Abbott Diabetes Care AV2-C Insulin Pump/Glucose Meter Transmitter User Manual 2 of 2
Abbott Diabetes Care Insulin Pump/Glucose Meter Transmitter 2 of 2
Contents
- 1. Regulatory statement
- 2. User manual 1 of 2
- 3. User manual 2 of 2
User manual 2 of 2
Section 6: When You’re Ready – Optional Settings 6.4 Enter Event Data Section 6: When You’re Ready – Optional Settings 6.4 Enter Event Data 6.4 Enter Event Data Purpose To enter event data into your Aviator Companion for a record of event history. When Do this procedure: • When you wish to enter insulin, meals, exercise, state of health, or generic event data into your companion. Materials • Your companion operating with all settings programmed. • Your pump operating with all settings programmed. • Assistance from healthcare professional as needed. Helpful Information Do This 2. Go to the INSULIN menu. a. Notice INSULIN is highlighted. b. Press Enter button. c. Notice Type is highlighted. d. Press Enter button. e. Scroll to select insulin type (Rapid, Intermediate, Pre-Mix, Long Acting, ShortActing, Inhaled) f. • You can ONLY perform this task using your companion. You CANNOT enter event data using your pump. Procedure: Press Enter button. g. Scroll to highlight Units. h. Press Enter button. i. Steps Do This 1. Access the SELECT EVENT menu. a. From the Home screen, notice Main is highlighted. b. Press Enter button. d. Press Enter button to go to SELECT EVENT menu. e. Decide what event you want to add. If you are adding an event for Then do this Insulin Go to Step 2. Food Go to Step 3. Exercise Go to Step 4. State of Health Go to Step 5. Generic Go to Step 6. 131 Scroll to select the units of insulin. Note: The range is 0.00 to 99.50. j. c. Scroll to highlight ADD EVENT. DOC15736_Rev-A-Man.indd 131-132 Steps Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. k. Scroll to highlight Done. l. Press Enter button to return to the Home screen. You have completed adding an insulin event. 132 2/9/09 11:29:46 AM Section 6: When You’re Ready – Optional Settings 6.4 Enter Event Data Steps Section 6: When You’re Ready – Optional Settings 6.4 Enter Event Data Do This Steps Do This a. Scroll to highlight FOOD. 4. Go to the EXERCISE menu. a. Scroll to highlight EXERCISE. 3. Go to the FOOD menu. b. Press Enter button. c. Notice Type is highlighted. b. Press Enter button. Note: You can just enter the exercise type and NOT the duration or intensity. d. Press Enter button. c. Notice Type is highlighted. e. Scroll to select meal type (Breakfast, Lunch, Dinner, and Snack). d. Press Enter button. f. e. Scroll to select exercise type (Aerobics, Walking, Jogging, Running, Swimming, Biking, Weights, or Other). Press Enter button. g. Notice Carbs (CARBOHYDRATE) is highlighted. f. h. Press Enter button. g. Scroll to highlight Duration. i. h. Press Enter button. Scroll to select the amount of Carbs. Note: The range is 0 to 350 grams. j. Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. k. Scroll to highlight Done. l. Press Enter button to return to the Home screen. You have completed adding a meal event. i. Press Enter button. Scroll to select the exercise duration. Note: The range is 0:00 to 5:00 hours. j. Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. k. Scroll to highlight Intensity. l. Press Enter button. m. Scroll to select exercise intensity (Low, Medium, High, None). n. Press Enter button. o. Scroll to highlight Done. p. Press Enter button to return to the Home screen. You have completed adding an exercise event. 133 DOC15736_Rev-A-Man.indd 133-134 134 2/9/09 11:29:46 AM Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Steps 5. Go to the STATE OF HEALTH menu. Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Do This Steps Do This a. Scroll to highlight STATE OF HEALTH. 6. Go to the GENERIC menu. a. Scroll to highlight GENERIC. b. Press Enter button. b. Press Enter button. Note: You can enter up to eight generic events. c. Notice State is highlighted. d. Press Enter button. c. Notice Event is highlighted. e. Scroll to select state of health (Normal, Cold, Sore Throat, Infection, Tired, Stress, Fever, Flu, Allergy, Period, Dizzy, Alcohol, Low Symptoms, or High Symptoms). d. Press Enter button. f. e. Scroll to select event number. Note: The range is 1 to 8. You need to define what the generic events 1 to 8 means and record in your Table of Settings in Section 12-Appendix A. Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. f. Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. g. Scroll to highlight Done. h. Press Enter button to return to the Home screen. g. Scroll to highlight Done. h. Press Enter button to return to the Home screen. You have completed adding a state of health event. You have completed adding a generic event. 7. Check your work. 135 DOC15736_Rev-A-Man.indd 135-136 Go back to each event menu to see if you have the correct information added. 136 2/9/09 11:29:46 AM Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports 6.5 Review History, Status, and Reports Purpose When Materials To review important system and diabetes care information using your Aviator Companion. Do this procedure when you need detailed information about: • • • • • • • • • • • • • • • Bolus status (up to 30 days) Basal status (up to 30 days) System status Pump levels Companion levels Pump version Companion version Bolus History BG History Line Graph BG Statistics Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Procedure: Steps 1. Decide if you need to review system status or reports. Do This If you are reviewing Then do this Last Bolus Status Basal Status System Status (Battery/Insulin levels) Pump Levels Companion Levels Pump Version Companion Version Go to Step 2 - STATUS menu. Bolus History BG History Line Graph BG Statistics Event History Pump Diary (Therapy, Events, Alarms) Go to Step 3 - REPORTS menu. Event History (up to 150 most recent events) Pump Diary (Therapy, Events, Alarms) Your companion and pump fully operating. Assistance from healthcare professional as needed. Helpful Information • If you need to call Customer Care, you may be asked to provide information from your companion or pump screens. • If you have unexplained high or low blood glucose, review your recent bolus history to see if you missed delivering a bolus or if you delivered an incorrect dose (see Section 11), as well as review your basal rates and daily totals to assist you or your healthcare professional to resolve the cause of the observation. • 137 DOC15736_Rev-A-Man.indd 137-138 138 2/9/09 11:29:46 AM Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Steps 2. Go to the STATUS menu. Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Steps Do This Note: The following screens will appear when the system is paired, Radio is ON, and pump communication is available. a. From the Home screen, Notice Main is highlighted. b. Press Enter button. Note: You can also access System Status screens from the System Status panel. c. Scroll to highlight STATUS. d. Press Enter button. e. Review the bolus status. f. Notice Next is highlighted. Note: You can scroll to highlight Done and Press Enter button to return to the MAIN MENU screen at any time. Do This q. Review the pump’s version. Note: The version numbers displayed on your system may be different. r. Notice Next is highlighted. s. Press Enter button. t. Review the companion’s version. u. Decide whether to return to MAIN MENU or Home screen. If Then do this MAIN MENU Notice Next is highlighted. Press Enter button. Home screen Scroll to highlight Done. Press Enter button.. You have completed reviewing status information about your pump. g. Press Enter button. h. Review the basal status. i. Notice Next is highlighted. j. Press Enter button. k. Review the pump’s battery and insulin levels. l. Notice Next is highlighted. m. Press Enter button. n. Review the companion’s battery level. o. Notice Next is highlighted. p. Press Enter button. Continued on next page. 139 DOC15736_Rev-A-Man.indd 139-140 140 2/9/09 11:29:46 AM Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Steps 3. Go to the REPORTS menu. Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Do This Steps Do This 4. View Bolus History. a. Scroll to highlight BOLUS HISTORY. a. From the Home screen, Notice Main is highlighted. b. Press Enter button. b. Press Enter button. c. Review your bolus history starting from the most recent bolus. c. Scroll to highlight REPORTS. d. Notice Next is highlighted. d. Press Enter button. e. Press Enter button to review another bolus. Note: The pump screen will only display Bolus History, Pump Diary, and Send Diary. e. Decide what to review. f. Press Enter button on Next to review as many bolus records as needed. If you are reviewing Then do this Bolus History Go to step 4. g. Highlight Done when you have reviewed enough bolus history records. BG History Go to Step 5. h. Press Enter button to return to the Home screen. Line Graph Go to Step 6. BG Statistics Go to Step 7. Event History Go to Step 8. Pump diary including Go to Step 9. therapy, events, and alarms You have completed reviewing your Bolus history. 5. View BG History. a. Scroll to highlight BG HISTORY. b. Press Enter button. c. Scroll to review your blood glucose readings. d. Press Enter button when you are done reviewing. e. Notice Done is highlighted. f. Press Enter button to return to the Home screen. You have completed reviewing your BG history. 141 DOC15736_Rev-A-Man.indd 141-142 142 2/9/09 11:29:47 AM Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Steps Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Do This Steps 6. View BG Line Graph. Do This 7. View BG Statistics. a. Scroll to highlight LINE GRAPH. a. Scroll to highlight BG STATISTICS. b. Press Enter button. b. Press Enter button. c. Review your blood glucose line graph. c. Scroll to review your blood glucose information for 7, 14, or 21 days as needed. d. Press Enter button. e. Scroll to select the time period to display on the line graph. (If a 4 hour time range is selected, then the bottom scroll displays data in 4 hour time periods from 12am to 11pm), and press Enter button. f. d. Press Enter button when you are done reviewing. Notice the time period highlighted at the bottom of the line graph. Press Enter button again to use the scroll to select a specific time period to view, for example, 5pm to 6pm. e. Notice Done is highlighted. f. Press Enter button to return to the Home screen. g. Press Back button to return to the REPORTS menu. You have completed reviewing your BG statistics. You have completed reviewing your BG line graph. 8. View Event History. a. Scroll to highlight EVENT HISTORY. b. Press Enter button. 143 DOC15736_Rev-A-Man.indd 143-144 144 2/9/09 11:29:47 AM Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Steps Section 6: When You’re Ready – Optional Settings 6.5 Review History, Status, and Reports Do This Steps Do This 9. View Pump Diary. a. Notice PUMP DIARY is highlighted. c. Scroll to select (View All, Insulin, Food, Exercise, State of Health, or Generic) event history to review. b. Press Enter button. c. Decide whether to view therapy, events, or alarms. Note: You can review up to the last 150 events, starting from the most recent events. d. Press Enter button. Note: Press the Back button to go backwards to a previous screen. 10. Review Therapy amounts. If you want to review Then do this Insulin therapy amounts Go to Step 10. Pump events Go to Step 11. Alarm history Go to Step 12. a. Notice Therapy is highlighted. b. Press Enter button. c. Review the bolus and basal insulin units, and basal percentage. d. Notice Next is highlighted. e. Press Enter button. Note: You can scroll to highlight Done and Press Enter button to return to the Home screen at any time. Note: If you want to go back to previous therapy screens, press the Back button. You can press Enter button on Next to go through all the therapy screens logged on the pump. When you press Enter button for the Next action on the last therapy screen, you will return to the PUMP DIARY screen. e. Press Enter button when you reach the end of data. f. Notice Done is highlighted. You have completed reviewing your insulin therapy amounts. g. Press Enter to return to the Home screen. You have completed reviewing your Event history. 145 DOC15736_Rev-A-Man.indd 145-146 146 2/9/09 11:29:47 AM Section 6: When You’re Ready – Optional Settings 6.6 Upload Data Steps 11. Review Events. Section 6: When You’re Ready – Optional Settings 6.6 Upload Data Do This Steps Note: Pump diary events provide information about your basal delivery programs and basal rates. Do This 12. View Alarms history. a. Scroll to highlight Alarms. b. Press Enter button. a. Scroll to highlight Events. b. Press Enter button. c. Review the basal delivery events that have occurred on your pump. c. Review the alarm history of your pump. d. Notice Next is highlighted. d. Notice Next is highlighted. Note: You can scroll to highlight Done and Press Enter button to return to the Home screen e. Press Enter button on Next to review your last 10 alarms as needed. e. Press Enter button on Next to review as many events as you need. Note: If you want to go back to previous event screens, press the Back button. f. When you are done reviewing, scroll to highlight Done. g. Press Enter button to return to the Home screen. You have completed reviewing the alarm history of your pump. f. When you are done reviewing, scroll to highlight Done. g. Press Enter button to return to the Home screen. 13. Check your work. You are able to obtain all information related to your companion and pump status and reports following the steps above. You have completed reviewing your pump events. 147 DOC15736_Rev-A-Man.indd 147-148 148 2/9/09 11:29:47 AM Section 6: When You’re Ready – Optional Settings 6.7 Companion Self Test 6.6 Section 6: When You’re Ready – Optional Settings 6.7 Companion Self Test Upload Data Purpose When Materials To upload event data from your companion to your computer. Do this procedure: Steps Do This 3. Check your work. a. Check that uploaded data is displayed on the CoPilot for FreeStyle Aviator screen. • When you wish to upload data from your companion to your computer. • Your companion and pump fully operating. • Assistance from healthcare professional as needed. Helpful Information • You will perform this task using the companion. • Make sure the USB cable is connected and the battery is charging. WARNING: Use ONLY the USB cable provided. Use of an unapproved cable may lead to loss of electromagnetic compatibility, and make the system more susceptible to electronic interference. Procedure: Steps Do This 1. Go to the Home screen. a. Follow instructions detailed in the CoPilot for FreeStyle Aviator user’s guide to perform the data upload 2. Upload data. a. The Aviator Companion will display the data transfer screen during the data transfer process. 149 DOC15736_Rev-A-Man.indd 149-150 150 2/9/09 11:29:47 AM Section 6: When You’re Ready – Optional Settings 6.7 Companion Self Test Section 6: When You’re Ready – Optional Settings 6.8 Pair Companion and Pump 6.7 Companion Self Test Purpose To perform a self test for the Aviator Companion to ensure that the display, audio, vibrator, backlight, test light, and memory functions are working. When Do this procedure: • Before you set up and use your companion and pump for the first time. • When you wish to self test the companion because you are NOT sure if all the Steps Do This 2. Observe Self Test. a. Check the display (the display will highlight). Note: The display automatically advances through the sequence of screens at a rate of 0.5 seconds per screen. functions are working properly. • Anytime you see the Low Battery Alert screen. Materials • Your companion operating with all settings programmed. • Assistance from healthcare professional as needed. b. Confirm audio sounds (you will hear beeps). Procedure: Steps Do This 1. Go to the SETUP menu. a. From the Home screen, notice Main is highlighted. c. Confirm vibrator (you will feel short vibes). b. Press Enter button. c. Scroll to highlight SETUP. d. Confirm backlight (the backlight turns on). d. Press Enter button. e. Scroll to highlight SELF TEST. f. e. Confirm test light (the test light turns on). Press Enter button. f. Check memory. Note: You will automatically return to the SETUP menu, and Home screen if no other actions are taken. 151 DOC15736_Rev-A-Man.indd 151-152 152 2/9/09 11:29:48 AM Section 6: When You’re Ready – Optional Settings 6.8 Pair Companion and Pump Section 6: When You’re Ready – Optional Settings 6.8 Pair Companion and Pump 6.8 Pair Companion and Pump Steps Do This 3. Check your work. Confirm that ALL functions are working properly when you performed the companion self-test. Call Customer Care, if any of the functions are NOT working, or you get a “Companion Memory Error” warning. Caution: If your pump audio or vibratory annunciators are not functioning, switch to insulin injections immediately AND contact your healthcare professional and/or Customer Care. Purpose When Materials To pair your Aviator Companion and Aviator Pump to operate as a system. Do this procedure: • • • • When you receive a new companion or pump that’s a replacement for your system. Your companion fully charged. Your pump with battery installed and initialized. Assistance from healthcare professional as needed. Helpful Information • Pairing establishes an association of your pump with your companion so that the two will only communicate with each other. • Your companion and pump should already be paired when you receive your FreeStyle Aviator System package. • The RF will automatically turn ON when pairing, if it is NOT already on. Procedure: Steps Do This 1. Go to the Companion’s SETUP menu. Note: The following steps are performed using your companion. a. Notice Main is highlighted. b. Press Enter button. c. Scroll to highlight SETUP. d. Press Enter button. 153 DOC15736_Rev-A-Man.indd 153-154 154 2/9/09 11:29:48 AM Section 6: When You’re Ready – Optional Settings 6.8 Pair Companion and Pump Steps 2. Go to the Companion’s PAIR PUMP menu to prepare the Companion. Section 6: When You’re Ready – Optional Settings 6.8 Pair Companion and Pump Do This Steps Do This a. Scroll to highlight PAIR PUMP. 4. Go to the Pump’s PAIR DEVICE menu to prepare the Pump. a. Scroll to highlight PAIR DEVICE. b. Press Enter button. b. Press Enter button. c. Notice PUMP screen is searching for companions. c. Notice CONFIRM screen with “Is Pump ready?” message displays. d. Notice No is highlighted. 3. Go to the Pump’s SETUP menu. Note: The following steps are performed using your pump. a. Notice Main is highlighted. b. Press Enter button. 5. Go to the Companion’s CONFIRM screen to pair pump. Note: The following steps are performed using your companion. a. Scroll to highlight Yes. b. Press Enter button. FPOc. Scroll to highlight SETUP. d. Press Enter button. 155 DOC15736_Rev-A-Man.indd 155-156 c. Notice COMPANION screen is searching for pumps. 156 2/9/09 11:29:48 AM Section 6: When You’re Ready – Optional Settings 6.9 Turn RADIO Off/On Steps 6. Confirm pairing of pump with Companion Section 6: When You’re Ready – Optional Settings 6.9 Turn RADIO Off/On Do This Steps Note: The following steps are performed using your companion. 8. Check your work. FPO b. Notice No is highlighted. c. Scroll to highlight Yes if pump is correct. a. Notice CONFIRM screen with “Pair with Pump S/NPPPPP.” Do This Verify that the companion and pump are paired by the serial numbers displayed on the Status screens. FPO d. Press Enter button. 7. Verify paired pump and Companion Verify that the companion and pump are paired by the Radio On signal in both devices displayed on the Home screens. 157 DOC15736_Rev-A-Man.indd 157-158 158 2/9/09 11:29:48 AM Section 6: When You’re Ready – Optional Settings 6.9 Turn RADIO Off/On Section 6: When You’re Ready – Optional Settings 6.10 Therapy Lockout 6.9 Turn RADIO Off/On Purpose To turn off the radio frequency signal between your Aviator Companion and Aviator Pump before you get on an airplane. When Do this procedure: Materials • • • • Steps Do This 2. Go to the RADIO menu on your Companion. a. Scroll to highlight RADIO. b. Press Enter button. Before you take off in an airplane or as directed by any other official. Your companion and pump fully operating. c. Notice Done is highlighted. Your companion and pump already paired. Assistance from healthcare professional as needed. Helpful Information d. Scroll to highlight Radio. e. Press Enter button. • If your companion and pump are NOT paired, radio setting will be Off. f. Procedure: Scroll to Off. g. Press Enter button. Steps Do This 1. Go to the SETUP menu on the Companion. a. From the Home screen, notice Main is highlighted. h. Notice Done is highlighted. i. Press Enter button. b. Press Enter button. c. Scroll to highlight SETUP. d. Press Enter button. 