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

User manual 2 of 2

1311326.4 Enter Event DataPurpose 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 InformationYou can ONLY perform this task using your companion. You • CANNOT enter event data using your pump.Procedure:Steps Do ThisAccess the 1. SELECT EVENT menu.From the Home screen, notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. ADD EVENT.Press d. Enter button to go to SELECT EVENT menu.Decide what event you want to add.e. If you are adding an event for Then do thisInsulin 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.Steps Do ThisGo to the 2. INSULIN menu. Notice a. INSULIN is highlighted.Press b. Enter button.Notice c. Type is highlighted.Press d. Enter button.Scroll to select insulin type (Rapid, Intermediate, Pre-Mix, Long Acting, Short-e. Acting, Inhaled)Press f. Enter button.Scroll to highlight g. Units.Press h. Enter button.Scroll to select the units of insulin.i. Note: The range is 0.00 to 99.50.Press j. Enter button.Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime.Scroll to highlight k. Done.Press l. Enter button to return to the Home screen.You have completed adding an insulin event.Section 6: When You’re Ready – Optional Settings6.4 Enter Event DataSection 6: When You’re Ready – Optional Settings6.4 Enter Event DataDOC15736_Rev-A-Man.indd 131-132 2/9/09 11:29:46 AM
133134Steps Do ThisGo to the 3. FOOD menu.Scroll to highlight a. FOOD.Press b. Enter button.Notice c. Type is highlighted.Press d. Enter button.Scroll to select meal type (Breakfast, Lunch, Dinner, and Snack).e. Press f. Enter button.Notice g. Carbs (CARBOHYDRATE) is highlighted.Press h. Enter button.Scroll to select the amount of Carbs.i. Note: The range is 0 to 350 grams.Press j. Enter button.Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime.Scroll to highlight k. Done.Press l. Enter button to return to the Home screen.You have completed adding a meal event.Steps Do ThisGo to the 4. EXERCISE menu. Scroll to highlight a. EXERCISE.Press b. Enter button.Note: You can just enter the exercise type and NOT the duration or intensity.Notice c. Type is highlighted.Press d. Enter button.Scroll to select exercise type (Aerobics, Walking, Jogging, Running, Swimming, e. Biking, Weights, or Other).Press f. Enter button.Scroll to highlight g. Duration.Press h. Enter button.Scroll to select the exercise duration.i. Note: The range is 0:00 to 5:00 hours.Press j. Enter button.Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime.Scroll to highlight k. Intensity.Press l. Enter button.Scroll to select exercise intensity (Low, Medium, High, None).m. Press n. Enter button.Scroll to highlight o. Done.Press p. Enter button to return to the Home screen.You have completed adding an exercise event.Section 6: When You’re Ready – Optional Settings6.4 Enter Event DataSection 6: When You’re Ready – Optional Settings6.4 Enter Event DataDOC15736_Rev-A-Man.indd 133-134 2/9/09 11:29:46 AM
135136Steps Do ThisGo to the 5. STATE OF HEALTH menu. Scroll to highlight a. STATE OF HEALTH.Press b. Enter button.Notice c. State is highlighted.Press d. Enter button.Scroll to select state of health (Normal, Cold, Sore Throat, Infection, Tired, e. Stress, Fever, Flu, Allergy, Period, Dizzy, Alcohol, Low Symptoms, or High Symptoms).Press f. Enter button.Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime.Scroll to highlight g. Done.Press h. Enter button to return to the Home screen.You have completed adding a state of health event.Steps Do ThisGo to the 6. GENERIC menu. Scroll to highlight a. GENERIC.Press b. Enter button.Note: You can enter up to eight generic events.Notice c. Event is highlighted.Press d. Enter button.Scroll to select event number.e. 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 f. Enter button.Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime.Scroll to highlight g. Done.Press h. Enter button to return to the Home screen.You have completed adding a generic event.Check your work.7. Go back to each event menu to see if you have the correct information added.Section 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsSection 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsDOC15736_Rev-A-Man.indd 135-136 2/9/09 11:29:46 AM
1371386.5 Review History, Status, and ReportsPurpose To review important system and diabetes care information using your Aviator Companion.When 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•Event History (up to 150 most recent events)•Pump Diary• (Therapy, Events, Alarms)Materials Your companion and pump fully operating.•Assistance from healthcare professional as needed.•Helpful InformationIf 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 deliv-•ering 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.•Procedure:Steps Do ThisDecide if you need to 1. review system status or reports.If you are reviewing Then do thisLast Bolus StatusBasal StatusSystem Status (Battery/Insulin levels)Pump LevelsCompanion LevelsPump VersionCompanion VersionGo to Step 2 - STATUS menu.Bolus HistoryBG HistoryLine GraphBG StatisticsEvent HistoryPump Diary (Therapy, Events, Alarms)Go to Step 3 - REPORTS menu.Section 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsSection 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsDOC15736_Rev-A-Man.indd 137-138 2/9/09 11:29:46 AM
139140Steps Do ThisGo to the 2. STATUS menu. Note: The following screens will appear when the system is paired, Radio is ON, and pump communication is available.From the a. Home screen, Notice Main is highlighted.Press b. Enter button.Note: You can also access System Status screens from the System Status panel.Scroll to highlight c. STATUS.Press d. Enter button.Review the bolus status.e. Notice f. Next is highlighted.Note: You can scroll to highlight Done and Press Enter button to return to the MAIN MENU screen at any time.Press g. Enter button.Review the basal status.h. Notice i. Next is highlighted.Press j. Enter button.Review the pump’s battery and insulin levels.k. Notice l. Next is highlighted.Press m. Enter button.Review the companion’s battery level.n. Notice o. Next is highlighted.Press p. Enter button.Continued on next page.Steps Do ThisReview the pump’s version.q. Note: The version numbers displayed on your system may be different.Notice r. Next is highlighted.Press s. Enter button.Review the companion’s version.t. Decide whether to return to u. MAIN MENU or Home screen.If Then do thisMAIN 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.Section 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsSection 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsDOC15736_Rev-A-Man.indd 139-140 2/9/09 11:29:46 AM
141142Steps Do ThisGo to the 3. REPORTS menu. From the a. Home screen, Notice Main is highlighted.Press b. Enter button.Scroll to highlight c. REPORTS.Press d. Enter button.Note: The pump screen will only display Bolus History, Pump Diary, and Send Diary.Decide what to review.e. If you are reviewing Then do thisBolus History Go to step 4.BG History Go to Step 5.Line Graph Go to Step 6.BG Statistics Go to Step 7.Event History Go to Step 8.Pump diary including therapy, events, and alarmsGo to Step 9.Steps Do ThisView Bolus History.4. Scroll to highlight a. BOLUS HISTORY.Press b. Enter button.Review your bolus history starting from the most recent bolus.c. Notice d. Next is highlighted.Press e. Enter button to review another bolus.Press f. Enter button on Next to review as many bolus records as needed.Highlight g. Done when you have reviewed enough bolus history records.Press h. Enter button to return to the Home screen.You have completed reviewing your Bolus history.View BG History.5. Scroll to highlight a. BG HISTORY.Press b. Enter button.Scroll to review your blood glucose readings.c. Press d. Enter button when you are done reviewing.Notice e. Done is highlighted.Press f. Enter button to return to the Home screen.You have completed reviewing your BG history.Section 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsSection 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsDOC15736_Rev-A-Man.indd 141-142 2/9/09 11:29:47 AM
143144Steps Do ThisView BG Line Graph.6. Scroll to highlight a. LINE GRAPH.Press b. Enter button. Review your blood glucose line graph.c. Press d. Enter button.Scroll to select the time period to display on the line graph. (If a 4 hour time e. range is selected, then the bottom scroll displays data in 4 hour time periods from 12am to 11pm), and press Enter button.Notice the time period highlighted at the bottom of the line graph. Press f. Enter button again to use the scroll to select a specific time period to view, for example, 5pm to 6pm.Press g. Back button to return to the REPORTS menu.You have completed reviewing your BG line graph.Steps Do ThisView BG Statistics.7. Scroll to highlight a. BG STATISTICS.Press b. Enter button. Scroll to review your blood glucose information for 7, 14, or 21 days as needed.c. Press d. Enter button when you are done reviewing.Notice e. Done is highlighted.Press f. Enter button to return to the Home screen.You have completed reviewing your BG statistics.View Event History.8. Scroll to highlight a. EVENT HISTORY.Press b. Enter button. Section 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsSection 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsDOC15736_Rev-A-Man.indd 143-144 2/9/09 11:29:47 AM
145146Steps Do ThisScroll to select (View All, Insulin, Food, Exercise, State of Health, or Generic) c. event history to review.Note: You can review up to the last 150 events, starting from the most recent events.Press d. Enter button.Note: Press the Back button to go backwards to a previous screen.Press e. Enter button when you reach the end of data.Notice f. Done is highlighted.Press g. Enter to return to the Home screen.You have completed reviewing your Event history.Steps Do ThisView Pump Diary.9. Notice a. PUMP DIARY is highlighted.Press b. Enter button.Decide whether to view therapy, events, or alarms.c. If you want to review Then do thisInsulin therapy amounts Go to Step 10.Pump events Go to Step 11.Alarm history Go to Step 12.Review Therapy 10. amounts. Notice a. Therapy is highlighted.Press b. Enter button.Review the bolus and basal insulin units, and basal percentage.c. Notice d. Next is highlighted.Press e. 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.You have completed reviewing your insulin therapy amounts.Section 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsSection 6: When You’re Ready – Optional Settings6.5 Review History, Status, and ReportsDOC15736_Rev-A-Man.indd 145-146 2/9/09 11:29:47 AM
147148Steps Do ThisReview Events.11. Note: Pump diary events provide information about your basal delivery programs and basal rates.Scroll to highlight a. Events.Press b. Enter button.Review the basal delivery events that have occurred on your pump.c. Notice d. Next is highlighted.Note: You can scroll to highlight Done and Press Enter button to return to the Home screen Press e. 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.When you are done reviewing, scroll to highlight f. Done.Press g. Enter button to return to the Home screen.You have completed reviewing your pump events.Steps Do ThisView Alarms history.12. Scroll to highlight a. Alarms.Press b. Enter button.Review the alarm history of your pump.c. Notice d. Next is highlighted.Press e. Enter button on Next to review your last 10 alarms as needed.When you are done reviewing, scroll to highlight f. Done.Press g. Enter button to return to the Home screen.You have completed reviewing the alarm history of your pump.Check your work.13. You are able to obtain all information related to your companion and pump status and reports following the steps above.Section 6: When You’re Ready – Optional Settings6.6 Upload DataSection 6: When You’re Ready – Optional Settings6.6 Upload DataDOC15736_Rev-A-Man.indd 147-148 2/9/09 11:29:47 AM
1491506.6 Upload DataPurpose To upload event data from your companion to your computer.When Do this procedure:When you wish to upload data from your companion to your computer.•Materials Your companion and pump fully operating.•Assistance from healthcare professional as needed.•Helpful InformationYou 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 ThisGo to the Home screen.1. Follow instructions detailed in the a. CoPilot for FreeStyle Aviator user’s guide to perform the data uploadUpload data.2. The Aviator Companion will display the data transfer screen during the data a. transfer process. Steps Do ThisCheck your work.3. Check that uploaded data is displayed on the a. CoPilot for FreeStyle Aviator screen.Section 6: When You’re Ready – Optional Settings6.7 Companion Self TestSection 6: When You’re Ready – Optional Settings6.7 Companion Self TestDOC15736_Rev-A-Man.indd 149-150 2/9/09 11:29:47 AM
