User Guide THERAPY MANAGEMENT SOFTWARE FOR DIABETES
6025179-014_b REF MMT-7335 © 2010 Medtronic MiniMed, Inc. All rights reserved. REAL-Time Revel™ is a trademark of Medtronic MiniMed, Inc. Paradigm®, Paradigm Link®, Guardian REAL-Time®, CareLink®, and Bolus Wizard® are registered trademarks of Medtronic MiniMed. BD Logic® is a registered trademark of Becton, Dickinson and Company.
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Contents Chapter 1 Chapter 2 1 Introduction 1 2 2 2 3 5 5 6 Features Security Related documents Assistance Supported devices Ordering How to use this guide User safety 8 Navigating the system 8 8 9 9 10 Opening CareLink Pro Workspaces Toolbar Patient tabs The Guide Me feature 10 Chapter 3 Turning Guide Me on and off 11 Getting started 11 11 12 12 13 13 15 15 16 16 16 Before you begin Primary system tasks Opening patient records Closing patient records Setting system preferences General pref
16 17 17 17 18 18 20 20 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Patient Lookup preferences Choosing data to display Changing the column order Finalizing patient lookup preferences Report Generation preferences Choosing data to display Changing the column order Finalizing report generation preferences 21 Profile workspace 21 22 22 Before you begin Adding new profiles Editing patient profiles 22 23 Deleting patient data from the system Linking to CareLink Personal 26 Hardware setup 26 Connectin
Chapter 8 46 46 46 46 47 Sensor and Meter Overview Report Logbook Report Device Settings Snapshot Daily Detail Report Exporting data 48 System administration 48 49 49 49 49 50 Applying software updates Turning off automatic updates Manually checking for updates Backing up and restoring the database Backing up the database Restoring the database 50 Chapter 9 When the system is unavailable 51 Troubleshooting 51 51 52 52 53 53 53 General application use errors Not connected to the database Forgot
CareLink Pro User Guide Contents viii
1 Introduction Thank you for choosing Medtronic Diabetes as your partner in helping you and your patients better manage diabetes therapy. We believe you will benefit from CareLink® Pro software’s leading edge technology and simple, menu-driven user interface. CareLink Pro allows you to acquire, store and report patient treatment and diagnostic data.
• There is a Guide Me feature to help users who are new to CareLink Pro. It gives hints and tips about the tasks they are performing. • An integrated help system is available throughout the software to provide information on specific areas of interest. Security • CareLink Pro can be password protected. • Transmission of patient data from CareLink Personal is encrypted using industry-standard Secure Sockets Layer (SSL) technology.
Supported devices CareLink Pro gets data from the following devices. NOTE: Some devices supported by this software may not be available in all countries where this software is approved for use.
Manufacturer Abbott: Roche: Blood glucose meters • Precision Xtra™ • TheraSense FreeStyle® • FreeStyle Flash™ • FreeStyle Papillon™ mini • FreeStyle Mini™ • Optium Xceed™ • Precision Xceed™ • Accu-Chek® Aviva • Accu-Chek® CompactPlus • Accu-Chek® Compact • Accu-Chek® Active Communication devices Com-Station For use with the Medtronic MiniMed 508 Pump. (See the Com-Station User Guide for details about the required hardware.
If your patient uses one of these devices • Bayer Ascensia® DEX® 2 • Bayer Ascensia® DEXTER-Z® II Select this device Bayer Ascensia® DEX® Bayer Glucometer ELITE® XL Bayer Ascensia ELITE™ Precision Xceed™ Optium Xceed™ Ordering To order Medtronic Diabetes products, visit the Medtronic Diabetes website at www.medtronicdiabetes.com or contact one of the following: • (800) 646-4633 • (818) 362-5958 NOTE: Meters can be ordered from their respective companies.
Term/style Meaning CAUTION: Alerts you of a potential hazard which, if not avoided, may result in minor or moderate damage to the software program or equipment. WARNING: Notifies you of a potential hazard which, if not avoided, could result in death or a serious injury. It may also describe potential serious adverse reactions and safety hazards. User safety Indications for use The CareLink Pro system is intended for use as a tool to help manage diabetes.
