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

Transcription

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

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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

37 Download a 507C or 508 insulin pump 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. 2. Select the device name from the Select Device dropdown menu. 3. 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. 4. Make sure that the Com-Station s communication interface cable is attached to the PC and connected to Port A on the Com-Station. 5. Turn on the Com-Station. A green light on the On/Off switch will illuminate indicating the Com-Station is on. 6. Press the Device Selector Switch on the Com-Station to the wave icon position, to indicate that a pump will be downloaded from the device cradle. 7. Clear any alarms on the pump. If pump battery is low, replace battery. 8. Remove belt clip from the pump. 9. Place the pump face up in the Com-Station cradle. 10. Select the Com Port from the Communication Port dropdown menu. 11. Review the on-screen instructions 12. Click the START DOWNLOAD button. The pump will automatically suspend itself during the download process and may beep. Allow 2-5 minutes for download to complete.selecting the CANCEL button will stop the download process.you may need to unsuspend the pump if you cancel the download. 13. A status bar will begin to move across the window. Take care not to bump the pump during download as this may disrupt data transmission. When the download is complete, a pop-up window appears, indicating that the download was successful. Chapter 4 31

38 14. Click the OK button.check your pump. If necessary, end Suspend Mode (press SEL and ACT on the pump). 15. Click the CLOSE button. Note: If download fails, review on screen instructions carefully and refer to Chapter 6, Troubleshooting for detailed information. Before downloading meter data Each meter must be correctly set to either On or Off when preparing for download. These meters must be turned Off in preparation for downloading and before connecting the meter cable: Medtronic MiniMed Paradigm Link Becton Dickinson BD Logic Roche Accu-Chek Advantage Roche Accu-Chek Complete LifeScan OneTouch Ultra LifeScan OneTouch FastTake MediSense Precision Xtra (meter turns on automatically when the cable is plugged in) These meters must be turned On: Bayer Glucometer DEX Bayer Glucometer DEX 2 Bayer Glucometer Elite XL (cable must be plugged in to the meter before turning on) LifeScan OneTouch Profile TheraSense FreeStyle Note: The Bayer Elite XL, and the BD Logic glucose meters will not download using the Com-Station. 32 Downloading your data

39 Downloading meters using the Com-Station 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. 2. Select the device name from the Select Device dropdown menu. 3. Click the Com-Station Connected checkbox for specific instructions for downloading with the Com-Station. 4. Connect the appropriate cable (contact glucose meter manufacturer for cable supplies) to Port B on the Com-Station using the serial adapter cable (the short cable that was supplied with your Com-Station). 5. Turn the Com-Station On. The green light on the On/Off switch will illuminate indicating that the Com-Station is turned On. 6. Press the device selector switch on the Com-Station to the B position, to indicate that the meter pass through port is being used. 7. Connect the other end of the meter cable to the supported model glucose meter. 8. Review and follow the on-screen instructions. The instructions will vary depending on the type of meter you are using. 9. Click the START DOWNLOAD button. 10. A status bar will indicate how much of the download has completed. When the download is complete, a pop-up window appears. 11. Click the OK button. 12. Click the CLOSE button. Note: If download fails, review the on-screen instructions carefully and refer to Chapter 6, Troubleshooting for detailed information. Chapter 4 33

40 Downloading meters connected directly to the PC 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. 2. Select the device name from the Select Device dropdown menu. 3. Connect the meter cable directly to the PC serial com port or to the communications interface cable connected to the PC serial com port. 4. Connect the other end of the meter cable to the supported model glucose meter. 5. Review and follow the on-screen instructions. The instructions will vary depending on the type of meter you are using. 6. Click the START DOWNLOAD button. 7. A status bar will indicate how much of the download has completed. When the download is complete, a pop-up window appears. 8. Click the OK button. 9. Click the CLOSE button. Note: If download fails, review the on-screen instructions carefully and refer to Chapter 6, Troubleshooting for detailed information. 34 Downloading your data

41 Downloading using the BD meter USB cable The BD-USB cable can be used to download: 511, 512/712, 515/715, and 522/722 pumps BD Logic meter Paradigm Link meter 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. 2. Select either Paradigm 512/712, 515/715 or 522/722, Paradigm 511, BD meter or Paradigm Link from the Select Device dropdown menu. 3. Select BD-USB from the Communication Port dropdown menu. 4. Review and follow the on-screen instructions. The instructions will vary depending on the type of meter or pump you are using. 5. Click the START DOWNLOAD button. 6. A status bar will indicate how much of the download has completed. When the download is complete, a pop-up window appears. 7. Click the OK button. 8. Click the CLOSE button. Chapter 4 35

42 36 Downloading your data

43 Chapter 5: Reports The software reads and records the pump and meter data during the downloading process. In this chapter you will learn how to read and understand the data displayed in each of the fourteen (14) reports: Current Settings Logbook History Logbook Diary Daily Summary Daily Details Modal Day Scatter Plot Modal Day Hourly Intervals Viewing reports Click the arrow button on the Report Display dropdown menu or click the side arrow button to either the left or right of the Report Display dropdown menu to view a report. Modal Day Time Periods Modal Week Daily Intervals Daily Averages Trend Pie and Histogram Charts Sensor Data Table Sensor Daily Overlay Sensor Summary Side arrow buttons allow you to scroll through the reports listed in the order of appearance. The Report Display dropdown menu allows you to scroll using the scroll bar to select a report. Chapter 5 37

44 Current settings report Basal Pattern Details box Pattern Settings box Reading and understanding the report The Current Settings report provides pump and/or meter information that has been downloaded to the patient file. The top of the report lists: name of downloaded device serial number download time - this is the date and time the device was downloaded to the software device reference time - this is the date and time set on the pump or meter at the time of download 38 Reports

45 The report has six tabs: Basal Standard Basal Pattern A Basal Pattern B General Settings Bolus Wizard Sensor Settings These tabs are available for displaying pump data only. Basal Pattern tabs Basal profile graph A basal profile graph is displayed for each Basal Pattern programmed on your pump. The graph shows the basal rates set on your pump for the entire 24 hour day. The basal rates appear as blue bars that look like steps if more than one rate is set on your pump. The height of each step represents the delivery rate. The width of each step represents the length of time set for each delivery rate. Profile details The profile details table display information about each of the basal patterns set on your pump. The table displays the following: Current Pattern in use on pump Number of basal rates (in the individual pattern set) Total 24-hour basal insulin delivery for each pattern Date of the last basal rate edit for each pattern Number of days from the last basal rate change Pattern settings box Pattern Settings displays the individual basal rates comprising the basal pattern displayed in the accompanying graph. Basal pattern A tab The Basal Pattern A graph displays the programmed basal pattern A rate along with a corresponding graph. Basal pattern B tab The Basal Pattern B graph displays the programmed basal pattern B rate along with a corresponding graph. General settings tab The general settings tab displays the settings of the insulin pump. The type of settings displayed will vary depending on the type of insulin pump downloaded. Chapter 5 39

46 Bolus Wizard tab The Bolus Wizard tab will be available for the Paradigm 512/712, 515/715, and 522/722 pumps only. The tab list the carbohydrate (carb) units, blood glucose (BG) units and Insulin type on the left-hand side and the table displays the time and setting of the Carb Ratio, Insulin Sensitivity and BG Target. Sensor settings tab Displays all your current sensor settings that you set in your pump. Logbook history report Pump data Meter data Reading and understanding the report The Logbook History report provides a table that can be customized to view pump and meter data. The pump and meter data is displayed by default, in chronological order by date/time according to the selected Report Range. 40 Reports