1511526.7 Companion Self TestPurpose 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 rst time.•When you wish to self test the companion because you are • NOT sure if all the 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.•Procedure:Steps Do ThisGo to the SETUP menu.1. From the a. Home screen, notice Main is highlighted.Press b. Enter button.Scroll to highlight c. SETUP.Press d. Enter button.Scroll to highlight e. SELF TEST.Press f. Enter button.Steps Do ThisObserve Self Test.2. Check the display (the display will highlight).a. Note: The display automatically advances through the sequence of screens at a rate of 0.5 seconds per screen.Confirm audio sounds (you will hear beeps).b. Confirm vibrator (you will feel short vibes).c. Confirm backlight (the backlight turns on).d. Confirm test light (the test light turns on).e. Check memory.f. Note: You will automatically return to the SETUP menu, and Home screen if no other actions are taken.Section 6: When You’re Ready – Optional Settings6.8 Pair Companion and PumpSection 6: When You’re Ready – Optional Settings6.7 Companion Self TestDOC15736_Rev-A-Man.indd 151-152 2/9/09 11:29:48 AM
153154Steps Do ThisCheck your work.3. Conrm 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.6.8 Pair Companion and PumpPurpose To pair your Aviator Companion and Aviator Pump to operate as a system.When Do this procedure:When you receive a new companion or pump that’s a replacement for your system.•Materials Your companion fully charged.•Your pump with battery installed and initialized.•Assistance from healthcare professional as needed.•Helpful InformationPairing 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 ThisGo to the Companion’s 1. SETUP menu.Note: The following steps are performed using your companion.Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. SETUP.Press d. Enter button.Section 6: When You’re Ready – Optional Settings6.8 Pair Companion and PumpSection 6: When You’re Ready – Optional Settings6.8 Pair Companion and PumpDOC15736_Rev-A-Man.indd 153-154 2/9/09 11:29:48 AM
155156Steps Do ThisGo to the Companion’s 2. PAIR PUMP menu to prepare the Companion.Scroll to highlight a. PAIR PUMP.Press b. Enter button.Notice c. CONFIRM screen with “Is Pump ready?” message displays.Notice d. No is highlighted.Go to the Pump’s 3. SETUP menu.<insert screen with SETUP highlighted>Note: The following steps are performed using your pump.Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. SETUP.Press d. Enter button.Steps Do ThisGo to the Pump’s 4. PAIR DEVICE menu to prepare the Pump. Scroll to highlight a. PAIR DEVICE.Press b. Enter button.Notice c. PUMP screen is searching for companions.Go to the Companion’s 5. CONFIRM screen to pair pump.Note: The following steps are performed using your companion.Scroll to highlight a. Yes.Press b. Enter button.Notice c. COMPANION screen is searching for pumps.Section 6: When You’re Ready – Optional Settings6.8 Pair Companion and PumpSection 6: When You’re Ready – Optional Settings6.8 Pair Companion and PumpFPODOC15736_Rev-A-Man.indd 155-156 2/9/09 11:29:48 AM
157158Steps Do ThisConrm pairing of 6. pump with Companion Note: The following steps are performed using your companion.Notice a. CONFIRM screen with “Pair with Pump S/NPPPPP.”Notice b. No is highlighted.Scroll to highlight c. Yes if pump is correct.Press d. Enter button.Verify paired pump 7. and Companion Verify that the companion and pump are paired by the Radio On signal in both devices displayed on the Home screens.Steps Do ThisCheck your work.8. <insert companion Status screen with paired pump information><insert pump Status screen with paired companion information>Verify that the companion and pump are paired by the serial numbers displayed on the Status screens.Section 6: When You’re Ready – Optional Settings6.9 Turn RADIO O/OnSection 6: When You’re Ready – Optional Settings6.9 Turn RADIO O/OnFPOFPODOC15736_Rev-A-Man.indd 157-158 2/9/09 11:29:48 AM
1591606.9 Turn RADIO O/OnPurpose To turn o the radio frequency signal between your Aviator Companion and Aviator Pump before you get on an airplane.When Do this procedure:Before you take o in an airplane or as directed by any other ocial.•Materials Your companion and pump fully operating.•Your companion and pump already paired.•Assistance from healthcare professional as needed.•Helpful InformationIf your companion and pump are • NOT paired, radio setting will be O.Procedure:Steps Do ThisGo to the 1. SETUP menu on the Companion. From the a. Home screen, notice Main is highlighted.Press b. Enter button.Scroll to highlight c. SETUP.Press d. Enter button.Steps Do ThisGo to the 2. RADIO menu on your Companion.Scroll to highlight a. RADIO.Press b. Enter button.Notice c. Done is highlighted.Scroll to highlight d. Radio.Press e. Enter button.Scroll to f. Off.Press g. Enter button.Notice h. Done is highlighted.Press i. Enter button.Go to the SETUP menu 3. on the pump. From the a. Home screen, notice Main is highlighted.Press b. Enter button.Scroll to highlight c. SETUP.Press d. Enter button.Section 6: When You’re Ready – Optional Settings6.9 Turn RADIO O/OnSection 6: When You’re Ready – Optional Settings6.10 Therapy LockoutDOC15736_Rev-A-Man.indd 159-160 2/9/09 11:29:48 AM
161162Steps Do ThisGo to the 4. RADIO menu on your Pump.Scroll to highlight a. RADIO.Press b. Enter button.Notice c. Done is highlighted.Scroll to highlight d. Radio.Press e. Enter button.Scroll to f. Off.Press g. Enter button.Notice h. Done is highlighted.Press Enter button.Check your work.5. Look at the system status panel on the Home screen to verify that the radio signal is o.To turn the radio signal back on, repeat all the steps above and scroll to select Radio to On.6.10 Therapy LockoutPurpose 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: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 ➢Materials Your companion fully operating.•Helpful InformationThe • Lockout setting is O by default.Procedure:Steps Do ThisGo to the 1. SETUP menu.From the a. Home screen, notice Main is highlighted.Press b. Enter button.Scroll to highlight c. SETUP.Press d. Enter button.Section 6: When You’re Ready – Optional Settings6.10 Therapy LockoutSection 6: When You’re Ready – Optional Settings6.10 Therapy LockoutDOC15736_Rev-A-Man.indd 161-162 2/9/09 11:29:48 AM
163164Steps Do ThisGo to the 2. THERAPY LOCKOUT screen. Scroll to highlight a. THERAPY LOCKOUT.Press b. Enter button.Notice c. Lockout is Off.Scroll to highlight d. Lockout.Press e. Enter button.Scroll to f. On.Press g. Enter button.Steps Do ThisSet Duration for 3. lockout.Note: The duration is set to Always by default when lockout is On.Notice a. Duration is highlighted.Decide what to do next.b. If you want duration to be Then do thisOnce Press 1. Enter button.Scroll to select 2. Once.Press 3. Enter button.Scroll to highlight 4. Done.Press 5. Enter button.Always Scroll to highlight Done.Press Enter button.Check your work.4. Go back to the THERAPY LOCKOUT screen and verify that the settings are correct.To unlock your pump therapy features, go to Step 5.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.1 Edit a Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.1 Edit a Basal ProgramDOC15736_Rev-A-Man.indd 163-164 2/9/09 11:29:48 AM
165166Steps Do ThisUnlock pump therapy 5. features. Note: If you attempt to access any basal or bolus features when Lockout is On, you will see a Confirmation screen.Notice the a. CONFIRM screen with “Insulin delivery changes are locked out.” message displays.Notice b. Cancel is highlighted.Note: If you select Cancel, you will return to the Home screen and pump therapy features remain locked out.Scroll to highlight c. Unlock.Press d. Enter button.Administer your basal or bolus insulin delivery as recommended by your e. healthcare professional.7 Creating and Editing Specialized Basal Programs to Meet Your Needs7.1 Edit a Basal ProgramPurpose To edit an existing basal program in your pump using your Aviator Companion.When Do this procedure:Whenever you need to edit an existing basal program, including adding or deleting basal •time blocks and basal rates.Materials 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.Important Note: It is strongly recommended that you and your healthcare professional work on ne tuning your basal rates. Always notify your healthcare professional if you make changes to prescribed plans of care.Helpful InformationThe • 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 Do ThisAccess BASAL MENU 1. from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BASAL.Press d. Enter button.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.1 Edit a Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.1 Edit a Basal ProgramDOC15736_Rev-A-Man.indd 165-166 2/9/09 11:29:48 AM
167168Steps Do ThisSelect 2. MODIFY program. Scroll to highlight a. MODIFY.Press b. Enter button.Notice c. Edit is highlighted.Press d. Enter button.Select the existing 3. program to edit.Notice *Daily is highlighted.Note: The * represents the active program, and Daily is the default program.If you want to Then do thisEdit your Daily program Press Enter button.Edit a dierent program Scroll to highlight the program you want to edit, for example, Travel. Press Enter button.Steps Do ThisDecide what edits you 4. want to make. If you want to Then do thisEdit an existing time block and basal rateScroll to the desired time block and 1. basal rate to edit.Press 2. Enter button.Go to Step 3. 5.Add a time block and basal rate Notice 1. Add Block is highlighted.Press 2. Enter button.Go to Step 3. 8.Delete a time block and basal rate Scroll to the desired time block and 1. basal rate to delete.Press 2. Enter button.Go to Step 3. 11.Return to the Home screen without editing a basal programScroll 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.Edit Time block.5. Scroll to highlight a. Time.Press b. Enter button.Scroll to select the desired time for the block.c. Press d. Enter button.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.1 Edit a Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.1 Edit a Basal ProgramDOC15736_Rev-A-Man.indd 167-168 2/9/09 11:29:49 AM
169170Steps Do ThisEdit Basal Rate.6. Notice a. Rate is highlighted.Press b. Enter button.Note: If you are keeping the same basal rate, leave the basal rate as shown.Scroll to select desired basal rate.c. Press d. Enter button.Notice e. Next is highlighted.Press f. Enter button.Decide what to do 7. next. If you want to Then do thisEdit another time block and basal rateScroll to another time block and basal rate that you 1. want to edit.Press 2. Enter button.Repeat Steps 5 and 6 to edit additional time blocks 3. and basal rates.Add a time block and basal rateNotice 1. Add Block is highlighted.Press 2. Enter button.Go to Step 3. 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 rateScroll to desired time block and basal rate to delete.1. Press 2. Enter button.Go to Step 3. 11.Be nished with all your edits and return to the Home screenScroll to highlight 1. Done.Press 2. Enter button.Go to Step 3. 13 to conrm you have completed this task.Steps Do ThisSet Time for new block.8. Notice a. Time is highlighted.Press b. Enter button.Scroll to select desired time for the block.c. Press d. Enter button.Note: The starting time for the new block will be ½ hour after the block you just created.Set Rate for new block.9. Notice a. Rate is highlighted.Press b. Enter button.Scroll to select desired basal rate for the block.c. Press d. Enter button.Notice e. Next is highlighted.Press f. Enter button.Decide what to do 10. next. If you want to Then do thisAdd another time block and basal rateScroll to highlight 1. Add Block.Press 2. Enter button.Repeat Steps 8 and 9 to add additional time 3. blocks and basal rates.Delete a time block and basal rateScroll to desired time block and basal rate 1. to delete.Press 2. Enter button.Go to Step 11.3. Be nished with all your edits and return to the Home screenScroll to highlight Done.Press Enter button.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.2 Create a New Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.2 Create a New Basal ProgramDOC15736_Rev-A-Man.indd 169-170 2/9/09 11:29:49 AM
171172Steps Do ThisDelete block(s).11. Notice a. Next is highlighted.Scroll to highlight b. Delete.Press c. Enter button.Notice d. CONFIRM screen and “Delete block?” message displays.Decide what to do.e. If you want to Then do thisDelete the time block and basal rateScroll to highlight 1. Yes.Press 2. Enter button.Note: Notice that the time block has been deleted from the list.Repeat Steps 10 and 11 to delete other blocks and 3. basal rates.Cancel deleting the time blockNotice 1. No is highlighted.Press 2. Enter button.Scroll to highlight 3. Next.Press 4. Enter button.Note: You will return to the list of time blocks and basal rates. Check the settings.Decide what to do 12. next. If you want to Then do thisMake any additional changes to the basal programGo back to Step 4.Be nished with all your edits and return to the Home screenScroll to highlight Done. Press Enter button.Check your work.13. 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.Note: The Daily basal rate is now reecting the edits made above.7.2 Create a New Basal ProgramPurpose To create up to four basal programs that suit your lifestyle, using the Aviator Companion.When Do this procedure:Whenever you need to create a weekend, exercise, sick day, or custom-named basal pro-•gram, 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 • Sec-tion 12 - Appendix A.Helpful InformationThe • 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 ThisAccess BASAL MENU 1. from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BASAL.Press d. Enter button.Access 2. MODIFY PROGRAM menu. Scroll to highlight a. MODIFY.Press b. Enter button.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.2 Create a New Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.2 Create a New Basal ProgramDOC15736_Rev-A-Man.indd 171-172 2/9/09 11:29:49 AM