• CareLink® Personal software (7333) • Solutions® Software for CGMS®iPro (7319) CareLink Pro User Guide Introduction 7
2 Navigating the system Before working with the CareLink Pro software, you should get acquainted with the user interface. The user interface includes menus, a toolbar, a navigation bar, workspaces, and a Guide Me window. Opening CareLink Pro 1 Double-click the CareLink Pro icon on your computer desktop, or select Medtronic CareLink Pro from the Programs list on your Windows Start menu. If your clinic requires you to enter a password, the login screen is displayed. a.
Profile: Allows you to maintain such patient information stored as name and date of birth. This workspace also allows you to link to a patient’s CareLink Personal account. Devices: Allows you to store information required to read a patient’s devices. Reports: Allows you to select parameters and choose reports to be generated for the patient. Until a profile is added and saved for a patient, only the Profile workspace is accessible for that patient.
The Guide Me feature A Guide Me feature is provided throughout CareLink Pro. It opens a window with context-aware hints and tips for actions you might take from the part of system that is active. Guide Me windows might also include >>learn more links. When clicked, these links take you to the relevant section in the online help for more details. The Guide Me feature is enabled by default. However, you can turn it off at any time.
3 Getting started The following information will guide you through starting the CareLink Pro software, opening and closing patient records, and setting preferences that apply to all patients in the system. Before you begin If this is the first time you are using CareLink Pro, you should be sure to set the General preferences (see General preferences on page 13).
Step Location Regularly back up the CareLink Pro database. Backing up the database on page 49 Update the CareLink Pro software. Applying software updates on page 48 Opening patient records As many as six patient records can be open at one time. If you have not yet created any patient profiles, see Adding new profiles on page 22. 1 Select File > Open Patient, or click the Open Patient button. A patient list similar to the following is displayed.
2 Do one of the following: a. Select File > Close Patient. b. Click the Close button on the patient tab. c. Press Ctrl+F4. Setting system preferences These preferences apply to all patients in the system. For preferences that affect only individual patients, see Verifying report settings on page 42.
2 Select Tools > Options. The following window is displayed. 3 Click to select the option button for the value you want: - Glucose Units: mg/dL or mmol/L - Carbohydrate Units: grams or Exchanges a. If you selected Exchanges for Carbohydrate Units, type the appropriate number in the grams are equal to 1 Exchange field. 4 Click to select or clear the check box in the Chart Options > Overview Report section.
6 Click to select or clear the check box in the Troubleshooting section. If the check box is selected, the application will save a record of device reads for troubleshooting purposes. 7 Click OK to save the General preferences. Patient profile preferences This is a global setting that defines the content of your profiles. You can customize fields in the Profiles workspace to include information that is most important to your clinic.
Adding a custom field 1 Select the check box to the left of an empty custom field. 2 Enter text to name the field (for example, Emergency Contact). This is the field name that will display on the patient profile. 3 To make the field required, select the check box in the Required column. NOTE: To remove a custom field from the profile, clear the check box next to the field(s) you want to remove.
2 Click the Patient Lookup tab. The following window is displayed. NOTE: Use the check boxes to choose the data you want on the Patient Lookup table. Use the up and down arrows to put the columns in order. Choosing data to display Use the check boxes to select the type of data you want to display, or to clear data you do not want to display on the Patient Lookup table.
Report Generation preferences The Data Table appears in the Select and Generate Reports window. This table is used during reporting. It contains daily information derived from your patient’s devices and, if applicable, their CareLink Personal software account. The data provided in this table helps you determine which days require a Daily Detail report. It also helps you decide which of the other reports you should run.
Column Name Definition № of Meter Readings The amount of readings for the specified date that were recorded by the included devices. Meter Readings Average The average of the glucose readings recorded by the included devices. Sensor Duration The amount of time within the specified date for which sensor date was recorded. Values are -- (none), 0:05 - 24:00. Sensor Average The average of sensor readings recorded in the specified date.
Column Name Definition № of Meal Boluses The number of bolus wizard events with carbohydrate amounts greater than zero that were recorded on the specified date. № of Correction Boluses The number of bolus wizard events with correction amounts greater than zero that were recorded on the specified date. № of Manual Boluses The number of bolus events recorded during the date, which were not bolus wizard events.
