s) day before missed or incorrectly timed?

Basal insulin injection missed?

Pre-meal insulin in prior evening(s) incorrectly timed or missed?

Variable SG with Low SG - Overnight


Basal insulin injection in evening(s) too high or missed?

Pre-meal insulin in prior evening(s) incorrectly timed or incorrect dose?





Low SG - Pre-breakfast*

Oral medication(s) too high or incorrectly timed in evening(s)?



Breakfast delayed?



Low SG - Post-breakfast*



Pre-breakfast insulin too high?

Insulin to carbohydrate ratio not optimal for pre-breakfast insulin?

Less food intake than usual?

Exercised around breakfast?

Low SG - Breakfast


Basal insulin injections too high?

Pre-breakfast insulin too high?


Delayed or less food intake than usual?

Exercised around breakfast?

High SG - Pre-breakfast*



Rebound hyperglycemia after nocturnal hypoglycemia?


Late evening snack?

High SG - Post-breakfast*


Pre-breakfast insulin incorrectly timed, too low, or missed?


High calorie or high carbohydrate foods?


High SG - Breakfast


Pre-breakfast insulin incorrectly timed, too low, or missed?



Variable SG - Pre-breakfast*

Inconsistent food intake day before? Breakfast time not consistent?



Oral medication(s) intermittently missed, too low, or incorrectly timed?



Variable SG with Low SG - Pre-breakfast*




Breakfast time not consistent?



Variable SG - Post-breakfast*

Inconsistent food intake?


Pre-breakfast insulin incorrectly timed, incorrect dose, or missed?


Variable SG with Low SG - Post-breakfast*



Pre-breakfast insulin incorrectly timed or incorrect dose?



Exercised around breakfast time?


Variable SG - Breakfast





Variable SG with Low SG - Breakfast






Exercised around breakfast time?

Low SG - Fasting




Breakfast delayed?



High SG - Fasting



Rebound hyperglycemia after nocturnal hypoglycemia?


Late evening snack?

Variable SG - Fasting

Inconsistent food intake day before? Breakfast time not consistent?







Variable SG with Low SG - Fasting




Breakfast time not consistent?



Low SG - Pre-lunch*


Basal insulin injections in morning(s) too high?

Lunch delayed?

Exercised before lunch?

Low SG - Post-lunch*


Basal insulin injections in morning(s) too high?

Pre-lunch insulin too high?

Insulin to carbohydrate ratio not optimal for pre-lunch insulin?


Exercised around lunch?

Low SG - Lunch





Lunch delayed?

Exercised around lunch?

High SG - Pre-lunch*


Basal insulin injections too low?

Pre-lunch insulin incorrectly timed, too low, or missed?

High calorie or high carbohydrate in prior meal?

Previous meal delayed or snacking?


High SG - Post-lunch*





High SG - Lunch





High calorie or high carbohydrate in prior/current meal?


Variable SG - Pre-lunch*

Occasional snack between meals?

Inconsistent meal schedule or meal size?


Pre-meal insulin for prior meal(s) incorrectly timed, too low, or missed?


Variable SG with Low SG - Pre-lunch*


Basal insulin injection in morning(s) too high or missed?

Pre-meal insulin for prior meal(s) incorrectly timed, dosed, or missed?

Inconsistent meal/snack schedule or size?

Inconsistent exercise in morning(s)?

Variable SG - Post-lunch*



Pre-lunch insulin incorrectly calculated?


Variable SG with Low SG - Post-lunch*


Pre-lunch insulin incorrectly timed or incorrect dose?



Variable SG with Low SG - Post-lunch*


Exercised around lunch time?

Variable SG - Lunch






Variable SG with Low SG - Lunch

Oral medication(s) too high or incorrectly timed in morning(s)?




Exercised around lunch time?

Low SG - Pre-dinner*



Dinner delayed?

Exercised before dinner?

Low SG - Post-dinner*



Pre-dinner insulin too high?

Insulin to carbohydrate ratio not optimal for pre-dinner insulin?


Exercised around dinner?

Low SG - Dinner





Dinner delayed?

Exercised around dinner?


High SG - Pre-dinner*



Pre-dinner insulin incorrectly timed, too low, or missed?

High calorie or high carbohydrate in prior meal?


High SG - Post-dinner*





High SG - Dinner





High calorie or high carbohydrate in prior/current meal?


Variable SG - Pre-dinner*






Variable SG with Low SG - Pre-dinner*




Inconsistent meal/snack schedule or size?

