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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 of Medtronic. ™* Third party 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™* ™* Ascensia, the Ascensia Care logo, CONTOUR, and BREEZE are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

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Tel: +44 1923-205167 Tel: +90 216 4694330 Österreich: USA: Medtronic Österreich GmbH Medtronic Diabetes Global Headquarters Tel: +43 (0) 1 240 44-0 24 Hour HelpLine: +1-800-646-4633 24 – Stunden – Hotline: 0820 820 190 To order supplies: +1-800-843-6687 Česká republika: : Medtronic Czechia s.r.o. Med Ek Service TOV Tel: +420 233 059 111 Tel: +380 50 3311898 Non-stop helpLine (24/7): or +380 50 4344346 +420 233 059 059 Лінія цілодобової підтримки: Zákaznický servis (8:00 - 17:00): 0 800 508 300 +420 233 059 950 Contents

Chapter 1 1 Introduction 2 CareLink Software for Professional CGM Systems 2 Indication for Use 2Contraindications 2 Storage and Transportation information 2 Disposal information 2 Computer system requirements 3Assistance

Chapter 2 4 One-time software and computer setup 5 Register clinic and create administrative user 5 Create multiple user accounts 6 Set clinic report settings 7 General Report Settings 7 Analysis Reports Settings 8 Required settings for Windows users 9 Required Internet browser settings 9 Enable JavaScript 9 Secure Browsing 9 Download and print resources 10 Print clinic information 10 User security advisory

Chapter 3 12 Using CareLink software with Envision Pro CGM system 13 Patient evaluation status 14 Confirm the information in the patient record 14 Force Close Evaluation 14 Enter patient log sheet data 14 Open the Logbook 15 Add and review events 15 Edit events 15 Remove events

CareLink Software — User Guide Contents vi 16 Exclude events 16 Sort events

Chapter 4 17 Using CareLink software with iPro2 recorders 18 Computer setup for iPro2 recorder upload 19 Open the patient record 20 Setup to upload your meter on Mac 21 Setup of LifeScan meters on Mac 21 Setup for all other meters or ComLink on Mac 22 Upload meter data 23 Enter patient log sheet data 23 Open the Logbook 23 Add events 24 Exclude BG meter readings 24 Edit events 24 Remove events 25 Sort events

Chapter 5 26 CareLink reports 27 View and print patient reports 27 About reports 28 Area under the curve (AUC) 28 Patient Report Settings 29 Modify patient report settings 29 Restore the default report settings 30 Generate a Data Table report 30 Export data to character-separated values (CSV) file

Chapter 6 31 Pattern Snapshot report 32 Overview of the Pattern Snapshot report 32 General statistics 33 Observed patterns and some possible causes 33 Observed patterns 35 Some possible causes 44 Sensor data graph

Chapter 7 45 CareLink software ongoing use 46 User tasks 46 Print more log sheets and other forms 46 Change your password or other user information 46 Edit patient information 46 Move a patient evaluation 47 Modify clinic information 47 Administrator tasks 47 Modify user accounts 48 Delete user accounts

CareLink Software — User Guide Contents vii Appendix A 49 Troubleshooting 49 Troubleshooting Envision Pro reference table 50 Troubleshooting iPro2 reference table 51 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 (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 make sure 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

CareLink Software — User Guide Introduction 2 • 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 to Windows 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 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 , 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

CareLink Software — User Guide Introduction 3 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 register your clinic only once using the Register Clinic link. After the initial registration, give administrative 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 registers another 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.

CareLink Software — User Guide One-time software and computer setup 5 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 an administrator 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.

xxxx xxxx xxxxxx xxxx

xxxxxxx xxxxx xxxxxx xxxxxxx xxxxx

xxxx xxx xxxx xxxx xxx xxxx

xxxx xxxx xxxxxx xxxx xxxxxxx

xxxxxxx xxxxx xxxxxx xxxxx xxxxx xxxx

xxx xxx xxx xx xxxxxx

xxxxxxxx xxxx xx xxx xxx xxxxx xxx xxxx xxx x xxxx xxx xxx

xxxxxxxx xxxx xx xxx xxx xxxxx xxx xxxx xxx x xxxx xxx xxx

xxxxxxxx xxxx xx xxx xxx xxxxx xxx xxxx xxx x

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

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.