3. Go to the SETUP menu on the pump. a. From the Home screen, notice Main is highlighted. b. Press Enter button. c. Scroll to highlight SETUP. d. Press Enter button. 159 DOC15736_Rev-A-Man.indd 159-160 160 2/9/09 11:29:48 AM Section 6: When You’re Ready – Optional Settings 6.10 Therapy Lockout 6.10 Steps Do This 4. Go to the RADIO menu on your Pump. a. Scroll to highlight RADIO. b. Press Enter button. c. Notice Done is highlighted. Therapy Lockout Purpose To lock and unlock the Aviator Pump’s basal and bolus features from your Aviator Companion. When Do this procedure when you wish to prevent access to the following pump options: d. Scroll to highlight Radio. e. Press Enter button. f. Scroll to Off. g. Press Enter button. h. Notice Done is highlighted. Press Enter button. Section 6: When You’re Ready – Optional Settings 6.10 Therapy Lockout Materials • Selecting either the basal or bolus panels on the Home screen. • Using the QBolus soft key on the Home screen. • Selecting any of the following on the MAIN MENU screen. ➢➢ START/STOP ➢➢ BOLUS ➢➢ BASAL ➢➢ PRIME • Your companion fully operating. Helpful Information • The Lockout setting is Off by default. Procedure: Steps 5. Check your work. Look at the system status panel on the Home screen to verify that the radio signal is off. To turn the radio signal back on, repeat all the steps above and scroll to select Radio to On. Do This 1. Go to the SETUP menu. a. From the Home screen, notice Main is highlighted. b. Press Enter button. c. Scroll to highlight SETUP. d. Press Enter button. 161 DOC15736_Rev-A-Man.indd 161-162 162 2/9/09 11:29:48 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Steps 2. Go to the THERAPY LOCKOUT screen. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Do This Steps Do This Note: The duration is set to Always by default when lockout is On. a. Scroll to highlight THERAPY LOCKOUT. 3. Set Duration for lockout. b. Press Enter button. a. Notice Duration is highlighted. b. Decide what to do next. c. Notice Lockout is Off. If you want duration to be Then do this Once 1. Press Enter button. 2. Scroll to select Once. 3. Press Enter button. d. Scroll to highlight Lockout. e. Press Enter button. f. 4. Scroll to highlight Done. 5. Press Enter button. Scroll to On. g. Press Enter button. Scroll to highlight Done. Always Press Enter button. 4. Check your work. Go back to the THERAPY LOCKOUT screen and verify that the settings are correct. To unlock your pump therapy features, go to Step 5. 163 DOC15736_Rev-A-Man.indd 163-164 164 2/9/09 11:29:48 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Steps 5. Unlock pump therapy features. Do This Note: If you attempt to access any basal or bolus features when Lockout is On, you will see a Confirmation screen. a. Notice the CONFIRM screen with “Insulin delivery changes are locked out.” message displays. b. Notice Cancel is highlighted. Note: If you select Cancel, you will return to the Home screen and pump therapy features remain locked out. c. Scroll to highlight Unlock. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program 7 Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Purpose When To edit an existing basal program in your pump using your Aviator Companion. Do this procedure: • Whenever you need to edit an existing basal program, including adding or deleting basal time blocks and basal rates. Materials d. Press Enter button. • Your companion with battery charged and basal settings programmed. • Your pump with the battery installed and basal settings programmed. • Healthcare professional’s recommendations for your personalized basal settings for the pump in Section 12 – Appendix A. e. Administer your basal or bolus insulin delivery as recommended by your healthcare professional. Important Note: It is strongly recommended that you and your healthcare professional work on fine tuning your basal rates. Always notify your healthcare professional if you make changes to prescribed plans of care. Helpful Information • The Edit program is one of the MODIFY program options from the BASAL MENU. The other Modify program options are Create program, Rename program and Delete program. • Your currently running active program will have an asterisk (*) to the left of the name. Procedure: Steps 1. Access BASAL MENU from Home screen. Do This a. Notice Main is highlighted. b. Press Enter button. c. Scroll to highlight BASAL. d. Press Enter button. 165 DOC15736_Rev-A-Man.indd 165-166 166 2/9/09 11:29:48 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Steps 2. Select MODIFY program. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Do This Steps a. Scroll to highlight MODIFY. 4. Decide what edits you want to make. b. Press Enter button. Do This If you want to Then do this Edit an existing time block and basal rate 1. Scroll to the desired time block and basal rate to edit. 2. Press Enter button. 3. Go to Step 5. Add a time block and basal rate c. Notice Edit is highlighted. 1. Notice Add Block is highlighted. 2. Press Enter button. d. Press Enter button. 3. Go to Step 8. Delete a time block and basal rate 3. Select the existing program to edit. 1. Scroll to the desired time block and basal rate to delete. 2. Press Enter button. Notice *Daily is highlighted. 3. Go to Step 11. Return to the Home screen without editing a basal program Note: The * represents the active program, and Daily is the default program. If you want to Then do this Edit your Daily program Press Enter button. Edit a different program Scroll to highlight the program you want to edit, for example, Travel. Press Enter button. Scroll to highlight Done. Press Enter button. Note: You MUST have at least ONE block and You MUST select Done to complete and save all the changes you have made. 5. Edit Time block. a. Scroll to highlight Time. b. Press Enter button. c. Scroll to select the desired time for the block. d. Press Enter button. 167 DOC15736_Rev-A-Man.indd 167-168 168 2/9/09 11:29:49 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.2 Create a New Basal Program Steps Do This Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.2 Create a New Basal Program Steps 6. Edit Basal Rate. 8. Set Time for new block. a. Notice Rate is highlighted. a. Notice Time is highlighted. b. Press Enter button. b. Press Enter button. Note: If you are keeping the same basal rate, leave the basal rate as shown. c. Scroll to select desired time for the block. c. Scroll to select desired basal rate. d. Press Enter button. d. Press Enter button. Note: The starting time for the new block will be ½ hour after the block you just created. e. Notice Next is highlighted. f. 7. Decide what to do next. Press Enter button. 9. Set Rate for new block. If you want to Then do this Edit another time block and basal rate 1. Scroll to another time block and basal rate that you want to edit. a. Notice Rate is highlighted. b. Press Enter button. c. Scroll to select desired basal rate for the block. 2. Press Enter button. d. Press Enter button. 3. Repeat Steps 5 and 6 to edit additional time blocks and basal rates. e. Notice Next is highlighted. Add a time block and 1. Notice Add Block is highlighted. basal rate 2. Press Enter button. 3. Go to Step 8. Note: If the last time block begins at 11:30 pm, the Add block option is removed from the screen and you CANNOT add another block. Delete a time block and basal rate Be finished with all your edits and return to the Home screen f. 10. Decide what to do next. Press Enter button. If you want to Then do this Add another time block and basal rate 1. Scroll to highlight Add Block. 2. Press Enter button. 2. Press Enter button. 3. Repeat Steps 8 and 9 to add additional time blocks and basal rates. 1. Scroll to desired time block and basal rate to delete. 3. Go to Step 11. Delete a time block and basal rate 1. Scroll to desired time block and basal rate to delete. 1. Scroll to highlight Done. 2. Press Enter button. 2. Press Enter button. 3. Go to Step 11. 3. Go to Step 13 to confirm you have completed this task. 169 DOC15736_Rev-A-Man.indd 169-170 Do This Be finished with all your edits and return to the Home screen Scroll to highlight Done. Press Enter button. 170 2/9/09 11:29:49 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.2 Create a New Basal Program Steps Do This 11. Delete block(s). a. Notice Next is highlighted. 7.2 Create a New Basal Program Purpose When b. Scroll to highlight Delete. c. Press Enter button. d. Notice CONFIRM screen and “Delete block?” message displays. e. Decide what to do. If you want to Then do this Delete the time block and basal rate 1. Scroll to highlight Yes. 2. Press Enter button. Note: Notice that the time block has been deleted from the list. 3. Repeat Steps 10 and 11 to delete other blocks and basal rates. Cancel deleting the time block Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.2 Create a New Basal Program 1. Notice No is highlighted. 2. Press Enter button. 3. Scroll to highlight Next. To create up to four basal programs that suit your lifestyle, using the Aviator Companion. Do this procedure: • Whenever you need to create a weekend, exercise, sick day, or custom-named basal program, in addition to your daily basal program. Materials • Your companion with battery charged and initial basal settings programmed. • Your pump with the battery installed and initial basal settings programmed. • Healthcare professional’s recommendations for your basal settings for the pump in Section 12 - Appendix A. Helpful Information • The Create program is one of the Modify program options from the BASAL MENU. The other Modify program options are Edit program, Rename program and Delete program. • You should consult your healthcare professional before creating any new basal programs. Procedure: Steps Do This 1. Access BASAL MENU from Home screen. a. Notice Main is highlighted. b. Press Enter button. 4. Press Enter button. Note: You will return to the list of time blocks and basal rates. Check the settings. 12. Decide what to do next. 13. Check your work. If you want to Then do this c. Scroll to highlight BASAL. Make any additional changes to the basal program Go back to Step 4. d. Press Enter button. Be finished with all your edits and return to the Home screen Scroll to highlight Done. Press Enter button. View the program you have just edited, and verify the settings that you have changed. Refer to Section 3.1.2 View Basal Program for the procedure as needed. 2. Access MODIFY PROGRAM menu. a. Scroll to highlight MODIFY. b. Press Enter button. Note: The Daily basal rate is now reflecting the edits made above. 171 DOC15736_Rev-A-Man.indd 171-172 172 2/9/09 11:29:49 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.3 Select a Basal Program Steps 3. Access CREATE PROGRAM menu. Do This Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.3 Select a Basal Program Steps Do This 5. Set Time for BLOCK 1. a. Scroll to highlight CREATE. a. Notice Time dashed line is highlighted. b. Press Enter button. b. Press Enter button. c. Notice Time is highlighted. 4. Decide the type of program to create. If you want to create Then do this Weekend basal program Notice Weekend is highlighted. Press Enter button. Exercise basal program Scroll to highlight Exercise. Press Enter button. Sick day basal program Scroll to highlight Sick. Press Enter button. Custom-named basal program 1. Scroll to highlight Custom. 2. Press Enter button. 3. Scroll to highlight each letter and press the Enter button each time, as you spell out the name for your customized program, for example, Travel. d. Press Enter button. e. Scroll to select desired start time for the block. f. Press Enter button. 6. Set Rate for BLOCK 1. a. Notice Rate is highlighted. b. Press Enter button. c. Scroll to select desired rate of insulin per hour. d. Press Enter button. Note: At least ONE block must be added. If NO additional blocks are added, the first block will prevail for 24 hours. Note: The first letter and a letter following a space is automatically capitalized. Note: To clear an entry if you make a mistake, highlight Erase and press the Enter button to erase the last letter entered as needed. 4. Scroll to highlight Next when you are done. 5. Press Enter button. Note: If you try to create more than 4 programs, the WARNING screen and the “Max number of programs already exist.” message displays. Notice that OK is highlighted, press Enter button to continue. 173 DOC15736_Rev-A-Man.indd 173-174 174 2/9/09 11:29:49 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.3 Select a Basal Program Steps 7. Decide whether to add or delete new blocks. Do This If you want to Then do this Add another time block and basal rate 1. Notice Next is highlighted 2. Press Enter button. 3. Notice Add block is highlighted. 4. Press Enter button. 5. Repeat Steps 5 and 6 to add additional time blocks and basal rates. Delete the time block and basal rate you just created 1. Scroll to highlight Delete. 2. Press Enter button. 3. Notice the CONFIRM screen and “Delete block?” message displays. 4. Scroll to highlight Yes. 5. Press Enter button. Add only ONE block and/or be finished with all your edits 8. Check your work. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.4 Rename a Basal Program 7.3 Select a Basal Program Purpose To activate the different basal programs by selecting and choosing between them using your Aviator Companion. When Do this procedure: Materials • Whenever you need to change your active basal program. • Your companion and pump fully operating with daily basal already started. • Your companion and pump with additional programs created, such as Weekend, Exercise, Sick day, or your custom-named program. • Instructions or assistance from your healthcare professional. • Your personalized Table of Settings in Section 12 - Appendix A. Helpful Information • The system allows you to program multiple basal profiles. The one you select is called the “active” program. When viewing your basal programs, the currently running active program will have an asterisk (*) to the left of the name. Important Note: It is strongly recommended that you and your healthcare professional work on fine tuning your basal rates. Always notify your healthcare professional if you make changes to prescribed plans of care. Scroll to highlight Done if not already highlighted. Press Enter button and return to the Home screen. Review the program you have just created. Refer to Section 3.1.2 View Basal Program for the procedure as needed. Record your personalized basal rate information for the new basal program(s) in the Table of Settings in Section 12 - Appendix A 175 DOC15736_Rev-A-Man.indd 175-176 176 2/9/09 11:29:49 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.4 Rename a Basal Program Procedure: Steps 1. Access BASAL MENU from Home screen. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.4 Rename a Basal Program Steps Do This 3. Select the program that you want to be active. a. Main is highlighted. b. Press Enter button. Do This Note: In this example, the Daily program is the currently active program running, because it has an * beside “Daily.” a. Scroll to highlight the desired program, for example, Weekend. b. Press Enter button. c. Scroll to highlight BASAL. d. Press Enter button. c. Notice the CONFIRM screen and “Start (your selected) program?” message displays. OR Note: This is a short cut to get to the SELECT PROGRAM screen when basal is delivering. OR d. Scroll to highlight Yes. e. Press Enter button. a. Scroll to select the Basal panel on the Home screen. Note: You will hear four short confirmation beeps from your pump. b. Press Enter button. c. Go to Step 3 4. Check your work. 2. Access SELECT PROGRAM menu. a. Scroll to highlight SELECT. Verify that the Home screen displays the active basal program you have just selected. b. Press Enter button. 177 DOC15736_Rev-A-Man.indd 177-178 178 2/9/09 11:29:50 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.5 Delete a Basal Program 7.4 Rename a Basal Program Purpose When Materials To rename an existing basal program of your pump using your Aviator Companion. Do this procedure: • • • • • Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.5 Delete a Basal Program Steps Do This 2. Access MODIFY PROGRAM menu. a. Scroll to highlight MODIFY. b. Press Enter button. When you CHOOSE to rename a previously created existing basal program. Your companion with battery charged and basal settings programmed. Your pump with the battery installed and basal settings programmed. Your pump with basal programs that have already been created and named. Your personalized Table of Settings in Section 12 - Appendix A. Helpful Information 3. Access RENAME PROGRAM screen. a. Scroll to highlight RENAME. b. Press Enter button. • The Rename program is one of the Modify program options in the Basal menu. The other Modify program options are Edit program, Create program and Delete program. Procedure: Steps Do This 1. Access BASAL Menu from Home screen. a. Notice Main is highlighted. 4. Select program to rename. b. Press Enter button. b. Press Enter button. c. Scroll to highlight BASAL. d. Press Enter button. a. Scroll to highlight the program you want to rename. 5. Delete existing program name. a. Scroll to highlight Erase. b. Keep pressing the Enter button to erase each letter of the old program name. 179 DOC15736_Rev-A-Man.indd 179-180 180 2/9/09 11:29:50 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.5 Delete a Basal Program Steps 6. Create new program name. Do This a. Scroll to highlight each letter and press the Enter button each time to spell out the new program name. Note: To clear an entry if you make a mistake, highlight Erase and press the Enter button to erase the last letter entered as needed. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.6 Set a Temporary Basal Program 7.5 Delete a Basal Program Purpose To remove (delete) a basal program already programmed into your pump using your Aviator Companion. When Do this procedure: Materials b. Scroll to highlight Next. c. Press Enter button. 7. Complete the name change. • • • • Whenever you need to delete an existing basal program. Your companion with battery charged and basal settings programmed. Your pump with the battery installed and basal settings programmed. Instruction or assistance from your healthcare professional. Helpful Information a. Scroll to highlight Done. b. Press Enter button to return to the Home screen. • The Delete program is one of the Modify program options. The other Modify program options are Edit program, Create program, and Rename program. • You CANNOT delete a basal program that is active. • Consult your healthcare professional before deleting any of your basal programs. Procedure: 8. Check your work. Review the program you have just renamed. Go to Section 3.1.2 View Basal Program for the procedure. Record the names and what they mean in your Table of Settings in Appendix A. Steps Do This 1. Access BASAL menu from Home screen. a. Notice Main is highlighted. b. Press Enter button. c. Scroll to highlight BASAL. d. Press Enter button. 181 DOC15736_Rev-A-Man.indd 181-182 182 2/9/09 11:29:50 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.6 Set a Temporary Basal Program Steps 2. Access MODIFY PROGRAM menu. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.6 Set a Temporary Basal Program Do This Steps Do This Notice the CONFIRM screen with “Delete program?” message displays. a. Scroll to highlight MODIFY. 5. Decide what to do next. b. Press Enter button. If you want to Then do this Delete the program 1. Scroll to highlight Yes. 2. Press Enter button. Note: The program is deleted from the pump’s memory and you will return to the Home screen. 3. Select DELETE program. 3. Go to Step 6 to check your work. a. Scroll to highlight Delete. Cancel deleting the program b. Press Enter button. 1. Notice No is highlighted. 2. Press Enter button. 3. Scroll to Highlight Done. 4. Press Enter button. 4. Select program to delete. Note: You will return to the Home screen. Your deletion is cancelled and the program is still an option a. Scroll to highlight the program you wish to delete. For example, Trip. Note: You CANNOT delete an active program, indicated with an asterisk *. b. Press Enter button. 6. Check your work. Verify that you have deleted the program. The program you deleted should NOT be listed when you review basal programs. Refer to Section 3.1.2 View Basal Program for the procedure as needed. Note: If you get this warning screen with OK highlighted, press Enter to clear the warning and return to the Home screen. Start over at Step 1 to delete a program that is NOT active. 