Medtronic MiniMed Solutions Pumps & Meters Software. Model MMT-7311 Version 7.0

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1 Medtronic MiniMed Solutions Pumps & Meters Software Model MMT-7311 Version 7.0

2 2005, Medtronic MiniMed. All rights reserved. Paradigm Link is a trademark of Medtronic MiniMed. Paradigm is a registered trademark of Medtronic MiniMed. Com-Station is a trademark of Medtronic MiniMed. ComLink is a trademark of Medtronic MiniMed. BD and BD Logic is a trademark of Becton, Dickinson and Company Glucometer Elite XL is a registered trademark of Bayer Corporation. Glucometer DEX is a registered trademark of Bayer Corporation. Glucometer DEX 2 is a registered trademark of Bayer Corporation. Ascensia is a trademark of Bayer Corporation. One Touch Profile is a registered trademark of Lifescan Inc. One Touch Ultra is a registered trademark of Lifescan Inc. One Touch FastTake is a registered trademark of Lifescan Inc. Accu-Chek Complete is a registered trademark of Roche Diagnostics Corporation. Accu-Chek Advantage is a registered trademark of Roche Diagnostics Corporation. FreeStyle is a trademark of TheraSense. Precision Xtra is a trademark of MediSense. Adobe Acrobat is a registered trademark of Adobe Systems Incorporated. Microsoft Windows 98SE, Microsoft Windows NT 4.0, Microsoft Windows 2000, Microsoft Windows Millennium Edition, and Microsoft Windows XP are registered trademarks of Microsoft Corporation. Palm Handhelds is a trademark of Palm Inc. Hotsync is a registered trademark of Palm Inc. U.S., international, and foreign patent applications are pending

3 Contents Chapter 1: Introduction... 1 Insulin pumps that work with this software... 1 Blood glucose meters that work with this software... 1 Assistance... 2 CD handling instructions... 2 Indications for use... 2 Contraindications... 2 Warnings... 2 Notes... 3 To Install the BD meter USB cable on Windows 98SE... 3 PC connections... 4 Optional components... 5 Meter options... 6 Chapter 2: Getting started...7 Main screen... 8 Using the software... 9 Menu bar with no file open... 9 Menu bar with file open... 9 Setup preferences General tab Customizing your settings Setting initial report display Setting initial report range Setting glucose units Setting time display Setting new patient time periods Reports tab Setting printing styles Clinic info tab Create a new patient record Analysis time periods Glucose range limits Patient information screen Patient records list To select a patient for downloading To edit an existing patient record i

4 ii To delete an existing patient record Chapter 3: How to work with files Opening patient files Opening previous version files Saving patient files Renaming patient files Printing To print current report Reports listed on the left side of the window Reports listed on the right side of the window To print selected reports Reports listed on the left side of the window Reports listed on the right side of the window To print a specific date range Chapter 4: Downloading your data Before downloading Download menu bar Download a Paradigm pump using ComLink Download a Paradigm pump using Paradigm Link Download a 507C or 508 insulin pump Before downloading meter data Downloading meters using the Com-Station Downloading meters connected directly to the PC Downloading using the BD meter USB cable Chapter 5: Reports Viewing reports Current settings report Reading and understanding the report Basal Pattern tabs Sensor settings tab Logbook history report Reading and understanding the report Pump Meter Omit feature Logbook history columns Logbook diary report Reading and understanding the report Daily summary report... 45

5 Reading and understanding the report Daily details report Reading and understanding the report Daily insulin legend Basal axis scale Bolus axis scale Daily BG carb legend Modal day scatter report Reading and understanding the report Modal day hourly intervals report Reading and understanding the report Modal day time periods report Reading and understanding the report Modal week daily intervals report Reading and understanding the report Daily averages trend report Reading and understanding the report Pie/histogram charts report Reading and understanding the report Sensor data table report Reading and understanding the report Sensor daily overlay report Reading and understanding the report Sensor summary report Reading and understanding the report Chapter 6: Troubleshooting My download was canceled My file is incompatible My file contains no data My file is read only Com Port 1 and/or 2 not listed Check hardware connections My software did not install I cannot open the software My temporary basal rate is longer than 4 hours My maximum basal rate is set to a rate greater than 25.5 units/hour I changed my insulin concentration setting Uninstalling the software Download error messages Icon table Software license agreement...91 Index iii