47 Customize your data The report can be customized for viewing pump and meter data. Pump This section allows you to select any or all of the pump data to be displayed in the report. Depending on the type of pump you have, your options will vary. 1. Click the checkbox next to the pump data you wish to be displayed. 507C, 508, and 511 options Paradigm 512/712, 515/715 and 522/722 pump options 2. Click the REDISPLAY button and only the pump data selected will be displayed. Meter In the Meter section the Display Meter checkbox must be selected to enable the radio button options. The options are All Data, Results High, Results Low, or Results Hypo. All Data - shows all High, Low, Hypo glucose results, and other meter result data. Results High - shows all glucose results above the high limit. Results Low - shows all the glucose results below the low limit (including the Hypo results). Results Hypo - shows all glucose results below the Hypo limit. This section allows you to select none or one (only) of the meter data types to be displayed in the report. To do this: 1. Click the radio button next to the meter data to be displayed. 2. Click the REDISPLAY button and only the meter data selected will be displayed. The SELECT ALL button, selects all the pump data and all the meter data to be displayed. Chapter 5 41

48 Omit feature You can omit meter BG data for reporting in statistical calculations and graphical displays in the other reports. By omitting the data the entire row will be crossed out, but can be restored for later use. Note: The omit feature is only available for.mmp files. To omit data: 1. Click on the row you wish to omit. 2. Click the OMIT button. 3. Notice the row is now crossed off. To restore the omitted data: 1. Click on the omitted row. 2. Click the RESTORE button. Note: On the day of download the partial day s data will be included in the Logbook History Report even though this day is not included in the Report Range. Logbook history columns Each column can be viewed in descending or ascending order. Date time The date is shown along with the time. The time will be displayed in either the international format (24-hour) or the AM/PM (12-hour), depending on the Setup Preferences General tab setting. Note: The total insulin delivered for each day is shown in blue. Description Displays the type of pump or meter reading displayed. For the pump, the description will list whether a bolus was delivered, if a basal change occurred, the status of the pump (in Suspend), any special settings such as Auto off, or alarms. For the meter, the description will list whether the meter data is high, low or hypo according to the glucose range settings. 42 Reports

49 Pump Meter Displays all insulin delivered, primes and boluses. Displays glucose meter readings. Logbook diary report The statistics table summarizes the data for the Report Range based on the assigned Analysis Time Periods. In this example the Report Range period is 4 weeks. Reading and understanding the report The Logbook Diary report displays all pump and meter data in chronological order by date/time according to the selected Report Range. The report displays BG/Carb and bolus data in five time periods: Overnight Morning Afternoon Evening Bed Time The beginning and ending time for each time period is set from the Patient Information screen. Each time period displays the time and value of the BG/Carb measurements, as well as the time and the number of units of bolus delivered. Chapter 5 43

50 Note: Carbohydrate data is only available when downloading the Paradigm 512/712,515/715, and 522/722 pumps and user entry of carb information into the Bolus Wizard feature on the pump. Each row contains a one day (24-hour) period of data. The report can be viewed in descending or ascending order. To change the view to ascending, click the top of BG:mmol/L Carb:gm column. The time periods can be modified to sort the data between adjacent time periods. To do this: 1. Click the VIEW PATIENT INFO button to open the Patient s information screen. 2. Click into the text box of the time period you want to adjust. 3. Use the up and/or down arrow button to adjust the time. 4. Click the OK button. 5. Click the REFRESH button. This will update the report with your adjusted time periods. 44 Reports

51 Daily summary report Glucose data Insulin data Reading and understanding the report The Daily Summary report provides a summary of glucose meter and pump data, displaying the data in a tabular and graphical format. The report is divided into two sections: Glucose Data on the top and Insulin Data on the bottom. Each column contains one day (24-hours) of data. To scroll through the report and view data from other days, click the 1 DAY button to scroll forward or back one day or click the 7 DAY button to scroll forward one full week or back one full week. The Total Range column represents the averages for the entire period specified in the Report Range. For example, if the report range is six weeks then the total range will display the average for all the data reported during the entire six week period. Note: On the date of the download a partial day is not included in this report. Only complete days are available for reporting. Chapter 5 45

52 Glucose data The Glucose Data section provides a summary of blood glucose meter data. The vertical glucose scale is fixed from 0 to 22.2 mmol/l or 0 to 400 mg/dl. Below is a portion of the report screen displaying glucose data. Total Range column - gives the average date for the entire Report Range period. Low BG Target High BG Target Glucose scale is fixed from mmol/l. Average glucose for the day. Daily Glucose Range for the day. Insulin data The Insulin Data section provides a summary of insulin delivery information. The vertical insulin scale is determined based on the daily insulin totals data. Below is a portion of the report screen displaying insulin data. Total Range column - gives the average for the entire Report Range period. Total carbohydrate intake for the day. Total insulin delivered for the day. Total carbohydrate entries for the day. Percentage of basal insulin delivered for the day. Percentage of bolus insulin delivered for the day. 46 Reports

53 Daily details report Insulin graph Glucose graph Reading and understanding the report The Daily Details report provides a detailed view of glucose meter data and pump data, displaying the data in a tabular and graphical format. The report displays one day (24-hour) period of data per screen. Use the horizontal scroll bar to view other days. Insulin graph The top graph shows the insulin delivery over a 24-hour period. The basal insulin delivery is plotted with a blue line. The left axis provides the scale for the basal insulin. The basal line changes color to reflect temporary basal rates (green), pump suspended (pink) and auto off (red). Bolus and prime delivery are indicated by vertical lines and blocks. The right axis provides a scale for bolus and prime delivery. A normal bolus is indicated by vertical purple lines. Square wave bolus delivery is indicated by blue blocks with the height indicating the insulin delivered, and the width indicating the duration. A Dual bolus delivery is indicated by a normal bolus followed by a square wave bolus. Chapter 5 47

54 Daily insulin legend To view the legend of symbols, click the SHOW INSULIN LEGEND button. Basal axis scale To enhance viewing of the Daily Details Report, change the scaling of the basal axis. For example, a high basal rate axis displaying a very low basal unit/hour may result in the basal rate line being too small to easily read. You can change the left vertical Basal axis. 1. Right click on the Basal axis and the following pop-up box appears. 2. Click the up and/or down arrow buttons to select the desired number. 3. Click the OK button. Bolus axis scale You can change the right vertical Bolus axis. 1. Right click on the Bolus axis and the following pop-up box appears. 2. Click the up and/or down arrow buttons to select the desired number. 3. Click the OK button. Note: Changes to the scale are kept in memory only when the file is open. 48 Reports

55 The basal profile displays the set profile rate, the set temporary basal rates, auto off periods, and suspend (on/off) periods. The graph uses different symbols for the different types of boluses. Normal boluses that occur at close points in time to one another are stacked and shown as a single bolus. BG/Carb graph The bottom graph shows BG and Carbohydrate measurements for each 24-hour period, depicting individual BG and carb amounts throughout the day. If you downloaded a 522/722 pump, your graph will display your sensor glucose values. All glucose values for the selected date will be displayed here unless omitted from the Logbook History Report. (Refer to the Omit feature section on page 37).The vertical BG scale is fixed from 0 to 22.2 mmol/l or 0 to 400 mg/dl. The vertical Carb scale is adjustable. Right click with your mouse on the carb (grams) axis and the following popup box appears: 1. Click the up and/or down arrow buttons to select the desired number. 2. Click the OK button. Daily BG carb legend To view the legend of symbols, click the SHOW GLUCOSE LEGEND button. History details The History Details table works like a mini log book displaying the Logbook History report data associated with the graphs. Sensor alarms and events are also displayed if a 522/722 pump is downloaded. Insulin statistics The Insulin Statistics table displays the insulin delivered for the day. Dual boluses are divided into the Normal bolus and the Square bolus. Delivery type A pie chart is also provided, depicting the basal and bolus percentage breakdown of the total insulin delivered for the day. Chapter 5 49

