User Guide. Here’s everything you’ll need to know.
Technical and Clinical Help If there is anything you don’t understand in the User Guide, if you have a question, or need assistance with your pump, contact your Animas Pump Support team at 1-877-937-7867 (or 1-877-YES-PUMP) at any time, day or night.
Table of Contents Welcome and Congratulations......................................................................................7 Technical and Clinical Help.........................................................................................8 Supply Reordering.....................................................................................................8 Important Note.........................................................................................................
Chapter 6 Using the Normal Bolus Feature.................................................................35 Chapter 7 Using Basal Program Features.....................................................................37 Setting a Basal Program............................................................................................37 Adding/Changing Segments in an Existing Basal Program.............................................39 Reviewing Basal Programs...................................................
Combo Bolus .......................................................................................................73 Reminders...........................................................................................................74 Bolus Reminders...................................................................................................74 BG Check Reminder...............................................................................................75 Delivery Speed – Bolus.....................
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Welcome and Congratulations You have begun a new way of life with your Animas® 2020 insulin pump. Your choice of pump therapy is a sign that you are committed to taking excellent care of yourself. The Animas® 2020 pump has been specially designed to help you manage your diabetes, using advanced technology and sophisticated safety systems. Your pump is used for insulin therapy to help maintain your blood glucose targets as recommended by your healthcare team.
Technical and Clinical Help If there is anything you don’t understand in the User Guide or if you have a question or need assistance with your pump, our Pump Support team is available to you 24/7. Call 1-877-937-7867 (or 1-877-YES-PUMP) for assistance any time, day or night. For non-urgent technical questions, please email pumpsupport@animascorp.com. We understand that you may have questions and concerns when using a new product.
Chapter 1 Important Information 1 This User Guide contains information about how to use, program and maintain your new pump. It is important to read it carefully. Even if you are an experienced pumper, keep your User Guide handy for reference. Warnings, cautions and safety tips are found throughout this Guide, indicated by a symbol. Warnings Do not attempt to connect to the pump before you have been trained on the Animas® 2020 or unless your Certified Animas® 2020 Pump Trainer is present.
1 • An extra pump cartridge cap (Call the Customer Care team at 1-866-406-4844 to order an extra cartridge cap.) • Glucagon Emergency Kit • Emergency contact phone numbers Be sure to inform a family member, co-worker and/or friend where this emergency kit is kept. Indications for Use Your Animas® 2020 insulin pump is indicated for use for the control of insulin-requiring diabetes. It is intended for use by one person. In the United States, it is prescription device.
1 Medical Procedures Procedure Patient is Pumper Healthcare Professional/ Technician is Pumper Pacemaker / AICD Disconnect pump and leave outside room during Follow normal safety practices and insertion of device and reprogramming. Infusion proceed to the designated safe set can remain in place. area while each X-ray is taken and during reprogramming. EKG No need to disconnect. Cardiac Catheter Disconnect pump and leave outside room during Follow normal safety practices and procedure.
1 Radiology (X-rays) and Medical Procedure Quick Reference Chart Page 12
1 Amusement Parks Very powerful electromagnets are sometimes used on “free-fall” amusement park rides. Insulin pumps should be removed and not taken on these “free-fall” types of rides. High gravity forces can be experienced when riding on some roller-coasters. It is recommended that you disconnect (NOT suspend) the pump while on roller-coaster rides.
1 Occasionally check to make sure the pump emits audible tones that are easily detectable. For example, the audible tones should be heard every time you replace the battery. If using the upload or download feature*, keep the communication window free of obstructions and refer to the Instructions for Use included with the IR (infra-red) Accessory Kit. *Contact your Animas Customer Care team at 1-866-406-4844 for information on ezManager® Software and IR Accessory Kit.
1 When you begin using the Audio Bolus feature, always look at the screen as you program so that you are completely comfortable with the feature before delivering a bolus via audio prompts only. Animas Corporation recommends that you have someone around you (family, friends, etc.) who understands diabetes and pump therapy, so in the event of an emergency, they can help you. Be sure they are familiar with any information given to you by your healthcare team.