4 Profile workspace A profile is similar to the cover page of a medical chart. It stores patient data such as name and date of birth. A profile is required before device data can be gathered and used for therapy reports. The Profile workspace also allows you set up a link to a patient’s CareLink Personal account. Once the link is established, you can retrieve patient data stored on CareLink Personal anytime— without the need to have the patient present.
Also, a username and password is required when you set up the link to a patient’s CareLink Personal account. The patient must be present to supply this data. Adding new profiles Each time you add a patient to the CareLink Pro system, you must start by filling out a profile for them. 1 Select File > New Patient, or click the Add Patient button. The Profile workspace is displayed. NOTE: To add or change fields on the patient profile, click customize fields. See Patient profile preferences on page 15.
2 Verify that this is the patient you want to delete. Deleting a patient profile also removes all of their data from the CareLink Pro database and cannot be undone. 3 Click >> delete patient record above the synchronization section of the profile. A message is displayed to alert you that all of the patient’s data will be erased when you delete the record. 4 Click Yes to delete the patient’s record.
7 If needed, print the Terms of Use for the patient by clicking the Print button. You are now linked to the patient's CareLink Personal account. Sending an e-mail invitation To send an e-mail inviting a patient to establish a CareLink Personal account, follow these steps: 1 Open the patient’s Profile workspace. 2 Make sure all required fields in the Patient Profile section are filled in. 3 Click SEND E-MAIL INVITATION TO PATIENT.
NOTE: If the patient no longer wants to share their CareLink Personal data, a message displays to let you know. 3 Any additional data retrieved from CareLink Personal will show up in the patient’s reports. Unlinking a patient’s CareLink Personal account from CareLink Pro You can unlink a patient’s CareLink Personal account from CareLink Pro. This option is only available after a patient has been linked.
5 Hardware setup To read data directly from a device, you must have the patient's device, and any cables or communications devices required to transfer the data to your computer. Alternatively, if the patient has uploaded their device data to their CareLink Personal account, you can obtain the data by linking to their account. To link to a patient's CareLink Personal account, see Linking to CareLink Personal.
Overview of hardware setup The following example shows the CareLink USB being used to communicate between the pump and the computer.
Optional ComLink for use with the Paradigm series pump: Optional Com-Station for use with the Medtronic MiniMed 508 pump CareLink Pro User Guide Hardware setup 28
6 Devices workspace Information that you will need to read a patient’s device, such as the make, model and serial number, is stored in The Devices workspace. Thus, you do not have to supply it each time you read data from the device. Devices on the Devices workspace are stored in one of two lists—Active Devices or Inactive Devices. When you add a device, it is automatically placed on the Active Devices list. You can only read data from devices displayed in the Active Devices list.
Before you begin Before you can open the Devices workspace for a patient, they must have a profile saved in the system. See Chapter 4, Profile workspace. To add a device or read data directly from it, the device must be communicating with the computer. See Chapter 5, Hardware setup to learn how to set up devices to communicate with the computer. Adding a device You can get data from the patient’s CareLink Personal account for a device not yet added.
NOTE: The pump model is listed on the back of the pump or on the pump status screen. 6 Select the option button to specify the device you are adding. If you selected the MiniMed 508 pump option, go to Step 9. 7 Click NEXT. The Serial Number page is displayed. NOTE: An error message is displayed if you do not enter the correct serial number. Check the examples on this page, and verify that you are entering the correct characters from the back of the pump. If necessary, re-type the six characters.
10 Click the Choose Port drop-down menu, and select the port that the ComLink, Paradigm Link®, CareLink USB, or Com-Station connects to on your computer. If you are not sure which port to choose, select Auto Detect (or USB). 11 Click NEXT. The Test Connection page similar to the following is displayed. 12 Follow any device instructions, and click TEST. A message displays to let you know if the connection was successful. If it was, go to the next step.
5 Select Blood Glucose Meter. The Add Blood Glucose Meter Wizard is displayed. 6 Click the option button to select the correct brand of meter. 7 Click NEXT. The Meter Model page is displayed (this page differs depending on the meter manufacturer). 8 Click to select the meter model you are adding.