CareLink Software — User Guide One-time software and computer setup 6 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:

CareLink Software — User Guide One-time software and computer setup 7 - 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.

CareLink Software — User Guide One-time software and computer setup 8 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.

CareLink Software — User Guide One-time software and computer setup 9 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.

CareLink Software — User Guide One-time software and computer setup 10 • 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.

CareLink Software — User Guide One-time software and computer setup 11 3

Using CareLink software with Envision Pro 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.

CareLink Software — User Guide Using CareLink software with Envision Pro CGM system 13 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 Close Evaluation 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.

CareLink Software — User Guide Using CareLink software with Envision Pro CGM system 14 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 the evaluation 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.

CareLink Software — User Guide Using CareLink software with Envision Pro CGM system 15 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.

CareLink Software — User Guide Using CareLink software with Envision Pro CGM system 16 4

Using CareLink software with iPro2 recorders

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 when reviewing 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. Close the 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 Patient List. 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.

CareLink Software — User Guide Using CareLink software with iPro2 recorders 18 NOTE: When a message asks to upload another evaluation for the sample patient, click Yes. 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, click Yes.

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.

CareLink Software — User Guide Using CareLink software with iPro2 recorders 19 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 to enter 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 before adding 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 one patient, 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

CareLink Software — User Guide Using CareLink software with iPro2 recorders 20 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 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.

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.

CareLink Software — User Guide Using CareLink software with iPro2 recorders 21 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 change on 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 has successfully 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 — User Guide Using CareLink software with iPro2 recorders 22 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.

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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 the evaluation 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.

CareLink Software — User Guide Using CareLink software with iPro2 recorders 23 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. 3 When you are 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 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.

CareLink Software — User Guide Using CareLink software with iPro2 recorders 24 3 When you are finished using the Logbook, click Done to return to the patient record screen. The reports regenerate automatically.

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.

CareLink Software — User Guide Using CareLink software with iPro2 recorders 25 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.

CareLink Software — User Guide CareLink reports 27 • 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.

CareLink Software — User Guide CareLink reports 28 • 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 Other Options 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.

CareLink Software — User Guide CareLink reports 29 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.

CareLink Software — User Guide CareLink reports 30 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.

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3 1 2

X X

X

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.

CareLink Software — User Guide Pattern Snapshot report 32 Item Description Avg SG is the average of all SG values during the current evaluation. If this patient Avg SG has a previous evaluation in CareLink software, the most recent previous Avg SG will also be displayed.

Estimated A1C is an estimated measurement of glycosylated hemoglobin. Estimated A1C does not replace the lab measurement of A1C and is calculated from limited SG data, from the current evaluation. Estimated A1C Formula: A1C% = (Avg SG + 46.7) / 28.7 A1C mmol/mol = (10.93* A1C) - 23.5

Time in range displays the percentage of time the patient is above, below, or within Time in range the 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.

CareLink Software — User Guide Pattern Snapshot report 33 priority number 1 2 3 pattern heading line 1 line 2 line 3

some possible causes

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

The pattern heading displays the SG pattern and corresponding time period. SG patterns will be High, Low, Variable with Low, or Variable. Time periods are defined by meal times, such as Breakfast, Lunch, and Dinner. For more information on time periods, see Analysis Reports Settings on page 7. Pattern heading NOTE: Overnight time is the combination of Evening and Sleeping time periods.

For High SG and Low SG patterns, Line 1 displays the number of days out of the number of evaluation days, when an excursion was observed. For example, High SG during the fasting period might be seen only on two days out of the three-day Line 1 evaluation. For Variable SG and Variable SG with Low SG patterns, Line 1 displays the number of excursions per day that occurred.

For High SG and Low SG patterns, Line 2 displays the number of days when excursions occurred between Lowest Limit and the Low value or between the High Line 2 value and the Highest Limit. For Variable SG and Variable SG with Low SG patterns, Line 2 displays the number of excursions per day that occurred below the Lowest Limit.

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

CareLink Software — User Guide Pattern Snapshot report 34 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 may not 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 injection in evening(s) too high?

Insulin to 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 Oral medication(s) too high or incorrectly timed?

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

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

Inconsistent food intake day before?

Inconsistent exercise schedule day before?

Alcohol consumed in prior evening(s)?