173174Steps Do ThisAccess CREATE 3. PROGRAM menu. Scroll to highlight a. CREATE.Press b. Enter button.Decide the type of 4. program to create. If you want to create Then do thisWeekend basal programNotice Weekend is highlighted.Press Enter button.Exercise basal programScroll to highlight Exercise.Press Enter button.Sick day basal programScroll to highlight Sick.Press Enter button.Custom-named basal programScroll to highlight 1. Custom.Press 2. Enter button.Scroll to highlight each letter and press the 3. Enter button each time, as you spell out the name for your customized program, for example, Travel.Note: The rst 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.Scroll to highlight 4. Next when you are done.Press 5. 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.Steps Do ThisSet Time for BLOCK 1.5. Notice a. Time dashed line is highlighted.Press b. Enter button.Notice c. Time is highlighted.Press d. Enter button.Scroll to select desired start time for the block.e. Press f. Enter button.Set Rate for BLOCK 1.6. Notice a. Rate is highlighted.Press b. Enter button.Scroll to select desired rate of insulin per hour.c. Press d. Enter button.Note: At least ONE block must be added. If NO additional blocks are added, the first block will prevail for 24 hours.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.3 Select a Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.3 Select a Basal ProgramDOC15736_Rev-A-Man.indd 173-174 2/9/09 11:29:49 AM
175176Steps Do ThisDecide whether to add 7. or delete new blocks. If you want to Then do thisAdd another time block and basal rateNotice 1. Next is highlightedPress 2. Enter button.Notice 3. Add block is highlighted.Press 4. Enter button.Repeat Steps 5 and 6 to add additional time blocks and 5. basal rates.Delete the time block and basal rate you just createdScroll to highlight 1. Delete.Press 2. Enter button.Notice the 3. CONFIRM screen and “Delete block?” message displays.Scroll to highlight 4. Yes.Press 5. Enter button.Add only ONE block and/or be nished with all your editsScroll to highlight Done if not already highlighted.Press Enter button and return to the Home screen.Check your work.8. 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 A7.3 Select a Basal ProgramPurpose To activate the dierent basal programs by selecting and choosing between them using your Aviator Companion.When Do this procedure:Whenever you need to change your active basal program.•Materials 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 InformationThe system allows you to program multiple basal proles. 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 ne tuning your basal rates. Always notify your healthcare professional if you make changes to prescribed plans of care.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.4 Rename a Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.3 Select a Basal ProgramDOC15736_Rev-A-Man.indd 175-176 2/9/09 11:29:49 AM
177178Procedure:Steps Do ThisAccess BASAL MENU 1. from Home screen.ORMaina. is highlighted.Press b. Enter button.Scroll to highlight c. BASAL.Press d. Enter button.ORNote: This is a short cut to get to the SELECT PROGRAM screen when basal is delivering.Scroll to select the a. Basal panel on the Home screen.Press b. Enter button.Go to Step 3c. Access 2. SELECT PROGRAM menu. Scroll to highlight a. SELECT.Press b. Enter button.Steps Do ThisSelect the program that 3. you want to be active. Note: In this example, the Daily program is the currently active program running, because it has an * beside “Daily.”Scroll to highlight the desired program, for example, Weekend.a. Press b. Enter button.Notice the c. CONFIRM screen and “Start (your selected) program?” message displays.Scroll to highlight d. Yes.Press e. Enter button.Note: You will hear four short confirmation beeps from your pump.Check your work.4. Verify that the Home screen displays the active basal program you have just selected.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.4 Rename a Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.4 Rename a Basal ProgramDOC15736_Rev-A-Man.indd 177-178 2/9/09 11:29:50 AM
1791807.4 Rename a Basal Program Purpose To rename an existing basal program of your pump using your Aviator Companion.When Do this procedure:When you CHOOSE to rename a previously created existing basal program.•Materials 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 InformationThe• Rename program is one of the Modify program options in the Basal menu. The other Modify program op-tions are Edit program, Create program and Delete program.Procedure:Steps Do ThisAccess 1. BASAL Menu from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BASAL.Press d. Enter button.Steps Do ThisAccess MODIFY 2. PROGRAM menu. Scroll to highlight a. MODIFY.Press b. Enter button.Access 3. RENAME PROGRAM screen. Scroll to highlight a. RENAME.Press b. Enter button.Select program to 4. rename. Scroll to highlight the program you want to rename.a. Press b. Enter button.Delete existing 5. program name. Scroll to highlight a. Erase.Keep pressing the b. Enter button to erase each letter of the old program name.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.5 Delete a Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.5 Delete a Basal ProgramDOC15736_Rev-A-Man.indd 179-180 2/9/09 11:29:50 AM
181182Steps Do ThisCreate new program 6. name. Scroll to highlight each letter and press the a. 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.Scroll to highlight b. Next.Press c. Enter button.Complete the name 7. change. Scroll to highlight a. Done.Press b. Enter button to return to the Home screen.Check your work.8. 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.7.5 Delete a Basal ProgramPurpose To remove (delete) a basal program already programmed into your pump using your Aviator Companion.When Do this procedure:Whenever you need to delete an existing basal program.•Materials 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 InformationThe • Delete program is one of the Modify program options. The other Modify program options are Edit pro-gram, 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:Steps Do ThisAccess 1. BASAL menu from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BASAL.Press d. Enter button.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.6 Set a Temporary Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.5 Delete a Basal ProgramDOC15736_Rev-A-Man.indd 181-182 2/9/09 11:29:50 AM
183184Steps Do ThisAccess 2. MODIFY PROGRAM menu. Scroll to highlight a. MODIFY.Press b. Enter button.Select 3. DELETE program.Scroll to highlight a. Delete.Press b. Enter button.Select program to 4. delete.Scroll to highlight the program you wish to delete. For example, Trip.a. Note: You CANNOT delete an active program, indicated with an asterisk *.Press b. Enter button.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. Steps Do ThisDecide what to do 5. next.Notice the CONFIRM screen with “Delete program?” message displays.If you want to Then do thisDelete the programScroll to highlight 1. Yes.Press 2. Enter button.Note: The program is deleted from the pump’s memory and you will return to the Home screen.Go to Step 6 to check your work.3. Cancel deleting the programNotice 1. No is highlighted.Press 2. Enter button.Scroll to Highlight 3. Done.Press 4. Enter button.Note: You will return to the Home screen. Your deletion is cancelled and the program is still an optionCheck your work.6. 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.Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.6 Set a Temporary Basal ProgramSection 7: Creating and Editing Specialized Basal Programs to Meet Your Needs7.6 Set a Temporary Basal ProgramDOC15736_Rev-A-Man.indd 183-184 2/9/09 11:29:50 AM
1851867.6 Set a Temporary Basal ProgramPurpose 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 •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.Helpful InformationA temporary basal rate is in eect 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 modied 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 dierent maximum basal delivery rate, you can only set the temporary rate to that number of units/hour maximum limit.Example A:You set your basal rate increment to 0.1 units/hour.1. You modied your maximum basal rate to 5.0 units/hour.2. Your regular daily basal rate is set at 0.5 units/hour.3. 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:You set your basal rate increment to 3.0 units/hour.1. You modied your maximum basal rate to 5.0 units/hour, telling the pump that you never want to have a 2. 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 eect.You may choose either specic 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.Procedure:Steps Do ThisAccess 1. BASAL MENU from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BASAL.Press d. Enter button.Choose SELECT 2. program. Scroll to highlight a. SELECT.Press b. Enter button.Select 3. TEMP BASAL.Scroll to highlight a. TEMP BASAL.Press b. Enter button.Set Duration.4. Notice a. Duration is highlighted.Press b. Enter button.Scroll to select the amount of time you want your temporary basal to be in c. effect.Note: The range is 30 minutes to 72 hours.Press d. Enter button.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.1 Deliver an Extended BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.1 Deliver an Extended BolusDOC15736_Rev-A-Man.indd 185-186 2/9/09 11:29:50 AM
187188Steps Do ThisDecide to set Percent 5. or Rate. 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 thisAt a percentage of the current rateNotice 1. Percent is highlighted.Press 2. Enter button.Scroll to select the desired percentage of the 3. active basal rate.Press 4. Enter button.As a set rate Notice 1. Percent is highlighted.Press 2. Enter button.Scroll to highlight 3. Rate.Press 4. Enter button.Scroll to select the desired units per hour for 5. the temporary basal delivery.Press 6. Enter button.Conrm and activate 6. Temp Basal. Verify the duration and percentage/rate is correct.a. Scroll up to make any changes as needed.b. Notice c. Activate is highlighted.Press d. Enter button.Check your work.7. 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.Record your personalized temporary basal values in the Table of Settings in Section 12 - Appendix A.8 Creating and Editing Specialized Bolus Programs to Meet Your Needs8.1 Deliver an Extended BolusPurpose To administer an extended bolus from your pump using your Aviator Companion.When Do this procedure:Whenever you need to deliver an extended bolus over a period of time.•Materials 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 InformationYou 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 - Appen-dix A.You should have set up your bolus options using the • SETUP WIZARD in Section 6.1.Procedure:Steps Do ThisAccess Bolus Menu 1. from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BOLUS.Press d. Enter button.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.1 Deliver an Extended BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.1 Deliver an Extended BolusDOC15736_Rev-A-Man.indd 187-188 2/9/09 11:29:50 AM
189190Steps Do ThisSelect 2. MANUAL Bolus.Scroll to highlight a. MANUAL.Press b. Enter button.Set Extended Bolus 3. Type. Notice a. Bolus Type is highlighted.Press b. Enter button.Scroll to display c. Extended.Press d. Enter button.Set Extended Bolus 4. amount. Notice a. Bolus is highlighted.Press b. Enter button.Scroll to select the extended bolus amount you want to deliver.c. Press d. Enter button.Set Duration for the 5. Extended Bolus.Notice a. Duration is highlighted.Press b. Enter button.Scroll to select the duration for extended bolus delivery.c. 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.Press Enter button.d. Steps Do ThisCheck that Extended 6. Bolus Type, Bolus amount and Duration time is correct.View a. Bolus Type, Bolus amount, and Duration settings on the BOLUS screen.Decide if you need to change a setting.b. If you want to Then do thisChange a setting Scroll up to highlight the setting you want to change.1. Press 2. Enter button.Scroll to desired setting.3. Press 4. Enter button.Keep the settings Go to the next step.Deliver Extended 7. bolus.Notice a. Deliver is highlighted.Press b. Enter button.Notice that the extended bolus is delivering.c. Allow the extended bolus to deliver the amount that was set for the specified d. time duration.Go to Step 10 to check your extended bolus delivery.e. You have completed delivering an Extended Bolus.Note: Go to Step 8 only if you want to STOP the Extended Bolus.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.1 Deliver an Extended BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.2 Deliver a Dual BolusDOC15736_Rev-A-Man.indd 189-190 2/9/09 11:29:51 AM