9 Click NEXT. The Communication Options page is displayed. NOTE: Only those choices that are valid for the meter you are adding are available for selection. 10 Click the Choose Port drop-down menu, and select the port that the ComLink, Paradigm Link, or CareLink USB connects to on your computer. If you are not sure which port to choose, select Auto Detect (or USB). 11 Click NEXT. The Test Connection page is displayed. 12 Follow the instructions given for the meter, and click TEST.
A message displays to let you know if the connection was successful. If it was, go to the next step. If not, make sure the hardware between the device and the computer is connected properly. Also, click BACK on the wizard to make sure the data you have entered is correct. 13 Click DONE. The meter is added to the patient’s Active Devices list. Making a device active or inactive Patient devices can be moved between the Active Devices list and the Inactive Devices list as needed.
4 Click >> delete this device under the device you want to delete. A message is displayed to alert you that the device and all of its data will be removed from the patient’s record. 5 Click YES to delete the device. The device and its data is removed from the Devices workspace and from the CareLink Pro system. Data from this device is no longer available for use in reports. Reading device data One way to get device data is to link to the patient’s existing CareLink Personal account.
WARNING: Please cancel or finish any temp basals or active boluses, and clear any active alarms. The pump will be suspended for reading. Once the read is complete, please verify the pump has resumed. CAUTION: Do not use the pump remote when the pump is being read. If the pump battery is low, the pump will not send data to the PC. Replace the battery if the status indicates battery power is low. 1 Click the patient’s tab or double-click their name on the Patient Lookup table.
7 Reports workspace CareLink Pro software provides a variety of reports to help you better manage your patients' diabetes treatment. The information contained in each report is based on data you obtain from a patient's devices and their CareLink Personal software account. Reports can be generated on screen, sent directly to a printer, or saved as TIFF or PDF files that you can attach to an Electronic Medical Record (EMR). You can generate several report types through a single operation.
Before you begin If you have a period of time you want reflected in a report, you must have a patient’s device data for that time period. You may also need to have the patient’s device connected to the computer to get current data before running reports. Be sure to take a close look at the Verify Report Settings step before running a report. This is where you can fine tune a report to capture the patient data you want.
The blue bars represent device data. The orange bar represents the reporting period that you selected. Overlap in the device data and reporting period means you have data for some or all of the displayed reporting period. The data calendar area initially displays the most current three months. To see other months, click the arrow buttons on either end of the months.
3 If the bars do not overlap, or there is not enough overlap, you have a few choices: - Adjust the reporting period. - Get additional device data. Getting additional device data 1 To get more data from a device, click the READ DEVICE button associated with the device. The Read Device bar is displayed. WARNING: Please cancel or finish any temp basals or active boluses, and clear any active alarms. The pump will be suspended for reading. Once the read is complete, please verify the pump has resumed.
7 Click OK. Device data is now visible within the data calendar. 8 Click NEXT at the top of the Reports workspace. The Verify Report Settings step is displayed. This allows you to make sure the settings for this patient are correct before you run the report(s). Verifying report settings 1 Make sure the Glucose Target settings are at the desired values. Type in these values, or click the up or down arrows in the Low and High fields to raise or lower the values.
NOTE: Meal periods cannot overlap, but start and end lines can border one another. Meal periods must be at least 60 minutes in length. 4 To use the settings from this meal for all of the patient’s other meals, make sure the check box next to Use these parameters for all of this patient’s meals is selected. 5 After you finish creating or editing a meal period, click SAVE. 6 To remove a meal period, click DELETE MEAL. Click DELETE when asked to confirm.
2 If data has been read from a pump or Guardian monitor more than once during this reporting period, there may be multiple device snapshots: a. Make sure the check box is selected next to Device Settings Snapshot. b. Click the drop-down arrow and select a snapshot date and time. - Pumps: Select a snapshot from the patient’s pump. - Guardian: Select a snapshot from the patient’s Guardian monitor. If either field is dimmed, there are no snapshots available during the reporting period.