CareLink Software — User Guide Pattern Snapshot report 35 Low SG - Pre-breakfast* Oral medication(s) too high or incorrectly timed in evening(s)?

Basal insulin injection in evening(s) too high?

Less food intake in prior evening(s)?

Breakfast delayed?

More exercise in prior evening(s)?

Alcohol consumed in prior evening(s)?

Low SG - Post-breakfast* Oral medication(s) too high or incorrectly timed?

Basal insulin injection in evening(s) too high?

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

Basal insulin injections too high?

Pre-breakfast insulin too high?

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

Delayed or less food intake than usual?

Exercised around breakfast?

High SG - Pre-breakfast* Oral medication(s) missed, too low, or incorrectly timed?

Basal insulin injection in evening(s) too low?

Rebound after nocturnal ?

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

Late evening snack?

High SG - Post-breakfast* Oral medication(s) missed, too low, or incorrectly timed?

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

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

High calorie or high carbohydrate foods?

CareLink Software — User Guide Pattern Snapshot report 36 High SG - Breakfast Oral medication(s) missed, too low, or incorrectly timed?

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

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

High calorie or high carbohydrate foods?

Variable SG - Pre-breakfast* Inconsistent food intake day before? Breakfast time not consistent?

Inconsistent exercise schedule day before?

Inconsistent sleep pattern?

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

Basal insulin injection missed?

Alcohol consumed in prior evening(s)?

Variable SG with Low SG - Pre-breakfast* Oral medication(s) too high or incorrectly timed in evening(s)?

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

Inconsistent food intake day before?

Breakfast time not consistent?

Inconsistent exercise schedule day before?

Alcohol consumed in prior evening(s)?

Variable SG - Post-breakfast* Inconsistent food intake?

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

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

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

Variable SG with Low SG - Post-breakfast* Oral medication(s) too high or incorrectly timed?

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

Pre-breakfast insulin incorrectly timed or incorrect dose?

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

Inconsistent food intake?

Exercised around breakfast time?

CareLink Software — User Guide Pattern Snapshot report 37 Variable SG - Breakfast Inconsistent food intake?

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

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

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

Variable SG with Low SG - Breakfast Oral medication(s) too high or incorrectly timed in evening(s)?

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

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

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

Inconsistent food intake?

Exercised around breakfast time?

Low SG - Fasting Oral medication(s) too high or incorrectly timed?

Basal insulin injection in evening(s) too high?

Less food intake in prior evening(s)?

Breakfast delayed?

More exercise in prior evening(s)?

Alcohol consumed in prior evening(s)?

High SG - Fasting Oral medication(s) missed, too low, or incorrectly timed?

Basal insulin injection in evening(s) too low?

Rebound hyperglycemia after nocturnal hypoglycemia?

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

Late evening snack?

Variable SG - Fasting Inconsistent food intake day before? Breakfast time not consistent?

Inconsistent exercise schedule day before?

Inconsistent sleep pattern?

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

Basal insulin injection missed?

Alcohol consumed in prior evening(s)?

CareLink Software — User Guide Pattern Snapshot report 38 Variable SG with Low SG - Fasting Oral medication(s) too high or incorrectly timed in evening(s)?

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

Inconsistent food intake day before?

Breakfast time not consistent?

Inconsistent exercise schedule day before?

Alcohol consumed in prior evening(s)?

Low SG - Pre-lunch* Oral medication(s) too high or incorrectly timed?

Basal insulin injections in morning(s) too high?

Lunch delayed?

Exercised before lunch?

Low SG - Post-lunch* Oral medication(s) too high or incorrectly timed?

Basal insulin injections in morning(s) too high?

Pre-lunch insulin too high?

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

Less food intake than usual?

Exercised around lunch?

Low SG - Lunch Oral medication(s) too high or incorrectly timed?

Basal insulin injections too high?

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

Less food intake than usual?

Lunch delayed?

Exercised around lunch?

High SG - Pre-lunch* Oral medication(s) missed, too low, or incorrectly timed?

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?

CareLink Software — User Guide Pattern Snapshot report 39 High SG - Post-lunch* Oral medication(s) missed, too low, or incorrectly timed?

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

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

High calorie or high carbohydrate foods?

High SG - Lunch Oral medication(s) missed, too low, or incorrectly timed?