191192Steps Do ThisDecide whether to 8. STOP extended bolus. Go to the a. MAIN MENU.Press b. Enter button.Notice c. STOP is highlighted.Press d. Enter button.Decide what to do next.e. If you want to Then do thisSTOP the extended bolus delivery immediatelyScroll to highlight 1. Yes.Press 2. Enter button.Continue to Step 9.3. Allow extended bolus to nish deliveringNotice 1. No is highlighted.Press 2. Enter button to return to the Home screen.Go to Step 10 to check your extended bolus delivery.3. Steps Do ThisDecide whether to 9. STOP basal delivery. 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.Notice the a. CONFIRM screen and “Stop (your active basal program)?” message displays.Decide what to do next.b. If you want to Then do thisSTOP the basal delivery now (e.g. to change batteries)Scroll to highlight 1. Yes.Press 2. Enter button.Notice that the basal program has stopped on the 3. Home screen.You have STOPPED the Extended bolus and also the Basal delivery. Check with your healthcare professional for recommendations.Continue the basal deliveryNotice 1. No is highlighted.Press 2. Enter button.Review the 3. 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.Check your work.10. 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.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.2 Deliver a Dual BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.2 Deliver a Dual BolusDOC15736_Rev-A-Man.indd 191-192 2/9/09 11:29:51 AM
1931948.2 Deliver a Dual BolusPurpose 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 aect your glucose both immediately and over a number of hours later.When Do this procedure:Whenever you need to deliver a dual bolus, which includes a normal bolus and •an extended bolus.Materials 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.Helpful InformationYou 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 carbohy-drate 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).Procedure:Steps Do ThisAccess 1. BOLUS MENU from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BOLUS.Press d. Enter button.Select 2. MANUAL bolus.Scroll to highlight a. MANUAL.Press b. Enter button.Set Dual Bolus Type.3. Notice a. Bolus Type is highlighted.Press b. Enter button.Scroll to display c. Dual.Press d. Enter button.Set Normal Bolus 4. amount. Notice a. Normal is highlighted.Press b. Enter button.Scroll to select the normal bolus amount you want to deliver.c. Press d. Enter button.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.2 Deliver a Dual BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.2 Deliver a Dual BolusDOC15736_Rev-A-Man.indd 193-194 2/9/09 11:29:51 AM
195196Steps Do ThisSet Extended Bolus 5. amount. Notice a. Extended is highlighted.Press b. Enter button.Scroll to select the extended bolus amount you want to deliver.c. Press d. Enter button.Set Duration for the 6. Extended Bolus. Notice a. Duration is highlighted.Press b. Enter button.Scroll to select the duration for the extended bolus delivery.c. Press d. Enter button.Check that the Normal 7. bolus, Extended bolus, and duration settings are correct. View a. Bolus Type, Bolus amount, and Duration settings on the BOLUS screen.Decide if you need to change a setting.b. If you want to Then do thisChange a setting Scroll up to highlight the setting you want to 1. change.Press 2. Enter button.Scroll to desired setting.3. Press 4. Enter button.Keep the settings Go to the next step.Steps Do ThisDeliver the Dual bolus.8. 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.Notice a. Deliver is highlighted.Press b. Enter button.Notice that the normal bolus is delivering.c. Decide whether to 9. stop the Dual bolus. If you want to Then do thisFinish delivering the normal bolusAllow the normal bolus to deliver the amount that was set.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 immediatelyNotice 1. Stop is highlighted.Press 2. Enter button.Notice the 3. STOPPED ALERT screen and “Dual bolus stopped.” message displays.Notice 4. Clear is highlighted (to conrm that the bolus is stopped).Press 5. Enter button to return to the Home screen.You have STOPPED the dual bolus.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.2 Deliver a Dual BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.3 Calculate and Deliver a Food BolusDOC15736_Rev-A-Man.indd 195-196 2/9/09 11:29:51 AM
197198Steps Do ThisDecide whether to 10. nish delivering the Extended Bolus.If you want to Then do thisFinish delivering the extended bolusAllow the extended bolus to deliver the amount that was set for the specied time duration.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 reects 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.Go to Step 13 to check your extended bolus delivery.STOP the extended bolusGo to the 1. MAIN MENU.Notice 2. STOP is highlighted.Press 3. Enter button.Continue to Step 11.4. Decide whether to 11. STOP the extended bolus.Notice the a. CONFIRM screen and “Stop Extended Bolus?” message displays.Decide what to do next.b. If you want to Then do thisSTOP the extended bolus delivery immediatelyScroll to highlight 1. Yes.Press 2. Enter button.Continue to Step 12.3. Allow extended bolus to nish deliveringNotice 1. No is highlighted.Press 2. Enter button to return to the Home screen.Go to Step 13 to check your extended bolus delivery.3. Steps Do ThisDecide whether to 12. STOP basal delivery. 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 recoverNotice the a. CONFIRM screen and “Stop (your active basal program)?” message displays.Decide what to do next.b. If you want to Then do thisSTOP the basal delivery now (e.g. to change batteries)Scroll to highlight 1. Yes.Press 2. Enter button.Notice that the basal program has STOPPED on the 3. Home screen.You have STOPPED the Extended bolus and also STOPPED the Basal delivery.Continue the basal deliveryNotice 1. No is highlighted.Press 2. Enter button.Note: You will automatically return to the Home screen.Review the 3. Last Bolus that was administered.You have STOPPED the Extended bolus but your basal program is still delivering insulin.Check your work.13. 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.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.3 Calculate and Deliver a Food BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.3 Calculate and Deliver a Food BolusDOC15736_Rev-A-Man.indd 197-198 2/9/09 11:29:51 AM
1992008.3 Calculate and Deliver a Food BolusPurpose To calculate and deliver a food bolus using your Aviator Companion.When Do this procedure:Whenever you want to calculate carbohydrates and administer a bolus to cover a meal or •snack.Materials 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 InformationTo be able to use this option, you must rst 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 ThisAccess 1. BOLUS MENU from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BOLUS.Press d. Enter button.Select 2. FOOD bolus.Scroll to highlight a. FOOD.Press Enter button.b. Steps Do ThisSet Carbs.3. Notice a. Carbs is highlighted.Press b. Enter button.Scroll to select the number of grams of carbohydrates you are planning to eat.c. Note: The range is 0-200 g.Press d. Enter button.Decide what to do next.4. 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 thisContinue to select bolus typeNotice Next is highlighted.Press Enter button.View Food Calculation DetailsScroll to highlight 1. Details.Press 2. Enter button.Review the insulin-to-carbohydrate ratio.3. Notice 4. Accept is highlighted.Press 5. Enter button.Change I:CHO ratio Scroll to highlight1. I:CHO.Press 2. Enter button.Scroll to change 3. I:CHO as needed.Note: The range is 1U/1g to1U/150g.Press 4. Enter button.Notice 5. Accept is highlighted.Press 6. Enter button.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.3 Calculate and Deliver a Food BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.4 Calculate and Deliver a Correction BolusDOC15736_Rev-A-Man.indd 199-200 2/9/09 11:29:51 AM
201202Steps Do ThisSet Bolus Type.5. Notice a. Bolus Type is highlighted. Normal is the default.Press b. 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.Scroll to select the bolus type you want to deliver.c. 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.Press d. Enter button.Review Bolus amount.6. Decide what to do next.If you want to Then do thisAccept the calculated bolus amount and continue to bolusNotice 1. Bolus is highlighted.Scroll to highlight 2. Deliver.Change the bolus amountNotice 1. Bolus is highlighted.Press 2. Enter button.Scroll to select the bolus amount to deliver.3. Press 4. Enter button.Conrm that bolus 7. 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.Scroll up to select and make edits as needed.Steps Do ThisDeliver Food bolus.8. Notice a. Deliver is highlighted.Press b. Enter button.Note: You will hear 2 quick beeps from your pump.Notice that the bolus is delivering.c. Decide what to do next.d. If you want to Then do thisFinish delivering food bolusAllow the food bolus to deliver the amount that was set.Note: Once the bolus has finished delivering, you will hear 2 more quick beeps and then return to the Home screen.Go to Step 9 to check your bolus delivery.STOP the food bolus delivery immediatelyNotice 1. Stop is highlighted.Press 2. Enter button.Notice the 3. STOPPED ALERT screen and “Normal bolus stopped.” message displays.Notice 4. Clear is highlighted.Press 5. Enter button to return to the Home screen.You have STOPPED the food bolus and it is reflected in the Bolus panel.Check your work.9. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.4 Calculate and Deliver a Correction BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.4 Calculate and Deliver a Correction BolusDOC15736_Rev-A-Man.indd 201-202 2/9/09 11:29:52 AM
2032048.4 Calculate and Deliver a Correction BolusPurpose To calculate and deliver a correction bolus using your Aviator Companion.When Do this procedure: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-•betes Educator as needed.Your personalized Table of Settings in • Section 12 - Appendix AHelpful InformationEstablish setting for programming a correction bolus and use of the bolus calculator with the instructions listed •in Section 6.1 before performing this task.Using this feature requires that you have a working understanding and knowledge of your insulin sensitivity, or •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 aect the dosage decision (such as anticipated increased physical activity), so be sure to discuss this feature with your healthcare team.Procedure:Steps Do ThisAccess 1. BOLUS MENU from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BOLUS.Press d. Enter button.Steps Do ThisSelect 2. CORRECTION bolus.Scroll to highlight a. CORRECTION.Press b. Enter button.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.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.Set Current BG.3. Scroll to highlight a. Current Bg.Press b. Enter button.Scroll to select your current blood glucose level.c. Press d. Enter button.Determine what to do 4. next.If you want to Then do thisContinue to select bolus typeNotice Next is highlighted.Press Enter button.View BG Calculation DetailsScroll to highlight 1. Details.Press 2. Enter button.Review the 3. Target BG, 1U Drop and, IOB.Notice 4. Accept is highlighted.Press 5. Enter button.Scroll to highlight 6. Next.Press 7. Enter button.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.5 Calculate and Deliver a Food & Correction BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.4 Calculate and Deliver a Correction BolusDOC15736_Rev-A-Man.indd 203-204 2/9/09 11:29:52 AM
205206Steps Do ThisSet Bolus Type.5. Notice a. Bolus Type is highlighted.Press b. 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.Scroll to select the bolus type you want to deliver.c. 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.Press d. Enter button.Review Bolus amount.6. Decide what to do next.If you want to Then do thisAccept the calculated bolus amount and continue to bolusNotice 1. Bolus is highlighted.Scroll to highlight 2. Deliver.Change the bolus amountNotice 1. Bolus is highlighted.Press 2. Enter button.Scroll to select the bolus amount to deliver.3. Press 4. Enter button.Conrm that bolus 7. 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.Steps Do ThisDeliver Correction 8. bolus.Notice a. Deliver is highlighted.Press b. Enter button.Note: You will hear 2 quick beeps from your pump.Notice that the bolus is delivering on the screen.c. Decide what to do next.d. If you want to Then do thisFinish delivering correction bolusAllow the correction bolus to deliver the calculated amount Note: Once the bolus has nished delivering, you will hear 2 more quick beeps and return to the Home screen.Go to Step 9 to check your bolus delivery.STOP the correction bolus delivery immediatelyNotice 1. Stop is highlighted.Press 2. Enter button.Notice the 3. STOPPED ALERT screen and “Normal bolus stopped.” message displays.Notice 4. Clear is highlighted.Press 5. Enter button to return to the Home screen.You have STOPPED the correction bolus and it is reected in the Bolus panel.Check your work.9. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.5 Calculate and Deliver a Food & Correction BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.5 Calculate and Deliver a Food & Correction BolusDOC15736_Rev-A-Man.indd 205-206 2/9/09 11:29:52 AM