• Report header — The report header contains identifying information, such as the name of the report, the patient's name, and the source of the data. • Carbohydrates and blood glucose levels — Within the graphs and charts, carbohydrate units are displayed in italics and blood glucose levels are displayed in bold. • Weekend data — Weekend days are in bold so you can easily identify them. • Legends — A legend of symbols appears at the bottom of each report.
Adherence Report The Adherence Report presents data that describes how insulin pumps and sensors are used and the patient’s behavior relevant to their therapy. It answers the question, “Was there enough data to provide an accurate picture of how the patient uses their insulin pump and sensor, if applicable” It also answers the question, “Do patients adhere to the therapy as instructed?” It also indicates whether you may need to speak to your patient about the way they are managing their diabetes.
Exporting data You can export device data that is acquired and stored by CareLink Pro. This gives you all of a patient’s device data to use for statistics or the creation of specialized reports or charts. The .csv file can be imported into Microsoft Excel or certain clinical statistics programs where you can further manipulate the data. The .csv file contains data recording the actions of the device.
8 System administration It is important that you regularly back up the CareLink Pro database. The database stores all system data that has accumulated in your patient’s records, including profile information, devicederived data, and report settings. It is also important that you have the latest version of CareLink Pro. Updated versions are available periodically, and may contain important enhancements. You can choose to search for updates or to be notified when they are available.
5 To begin using the latest version of CareLink Pro, click YES to close and re-open the software application. Click NO if you would prefer to wait before re-starting CareLink Pro. Turning off automatic updates If you do not want to receive automatic notification of CareLink Pro updates, follow these steps: 1 Select Tools > Options. 2 Click the General tab. 3 Under the Communications section, clear the check box next to Automatically check for software updates.
3 Navigate to the location on your computer where you want to save the backup file. If you want to change the name of the backup file, type it into the File name box. 4 Click Save. A progress bar is displayed while the database is saved. A message is displayed when the backup is complete. 5 Click OK to close the message. Restoring the database The current database may need to be replaced if it can no longer be accessed or used.
9 Troubleshooting This topic is designed to help you solve issues that may occur while using CareLink Pro software. It also contains instructions for uninstalling the CareLink Pro software if necessary. General application use errors If you try to download a software upgrade over the Internet, you may receive the message that you do not have sufficient privileges to do so. You must have administrative privileges to download CareLink Pro software upgrades.
Forgot the clinic password for CareLink Pro If no one can remember the password your clinic uses to log in to CareLink Pro, the CareLink Pro software must be re-installed, and a new database created. Once you re-install the software, you will not be able to access any patient information that was in the previous database. Store the password that you created during the new installation somewhere in the office so that you will not lose future data.
Error Explanation This pump is delivering a bolus. Please cancel the bolus or wait until it completes, and then try again. The pump you are attempting to read is delivering a bolus. Either wait until the bolus completes to read the pump, or cancel the bolus and then read the pump. The device returned invalid entries; all data read will be discarded. Contact the 24 Hour HelpLine (see Assistance on page 2).
2 Select Add or Remove Programs.The Windows Add or Remove Programs window is displayed. 3 Scroll down to Medtronic CareLink Pro and click on it. 4 Click Remove. The Install Shield Wizard is displayed. 5 Click Next. A message is displayed asking you to confirm that you want to remove the application. 6 Click Yes. The uninstall program runs and removes the program and all of its files from your computer. When it is done, a message displays on the wizard screen confirming the uninstall.
10 Icon table The icons and symbols on the packaging labels and the equipment are described in the following table: Description One per container/package Icon (1X) CD enclosed Attention, see instructions for use Date of manufacture (Year) Catalogue number Conformité Européene (European Conformity). This symbol means that the device fully complies with MDD 93/42/EEC and R&TTE Directive 1999/5/EC.
A CSV data When you export report data from the CareLink Pro software, it is exported into a .csv file. This file can then be imported into a spreadsheet application, such as Microsoft Excel. See the CSV file column definitions for a complete listing of the data that can be contained in a CSV file. The CSV file contains the name and Patient ID for the patient, the reporting period, and identifies each device included in the report.