56 Modal day scatter report The shaded and white columns represent the Analysis Time Periods for Overnight, Morning, Afternoon, Evening and Bedtime. Reading and understanding the report The Modal Day Scatter report displays meter glucose data over a 24-hour period. Each BG value is plotted on the graph as a blue star. All of the glucose data contained in the selected report range, unless omitted from the Logbook History report (refer to the Omit feature in the Logbook History report section) will be plotted on the graph. The vertical axis reports glucose values from mmol/l or mg/dl. The horizontal axis displays the time of day in hourly intervals with a scale from international (24 Hr) 0:00 to 23:59 or 12:00am to 11:59pm. 50 Reports

57 Average glucose line The hourly average line can be connected by clicking the SHOW AVERAGE LINE button. This shows the average glucose for each hourly interval connected over the course of the day. (See Modal Day Hourly Intervals Report). The statistics table summarizes all the glucose values data for the selected Report Range. The High, Low, and Hypo Glucose Range Limit settings appear as horizontal lines across the graph. The area between the High and Low limits is shaded green. The Hypo limit line is plotted as a red line. Chapter 5 51

58 Day lines The Day Lines can be connected by clicking the SHOW DAY LINES button. The connected glucose values display each day in a different color. It highlights any trends associated with daily glucose testing patterns. 52 Reports

59 Modal day hourly intervals report Reading and understanding the report The Modal Day Hourly Intervals report displays glucose meter data in hourly intervals over a 24 hour period (from midnight to midnight). The vertical glucose scale is fixed from 0 to 22.2 mmol/l or 0 to 400 mg/dl. The horizontal axis displays the time of day in hourly intervals with a scale from 0:00 to 23:59 or 12 am to 11:59 pm. All the glucose data contained in the selected report range, unless omitted from the Logbook History report, (refer to the Omit feature in the Logbook History report section), is included in the reported data. The average glucose is also displayed on the graph. The report evaluates all the individual glucose results for each hourly interval and displays an average of all the results for the preceding hour (60 minutes). The average glucose result is reported on the hour. For example, at 07:00 the average glucose reported is the average of all the glucose measurements taken throughout the Report Range between 06:01 and 07:00. (See Modal Day Scatter Plot Report for the individual glucose values.) Chapter 5 53

60 Connect averages The data points for each hour can be connected by clicking on the CONNECT AVERAGES button. The statistics table displays the BG data for the entire report range. The statistics table reports the statistical values associated with each hourly time interval. 54 Reports

61 Modal day time periods report Reading and understanding the report The Modal Day Time Periods report displays meter glucose data on a 24-hour scale. The vertical glucose scale is fixed from 0 to 22.2 mmol/l or 0 to 400 mg/dl. The horizontal axis displays the time of day in hourly intervals. All the glucose data contained in the selected report range, unless omitted from the Logbook History report (refer to the Omit feature in the Logbook History report section) are included in the data set for statistical calculation. The average glucose results for each time period are displayed. Each time period contains an average glucose value unless no data is available. The average glucose values appear as square symbols. Chapter 5 55

62 Connect averages The data points for each time period can be connected by clicking on the CONNECT AVERAGES button.the shaded and white columns represent the Analysis Time Periods for Overnight, Morning, Afternoon, Evening and Bedtime. The statistics table beside the graph displays the statistical values associated with the glucose data for the total Report Range. The statistics table provided below the graph reports the values associated with each individual Time Period. 56 Reports

63 Modal week daily intervals report Reading and understanding the report The Modal Week Daily Intervals report displays meter glucose data and insulin delivery for each day of the week. The average of each glucose value for each daily interval is plotted on the graph. The left vertical axis reports glucose values from mmol/l or mg/dl. The right vertical axis reports the total insulin unit values from 0 to 150 units. The horizontal axis reports the days of the week, Monday through Sunday. All the glucose data contained in the selected report range, unless omitted from the Logbook History Report (refer to the Omit feature in the Logbook History report section) are included in the data set for statistical calculation. The average glucose value for each day of the week is displayed, unless no data is available. All glucose results for the individual day of the week are included in the average result for the daily interval. Chapter 5 57

64 Connect averages To connect the glucose average values click the CONNECT AVERAGES button. The statistics table beside the graph displays the summary statistics of the glucose and total insulin data for the entire report range. The table reports the statistical values for BG and insulin for each day of the week. The average glucose value appears as a square symbol and is plotted in each daily interval. The total insulin average is graphed as a histogram bar in each daily interval. The High, Low, and Hypo Glucose Range Limit settings appear as horizontal lines across the graph. The area between the High and Low limits is shaded green. The Hypo limit line is plotted as a red line. 58 Reports

65 Daily averages trend report Reading and understanding the report This Daily Averages Trend report displays the average glucose value for each calendar day within the Report Range. (unless no data is available) The vertical axis reports glucose values from mmol/l or mg/dl. The horizontal axis reports the calendar date and month for each day within the entire Report Range. All the glucose data contained in the selected report range, unless omitted from the Logbook History Report (refer to the Omit feature in the Logbook History report section) are included in the reported data and the average glucose value for each day is displayed on the graph. The High, Low, and Hypo Glucose Range Limit settings appear as horizontal lines across the graph. The area between the High and Low limits is shaded green. The Hypo limit line is plotted as a red line. Chapter 5 59

66 Connect averages To connect the glucose average values click the CONNECT AVERAGES button. The statistics table displays the values associated with the glucose data for the total Report Range. The % Within Range is the percentage of the total number of readings that are equal to or within the glucose range high and low limits. The % High is the percentage of the total number of readings that are above the glucose range high limit. The % Low is the percentage of the total number of readings that are below the glucose range low limit. # of Hypos are the number of glucose results that are below the glucose range hypo limit. 60 Reports

67 Pie/histogram charts report Pie charts Histogram chart Reading and understanding the report The Pie/Histogram Chart report provides an analysis of the patient s blood glucose values. Pie chart Pie charts are displayed for each time (analysis) period. The percent spent Within limits is indicated in green, the percent spent in High is indicated in red, and the percent spent in Low is indicated in blue. Select a time period by clicking the radio button or click on the small pie chart to view the corresponding histogram. All the glucose data contained in the selected date range, unless omitted from the Logbook History Report (see the Omit feature in the Logbook History report section) will be included on the chart display. Histogram The scale is in intervals of 2.5 for mmol/l and 50 for mg/dl. This creates ten interval ranges for BG readings. A bar is displayed for each interval based on the percentage of the total results that fall within the interval range. For example, if five results out of a total of 50 results are in the range , then a bar with a height of 10 percent is displayed for the glucose interval. Chapter 5 61

68 Sensor data table report Reading and understanding the report The Sensor Data Table report displays all sensor glucose values, ISIG values, sensor life cycle events and sensor alarms in chronological order by date/time according to the selected date range. The report displays: Date/Time Glucose (mg/dl or mmol/l) ISIG Bolus Insulin Carbohydrates Alarms and Events The report can be viewed in descending or ascending order. To change the view, click the top of the Date/Time column. Note: The maximum and minimum glucose values reportable from the sensor are 22.2 mmol/l (400 mg/dl) and 2.2 mmol/l (40 mg/dl) respectively. Thus, the sensor glucose plot line will appear as a flat line for glucose values that exceed these limits. 62 Reports

69 Sensor daily overlay report Reading and understanding the report The Sensor Daily Overlay report displays sensor glucose data over a 24-hour period. Each sensor glucose value is plotted on the graph with a colored line. Each day of the week is plotted with a different line color. Click the legend button to view the Sensor Modal Day legend. It will display 7 days of data. If there is less than 7 days of data, all data available will be displayed. If there is more than 7 days of data, only 7 days will be displayed. The vertical axis reports glucose values from mmol/l or mg/dl. The horizontal axis displays the time of day in hourly intervals with a scale from international (24 Hr) 0:00 to 23:59 or 12:00am to 11:59pm. Chapter 5 63