Inconsistent exercise in morning(s)?

Variable SG - Post-dinner*




Variable SG - Post-dinner*

Pre-dinner insulin incorrectly calculated?


Variable SG with Low SG - Post-dinner*


Pre-dinner insulin incorrectly timed or incorrect dose?



Exercised around dinner time?

Variable SG - Dinner






Variable SG with Low SG - Dinner

Oral medication(s) too high or incorrectly timed in morning(s)?


Pre-dinner insulin incorrectly timed, incorrect dose, or missed?


Exercised around dinner time?

*Patterns with sufficient meal markers.


Sensor data graph

The Overlay graph displays information gathered from the evaluation period.

overlay graph

a b

d

c

Item Description

aPriority number indicators for the patterns listed in the Observed patterns and somepossible causes section. The horizontal lines indicate the period of the observedpattern (for example, Breakfast).

b Average SG values are displayed for every 3-hour period.

c

Solid colored lines trace daily SG values. The dotted line traces the Avg SG for theevaluation period. Open circles on the plot lines represent meal markers.

NOTE: Meal markers are plotted on the SG trace line for the daythey occur. However, BG values do not appear on this patternsnapshot.

d Light green band represents the target range as defined by the High and LowGlucose Target Range in Patient Report Settings.


7

CareLink software ongoing use

Key Notes:

• Click the Resources hyperlink in CareLink software to print the newest log sheets and other

forms.

• Only administrative users can add, modify, and delete CareLink software user accounts.

Always make sure more than one person has administrative privileges.

• Any CareLink software user can edit patient information when needed.

CareLink Software — User Guide CareLink software ongoing use 45

User tasks

Print more log sheets and other forms

Your original product order shipment may have included samples of patient log sheets, clinic

equipment logs, and other documents that your clinic wants to use regularly. You can easily

download and print more of these documents.

1 Click the Resources link at the bottom of the CareLink software screen.

2 Find the document that you want and open it.

3 Select the print option in your browser.

Change your password or other user information

As a CareLink software user, you can change your own password, email address, and other

information in your user account.

1 Sign in to CareLink software.

2 Click the My Info link. The My Info screen is displayed.

3 To change your password, select the Change Password check box. The password fields

become active. Enter your current password in the Current Password field, type your new

password in the New Password field, and then retype it in the Re-enter New Passwordfield.

4 Modify the other information as needed.

5 Click the Save button. If you changed your password, use your new password the next time

you sign in.

Edit patient information

You may occasionally need to update patient information. Any user can update any patient's

information for your clinic.

1 On the patient record screen, click the Edit Patient Information link.

2 Update the patient's information as needed.

3 Click the Save button. The changes have been saved, and any information that shows up

on reports will be updated the next time you generate reports for the patient.

Move a patient evaluation

If you accidentally upload an evaluation to the wrong patient record in CareLink software, you

can move the evaluation to the correct patient record.


Use the clinic equipment log sheet, if needed, to help you find the dates when each patient

wore the recorder.

1 Confirm that the patient, whose evaluation was uploaded incorrectly, has been added to

CareLink software. If the patient record does not exist yet, you need to create it now. For

details, see Patient evaluation status on page 13.

2 After you have confirmed that the correct patient exists in the system, open the patient

record that contains the evaluation that needs to be moved.

3 Find the evaluation you want to move within the list of evaluations for that patient.

4 If you see a message that the evaluation is incomplete, enter the patient's BG meter readings

by uploading the meter or using the Logbook.

5 In the Other Options drop-down list, select Move this evaluation.

6 Follow the on-screen instructions to find the correct patient and move the evaluation to

that patient's record.

When the move is complete, the reports regenerate for the correct patient.

Modify clinic information

You may periodically need to edit the identifying information of the clinic when the account

was first created. Some of this information appears on patient reports, so it is important to

keep the clinic information accurate.

1 In the Clinic Settings tab, click Clinic Information. The clinic information is displayed.

If you do not see the Clinic Settings tab, click the Home tab. You should now see the ClinicSettings tab.

2 Update the information as needed and click the Save button.

3 When you are finished, click Close clinic settings to return to the Patient List.

Administrator tasks

An administrative user can create, modify, or delete CareLink software user accounts for your

clinic as needed. For details on creating user accounts, see Create multiple user accounts on page 5.

Modify user accounts

A user with administrative privileges can modify a user account. For example, you may need

to change a user password, or grant or remove administrative privileges.


2 Select the user account and click the Open user button. The user account information

appears.