6 iv

7 Chapter 1: Introduction Thank you for choosing the Medtronic MiniMed Solutions Pumps & Meters software (MMT-7311) Version 7.0. Insulin pumps that work with this software Medtronic MiniMed 507C insulin infusion pump 508 insulin infusion pump 511, 512/712, 515/715, and 522/722 Paradigm infusion pumps Blood glucose meters that work with this software Medtronic MiniMed Paradigm Link Blood Glucose Monitor Powered by BD Logic Technology Becton Dickinson BD Logic Roche Diagnostics Accu-Chek Complete Accu-Chek Advantage Lifescan OneTouch Profile OneTouch Ultra OneTouch FastTake Bayer Glucometer Elite XL Glucometer DEX Glucometer DEX 2 MediSense Precision Xtra TheraSense FreeStyle Note: At the time of press the Bayer brand name Glucometer was replaced by Ascensia. The Medtronic MiniMed Com-Station, ComLink, and Paradigm Link are accessory components of the Medtronic MiniMed pump and meter system. Chapter 1 1

8 The Com-Station allows communication to take place between the PC and the 507C and 508 insulin pumps. The ComLink and Paradigm Link allow communication to take place between the PC and the 511, 512/712, 515/715, and 522/722 insulin pumps. The Hardware connections diagram included with this software will help you to set up your hardware. Refer to the Com-Station, ComLink, and Paradigm Link user guides for detailed instructions. Assistance For assistance please call your local representative listed on the enclosed Medtronic Minimed International Contact card. CD handling instructions To protect the disc from scratches, fingerprints, dust particles and smears, never touch the recording side or place it face down on a hard surface. Avoid exposing the disc to direct sunlight, high temperatures, dust or dirt. Indications for use Medtronic MiniMed Solutions Pumps & Meters is intended for use as a tool to optimize diabetes management. It is one of many components used in intensive treatment of diabetes. The purpose of this software is to provide reports that can be used to identify trends and analyze a person s management of diabetes. Contraindications This software should not be used with devices that are not listed on page one. Nor should this product be used for the treatment of medical conditions other than diabetes. Warnings This product is intended to be used solely in conjunction with the consultation of a healthcare professional familiar with the diagnosis and treatment of diabetes. This product is not intended to produce medical advice and should not be relied upon for such purpose. Prior to any adjustment of insulin therapy, please review and agree upon an appropriate glucose testing pattern with your healthcare professional. 2 Introduction

9 Notes The duration of a Temporary Basal Rate setting on the 508 pump is reported inaccurately by this software if the duration was set to a time greater than 4 hours. See My temporary basal rate is longer than 4 hours in Chapter 6 for detailed information. The Maximum Basal Rate setting on the 508 pump is reported inaccurately by this software if the Maximum Basal Rate is set to a rate greater than 25.5 units/hour. No other results are affected. Do not rely on the Maximum Basal Rate setting reported. Insulin Concentration setting changes on the 507C and 508 pumps will cause inaccurate results to be reported by this software for the Maximum Basal Rate setting, The Maximum Bolus setting, and the basal insulin delivery profile on the day of the concentration change. See I changed my insulin concentration setting in Chapter 6 for detailed information. To Install the BD meter USB cable on Windows 98SE The first time you connect the BD meter USB cable to your USB port on the computer, complete the following procedure. 1. When you connect the BD meter USB cable to the USB port, the following message appears. 2. Disregard insert disk. Click the OK button and the following window appears. 3. Disregard Insert BD USB Driver Installation in the selected drive. 4. Click the dropdown arrow on the Copy files from: dropdown menu. Select the USB2SerialDirectory along with the drive letter from the dropdown menu list. In the example, C is the drive letter. Depending on the drive letter that you installed your Solutions software to, that letter will appear before the directory Chapter 1 3

10 name. If you do not see the directory in the dropdown menu, click the BROWSE button. The following window appears. 5. Look in the drive where you installed the Solutions software. See example above. 6. Find the folder USB2SerialDirectory and double click to display the folder name in the Copy files from: dropdown menu. 7. Click the OK button. The USB driver will now be installed. 8. If you have difficulty installing the USB driver, please contact your local Medtronic MiniMed representative. Hardware connections The hardware connection diagrams that follow have instructions for connecting your pump or meter to your computer. PC connections USB Port Serial Port 4 Introduction