70 Your high glucose limit is displayed as a red dash line and your low glucose limit is displayed as a blue dashed line. In this example the high limit is 7.8 mmol/l and the low limit is 3.9 mmol/l. Note: The maximum and minimum glucose values reportable from the sensor are 22.2 mmol/l (400 mg/dl) and 2.2 mmol/l (40 mg/dl) respectively. Thus, the sensor glucose plot line will appear as a flat line for glucose values that exceed these limits. Sensor summary report Reading and understanding the report The Sensor Summary Report displays a summary of sensor glucose data and meter glucose data. Each column contains one day (24-hour period) of data. The totals column (the last column) summarizes all the data for the entire period. The report can contain up to 7 days of data and the screen allows you to scroll horizontally and vertically. Each section of the Sensor Summary Report contains the following data: # of Sensor Values number of calibrated sensor glucose values per day. A maximum of 12 values per hour are possible and up to 288 values per day. 64 Reports

71 Average (mg/dl or mmol/l) the average value of all the sensor glucose values per day as well as the total period. Min Max (mg/dl or mmol/l) the range of sensor glucose values per day as well as the total period. STDev (mg/dl or mmol/l) the standard deviation calculated for the day s sensor glucose values as well as the total for the period. Meter the fingerstick meter BG values that were entered into the pump. # of Meter Values the number of finger-stick meter readings entered into the pump for sensor calibration. Average (mg/dl or mmol/l) average of all the meter readings entered into the pump for calibration including readings not used by the algorithm for sensor calibration. Min Max (mg/dl or mmol/l) the range of meter readings entered into the pump including readings not used by the algorithm for sensor calibration. Excursions an excursion occurs when the patient s glucose level goes above or below their glucose target range as set on the Patient Entry and Edit screen. These results are dependent on the settings for the target range upper and lower limit. If the limits are changed the results for excursions may change. # of Excursions the total number of excursions, including high and low for each day and the total number of excursions for each day added together and totaled in the last column. # of High Excursions the total number of times the patient s glucose level exceeded the Upper Limit target range for the day and the total number for each day added together and totaled in the last column. # of Low Excursions the total number of times the patient s glucose level went below the Lower Limit target range for the day and the total number for each day added together and totaled in the last column. Duration Above High Limit the time displayed in hours and minutes that the patient was above their set target range. Also displays the percentage of time spent above their set target range as well as the time and percent for the total period. Duration Within Limits the time displayed in hours and minutes that the patient was within the set target range. Also displays the percentage of time spent within their set target range as well as the time and percent for the total period. Duration Below Low Limit the time displayed in hours and minutes that the patient was below their set target range. Also displays the percentage of time spent below their set target range as well as the time and percent for the total period. Chapter 5 65

72 Pie Chart displays the % of time above the upper limit, the % of time within limits and the % of time below the set limit for each day as well as for the total period. Above limits is displayed in Red, within limits in Green, and below limits in Blue. Glucose Area Above High Limit (mg/dl *Day or mmol/l *Day) the area created between the glucose profile and the target upper limit boundary, during the periods of excursions. This reference value provides a relative indication of the overall extent and duration of glucose excursions for a given day and for the total period. Glucose Area Below Low Limit (mg/dl or mmol/l) the area created between the glucose profile and the target lower limit boundary, during the periods of excursions. This reference value provides a relative indication of the overall extent and duration of glucose excursions for a given day and for the total period. Note: The maximum and minimum glucose values reportable from the sensor are 22.2 mmol/l (400 mg/dl) and 2.2 mmol/l (40 mg/dl) respectively. Thus, the sensor glucose plot line will appear as a flat line for glucose values that exceed these limits. 66 Reports

73 Chapter 6: Troubleshooting This chapter covers the software error messages, the troubleshooting instructions and all the downloading problems that you may encounter. My download was canceled There are three possible download canceled errors that you may receive. Download CANCELED! The cancel button was clicked during download and ended the download session. If download is canceled, the program does not keep any data received. Resume download when ready. Download CANCELED! Please check pump first: Cancel SUSPEND, if necessary. The cancel button was clicked during the 508 or Paradigm pump download and ended the download session. If download is canceled, the program does not keep any of the data received. Resume the pump insulin delivery if the pump is left in Suspend mode. Resume download when ready. Download CANCELED! Please check pump first: Cancel SUSPEND, if necessary. Reprogram AUTO OFF setting. The cancel button was clicked during the 507C pump download and ended the download session. If download is canceled, the program does not keep any of the data it received. Resume the pump insulin delivery if the pump is left in Suspend mode. Check the pump Auto Off setting and reprogram it if the desired setting is greater than 0 hours. Resume download when ready. Chapter 6 67

74 My file is incompatible This database is incompatible with the current software version Please select another file. The file selected to Open was not created with this version Pumps & Meters software or the previous version 3.0, 4.1, 5.0, and 6.0 Pumps & Meters software. It is also possible that the file has been damaged and cannot be opened by the program. Data File Open Error Select a different data file. The file selected to Open has been damaged or modified by another program and cannot be opened by the Pumps & Meters program. My file contains no data The selected file contains no data. The file selected to Open does not contain any information in the database. My file is read only Cannot write to a read-only file. It is not permitted to save changes to the file because the file properties attribute was set by the user to READ ONLY. Cannot download to a read-only file. It is not permitted to download device data to the file because the file properties attribute was changed by the user to READ ONLY. Cannot overwrite Current file. It is not permitted to save a file to the same file name as the currently opened file using the Save As selection from the File menu. Selecting a valid com port To solve communication problems, it may be necessary to select a different Com Port. Com Port 1 is the most common valid selection. Try each Com Port that 68 Troubleshooting

75 appears in the Communications Port dropdown menu from the Download Device window. Com Port 1 and/or 2 not listed If com port 1 or 2 are not available from the dropdown menu, a different software application is using the missing com port. To find the missing Com Port: 1. Exit the Medtronic MiniMed Solutions software. 2. Exit any application that communicates through the Com Ports. 3. Exit any applications that may be controlling the Com Ports. Typically these applications can be found in the system tray (lower right corner of the desktop). For example, Palm handheld users must exit HotSync Manager to gain access to the associated Com Port. 4. Restart the Medtronic MiniMed Solutions software. 5. Check the Communications Port dropdown menu from the Download Device window. If you continue to experience difficulty locating the Com Port or downloading devices connected to the Com Port then check the PC Communication Port settings in the Windows operating system, complete the following steps: 1. Go to Start>Settings>Control Panel>System>Hardware>Device Manager. 2. Find Ports (COM and LPT) and click the + next to Ports to display the list of communication ports available. 3. Select the desired Communications Port (i.e. COM1, COM2, or COM3) and right click to select Properties. 4. Click Port Settings and then Advanced to check the following settings are displayed. Chapter 6 69

76 5. Verify the required serial port settings are set correctly, as shown in the table below: Port Settings Set to PC Com Port: Enabled Bits per second: 9600 (baud rate) Data bits: 8 Parity: None Stop bits: 1 Flow control: xon/xoff Advanced Set to FIFO buffers: Receive buffer: Transmit buffer checked (enabled) ¾ high or greater ¾ high or greater If any changes are made, click the OK button. Check hardware connections Refer to the Hardware Connections document provided with this User Guide for hardware connection information. Here are some tips for checking hardware connections: Make sure there are no loose connections of the communication interface cable connected to the PC, the Com-Station, the ComLink, and the Paradigm Link. The serial communication interface cable can also be used for connecting meter serial cables to the PC. Make sure there are no loose connections to the PC, with the communication interface cable or at the meter port end. The communication interface cable attached to the PC should connect with Port A on the Com-Station (on the back) not Port B (on the side). If connecting meter cables through the Com-Station make sure that the Serial Adapter Cable is connected to Port B on the Com-Station. Meter cables (except for the Bayer Elite XL meter and the BD Logic Meter) can be connected to the Serial Adapter Cable attached to the Com-Station Port B. Do not substitute the Com-Station Serial Adapter cable with another cable. This is a special cable available from Medtronic MiniMed. Meter cables can be connected to the communication interface cable attached to the PC Serial Com Port or they can be attached directly to the PC Serial Com Port. 70 Troubleshooting