3 To edit the user account information, such as the password, enter the information and click

the Save button.


Delete user accounts

A user with administrative privileges can delete a user account. You need to delete user

accounts for users who no longer should have access to CareLink software for your clinic, that

way they can no longer access patient records.


2 Select the user account and click the Open user button. The user account information

appears.

3 To delete the user account, click the Delete User button.

4 In the confirmation screen, click Yes.


A

Troubleshooting

This appendix contains troubleshooting information for the CareLink software for Professional

CGM systems. Please refer to these instructions before contacting your local representative or

helpline.

Troubleshooting Envision Pro reference table

Troubleshooting Envision Pro reference table

Problem Possible causes Next steps

The reports only show apartial evaluation. Dataends before the evaluationwas supposed to end.

A common cause of apartial evaluation is sensorpullout.

If the sensor was notpulled out, you may haveForce Closed an evaluation.Only the data previouslyuploaded to CareLink willbe visible.

• If the sensor pulled out, make sure that thesensor is fully inserted and properly taped tothe skin for future evaluations.

• If you saw a CareLink software error message,see the troubleshooting steps for that errormessage in this section.

There are gaps in thesensor data in the reports.

A common cause of datagaps is partial sensorpullout.

Some sensor pullouts can be avoided by applyingan adhesive dressing over the recorder and sensor.

CareLink Software — User Guide Troubleshooting 49

Troubleshooting iPro2 reference table

Troubleshooting iPro2 reference table


The reports only show apartial evaluation. Dataends before the evaluationwas supposed to end.

A common cause of apartial evaluation is sensorpullout.

If the sensor was notpulled out, the iPro2recorder battery may nothave had sufficient powerto complete the evaluation.CareLink software checksthe battery and displays amessage during the uploadprocess to warn you thatthe iPro2 Recorder batteryis not charging properly:

Possible damage to iPro2recorder battery. Pleaserefer to the User Guidefor assistance.

Also, the Dock displays asolid red warning lightwhen there may be aproblem with the iPro2recorder battery.

• If the sensor pulled out, make sure that thesensor is fully inserted and properly taped tothe skin for future evaluations.

• If you did not see an error message in CareLinksoftware during the uploading process, it couldbe that there are not enough BG meter readingsfor calibration after a certain point in theevaluation.

Make sure that you have entered all thepatient's BG meter readings into CareLinksoftware. CareLink software needs good BGmeter readings to calibrate sensor data. Lessthan three BG meter readings per day, or morethan 12 hours between BG meter readings, canresult in data gaps.

• If you saw a CareLink software error message,see the troubleshooting steps for that errormessage in this section.

There are gaps in thesensor data in the reports.

A common cause of datagaps is partial sensorpullout.

There can also becalibration problems dueto an insufficient numberof BG meter readings,readings that are morethan 12 hours apart, orreadings that are out ofthe expected range.

• Make sure that you have entered all of thepatient's BG meter readings into CareLinksoftware. CareLink software needs good BGmeter readings in order to calibrate and reportsensor data. Less than three per day can resultin data gaps.

• Also check the sensor trace on reports to see ifthere are BG meter readings not used forcalibration. Bad BG meter readings are identifiedas calibration errors. These BG meter readingsare not used for calibration and cause thesensor plot to stop. The sensor plot starts againat a good BG meter reading. You can eliminatesome data gaps by excluding bad BG meterreadings using the Exclude feature in theLogbook.

• Some sensor pullouts can be avoided byapplying an adhesive dressing over the iPro2recorder and sensor.

• Always advise patients to test their BG at leastfour times a day.

I uploaded the wrongmeter for a patient. Can Ifix this?

The wrong patient meterwas uploaded.

• In the Logbook screen, check the Exclude checkbox to exclude all of the BG meter readings thatcame from the wrong meter. The readings fromthe wrong meter are still in the Logbook, butthey will not affect sensor calibration orreports. If you find the right meter or log sheetsfor the patient, you can manually enter the BGmeter readings from the right meter.

• You can still upload the meter to the correctpatient evaluation.

I uploaded the wrongevaluation for a patient.Can I fix this?

The wrong patientevaluation was uploaded.

Yes, you can move the entire evaluation from theincorrect patient record to the correct patientrecord. For details, see Move a patient evaluation onpage 46.


CareLink uploader messages with iPro2

CareLink uploader error messages with iPro2


The CareLink uploaderdisplayed this messageduring the upload process:

No device was detectedconnected to the iPro2Dock. Please check thatthe device is properlyseated in the iPro2 Dock.