2072088.5 Calculate and Deliver a Food & Correction BolusPurpose 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: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 InformationTo administer a • food and correction bolus, you must rst 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:Steps Do ThisAccess 1. BOLUS MENU from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BOLUS.Press d. Enter button.Steps Do ThisSelect 2. FOOD & CORRECTION Bolus. Scroll to highlight a. FOOD & CORRECT.Press b. Enter button.Set Carbs.3. Notice a. Carbs is highlighted.Press b. Enter button.Scroll to select the number of grams of carbohydrates you are planning to eat.c. Note: The range is 1-200 grams.Press d. Enter button.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.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.5 Calculate and Deliver a Food & Correction BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.5 Calculate and Deliver a Food & Correction BolusDOC15736_Rev-A-Man.indd 207-208 2/9/09 11:29:52 AM
209210Steps Do ThisDecide what to do 4. about I:CHO ratio. If you want to Then do thisContinue to select bolus typeNotice Next is highlighted.Press Enter button.View Food Calculation DetailsScroll to highlight 1. Details.Press 2. Enter button.Review the insulin-to-carbohydrate ratio.3. Notice 4. Accept is highlighted.Press 5. Enter button.Change I:CHO ratio Scroll to highlight 1. I:CHO.Press 2. Enter button.Scroll to change 3. I:CHO as needed.Note: The range is 1U/1g to1U/150g.Press 4. Enter button.Notice 5. Accept is highlighted.Press 6. Enter button.Notice 7. Next is highlighted.Press 8. Enter button.Steps Do ThisSet CURRENT BG.5. Noticea. Current Bg is highlighted.Press b. Enter button.Scroll to select your current blood glucose level.c. 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).Press d. Enter button.Decide what to do next.6. If you want to Then do thisContinue to select bolus typeNotice Next is highlighted.Press Enter button.View BG Calculation DetailsScroll to highlight 1. Details.Press 2. Enter button.Review the 3. 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 rst insulin action time, based on initial setup.Notice 4. Accept is highlighted.Press 5. Enter button.Notice 6. Details is highlighted.Scroll to highlight 7. Next.Press 8. Enter button.Note: The recommended calculated bolus amount is displayed. You should change this only if you purposely want to give a dierent amount than what is recommended by the pump.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.5 Calculate and Deliver a Food & Correction BolusSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.6 Deliver a Quick Bolus from QBolus MenuDOC15736_Rev-A-Man.indd 209-210 2/9/09 11:29:52 AM
211212Steps Do ThisSet Bolus Type.7. Notice a. Bolus Type is highlighted on the BOLUS screen.Press b. 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.Scroll to select the bolus type you want to deliver.c. Note: Remember to also set the duration for Extended and Dual bolus types if you are delivering either type of bolus.Press d. Enter button.Set Bolus.8. Decide what to do next.If you want to Then do thisAccept the calculated bolus amount and continue to bolusNotice 1. Bolus is highlighted.Scroll to highlight 2. Deliver.Change the bolus amountNotice 1. Bolus is highlighted.Press 2. Enter button.Scroll to adjust the amount that was 3. calculated.Press 4. Enter button.Check that bolus type 9. and bolus amount is correct.Check your Bolus Type and Bolus amount settings on the screen.Scroll up to select and make edits as needed.Steps Do ThisDeliver 10. Food & Correction bolus.Notice a. Deliver is highlighted.Press b. Enter button.Note: You will hear 2 quick beeps from your pump.Notice that the bolus is delivering on the screen.c. Decide what to do next.d. If you want to Then do thisFinish delivering food and correction bolusAllow the food and correction bolus to deliver the amount that was set.Note: Once the bolus has nished delivering, you will hear 2 more quick beeps and then you will return to the Home screen.Go to Step 11 to check your bolus delivery.STOP the food and correction bolus delivery immediatelyNotice 1. Stop is highlighted.Press 2. Enter button.Notice the 3. STOPPED ALERT screen and “Normal bolus stopped.” message displays.Notice 4. Clear is highlighted.Press 5. Enter button to clear message and return to the Home screen.You have STOPPED the food and correction bolus, and it is reected on the Bolus panel.Check your work.11. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.6 Deliver a Quick Bolus from QBolus MenuSection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.7 Deliver a Quick Bolus from QBolus Soft KeyDOC15736_Rev-A-Man.indd 211-212 2/9/09 11:29:53 AM
2132148.6 Deliver a Quick Bolus from QBolus MenuPurpose To administer a normal bolus using the QBOLUS menu of your Aviator Companion.When Do this procedure:Whenever you need to deliver a normal bolus from the • Qbolus menu.Note: The increments are either 0.5 or 1.0 Units.Materials Your companion set up with basal delivery started.•Your pump set up with basal delivery started.•Bolus recommendations from your healthcare professional.•Procedure:Steps Do ThisAccess 1. BOLUS MENU from Home screen. Notice a. Main is highlighted.Press b. Enter button.Scroll to highlight c. BOLUS.Press d. Enter button.Set 2. QBOLUS.Notice a. QBOLUS is highlighted.Press b. Enter button.Scroll to select the desired quick bolus amount to administer.c. Note: The increments are either 0.5 or 1.0 Units.Press d. Enter button.Steps Do ThisDeliver Quick bolus.3. Notice that the bolus is delivering on the screen.a. Note: You will hear 2 quick beeps from your pump.Decide what to do next.b. If you want to Then do thisFinish delivering the quick bolusAllow the quick bolus to deliver the amount that you set.Note: Once the bolus has nished 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.STOP the quick bolus delivery immediatelyNotice 1. Stop is highlighted.Press 2. Enter button.Notice the 3. STOPPED ALERT screen and “Normal bolus stopped.” message displays.Notice 4. Clear is highlighted.Press 5. Enter button to clear message and return to the Home screen.You have STOPPED the quick bolus and it is reected on the Bolus panel.Check your work.4. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen.Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.7 Deliver a Quick Bolus from QBolus Soft KeySection 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs8.7 Deliver a Quick Bolus from QBolus Soft KeyDOC15736_Rev-A-Man.indd 213-214 2/9/09 11:29:53 AM
2152168.7 Deliver a Quick Bolus from QBolus Soft KeyPurpose To administer a normal bolus using the QBolus soft key from your companion’s Home screen.When Do this procedure:Whenever you need to administer a normal bolus quickly, conveniently, and discreetly, •using the fewest steps possible.Materials Your companion and pump set up with basal delivery started.•Bolus recommendations from your healthcare professional.•Helpful InformationA • Normal bolus may be delivered using the QBolus soft key from your companion’s Home screen. You should have already set up the bolus increments using the procedure in Section 6.1.Procedure:Steps Do ThisLocate the QBolus 1. soft key on your companion.QBolusSoft KeyLocate the QBolus soft key (also called the Backlight soft key) on the bottom left of your companion.Steps Do ThisInitiate the number 2. of bolus increments to deliver.1 button push displays:2 button pushes displays:3 button pushes displays:Press the a. QBolus soft key the same number of times as the number of increments to deliver, companion sounds a beep with each press.Note: You may have to press the soft key once to wake companion up.Note: The increments for the one-button bolus are either 0.5 or 1.0 Units.Notice that after a few seconds, the companion will b. beep the same number of times that you pressed the QBolus soft key to verify your instructions.After the beeps, press the c. QBolus soft key ONE MORE TIME within 2 seconds to CONFIRM the correct number of increments for bolus delivery.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.Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Section 9: Respond to Alarms, Alerts, Errors, and Other ProblemFPOScreen shotDOC15736_Rev-A-Man.indd 215-216 2/9/09 11:29:53 AM
217218Steps Do ThisDeliver the bolus.3. Notice that the bolus is delivering on the screen.a. Decide what to do next.b. If you want to Then do thisFinish delivering the quick bolusAllow the bolus to deliver the amount that you set. Note: Once the bolus has nished delivering, you will hear 2 more quick beeps and then you will return to the Home screen.Go to Step 4 to check your bolus delivery.STOP the quick bolus immediatelyNotice 1. Stop is highlighted.Press 2. Enter button.Notice the 3. STOPPED ALERT screen and “Normal bolus stopped.” message displays.Notice 4. Clear is highlighted.Press 5. Enter button to clear message and return to the Home screen.You have STOPPED the quick bolus and it is reected 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.9 Respond to Alarms, Alerts, Errors, and Other ProblemsPurpose 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 Your companion and pump may either be operating normally or in an alarm failsafe battery state (non-rechargeable).Your personalized Table of Settings in Section 12- Appendix A.Helpful InformationThis section oers suggestions for addressing problems or diculties that you may experience with your com-•panion and pump.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 •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 denitions of dierent 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,• Section 9: Respond to Alarms, Alerts, Errors, and Other ProblemSection 9: Respond to Alarms, Alerts, Errors, and Other ProblemDOC15736_Rev-A-Man.indd 217-218 2/9/09 11:29:53 AM
219220You 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 modeA 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 modeYour 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.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 specic, limited amount of time.You CANNOT use sleep mode with alarms.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 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.All Companion related alerts appear as text on the screen of your Companion. For example, a low battery alert •on your Companion battery. 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:Steps Do ThisDetermine what you 1. need to resolve. If you are resolving Then do thisAn alarm or alert Go to Step 2. A companion alert Go to Step 3.System errors Go to Step 4.Other problems or diculties with your pump.Go to Step 5.Steps Do ThisIdentify the type 2. of pump alarm or alert and respond as appropriate.Look at the screen of your pump.If the alarm/alert is aThen do thisBad battery alarmNotice 1. Clear is highlighted.Press 2. Enter button to clear the alarm.Change the battery 3. within 15 minutes to avoid losing information (see Section 1.4) and resume basal delivery.Conrm or reset 4. Time and Date.RESTART5. basal delivery (see Section 3.1.1).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.Stopped bolus alertNotice 1. Clear is highlighted.Press 2. Enter button to clear the alert.Review the amount of the last bolus that was delivered 3. and accommodate for undelivered insulin, if you accidentally stopped your bolus.Inactivity alertORInactivity alarmNotice 1. Clear is highlighted.Press 2. Enter button to clear the alert, reactivate your pump and return to the Home screen.RESTART3. 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.Section 9: Respond to Alarms, Alerts, Errors, and Other ProblemSection 9: Respond to Alarms, Alerts, Errors, and Other ProblemDOC15736_Rev-A-Man.indd 219-220 2/9/09 11:29:53 AM
221222Steps Do ThisIdentify the type of pump alarm or alert and respond as appropriate (continued).If the alarm/alert is anThen do thisOcclusion alarm 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.Notice 1. Clear is highlighted.Press 2. Enter button to clear the alarm and return to the Home screen.Check your blood glucose level.3. Disconnect the pump.4. Administer an insulin injection if necessary as it is 5. possible that your pump has NOT been delivering insulin for some time.Change your infusion set and reservoir immediately.6. 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.Prime the pump (see 7. Section 2.4) to see if insulin is being pumped.❏• If insulin IS being pumped, nish 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.Steps Do ThisIdentify the type of pump alarm or alert and respond as appropriate (continued).If the alarm/alert is aThen do thisNo insulin alarm Notice 1. Clear is highlighted.Press 2. Enter button to clear the alarm and return to the Home screen.Disconnect tubing from cannula and remove cannula 3. from infusion site.Replace reservoir with a new reservoir lled with 4. insulin (see Section 2.3).Prime pump (see 5. Section 2.4).Insert new infusion set.6. Prime cannula.7. RESTART8. basal delivery.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 Notice 1. Clear is highlighted.Press 2. Enter button to clear the alarm and return to the Home screen.Disconnect tubing from cannula and remove cannula 3. from infusion site.Remove reservoir and replace it (see 4. Section 2.3).Prime Pump (see 5. Section 2.4).Insert new infusion set.6. Prime cannula.7. RESTART8. basal delivery.Contact Customer Care if problem persists.9. 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.Section 9: Respond to Alarms, Alerts, Errors, and Other ProblemSection 9: Respond to Alarms, Alerts, Errors, and Other ProblemDOC15736_Rev-A-Man.indd 221-222 2/9/09 11:29:54 AM