11 Optional components To Serial Port ComLink For use with Paradigm family of pumps To power outlet To serial Port Do not connect the ComLink cable or these meter cables to Com-Station Serial Adapter Cable and Port B. Port A Port B Connect meter serial cable to Com-Station Serial Adapter cable and Port B (optional). Com-Station For use with model 507C and 508 pumps Chapter 1 5

12 Meter options To USB Port or To Serial Port Paradigm Link To USB Port or To Serial Port BD Logic To Serial Port Elite XL All connections below: To Serial Port Accu-Check Interface Box Bottom TheraSense FreeStyle Bayer DEX / DEX 2 MediSense Precision Xtra One Touch Fast Take One Touch Profile One Touch Ultra Accu-Chek Advantage Accu-Chek Complete 6 Introduction

13 Chapter 2: Getting started The Front Page appears after clicking the Solutions desktop. icon on your The Front Page allows you to: Download pumps and meters Open files Open User Guide Setup preferences Go to Main screen Access web links (Internet required) Chapter 2 7

14 Main screen From here, you can: Open the Setup Preferences screens from the File menu Click the LIST button to open the Patient Records List screen Click the OPEN button to open a patient file Click the Links menu to return to the Front page and/or to access the web links 8 Getting started

15 Using the software This section shows you how to move through the software. Menu bar with no file open Until you open a file, some of the features are grayed out. Click the LIST button to open the Patient Records List screen. Menu bar with file open Click the OPEN button to open a patient file Once a file has been opened all buttons and options from the dropdown menus are available. Click the VIEW PATIENT INFO button to open the Patient Information screen. The Report Display dropdown menu lists all of the reports. Click the REFRESH button to update the screen if you change the Glucose Range Limits or the Report Range. Clicking the REFRESH button displays your changes. When Custom is selected from the Report Range dropdown menu, the From and To dropdown menus become available allowing dates to be adjusted. To change any of the High, Low, or Hypo Glucose Range Limits, Click the up and/or down arrow buttons. Chapter 2 9

16 Setup preferences Select Setup Preferences from the File menu or from the Front Page.This allows you to set the initial patient information for all new patient records created on the Patient Records List. Setup Preferences has three tabs: General Reports Clinic Info Move between the tabs by clicking on them with the mouse pointer. General tab The General tab is used to set the following: These settings apply to all newly created patient records: Initial Report Range New Patient Time Periods New Patient Glucose Range Limits These settings apply to all patient files: Initial Report Display Glucose Units Time Display 10 Getting started

17 Customizing your settings You can customize the following settings: Setting initial report display The Report selected here will be the first report that is displayed for all newly downloaded and opened patient files. 1. Click the arrow button on the Initial Report Display dropdown menu. 2. Select the desired Report type. Setting initial report range The Initial Report Range selected here will be the report range displayed for all newly downloaded patient files. 1. Click the arrow button on the Initial Report Range dropdown menu. 2. Select the desired Report Range. Setting glucose units Select one of the radio buttons in the Glucose Units section. Select either mg/dl or mmol/l. Setting time display Select one of the radio buttons in the Time Display section. Select either AM/ PM (12-Hr) or International (24-Hr). Note: The Glucose Units and Time Display are settings that apply to all patient reports. Setting new patient time periods There are two ways to change the time for the patient time periods: Click the up and down arrow buttons Right click in the text box and use the clock To use the up and down arrow buttons: 1. Highlight the hour or minutes. 2. Click the up or down arrow button to make the change. Chapter 2 11

18 To use the clock: 1. Right click into the time period text box. 2. The clock appears. 3. Move the hands of the clock with your mouse to the correct time. 4. Click the OK button. Note: The textbox will appear yellow if one time period overlaps another time period. Setting new patient glucose range limits The Glucose Range Limits are used on the graphical displays and in some of the summary statistics tables showing blood glucose results. Glucose results are considered High when they are above the high limit, Low when they are below the low limit, and Hypo when they are below the hypo limit. Click the up and down arrow buttons in the New Patient Glucose Range Limits section to change the initial glucose target for the High, Low, and Hypo limits Note: The High, Low, and Hypo text boxes will appear yellow if you change the glucose target too low or too high. 12 Getting started