Basal insulin injections too low?

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

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

High calorie or high carbohydrate in prior/current meal?

Previous meal delayed or snacking?

Variable SG - Pre-lunch* Occasional snack between meals?

Inconsistent meal schedule or meal size?

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

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

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

Variable SG with Low SG - Pre-lunch* Oral medication(s) too high or incorrectly timed?

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* Inconsistent food intake?

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

Pre-lunch insulin incorrectly calculated?

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

Variable SG with Low SG - Post-lunch* Oral medication(s) too high or incorrectly timed?

Pre-lunch insulin incorrectly timed or incorrect dose?

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

CareLink Software — User Guide Pattern Snapshot report 40 Variable SG with Low SG - Post-lunch* Inconsistent food intake?

Exercised around lunch time?

Variable SG - Lunch Occasional snack between meals?

Inconsistent meal schedule or meal size?

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

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

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

Variable SG with Low SG - Lunch Oral medication(s) too high or incorrectly timed in morning(s)?

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

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

Inconsistent meal schedule or meal size?

Exercised around lunch time?

Low SG - Pre-dinner* Oral medication(s) too high or incorrectly timed?

Basal insulin injections too high?

Dinner delayed?

Exercised before dinner?

Low SG - Post-dinner* Oral medication(s) too high or incorrectly timed?

Basal insulin injections too high?

Pre-dinner insulin too high?

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

Less food intake than usual?

Exercised around dinner?

Low SG - Dinner Oral medication(s) too high or incorrectly timed?

Basal insulin injections too high?

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

Less food intake than usual?

Dinner delayed?

Exercised around dinner?

CareLink Software — User Guide Pattern Snapshot report 41 High SG - Pre-dinner* Oral medication(s) missed, too low, or incorrectly timed?

Basal insulin injections too low?

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

High calorie or high carbohydrate in prior meal?

Previous meal delayed or snacking?

High SG - Post-dinner* Oral medication(s) missed, too low, or incorrectly timed?

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

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

High calorie or high carbohydrate foods?

High SG - Dinner Oral medication(s) missed, too low, or incorrectly timed?

Basal insulin injections too low?

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

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

High calorie or high carbohydrate in prior/current meal?

Previous meal delayed or snacking?

Variable SG - Pre-dinner* Occasional snack between meals?

Inconsistent meal schedule or meal size?

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

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

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

Variable SG with Low SG - Pre-dinner* Oral medication(s) too high or incorrectly timed?

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-dinner* Inconsistent food intake?

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

CareLink Software — User Guide Pattern Snapshot report 42 Variable SG - Post-dinner* Pre-dinner insulin incorrectly calculated?

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

Variable SG with Low SG - Post-dinner* Oral medication(s) too high or incorrectly timed?

Pre-dinner insulin incorrectly timed or incorrect dose?

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

Inconsistent food intake?

Exercised around dinner time?

Variable SG - Dinner Occasional snack between meals?

Inconsistent meal schedule or meal size?

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

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

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

Variable SG with Low SG - Dinner Oral medication(s) too high or incorrectly timed in morning(s)?

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

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

Inconsistent meal schedule or meal size?

Exercised around dinner time?

*Patterns with sufficient meal markers.

CareLink Software — User Guide Pattern Snapshot report 43 Sensor data graph

The Overlay graph displays information gathered from the evaluation period.

a b

c

overlay graph

d

Item Description Priority number indicators for the patterns listed in the Observed patterns and some a possible causes section. The horizontal lines indicate the period of the observed pattern (for example, Breakfast).

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

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

c NOTE: Meal markers are plotted on the SG trace line for the day they occur. However, BG values do not appear on this pattern snapshot.

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

CareLink Software — User Guide Pattern Snapshot report 44 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 Password field. 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.

CareLink Software — User Guide CareLink software ongoing use 46 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 Clinic Settings 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.

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

CareLink Software — User Guide CareLink software ongoing use 47 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.

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

CareLink Software — User Guide CareLink software ongoing use 48 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 A common cause of a partial evaluation is sensor pullout. • If the sensor pulled out, make sure that the The reports only show a sensor is fully inserted and properly taped to partial evaluation. Data If the sensor was not the skin for future evaluations. ends before the evaluation pulled out, you may have • If you saw a CareLink software error message, was supposed to end. Force Closed an evaluation. see the troubleshooting steps for that error Only the data previously message in this section. uploaded to CareLink will be visible.