223224Steps Do ThisIdentify the type of pump alarm or alert and respond as appropriate (continued).<Insert screen shots><insert screenshots>If the alarm/alert is aThen do thisLow 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.Notice 1. Sleep is highlighted.Scroll to highlight 2. Clear.Press 3. Enter button to clear the alert and return to Home screen.Replace the battery as soon as possible (see 4. Section 1.4).Cancellation alert Notice 1. Clear is highlighted.Press 2. Enter button to clear the alert.Reenter your changes/edits ONLY if necessary so that 3. they are saved.Note: Change the idle screen time to a longer period if this occurs frequently.Low insulin alert Notice 1. Sleep is highlighted.Scroll to highlight 2. Clear.Press 3. Enter button to clear the alert and return to Home screen.Replace and rell the reservoir as soon as possible 4. (see Section 2.3).Continued on next page.Steps Do ThisIdentify the type of pump alarm or alert and respond as appropriate (continued).If the alarm/alert is aThen do thisPump idle alert/pump NOT startedNotice 1. Sleep is highlighted.Decide what to do next.2. If you want to ThenClear the alert Scroll to highlight Clear and press Enter button to return to Home screen.Put pump back to sleep againPress Enter button to put pump back to sleep again.Put pump back to sleep for a longer timeScroll to highlight Sleep Time.Press Enter button.Scroll to change the sleep time.Press Enter button.Note: Change the length of Sleep Time as needed.START3. basal delivery (see Section 3.1.1) per healthcare professional recommendations.Identify the type of 3. Companion alert and respond as appropriate.If the alarm/alert is aThen do thisLow battery alertNotice 1. OK is highlighted.Press 2. Enter button to clear the alert and return to Home screen.Recharge the battery as soon as possible. The alert 3. indicates that you have 30% of battery charge remaining. (see Section 1.3).Section 9: Respond to Alarms, Alerts, Errors, and Other ProblemSection 9: Respond to Alarms, Alerts, Errors, and Other ProblemFPOFPODOC15736_Rev-A-Man.indd 223-224 2/9/09 11:29:54 AM
225226Steps Do ThisVery Low battery alertNotice 1. OK is highlighted.Press 2. Enter button to clear the alert and return to Home screen.Recharge the battery as soon as possible. The alert 3. indicates that you have 15% of battery charge remaining. (see Section 1.3).Depleted battery alertNotice 1. OK is highlighted.Press 2. Enter button to clear the alert and return to Home screen.The companion may shut down at any time. Recharge 3. the battery immediately to continue using the Companion (see Section 1.3).BG check not available alertRemove the test strip from the strip port. 1. Remove the USB cable from the USB port on the 2. Companion.Insert a 3. 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.Steps Do ThisResolve System Errors.4. Contact Customer Care.a. NOTb. 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.Troubleshoot pump 5. problems or issues.Identify what the problem may be.If ThenYour pump won’t turn onRemove and reinsert battery. (see 1. Section 1.4)Insert a new AAA alkaline battery (2. Energizer and Duracell brands are recommended) if the issue is NOT resolved.Contact Customer Care or your healthcare 3. 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)Use 1. ONLY Energizer or Duracell alkaline batteries.Set your pump to 2. audio instead of vibrate.Reduce the use of the backlight if possible.3. Respond to alarms as quickly as possible, as batteries 4. will run down quicker if the pump is allowed to alarm for long periods of time.Contact Customer Care if the issue is still 5. NOT resolved.Your pump’s screen is hard to read or is distortedTurn on the backlight if you are in a dark room.1. Remove your sunglasses if applicable.2. Move indoors or into the shade if applicable.3. Keep your pump out of direct heat (e.g., away from 4. heaters) or cold (e.g., by placing under your clothing on a cold day).Contact Customer Care if the issue is still 5. NOT resolved.Continued on next page.Section 9: Respond to Alarms, Alerts, Errors, and Other ProblemSection 9: Respond to Alarms, Alerts, Errors, and Other ProblemDOC15736_Rev-A-Man.indd 225-226 2/9/09 11:29:54 AM
227228Steps Do ThisTroubleshoot pump problems or issues (continued).If Then do thisBasal delivery won’t startCheck that the devices are paired properly.1. Check that you are delivering a large enough volume of 2. 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).Note: If you attempt to start basal delivery and the pump needs to be primed, the pump will display a warning to prime pump rst.Check that the insulin reservoir is lled. If empty, ll the 3. reservoir.Note: The pump will display a NO INSULIN ALARM. Refer to Step 2 for more information.Contact Customer Care or your health care professional if 4. you are still unable to start basal delivery.Your pump got wetTowel dry the outside of the pump.1. Inspect the reservoir and battery compartments and dry 2. any water you nd.Caution: Do NOT use a hair dryer to dry your pump.If your pump was submerged in salt water, thoroughly 3. clean with a damp cloth before drying with towel.Refer to 4. Section 4.1 for additional details on what to do.Contact Customer Care or your healthcare professional if 5. you are unable to use your pump.Steps Do ThisTroubleshoot pump problems or issues (continued).If Then do thisYou dropped your pumpExamine the screen and buttons for chips, cracks, or other 1. 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.Carefully examine the pump, making sure the battery cap 2. and reservoir cap are secure.Examine the infusion set for damage, making sure the 3. tubing, tubing connector, and soft cannula are intact.Caution: If your pump has been dropped, the waterproof capability of your pump may be compromised.If you suspect that your pump has been damaged, and 4. are concerned that its waterproof capability has been compromised, please contact Customer Care.You suspect pump alarm(s) may not be functioning correctly (check for operational safety).Stop basal delivery.1. Set it aside for 5 minutes without starting basal delivery.2. Let the alarm escalate and check that it cycles through 3. both audio and vibratory annunciation.Check that the pump’s audio speakers sound as part of 4. 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.Check your work.6. Make sure your pump is operating fully and normally again after responding to the alarm, alert, system error, or other problem(s).Section 10: System MaintenanceSection 10: System MaintenanceDOC15736_Rev-A-Man.indd 227-228 2/9/09 11:29:54 AM
22923010 System MaintenancePurpose 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: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.•Materials One • Duracell MN2400 or Energizer E92 AAA alkaline primary battery (non-rechargeable).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 BatteryHelpful InformationStop • 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 •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.If you do • NOT install a new battery within 15 minutes of taking out the old one, you will need to reset the time 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 PumpHelpful InformationDo • NOT use organic solvents (e.g., lighter uid, 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 Do ThisWipe your companion or 1. pump.Caution: Do NOT place Aviator Companion or Aviator Pump under water.Wipe the outside with a cloth dampened with mild soapy water.Dry your companion or pump.2. Wipe clean with a damp cloth, then wipe dry with a dry cloth.Section 10: System MaintenanceSection 10: System MaintenanceDOC15736_Rev-A-Man.indd 229-230 2/9/09 11:29:54 AM
23123210.3. Store Your Aviator Companion and Aviator PumpHelpful InformationStop all delivery prior to removing the pump battery.•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.•Store your Aviator Companion and pump in a clean, dry place where there are • NOT extreme temperatures, high humidity, or extreme atmospheric pressures.10.4. Handle a Damaged or Wet Companion or PumpCaution: 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.Helpful InformationBe 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 nd with a Q-tip. Do NOT use a hair dryer to dry your pump. If your pump was submerged in salt wa-ter, 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 in-stalled, submersion will likely damage internal pump components. Call Customer Care.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 ser-•vicing or replacing your pump.10.5. Conditions for Transport, Storage, and UseHelpful InformationDo • NOT to subject your companion or pump to extreme conditions, which may cause malfunctions and pos-sible adverse events or serious injury.Try to AVOID:Exposing your companion or pump to temperatures above 104ºF (40ºC), as might happen in a sauna or on a •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 •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.Section 11: Manage Your Diabetes SafelySection 11: Manage Your Diabetes SafelyDOC15736_Rev-A-Man.indd 231-232 2/9/09 11:29:54 AM
23323411 Manage Your Diabetes SafelyThis 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.IndicationThe 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.ContraindicationsThe Aviator System is NOT intended for:People who are unwilling to consistently test their blood glucose levels at least 4 times a day.•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.People whose hearing is impaired to the point where they • CANNOT hear the companion or pump’s alarms.Blood Glucose TestingYour 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 de-•pleted 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.•More frequently during times of illness, injury or stress.•When you rst 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 Administration of a Correction BolusIf you get two consecutive unexplainable high blood glucose readings while on pump therapy, do the following:If your healthcare professional plan calls for a correction bolus, follow the recommendations for 1. administering the correction bolus.Check for ketones, if your healthcare professional instructed you to do so.2. Evaluate your pump and infusion set for loose connections or insulin leakage.3. Check your pump programming to conrm you are receiving your expected basal rate dose.4. Check bolus history to ensure you have received your last several boluses.5. Check your daily total insulin amount to make sure that you are on track with the amount of insulin you 6. have been using.Inspect your tubing for air bubbles. Check to see if it is connected to your site correctly and that your site 7. has NOT accidentally become dislodged.Evaluate other causes of unexpected high blood sugars:8. 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 •levels?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?•If there is 9. 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 dierent 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.If in doubt with any step, contact your healthcare professional for guidance.10. Section 11: Manage Your Diabetes SafelySection 11: Manage Your Diabetes SafelyDOC15736_Rev-A-Man.indd 233-234 2/9/09 11:29:54 AM
235236FreeStyle Aviator Safety FeaturesA 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 InformationMaximum 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 6Maximum Basal RateLimits your basal insulin delivery, so you don’t accidentally set a basal rate that is too high (protects from over-infusion).See Section 6Bolus Calculator Allows you to easily calculate an insulin bolus. Clearly shows you the data used to determine units to deliver (protects from over- or under-infusion). Also allows you to adjust a bolus.See Section 6Speaker Backups The Aviator Pump has a set of backup speakers to make sure the audio tones are heard.N/AEssentials for Safe and Eective UseIn order to use your FreeStyle Aviator System safely and eectively, 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 TherapyComplications 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 specic 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.InfectionsWays 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 red-dened 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 ad-dress 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 ques-tions, contact your healthcare professional.HypoglycemiaHypoglycemia, 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.•Section 11: Manage Your Diabetes SafelySection 11: Manage Your Diabetes SafelyDOC15736_Rev-A-Man.indd 235-236 2/9/09 11:29:54 AM