The iPro2 recorder is not inthe Dock, or it is notproperly connected. Thismessage may also appear ifthe iPro2 recorderconnector pins aredamaged or corroded, or ifthere is moisture in theconnector opening.

• If your iPro2 recorder is connected, trydisconnecting and reconnecting the iPro2recorder to the iPro2 Dock.

• If the white Dock power light is on, but thethree lights do not flash when you connect theiPro2 recorder, the iPro2 recorder may bedamaged. Check the iPro2 recorder connectorpins for moisture, damage, or corrosion. Forassistance in locating the connector pins, seethe iPro2 System User Guide.

• If the iPro2 recorder connector pins aredamaged or corroded, the iPro2 recordercannot communicate with the Dock or CareLinksoftware. Contact your local representative orhelpline. It may be time to replace the iPro2recorder.


iPro2 recorder batterypower too low forcommunications. Pleasewait for the battery tocharge. This may takeseveral minutes.

The red warning light onthe Dock is on.

!!!!!

The iPro2 recorder batterymay be reaching the endof its life. However, thismessage may also appear ifthe iPro2 recorderconnector pins aredamaged or corroded, or ifthere is moisture in theconnector opening.

• Disconnect the iPro2 recorder and reconnect itto the Dock. Allow the iPro2 recorder to chargefor 20 minutes. The green charging light mayflash at first, but if the red warning light turnson again, check the iPro2 recorder connectorpins for moisture, damage, or corrosion. Forassistance in locating the connector pins, seethe iPro2 System User Guide.

• If the red warning light continues to turn on,perform a reset as described in the iPro2 SystemUser Guide. Please note that if you saw this errormessage in the CareLink uploader, the recentpatient data was successfully uploaded, but youmay wish to confirm this before performing thereset. If the Dock displays a solid green charginglight, the reset was successful.

• If the iPro2 recorder connector pins aredamaged or corroded, or the Dock still displaysa red warning light for the iPro2 recorder afterthe reset, contact your local representative orhelpline. It may be time to replace the iPro2recorder.





Possible damage to iPro2recorder circuitry. Pleaserefer to the User Guidefor assistance.


!!!!!

There may be moisture,damage, or corrosion inthe iPro2 recorderconnector opening, or theiPro2 recorder may need tobe reset.

• Disconnect the iPro2 recorder and reconnect itto the Dock. Charge the iPro2 recorder for 20minutes. If the Dock displays a solid greencharging light, the reconnection was successful.

• If the green charging light flashes at first, andthen the red warning light turns on, check theiPro2 recorder connector pins. For assistance inlocating the connector pins, see the iPro2System User Guide.

• If you do not find any problems inside of theconnector opening, and the green charginglight never remains solid without flashing whenyou connect the iPro2 recorder to the Dock,perform a reset as described in the iPro2 SystemUser Guide, and charge the iPro2 recorder forone hour. Please note that if you saw this errormessage in the CareLink uploader, the recentpatient data was successfully uploaded, but youmay wish to confirm this before performing thereset. If the Dock displays a solid green charginglight, the reset was successful.

• If the red warning light continues to turn on,contact your local representative or helpline. Itmay be time to replace the iPro2 recorder.


Possible damage to iPro2recorder battery. Pleaserefer to the User Guidefor assistance.


!!!!!

There may be moisture,damage, or corrosion inthe iPro2 recorderconnector opening, or theiPro2 recorder may need tobe reset.



• If you do not find any problems inside of theconnector opening, and the green charginglight never remains on without flashing whenyou connect the iPro2 recorder to the Dock,perform a reset as described in the iPro2 SystemUser Guide, and charge the iPro2 recorder forone hour. Please note that if you saw this errormessage in the CareLink uploader, the recentpatient data was successfully uploaded, but youmay wish to confirm this before performing thereset. If the Dock displays a solid green charginglight, the reset was successful.

• If the red warning light continues to turn on,contact your local representative or helpline. Itmay be time to replace the iPro2 recorder.

The CareLink uploaderdisplayed this messagewhen initiating an iPro2upload:

More than one iPro2Dock is connected to thecomputer. Please connectonly one iPro2 Dock.

There may be multipleiPro2 Docks attached tothe computer.

Disconnect all Docks except the one containing theiPro2 recorder to upload and try again.