A common cause of data There are gaps in the Some sensor pullouts can be avoided by applying gaps is partial sensor sensor data in the reports. an adhesive dressing over the recorder and sensor. pullout.

CareLink Software — User Guide Troubleshooting 49 Troubleshooting iPro2 reference table

Troubleshooting iPro2 reference table Problem Possible causes Next steps A common cause of a partial evaluation is sensor pullout. • If the sensor pulled out, make sure that the If the sensor was not sensor is fully inserted and properly taped to pulled out, the iPro2 the skin for future evaluations. recorder battery may not have had sufficient power • If you did not see an error message in CareLink to complete the evaluation. software during the uploading process, it could CareLink software checks be that there are not enough BG meter readings the battery and displays a for calibration after a certain point in the The reports only show a message during the upload evaluation. partial evaluation. Data process to warn you that Make sure that you have entered all the ends before the evaluation the iPro2 Recorder battery patient's BG meter readings into CareLink was supposed to end. is not charging properly: software. CareLink software needs good BG meter readings to calibrate sensor data. Less Possible damage to iPro2 than three BG meter readings per day, or more recorder battery. Please than 12 hours between BG meter readings, can refer to the User Guide result in data gaps. for assistance. • If you saw a CareLink software error message, Also, the Dock displays a see the troubleshooting steps for that error solid red warning light message in this section. when there may be a problem with the iPro2 recorder battery.

• Make sure that you have entered all of the patient's BG meter readings into CareLink software. CareLink software needs good BG meter readings in order to calibrate and report sensor data. Less than three per day can result A common cause of data in data gaps. gaps is partial sensor • Also check the sensor trace on reports to see if pullout. there are BG meter readings not used for calibration. Bad BG meter readings are identified There can also be as calibration errors. These BG meter readings calibration problems due There are gaps in the are not used for calibration and cause the to an insufficient number sensor data in the reports. sensor plot to stop. The sensor plot starts again of BG meter readings, at a good BG meter reading. You can eliminate readings that are more some data gaps by excluding bad BG meter than 12 hours apart, or readings using the Exclude feature in the readings that are out of Logbook. the expected range. • Some sensor pullouts can be avoided by applying an adhesive dressing over the iPro2 recorder and sensor. • Always advise patients to test their BG at least four times a day.

• In the Logbook screen, check the Exclude check box to exclude all of the BG meter readings that came from the wrong meter. The readings from the wrong meter are still in the Logbook, but I uploaded the wrong The wrong patient meter they will not affect sensor calibration or meter for a patient. Can I was uploaded. reports. If you find the right meter or log sheets fix this? for the patient, you can manually enter the BG meter readings from the right meter. • You can still upload the meter to the correct patient evaluation.

Yes, you can move the entire evaluation from the I uploaded the wrong The wrong patient incorrect patient record to the correct patient evaluation for a patient. evaluation was uploaded. record. For details, see Move a patient evaluation on Can I fix this? page 46.

CareLink Software — User Guide Troubleshooting 50 CareLink uploader messages with iPro2

CareLink uploader error messages with iPro2 Problem Possible causes Next steps • If your iPro2 recorder is connected, try disconnecting and reconnecting the iPro2 recorder to the iPro2 Dock. • If the white Dock power light is on, but the The iPro2 recorder is not in The CareLink uploader three lights do not flash when you connect the the Dock, or it is not displayed this message iPro2 recorder, the iPro2 recorder may be properly connected. This during the upload process: damaged. Check the iPro2 recorder connector message may also appear if pins for moisture, damage, or corrosion. For No device was detected the iPro2 recorder assistance in locating the connector pins, see connected to the iPro2 connector pins are the iPro2 System User Guide. Dock. Please check that damaged or corroded, or if the device is properly there is moisture in the • If the iPro2 recorder connector pins are seated in the iPro2 Dock. connector opening. damaged or corroded, the iPro2 recorder cannot communicate with the Dock or CareLink software. Contact your local representative or helpline. It may be time to replace the iPro2 recorder.