1 To avoid risk of explosion, do not use the pump in the presence of explosive gases. Your Animas® 2020 pump is designed to achieve optimum performance and battery life with an Energizer® Lithium L91 AA battery (1.5V). Rechargeable batteries and CarbonZinc batteries do not have the necessary characteristics to power the pump and should not be used. Some AA lithium batteries are available with other voltages such as 3.6V or 4.0V. Do not use these batteries. Use of anything other than a 1.
Chapter 2 Package Contents 2 Take a minute to check the contents of your Animas® 2020 shipping box. It should include: • • • • Your Animas® 2020 insulin pump One Energizer® Lithium L91 AA battery (1.
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Chapter 3 Explanation of Symbols 3 Shown below are symbols you will find on your Animas® 2020 insulin pump and its packaging. On the front of the pump: Up Arrow button Down Arrow button OK button On the top of the pump: Contrast button On the back of the pump: ! S/N Important Information (See User Guide for Instructions for Use) Serial Number Date of Manufacture IPX8 Water-Tight Equipment (protected against the effects of submersion; tested to 12 feet/3.
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Chapter 4 Introduction to Your Animas® 2020 Pump 4 An insulin pump is a tool to allow you to better manage your diabetes by mimicking the way a healthy pancreas delivers insulin. When connected to a properly inserted infusion set, your pump delivers insulin at a continuous, low level (basal) rate, 24 hours a day. You program delivery of a higher level dose (bolus) of insulin to cover food eaten or to correct high blood glucose (BG).
4 Contrast Button Pressing this button adjusts the contrast of your display. There are three contrast levels: Dim, Default and Bright. To preserve battery life, your pump display will Auto-dim when a button is not pressed for half the time your display time-out is set. While in Auto-dim mode, you can restore to the default contrast level you have set by pressing the Contrast button on top of the pump.
4 Cartridge Compartment Cap This cap secures your cartridge and infusion set in the pump. Never tighten the cartridge cap when your infusion set is attached to your body. Tightening the cartridge cap while your infusion set is attached to your body may result in unwanted insulin delivery. IR Window for Download The IR window is framed in blue. This is the infrared communication window used for downloading your pump data.
4 When the pump times out, the screen display is blank. The battery life indicator is shaded to show approximate battery life remaining. Main Menu Screen This screen shows all Main Menu options. Bolus This selection takes you to the Normal Bolus screen. If you have activated Advanced Bolus features, the Bolus Menu will be displayed. Here you can select bolus options, program and activate your bolus dose.
Chapter 5 Getting Your Pump Ready 5 Before proceeding with this chapter, you should have completed your pump start training. To complete this section, you will need the following items: • Animas® 2020 Insulin Pump • Energizer® Lithium L91 AA battery (1.5V) • Coin • Infusion set with standard Luer connector • Animas® 2.
5 Changing the Battery Each time you change the battery • A full rewind and prime sequence is required. See this section, Priming the Pump and Infusion Set • The Insulin on Board calculation starts over at zero • The Combo bolus returns to the factory set default duration and split • Review your basal program settings Low Battery Warning means battery life will end in minimum 1 hour. 1. Use a coin to unscrew the battery cap with a counter-clockwise motion. 2.
5 7. Check the displayed time/date, battery type and language. If correct, scroll down to highlight Confirm and press the OK button. The Home screen will be displayed. For more details on changing the time and date, see next section, Setup – Basics, Setting/Changing Time and Date. Note: The time and date must be set to Confirm the Verify screen. 8. To change the battery type, highlight the battery field and press OK to activate Edit mode (indicated by flashing cursor). 9.
5 4. Use the Up/Down arrows to change to your desired settings. Press the OK button to confirm your setting and exit Edit mode. 5. Use the Up/Down arrows to select the next field. Repeat the above process. Scroll to highlight Main Menu and press OK button when finished. The Main Menu screen will be displayed. If you select the 12 hour time format, the AM/PM indicators will change as you scroll to set the time. Be sure the desired AM or PM selection is correctly displayed when setting the time.
5 Normal Bolus Sound Audio Bolus Sound (OFF is not an option for this sound setting) Temp Basal Sound These are the options from the first Setup Sound Menu. They can be set to one of the following: Vibrate, Low volume, Medium volume, High volume or can be shut off completely. For safety reasons, some of the alerts cannot be turned off.