77 Check the cable. Non-standard cables, cable extensions, and cable adapters are common sources of problems. The communication interface cable (the long cable that was supplied with the Com-Station) should be used to connect the Com-Station to the computer. Do not use the short cable that was provided, the short cable is for connecting the glucose meter to the Com-Station Port B. Do not connect the ComLink to the Com-Station. My software did not install Check the minimum system requirements. Close all other programs during software installation. Do not run other Medtronic MiniMed software programs at the same time while using the Pumps and Meters software. I cannot open the software If the Pumps & Meters program fails to launch when clicking on the program icon then check the following: 1. Press the Ctrl Alt Delete keys simultaneously on the keyboard to display the Task Manager window. 2. See if PMDownload is displayed in the window as running. 3. If it is, then highlight the PMDownload line and click the END TASK button to clear the program from the list. 4. Close the Task Manager and try again to launch the Pumps & Meters program by clicking on the desktop icon. My temporary basal rate is longer than 4 hours 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. The rate for the Temporary Basal Rate setting is reported correctly and insulin delivery statistics are not affected by this anomaly. Do not rely on the time duration reported for a Temporary Basal Rate setting at the date and time of those events. Chapter 6 71

78 My maximum basal rate is set to a rate greater than 25.5 units/hour 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 by this anomaly. Do not rely on the Maximum Basal Rate setting reported. I changed my insulin concentration setting Insulin Concentration setting changes on the 507C and 508 pump 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. The date, time and concentration of the Insulin Concentration change event are correctly reported. Do not rely on the Maximum Basal Rate setting, the Maximum Bolus setting and the basal insulin delivery profile reported on the day of the insulin concentration change. 72 Troubleshooting

79 Uninstalling the software The software can be removed using the uninstall feature of the Microsoft Windows desktop: 1. Click the START button. 2. Select Settings, and a list of options will appear. 3. Select and click on Control Panel. A menu of Control Panel options will appear. 4. Double click on the Add/Remove Programs option. 5. The Add/Remove program Properties window appears with the Install/Uninstall menu tab open. If not, click once on the Install/Uninstall tab to activate the menu. 6. Scroll through the list of software programs and click on the MM Solutions P&M 7.0 software. 7. Click the CHANGE/REMOVE button and the InstallShield Wizard Window will appear. 8. Select the Remove radio button and click the NEXT button to remove all installed components. 9. Click the OK button to confirm uninstall. 10. Click the YES button to remove read-only files. 11. Click the FINISH button. 12. The Solutions Pump & Meters software has now been removed. Note: Uninstalling the software will not remove or delete any existing patient files. Chapter 6 73

80 Download error messages The error messages are numbered 10 through 40. Note: There are no error message numbers, 11, 13, 21, and 22. Message #10: PC Communication Port not selected. Cause: Com-Port has not been selected. What to do: Select a ComPort from the Download Device screen. If the Com Port is not listed in the dropdown menu, see the section, Select a Valid ComPort, in this chapter. Message #12: Download FAILED! Cause: The meter was accidentally disconnected from the meter cable, the meter was turned On or Off while the meter was still downloading data or the software determined there was a problem with the data received from the meter. What to do: Check all meter cable connections. Verify that the meter cable is fully inserted into the meter port. Review the download instructions provided on screen for the meter to verify proper steps. Repeat download. 74 Troubleshooting

81 Message #14: Download FAILED! NO METER DETECTED. Review download instructions carefully - Try again. (See User Guide for Troubleshooting Help) Cause: Program is unable to communicate with the meter due to the following possibilities: the wrong meter is selected, the wrong meter is connected, the meter is not connected properly, or the meter is not set correctly for downloading. What to do: If connected to the Com-Station, check Com-Station cable connections. Verify Com-Station power switch is in the On position, and device selector switch is in the B position. Verify that the correct meter name is selected in the Download Device screen. Check that the meter communication cable is securely attached to the desired serial Com Port connector on the back of the PC. Verify that the meter cable is fully inserted into the meter port. Verify that the desired PC Communication Port, i.e. COM1, COM2, COM3 is selected in the Communication Port dropdown menu from the Download Device screen. Select the Communication Port that the meter cable is connected to on the PC. If the desired Com Port is not displayed on the dropdown menu then see section, Select a Valid Com Port, in this chapter. Use a different PC Communication Port if problems persist. See section, Select a Valid Com Port, in this chapter for information on checking the Com Port setup. Repeat download. Note: If using the Paradigm Link, BD Logic or the Bayer Elite XL meter, make sure it is not connected to the Com-Station. Message #15: Download FAILED! NO COM-STATION DETECTED...Please check Com-Station setup. Review download instructions carefully - Try again. (See User Guide for Troubleshooting Help) Cause: Program is unable to communicate with the Com-Station and cannot download the selected 507C or 508 pump. What to do: Check that the communication interface cable is securely attached to the desired serial Com Port connector on the back of the PC. Chapter 6 75

82 Check that the long communication interface cable is securely attached to the port A on the rear of the Com-Station. Make sure it is not connected to port B on the side of the Com-Station. Make sure the Com-Station power cable is connected to the power outlet and is plugged into the back of the Com-Station. The Com-Station power switch should be pressed down towards the ON position and the light should be glowing on the power switch. Make sure the Com-Station device selector switch is pressed down towards the Wave icon position. Verify that a 507C or 508 pump was selected from the Download Device screen. Verify a Com Port is selected, i.e. COM1, COM2, COM3 and that the same Com Port is connected on the PC. If the desired Com Port is not displayed on the dropdown menu then see section, Select a Valid Com Port, in this chapter. Use a different PC Communication Port if problems persist. See section, Select a Valid Com Port, in this chapter for information on checking the Com Port setup. Repeat download. Message #16: Pump Download FAILED! NO PUMP DETECTED. Please check the following: No Alarms, Suspend or Bolus in progress displayed on pump. Pump lying flat and face up in Com-Station cradle. (See User Guide for troubleshooting Help) Cause: Program is communicating with the Com-Station but there is no response from the selected 507C or 508 pump. What to do: If the current Basal rate is set to deliver greater than 15 units per hour, the pump may not download. See the pump user guide for instructions on setting temporary basal rates. Be sure to cancel the temporary basal setting following download. Clear any pump alarms. Verify pump is showing the main time and date screen. Cancel any boluses or cancel suspend on the pump. Replace batteries if lowbatt message is displayed on pump. Clean the small window lenses visible within the Com-Station cradle and on the back of the pump. Make sure pump is lying flat in the Com-Station cradle. Repeat download. 76 Troubleshooting

83 Message #17: Download FAILED! NO PARADIGM PUMP DETECTED...Please check the following: Verify S/N (serial number) entry matches pump and selected device name. Relocate ComLink and Paradigm pump away from PC. Review download instructions carefully - Try again. (See User Guide for Troubleshooting Help) Cause: Program is communicating with the ComLink but there is no response from the Paradigm pump. What to do: Verify the serial number on the back of the pump is correctly displayed on the download device screen. Verify the pump battery status is normal; if low, replace pump battery. Verify the ComLink is not directly attached to the PC but to the communication interface cable which is connected to the PC. Extend the communication interface cable the full length away from the PC and move it away from other possible sources of interference. Verify the pump is within 6 feet of the ComLink. Verify the pump is not in its carrying case. Make sure there is no radio frequency from other electronic devices preventing communication. These devices can include some cell phones, cordless phones, televisions, computers, radios and other Paradigm pumps and meters. To restore communication, move the ComLink and Paradigm pump away from these other devices or turn these other devices off. Move ComLink and pump away from possible sources of interference. If necessary, place ComLink and pump inside an aluminum container to create a shield and prevent interference from downloading. Repeat download. Message #18: Download FAILED! Pump battery status is Low. Replace batteries and try again. Cause: Batteries in pump are low. What to do: Replace batteries in pump. Repeat download. Chapter 6 77