• Disconnect the iPro2 recorder and reconnect it to the Dock. Allow the iPro2 recorder to charge for 20 minutes. The green charging light may The CareLink uploader flash at first, but if the red warning light turns displayed this message on again, check the iPro2 recorder connector during the upload process: pins for moisture, damage, or corrosion. For iPro2 recorder battery assistance in locating the connector pins, see The iPro2 recorder battery power too low for the iPro2 System User Guide. may be reaching the end communications. Please • If the red warning light continues to turn on, of its life. However, this wait for the battery to perform a reset as described in the iPro2 System message may also appear if charge. This may take User Guide. Please note that if you saw this error the iPro2 recorder several minutes. message in the CareLink uploader, the recent connector pins are patient data was successfully uploaded, but you damaged or corroded, or if The red warning light on may wish to confirm this before performing the there is moisture in the the Dock is on. reset. If the Dock displays a solid green charging connector opening. light, the reset was successful. • If the iPro2 recorder connector pins are ! damaged or corroded, or the Dock still displays a red warning light for the iPro2 recorder after the reset, contact your local representative or helpline. It may be time to replace the iPro2 recorder.

CareLink Software — User Guide Troubleshooting 51 CareLink uploader error messages with iPro2 Problem Possible causes Next steps • Disconnect the iPro2 recorder and reconnect it to the Dock. Charge the iPro2 recorder for 20 minutes. If the Dock displays a solid green charging light, the reconnection was successful. • If the green charging light flashes at first, and The CareLink uploader then the red warning light turns on, check the displayed this message iPro2 recorder connector pins. For assistance in during the upload process: locating the connector pins, see the iPro2 Possible damage to iPro2 System User Guide. recorder circuitry. Please There may be moisture, • If you do not find any problems inside of the refer to the User Guide damage, or corrosion in connector opening, and the green charging for assistance. the iPro2 recorder light never remains solid without flashing when connector opening, or the you connect the iPro2 recorder to the Dock, The red warning light on iPro2 recorder may need to the Dock is on. perform a reset as described in the iPro2 System be reset. User Guide, and charge the iPro2 recorder for one hour. Please note that if you saw this error message in the CareLink uploader, the recent ! patient data was successfully uploaded, but you may wish to confirm this before performing the reset. If the Dock displays a solid green charging light, the reset was successful. • If the red warning light continues to turn on, contact your local representative or helpline. It may be time to replace the iPro2 recorder.

• Disconnect the iPro2 recorder and reconnect it to the Dock. Charge the iPro2 recorder for 20 minutes. If the Dock displays a solid green charging light, the reconnection was successful. • If the green charging light flashes at first, and The CareLink uploader then the red warning light turns on, check the displayed this message iPro2 recorder connector pins. For assistance in during the upload process: locating the connector pins, see the iPro2 Possible damage to iPro2 System User Guide. recorder battery. Please There may be moisture, • If you do not find any problems inside of the refer to the User Guide damage, or corrosion in connector opening, and the green charging for assistance. the iPro2 recorder light never remains on without flashing when connector opening, or the you connect the iPro2 recorder to the Dock, The red warning light on iPro2 recorder may need to the Dock is on. perform a reset as described in the iPro2 System be reset. User Guide, and charge the iPro2 recorder for one hour. Please note that if you saw this error message in the CareLink uploader, the recent ! patient data was successfully uploaded, but you may wish to confirm this before performing the reset. If the Dock displays a solid green charging light, the reset was successful. • If the red warning light continues to turn on, contact your local representative or helpline. It may be time to replace the iPro2 recorder.

The CareLink uploader displayed this message when initiating an iPro2 There may be multiple upload: Disconnect all Docks except the one containing the iPro2 Docks attached to iPro2 recorder to upload and try again. More than one iPro2 the computer. Dock is connected to the computer. Please connect only one iPro2 Dock.