19 Reports tab This is where you set how you would like to print your reports. The software offers several different styles. Setting printing styles To select and/or change any of these reports for printing: 1. Click the checkbox next to the report. 2. Click the up and/or down arrow buttons on the text box to the right of the report to select the number of pages you wish to print. Do one of the following: Click the OK button to save the information. Click the CANCEL button to exit the window without saving the changes. Note: The settings chosen here will be saved and displayed in the print window when you print your report, but they can be modified at the time of printing. The following reports can be several pages long: Current Settings - the Report can be up to 4 pages Logbook History - the Report can be up to 100 pages Logbook Diary - the Report can be up to 100 pages Daily Summary - the Report can be up to 13 pages Daily Detail - the Report can be up to 90 pages Pie/Histogram Charts - the Report can be up to 6 pages Sensor Data Table - the Report can be up to 100 pages Chapter 2 13

20 Clinic info tab The Clinic Info tab is used to list the clinic name and contact information. This information will be displayed at the bottom of each printed report. Entry in these fields is optional. 1. Click into each of the text boxes and type the clinic name, address, and phone number. Do one of the following: Click the OK button to save the information. Click the CANCEL button to exit the window without saving the changes. 14 Getting started

21 Create a new patient record A patient record must be created before downloading patient data. 1. Click the LIST button to go to the Patient Records List screen 2. Click the NEW PATIENT button. 3. The Patient Record screen appears. The shaded fields require data to be entered. 4. Enter the patient s last and first name. Use the tab key or your mouse to move through each of the text boxes. 5. Enter the Patient ID(Each patient should be assigned a unique ID number). 6. Enter the Physician name (if desired). 7. If you have a Paradigm insulin pump enter the first 6 digits of the pump serial number (located on back of pump). Chapter 2 15

22 Analysis time periods The time periods for an individual patient can be set. The initial values displayed are determined by the Setup Preferences settings. Only the start times can be set. The start time of one range determines the end time for the previous range. Overnight always begins at midnight and the start time for morning automatically sets the end time for the overnight period. 8. Click the up and down arrow buttons to change the time. or 9. Right-click in the text box where you wish to make a change, to bring up the clock, move the hands of the clock to change the time. Glucose range limits To set the glucose range limits for an individual patient. 10. Use the up and down arrow buttons. This allows you to customize glucose limits for each patient. 11. Click the OK button. The patient record will now appear in the Patient Records List. 16 Getting started

23 Patient information screen Once the Patient Record has been created, data has been downloaded, and saved the information can be viewed and edited by clicking the VIEW PATIENT INFO button. The Patient Information screen appears. Additional Display Options available only for Paradigm pumps. Click one of the radio buttons to select either meter or pump data to be displayed on the reports. To make changes to the patient information: 1. Click the up and/or down arrow buttons in either the Analysis Time Periods section to change the time, or the Glucose Range Limits section to change glucose limits. 2. Click the OK button to save the changes. Chapter 2 17

24 Patient records list The Patient Records List screen lists the patient records that have been created and saved. From this screen you can: Create a new patient record Select a patient to download device data and create a new patient file Edit an existing patient record Delete an existing patient record Patient records can be sorted in ascending or descending order. Click on the column heading to change from ascending to descending and vice versa. 18 Getting started

25 To select a patient for downloading 1. Double click on the patient name or click once on the patient name and click the SELECT button. 2. The Download Device screen appears. 3. Refer to the Downloading chapter for further instruction on downloading pumps and/or meters. To edit an existing patient record 1. Click the patient name. 2. Click the EDIT button to go to the Patient Record screen. 3. Type your changes into the appropriate fields to make your edits. 4. Click the OK button. Chapter 2 19

26 To delete an existing patient record 1. Click the patient name. 2. Click the DELETE button. A pop-up box will be displayed, with the patient s name. Jane Doe is shown in the example. 3. Click the YES button. 20 Getting started

27 Opening patient files Chapter 3: How to work with files 1. Select Open Files from the Front Page, or if already in the program, click the OPEN button from the menu bar. The following window will appear. 2. Select the desired folder if the file is not saved in the default (PatientData) folder. 3. Select the desired patient file (with the.mmp or the.mmd file extension). 4. Click the OPEN button. The initial report screen will appear. Chapter 3 21