84 Message #19: Download FAILED! Try Again. Please check pump first: Cancel SUSPEND if necessary. (See User Guide for Troubleshooting Help) Cause: The 508 pump was removed from the cradle while the pump was still downloading data or the software determined there was a problem with the data received from the pump. What to do: Ensure that the pump is out of Suspend mode prior to repeating the download. Do not remove the pump from the Com-Station while downloading data until the Download Complete message is displayed. Verify Com-Station power is turned on and that the Device Selector Switch is in the wave icon position. Clean the small window lenses visible within the Com-Station cradle and on the back of the pump. Make sure the pump is lying flat in the Com-Station cradle. Repeat download. Message #20: Download FAILED! Try Again. Please check pump first: Cancel SUSPEND if necessary. Reprogram AUTO OFF setting. (See User Guide for Troubleshooting Help) Cause: The 507C pump was removed from the cradle while the pump was still downloading data or the software determined there was a problem with the data received from the pump. What to do: Ensure the pump is out of Suspend mode prior to repeating the download. Do not remove the pump from the Com-Station while downloading data until the Download Complete message is displayed. Verify Com-Station power is turned on and that the Device Selector Switch is in the wave icon position. Clean the small window lenses visible within the Com-Station cradle and on the back of the pump. Make sure the pump is lying flat in the Com-Station cradle. Repeat download. 78 Troubleshooting

85 Message #23: Please enter the first 6 digits of the serial number for your Paradigm pump. Cause: No pump serial number was entered in the Download Device screen for downloading the Paradigm pump or less than the required 6 numbers were entered in the Paradigm Pump S/N field. What to do: Enter the first six digits of the serial number (S/N #) for the pump. The S/N can be found either on the back of the pump or near the bottom of the pump Status screen. Verify that all six digits are properly entered in the Download Device screen. Message #24: Maximum number of device downloads completed. Cannot download any more devices to this file. Cause: A pump and six meters have already been downloaded to this patient file. What to do: Click the OK button to clear this message. Click the CLOSE button to exit the Download Device screen. Close the existing patient file and save the existing patient file to disk prior to closing when prompted. Click the LIST button and select the patient record belonging to the patient pump or meter desired for downloading. Click the DOWNLOAD button to display the Download Device screen and select the desired pump or meter for downloading. Message #25: Maximum number of meter downloads completed. Cannot download any more meters to this file. Cause: This message displays if six meters have already been downloaded to the patient file. What to do: Click the OK button to clear the message. Click the CLOSE button to exit the Download Device screen. Close the existing patient file and save the existing patient file to disk prior to closing when prompted. Chapter 6 79

86 Click the LIST button and select the patient record belonging to the patient meter desired for downloading. Click the DOWNLOAD button to display the Download Device screen and select the desired meter for downloading. Message #26: Maximum number of pump downloads completed. Cannot download any more pumps to this file. Cause: This message alerts you that a pump has already been downloaded to this patient file. Only one pump can be successfully downloaded to a single patient file. It is not possible to download another pump to this open patient file. What do to: Click the OK button to clear the message. Click the CLOSE button to exit the Download Device screen. Close the existing patient file and save the existing patient file to disk prior to closing when prompted. Click the LIST button and select the patient record belonging to the patient pump desired for downloading. Click the DOWNLOAD button to display the Download Device screen and select the pump for downloading. Message #27: Pump Download FAILED! NO COMLINK DETECTED... Please check the following: Verify PC Com Port setting and ComLink connection. Review download instructions carefully - Try again. (See User Guide for Troubleshooting Help) Cause: Program is unable to communicate with the ComLink and cannot download the Paradigm pump. What to do: Check that the communication interface cable is securely attached to the desired serial Com Port connector on the back of the PC. Verify the ComLink is attached to the communication interface cable. Verify a Com Port is selected, i.e. COM1, COM2, COM3 and that the same Com Port is connected on the PC. If the desired Com Port is not displayed on the dropdown menu then see section, Select a Valid Com Port, in this chapter. 80 Troubleshooting

87 Use a different PC Com Port if problems persist. See section, Select a Valid Com Port, in this chapter for information on checking the Com Port setup. Repeat download. Message #28: Pump Download FAILED! COMMUNICATION INTERRUPTED...Please check the following: Relocate ComLink and Paradigm pump away from PC. Move ComLink and pump closer to each other. Cancel SUSPEND if necessary. (See User Guide for Troubleshooting Help) Cause: Program communicating with ComLink and the Paradigm pump but the communication between the ComLink and the pump was interrupted during downloading. What to do: Verify the ComLink is not directly attached to the PC but to the communication interface cable which is connected to the PC. Extend the communication interface cable the full length away from the PC and move it away from other possible sources of interference. Verify the pump is within 6 feet of the ComLink. Verify the pump is not in its carrying case. Move ComLink and pump away from possible sources of interference. If necessary, place ComLink and pump inside an aluminum container to create a shield and prevent interference from downloading. Repeat download. Message #29: Device is not supported. Please replace the device and try again. Cause: Attempted to download a 407C pump or other unsupported device. What to do: Refer to Chapter 1, Introduction, for list of supported devices. Message #30: Meter and PC clocks differ by - greater than 1 day. Data in device memory may not be synchronized with local time and other downloaded devices. This can affect the accuracy of reports! Continue Download? Cause: The date and time setting on the meter are not set correctly to within 1 day of the PC date and time setting. Chapter 6 81

88 Note: The date and time settings for existing data already stored in meter memory cannot be revised by changing the meter date/time. When continuing the download, the downloaded meter data may not accurately represent the date and times the meter values were actually taken. This can impact the accuracy of some glucose statistics and the correlation of values with insulin data at various times of the day or by date. Future readings taken with the meter following adjustment of the meter date and time settings will be correctly displayed and reported according to the actual time the results were taken. Meters can hold several hundred meter values in memory. Note in your manual logbook the old date and time on your meter display along with the new date and time updated on your meter display so that this information can be used in evaluating future downloaded meter data. Use careful judgment in reviewing glucose values taken prior to this latest date and time adjustment. What to do: Click the YES button to continue the download or the NO button to cancel the download. Verify that the date and time are set correctly on your PC and your meter and adjust accordingly. Verify the meter is set correctly for AM verses PM, if using a 12 hour clock. Message #31: Pump and PC clocks differ by - greater than 1 day. Data in device memory may not be synchronized with local time and other downloaded devices. This can affect the accuracy of reports! Continue Download? Cause: The date and time setting on the pump are not set correctly to within 1 day of the PC date and time setting. Note: The date and time settings for existing data already stored in pump memory cannot be revised by changing the pump date/time. When continuing the download, the downloaded pump data may not accurately represent the date and times the recorded insulin amounts were actually taken. This can impact the accuracy of certain insulin statistics and the correlation of values with glucose data at various times of the day or by date. Future values stored in pump memory following adjustment of the pump date and time settings will be correctly displayed and reported according to the actual time insulin was taken. The pump can hold several hundred values in memory. Note in your manual logbook the old date and time on your pump display along with the new date and time updated on your pump display so that this information can be used in evaluating future downloaded pump data. Use careful judgment in reviewing insulin values recorded prior to this latest date and time adjustment. 82 Troubleshooting