237238If 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.”Eat approximately 1. 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.Wait 15 minutes and then check your blood glucose level again.2. If your blood glucose level is still too low, repeat steps 1 and 2 until your blood glucose level measures 3. within your acceptable range.Once your blood glucose level is normalized, resume your usual meal and snack schedule. If you will 4. 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.HyperglycemiaHyperglycemia, 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:Interrupted insulin delivery due to:1. 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.•Under delivery of insulin.2. 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.•Eating more carbohydrates than you anticipated or was aware of.3. Illness, infection, stress, menses, less activity or exercise.4. Insulin has gone bad (e.g. exposed to high temperature, expired.)5. Taking a medication that raises blood glucose. (Check with your healthcare professional or pharmacist).6. 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 health-•care 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 KetoacidosisDiabetic Ketoacidosis (DKA) can develop if your blood glucose levels have been too high for a period of time. DKA is dierent 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 decient.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 u-like symptoms, include:Headache.•Stomach ache.•Fruity odor on breath.•Very dry mouth.•Shortness of breath.•Nausea/vomiting.•Section 11: Manage Your Diabetes SafelySection 11: Manage Your Diabetes SafelyDOC15736_Rev-A-Man.indd 237-238 2/9/09 11:29:55 AM
239240Possible causes of DKA include:Improper use of insulin.•Infection or illness.•Stress.•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.•Talk with your healthcare professional if you have any questions about DKA or what you can do to prevent it.How Illness Aects Blood Glucose LevelsInfection 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 specic 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 ManagementWhen you are sick, your body’s stress level increases. The body produces hormones to help ght o the sickness. However, there are side eects: blood glucose levels increase and insulin’s ability to lower blood glucose levels decrease. In this situation, blood glucose levels are much more dicult 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.•How Exercise Aects Blood Glucose LevelsExercise 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.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 aects 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.Your Daily KitYou 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 UseIf 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 ProceduresYou 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 discon-nect 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 pro-cedures, hospitalizations, surgeries, or ER visits.Section 12: AppendicesAppendix A: Table of SettingsSection 11: Manage Your Diabetes SafelyDOC15736_Rev-A-Man.indd 239-240 2/9/09 11:29:55 AM
241242Frequently Asked QuestionsQ. 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.Q. Should I insure my pump?A. Contact your insurance provider to see if they oer coverage.Q. Is it okay to take a break from pump therapy?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.Q. Is a pump support group worthwhile?A. Many people nd 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.12 Appendices A. Table of SettingsEveryone has dierent 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 SettingsRecord your pump settings here for future reference:SETUP WIZARD: Language, Time/Date, and Insulin SettingsSetting What it Allows You to DoOptions AvailableFactory DefaultYour SettingLanguage Set the language your pump will use for its text instructions.English English EnglishTime/Date FormatTime 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 hourDate Select the date format. Month/day/year or day/month/yearMmm dd, yyyyCurrent Time Set the time. N/A -- N/ACurrent Date Set the date. N/A -- N/AInsulinConcentration The insulin concentration on your pump is xed at U100.U100 U100Section 12: AppendicesAppendix A: Table of SettingsSection 12: AppendicesAppendix A: Table of SettingsDOC15736_Rev-A-Man.indd 241-242 2/9/09 11:29:55 AM
243244Setting What it Allows You to DoOptions AvailableFactory DefaultYour SettingType Select the type of insulin you will be using in your pump.Rapid or short RapidAction Time Set the action time of the insulin you will be using in your pump.2 to 8 hours 5 hours 00 minutesSETUP WIZARD: Bolus and Basal SettingsBolus LimitsIncrement Set the increments (in Units) of insulin that may be programmed for a bolus.0.05U, 0.1U, 0.5U, or 1.0U0.1UMaximum Set the maximum programmable amount of insulin for a single bolus.0.1 - 50.0 when increment =>0.1 units0.05 – 9.95 when increment = 0.05 units10.0UOne-Button BolusOn/O Turn the one-button bolus function on or o.On/O OIncrement Set the One-Button bolus increment (how much each button press increases the bolus amount).0.5U or 1.0U If One-Button is “o”, there is no option. If set to “on”, 0.5UBolus CalculatorCarb Ratios Select the amount of bolus insulin needed to handle each gram of carbohydrate you plan to eat, for up to 24 dierent time blocks.1-150 (1U/1g-1U/150g)--Setting What it Allows You to DoOptions AvailableFactory DefaultYour Setting1 U Drop Set how much 1U of insulin will lower your blood glucose level, for up to 24 dierent time blocks.5 - 500 mg/dL(0.28 – 27.8 mmol/L)--Blood Glucose RangeBlood Glucose TargetsSet the values for your blood glucose targets for up to 24 dierent time blocks.50-300 mg/dL(2.8 – 16.7 mmol/L)110 mg/dL(6.1 mmol/L)Basal SettingsIncrement Select the increment for changes in basal insulin delivery rates0.05 U/h, 0.10 U/h, 0.50 U/h, or 1.00 U/h0.05 U/hMaximum 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/hTemporary 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 PercentSETUP WIZARD: Feedback and Alerts/AlarmsPump Feedback OptionsFeedback Set your pump to give either audio (beeps) or vibratory signals.Audio or Vibrate AudioSection 12: AppendicesAppendix A: Table of SettingsSection 12: AppendicesAppendix A: Table of SettingsDOC15736_Rev-A-Man.indd 243-244 2/9/09 11:29:55 AM
245246Setting What it Allows You to DoOptions AvailableFactory DefaultYour SettingAudio Set the volume of auditory alerts.Note: All vibrations are at the same intensity.Low, Medium, or HighIf audio is selected, “High”Companion Feedback OptionsFeedback Set your Companion to give audio (beeps) and/or vibratory signals and progress tones.Audio and/or Vibrate AudioAudio Set the volume of auditory alerts.Low, Medium, or HighIf audio is selected, “Low”Vibrate Set the length of vibratory alerts.Long, Medium, or ShortIf audio is selected, “Long”Progress Tones Set the volume of progress tones.Low, Medium, or HighIf audio is selected, “Low”Occlusion AlarmSensitivity Set the level of sensitivity of the Occlusion Alarm.Low or High HighSetting What it Allows You to DoOptions AvailableFactory DefaultYour SettingLow Insulin AlertLow Alert Select the insulin level that will trigger the Low Insulin Alert.5 – 50U 20UInactivity AlarmInactivity Set the time of the Inactivity Alarm.1 – 24 hr 1 hrSETUP WIZARD: Display and Locked Items SettingsDisplay SettingsButtons Invert the screen to suit your hand preference (right or left handed).On Right/On Left RightTimeout Set the amount of time the display may remain idle before reverting to the “idle” screen.15 - 120 seconds 15 secondsHome Select the Home screen display format.Information or ActivityInformationCursor Select how highlighted options will appear.Highlight or Outline HighlightContrast Select the contrast of the companion display. (this setting is only available on the Companion)0 - 2 2Magnify Select whether highlighted options will be magnied in larger font size. (This setting is only available on the pump)On or O OnSection 12: AppendicesAppendix A: Table of SettingsSection 12: AppendicesAppendix A: Table of SettingsDOC15736_Rev-A-Man.indd 245-246 2/9/09 11:29:55 AM
247248Setting What it Allows You to DoOptions AvailableFactory DefaultYour SettingLocked ItemsNote: Locked items can only be accessed through the SETUP WIZARD.Basal Lock or unlock basal functions on the pump (select, edit, create, delete, rename program).Unlocked or Locked UnlockedBolus Lock or unlock bolus functions on the pump (One-Button Bolus, Food and Correction Bolus, Correction Bolus, Food Bolus, Manual Bolus).Unlocked or Locked UnlockedPrime Lock or unlock prime functions on the pump (tubing, cannula). Unlocked or Locked UnlockedTherapy LockoutNote: Therapy Lockout is only available on the Companion.Therapy LockoutDisable access to start/stop delivery features on the Companion including Basal and Bolus. On or O ODuration Set the lockout duration. Once or Always If “On” is selected duration is “Once”2. Personal SettingsRecord your personal settings here for future reference:Standard Daily Basal RatesBasal Rate Start Time Basal Rate (Units/h) Basal Rates: Alternate Pattern 1 (for example workout days)Use these basal rates when Basal Rate Start Time Basal Rate (Units/h)Section 12: AppendicesAppendix A: Table of SettingsSection 12: AppendicesAppendix A: Table of SettingsDOC15736_Rev-A-Man.indd 247-248 2/9/09 11:29:55 AM
249250Basal Rates: Alternate Pattern 2Use these basal rates when Basal Rate Start Time Basal Rate (Units/h) Basal Rates: Alternate Pattern 3Use these basal rates when Basal Rate Start Time Basal Rate (Units/h) Temporary Basal SettingsFor detailed information about setting a Temporary Basal, see Section 7.6.When to use Temporary Basal: What to set Temporary Basal at (indicate if this is a percentage of your standard basal pattern or a specic Unit rate):Bolus SettingsFor 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: When to use the One-Button Bolus function: 3. Other InformationRecord any additional instructions from your healthcare professional below.Section 12: AppendicesAppendix B: SETUP WIZARD Default Conguration and SettingsSection 12: AppendicesAppendix B: SETUP WIZARD Default Conguration and SettingsDOC15736_Rev-A-Man.indd 249-250 2/9/09 11:29:55 AM
251252 B. SETUP WIZARD Default Conguration and SettingsWizard Step Item ScreenDefault Cong Valid Values Increment1 Language SELECT LANGUAGE English VALUE CANNOT BE CHANGED N/A1 Time TIME/DATE FORMAT 12 Hour “12 Hour,” “24 Hour” N/A1 Date TIME/DATE FORMAT Mmm dd, yyyy “Mmm dd, yyyy”, “dd Mmm yyyy” N/A1 Hour SET TIME -- 01 – 12 (12hr); 00 – 23 (24hr) 11 Minute SET TIME -- 00 – 59 11 AM/ PM SET TIME AM “AM”, “ PM” N/A1 Month SET DATE -- “Jan”, “Feb”, “Mar”, “Apr”, “May”, “Jun”, “Jul”, “Aug”, “Sep”, “Oct”, “Nov”, “Dec” N/A1 Day SET DATE -- 01 – 31 11 Year SET DATE -- 2007 – 2049 11 Type INSULIN PROFILE Rapid “Rapid”, “Short” N/A1 Action Time INSULIN PROFILE 5h 00m 2h 00m – 8h 00m 15 (min)1 Time INACTIVITY ALARM -- h 1 – 24 (always On) 12 Buttons DISPLAY on Right “on Right”, “on Left” N/A2 Timeout DISPLAY 15 Sec 15 – 120 152 Home DISPLAY Information “Information”, “Activity” N/A2 Cursor EDIT MODE Highlight “Highlight”, “Outline” N/A2 Magnify EDIT MODE On “On”, “O” N/A3Time, 1U Drop 1U DROP --24 blocks of time allowed 5 – 500 mg/dL (0.28 – 27.8 mmol/L)Programming starting value: 50 in one unit increments1 hour 13 Time, I:CHO CARB RATIOS --24 blocks of time allowed 1 – 150 (1U/1g – 1U/150g) Programming starting value: 1U/15gCarbs – 1 – 200 grams1 hour 113Time, mg/dL 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)1 hour 24 Increment BOLUS LIMITS 0.1 U “0.5 U”, “1.0 U” N/A4 Maximum BOLUS LIMITS 10.0 U 0.1 –50.0 when increment => 0.1 units 0.05 – 9.95 when increment = 0.05 = IncrementWizard Step Item ScreenDefault Cong Valid Values Increment4 On/O ONE-BUTTON BOLUS On “O”, “On” N/A4 Increment ONE-BUTTON BOLUSEnabled 0.5 U 0.5 or 1.0 (0.5 or 1.0) 0.54 Increment BASAL LIMITS 0.05 U/h “0.05 U/h”, “0.10 U/h”, “0.50 U/h”, “1.00 U/h” N/A4 Maximum BASAL LIMITS 2.00 U/h 0.05 – 30.00 .054 Temp BASAL SETUP Percent “Units”, “Percent” N/A5 Pump AUDIO/VIBE Audio “Audio”, “Vibrate” N/A5 Audio AUDIO/VIBE High “Medium”, “High”, “Low” N/A5 Sensitivity OCCLUSION ALARM High “High”, “Low” N/A5 Low Alert LOW INSULIN ALERT 20 U 5 – 50 56 Basal LOCKED ITEMS Unlocked “Unlocked”, “Locked” N/A6 Bolus LOCKED ITEMS Unlocked “Unlocked”, “Locked” N/A6 Prime LOCKED ITEMS Unlocked “Unlocked”, “Locked” N/A7 Time Add Block 1 12:00 a.m. 12:00 a.m. – 11:30 p.m. 30 (min)7Rate Add Block 1 -- 0.00 – Max Limit (user programmable)user programmable7 Time Add Block n+1 -- Time of Block n +:30 – 11:30 p.m. (or 23:30 for 24 hour) 30 (min)7Rate Add Block n+1 -- 0.00 – Max Limit (user programmable)user programmableSection 12: AppendicesAppendix B: SETUP WIZARD Default Conguration and SettingsSection 12: AppendicesAppendix C: Device Specications – CompanionDOC15736_Rev-A-Man.indd 251-252 2/9/09 11:29:55 AM