28 Opening previous version files Files created in version 3.0, 4.1, 5.0, and 6.0 can be opened in 7.0. The version 3.0 files have an.mmd file extension. The 3.0 files are limited to a 2 week Report Range and cannot be changed. The 4.1 files have a 90 day Report Range and no devices can be downloaded to them. The 4.1, 5.0, and 6.0 files have an.mmp file extension just like the 7.0 files. Saving patient files Note: Newly created files are given a.mmp file extension and any changes made to the settings can be re-saved to the file. Save the patient file following a download: 1. Click the SAVE button and the Save Patient File window appears. 2. The default file name assigned by the program uses the last name, first initial, patient ID, and the date. The file is then saved in the folder named PatientData. The directory folder can be selected and the file name can be changed if desired. The PatientData folder is located within the MM Solutions P&M folder which is located within the MM Solutions folder in the Program Files on the hard drive. Default location: C:\Program Files\MMSolutions\MM Solutions P & M \PatientData. 3. If you wish to save the file using a different file name, type the new desired file name in the field labeled, File name. 4. To save the data in a different directory or another drive, use the folder icon on top of the Save As window to select the desired location before clicking the SAVE button. 5. Click the SAVE button. If you download the patient data again on the same day and DO NOT want to overwrite the existing file, revise the assigned file name before saving. 22 How to work with files

29 Renaming patient files This feature allows you to replace the Patient name and ID fields. A new file is created with the new patient information while still maintaining the original patient file. This allows the sharing of patient case studies without disclosing confidential patient information. To rename a patient file: 1. Open an existing.mmp patient file. 2. Select Rename Patient from the Patient menu. 3. The Rename Patient File pop-up window appears with the current patient information. 4. Type the Last Name, First Name, and Patient ID and Physician in the text boxes. In the example below, Jane Doe replaces John Doe. 5. Click the OK button. The Save As window will appear. Chapter 3 23

30 6. Verify the correct patient file is being renamed and click the SAVE button. 7. If you wish to save the file using a different file name, highlight the assigned file name, change the name, and click the SAVE button. The Patient file has been renamed. Printing There are two ways to print your report: Click the PRINT button Select Print from the File menu Depending on the report that you have open, your printing options will vary. To print a report using the PRINT button: 1. Click the PRINT button. If you are printing the Logbook History Report or the Logbook Diary Report the following popup box will appear. 2. Click the up and/or down arrow buttons to select the number of pages to print. In the example above, the first 4 pages of the report will print. 3. Click the PRINT button. Note: The Daily Details Report and the Daily Summary Report will print only the current page on the screen when you click the PRINT button. To print a report by selecting Print from the File menu: 1. Select Print from the File menu. 2. The Report Print Selection window appears. 24 How to work with files

31 The window will display the initial settings set from the Reports tab. (See the Report tab section in Getting Started.) The printing window is divided into two parts: Reports on the left side of the window have more than one page available for printing. Reports on the right side of the window are only one page in length. To print current report Reports listed on the left side of the window 1. Click the up or down arrow button next to the report name you currently have opened, to select the number of pages you want to print. 2. Click the PRINT CURRENT REPORT button. Reports listed on the right side of the window 1. Click the PRINT CURRENT REPORT button. To print selected reports Reports listed on the left side of the window 1. Click the checkbox next to each report you wish to print. To select a report that is not selected, click the checkbox in front of the report name. 2. Click the up or down arrow button next to the report names you have selected to select the number of pages desired for printing. 3. Click the PRINT SELECTED REPORTS button to print all the reports that have been selected with a checkmark. Chapter 3 25

32 Reports listed on the right side of the window 1. Click the checkbox next to each report you wish to print. 2. Click the PRINT SELECTED REPORTS button to print all the reports that have been selected with a checkmark. Click the SELECT ALL button to select and print all of the reports. If you want to clear all your selections and start over, click the CLEAR ALL button. To print a specific date range While in a report and you wish to print a specific date range for the report, the Report Range feature allows you to customize a from and to date range. Prior to clicking the PRINT button or selecting Print from the File menu: 1. Click the arrow on the Report Range dropdown menu. 2. Select Custom. 3. Click the arrow on the From dropdown menu. 4. Select the date. Click the side arrow buttons to move through previous or subsequent months. 5. Click the arrow on the To dropdown menu. Click the side arrow buttons to move through previous or subsequent months 6. Select the date. 7. Click the REFRESH button. 8. Select Print from the File menu. 9. Click the PRINT CURRENT REPORT button. 26 How to work with files