183 DOC15736_Rev-A-Man.indd 183-184 184 2/9/09 11:29:50 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus 7.6 Set a Temporary Basal Program Purpose To program a temporary basal rate and the length of time you want the temporary basal rate to last, using your Aviator Companion. When Do this procedure: • When you want to make a one time, temporary change to the currently delivered basal Procedure: Steps Do This 1. Access BASAL MENU from Home screen. a. Notice Main is highlighted. b. Press Enter button. rate, for example, when you exercise or when you are sick. Materials • Your companion and pump fully operating and delivering basal insulin. • Healthcare professional’s instructions for your temporary basal pump settings. • Your personalized Table of Settings in Section 12 - Appendix A. c. Scroll to highlight BASAL. Helpful Information d. Press Enter button. A temporary basal rate is in effect from 30 minutes to 72 hours in increments of 30 minutes. This temporary rate is limited by the set up of your pump’s maximum basal rate setting (Refer to Section 6). If you have NOT modified your maximum basal delivery rate, you will be allowed to increase your basal rate to a value up to 30 units per hour (default). If you set up a different maximum basal delivery rate, you can only set the temporary rate to that number of units/hour maximum limit. Example A: 1. You set your basal rate increment to 0.1 units/hour. 2. You modified your maximum basal rate to 5.0 units/hour. 3. Your regular daily basal rate is set at 0.5 units/hour. Setting a temporary basal rate of 10% for a duration of 3 hours would result in a temporary basal rate of 0.05 units/hour. If the desired temporary basal delivery rate is higher than the maximum basal rate of your pump settings, your pump will NOT deliver the requested temporary rate. Example B: 1. You set your basal rate increment to 3.0 units/hour. 2. You modified your maximum basal rate to 5.0 units/hour, telling the pump that you never want to have a basal rate to exceed 5.0 units/hour. If you set a 200% temporary basal, this will result in a basal rate of 6.0 units/hour. This is more than the basal maximum, so it would NOT be allowed by the pump. Your pump will beep and display a “Warning: invalid % Maximum rate exceeded” screen. You will have to increase the basal maximum and reset a temporary basal rate within the range for it to take effect. • You may choose either specific units/hour OR a percentage of your current active basal rate. • The active basal program will resume when the temporary basal delivery is either manually stopped or reaches completion of duration. • Refer to Section 11 for more information on how to set temporary basal to manage exercise or illness. 185 DOC15736_Rev-A-Man.indd 185-186 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus 2. Choose SELECT program. a. Scroll to highlight SELECT. b. Press Enter button. 3. Select TEMP BASAL. a. Scroll to highlight TEMP BASAL. b. Press Enter button. 4. Set Duration. a. Notice Duration is highlighted. b. Press Enter button. c. Scroll to select the amount of time you want your temporary basal to be in effect. Note: The range is 30 minutes to 72 hours. d. Press Enter button. 186 2/9/09 11:29:50 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus Steps 5. Decide to set Percent or Rate. Do This Caution: When setting a temporary basal percent, make sure that you are setting the percentage of your basal that will be delivered, and NOT the percentage reduction in your basal rate. Example: If your active basal rate is 0.35 U/h, then selecting 75% will set the temporary basal at 0.26 U/h, which is 75% of the current basal. If you want to set the temporary basal Then do this At a percentage of the current rate 1. Notice Percent is highlighted. 2. Press Enter button. 3. Scroll to select the desired percentage of the active basal rate. 4. Press Enter button. Notice Percent is highlighted. Press Enter button. Scroll to highlight Rate. Press Enter button. Scroll to select the desired units per hour for the temporary basal delivery. 6. Press Enter button. As a set rate 6. Confirm and activate Temp Basal. 1. 2. 3. 4. 5. a. Verify the duration and percentage/rate is correct. b. Scroll up to make any changes as needed. c. Notice Activate is highlighted. d. Press Enter button. 7. Check your work. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus 8 Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus Purpose To administer an extended bolus from your pump using your Aviator Companion. When Do this procedure: Materials • • • • • Whenever you need to deliver an extended bolus over a period of time. Your companion set up with basal delivery started. Your pump set up with basal delivery started. Bolus recommendations from your healthcare professional. Your personalized Table of Settings in Section 12 - Appendix A. Helpful Information • You will perform this task using the companion. To administer an extended bolus using your pump, refer to Sec- tion 12. • Bolus insulin is the insulin you program whenever you need insulin other than your basal needs. For example you would bolus for a meal or bolus to correct for blood glucose levels that are higher than your target glucose range. You can record your personalized bolus recommendations in the Table of Settings in Section 12 - Appendix A. • You should have set up your bolus options using the SETUP WIZARD in Section 6.1. Procedure: Steps 1. Access Bolus Menu from Home screen. Do This a. Notice Main is highlighted. b. Press Enter button. Notice that the Temp Basal is activated and displayed in the Basal panel on the Home screen. Note: When the duration for the temporary basal is over, it will automatically revert back to your Daily basal program. c. Scroll to highlight BOLUS. d. Press Enter button. Record your personalized temporary basal values in the Table of Settings in Section 12 - Appendix A. 187 DOC15736_Rev-A-Man.indd 187-188 188 2/9/09 11:29:50 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus Steps Do This Steps Do This a. Scroll to highlight MANUAL. 6. Check that Extended Bolus Type, Bolus amount and Duration time is correct. a. View Bolus Type, Bolus amount, and Duration settings on the BOLUS screen. b. Decide if you need to change a setting. 2. Select MANUAL Bolus. b. Press Enter button. 3. Set Extended Bolus Type. a. Notice Bolus Type is highlighted. b. Press Enter button. c. Scroll to display Extended. d. Press Enter button. 4. Set Extended Bolus amount. 7. Deliver Extended bolus. If you want to Then do this Change a setting 1. 2. 3. 4. Keep the settings Go to the next step. Scroll up to highlight the setting you want to change. Press Enter button. Scroll to desired setting. Press Enter button. a. Notice Deliver is highlighted. b. Press Enter button. c. Notice that the extended bolus is delivering. a. Notice Bolus is highlighted. b. Press Enter button. c. Scroll to select the extended bolus amount you want to deliver. d. Press Enter button. 5. Set Duration for the Extended Bolus. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus d. Allow the extended bolus to deliver the amount that was set for the specified time duration. e. Go to Step 10 to check your extended bolus delivery. You have completed delivering an Extended Bolus. Note: Go to Step 8 only if you want to STOP the Extended Bolus. a. Notice Duration is highlighted. b. Press Enter button. c. Scroll to select the duration for extended bolus delivery. Note: The range depends on the amount of the bolus. When divided across the full duration, the rate is NOT less than 0.05 U/h. d. Press Enter button. 189 DOC15736_Rev-A-Man.indd 189-190 190 2/9/09 11:29:51 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus Steps 8. Decide whether to STOP extended bolus. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus Do This Steps a. Go to the MAIN MENU. 9. Decide whether to STOP basal delivery. b. Press Enter button. Do This Note: Unless you had to change the battery, you will normally NOT stop basal delivery even though the CONFIRM screen and “Stop (your active basal program)?” message displays. a. Notice the CONFIRM screen and “Stop (your active basal program)?” message displays. c. Notice STOP is highlighted. b. Decide what to do next. d. Press Enter button. If you want to Then do this STOP the basal delivery now (e.g. to change batteries) 1. Scroll to highlight Yes. e. Decide what to do next. If you want to Then do this STOP the extended bolus delivery immediately 1. Scroll to highlight Yes. 2. Press Enter button. 3. Continue to Step 9. Continue the basal delivery Allow extended bolus to finish delivering 1. Notice No is highlighted. 2. Press Enter button to return to the Home screen. 2. Press Enter button. 3. Notice that the basal program has stopped on the Home screen. You have STOPPED the Extended bolus and also the Basal delivery. Check with your healthcare professional for recommendations. 1. Notice No is highlighted. 2. Press Enter button. 3. Review the Last Bolus (Ext.) that was administered and basal is still delivering on the Home screen. You have STOPPED the Extended bolus but your basal program is still delivering insulin. 3. Go to Step 10 to check your extended bolus delivery. 10. Check your work. Check that the extended bolus amount, and time duration is displayed in the Bolus box on Home screen. Review the extended bolus amount and time that is being administered. If you want to STOP the Extended Bolus, go to Step 8. 191 DOC15736_Rev-A-Man.indd 191-192 192 2/9/09 11:29:51 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus 8.2 Deliver a Dual Bolus Purpose When To administer a dual bolus using your Aviator Companion so that you can deliver a bolus immediately and also trickle out insulin as the food you eat is converted into glucose over time. The pump has the option to deliver two waves of insulin over a period of time. This option is helpful if there are foods in your meal plan that have a long duration and require longer periods of digestion. These foods will affect your glucose both immediately and over a number of hours later. Procedure: Steps Do This 1. Access BOLUS MENU from Home screen. a. Notice Main is highlighted. b. Press Enter button. Do this procedure: • Whenever you need to deliver a dual bolus, which includes a normal bolus and c. Scroll to highlight BOLUS. an extended bolus. Materials Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus • • • • d. Press Enter button. Your companion set up with basal delivery started. Your pump set up with basal delivery started. Bolus recommendations from your healthcare professional. Refer to your personalized Table of Settings in Section 12 - Appendix A as needed. 2. Select MANUAL bolus. a. Scroll to highlight MANUAL. Helpful Information b. Press Enter button. • You should have already set up your bolus options via the SETUP WIZARD. You should record your personalized list of your bolus options in the Table of Settings in Appendix A. These options can be changed via the SETUP WIZARD. • Discuss with your healthcare professional what types of foods would require a dual bolus. For example, you may want to consider a dual bolus for eating: pizza (due to the carbohydrate content of the dough plus the high fat content of the cheese, sausage, pepperoni, etc.); appetizers at a party (such as nibbling chips or other carbohydrate foods for an extended period of time); Mexican food (the carbohydrates from chips, beans and rice plus the protein and fat from the meat and cheese). 3. Set Dual Bolus Type. a. Notice Bolus Type is highlighted. b. Press Enter button. c. Scroll to display Dual. d. Press Enter button. 4. Set Normal Bolus amount. a. Notice Normal is highlighted. b. Press Enter button. c. Scroll to select the normal bolus amount you want to deliver. d. Press Enter button. 193 DOC15736_Rev-A-Man.indd 193-194 194 2/9/09 11:29:51 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus Steps 5. Set Extended Bolus amount. Do This Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.3 Calculate and Deliver a Food Bolus Steps 8. Deliver the Dual bolus. a. Notice Extended is highlighted. b. Press Enter button. b. Press Enter button. d. Press Enter button. c. Notice that the normal bolus is delivering. a. Notice Duration is highlighted. b. Press Enter button. c. Scroll to select the duration for the extended bolus delivery. d. Press Enter button. 7. Check that the Normal bolus, Extended bolus, and duration settings are correct. 9. Decide whether to stop the Dual bolus. If you want to Then do this Finish delivering the normal bolus Allow the normal bolus to deliver the amount that was set. a. View Bolus Type, Bolus amount, and Duration settings on the BOLUS screen. b. Decide if you need to change a setting. If you want to Then do this Change a setting 1. Scroll up to highlight the setting you want to change. 2. Press Enter button. Keep the settings Note: Once the bolus has finished delivering, you will hear 2 more quick beeps or feel 2 more short vibrations on your pump and you will return to the Home screen. Go to Step 10. STOP the dual bolus immediately 1. Notice Stop is highlighted. 2. Press Enter button. 3. Notice the STOPPED ALERT screen and “Dual bolus stopped.” message displays. 3. Scroll to desired setting. 4. Notice Clear is highlighted (to confirm that the bolus is stopped). 4. Press Enter button. 5. Press Enter button to return to the Home screen. Go to the next step. You have STOPPED the dual bolus. 195 DOC15736_Rev-A-Man.indd 195-196 Note: If you changed only the Normal or Extended Bolus settings in Step 7, and did NOT change the Duration, scroll to highlight Deliver. The Dual bolus is now set to deliver. a. Notice Deliver is highlighted. c. Scroll to select the extended bolus amount you want to deliver. 6. Set Duration for the Extended Bolus. Do This 196 2/9/09 11:29:51 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.3 Calculate and Deliver a Food Bolus Steps 10. Decide whether to finish delivering the Extended Bolus. Do This Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.3 Calculate and Deliver a Food Bolus Steps If you want to Then do this Finish delivering the extended bolus Allow the extended bolus to deliver the amount that was set for the specified time duration. 12. Decide whether to STOP basal delivery. Note: Once the Normal bolus is completely delivered, you will automatically return to the Home screen where you will see the extended bolus, bolus amount, and time duration displayed in the Bolus panel. You will also see the IOB value, which reflects the Normal bolus that was delivered. Another possible reason to stop basal here is when you realize there is too much IOB and need some time to recover. Note: Unless you wanted to change the battery you will normally NOT stop basal delivery even though the CONFIRM screen and “Stop (your active basal program)?” message displays. Another possible reason to stop basal here is when you realize there is too much IOB and need some time to recover a. Notice the CONFIRM screen and “Stop (your active basal program)?” message displays. b. Decide what to do next. Go to Step 13 to check your extended bolus delivery. STOP the extended bolus Do This 1. Go to the MAIN MENU. If you want to Then do this STOP the basal delivery now (e.g. to change batteries) 1. Scroll to highlight Yes. Continue the basal delivery 1. Notice No is highlighted. 2. Notice STOP is highlighted. 3. Press Enter button. 4. Continue to Step 11. 11. Decide whether to STOP the extended bolus. a. Notice the CONFIRM screen and “Stop Extended Bolus?” message displays. Then do this STOP the extended bolus delivery immediately 1. Scroll to highlight Yes. Allow extended bolus to finish delivering 1. Notice No is highlighted. 2. Press Enter button. 3. Review the Last Bolus that was administered. You have STOPPED the Extended bolus but your basal program is still delivering insulin. 2. Press Enter button. 3. Continue to Step 12. 2. Press Enter button to return to the Home screen. 3. Go to Step 13 to check your extended bolus delivery. 197 DOC15736_Rev-A-Man.indd 197-198 3. Notice that the basal program has STOPPED on the Home screen. You have STOPPED the Extended bolus and also STOPPED the Basal delivery. Note: You will automatically return to the Home screen. b. Decide what to do next. If you want to 2. Press Enter button. 13. Check your work. Check that the extended bolus amount, and time duration is displayed in the Bolus panel on Home screen. Review the extended bolus amount and the time that it is being administered. Review the IOB value, which reflects the normal bolus that was delivered. 198 2/9/09 11:29:51 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.3 Calculate and Deliver a Food Bolus 8.3 Calculate and Deliver a Food Bolus Purpose When Materials To calculate and deliver a food bolus using your Aviator Companion. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.4 Calculate and Deliver a Correction Bolus Steps Do This 3. Set Carbs. a. Notice Carbs is highlighted. Do this procedure: • Whenever you want to calculate carbohydrates and administer a bolus to cover a meal or snack. b. Press Enter button. c. Scroll to select the number of grams of carbohydrates you are planning to eat. Note: The range is 0-200 g. • Your companion set up with basal delivery started. • Your pump set up with basal delivery started. • Bolus recommendations from your healthcare professional and assistance from Diabetes Educator as needed. • Your personalized Table of Settings in Section 12 - Appendix A. Helpful Information • To be able to use this option, you must first have an understanding of carbohydrate counting, and have refer- ences for the carbohydrate content of foods. Consult your Diabetes Educator and/or Registered Dietitian before using this feature. • You can set up bolus calculator options and bolus limits in Section 6.1 before performing this task. It would be easier to program a food bolus and use the bolus calculator if you have established settings. Procedure: Steps Do This 1. Access BOLUS MENU from Home screen. a. Notice Main is highlighted. d. Press Enter button. 4. Decide what to do next. Note: The I:CHO ratio is established when setting up your pump using the SETUP WIZARD in Section 6.1. Unless instructed otherwise by your healthcare professional, do NOT change this value. If you want to Then do this Continue to select bolus type Notice Next is highlighted. Press Enter button. View Food Calculation Details 1. Scroll to highlight Details. 2. Press Enter button. 3. Review the insulin-to-carbohydrate ratio. 4. Notice Accept is highlighted. b. Press Enter button. 5. Press Enter button. Change I:CHO ratio 1. Scroll to highlight I:CHO. 2. Press Enter button. c. Scroll to highlight BOLUS. d. Press Enter button. 3. Scroll to change I:CHO as needed. Note: The range is 1U/1g to1U/150g. 4. Press Enter button. 5. Notice Accept is highlighted. 6. Press Enter button. 2. Select FOOD bolus. a. Scroll to highlight FOOD. b. Press Enter button. 199 DOC15736_Rev-A-Man.indd 199-200 200 2/9/09 11:29:51 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.4 Calculate and Deliver a Correction Bolus Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.4 Calculate and Deliver a Correction Bolus Steps Do This Steps Do This 5. Set Bolus Type. a. Notice Bolus Type is highlighted. Normal is the default. 8. Deliver Food bolus. a. Notice Deliver is highlighted. b. Press Enter button. b. Press Enter button. Note: You will hear 2 quick beeps from your pump. Note: The recommended calculated bolus amount is displayed. Pay careful consideration before changing the recommended amount, depending on situations such as exercise, stress, sickness, etc. that may influence more or less insulin delivery at this time. c. Notice that the bolus is delivering. d. Decide what to do next. c. Scroll to select the bolus type you want to deliver. Note: Remember to also set the duration for Extended or Dual bolus types if you are delivering either type of bolus. Refer to Section 8.1 or 8.2 as needed. If you want to Then do this Finish delivering food bolus Allow the food bolus to deliver the amount that was set. d. Press Enter button. 6. Review Bolus amount. Go to Step 9 to check your bolus delivery. Decide what to do next. If you want to Then do this Accept the calculated bolus amount and continue to bolus 1. Notice Bolus is highlighted. Change the bolus amount 1. Notice Bolus is highlighted. Note: Once the bolus has finished delivering, you will hear 2 more quick beeps and then return to the Home screen. STOP the food bolus delivery immediately 2. Scroll to highlight Deliver. 1. Notice Stop is highlighted. 2. Press Enter button. 3. Notice the STOPPED ALERT screen and “Normal bolus stopped.” message displays. 4. Notice Clear is highlighted. 5. Press Enter button to return to the Home screen. You have STOPPED the food bolus and it is reflected in the Bolus panel. 2. Press Enter button. 3. Scroll to select the bolus amount to deliver. 4. Press Enter button. 7. Confirm that bolus type, bolus amount (and duration) are correct. Check your Bolus Type and Bolus settings on the BOLUS screen. Note: The value displayed is from the bolus calculator. 9. Check your work. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen. Scroll up to select and make edits as needed. 