The CareLink uploaderdisplayed this messageduring an iPro2 upload:

The iPro2 recorder datacould not be cleared.Check the patient recordto ensure that the datahas been received by theCareLink software. Youmay reset the iPro2recorder using the iPro2Dock. For instructions onhow to reset the iPro2recorder, refer to theUser Guide.

The iPro2 recorder batterymay be damaged.



• If you do not find any problems inside of theconnector opening, and the green charginglight never remains on without flashing whenyou connect the iPro2 recorder to the Dock,perform a reset as described in the iPro2 SystemUser Guide, and charge the iPro2 recorder forone hour. Please note that if you saw this errormessage in CareLink software, the recentpatient data was successfully uploaded, but youmay wish to confirm this before performing thereset. If the Dock displays a solid green charginglight, the reset was successful.

The CareLink uploaderdisplayed this messageduring an iPro2 upload:

The iPro2 recorder doesnot contain any patientevaluation data. Pleaseverify that the correctiPro2 recorder isconnected to thecomputer. If this iPro2recorder has been resetusing the iPro2 Dockreset button, then alldata has been cleared.

The iPro2 recorder containsno patient evaluation data.One of several events mayhave occurred:

The reset button on theiPro2 recorder was pressed.

The recorder data hasalready been read andloaded into CareLink iPro.The recorder data isintentionally cleared by theCareLink uploaderapplication after the iPro2recorder is successfullyread and accepted byCareLink.

The iPro2 recorder has notbeen used in an evaluation.The iPro2 may be a newdevice or mistaken foranother device that wasused in an evaluation.

• Confirm the correct iPro2 recorder has beenuploaded.

• If you are uploading the correct iPro2 recorder,confirm that the current evaluation was notalready uploaded, as the data would have beenerased upon a successful upload. You may wantto check to confirm the upload occurred in thecorrect patient record.


Glossary

A1C - Glycosylated hemoglobin

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

Average Sensor Glucose (Avg SG) - This value is the average of all sensor glucose values duringthe current evaluation.

BG - Blood Glucose

BG reading - Blood glucose measurement that is taken by a blood glucose meter.

Calibrate - Check, adjust, or set to a standard. Sensor data is calibrated using BG meter readingswhen using iPro2.

Docking station (Dock) - Device that performs two functions: uploading glucose sensor data froman iPro2 recorder to CareLink software; and charging the iPro2 recorder. The Dock can beconnected to a computer or to an electrical socket.

Envision recorder - Disposable device that continuously records sensor glucose data whileconnected to a glucose sensor. The recorder receives and sends data to the Envision Pro app tobe uploaded into CareLink software to view sensor data on reports.

Estimated A1C - An estimated measurement of glycosylated hemoglobin.

Evaluation - Also known as "Study", refers to the period of time that a patient wears a glucosesensor and iPro2 or Envision Pro recorder. This word also refers to an upload of glucose sensordata from an iPro2 or Envision Pro recorder into CareLink software, along with any Logbookevents and meter data uploaded from an iPro2 recorder. Each evaluation has its own set ofreports.

HCP - Health Care Professional

iPro2 digital recorder (iPro2 recorder) - Device that continuously records sensor glucose datawhile connected to a glucose sensor. You can upload the data to CareLink software byconnecting the iPro2 recorder to a Dock, and view the sensor data on reports.

Logbook - A screen in CareLink software that lets you manually enter events such as meals,exercise, and medication taken, so that these events show up on reports. The Logbook alsodisplays BG meter readings, and possibly other events, which you upload from a supportedblood glucose meter into CareLink software when using iPro2.

Mean Absolute Difference % (MAD%) - Represents the level of accuracy in calibration of thesensor 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 andBG meter readings, dividing by the BG meter reading, and then averaging across all pairs.

CareLink Software — User Guide Glossary 54

Mean Absolute Difference (MAD) - Represents the level of accuracy in calibration of the sensor toBG meter readings. The lower this number, the greater the calibration accuracy. MAD iscalculated by taking the difference between closely occurring pairs of sensor glucose and BGmeter readings 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 tocalculate the blood glucose level. The meter then displays the level in mmol/L or mg/dL.

PDF - Portable Document Format

QR - Quick Response

TLS - Transport Layer Security

Upload - The process of transferring diabetes device data to the CareLink software.