CareLink Software — User Guide Troubleshooting 52 CareLink uploader error messages with iPro2 Problem Possible causes Next steps • Disconnect the iPro2 recorder and reconnect it to the Dock. Charge the iPro2 recorder for 20 minutes. If the Dock displays a solid green The CareLink uploader charging light, the reconnection was successful. displayed this message • If the green charging light flashes at first, and during an iPro2 upload: then the red warning light turns on, check the The iPro2 recorder data iPro2 recorder connector pins. For assistance in could not be cleared. locating the connector pins, see the iPro2 Check the patient record System User Guide. to ensure that the data The iPro2 recorder battery • If you do not find any problems inside of the has been received by the may be damaged. connector opening, and the green charging CareLink software. You light never remains on without flashing when may reset the iPro2 you connect the iPro2 recorder to the Dock, recorder using the iPro2 perform a reset as described in the iPro2 System Dock. For instructions on User Guide, and charge the iPro2 recorder for how to reset the iPro2 one hour. Please note that if you saw this error recorder, refer to the message in CareLink software, the recent User Guide. patient data was successfully uploaded, but you may wish to confirm this before performing the reset. If the Dock displays a solid green charging light, the reset was successful.

The iPro2 recorder contains no patient evaluation data. One of several events may have occurred: The CareLink uploader The reset button on the displayed this message iPro2 recorder was pressed. during an iPro2 upload: The recorder data has • Confirm the correct iPro2 recorder has been The iPro2 recorder does already been read and uploaded. not contain any patient loaded into CareLink iPro. evaluation data. Please The recorder data is • If you are uploading the correct iPro2 recorder, verify that the correct intentionally cleared by the confirm that the current evaluation was not iPro2 recorder is CareLink uploader already uploaded, as the data would have been connected to the application after the iPro2 erased upon a successful upload. You may want computer. If this iPro2 recorder is successfully to check to confirm the upload occurred in the recorder has been reset read and accepted by correct patient record. using the iPro2 Dock CareLink. reset button, then all data has been cleared. The iPro2 recorder has not been used in an evaluation. The iPro2 may be a new device or mistaken for another device that was used in an evaluation.

CareLink Software — User Guide Troubleshooting 53 Glossary

A1C - Glycosylated hemoglobin Area Under the Curve (AUC) - Indicates the amount in high and low excursions as determined by preset values. Excursion data indicates the frequency of highs or lows. AUC indicates the magnitude of events by showing how far out of range and for how long. Average Sensor Glucose (Avg SG) - This value is the average of all sensor glucose values during the 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 readings when using iPro2. Docking station (Dock) - Device that performs two functions: uploading glucose sensor data from an iPro2 recorder to CareLink software; and charging the iPro2 recorder. The Dock can be connected to a computer or to an electrical socket. Envision recorder - Disposable device that continuously records sensor glucose data while connected to a glucose sensor. The recorder receives and sends data to the Envision Pro app to be 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 glucose sensor and iPro2 or Envision Pro recorder. This word also refers to an upload of glucose sensor data from an iPro2 or Envision Pro recorder into CareLink software, along with any Logbook events and meter data uploaded from an iPro2 recorder. Each evaluation has its own set of reports. HCP - Health Care Professional iPro2 digital recorder (iPro2 recorder) - Device that continuously records sensor glucose data while connected to a glucose sensor. You can upload the data to CareLink software by connecting 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 also displays BG meter readings, and possibly other events, which you upload from a supported blood glucose meter into CareLink software when using iPro2. Mean Absolute Difference % (MAD%) - Represents the level of accuracy in calibration of the sensor to BG meter readings. The lower this number, the greater the calibration accuracy. MAD % is calculated by taking the difference between closely occurring pairs of sensor glucose and BG meter readings, dividing by the BG meter reading, and then averaging across all pairs.