201 DOC15736_Rev-A-Man.indd 201-202 202 2/9/09 11:29:52 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.4 Calculate and Deliver a Correction Bolus 8.4 Calculate and Deliver a Correction Bolus Purpose When To calculate and deliver a correction bolus using your Aviator Companion. Do this procedure: Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Steps Do This 2. Select CORRECTION bolus. a. Scroll to highlight CORRECTION. Note: You may get a WARNING screen and message “Less than 2 hours since last bolus.” with OK highlighted. Consider the possible safety issues if another bolus is delivered at this time, prior to pressing the Enter button. • Whenever you want to calculate and administer a correction bolus because your blood glucose levels are higher than your target glucose. Materials • Your companion set up with basal delivery started. • Your pump and pump set up with basal delivery started. • Bolus recommendations from your healthcare professional and assistance from your Dia- Note: If there is NO bolus history, and the pump has NOT been powered on for the duration of the action time, you may get a CONFIRMATION screen and message “Last bolus time unknown. Continue?” displayed. Press Enter to continue. betes Educator as needed. • Your personalized Table of Settings in Section 12 - Appendix A Helpful Information b. Press Enter button. 3. Set Current BG. • Establish setting for programming a correction bolus and use of the bolus calculator with the instructions listed a. Scroll to highlight Current Bg. • Using this feature requires that you have a working understanding and knowledge of your insulin sensitivity, or c. Scroll to select your current blood glucose level. b. Press Enter button. in Section 6.1 before performing this task. correction factor, and know your BG targets obtained from your healthcare team. Refer to Section 12 –Appendix A for calculation sheet. • While the pump will provide a suggested dose based on the settings you have established, there may be other factors that may affect the dosage decision (such as anticipated increased physical activity), so be sure to discuss this feature with your healthcare team. Procedure: Steps 1. Access BOLUS MENU from Home screen. Do This a. Notice Main is highlighted. d. Press Enter button. 4. Determine what to do next. If you want to Then do this Continue to select bolus type Notice Next is highlighted. Press Enter button. View BG Calculation Details 1. Scroll to highlight Details. 2. Press Enter button. b. Press Enter button. 3. Review the Target BG, 1U Drop and, IOB. 4. Notice Accept is highlighted. 5. Press Enter button. c. Scroll to highlight BOLUS. 6. Scroll to highlight Next. d. Press Enter button. 7. Press Enter button. 203 DOC15736_Rev-A-Man.indd 203-204 204 2/9/09 11:29:52 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Steps Do This Steps Do This 5. Set Bolus Type. a. Notice Bolus Type is highlighted. 8. Deliver Correction bolus. a. Notice Deliver is highlighted. b. Press Enter button. Note: The recommended calculated bolus amount is displayed. Pay careful consideration before changing the recommended amount, depending on situations such as exercise, stress, sickness, etc. that may influence more or less insulin delivery at this time. b. Press Enter button. Note: You will hear 2 quick beeps from your pump. c. Notice that the bolus is delivering on the screen. d. Decide what to do next. c. Scroll to select the bolus type you want to deliver. Note: Remember to also set the duration for Extended or Dual bolus types if you are delivering either type of bolus. Refer to Section 8.1 or 8.2 as needed. If you want to Then do this Finish delivering correction bolus Allow the correction bolus to deliver the calculated amount d. Press Enter button. 6. Review Bolus amount. Go to Step 9 to check your bolus delivery. Decide what to do next. If you want to STOP the correction bolus delivery immediately Then do this Accept the calculated 1. Notice Bolus is highlighted. bolus amount and 2. Scroll to highlight Deliver. continue to bolus Change the bolus amount Note: Once the bolus has finished delivering, you will hear 2 more quick beeps and return to the Home screen. 1. Notice Stop is highlighted. 2. Press Enter button. 3. Notice the STOPPED ALERT screen and “Normal bolus stopped.” message displays. 4. Notice Clear is highlighted. 1. Notice Bolus is highlighted. 5. Press Enter button to return to the Home screen. You have STOPPED the correction bolus and it is reflected in the Bolus panel. 2. Press Enter button. 3. Scroll to select the bolus amount to deliver. 4. Press Enter button. 9. Check your work. 7. Confirm that bolus type, bolus amount (and duration) is correct. Check your Bolus Type and Bolus amount settings on the BOLUS screen. Scroll up to select and make edits as needed. 205 DOC15736_Rev-A-Man.indd 205-206 Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen. 206 2/9/09 11:29:52 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus 8.5 Calculate and Deliver a Food & Correction Bolus Purpose To calculate and deliver a bolus when you are about to eat and your blood glucose levels are above or below your pre-meal target goals. When Do this procedure: Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Steps Do This 2. Select FOOD & CORRECTION Bolus. a. Scroll to highlight FOOD & CORRECT. b. Press Enter button. • Whenever you want to administer a bolus because you are about to eat a meal, and your blood glucose is above or below your target range. Materials • Your companion with basal delivery started. • Your pump set up with basal delivery started. • Bolus recommendations from your healthcare professional and assistance from your Diabetes Educator as needed. • Your personalized Table of Settings in Section 12 - Appendix A. Helpful Information 3. Set Carbs. a. Notice Carbs is highlighted. b. Press Enter button. c. Scroll to select the number of grams of carbohydrates you are planning to eat. • To administer a food and correction bolus, you must first have an understanding and knowledge of your insu- lin sensitivity, or correction factor and your I:CHO ratio, which you will have obtained from your healthcare team (see Section 6.1 for additional settings). Procedure: Note: The range is 1-200 grams. d. Press Enter button. Note: The I:CHO ratio is established when setting up your pump using the SETUP WIZARD in Section 6.1. Steps Do This 1. Access BOLUS MENU from Home screen. a. Notice Main is highlighted. Unless instructed otherwise by your healthcare professional, do NOT change this value. b. Press Enter button. c. Scroll to highlight BOLUS. d. Press Enter button. 207 DOC15736_Rev-A-Man.indd 207-208 208 2/9/09 11:29:52 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Steps 4. Decide what to do about I:CHO ratio. Do This If you want to Then do this Continue to select bolus type Notice Next is highlighted. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.6 Deliver a Quick Bolus from QBolus Menu Steps Do This 5. Set CURRENT BG. a. Notice Current Bg is highlighted. b. Press Enter button. c. Scroll to select your current blood glucose level. Press Enter button. View Food Calculation Details Note: The default value is whatever your current Target BG is. When Target BG is NOT defined in WIZARD, both Current BG and Target BG defaults to 110 mg/dL (6.1 mmol/L). 1. Scroll to highlight Details. 2. Press Enter button. d. Press Enter button. 3. Review the insulin-to-carbohydrate ratio. 4. Notice Accept is highlighted. 5. Press Enter button. Change I:CHO ratio 1. Scroll to highlight I:CHO. 2. Press Enter button. 3. Scroll to change I:CHO as needed. Note: The range is 1U/1g to1U/150g. 4. Press Enter button. 5. Notice Accept is highlighted. 6. Press Enter button. 7. Notice Next is highlighted. 8. Press Enter button. 6. Decide what to do next. If you want to Then do this Continue to select bolus type Notice Next is highlighted. Press Enter button. View BG Calculation Details 1. Scroll to highlight Details. 2. Press Enter button. 3. Review the IOB on the BG CALC DETAILS screen, and make changes as needed. Note: You CANNOT change the IOB on this screen. When IOB is questionable, a question mark appears next to it on the BG CALC DETAILS screen. For example, IOB may be questionable when you initially turn on the pump within the first insulin action time, based on initial setup. 4. Notice Accept is highlighted. 5. Press Enter button. 6. Notice Details is highlighted. 7. Scroll to highlight Next. 8. Press Enter button. Note: The recommended calculated bolus amount is displayed. You should change this only if you purposely want to give a different amount than what is recommended by the pump. 209 DOC15736_Rev-A-Man.indd 209-210 210 2/9/09 11:29:52 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.6 Deliver a Quick Bolus from QBolus Menu Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.7 Deliver a Quick Bolus from QBolus Soft Key Steps Do This Steps 7. Set Bolus Type. a. Notice Bolus Type is highlighted on the BOLUS screen. 10. Deliver Food & Correction bolus. b. Press Enter button. Note: You will hear 2 quick beeps from your pump. c. Notice that the bolus is delivering on the screen. c. Scroll to select the bolus type you want to deliver. d. Decide what to do next. Note: Remember to also set the duration for Extended and Dual bolus types if you are delivering either type of bolus. d. Press Enter button. Decide what to do next. If you want to Then do this Accept the calculated bolus amount and continue to bolus 1. Notice Bolus is highlighted. Change the bolus amount 1. Notice Bolus is highlighted. 2. Press Enter button. 211 DOC15736_Rev-A-Man.indd 211-212 Finish delivering food and correction bolus Allow the food and correction bolus to deliver the amount that was set. Note: Once the bolus has finished delivering, you will hear 2 more quick beeps and then you will return to the Home screen. 1. Notice Stop is highlighted. 2. Press Enter button. 3. Notice the STOPPED ALERT screen and “Normal bolus stopped.” message displays. 4. Notice Clear is highlighted. 5. Press Enter button to clear message and return to the Home screen. 4. Press Enter button. Scroll up to select and make edits as needed. Then do this STOP the food and correction bolus delivery immediately 2. Scroll to highlight Deliver. Check your Bolus Type and Bolus amount settings on the screen. If you want to Go to Step 11 to check your bolus delivery. 3. Scroll to adjust the amount that was calculated. 9. Check that bolus type and bolus amount is correct. a. Notice Deliver is highlighted. b. Press Enter button. Note: The recommended calculated bolus amount is displayed. You should change this only if you purposely want to give a different amount than what is recommended by the pump. 8. Set Bolus. Do This You have STOPPED the food and correction bolus, and it is reflected on the Bolus panel. 11. Check your work. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen. 212 2/9/09 11:29:53 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.7 Deliver a Quick Bolus from QBolus Soft Key 8.6 Deliver a Quick Bolus from QBolus Menu Purpose When To administer a normal bolus using the QBOLUS menu of your Aviator Companion. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.7 Deliver a Quick Bolus from QBolus Soft Key Steps Do This 3. Deliver Quick bolus. a. Notice that the bolus is delivering on the screen. Note: You will hear 2 quick beeps from your pump. Do this procedure: • Whenever you need to deliver a normal bolus from the Qbolus menu. Materials b. Decide what to do next. Note: The increments are either 0.5 or 1.0 Units. If you want to Then do this • Your companion set up with basal delivery started. • Your pump set up with basal delivery started. • Bolus recommendations from your healthcare professional. Finish delivering the quick bolus Allow the quick bolus to deliver the amount that you set. Procedure: Note: Once the bolus has finished delivering, you will hear 2 more quick beeps from your pump and return to the Home screen. Go to Step 4 to check your bolus delivery. Steps Do This 1. Access BOLUS MENU from Home screen. a. Notice Main is highlighted. STOP the quick bolus delivery immediately b. Press Enter button. 1. Notice Stop is highlighted. 2. Press Enter button. 3. Notice the STOPPED ALERT screen and “Normal bolus stopped.” message displays. 4. Notice Clear is highlighted. 5. Press Enter button to clear message and return to the Home screen. c. Scroll to highlight BOLUS. d. Press Enter button. You have STOPPED the quick bolus and it is reflected on the Bolus panel. 4. Check your work. 2. Set QBOLUS. a. Notice QBOLUS is highlighted. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen. b. Press Enter button. c. Scroll to select the desired quick bolus amount to administer. Note: The increments are either 0.5 or 1.0 Units. d. Press Enter button. 213 DOC15736_Rev-A-Man.indd 213-214 214 2/9/09 11:29:53 AM Section 9: Respond to Alarms, Alerts, Errors, and Other Problem 8.7 Deliver a Quick Bolus from QBolus Soft Key Purpose When To administer a normal bolus using the QBolus soft key from your companion’s Home screen. Do this procedure: • Whenever you need to administer a normal bolus quickly, conveniently, and discreetly, Materials using the fewest steps possible. Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps Do This 2. Initiate the number of bolus increments to a. Press the QBolus soft key the same number of times as the number of increments to deliver, companion sounds a beep with each press. deliver. 1 button push displays: • Your companion and pump set up with basal delivery started. • Bolus recommendations from your healthcare professional. c. After the beeps, press the QBolus soft key ONE MORE TIME within 2 seconds to CONFIRM the correct number of increments for bolus delivery. • A Normal bolus may be delivered using the QBolus soft key from your companion’s Home screen. You should Procedure: Steps Do This 1. Locate the QBolus soft key on your companion. Locate the QBolus soft key (also called the Backlight soft key) on the bottom left of your companion. Note: The increments for the one-button bolus are either 0.5 or 1.0 Units. b. Notice that after a few seconds, the companion will beep the same number of times that you pressed the QBolus soft key to verify your instructions. Helpful Information have already set up the bolus increments using the procedure in Section 6.1. Note: You may have to press the soft key once to wake companion up. 2 button pushes displays: Note: You MUST press the Bolus button after the complete feedback beeps within 2 seconds, or the bolus is cancelled. Note: The bolus will also be cancelled if you press the Bolus button before the feedback completes. 3 button pushes displays: FPO Screen shot QBolus Soft Key 215 DOC15736_Rev-A-Man.indd 215-216 216 2/9/09 11:29:53 AM Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Section 9: Respond to Alarms, Alerts, Errors, and Other Problem 9 Respond to Alarms, Alerts, Errors, and Other Problems Steps Do This 3. Deliver the bolus. a. Notice that the bolus is delivering on the screen. b. Decide what to do next. If you want to Then do this Finish delivering the quick bolus Allow the bolus to deliver the amount that you set. Note: Once the bolus has finished delivering, you will hear 2 more quick beeps and then you will return to the Home screen. Purpose To resolve alarm and alert messages, error codes, or problems related to your Aviator Companion and Aviator Pump. When Do this procedure: • When you receive an alarm, alert, or error code on your companion or pump. • Your companion or pump is NOT turning on, you CANNOT start basal delivery, dropping your companion or pump, or other problems, etc. Materials Go to Step 4 to check your bolus delivery. STOP the quick bolus immediately Your personalized Table of Settings in Section 12- Appendix A. 1. Notice Stop is highlighted. 2. Press Enter button. Your companion and pump may either be operating normally or in an alarm failsafe battery state (non-rechargeable). Helpful Information 3. Notice the STOPPED ALERT screen and “Normal bolus stopped.” message displays. • This section offers suggestions for addressing problems or difficulties that you may experience with your com- 4. Notice Clear is highlighted. • Call your healthcare professional for questions about your blood glucose control or diabetes management. • Call Customer Care, 24 hours a day, 7 days a week, for questions involving the mechanics of your companion or 5. Press Enter button to clear message and return to the Home screen. You have STOPPED the quick bolus and it is reflected in the Bolus panel. 4. Check your work. Look at the Bolus box on the Home screen to review the amount and time of the last bolus. panion and pump. pump, or regarding any alarms and errors not covered in this section. • You may also check the Table of Contents and Index for sections that may be helpful. • Refer to the Glossary for the definitions of different Alarms and Alerts. WARNING: • While an ALARM is active, insulin delivery IS stopped. Therefore, it is important for you to respond to an alarm as soon as possible to prevent medically adverse events or serious injury. • Insulin delivery does NOT stop with an ALERT. However, delivery is NOT occurring when you get a pump idle alert, because you have NOT begun insulin delivery yet. • All alarms and alerts appear as text on the screen of your companion or pump. For example, 217 DOC15736_Rev-A-Man.indd 217-218 218 2/9/09 11:29:53 AM Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Section 9: Respond to Alarms, Alerts, Errors, and Other Problem • You are also alerted to an insulin delivery (pump) alarm or alert either by sound or vibration (on the pump). If your pump is in AUDIO mode A beep will sound. This beep will gradually change to continuous tones of increasing frequency and higher pitch until the alarm/alert is addressed or, in the case of alerts, if the SLEEP mode is activated. If your pump is in VIBRATE mode Your pump will vibrate initially, but eventually the vibrations will change to beeps, which will gradually change to continuous tones of increasing frequency unless the alarm/alert is addressed or, in the case of alerts, if the SLEEP mode is activated. Steps Do This 2. Identify the type of pump alarm or alert and respond as appropriate. Look at the screen of your pump. If the alarm/ alert is a Then do this Bad battery alarm 1. Notice Clear is highlighted. 3. Change the battery within 15 minutes to avoid losing information (see Section 1.4) and resume basal delivery. • Sleep mode is like hitting a snooze button on an alarm clock. Sleep mode gives you the option of postponing your response to an ALERT or reminder for a specific, limited amount of time. 4. Confirm or reset Time and Date. You CANNOT use sleep mode with alarms. 5. RESTART basal delivery (see Section 3.1.1). • Sleep mode can be used to quiet an alert for as little as 15 minutes or as long as 12 hours. An exception is the Note: Refer to your Table of Settings in Section 12 -Appendix A to determine the method of insulin replacement as recommended by your healthcare professional, if NOT able to replace battery right away until the issue is resolved. Pump Idle Alert which is 15 minutes to a maximum of 1 hour. WARNING: If you receive an occlusion alarm, you MUST disconnect from the pump using the quick disconnect feature of the Infusion Set before investigating the cause of the occlusion. Bolus delivery may occur when the cause of the occlusion is removed. • Discuss the occlusion alarm setting with your healthcare professional to help you determine which setting is best for you. Stopped bolus alert • All Companion related alerts appear as text on the screen of your Companion. For example, a low battery alert • You are also alerted to a companion alert either by sound or vibration on the Companion. • Companion related alerts will not gradually escalate in the way a pump alarm or alert does. Procedure: 1. Determine what you need to resolve. Do This If you are resolving Then do this An alarm or alert Go to Step 2. A companion alert Go to Step 3. System errors Go to Step 4. Other problems or difficulties with your pump. Go to Step 5. 219 DOC15736_Rev-A-Man.indd 219-220 1. Notice Clear is highlighted. 2. Press Enter button to clear the alert. 3. Review the amount of the last bolus that was delivered and accommodate for undelivered insulin, if you accidentally stopped your bolus. on your Companion battery. Steps 2. Press Enter button to clear the alarm. Inactivity alert 1. Notice Clear is highlighted. OR 2. Press Enter button to clear the alert, reactivate your pump and return to the Home screen. Inactivity alarm 3. RESTART basal delivery if delivery has stopped. Note: Refer to your Table of Settings in Section 12 -Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. Change the length of the inactivity time as needed. Continued on next page. 220 2/9/09 11:29:53 AM Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps Identify the type of pump alarm or alert and respond as appropriate (continued). Do This If the alarm/ alert is an Occlusion alarm Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps Then do this WARNING: If you receive an occlusion alarm, you MUST disconnect from the pump using the quick disconnect feature of the Infusion Set before investigating the cause of the occlusion. Bolus delivery may occur when the cause of the occlusion is removed. Identify the type of pump alarm or alert and respond as appropriate (continued). Do This If the alarm/alert is a Then do this No insulin alarm 1. Notice Clear is highlighted. 