253254Other Preferences That are Not Part of the WizardMenu Item ScreenDefault Cong Valid Values IncrementREMINDERS Reminders 1 – 6 On/OO “On,” “O” N/AREMINDERS Reminders 1 – 6 MessageTest “Test”, “Wakeup”, “Basal”, “Bolus”, “Exercise”, “Meeting”, “Pickup”, “Snack”, “Meds”N/AREMINDERS Disable All Care Comments On “On”, “O” N/AREMINDERS On/O Insulin Temp Care CommentsO “O”, “On” N/AREMINDERS On/O Site Change Care CommentsO “O”, “On” N/AREMINDERS Frequency Site Change Care Comments2.0 days 2.0, 2.5, 3.0 N/AREMINDERS On/O Check BG Care CommentO “O”, “On” N/A C. Device Specications – CompanionAssay Method (FreeStyle Lite Blood Glucose meter):Coulometric electrochemical sensorAutomatic shuto: User settable up to two minutes after last user actionCalibration (FreeStyle Lite Blood Glucose meter): Plasma equivalentHematocrit (FreeStyle Lite Blood Glucose meter): 15% to 65%Measurement Units: Either mg/dL or mmol/LResult 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, capillarySample size (FreeStyle Lite Blood Glucose meter):0.3 microlitre (300 nanolitres)Test time (FreeStyle Lite Blood Glucose meter): Average of 5 secondsDimensions: 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: YesAudio/Vibe Alert: YesWeight: 2.6 oz (75 grams)Companion Battery: Lithium polymer, 3.7V 690mAhBattery Life: 3 daysThe 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 monthMemory: 90 days worth of events. All events can be seen if downloaded to a PC.Water Resistance: NoneOperational 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.Section 12: AppendicesAppendix D: Device Specications – PumpSection 12: AppendicesAppendix D: Device Specications – PumpDOC15736_Rev-A-Man.indd 253-254 2/9/09 11:29:56 AM
255256 D. Device Specications – PumpDimensions: 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: YesAudio/Vibe Alert: YesWeight: 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).Reservoir: Single use plastic reservoirReservoir Connection: Proprietary secure connectorBasal Increment: 0.05 unitsTotal Basal Rates: 48/dayBasal Prole Conguration: Numerical displayBasal Proles: 4Basal Interval: 30 minutesBasal Frequency: Every 3 minutesBasal Rate Range: 0.05 to 30U/hTemporary 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 specied 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 specied 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 50UBolus 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 secondPrime Deliver Rate: At least 0.1U per secondExtended Bolus: Yes1 U Bolus Duration: 10 seconds typicalInactivity Alarm: Always on, 1 – 24 hours.Maximum Time to Assert Occlusion Alarm: Occlusion Alarm set to High Sensitivity1 U/hr Approximately 3 hrs Approximately 6 hrs 0.05U/hr Approximately 60 hrs Approximately 120 hrsOcclusion Alarm Threshold/Pressure (Maximum Infusion Pressure) 25 psig (pounds per square inch gauge)Bolus Volume upon Release of an Occlusion Approximately 2.0 unitsPump Battery: One AAA battery (Energizer E92 or Duracell MN2400 recommended). Other models from these companies have not been tested.Battery Life: 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 weekMemory: 90 days worth of events; display shows last 30, remainder can be seen if downloaded to a PCWater Resistance: Water resistant to IPX8Moisture Protection: IPX8 (Water resistant to 8 feet [2.4 meters] for 30 minutes and 12 feet [3.6 meters] for 3 minutes)IEC Classication: Internally powered equipment, Type BF applied part (protection against electric shock)Reservoir Volume: 250U or 2.5 mLOperational Conditions (Temperature and Humidity):41°F – 104°F (5°C to 40°C) with 10% to 90% relative humidityStorage 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 6UBasal 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.Section 12: AppendicesAppendix E: FCC Compliance InformationSection 12: AppendicesAppendix F: Electromagnetic InformationDOC15736_Rev-A-Man.indd 255-256 2/9/09 11:29:56 AM
257258 E. FCC Compliance InformationModel 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 o 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.F. Electromagnetic InformationElectromagnetic Interference (EMI) from Radio Wave SourcesBattery 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 Identication (RFID) systems. The interference from these electromagnetic eld 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 LevelThe 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 PerformanceCISPR 11 IEC 61000-4-2 IEC 61000-4-8Criteria Required Performance (Radiated Emissions) Group 1 Class B PassIEC 60601-2-24 IEC 60601-2-24Criteria Met N/A (Electro Static Discharge) +/-8kV Direct, HCP and VCP Discharges +/-15KV Air Discharges Pass(Magnetic Immunity) 400 A/m PassSection 12: AppendicesAppendix G: Accuracy of Flow RateSection 12: AppendicesAppendix G: Accuracy of Flow RateDOC15736_Rev-A-Man.indd 257-258 2/9/09 11:29:56 AM
259260 G. Accuracy of Flow RateThis graph shows the ow 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. 0.0200.0150.0100.0050.000 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400Time (minutes)Flow (mL/h)This graph show the maximum errors observed for specic 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.2015105-5-10-15-20015 60 150Observation Interval (minutes)330 570 930Percentage Error of Flow (%)Overall percentage error: -1.1%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 ow 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 ow rate may be less accurate. This graph shows the calculated ow rate during the stabilization period. Encoder data was collected at a basal rate of 0.05U/h.0.0100.0090.0060.0070.0080.0030.0040.0050.0020.00000.001100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400Time (minutes)Flow (mL/h)This graph show the maximum errors calculated for specic observation intervals. Encoder data was collected at a basal rate of 0.05U/h.2015105-5-10-15-20015 60 150Observation Interval (minutes)330 570 930Percentage Error of Flow Rate (%)Overall percentage error: -0.01%Section 12: AppendicesAppendix H: Alarm PrioritySection 12: AppendicesAppendix I: Aviator Menus - CompanionDOC15736_Rev-A-Man.indd 259-260 2/9/09 11:29:56 AM
261262 H. Alarm PriorityThis 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.’All of the Aviator Pump alarms are classied 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 I. FreeStyle Aviator Menus – CompanionHOME 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 VersionSection 12: AppendicesAppendix I: Aviator Menus - CompanionSection 12: AppendicesAppendix I: Aviator Menus - CompanionDOC15736_Rev-A-Man.indd 261-262 2/9/09 11:29:56 AM
263264 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 Prole 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 RadioSection 12: AppendicesAppendix J: Aviator Menus - PumpSection 12: AppendicesAppendix J: Aviator Menus - PumpDOC15736_Rev-A-Man.indd 263-264 2/9/09 11:29:56 AM
265266 J. FreeStyle Aviator Menus – PumpHOME 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 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 Prole 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/VibeSection 12: AppendicesAppendix J: Aviator Menus - PumpGlossaryDOC15736_Rev-A-Man.indd 265-266 2/9/09 11:29:56 AM
267268 Occlusion Alarm Low Insulin Alert Locked items Name Values Pair Device Radio RF StatsGlossary (Key terms are in Blue the rst 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. Deliv-ery 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/o 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/o 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 deliver-ing 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.Glossary GlossaryDOC15736_Rev-A-Man.indd 267-268 2/9/09 11:29:56 AM
269270Basal Settings• – Settings that allow you to dene the basal amount, basal maximum limit, and the temporary basal format.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, 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 dierent 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 cor-rect 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 ac-count, 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 in-sertion of the infusion set, the center of the cannula contains a ne 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 aects your blood glucose levels. The pri-mary energy source from food.Care Comments• – Alerts for specic activities, i.e. such as to remind you to change your infusion set. You can turn these on or o.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 pro-grammed 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 specic name, i.e., on week-ends, 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 accumu-lation 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 eect on your glucose as well as a longer eect, 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/o 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 Glossary GlossaryDOC15736_Rev-A-Man.indd 269-270 2/9/09 11:29:56 AM
271272select an item and to move forward to the next screen. You can also stop a normal bolus in progress.Extended Bolus• – A bolus delivered over a determined period of time that is sometimes used to better match a food that is absorbed slowly.Food Bolus • – A bolus calculator option that allows administration of a bolus to account for food about to be 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 prole 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 bo-lus 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 prole 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 denes 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 calcu-lator helps you decide how much insulin may be needed for that food. It does NOT take into account food other than carbohydrates.Inactivity Alarm –• A safety alarm that sound when you have NOT touched any buttons within the time period selected. If you do NOT respond to an inactivity alert within 15 minutes, the INACTIVITY ALARM will sound and basal insulin delivery is stopped.Inactivity Alert –• When the inactivity time has elapsed without any interaction on the pump, the pump rst displays the INACTIVITY ALERT screen to keep delivery going.Indication • – A description of what the pump should be used for.Information Display • – Home screen conguration that provides important status information concerning basal and bolus delivery. Also oers 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.Glossary GlossaryInfusion 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 is taken in by injection or through use of a pump.Insulin On Board (IOB) • – The amount of insulin units that remain active in your body. The IOB is calculated us-ing the insulin action time setting chosen in your insulin prole (see Section 2.1), along with looking at ear-lier 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 ll 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 lling 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.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-ately puts the pump to sleep by pressing and holding the back button on the Home screen.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, 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 uid. The alarm occurs when pressure is detected DOC15736_Rev-A-Man.indd 271-272 2/9/09 11:29:56 AM
273274Resourcesas 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 adjust-able 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 properly in the pump. This connects the Reservoir to the infusion setReservoir 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 dierent basal program.SETUP WIZARD• – An easy way to set up your pump. Individual SETUP WIZARD options are also accessible via the SETUP Menu. This feature is typically used the rst 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 specied 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 indi-cate 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 dierent than desired blood glucose range.Temporary Basal • – A way to deliver basal insulin at a dierent rate for a temporary period of time, such as for exercise or illness. You may choose either specic 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.DOC15736_Rev-A-Man.indd 273-274 2/9/09 11:29:57 AM
275ResourcesResources 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, MDInsulin Pump Therapy Demystied: An Essential Guide for Everyone Pumping Insulin•by Gabrielle Kaplan-MayerPumping Insulin: Everything You Need for Success with an Insulin Pump•by John Walsh, PA, CDE and Ruth Roberts, MAWeb Sites:Abbott Diabetes Care•www.AbbottDiabetesCare.com•American Diabetes Association•www.diabetes.orgCenters for Disease Control Diabetes Public Health Resource•www.cdc.gov/diabetesDiabetes Exercise and Sports Association•www.diabetes-exercise.orgUS Food and Drug Administration Diabetes Information•www.fda.gov/diabetesInsulin Pump Online Support•www.insulin-pumpers.orgPump Supplies:Unique Accessories Inc.•www.uniaccs.comDiabetes Mall•www.Diabetesnet.com/diabetes_technologyPump Wear Inc.•www.pumpwearinc.comDOC15736_Rev-A-Man.indd 275 2/9/09 11:29:57 AM
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Caution: Federal Law restricts this device to sale by or on the order of a physician.(Patent information to be placed here.)©2008 Abbott DOC15736 Rev. A 12/08Distributed by:(Place distribution addresses here.)Humalog®, Apidra®, Novolog®, and Kendall Monoject™ are not trademarks of the Abbott Group of Companies.DOC15736_Rev-A-Cvr.indd 4 2/9/09 11:32:19 AM

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