USB - Universal Serial Bus

CareLink Software — User Guide Glossary 55

Index

A

accessingLogbook screen 14, 23

accessing patient records 13, 19activity, entering in Logbook 15, 23adding

Logbook events 15, 23administrative user

creating first 5deleting user accounts 48modifying user accounts 47tasks in CareLink software 47

Analysis reportsabout 27settings 7

area under the curve 28assistance 3AUC 28

B

Back buttonInternet Explorer secure setting 9

BG meter readings, excluding fromcalibration 24

blood glucose meteruploading data 22

blood glucose meter readingsentering in CareLink software 14, 23

browserrequired settings 9supported browsers 2

C

calibration, improving 24CareLink software

about uploading data 12, 17adding Logbook events 15, 23changing password or user information 46Data Table report 30

deleting user accounts 48editing Logbook events 15, 24editing patient information 46entering blood glucose data 15, 23excluding BG meter readings 24excluding Logbook events 16exporting data 30ongoing use, administrator tasks 47ongoing use, user tasks 46opening patient records 13, 19patient report settings 28printing reports 27removing Logbook events 15, 24reports 26, 27restoring default patient report settings 29software setup 4sorting Logbook events 16, 25uploading meter data 22viewing reports 27

clinic registration 5clinic report settings 6common tasks in CareLink software

administrator tasks 47regular user tasks 46

computer system requirements 2correcting Logbook events 24creating

CSV file 30Data Table report 30user accounts 5

CSV file export 30

D

Daily Overlay report, about 27Daily Summary report, about 27daily use

common tasks in CareLink software 46managing users in CareLink software 47

dataexporting to CSV 30log sheets, entering 14, 23uploading blood glucose meter 22

Data Table report, generating 30CareLink Software — User Guide Index 56

default report settings 6deleting

user accounts 48deleting Logbook events 15, 24

E

editingCareLink software users 47Logbook events 15, 24

enrolling clinic 5entering log sheet data 14, 23equipment log

printing new copies 9Excel data export 30excluding

Logbook events 16excluding BG meter readings 24excluding Logbook events 16exercise, entering in Logbook 15, 23exporting data 30

F

first time setupsoftware setup 4

frequently asked questions 49, 50

G

general report settings 7generating

CSV file 30Data Table report 30

glucose unitssystem default setting 6

I

installation of software 18Internet browser, required settings 9Internet Explorer

back button 9secure setting 9

secure browser setting 9iPro2 recorder

computer setup 18

J

Java installation 18JavaScript, enabling 9

L

log sheetsentering data 14, 23

Logbookadding events 15, 23editing events 15, 24entering data 14, 23excluding BG meter readings 24excluding events 16opening 14, 23removing events 15, 24sorting events 16, 25

M

Mac setup, meter uploads 20meals, entering in Logbook 15, 23medication, entering in Logbook 15, 23meter

excluding meter readings 24uploading data 22

modifyingclinic information 47Logbook events 15, 24patient report settings 28user accounts 47

moving a patient study 46

O

office registration 5opening

Logbook screen 14, 23patient record 13, 19

operating system requirements 2

P

password, CareLink software 46patient information, editing 46patient instructions sheet

printing new copies 9patient log sheet

printing new copies 9patient records

opening 13, 19patient report settings 28patient return visit 12, 17patient study

moving a patient study 46previewing reports 27printing reports 27

R

registering clinic 5removing

CareLink software users 48Logbook events 15, 24

CareLink Software — User Guide Index 57

report settingsclinic 6general 7restoring default, patient settings 29

reportsabout 26, 27Analysis 27Analysis Reports Settings 7area under the curve (AUC) 28clinic report settings 6CSV file 30Daily Overlay 27Daily Summary 27Data Table 30General Report Settings 7patient report settings 28printing 27restoring default patient report settings 29viewing 27

reports settingsAnalysis 7

required browser settings 9enabling JavaScript 9

resources, downloading and printing 9restoring default patient report settings 29

S

Secure browser setting for Internet Explorer 9setting clinic report settings 6setting up computers for uploading 18setup

CareLink software 4clinic 5computers for uploading 18user accounts 5

software drivers 18software installation 18software requirements 2sorting Logbook events 16, 25spreadsheet data export 30support, software requirements 2system requirements, computer 2

T

target glucose range, setting system default 6time display, setting system default 6troubleshooting

about 49CareLink software 51Data Table report 30troubleshooting reference table 49, 50

U

uploadingmeter data 22

uploading dataabout 12, 17

user accountscreating 5deleting 48modifying 47

V

viewingLogbook events 16, 25patient reports 27

CareLink Software — User Guide Index 58

carelink€¦ · medtronic gmbh geschäftsbereich diabetes telefon: +49 2159 8149-370 telefax: +49...

Documents