2. Press Enter button to clear the alarm and return to the Home screen. 3. Disconnect tubing from cannula and remove cannula from infusion site. 4. Replace reservoir with a new reservoir filled with insulin (see Section 2.3). 5. Prime pump (see Section 2.4). 6. Insert new infusion set. 7. Prime cannula. 8. RESTART basal delivery. 1. Notice Clear is highlighted. 2. Press Enter button to clear the alarm and return to the Home screen. 3. Check your blood glucose level. 4. Disconnect the pump. 5. Administer an insulin injection if necessary as it is possible that your pump has NOT been delivering insulin for some time. 6. Change your infusion set and reservoir immediately. Note: Refer to your Table of Settings in Section 12 -Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. 7. Prime the pump (see Section 2.4) to see if insulin is being pumped. • ❏ If insulin IS being pumped, finish priming, reconnect pump and start basal delivery again. • ❏ If insulin is NOT being pumped, change infusion site and tubing, then change the reservoir, before calling Customer Care or your healthcare professional for further assistance. Note: If you get frequent occlusion alarms, talk to your healthcare professional about setting high or low sensitivity for alarm, as well as best sites for infusion set and tubing. Continued on next page. 221 DOC15736_Rev-A-Man.indd 221-222 Note: Refer to your Table of Settings in Section 12 -Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. Reservoir alarm 1. Notice Clear is highlighted. 2. Press Enter button to clear the alarm and return to the Home screen. 3. Disconnect tubing from cannula and remove cannula from infusion site. 4. Remove reservoir and replace it (see Section 2.3). 5. Prime Pump (see Section 2.4). 6. Insert new infusion set. 7. Prime cannula. 8. RESTART basal delivery. 9. Contact Customer Care if problem persists. Note: Refer to your Table of Settings in Section 12 -Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. Continued on next page. 222 2/9/09 11:29:54 AM Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps Identify the type of pump alarm or alert and respond as appropriate (continued). Do This If the alarm/alert is a Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps Then do this Low battery alert Note: The Aviator Pump will notify the user when the battery is nearing depletion NOT less than 24 hours before the pump stops delivery due to a depleted battery. Identify the type of pump alarm or alert and respond as appropriate (continued). Do This If the alarm/alert Then do this is a Pump idle alert/ pump NOT started 1. Notice Sleep is highlighted. 2. Scroll to highlight Clear. 3. Press Enter button to clear the alert and return to Home screen. FPO 4. Replace the battery as soon as possible (see Section 1.4). Cancellation alert 1. Notice Clear is highlighted. 2. Press Enter button to clear the alert. 2. Scroll to highlight Clear. 3. Press Enter button to clear the alert and return to Home screen. FPO 4. Replace and refill the reservoir as soon as possible (see Section 2.3). Continued on next page. 223 DOC15736_Rev-A-Man.indd 223-224 If you want to Then Clear the alert Scroll to highlight Clear and press Enter button to return to Home screen. Put pump back to sleep again Press Enter button to put pump back to sleep again. Put pump back to sleep for a longer time Scroll to highlight Sleep Time. Press Enter button. Scroll to change the sleep time. Press Enter button. 3. START basal delivery (see Section 3.1.1) per healthcare professional recommendations. Note: Change the idle screen time to a longer period if this occurs frequently. 1. Notice Sleep is highlighted. 2. Decide what to do next. Note: Change the length of Sleep Time as needed. 3. Reenter your changes/edits ONLY if necessary so that they are saved. Low insulin alert 1. Notice Sleep is highlighted. 3. Identify the type of Companion alert and respond as appropriate. If the alarm/alert Then do this is a Low battery alert 1. Notice OK is highlighted. 2. Press Enter button to clear the alert and return to Home screen. 3. Recharge the battery as soon as possible. The alert indicates that you have 30% of battery charge remaining. (see Section 1.3). 224 2/9/09 11:29:54 AM Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps Do This Very Low battery alert 1. Notice OK is highlighted. 1. Notice OK is highlighted. Do This 4. Resolve System Errors. a. Contact Customer Care. b. NOT all system errors will indicate a failure in the pump system. However, if the pump fails, you MUST DISCONTINUE use of the pump. Refer to your Table of Settings in Section 12 -Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. 5. Troubleshoot pump problems or issues. Identify what the problem may be. If Then Your pump won’t turn on 1. Remove and reinsert battery. (see Section 1.4) 2. Press Enter button to clear the alert and return to Home screen. 3. The companion may shut down at any time. Recharge the battery immediately to continue using the Companion (see Section 1.3). BG check not available alert Steps 2. Press Enter button to clear the alert and return to Home screen. 3. Recharge the battery as soon as possible. The alert indicates that you have 15% of battery charge remaining. (see Section 1.3). Depleted battery alert Section 9: Respond to Alarms, Alerts, Errors, and Other Problem 1. Remove the test strip from the strip port. 2. Remove the USB cable from the USB port on the Companion. 3. Insert a FreeStyle Lite Test Strip into the strip port to perform a blood glucose test (see Section 5.2). WARNING: Use ONLY the USB cable provided. Use of an unapproved cable may lead to loss of electromagnetic compatibility, and make the system more susceptible to electronic interference. 2. Insert a new AAA alkaline battery (Energizer and Duracell brands are recommended) if the issue is NOT resolved. 3. Contact Customer Care or your healthcare professional if the issue is still NOT resolved. Your pump’s batteries are NOT lasting very long (occurs when backlight is used frequently or pump is allowed to alarm for long periods of time) 1. Use ONLY Energizer or Duracell alkaline batteries. Your pump’s screen is hard to read or is distorted 1. Turn on the backlight if you are in a dark room. 2. Set your pump to audio instead of vibrate. 3. Reduce the use of the backlight if possible. 4. Respond to alarms as quickly as possible, as batteries will run down quicker if the pump is allowed to alarm for long periods of time. 5. Contact Customer Care if the issue is still NOT resolved. 2. Remove your sunglasses if applicable. 3. Move indoors or into the shade if applicable. 4. Keep your pump out of direct heat (e.g., away from heaters) or cold (e.g., by placing under your clothing on a cold day). 5. Contact Customer Care if the issue is still NOT resolved. Continued on next page. 225 DOC15736_Rev-A-Man.indd 225-226 226 2/9/09 11:29:54 AM Section 10: System Maintenance Steps Troubleshoot pump problems or issues (continued). Section 10: System Maintenance Do This Steps If Then do this Basal delivery won’t start 1. Check that the devices are paired properly. 2. Check that you are delivering a large enough volume of insulin for priming to be completed in both the tubing and cannula. If a tiny amount of insulin has NOT come out of the end of the tubing, you may need to increase the amount of the prime to at least 4 – 6 units (see Section 2.4). Troubleshoot pump problems or issues (continued). Do This If Then do this You dropped your pump 1. Examine the screen and buttons for chips, cracks, or other damage. Caution: If your pump is cracked or a button is torn, switch to insulin injections immediately AND contact your healthcare professional and/or Customer Care. 2. Carefully examine the pump, making sure the battery cap and reservoir cap are secure. 3. Examine the infusion set for damage, making sure the tubing, tubing connector, and soft cannula are intact. Note: If you attempt to start basal delivery and the pump needs to be primed, the pump will display a warning to prime pump first. Caution: If your pump has been dropped, the waterproof capability of your pump may be compromised. 3. Check that the insulin reservoir is filled. If empty, fill the reservoir. Note: The pump will display a NO INSULIN ALARM. Refer to Step 2 for more information. 4. If you suspect that your pump has been damaged, and are concerned that its waterproof capability has been compromised, please contact Customer Care. 4. Contact Customer Care or your health care professional if you are still unable to start basal delivery. You suspect pump alarm(s) may not be functioning correctly (check for operational safety). Your pump got 1. Towel dry the outside of the pump. wet 2. Inspect the reservoir and battery compartments and dry any water you find. Caution: Do NOT use a hair dryer to dry your pump. 3. If your pump was submerged in salt water, thoroughly clean with a damp cloth before drying with towel. 5. Contact Customer Care or your healthcare professional if you are unable to use your pump. 6. Check your work. DOC15736_Rev-A-Man.indd 227-228 2. Set it aside for 5 minutes without starting basal delivery. 3. Let the alarm escalate and check that it cycles through both audio and vibratory annunciation. 4. Check that the pump’s audio speakers sound as part of the transition from idle mode to basal delivery mode, or following insertion of a battery. Caution: If your pump audio or vibratory annunciators are not functioning, switch to insulin injections immediately AND contact your healthcare professional and/ or Customer Care. 4. Refer to Section 4.1 for additional details on what to do. 227 1. Stop basal delivery. Make sure your pump is operating fully and normally again after responding to the alarm, alert, system error, or other problem(s). 228 2/9/09 11:29:54 AM Section 10: System Maintenance Section 10: System Maintenance 10 System Maintenance • If you do NOT install a new battery within 15 minutes of taking out the old one, you will need to reset the time Purpose To keep your companion and pump in good working order. To assist you with battery-related issues, cleaning, storage and what to do if companion or pump is damaged or gets wet. When Do this procedure when: Materials • • • • • You need to replace your pump battery. You need to clean your companion and pump. You need to transport or store your companion and pump. Your companion or pump is damaged or gets wet. One Duracell MN2400 or Energizer E92 AAA alkaline primary battery (nonrechargeable). • One cloth dampened with mild soapy water. • One damp cloth. • One dry cloth. WARNING: Do NOT use lithium, nickel cadmium (NiCad), nickel metal hydride (NiHM), carbon zinc (heavy duty), or rechargeable batteries. These types of batteries will NOT power Aviator Pump properly, and/or the battery level indicator may not display accurately. Basal delivery MUST be stopped before removing the battery (Section 3.1.3). 10.1. Replace Pump Battery Helpful Information • Stop ALL delivery prior to removing the battery. • Always carry a spare battery with your pump supplies. • Do NOT use a cold battery (e.g., one that has just been in your refrigerator or in cold weather). If the battery is cold, the pump may display a battery-related alarm: the pump may NOT be receiving full power. The battery level display may be inaccurate. • Your battery is expected to last at least 30 days. Battery life may be shortened if you select the vibrate mode, or and date, you will lose your bolus history and Insulin-on-Board (IOB) calculation. You will NOT be able to receive IOB information until the next bolus is delivered and a calculation can be established. • Batteries should be disposed of in accordance with local regulations. • For detailed instructions on battery insertion, see Section 1.4. • RESTART basal delivery as recommended by your healthcare professional. Note: The Aviator Pump will notify the user with a low battery alert when the battery is nearing depletion NOT less than 24 hours before the pump stops delivery due to a depleted battery. Note: The Aviator Companion contains lithium batteries. At the end of their useful life, dispose system components and accessories according to local environment and other rules and regulations that may apply. Contact Customer Care for replacements. 10.2. Clean Your Companion and Pump Helpful Information • Do NOT use organic solvents (e.g., lighter fluid, paint thinner, nail polish remover) and be sure that your hands are free of these products before touching the companion or pump. • Do NOT use household cleaners (e.g., petroleum-based products, bleach, and jewelry cleaner) or products containing high levels of N, N-diethyl-m-toluamide (DEET) near the companion or pump and be sure that your hands are free of these products before touching the companion or pump. • • • • Do NOT use abrasive cleaners, scouring pads, or sharp instruments. Do NOT use lubricants with your companion or pump. Do NOT steam or sterilize your companion or pump. Do NOT put your companion or pump in the dishwasher or microwave. Procedure: Steps 1. Wipe your companion or pump. 2. Dry your companion or pump. Do This Caution: Do NOT place Aviator Companion or Aviator Pump under water. Wipe the outside with a cloth dampened with mild soapy water. Wipe clean with a damp cloth, then wipe dry with a dry cloth. use the backlight frequently. The battery life will also vary based on the number of alarms or alerts you receive. • Do NOT remove the battery unless you are installing a new battery or are storing your pump for a long period of time. 229 DOC15736_Rev-A-Man.indd 229-230 230 2/9/09 11:29:54 AM Section 11: Manage Your Diabetes Safely 10.3. Section 11: Manage Your Diabetes Safely Store Your Aviator Companion and Aviator Pump Helpful Information • • • • 10.5. Conditions for Transport, Storage, and Use Helpful Information Stop all delivery prior to removing the pump battery. • Do NOT to subject your companion or pump to extreme conditions, which may cause malfunctions and possible adverse events or serious injury. Remove the battery before storing your pump. Store your pump with the battery cap and dust cap in place to protect the inside of your pump. Try to AVOID: Store your Aviator Companion and pump in a clean, dry place where there are NOT extreme temperatures, high humidity, or extreme atmospheric pressures. • Exposing your companion or pump to temperatures above 104ºF (40ºC), as might happen in a sauna or on a 10.4. Handle a Damaged or Wet Companion or Pump Caution: If your companion or pump is cracked or a button is torn, discontinue use and switch to an alternate insulin therapy method immediately. Follow your healthcare professional’s recommendations for alternate insulin delivery method in Section 12-Appendix A and/or call Customer Care. ONLY the personnel at Abbott Diabetes Care should take care of a damaged pump. very hot day. • Allowing your companion or pump to absorb radiant heat (e.g., sunlight) that would increase its temperatures to above 104 ºF (40ºC). This can also damage your insulin in the tubing exposed to the radiant heat. • Using a dark colored pump case, which would increase the intensity of radiant heat. • Lowering the temperature of your companion or pump below 41ºF (1ºC). • Storing your pump below or above the recommended temperature when you are not using the pump. Note that storage temperature should be between -4°F to 104°F (-20°C to 43°C). • Exposing your companion or pump to very high humidity (over 100 percent) for prolonged periods of time. Your Helpful Information • Be careful NOT to drop your companion or pump, or hit it against hard surfaces. • Check for missing segments and that the screens display correctly and audio / vibration occurs after installing a pump battery. Also verify the audio / vibration test when starting basal delivery. • Do NOT submerge the companion in water. If it is accidentally dropped in water, towel dry the outside of the companion. Do NOT use a hair dryer to dry your companion. • If your pump is accidentally submerged in water and the battery cap and infusion set hub are in place, you can towel dry the outside of the pump. Inspect the reservoir compartment and battery compartment and dry any water you find with a Q-tip. Do NOT use a hair dryer to dry your pump. If your pump was submerged in salt water, thoroughly clean with a damp cloth before drying. • If your pump is accidentally submerged in water and the battery cap or the infusion set is NOT properly installed, submersion will likely damage internal pump components. Call Customer Care. system may NOT operate properly. • Low atmospheric pressures (Elevation 10,000 feet [3048 meters] and above. Commercial airliners are OK because of the pressurized cabins.) Your system may NOT operate properly. • The Aviator Companion contains lithium batteries. At the end of their useful life, dispose system components and accessories according to local environment and other rules and regulations that may apply. • Avoid getting dirt, dust, blood, control solution, water or any other liquid in the Aviator Companion’s test strip and data port. • When traveling by air, pack your extra lithium batteries in checked baggage. Caution: If your pump is exposed to these extreme ranges, there is a possibility the insulin in your pump will be damaged or destroyed. The insulin in the insulin reservoir may need to be replaced (see Section 2.3), and the infusion set changed. Please check with your healthcare professional. • If your companion is accidentally submerged in water, you can towel dry the outside of the companion. Do NOT recharge or reuse the Companion. Contact Customer Care. • You should remove your pump before every prolonged exposure to water, including bathing, showering, and swimming. • Because of the Aviator Pump’s unique hub connection, use ONLY Aviator-compatible sets with the pump. • If your pump is damaged, it will need to be serviced or replaced. Call Customer Care for information about servicing or replacing your pump. 231 DOC15736_Rev-A-Man.indd 231-232 232 2/9/09 11:29:54 AM Section 11: Manage Your Diabetes Safely Section 11: Manage Your Diabetes Safely 11 Manage Your Diabetes Safely Administration of a Correction Bolus This section provides detailed information related to the safe use of your companion and pump. It describes what the companion and pump are used for and what it must NEVER be used for. Review this section carefully. If you have any questions or concerns after reviewing this section, contact Customer Care or your healthcare professional for assistance. If you get two consecutive unexplainable high blood glucose readings while on pump therapy, do the following: Indication The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. The FreeStyle Aviator System is also intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). The system is available by prescription only. Contraindications 1. If your healthcare professional plan calls for a correction bolus, follow the recommendations for administering the correction bolus. 2. Check for ketones, if your healthcare professional instructed you to do so. 3. Evaluate your pump and infusion set for loose connections or insulin leakage. 4. Check your pump programming to confirm you are receiving your expected basal rate dose. 5. Check bolus history to ensure you have received your last several boluses. 6. Check your daily total insulin amount to make sure that you are on track with the amount of insulin you have been using. 7. Inspect your tubing for air bubbles. Check to see if it is connected to your site correctly and that your site has NOT accidentally become dislodged. 