Column heading Definition Bolus Volume Selected (U) The number of units of insulin selected to be delivered during the bolus insulin delivery. Bolus Volume Delivered (U) The number of insulin units actually delivered during the bolus insulin delivery. Programmed Bolus Duration (h) Duration of a square bolus or the square portion of a dual wave bolus. Prime Type Manual or fixed. Manual is used just after a rewind, to fill the infusion set tubing with insulin before inserting it.
Column heading Definition Sensor Glucose (mg/dL or mmol/L) The sensor glucose value. ISIG value Input signals (ISIG), being read from the sensor, measured in nanoamperes (nA).
Glossary A1c - Glycosylated hemoglobin A1c Test - Hemoglobin A1c test, used to interpret blood glucose level over a period of time. Area Under the Curve (AUC) - Indicates the amount in high and low excursions as determined by preset values. Excursion data indicates the frequency of highs or lows. AUC indicates the magnitude of events by showing how far out of range and for how long. Audio bolus - The pump can be programmed so the user hears a beep when they select a bolus insulin amount (0.5 or 1.
Carb units - The food entry when using the Bolus Wizard. Entered as (carbohydrate) grams or exchanges. CareLink® Personal - An online service that allows management of diabetes data via the Internet. CH - Carbohydrate ComLink - A radio frequency (RF) transceiver device used to download Paradigm pump data to the computer. Com-Station - A device used to download MiniMed 508 pump and pass-through third-party meter data to the computer.
(2) It is also used in this system to refer to hypertext links. When clicked on, hypertext links take you to another place in the system or to another Web site. Low Glucose - The pump will alarm if the sensor indicates that the user’s sensor glucose is at or below this value. You have the option to turn this feature on or off.
Index A about reports 44 Adherence report 46 Daily Detail report 46 Dashboard and Episode Summary 45 Device Settings Snapshot 46 Logbook report 46 Sensor & Meter Overview report 46 activating devices 35 adding a device to the system 30 adding a Guardian monitor to the system 30 adding a meter to the system 32 equivalent meter names to choose 4 adding a patient 22 adding a patient’s device to the system Guardian monitor 30 meters 32 pumps 30 adding a pump to the system 30 Adherence report about 46 B backing
selecting report types and inclusion dates 43 selecting the reporting period 39 verifying report settings 42 CSV files exporting device data to 47 D Daily Detail report about 46 Dashboard and Episode Summary about 45 data communications cable 4 data communications cable supported 5 database copying for backup 49 restoring with backup copy 50 deleting a patient’s device from the system 35 device data getting data from CareLink Personal 24 getting it from a patient’s device 36 linking to CareLink Personal 23
patient lookup preferences, changing column order 17 patient profile preferences 15 patient profile preferences, adding a custom field 16 patient profile preferences, changing field order 16 patient profile preferences, choosing data fields 15 report generation preferences, changing column order 20 report generation preferences, choosing data 18 understanding 13 glucose meters supported 3 glucose meters supported by CareLink Pro 3 Guardian monitor adding to the system 30 Guardian monitors inactivating 35 Gu
open patient preferences setting 17 choosing data 17 opening reports workspace 39 opening CareLink Pro 8 entering your password 8 logging in 8 opening patient profiles 12 optional devices for communicating with computer 28 ordering devices 5 Medtronic MiniMed products 5 meters 5 Paradigm Link 5 pumps 5 overview of CareLink Pro 1 P Paradigm Link ordering 5 password entering for CareLink Pro 8 patient lookup preferences setting 17 changing column order 17 patient profile preferences setting 15, 16 adding a c
reporting period selecting 39 reports about 45, 46 Adherence report 46 Daily Detail report 46 Dashboard and Episode Summary 45 Device Settings Snapshot 46 Logbook report 46 Sensor & Meter Overview report 46 creating 39, 40, 41, 42, 43, 44 checking for device data 40 getting new device data 41 opening the reports workspace 39 previewing 44 printing 44 saving 44 selecting devices 40 selecting report types and inclusion dates 43 selecting the reporting period 39 verifying settings 42 creating your own 47 previ
user interface Guide Me 10 navigating 8 toolbar 9 user safety contraindications 6 indications for use 6 warnings 6 V verifying report settings 42 W warnings 6 workspaces 8 CareLink Pro User Guide Index 67