33 Chapter 4: Downloading your data Before downloading For best results, synchronize the clocks of the pump and meter at least twelve weeks prior to a download. When downloading a pump and a meter, either one can be downloaded first. Close all other software programs. Each file will allow up to one pump download and up to six meter downloads. Following a download, all reports will be available for display if data is available. Note: The information presented by this software is based on the data from the downloaded devices. It is very important to synchronize the pump and meter during the period of use for the data to be displayed accurately. The internal clock/ calendars for each device must be set to the correct time and date for the glucose and insulin information to be synchronized. Glucose values will then be linked to the corresponding insulin bolus. This association is only possible when the clock and calendars in the pump and meter are set to the same date and time. The date and time for each device may be set by following the instructions provided with that device. Download menu bar Com-Station Connected checkbox Paradigm Pump Serial Number textbox Communication Port dropdown menu ComLink Connected checkbox Select Device dropdown menu Chapter 4 27

34 Download a Paradigm pump using ComLink 1. Click the DOWNLOAD PUMPS AND METERS tab from the Front page or if already in the program select patient name from Patient Records List and click the SELECT button. 2. The Download Device screen appears. 3. Select the device name from the Select Device dropdown menu. 4. Enter the first six digits of the pump serial number into the Paradigm Pump S/N text box. The number is located on the back of the pump or at the bottom of the pump status screen. 5. Select the com port from the Communication Port dropdown menu. 6. Check the ComLink Connected checkbox. 7. Position the pump within two meters of ComLink to download. 8. Make sure that a bolus is not in process. If a bolus is being delivered, allow bolus to finish or cancel bolus before downloading pump. Note: The ComLink will not work if connected to the Com-Station meter passthrough port. 9. Connect the ComLink to the communication interface cable provided. Connect the other end of the cable to the selected PC serial port. 10. Extend the cable (provided) the full length, away from the PC, to minimize possible communication interference from the PC. 11. Clear any alarms on the pump. If pump battery is low, replace battery. 12. Review the on-screen instructions. 28 Downloading your data

35 13. Click the START DOWNLOAD button. The pump will automatically go into Suspend Mode during the download process. Selecting the CANCEL button will stop the download process. You may need to Unsuspend/Resume the pump if you cancel. 14. A status bar will begin to move across the window. The download is complete, when a pop-up window appears, indicating that the download was successful. 15. Click the OK button. 16. Click the CLOSE button. Note: If download fails, review on screen instructions carefully and refer to Chapter 6, Troubleshooting for detailed information. Download a Paradigm pump using Paradigm Link 1. Click the DOWNLOAD PUMPS AND METERS tab from the Front page or if already in the program select patient name from Patient Records List and click the SELECT button.the Download Device screen appears. Chapter 4 29

36 2. Select the device name from the Select Device dropdown menu. 3. Enter the first six digits of the pump serial number into the Paradigm Pump S/N text box. The number is located on the back of the pump or at the bottom of the status screen. 4. Select the com port from the Communication Port dropdown menu. If using the BD meter USB data cable select BD-USB from the menu. If using the BD meter serial data cable select Com 1, Com 2, etc. from the menu. 5. Position the pump within six feet of the Paradigm Link to download. 6. Make sure that a bolus is not in process. If a bolus is being delivered, allow bolus to finish or cancel bolus before downloading pump. 7. Turn the Paradigm Link off and connect the Paradigm Link to the BD meter cable. Connect the other end of the cable to the selected PC com port. 8. Extend the data cable the full length, away from the PC, to minimize possible communication interference from the PC. 9. Clear any alarms on the pump. If pump battery is low, replace battery. 10. Review the on-screen instructions. 11. Click the START DOWNLOAD button. The pump will automatically go into Suspend Mode during the download process. Selecting the CANCEL button will stop the download process. You may need to Unsuspend/Resume pump if you cancel. 12. A status bar will begin to move across the window. The download is complete, when a pop-up window appears, indicating that the download was successful. 13. Click the OK button. 14. Click the CLOSE button. 30 Downloading your data

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