8. Evaluate other causes of unexpected high blood sugars: The Aviator System is NOT intended for: • • • • • People who are unwilling to consistently test their blood glucose levels at least 4 times a day. • Are you sick? • Have you had a change in your physical condition (pain, menses, surgery, illness)? • Has your insulin been exposed to higher temperatures in the day or hours leading up to these higher People who are unwilling to self-insert an infusion set every 2-3 days. People who don’t want to work closely with their healthcare professional. People whose vision is impaired to the point where they CANNOT read the companion or pump’s screen. levels? People whose hearing is impaired to the point where they CANNOT hear the companion or pump’s alarms. • Have you recently started taking a medication that could be causing your blood sugar to be high? • Have you encountered additional personal or physical stress in the hours leading up to this episode? Blood Glucose Testing Your blood glucose levels should stay within the range determined by you and your healthcare professional. It is extremely important that you check your blood glucose levels regularly and often while using your insulin pump. In addition to this ongoing testing, your blood glucose level must also be tested: • Whenever you stop your pump’s operation for any length of time, as the insulin level in your blood will be depleted quickly and blood glucose levels will rise rapidly when the pump is stopped. • • • • Within 1-3 hours of replacing the insulin reservoir and/or inserting/attaching a new infusion set. 9. If there is NO clear reason for the high blood sugars, then it is recommended that you disconnect your infusion set from your body, throw away the set, tubing, and reservoir of insulin. Fill a new reservoir with fresh insulin, prime your system, and reinsert a new set into a different area of your body. Continue to measure your blood glucose levels every 1 to 3 hours after the new insertion to insure your blood glucose levels return to your normal levels. 10. If in doubt with any step, contact your healthcare professional for guidance. More frequently during times of illness, injury or stress. When you first start pump therapy and are adjusting your basal rates. When changing insulin dosages. Refer to Section 5 for more information about testing your blood glucose using your integrated Aviator Companion Blood Glucose Meter. Two Consecutive High Blood Glucose Readings despite the 233 DOC15736_Rev-A-Man.indd 233-234 234 2/9/09 11:29:54 AM Section 11: Manage Your Diabetes Safely Section 11: Manage Your Diabetes Safely FreeStyle Aviator Safety Features A number of advanced safety features are incorporated into the Aviator Pump. Some of the more important features are listed in the table below. Safety Feature What It Does To Set the Safety Feature or for More Information Maximum Bolus Limits the size of your bolus, so you don’t accidentally give yourself too much insulin in a single bolus (protects from over-infusion). See Section 6 Maximum Basal Rate Limits your basal insulin delivery, so you don’t accidentally set a basal rate that is too high (protects from over-infusion). See Section 6 Bolus Calculator Allows you to easily calculate an insulin bolus. Clearly shows you the data used to determine units to deliver (protects from over- or underinfusion). Also allows you to adjust a bolus. See Section 6 The Aviator Pump has a set of backup speakers to make sure the audio tones are heard. N/A Speaker Backups Essentials for Safe and Effective Use In order to use your FreeStyle Aviator System safely and effectively, you will need: • Support from and close contact with your healthcare professional trained in the use of insulin pumps. • A commitment to follow-up appointments for continuing care. • An understanding of the basic principles of diabetes care. • An understanding of basal and bolus insulin use. • Dedication to frequent blood glucose testing: 4 or more times per day and appropriate actions based on testing results. • A backup plan of insulin administration, in case of interruption of pump usage. Potential Risks Connected with Pump Therapy Complications can arise as a result of pump therapy if you are NOT attentive to routine glucose testing and evaluation. These risks include: • Frequent or severe hypoglycemia. • Diabetic Ketoacidosis (DKA). • Infections where you insert your cannula for insulin delivery. The best way to avoid any risk while using the pump is to be prepared with a written plan from your healthcare professional to deal with each risk. Each risk has specific ways your healthcare professional can instruct you to lessen the risk. Frequent glucose monitoring and taking action with the results will also protect you from undetected high or low blood glucose. 235 DOC15736_Rev-A-Man.indd 235-236 Infections Ways to avoid the potential for infection: • Always clean the intended insertion site with soap and warm water or a solution suggested by your healthcare professional. • Do NOT blow on your site to help it dry after you clean it. You may transfer germs from your mouth and/or lungs onto your skin. These germs then enter your skin when you insert the cannula. • Be diligent in changing your infusion set at least every 3 days. Do NOT use your infusion set for long periods of time. This will increase your chance for infection and may potentially eliminate the site from future use. Other points about your infusion site: • Select infusion sites away from scarred or infected areas, and rotate infusion site locations regularly. • When you remove your infusion set, there may be some clear drainage or a small “bump” under the surface of • • • • the skin where the cannula is inserted. The bump should heal and go away over a few days. If it becomes worse, check with your healthcare professional for any infection. Your infusion site should never have any type of cloudy, smelly, or colored drainage. There may be slight redness around the site from your adhesive tape but there should NOT be a ring of reddened skin around the infusion site. Your site should NOT be tender or hurt. If you notice any drainage, redness, hot to the touch, tenderness or lumps at the infusion site, you need to contact your healthcare professional immediately. They will help you address the problem quickly so you avoid additional problems of infection moving to another area of tissue. Most commonly, a mild antibiotic is prescribed to help cure the infection. When inserting a new infusion set, avoid inserting within 2 inches of a site that had been infected. Failure to do so could result in further infection, DKA and/or high blood glucose due to absorption issues. If you have questions, contact your healthcare professional. Hypoglycemia Hypoglycemia, or low blood sugar, occurs when your blood glucose level falls below the lower limit of your established safe blood glucose range. Symptoms of hypoglycemia include: • Feeling light-headed, dizzy, confused, sleepy, weak, nervous, and/or hungry. • Shakiness. • Excessive perspiration. Common causes of hypoglycemia include: • • • • Too much insulin. Skipping a meal (or eating a meal that is smaller than you anticipated). Heavy exercise or a higher-than-normal activity level. Excessive consumption of alcohol. 236 2/9/09 11:29:54 AM Section 11: Manage Your Diabetes Safely If you are experiencing any of the symptoms of hypoglycemia, you should test your blood glucose level. If it is below your lower blood glucose target, follow the “Rule of 15.” 1. Eat approximately 15 grams of simple carbohydrate (1/2 cup fruit juice or sweetened soda, 3-4 glucose tablets or glucose gel). NO fat should be in the foods used to treat hypoglycemia to make them fast to absorb. 2. Wait 15 minutes and then check your blood glucose level again. 3. If your blood glucose level is still too low, repeat steps 1 and 2 until your blood glucose level measures within your acceptable range. 4. Once your blood glucose level is normalized, resume your usual meal and snack schedule. If you will NOT be eating a meal within an hour, you should consider having a snack. Severe hypoglycemia may require an injection of the hormone glucagon. You should have a Glucagon Emergency Kit as part of your emergency kit. Your entire emergency kit should be kept with you at all times. You should let family members, co-workers, and close friends know where it is and how to use it. Ask your healthcare professional how to use glucagon. Note: You should talk with your healthcare professional if you are experiencing hypoglycemia frequently. Hyperglycemia Hyperglycemia, or high blood sugar, occurs when your blood glucose level is higher than the upper limit of the blood glucose range set by you and your healthcare professional. Possible symptoms of hyperglycemia are: • An increased hunger or thirst. • A need to urinate frequently. • Blurred vision. Possible reasons for hyperglycemia are: 1. Interrupted insulin delivery due to: • Occlusion in the tubing or infusion set. • The tubing has tangles or kinks. • The insulin reservoir is empty. • The infusion set or cannula is dislodged. 2. Under delivery of insulin. • Check to see if you are receiving your expected basal rate dose. • Check your bolus history. • Check your total daily insulin delivered. • Your basal or bolus doses may need to be adjusted. 3. Eating more carbohydrates than you anticipated or was aware of. 4. Illness, infection, stress, menses, less activity or exercise. 237 DOC15736_Rev-A-Man.indd 237-238 Section 11: Manage Your Diabetes Safely 5. Insulin has gone bad (e.g. exposed to high temperature, expired.) 6. Taking a medication that raises blood glucose. (Check with your healthcare professional or pharmacist). Possible interventions: • Use your pump to administer a correction bolus (see Section 8). Test your blood glucose level again after an hour. • If you think the companion or pump is NOT functioning properly, you need to disconnect from the pump and administer insulin using an alternate delivery method. Call Customer Care to report the problem with your pump. • If you think there is a problem with the tubing or infusion set, remove the old infusion set from the pump and replace with a new infusion set. Follow the instructions for priming and reinsertion (See Section 2.4 and your infusion set’s Instructions for Use). • If you are unable to determine the reason for your hyperglycemia and are unable to correct it, call your healthcare professional. • If your blood glucose level is very high, you should check your urine or blood for ketones and follow the advice of your healthcare professional. Diabetic Ketoacidosis Diabetic Ketoacidosis (DKA) can develop if your blood glucose levels have been too high for a period of time. DKA is different from hyperglycemia in that in addition to an elevated blood glucose level, your body is producing ketones, which change the pH (acidity) of your blood. DKA is extremely serious, and requires immediate treatment by your healthcare professional. Contact your healthcare professional immediately if you suspect DKA. DKA can be life threatening. How long it takes to develop DKA is based on the individual. No matter what your particular situation, once insulin delivery stops (from a clog, dislocation of your infusion set, disconnecting and forgetting to reconnect), within 3-5 hours (the duration of action of the insulin used in your pump) you will be insulin deficient. If you do NOT restore insulin delivery, you are at risk of even higher blood glucose levels and the development of ketones, which, if left untreated, can lead to the life-threatening consequences of DKA. It is VERY IMPORTANT that any time you discover insulin delivery has been disrupted, you should immediately test your urine or blood for ketones. Follow the plan you and your healthcare provider have designed. Symptoms of DKA, which can be mistaken for flu-like symptoms, include: • Headache. • Stomach ache. • Fruity odor on breath. • Very dry mouth. • Shortness of breath. • Nausea/vomiting. 238 2/9/09 11:29:55 AM Section 11: Manage Your Diabetes Safely Section 12: Appendices Appendix A: Table of Settings Possible causes of DKA include: • Improper use of insulin. • Infection or illness. • Stress. How Exercise Affects Blood Glucose Levels Your risk of DKA is lessened if you follow these guidelines: • Work with your healthcare professional to make sure your pump is programmed properly, that you know how to use your pump, and that your selected bolus and basal insulin doses are appropriate. • Always have insulin and reservoirs available. • Keep your emergency kit with backup insulin supplies with you at all times. • Monitor your blood glucose level closely when you are ill or during periods of high activity or stress. Your insulin pump can be programmed with a basal insulin pattern or a temporary basal rate that can be used on days you are exercising (see Section 7.6). You may want to talk with your healthcare professional about this option or any other questions you may have about how exercise affects your blood glucose levels and insulin needs. In addition, there are other resources that may be helpful to understand the impact of exercise on your diabetes. See the Resources section of this User Guide for additional resources on exercise and diabetes. Exercise can help lower blood glucose levels. The more active you are, the more dramatic this lowering will be. When starting or stopping an exercise program (or increasing or decreasing your level of activity), you may have to adjust your basal rates. Your food intake may also need to be adjusted. Talk with your healthcare professional if you have any questions about DKA or what you can do to prevent it. How Illness Affects Blood Glucose Levels Infection or illness is usually accompanied by higher than normal blood glucose levels (hyperglycemia). Your insulin needs will most likely increase when you are ill. Follow these guidelines: • Insulin must be taken when you are ill; contact your healthcare professional for specific advice, but do NOT stop taking basal insulin, even if you feel too sick to eat. • Check your blood glucose level every 2-4 hours. • Check your blood or urine for ketones; Your insulin pump can be programmed with a basal insulin pattern that can be used when you are ill (see Section 7); you may want to talk with your healthcare professional about this option. Sick Day Management When you are sick, your body’s stress level increases. The body produces hormones to help fight off the sickness. However, there are side effects: blood glucose levels increase and insulin’s ability to lower blood glucose levels decrease. In this situation, blood glucose levels are much more difficult to keep in your target range, which could lead to DKA. You need to plan ahead, work with your healthcare professional, and prepare a sick day plan in advance. The plan should include: • When to call your healthcare team. • How often to test blood glucose. • When and how often to test for ketones. • What medicines to take. • A plan for eating. • Contact numbers for your healthcare team. 239 DOC15736_Rev-A-Man.indd 239-240 Your Daily Kit • You must have a backup plan in case something goes wrong with your pump or you have a medical emergency. Keep a daily kit with you at all times. Let family members, co-workers, and close friends know where it is and how to use it. Your kit should include: • Blood glucose monitoring supplies. • Ketone monitoring supplies. • Glucose tablets/gel or liquid or other sources of carbohydrate to treat a low glucose. • A Glucagon Emergency Kit (Glucagon Emergency Kits have an expiration date; check frequently to make sure your kit has NOT expired). • An extra insulin infusion set. • An extra unopened pump reservoir. • An extra AAA alkaline battery. • Dressings and adhesives. • Spare battery cap. • Insulin syringe and short or rapid-acting insulin vial or insulin pen. Remember, insulin is sensitive to temperature extremes. Replace your spare insulin monthly. Discontinuing Pump Use If you and your healthcare professional determine that stopping pump therapy makes sense, you must be prepared to switch to an alternate insulin therapy method. Medical Procedures You may need to suspend pump use for/during certain medical procedures. Keep these points in mind: • Do NOT expose your companion or pump to MRI, X-ray, CAT scan, or ultrasound equipment. ALWAYS disconnect your companion and pump and store it away from the machines. Do NOT bring the companion and/or pump into the procedure room at any time. • Talk with your healthcare professional about whether or NOT you should use your pump during outpatient procedures, hospitalizations, surgeries, or ER visits. 240 2/9/09 11:29:55 AM Section 12: Appendices Appendix A: Table of Settings Section 12: Appendices Appendix A: Table of Settings 12 Appendices A. Table of Settings Frequently Asked Questions Q. How do I obtain supplies for my pump? A. Supplies for the Aviator Pump can be obtained by calling Customer Care. Q. When a question or problem arises, should I call Customer Care or my healthcare provider? A. In general, if you have a question about the programming or operation of your pump, you should call Customer Care. If you have a question about your personal insulin therapy, treatment plan, or diabetes management, you should contact your healthcare professional. Everyone has different insulin requirements and pump preferences. Before you begin using your pump, you will need to work with your healthcare professional to determine the correct pump settings to meet your individual needs. It is important to keep your personal settings charts updated. Remember to record any changes recommended by your healthcare professional. The table below provides the options available as well as the factory default setting. 1. Pump Settings Q. Should I insure my pump? Record your pump settings here for future reference: A. Contact your insurance provider to see if they offer coverage. SETUP WIZARD: Language, Time/Date, and Insulin Settings Q. Is it okay to take a break from pump therapy? Setting Options Available Factory Default Your Setting A. Consult your healthcare professional before changing or stopping pump therapy. If you take a break from pump therapy, you must switch back to injecting insulin. Be sure to administer insulin for meals and to cover basal insulin requirements. What it Allows You to Do Language Set the language your pump will use for its text instructions. English English English Time Select the time format. 12-hour (e.g., 1 PM will appear as 1:00 PM) or 24-hour (e.g., 1 PM will appear as 13:00). 12 hour Date Select the date format. Month/day/year or day/month/year Mmm dd, yyyy Current Time Set the time. N/A -- N/A Current Date Set the date. N/A -- N/A The insulin concentration on your pump is fixed at U100. U100 Time/Date Format Q. Is a pump support group worthwhile? A. Many people find a pump support group helpful. It can be a place to go where you can discuss pump therapy with – and be supported by – your peers. If you are interested in a pump support group, ask your healthcare professional. Insulin Concentration 241 DOC15736_Rev-A-Man.indd 241-242 U100 242 2/9/09 11:29:55 AM Section 12: Appendices Appendix A: Table of Settings Section 12: Appendices Appendix A: Table of Settings Setting What it Allows You to Do Options Available Factory Default Type Select the type of insulin you will be using in your pump. Rapid or short Rapid Set the action time of the insulin you will be using in your pump. 2 to 8 hours Action Time 5 hours 00 minutes Your Setting Setting What it Allows You to Do Options Available 1 U Drop Set how much 1U of insulin will lower your blood glucose level, for up to 24 different time blocks. 5 - 500 mg/dL Maximum Set the increments (in Units) of insulin that may be programmed for a bolus. 0.05U, 0.1U, 0.5U, or 1.0U Set the maximum programmable amount of insulin for a single bolus. 0.1 - 50.0 when increment =>0.1 units Turn the one-button bolus function on or off. On/Off Set the One-Button bolus increment (how much each button press increases the bolus amount). 0.5U or 1.0U 0.1U Increment (0.28 – 27.8 mmol/L) 50-300 mg/dL 110 mg/dL (2.8 – 16.7 mmol/L) (6.1 mmol/L) Increment Select the increment for changes in basal insulin delivery rates 0.05 U/h, 0.10 U/h, 0.50 U/h, or 1.00 U/h 0.05 U/h Maximum Select the maximum amount of insulin to be used for hourly basal insulin delivery rates. 0.05 U/h to 30.00 U/h 2.00 U/h Temporary Set the format used to program a temporary basal rate in either absolute Units or as a percentage of the programmed basal rate. Units or Percent Percent Basal Settings 10.0U 0.05 – 9.95 when increment = 0.05 units One-Button Bolus On/Off -- Set the values for your blood glucose targets for up to 24 different time blocks. Bolus Limits Increment Your Setting Blood Glucose Range Blood Glucose Targets SETUP WIZARD: Bolus and Basal Settings Factory Default Off If One-Button is “off”, there is no option. If set to “on”, 0.5U Bolus Calculator Carb Ratios Select the amount of 1-150 (1U/1gbolus insulin needed 1U/150g) to handle each gram of carbohydrate you plan to eat, for up to 24 different time blocks. 243 DOC15736_Rev-A-Man.indd 243-244 -- SETUP WIZARD: Feedback and Alerts/Alarms Pump Feedback Options Feedback Set your pump to give either audio (beeps) or vibratory signals. Audio or Vibrate Audio 244 2/9/09 11:29:55 AM Section 12: Appendices Appendix A: Table of Settings Section 12: Appendices Appendix A: Table of Settings Setting What it Allows You to Do Options Available Factory Default Audio Set the volume of auditory alerts. Low, Medium, or High If audio is selected, “High” Note: All vibrations are at the same intensity. Audio Vibrate Progress Tones Options Available Factory Default Select the insulin level that will trigger the Low Insulin Alert. 