89 Check the Logbook History report using the 12 week Report Range for a pump event noting any date/time setting change with the old and the new settings reported. What to do: Click the YES button to continue the download or the NO button to cancel the download. Verify that the date and time are set correctly on your PC and your pump and adjust accordingly. Verify the pump is set correctly for AM verses PM, if using a 12 hour clock. Message #32: Meter and PC clocks differ by - greater than 5 minutes: Data in device memory may not be synchronized with local time and other downloaded devices. This can affect the accuracy of the reports! Continue download? Cause: The date and time setting on the meter are not set correctly to within 5 minutes of the PC date and time setting. Note:The date and time settings for existing data already stored in meter memory cannot be revised by changing the meter date/time. When continuing the download, the downloaded meter data may not accurately represent the date and times the meter values were actually taken. This can impact the accuracy of some glucose statistics and the correlation of values with insulin data at various times of the day or by date. Future readings taken with the meter following adjustment of the meter date and time settings will be correctly displayed and reported according to the actual time the results were taken. Meters can hold several hundred meter values in memory. Note in your manual logbook the old date and time on your meter display along with the new date and time updated on your meter display so that this information can be used in evaluating future downloaded meter data. Use careful judgment in reviewing glucose values taken prior to this latest date and time adjustment. What to do: Click the YES button to continue the download or the NO button to cancel the download. Verify that the date and time are set correctly on your PC and your meter and adjust accordingly. Verify the meter is set correctly for AM verses PM, if using a 12 hour clock. Chapter 6 83

90 Message #33: Pump and PC clocks differ by - greater than 5 minutes. Data in device memory may not be synchronized with local time and other downloaded devices. This can affect the accuracy of reports! Continue download? Cause: The date and time setting on the pump are not set correctly to within 5 minutes of the PC date and time setting. Note: The date and time settings for existing data already stored in pump memory cannot be revised by changing the pump date/time. When continuing the download, the downloaded pump data may not accurately represent the date and times the recorded insulin amounts were actually taken. This can impact the accuracy of certain insulin statistics and the correlation of values with glucose data at various times of the day or by date. Future values stored in pump memory following adjustment of the pump date and time settings will be correctly displayed and reported according to the actual time insulin was taken. The pump can hold several hundred values in memory. Note in your manual logbook the old date and time on your pump display along with the new date and time updated on your pump display so that this information can be used in evaluating future downloaded pump data. Use careful judgment in reviewing insulin values recorded prior to this latest date and time adjustment. Check the Logbook History report using the 12 week Report Range for a pump Event noting any date/time setting change with the old and the new settings reported. What to do: Click the YES button to continue the download or the NO button to cancel the download. Verify that the date and time are set correctly on your PC and your pump and adjust accordingly. (See the pump User Guide for instructions on changing the pump date and time). Verify the pump is set correctly for AM verses PM, if using a 12 hour clock. Message #34: No BD-USB Cable detected! Connect BD meter cable to USB port. Try Again. Cause: Either the BD Meter cable is not connected to USB Port, or the windows operating system does not support BD-USB cable operation. What to do: Verify the BD meter cable is connected to the USB port. 84 Troubleshooting

91 If using Win95 or Win NT, your operating system is not compatible for BD-USB driver functionality. Obtain a BD meter serial cable for use with BD Logic and Paradigm Link. Message #35: Pump Download FAILED! NO PARADIGM LINK COMMUNICATION DETECTED. Verify PC Com Port setting and Paradigm Link Meter connection. Remove and reattach cable to meter strip port. Review download instructions carefully - Try again. (See User Guide for Troubleshooting Help) Cause: Program is unable to communicate with the Paradigm Link and cannot download the Paradigm pump. What to do: Check that the BD meter cable is securely attached to the desired Com Port connector on the back of the PC. Verify the meter is Off and the BD cable is fully inserted into the Paradigm Link meter strip port. Place the meter and cable on a flat surface. Remove and re-attach the BD cable to the meter strip port. Verify a Com Port is selected, i.e. COM1, COM2, COM3, or BD-USB and that the same Port is connected on the PC. If the desired Com Port is not displayed on the dropdown menu then see section, Select a Valid Com Port, in this chapter. If using the BD meter USB data cable select BD-USB from the Communications Port dropdown menu. Repeat download. Check the Paradigm Link meter battery and replace if low. Message #36: Pump Download FAILED! NO PARADIGM PUMP DETECTED..., Please check the following: Verify S/N (serial number) entry matches pump and selected device name. Relocate Paradigm Link meter and Paradigm pump away from PC. Review download instructions careful -Try again. (See User Guide for Troubleshooting Help) Cause: Program is communicating with the Paradigm Link but there is no response from the Paradigm pump. What do to: Verify that the correct pump name is selected in the Download Device screen. Cancel any boluses or cancel suspend on the pump. Position Paradigm Link and pump away from PC. Chapter 6 85

92 Verify the serial number on the back of the pump is correctly displayed on the download menu screen. Verify the pump battery status is normal; if low, replace pump battery. Extend the BD meter cable and the meter the full length away from the PC and move it away from other possible sources of interference. Verify the pump is within 6 feet of the Paradigm Link. Verify the pump is not in its carrying case. Repeat download. Message #37: Meter Download FAILED! NO PARADIGM LINK METER DETECTED. Verify PC Com Port setting and Paradigm Link Meter connection. Remove and reattach cable to meter strip port. Review download instructions carefully - Try again. (See User Guide for Troubleshooting Help) Cause: Program is unable to communicate with the Paradigm Link due to the following possibilities: the wrong meter is selected, the wrong meter is connected, the Paradigm Link is not connected properly, or the meter is not set correctly for downloading. What to do: Verify that the correct meter name is selected in the Download Device screen. Check that the meter communication cable is securely attached to the desired Com Port connector on the back of the PC. Verify the meter is Off and the BD cable is fully inserted into the Paradigm Link meter strip port. Place the meter and cable on a flat surface. Remove and re-attach the BD cable to the meter strip port. Check the Paradigm Link meter battery and replace if low. Message #38: Meter Download FAILED! NO BD LOGIC METER DETECTED. Verify PC Com Port setting. Review download instructions carefully - Try again. (See User Guide for Troubleshooting Help) Cause: Program is unable to communicate with the BD Logic meter due to the following possibilities: the wrong meter is selected, the BD Logic meter is not connected properly, or the BD Logic meter is not set correctly for downloading. 86 Troubleshooting

93 What to do: Verify that the correct meter name is selected in the Download Device screen. Check that the meter communication cable is securely attached to the desired Com Port connector on the back of the PC. Verify the meter is Off and the BD cable is fully inserted into the BD Logic meter strip port. Place the meter and cable on a flat surface. Remove and re-attach the BD cable to the meter strip port. Check the BD Logic meter battery and replace if low. Message #39: Download FAILED! NO METER DETECTED. Please check Com- Station setup. Review download instructions carefully - Try again. (See User Guide for Troubleshooting Help) Cause: Program is unable to communicate with the meter due to the following possibilities: the wrong meter is selected, the wrong meter is connected, the meter is not connected properly, or the meter is not set correctly for downloading. What to do: If connected to the Com-Station, check Com-Station cable connections. Verify Com-Station power switch is in the On position, and device selector switch is in the B position. Verify that the correct meter name is selected in the Download Device screen. Check that the meter communication cable is securely attached to the desired serial Com Port connector on the back of the PC. Verify that the meter cable is fully inserted into the meter port. Verify that the desired PC Communication Port, i.e. COM1, COM2, COM3 is selected is in the Communication Port dropdown menu from the Download Device screen. Select the Communication Port that the meter cable is connected to on the PC. If the desired Com Port is not displayed on the dropdown menu then see section, Select a Valid Com Port, in this chapter. Chapter 6 87