CareLink Software — User Guide Glossary 54 Mean Absolute Difference (MAD) - Represents the level of accuracy in calibration of the sensor to BG meter readings. The lower this number, the greater the calibration accuracy. MAD is calculated by taking the difference between closely occurring pairs of sensor glucose and BG meter readings and then averaging across all pairs. Meter - A for determining the approximate concentration of glucose in the blood. A small drop of blood is placed on a disposable test strip, which the meter reads and uses to calculate the blood glucose level. The meter then displays the level in 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 deleting user accounts 48 editing Logbook events 15, 24 editing patient information 46 accessing entering blood glucose data 15, 23 Logbook screen 14, 23 excluding BG meter readings 24 accessing patient records 13, 19 excluding Logbook events 16 activity, entering in Logbook 15, 23 exporting data 30 adding ongoing use, administrator tasks 47 Logbook events 15, 23 ongoing use, user tasks 46 administrative user opening patient records 13, 19 creating first 5 patient report settings 28 deleting user accounts 48 printing reports 27 modifying user accounts 47 removing Logbook events 15, 24 tasks in CareLink software 47 reports 26, 27 Analysis reports restoring default patient report settings 29 about 27 software setup 4 settings 7 sorting Logbook events 16, 25 area under the curve 28 uploading meter data 22 assistance 3 viewing reports 27 AUC 28 clinic registration 5 clinic report settings 6 B common tasks in CareLink software administrator tasks 47 Back button regular user tasks 46 Internet Explorer secure setting 9 computer system requirements 2 BG meter readings, excluding from correcting Logbook events 24 calibration 24 creating blood glucose meter CSV file 30 uploading data 22 Data Table report 30 blood glucose meter readings user accounts 5 entering in CareLink software 14, 23 CSV file export 30 browser required settings 9 D supported browsers 2 Daily Overlay report, about 27 C Daily Summary report, about 27 daily use calibration, improving 24 common tasks in CareLink software 46 CareLink software managing users in CareLink software 47 about uploading data 12, 17 data adding Logbook events 15, 23 exporting to CSV 30 changing password or user information 46 log sheets, entering 14, 23 Data Table report 30 uploading blood glucose meter 22 Data Table report, generating 30

CareLink Software — User Guide Index 56 default report settings 6 Logbook deleting adding events 15, 23 user accounts 48 editing events 15, 24 deleting Logbook events 15, 24 entering data 14, 23 excluding BG meter readings 24 E excluding events 16 opening 14, 23 removing events 15, 24 editing sorting events 16, 25 CareLink software users 47 Logbook events 15, 24 enrolling clinic 5 M entering log sheet data 14, 23 equipment log Mac setup, meter uploads 20 printing new copies 9 meals, entering in Logbook 15, 23 Excel data export 30 medication, entering in Logbook 15, 23 excluding meter Logbook events 16 excluding meter readings 24 excluding BG meter readings 24 uploading data 22 excluding Logbook events 16 modifying exercise, entering in Logbook 15, 23 clinic information 47 exporting data 30 Logbook events 15, 24 patient report settings 28 F user accounts 47 moving a patient study 46 first time setup software setup 4 O frequently asked questions 49, 50 office registration 5 G opening Logbook screen 14, 23 patient record 13, 19 general report settings 7 operating system requirements 2 generating CSV file 30 Data Table report 30 P glucose units system default setting 6 password, CareLink software 46 patient information, editing 46 I patient instructions sheet printing new copies 9 patient log sheet installation of software 18 printing new copies 9 Internet browser, required settings 9 patient records Internet Explorer opening 13, 19 back button 9 patient report settings 28 secure setting 9 patient return visit 12, 17 secure browser setting 9 patient study iPro2 recorder moving a patient study 46 computer setup 18 previewing reports 27 printing reports 27 J R Java installation 18 JavaScript, enabling 9 registering clinic 5 removing L CareLink software users 48 Logbook events 15, 24 log sheets entering data 14, 23

CareLink Software — User Guide Index 57 report settings uploading data clinic 6 about 12, 17 general 7 user accounts restoring default, patient settings 29 creating 5 reports deleting 48 about 26, 27 modifying 47 Analysis 27 Analysis Reports Settings 7 V area under the curve (AUC) 28 clinic report settings 6 CSV file 30 viewing Daily Overlay 27 Logbook events 16, 25 Daily Summary 27 patient reports 27 Data Table 30 General Report Settings 7 patient report settings 28 printing 27 restoring default patient report settings 29 viewing 27 reports settings Analysis 7 required browser settings 9 enabling JavaScript 9 resources, downloading and printing 9 restoring default patient report settings 29 S

Secure browser setting for Internet Explorer 9 setting clinic report settings 6 setting up computers for uploading 18 setup CareLink software 4 clinic 5 computers for uploading 18 user accounts 5 software drivers 18 software installation 18 software requirements 2 sorting Logbook events 16, 25 spreadsheet data export 30 support, software requirements 2 system requirements, computer 2 T target glucose range, setting system default 6 time display, setting system default 6 troubleshooting about 49 CareLink software 51 Data Table report 30 troubleshooting reference table 49, 50 U uploading meter data 22

CareLink Software — User Guide Index 58