5 – 50U 20U Set the time of the Inactivity Alarm. 1 – 24 hr 1 hr Low Alert Audio Inactivity Set the volume of auditory alerts. Low, Medium, or High If audio is selected, “Low” Display Settings Buttons Invert the screen to suit your hand preference (right or left handed). On Right/On Left Right Set the length of vibratory alerts. Long, Medium, or Short If audio is selected, “Long” Timeout Set the amount of time the display may remain idle before reverting to the “idle” screen. 15 - 120 seconds 15 seconds Home Select the Home screen display format. Information or Activity Information Cursor Select how highlighted options will appear. Highlight or Outline Highlight Contrast Select the contrast of the companion display. (this setting is only available on the Companion) 0-2 Magnify Select whether highlighted options will be magnified in larger font size. (This setting is only available on the pump) On or Off On Set the volume of progress tones. Your Setting Low Insulin Alert Audio and/or Vibrate SETUP WIZARD: Display and Locked Items Settings Low, Medium, or High Set the level of sensitivity Low or High of the Occlusion Alarm. 245 DOC15736_Rev-A-Man.indd 245-246 What it Allows You to Do Set your Companion to give audio (beeps) and/ or vibratory signals and progress tones. If audio is selected, “Low” Occlusion Alarm Sensitivity Setting Inactivity Alarm Companion Feedback Options Feedback Your Setting High 246 2/9/09 11:29:55 AM Section 12: Appendices Appendix A: Table of Settings Setting What it Allows You to Do Options Available Factory Default Locked Items Note: Locked items can only be accessed through the SETUP WIZARD. Lock or unlock basal functions on the pump (select, edit, create, delete, rename program). Unlocked or Locked Unlocked Bolus Lock or unlock bolus functions on the pump (One-Button Bolus, Food and Correction Bolus, Correction Bolus, Food Bolus, Manual Bolus). Unlocked or Locked Unlocked Prime Lock or unlock prime functions on the pump (tubing, cannula). Unlocked or Locked Unlocked Record your personal settings here for future reference: Standard Daily Basal Rates Therapy Lockout Disable access to start/ stop delivery features on the Companion including Basal and Bolus. On or Off Off Duration Set the lockout duration. Once or Always If “On” is selected duration is “Once” Basal Rate (Units/h) Basal Rates: Alternate Pattern 1 (for example workout days) Use these basal rates when Basal Rate Start Time Therapy Lockout Note: Therapy Lockout is only available on the Companion. DOC15736_Rev-A-Man.indd 247-248 2. Personal Settings Basal Rate Start Time Basal 247 Your Setting Section 12: Appendices Appendix A: Table of Settings Basal Rate (Units/h) 248 2/9/09 11:29:55 AM Section 12: Appendices Appendix B: SETUP WIZARD Default Configuration and Settings Basal Rates: Alternate Pattern 2 For detailed information about setting a Temporary Basal, see Section 7.6. Use these basal rates when Basal Rate Start Time Temporary Basal Settings Section 12: Appendices Appendix B: SETUP WIZARD Default Configuration and Settings Basal Rate (Units/h) When to use Temporary Basal: What to set Temporary Basal at (indicate if this is a percentage of your standard basal pattern or a specific Unit rate): Bolus Settings For detailed information about Bolus programming, see Section 8. When to use a Normal bolus: When to use an Extended bolus: When to use a Dual bolus: Basal Rates: Alternate Pattern 3 When to use the One-Button Bolus function: Use these basal rates when Basal Rate Start Time Basal Rate (Units/h) 249 DOC15736_Rev-A-Man.indd 249-250 3. Other Information Record any additional instructions from your healthcare professional below. 250 2/9/09 11:29:55 AM Section 12: Appendices Appendix B: SETUP WIZARD Default Configuration and Settings Section 12: Appendices Appendix C: Device Specifications – Companion B. SETUP WIZARD Default Configuration and Settings Wizard Step Item Screen Default Config Language SELECT LANGUAGE English VALUE CANNOT BE CHANGED N/A Time TIME/DATE FORMAT 12 Hour “12 Hour,” “24 Hour” N/A Date TIME/DATE FORMAT Mmm dd, yyyy “Mmm dd, yyyy”, “dd Mmm yyyy” N/A Hour SET TIME -- 01 – 12 (12hr); 00 – 23 (24hr) Minute SET TIME -- 00 – 59 AM/ PM SET TIME AM Month SET DATE Day Valid Values Increment Wizard Step Item Screen Default Config On/Off ONE-BUTTON BOLUS On Increment ONE-BUTTON BOLUS Enabled 0.5 U Increment BASAL LIMITS Maximum Valid Values “Off”, “On” N/A 0.5 or 1.0 (0.5 or 1.0) 0.5 0.05 U/h “0.05 U/h”, “0.10 U/h”, “0.50 U/h”, “1.00 U/h” N/A BASAL LIMITS 2.00 U/h 0.05 – 30.00 .05 Temp BASAL SETUP Percent “Units”, “Percent” N/A Pump AUDIO/VIBE Audio “Audio”, “Vibrate” N/A Audio AUDIO/VIBE High “Medium”, “High”, “Low” N/A Sensitivity OCCLUSION ALARM High “High”, “Low” N/A Low Alert LOW INSULIN ALERT 20 U 5 – 50 Basal LOCKED ITEMS Unlocked “Unlocked”, “Locked” N/A Bolus LOCKED ITEMS Unlocked “Unlocked”, “Locked” N/A N/A “AM”, “ PM” N/A -- “Jan”, “Feb”, “Mar”, “Apr”, “May”, “Jun”, “Jul”, “Aug”, “Sep”, “Oct”, “Nov”, “Dec” N/A SET DATE -- 01 – 31 Year SET DATE -- 2007 – 2049 Type INSULIN PROFILE Rapid Action Time INSULIN PROFILE 5h 00m 2h 00m – 8h 00m 15 (min) Time INACTIVITY ALARM -- h 1 – 24 (always On) Buttons DISPLAY on Right “on Right”, “on Left” N/A Timeout DISPLAY 15 Sec 15 – 120 15 Home DISPLAY Information “Information”, “Activity” N/A Cursor EDIT MODE Highlight “Highlight”, “Outline” N/A Magnify EDIT MODE On “On”, “Off” N/A Prime LOCKED ITEMS Unlocked “Unlocked”, “Locked” Time, 1U Drop 24 blocks of time allowed 5 – 500 mg/dL (0.28 – 27.8 mmol/L) Programming starting value: 50 in one unit increments 1 hour Time Add Block 1 12:00 a.m. 12:00 a.m. – 11:30 p.m. Rate Add Block 1 -- -- 24 blocks of time allowed 1 – 150 (1U/1g – 1U/150g) Programming starting value: 1U/15g Carbs – 1 – 200 grams 0.00 – Max Limit (user programmable) 1 hour Time Add Block n+1 -- Time of Block n +:30 – 11:30 p.m. (or 23:30 for 24 hour) Rate Add Block n+1 -- -- 1 hour 0.00 – Max Limit (user programmable) BG TARGETS 24 blocks of time allowed 50 – 300 mg/dL (2.8 – 16.7 mmol/L) Default value is 110 mg/dL (6.1 mmol/L) Time, I:CHO 1U DROP CARB RATIOS -- “Rapid”, “Short” Time, mg/dL Increment BOLUS LIMITS 0.1 U “0.5 U”, “1.0 U” Maximum BOLUS LIMITS 10.0 U 0.1 –50.0 when increment => 0.1 units 0.05 – 9.95 when increment = 0.05 251 DOC15736_Rev-A-Man.indd 251-252 N/A Increment 30 (min) user programmable 30 (min) user programmable N/A = Increment 252 2/9/09 11:29:55 AM Section 12: Appendices Appendix D: Device Specifications – Pump C. Device Specifications – Companion Other Preferences That are Not Part of the Wizard Menu Item REMINDERS Reminders 1 – 6 On/Off Off Reminders 1 – 6 Message Test REMINDERS REMINDERS Disable All Screen Default Config Care Comments On Valid Values “On,” “Off” Increment N/A “Test”, “Wakeup”, “Basal”, “Bolus”, “Exercise”, “Meeting”, “Pickup”, “Snack”, “Meds” N/A “On”, “Off” N/A REMINDERS On/Off Insulin Temp Care Comments Off “Off”, “On” N/A REMINDERS On/Off Site Change Care Comments Off “Off”, “On” N/A REMINDERS Frequency Site Change Care Comments 2.0 days 2.0, 2.5, 3.0 N/A Check BG Care Comment Off REMINDERS On/Off 253 DOC15736_Rev-A-Man.indd 253-254 “Off”, “On” N/A Section 12: Appendices Appendix D: Device Specifications – Pump Assay Method (FreeStyle Lite Blood Glucose meter): Coulometric electrochemical sensor Automatic shutoff: User settable up to two minutes after last user action Calibration (FreeStyle Lite Blood Glucose meter): Plasma equivalent Hematocrit (FreeStyle Lite Blood Glucose meter): 15% to 65% Measurement Units: Either mg/dL or mmol/L Result Range (FreeStyle Lite Blood Glucose meter): 20 to 500 mg/dL (1.1 to 27.8 mmol/L) Sample (FreeStyle Lite Blood Glucose meter): Whole blood, capillary Sample size (FreeStyle Lite Blood Glucose meter): 0.3 microlitre (300 nanolitres) Test time (FreeStyle Lite Blood Glucose meter): Average of 5 seconds Dimensions: 3.89 X 2.44 x 0.63” (99 X 62 X 16 mm ) Display Type: • Dot graphic Display Viewable Dimensions: 1.77 x 1.28” (45 X 32.5 mm) Display Backlight: Yes Audio/Vibe Alert: Yes Weight: 2.6 oz (75 grams) Companion Battery: Lithium polymer, 3.7V 690mAh Battery Life: 3 days The expected life of the battery is dependant upon the following usage: - 5 boluses per day with total daily bolus delivery of 24 Units (U100) - Basal delivery of 1U/h (U100) 24 hr/day, 7 days/week - Prime of 20 Units (U100) occurs 3 times per week. - 5 blood glucose readings per day - Enter and log 8 events per day - Data transfer to CoPilot three times per month Memory: 90 days worth of events. All events can be seen if downloaded to a PC. Water Resistance: None Operational Conditions (Temperature, Humidity and Pressure): 41°F – 104°F (5°C to 40°C) with 10% to 90% relative humidity 14.7 psia - 10.2 psia (equivalent to an altitude of sea level to 10,000 feet [3048 meters] under standard atmospheric conditions) Storage Range Shipping container for 1 year at -4 – 113°F, average temperature at 72.5°F (-20°C to 45°C, average temperature at 22.5°C) with 10% to 90% relative humidity, non-condensing. Data Storage Time: The Companion has the ability to store a minimum of 90 days of events in non-volatile memory for the expected life of the companion. 254 2/9/09 11:29:56 AM Section 12: Appendices Appendix E: FCC Compliance Information D. Device Specifications – Pump Dimensions: Section 12: Appendices Appendix F: Electromagnetic Information Maximum Time to Assert Occlusion Alarm: 3.3 X 1.8 X 0.75” (84 X 46 X 19 mm) • Display Type: Dot graphic Display Viewable Dimensions: 0.97” X 0.76” (24.7 X 19.4 mm ) Display Backlight: Yes Audio/Vibe Alert: Occlusion Alarm set to High Sensitivity 1 U/hr 0.05U/hr Approximately 3 hrs Approximately 60 hrs Approximately 6 hrs Approximately 120 hrs Yes Occlusion Alarm Threshold/Pressure (Maximum Infusion Pressure) 25 psig (pounds per square inch gauge) Weight: Without battery and reservoir/hub, weight is approximately 2.7 oz (76.5 g). Add battery and empty reservoir, weight is approximately 3.3 oz (93.6 g). Bolus Volume upon Release of an Occlusion Approximately 2.0 units Reservoir: Single use plastic reservoir Pump Battery: Reservoir Connection: Proprietary secure connector One AAA battery (Energizer E92 or Duracell MN2400 recommended). Other models from these companies have not been tested. Basal Increment: 0.05 units Battery Life: Total Basal Rates: 48/day Basal Profile Configuration: Numerical display Basal Profiles: 30 days (in typical use cases) The expected life of the battery is dependent upon the following usage: Basal: 1 U/h (U100) 24 hr/day, 7 days/week Bolus: 5 boluses per day with a total daily bolus delivery of 24 Units (U100) Prime: 20 Units (U100) occurs three times a week Basal Interval: 30 minutes Memory: 90 days worth of events; display shows last 30, remainder can be seen if downloaded to a PC Basal Frequency: Every 3 minutes Water Resistance: Water resistant to IPX8 Basal Rate Range: 0.05 to 30U/h Moisture Protection: IPX8 (Water resistant to 8 feet [2.4 meters] for 30 minutes and 12 feet [3.6 meters] for 3 minutes) Temporary Basal: +/- 10% increment between 0-200% for 0.05 to 30U/h* OR +/- 0.05 unit increment, single rate for 0.05 to 30U/h. You may set a temporary basal for up to 72 hours. • * The minimum allowable percentage is equal to the minimum basal rate (0.05) divided by the lowest basal rate over the specified duration of the temporary basal that is greater than 0. (e.g. if the lowest basal rate greater than 0.0U over the duration is 0.20U, the minimum percentage is 25% — 0.05/0.2 = 0.25) The maximum allowable percentage is equal to the maximum basal limit (Setup: Basal Limits: Maximum) divided by the highest basal rate over the specified duration of the temporary basal, truncated to the nearest 10%. (e.g. if the highest basal rate over the duration is 1.35 U/h, and the maximum basal limit is 2.00 U/h, the maximum percentage is 140% — 2.00/1.35 = 1.48) Bolus Dose Range: 0.05 to 50U Bolus Increments: 0.05U, 0.1, 0.5 or 1.0 using One-Button Bolus (audio/vibrate) Normal Bolus Delivery Rate: At least 0.1U per second Prime Deliver Rate: At least 0.1U per second Extended Bolus: Yes 1 U Bolus Duration: 10 seconds typical Inactivity Alarm: Always on, 1 – 24 hours. 255 DOC15736_Rev-A-Man.indd 255-256 IEC Classification: Internally powered equipment, Type BF applied part (protection against electric shock) Reservoir Volume: 250U or 2.5 mL Operational Conditions (Temperature and Humidity): 41°F – 104°F (5°C to 40°C) with 10% to 90% relative humidity Storage Range: Shipping container for 1 year at -4°F – 113°F, average temperature at 72.5°F (-20°C to 45°C, average temperature at 22.5°C) with 10% to 90% relative humidity. Accuracy: Bolus Accuracy : +0.1U / -0.2U (or +0.001ml/-0.002ml); for doses from 0.05U to 2U inclusive +5% / -10%; for doses greater than 2U up to and including 6U +5% / -5% for doses greater than 6U Basal Accuracy: +/-5% Data Storage: The Pump has the ability to store a minimum of 2700 patient events in non-volatile memory for the expected life of the pump. 256 2/9/09 11:29:56 AM Section 12: Appendices Appendix G: Accuracy of Flow Rate E. FCC Compliance Information Electromagnetic Information Electromagnetic Interference (EMI) from Radio Wave Sources Model Number: PRT12354-xxx and PRT15751-xxx. FCC Rules: Tested to comply with FCC Part 15, Class B, Security/Remote control Transmitter. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or locate the receiving antenna. • Increase the separation between the equipment and transmitter. • Consult the dealer or an experienced radio/TV technician for help. The user is cautioned that changes or modifications not expressly approved by Abbott Diabetes Care may void the user’s authority to operate this device. 257 DOC15736_Rev-A-Man.indd 257-258 F. Section 12: Appendices Appendix G: Accuracy of Flow Rate Battery powered insulin delivery devices such as the Abbott Diabetes Care Inc. FreeStyle Aviator System may be susceptible to electromagnetic interference (EMC) such as Radio and TV station towers, amateur radio (HAM) transmitters, two way radios, cell phones, Electronic Article Surveillance (EAS) systems and Radio Frequency Identification (RFID) systems. The interference from these electromagnetic field sources may cause the insulin pump to STOP delivery of the insulin or degrade the image on the companion and pump screens. It can also permanently damage the control system of the insulin delivery pump and companion. Immunity Level The intensity of the EMI can be measured in volts per meter (V/m). The immunity level of the FreeStyle Aviator System is 10 V/m as mandated by the standard, IEC 60601-2-24. Some cellular telephones and similar products transmit signals while they are turned on, even when NOT being used. EMC/EMI Declaration: Reference Document Performance CISPR 11 IEC 61000-4-2 IEC 61000-4-8 Criteria Required Performance (Radiated Emissions) Group 1 Class B Pass IEC 60601-2-24 IEC 60601-2-24 Criteria Met N/A (Electro Static Discharge) +/-8kV Direct, HCP and VCP Discharges +/-15KV Air Discharges Pass (Magnetic Immunity) 400 A/m Pass 258 2/9/09 11:29:56 AM Section 12: Appendices Appendix H: Alarm Priority G. Accuracy of Flow Rate This graph shows the flow rate during the stabilization period. Measurements were made at a basal rate of 1U/h, in accordance to IEC 60601-2-24:1998 using an Aviator Insulin Reservoir and a Unomedical Comfort infusion set. 0.020 Section 12: Appendices Appendix I: Aviator Menus - Companion At the minimum rate of 0.05 U/h (0.0005 mL/h), setup errors associated with the IEC 60602-2-24 test are too large to accurately determine the flow rate of the pump. An alternate test method was used which determines delivery accuracy by analyzing the movement of drive motor, as reported by an encoder on the motor shaft. Actual insulin flow rate may be less accurate. This graph shows the calculated flow rate during the stabilization period. Encoder data was collected at a basal rate of 0.05U/h. 0.010 0.015 0.009 0.007 0.010 Flow (mL/h) Flow (mL/h) 0.008 0.005 0.006 0.005 0.004 0.003 0.002 0.000 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 0.001 Time (minutes) This graph show the maximum errors observed for specific observation intervals. Measurements were made at a basal rate of 1U/h, in accordance to IEC 60601-2-24:1998 using an Aviator Insulin Reservoir and a Unomedical Comfort infusion set. 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 Time (minutes) This graph show the maximum errors calculated for specific observation intervals. Encoder data was collected at a basal rate of 0.05U/h. 15 20 10 15 10 Overall percentage error: -1.1% -5 -10 -15 -20 15 60 150 330 570 Observation Interval (minutes) 930 Percentage Error of Flow Rate (%) Percentage Error of Flow (%) 20 0.000 Overall percentage error: -0.01% -5 -10 -15 -20 259 DOC15736_Rev-A-Man.indd 259-260 15 60 150 330 570 Observation Interval (minutes) 930 260 2/9/09 11:29:56 AM Section 12: Appendices Appendix I: Aviator Menus - Companion H. Alarm Priority I. FreeStyle Aviator Menus – Companion This section documents the Aviator Pumps alarm priorities in accordance with the 60601-1-8:2006 - `Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.’ HOME All of the Aviator Pump alarms are classified as MEDIUM PRIORITY per the 60601-1-8:2006 collateral safety standard. Failure to respond to the cause of an Aviator alarm condition may potentially result in adverse medical conditions (including death or irreversible injury) over an extended time period. While an alarm is active, insulin delivery is stopped. Therefore, it is important that you to respond to all alarms without delay. Possible Aviator alarms are: · Inactivity Alarm · Reservoir Alarm · No insulin alarm · Occlusion alarm 261 DOC15736_Rev-A-Man.indd 261-262 Section 12: Appendices Appendix I: Aviator Menus - Companion MAIN MENU START BASAL/STOP DELIVERY BOLUS MENU QBolus Manual Normal Extended Dual Food Correction Food & Correction History BASAL MENU Start/Stop Basal Select Daily Temp Basal View Daily Modify Edit Create Rename Delete ALARMS Audio/Vibrate Inactivity Occlusion Reminders Care Comments Low Insulin STATUS System Status (Bolus & Basal) Pump Levels Controller Levels Pump Version Controller Version 262 2/9/09 11:29:56 AM Section 12: Appendices Appendix J: Aviator Menus - Pump PRIME MENU Tubing Cannula REPORTS MENU Pump Diary Therapy Events Alarms BG History Line Graph BG Statistics 7 Day Average 14 Day Average 21 Day Average ADD EVENT Insulin Food Exercise State of Health Generic SETUP Time/Date Basal Limits Basal Setup Bolus Limits Insulin Preferences Buttons Timeout Home Cursor Magnify Contrast Therapy Lockout Target Range Wizard Select Language Time/Date Time/Date Format Insulin Profile Insulin Type Insulin Action Time Inactivity Alarm Set Display Preferences Timeout Home Edit Mode Cursor Type Magnify Bolus Calculator Options 1U Drop Carb Ratios BG Targets Bolus Limits One-Button Bolus Basal Limits Basal Setup (Temp) Audio/Vibe Occlusion Alarm Low Insulin Alert Locked items Name Values Self Test Pair Pump Radio 263 DOC15736_Rev-A-Man.indd 263-264 Section 12: Appendices Appendix J: Aviator Menus - Pump 264 2/9/09 11:29:56 AM Section 12: Appendices Appendix J: Aviator Menus - Pump Glossary J. FreeStyle Aviator Menus – Pump HOME MAIN MENU START BASAL/STOP DELIVERY BOLUS MENU QBolus Manual Normal Extended Dual Food Correction Food & Correction History BASAL MENU Start/Stop Basal Select Daily Temp Basal View Daily Modify Edit Create Rename Delete ALARMS Audio/Vibrate Inactivity Occlusion Reminders Care Comments STATUS Bolus Status Basal Status Pump Levels Pump Version PRIME MENU Tubing Cannula 265 DOC15736_Rev-A-Man.indd 265-266 REPORTS MENU Bolus History Pump Diary Therapy Events Alarms SETUP Time/Date Basal Limits Basal Setup Bolus Limits Insulin Preferences Display Edit Mode Model Wizard Select Language Time/Date Time/Date Format Insulin Profile Insulin Type Insulin Action Time Inactivity Alarm Set Display Preferences Buttons Timeout Home Edit Mode Cursor Magnify Bolus Calculator Options 1U Drop Carb Ratios BG Targets Bolus Limits One-Button Bolus Basal Limits Basal Setup (Temp) Audio/Vibe 266 2/9/09 11:29:56 AM Glossary Glossary Glossary Occlusion Alarm Low Insulin Alert Locked items Name Values Pair Device Radio RF Stats (Key terms are in Blue the first time it is used in the User Guide Sections) • Activity Display - Menu driven Home screen. • Alarm – The way your pump tells you an event has occurred that requires your immediate attention. Delivery of insulin IS stopped. • Alarm Settings – Settings that allow you to customize how your pump communicates alarms to you. • Alert – The way your