94 Use a different PC Communication Port if problems persist. See section, Select a Valid Com Port, in this chapter for information on checking the Com Port setup. Repeat download. Note: If using the Paradigm Link, BD Logic or the Bayer Elite XL meter make sure it is not connected to the Com-Station. Message #40: Pump Download FAILED! COMMUNICATION INTERRUPTED..., Please check the following: Relocate Paradigm Link meter and Paradigm pump away from PC. Move Paradigm Link and pump closer to each other. Cancel SUSPEND if necessary. (See User Guide for Troubleshooting Help) Cause: Program is communicating with the Paradigm Link and the Paradigm pump but the communication between the Paradigm Link and the Paradigm pump was interrupted during downloading. What to do: Extend the BD meter cable and the meter the full length away from the PC and move it away from other possible sources of interference. Verify the pump is within 6 feet of the ComLink. Verify the pump is not in its carrying case. Move Paradigm Link and pump away from possible sources of interference. Verify the meter is Off and the BD cable is fully inserted into the Paradigm Link meter strip port. Place the meter and cable on a flat surface. Remove and re-attach the BD cable to the meter strip port. Repeat download. 88 Troubleshooting

95 Icon table The icons and symbols on the packaging labels and the equipment are described in the table that follows. One Per Container/Package Attention: See Instructions for Use (1x) CD enclosed Important documents enclosed Catalogue number CE mark by notified body as a medical device REF 0459 Chapter 6 89

96 90 Troubleshooting

97 Software license agreement BY INSTALLING, COPYING OR OTHERWISE USING THIS SOFTWARE YOU ARE CONSENTING TO BE BOUND BY THIS AGREEMENT. IF YOU DO NOT AGREE TO ALL OF THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE COMPLETE SOFTWARE PACKAGE AND THE ACCOMPANYING ITEMS (INCLUDING WRITTEN MATERIALS) TO THE PLACE YOU OBTAINED THEM. 1. Definitions: Medtronic MiniMed means Medtronic MiniMed, Inc. Software means the computer program contained in this package and all updates to the computer program. The term also includes all copies of any part of the computer program. Documentation means the User Guide and any other printed materials accompanying the Software. Product means the Software and Documentation. 2. Grant of License and Scope of Grant Medtronic MiniMed grants you a personal, nonexclusive license to: use the Software on a single computer; use the Software on a network, provided that each person accessing the Software through the network must have a separate copy of the Software licensed to that person; use the Software on a second computer so long as only one copy is used at a time; make one copy of the Software for archival purposes, or copy the Software onto the hard disk of your computer and retain the original for archival purposes. Under the scope of this nonexclusive license, you may not: permit other individuals to use the Software except under the terms listed above; permit concurrent use of the Software except under the terms listed above; modify, translate, reverse engineer, decompile, disassemble (except to the extent applicable laws specifically prohibit such restriction), or create derivative works based on the Software; copy the Software other than as specified above; sublicense, rent, lease, grant a security interest in, or otherwise transfer rights to the Software; or remove any proprietary notices or labels on the Software. 3. Disclaimer of Warranties To the maximum extent permitted by applicable law, Medtronic MiniMed reserves all rights not expressly granted to you. Medtronic MiniMed may cancel this License Agreement if 91

98 you do not abide by all of the terms and conditions of the License Agreement, in which case you must destroy all copies of the Product and its component parts. Any written or oral information or advice given by Medtronic MiniMed dealers, distributors, agent, or employees will in no way increase the scope of this warranty. Notwithstanding any damages that you might incur for any reason whatsoever, the entire liability of Medtronic MiniMed under any provision of this License Agreement and your exclusive remedy will be, at the sole option of Medtronic MiniMed, replacement of the Product or Medtronic MiniMed's reasonable effort to make the Product meet the warranty set forth above. The limitations, exclusions and disclaimers herein shall apply to the maximum extent permitted by applicable law, even if any remedy fails its essential purpose. MEDTRONIC MINIMED MAKES NO EXPRESS WARRANTY AND MEDTRONIC MINIMED EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WARRANTIES OF MERCHANTABILITY, OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF NONINFRINGEMENT OF THIRD PARTIES' RIGHTS. NO MEDTRONIC MINIMED DEALER, AGENT OR EMPLOYEE IS AUTHORIZED TO MAKE ANY MODIFICATIONS, EXTENSIONS, OR ADDITIONS TO THIS WARRANTY. If any modifications are made to the Software by you during the warranty period, if the Product is subjected to accident, abuse, or improper use; or if you violate the terms of this Agreement, then this warranty shall immediately be terminated. 4. No Liability for Consequential Damages To the maximum extent permitted by applicable law, in no event shall Medtronic MiniMed, its employees, agents, subcontractors or suppliers be liable for any special, incidental, consequential or punitive damages whatsoever (including without limitation, damages for loss of profits, business interruption, loss of information, or other pecuniary loss) arising out of, or in any way related to, the use of or inability to use this Medtronic MiniMed Product, even in the event of fault, tort (including negligence), strict liability, breach of contract or breach of warranty of Medtronic MiniMed, and if Medtronic MiniMed has been advised of the possibility of such damages. 5. No Medical Advice This Product should be used solely in conjunction with the consultation of a physician familiar with the diagnosis and treatment of diabetes. THIS PRODUCT DOES NOT PROVIDE ANY MEDICAL ADVICE WHATSOEVER AND MAY NOT BE RELIED UPON FOR SUCH PURPOSE. By use of this Product, the user agrees to indemnify and hold Medtronic MiniMed harmless from any claim, liability, suit or damages sought from or brought against Medtronic MiniMed (including reasonable attorney's fees and the allocable cost of in-house counsel) and arising as a result of the use of the Software. 6. Copyright/Proprietary Protection 92 Software license agreement

99 The Product is owned by Medtronic MiniMed and is protected by United States and International Copyright laws and international trade provisions. Medtronic MiniMed may have patents, patent applications, trademarks, copyrights or other intellectual property rights covering subject matter in this document. Except as expressly provided in this license agreement, you do not have any license to these patents, trademarks, copyrights, or other intellectual property. 93

100 94 Software license agreement

101 Index A Assistance 2 C CD handling instructions 2 Clinic info tab 14 Com-Station 1 Contraindications 2 D delete a file 20 Download C or 508 insulin pump 31 before downloading 27 before downloading meters 32 meters connected directly to the PC 34 meters using the Com-Station 33 Paradigm pump 28 paradigm pump using Paradigm Link 29 using BD-USB cable 35 E Edit a file 19 error messages 74 F Files open 21 previous version 22 renaming 23 saving 22 Front Page 7 G General glucose range limits 12 glucose units 11 initial report display 11 initial report range 11 new patient time periods 11 time display 11 General tab 10 I Indications for use 2 M Main screen 8 MediSense 1 Meters Bayer 1 Glucometer DEX 1, 32 Glucometer DEX 2 1, 32 Glucometer Elite XL 1, 32 Becton Dickinson 1 BD Logic 1, 32 Lifescan 1 OneTouch Fast Take 1 OneTouch Fasttake 32 OneTouch Profile 1, 32 OneTouch Ultra 1, 32 MediSense Precision Xtra 1, 32 Medtronic MiniMed 1 Paradigm Link 1, 2, 32 Roche Diagnostics 1 Accu-chek Complete 1, 32 TheraSense 1 FreeStyle 1, 32 meters 33 N new patient record 15 P Paradigm Link 1 Patient information screen 17 Patient records list 18 Print current report 25 95

102 R date 26 reports 24 selected report 25 Reports current settings report 38 daily averages trend report 59 daily summary report 45 logbook diary report 43 logbook history report 40 modal day hourly intervals report 53 modal day scatter report 50 modal day time periods report 55 modal week daily intervals report 57 pie/histogram report 61 Printing 13 Sensor daily overlay report 63 Sensor data table report 62 Sensor summary report 64 viewing 37 Roche Diagnostics Accu-Chek Advantage 1, 32 S sensor daily overlay report 63 Sensor summary report 64 Setup preferences 10 T Troubleshooting 67 W Warnings 2 96 Index