pump tells you an event has occurred that requires your attention in the near future. Delivery of insulin is NOT stopped. • Alert Settings – Settings that allow you to customize how your pump communicates alerts to you. • Audio/Vibe Settings – Settings that allow you to decide whether your pump uses audio (beeps) or vibrations when there is an alarm. • Back Button (companion) - The oval shaped lower button on the right side of the companion screen below the jogwheel. It is used to cancel a change made to a value, and to move back to the previous screen. • Back Button (pump) – The top button on the right side of the pump screen with an indented triangle pointing to the left when in the right-hand mode. It is used to cancel a change made to a value, and to move back to the previous screen. • Backlight/QBolus Soft Key (companion) - To turn on/off the backlight, press the bottom left soft key on the companion with the light bulb icon for 2 seconds, when you are NOT at the Home screen. To deliver a quick bolus, press the QBolus soft key from the Home screen. Using the jogwheel, select amount of bolus to deliver and press Enter button. • Backlight/Enter Button (pump) – The bottom button on the right side of the pump screen with an indented triangle pointing to the right. To turn on/off the backlight, press this button for 2 seconds. It is also used to select an item, or to move forward to the next screen. • • • • Basal – The “baseline” or background level of insulin that you need delivered throughout the day. Basal Block – A programmed basal rate for a period of time during the day. Basal Insulin – The small, frequent pulses of background insulin that your body continuously needs. Basal Menu – Allows you to get to the basal-related functions to make changes in the basal settings on your pump. • Basal Panel – Displays the status of whether basal has started or stopped, and which active program is delivering the basal. When highlighted and selected, allows you to access basal options. • Basal Program – A sequence of up to 48 basal blocks for a 24-hour period. • Basal Rates – The rates of insulin delivery you set when you are creating basal programs. Basal rates can vary throughout the day. 267 DOC15736_Rev-A-Man.indd 267-268 268 2/9/09 11:29:56 AM Glossary Glossary • Basal Settings – Settings that allow you to define the basal amount, basal maximum limit, and the temporary • Care Comments – Alerts for specific activities, i.e. such as to remind you to change your infusion set. You can • Battery Cap – Cap cover for the battery compartment. • Battery Compartment – Where the pump battery is stored. • BG Target -- The blood glucose you wish your pump to correct to. It is used in the correction bolus calculator, • • • • • • basal format. and abbreviated as Target BG. This target value is developed with the guidance of your health care professional and varies from person to person Note that it may be different than your desired blood glucose range. • Blood Glucose (BG) – The main sugar found in the blood and the body’s main source of energy. This is also called blood sugar. • Blood Glucose Level –The amount of glucose in a sample of blood. • Blood Glucose Meter Test Strip Port – The port where you insert a FreeStyle Lite Test Strip when checking your blood glucose. • Bolus – An extra burst of insulin taken either to cover the rise in blood glucose that occurs after eating, or to correct high blood glucose. • Bolus/Wake Up Button (pump) – The button on the side of the pump. Press it the number of times needed to deliver a quick bolus using the One-Button Bolus function. You can also press it once to stop a normal bolus in progress. The pump will timeout in 15-120 seconds. Press and hold the button to wake up the pump from sleep mode to display the Home screen. • Bolus Calculator – Settings for calculating a bolus based on food intake, and/or a correction to a desired blood glucose level. It helps you calculate the correct dose of insulin based on carbohydrates, current blood glucose, and how much insulin from earlier boluses remains active in the body. It does NOT take other factors into account, such as exercise, illness, and food other than carbohydrate. • Bolus History – A list of your last 10 boluses. • Bolus Options –Settings to customize your bolus insulin settings, including bolus increments and maximums, as well as your bolus calculator options. • Bolus Panel – Displays the status of the most recent or last bolus given including bolus volume and time. • Cancellation Alert – Occurs when the screen timed out when there are pending changes on a screen, or if you pressed and held the Back button to return to the Home screen when there are pending changes on a screen, intentionally canceling the change. • Cannula – A slender plastic tube that is under the skin that is used to deliver insulin in your body. During the insertion of the infusion set, the center of the cannula contains a fine gauge needle to help the cannula penetrate the skin. The needle is then removed after insertion, leaving the plastic cannula in your skin. • Cannula Housing – The part of the infusion set where the tubing connects to the infusion set on your body. • Carbohydrates (CHO) – The component of food that most directly affects your blood glucose levels. The primary energy source from food. 269 DOC15736_Rev-A-Man.indd 269-270 turn these on or off. Check BG – An alert to remind you to check your blood glucose levels 2 hours following a site change. Companion Screen – The part of the companion where the information is displayed. Connector Needle – The part of the infusion set that contains a needle to connect to the cannula. Contraindications – Descriptions of what the pump is NOT intended for. Correction Bolus – A bolus given to lower blood glucose level elevated above the target blood glucose level. Correction Factor – Also known as sensitivity factor and 1 U Drop. This amount is how much blood glucose drops with delivery of 1 units of short or rapid-acting insulin. The number is unique to each user and is programmed into the pump for use in the bolus calculator. When glucose is high or low the calculator will use this information to estimate your insulin dose. • Create Program – Allows you to create up to four basal programs and assign each a specific name, i.e., on weekends, during exercise, or when you are ill. • Cursor – A setting that allows you to change the appearance of the selection cursor from a dark highlight cursor (reverse video) to an outline cursor. • Dawn Phenomenon – A period of time occurring in the middle of the sleep cycle where the body releases extra amounts of glucose into the blood stream, requiring a temporary increase in your basal insulin needs. • Delete Program – Function that allows you to delete a basal program. • Diabetic Ketoacidosis (DKA)– A potentially life threatening emergency condition in which extremely high blood glucose levels from a severe lack of insulin, result in the breakdown of body fat for energy and an accumulation of ketones in the blood and urine. • Display Preferences—Settings that allow you to choose right or left display, timeout, home screen appearance, viewing the cursor in highlight or outline mode, and whether or not you want to magnify the text. • Display Right or Left – A setting that allows you to switch the screen orientation such that the buttons are on the right side of the pump or on the left side of the pump. • Dual Bolus – A bolus that combines a NORMAL bolus with an EXTENDED bolus. It is sometimes used when food is consumed that may have both an early effect on your glucose as well as a longer effect, such as pizza. • Dust Cover – The cover that comes with your pump used to protect the reservoir compartment. • Edit Program – Allows you to make changes to an existing basal program, including adding or deleting basal time blocks and basal rates. • Enter/Backlight Button (pump) - The bottom button on the right side of the pump screen with an indented triangle pointing to the right. It is used to select an item, or to move forward to the next screen. To turn on/off the backlight, press this button for 2 seconds. • Enter Button/Jogwheel (companion) - The top jogwheel button on the right side of the companion. The jogwheel scrolls to allow you to move up and down through the companion. You can also depress this button to 270 2/9/09 11:29:56 AM Glossary Glossary • Extended Bolus – A bolus delivered over a determined period of time that is sometimes used to better match a • Infusion Set Tubing – Part of the infusion set that carries insulin from the pump to the cannula. • Insulin – A hormone that helps the body use glucose for energy. When the body cannot make enough insulin, it • Food Bolus – A bolus calculator option that allows administration of a bolus to account for food about to be • Insulin On Board (IOB) – The amount of insulin units that remain active in your body. The IOB is calculated us- select an item and to move forward to the next screen. You can also stop a normal bolus in progress. food that is absorbed slowly. eaten. • Food and Correction Bolus – A Bolus Calculator option that allows administration of a bolus to correct blood glucose levels that are higher than the desired blood glucose level and takes into account food about to be eaten. • Highlight – Setting the Cursor to highlight gives the text a highlighted display as you scroll and select options. • Home Screen: • The Information-based home screen provides details about current basal and bolus status, including the time and amount of your last bolus and whether basal delivery is running or stopped. When basal delivery is running, the name of the active basal profile and delivery rate is displayed. • The Activity-based home screen provides direct access to the pump options. Information about the basal and last bolus status is accessible through the STATUS option. • Home Screen Appearance - The Information-based home screen provides details about current basal and bolus status, including the time and amount of your last bolus, and whether basal delivery is running or stopped. When basal delivery is running, the name of the active basal profile and delivery rate is displayed. • Hyperglycemia – Blood glucose levels that are higher than target level. • Hypoglycemia – Blood glucose levels that are lower than target level. • I:CHO (or Carb Ratio) – Insulin-to-carbohydrate ratio that defines how many grams of carbohydrates 1 unit of insulin covers. CHO is an abbreviation for carbohydrate. This number is programmed into the pump for use by the bolus calculator. When you program in your number of carbohydrates you are about to eat, the bolus calculator helps you decide how much insulin may be needed for that food. It does NOT take into account food other than carbohydrates. is taken in by injection or through use of a pump. ing the insulin action time setting chosen in your insulin profile (see Section 2.1), along with looking at earlier boluses delivered. In addition, if a correction dose has recently been given, (for information on correction boluses, refer to Section 8.4.) the IOB feature may help you prevent giving too much insulin to correct your high glucose. • Insulin Reservoir – The reservoir holds the insulin that the pump will deliver to your body. The reservoir holds 250 units of insulin. Your healthcare professional will tell you how much insulin to use to fill the reservoir. The reservoir is a single-use only item. • Insulin Reservoir Vial Adapter – Attaches to the top of the insulin vial and is used in place of a filling needle to transfer liquid into the insulin reservoir. • Insulin Temp – An alert that lets you know if the temperature of the pump is too hot or too cold. • Introducer Needle – The needle that guides the insertion of the cannula in your body. The needle is removed and only the cannula is left in your body. • IOB Panel – Provides an indication of the amount of insulin that is still active in your body from past boluses. • Jogwheel/Enter Button (companion) - The top jogwheel button on the right side of the companion. It scrolls to allow you to move up and down through the companion. You can also use this button to select an item and to move forward to the next screen. You can also stop a normal bolus in progress. • Levels Panel – Displays the battery and insulin reservoir levels by icons. • Locked Item Setting – Setting that allows change of whether Bolus and Basal Menu options are locked (inac- cessible) or unlocked (accessible). This is a safety feature to prevent unwanted changes in insulin, by a child for example. • Inactivity Alarm – A safety alarm that sound when you have NOT touched any buttons within the time period • Low Insulin Alert – An alert, based on programmed settings telling when insulin is getting low. • Low Power Sleep State – This means the display is blank when the display timed out or when the user deliber- • Inactivity Alert – When the inactivity time has elapsed without any interaction on the pump, the pump first • Magnify – Turning the Magnify option to On makes the text larger and easier to view on the screen. • Main Menu – Lists the options to start/stop basal, go to bolus menu, basal menu, Alarm Setup, bolus status, selected. If you do NOT respond to an inactivity alert within 15 minutes, the INACTIVITY ALARM will sound and basal insulin delivery is stopped. displays the INACTIVITY ALERT screen to keep delivery going. • Indication – A description of what the pump should be used for. • Information Display – Home screen configuration that provides important status information concerning basal and bolus delivery. Also offers short cuts to get to lower level menus. • Infusion Set – The combination of the reservoir cap, tubing, and cannula that delivers insulin from the pump’s reservoir into the body. It is used one time only, and is discarded after each use. 271 DOC15736_Rev-A-Man.indd 271-272 ately puts the pump to sleep by pressing and holding the back button on the Home screen. prime menu, reports menu, and setup menu. • Manual Bolus – A bolus that is delivered without using the bolus calculator. • Modify Program – Allows edit, create, rename, or delete basal programs. • Normal Bolus – A one time quick dose of insulin that is programmed when you eat or need a dose of insulin to be delivered immediately. • Occlusion Alarm – Alarm that alerts you to an obstruction of fluid. The alarm occurs when pressure is detected 272 2/9/09 11:29:56 AM Resources as the pump tries to deliver insulin. It tells you there may be a problem with your infusion site and that insulin may NOT be delivered. An Occlusion Alarm STOPS insulin delivery. The sensitivity setting of the alarm is adjustable and may be changed. • One-Button Bolus – A function that allows you to deliver a Normal Bolus with fewer steps using the pump, simply by pressing the One-Button Bolus button without looking at the display. The pump makes special sounds or vibration patterns that guide you through the procedure. This same function is performed using the QBolus soft key on the companion. • 1U Drop – Sets how much 1 unit of insulin will lower blood glucose level. • Outline – Setting the Cursor to Outline gives the text an outline around it as you scroll and select options. • Prime – A procedure to make sure that air is removed from the entire infusion set before you attach the pump’s tubing to your body. This important procedure is done to make sure you receive the correct amount of insulin. • Pump Diary – An option that allows you to review your insulin therapy amounts, pump-related events, and alarm history. • Pump Idle – This means the basal delivery is stopped for 5 minutes. • Pump Idle Alert – Occurs when the basal has been stopped for 5 minutes. This alert can be put to sleep for up to one hour. A pump idle alert would NOT occur until you have completed the SETUP WIZARD. After that, if for any reason the basal is stopped for 5 minutes, the pump idle alert will sound. • • • • • Pump Screen – The part of the pump where the information is displayed. QBolus – A manual option to deliver a Normal bolus of insulin, using fewer steps than the Normal Bolus option. Reminders –Alerts reminding you to do certain things, such as eat a snack or test blood glucose levels. Rename Program – Allows changing the name of a basal program. Reports – The menu that allows you to review bolus history and the pump diary that logs various pump-related events and information. • Reservoir Alarm – Occurs when the reservoir is removed while the pump is still delivering insulin. • Reservoir Cap – The clear plastic cap and handle that is on the outside of the pump when the reservoir is placed the SETUP Menu. This feature is typically used the first time you set up all the features of your pump. • Site Change – A programmable alert that reminds you to change your site 2, 2.5, or 3 days following a cannula prime, after you inserted your infusion set. • • • • • Sleep Mode – A way to silence alerts for a specified period of time. Start Basal – Allows you to start an existing basal program. Stop Basal – Allows you to stop the actively running basal program. Stop Bolus – A function that allows you to stop any type of bolus delivery of insulin as it is occurring. System Error – An error that must be addressed immediately by calling Customer Care. It sometimes may indicate a pump failure. • Target blood glucose – The blood glucose value to correct to. It is used in the correction bolus calculator, and abbreviated as Target BG. Note that it may be different than desired blood glucose range. • Temporary Basal – A way to deliver basal insulin at a different rate for a temporary period of time, such as for exercise or illness. You may choose either specific units/hour or percentage, of your currently active basal rate. • • • • • Timeout – The time before the pump display goes blank. The timeout can be set from 15 to 120 seconds. USB Port – The USB port to connect to the charger for your companion’s battery. Vial Adaptor Cap – The cap that covers the top of the vial adaptor to store unused insulin. View Program – Allows you to view all existing basal programs. Wake Up/Soft Key to MAIN MENU (companion)– To wake up the companion, press the bottom right button with the Power icon for 2 seconds to access the MAIN MENU. • Wake Up/Bolus Button (pump) – The button on the side of the pump. Press and hold the button to wake up the pump from sleep mode to display the Home screen. Press it the number of times needed to deliver a quick bolus using the One-Button Bolus function. You can also press it once to stop a normal bolus in progress. The pump will timeout in 15-120 seconds. properly in the pump. This connects the Reservoir to the infusion set • Reservoir Compartment – The hollow area in the pump that encloses the insulin reservoir. • Reservoir Plunger – The gray plunger of the insulin reservoir. • Reservoir Plunger Handle – The white removable handle attached to the end of the plunger. Used to draw insulin into the reservoir. • Scroll Pad – The indented, oval area on the right side of the pump when in right-hand mode. It scrolls to allow you to move up and down through the pump options. It is like the scroll pad on a computer. • Select Program – Allows you to choose and start a different basal program. • SETUP WIZARD – An easy way to set up your pump. Individual SETUP WIZARD options are also accessible via 273 DOC15736_Rev-A-Man.indd 273-274 274 2/9/09 11:29:57 AM Resources Resources The following books and web sites may be of help as you begin pump therapy: Books: • Smart Pumping: A Practical Approach to Insulin Pumping by Howard Wolpert, MD • Insulin Pump Therapy Demystified: An Essential Guide for Everyone Pumping Insulin by Gabrielle Kaplan-Mayer • Pumping Insulin: Everything You Need for Success with an Insulin Pump by John Walsh, PA, CDE and Ruth Roberts, MA Web Sites: • Abbott Diabetes Care • www.AbbottDiabetesCare.com • American Diabetes Association www.diabetes.org • Centers for Disease Control Diabetes Public Health Resource www.cdc.gov/diabetes • Diabetes Exercise and Sports Association www.diabetes-exercise.org • US Food and Drug Administration Diabetes Information www.fda.gov/diabetes • Insulin Pump Online Support www.insulin-pumpers.org Pump Supplies: • Unique Accessories Inc. www.uniaccs.com • Diabetes Mall www.Diabetesnet.com/diabetes_technology • Pump Wear Inc. www.pumpwearinc.com 275 DOC15736_Rev-A-Man.indd 275 2/9/09 11:29:57 AM DOC15736_Rev-A-Cvr.indd 3 2/9/09 11:32:16 AM Distributed by: (Place distribution addresses here.) Caution: Federal Law restricts this device to sale by or on the order of a physician. (Patent information to be placed here.) Humalog®, Apidra®, Novolog®, and Kendall Monoject™ are not trademarks of the Abbott Group of Companies. ©2008 Abbott DOC15736 Rev. A 12/08 DOC15736_Rev-A-Cvr.indd 4 2/9/09 11:32:19 AM
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