5 The Cartridge Filling the Cartridge Refer to the Instructions for Use included with your cartridges. Connecting the Tubing to the Cartridge These steps must be followed in order. To complete this section, you will need the following: • Filled Animas® 2.0 mL Cartridge (200 unit/2ml)* • Infusion set compatible with your Animas® 2020** • Skin prep such as Skin Prep® *Efficacy of pump cannot be guaranteed if cartridges other than those manufactured by Animas Corporation are used.
5 6. Remove cap from the filled cartridge tip. To avoid insulin spillage and introduction of air in the cartridge, it should never be filled beyond the 2.0 mL mark. The plunger is properly positioned for maximum fill when the black o-ring nearest the plunger tip is centered on the 2.0 mL mark. Attach infusion set Luer connector to cartridge tip using clockwise motion until finger tight and then twist another quarter of a turn.
5 Priming the Pump and Infusion Set These steps must be followed in order. Note: As each step is completed, the checkbox on the ezPrime menu will be shaded. Never prime tubing or tighten the cartridge cap while the infusion set is connected to your body. Doing so while the infusion set is connected to your body can result in unintended delivery of insulin, which can result in serious injury or death. 1. Make sure you are disconnected from the pump. 2. From Main Menu, select Prime/Rewind. 3.
5 Never prime tubing or tighten the cartridge cap while the infusion set is connected to your body. Doing so while the infusion set is connected to your body can result in unintended delivery of insulin, which can result in serious injury or death. Note: If screen display has timed out while loading your cartridge, select Prime/Rewind from Main Menu and highlight Load Cart from ezPrime Menu. Press OK to display Rewind Complete screen. Continue with Step 8. 8.
5 12. From the ezPrime Menu, Fill Cannula is highlighted. Press the OK button. The Fill Cannula screen is displayed. 13. Use the Up/Down arrows to enter the amount of insulin needed to bolus to fill the cannula. Refer to the Instructions for Use included with your infusion set for details on how much insulin is required to fill the cannula. Note: The maximum Fill Cannula amount is 1U at a time. The Fill Cannula step is not required for the pump to operate.
Chapter 6 Using the Normal Bolus Feature 6 Your Animas® 2020 offers several advanced bolus options, which can be activated from the Setup Advanced Menu. The bolus feature allows you to program an insulin delivery to cover food eaten or high blood glucose. You and your healthcare team can determine which features are best for you. See Chapter 11, Advanced Features. This chapter covers the basics of a Normal bolus, which is used to cover food you’ve eaten and to correct high blood glucose. 1.
6 Note: You can check when you last gave a bolus by looking in History or Status. These features are covered later. Note: If you have Advanced Bolus and Reminders features turned on, the Bolus Menu at right will be displayed when you select Bolus from the Main Menu.
Chapter 7 Using Basal Program Features 7 You can program your Animas® 2020 to display either 1 or 4 basal program options. Basal insulin is delivered continuously to help keep your blood glucose in target between meals. Having more than one pre-set basal program makes it easy for you to switch based on your weekday needs versus weekend needs, or to accommodate for shift work and menstruation.
7 Note: You do not have to Suspend the pump to edit an active program. When you select Edit from the Basal Menu, your Animas® 2020 automatically suspends delivery. When you exit the Edit mode, the active program delivery automatically resumes. 4. The Basal Options screen is displayed. Edit is highlighted. Press the OK button. From the Edit Basal screen, you can edit the basal segments of the selected program. 5. Scroll to the desired U/hr field.
7 Note: The next available empty basal segment will appear automatically as you program the previous segment. If the next empty basal segment does not appear, you have programmed all 12 possible segments. 8. Change next Start time field as desired, press the OK button to exit Edit mode. Segments can start on the hour or half hour. Note: The 24 hour Total changes automatically as you change U/hr settings. 9. Continue until basal segments have been set as recommended by your healthcare team. 10.
7 5. Check that the AM/PM settings are correct. If you program a segment to start at the same time as an existing segment, the previously entered segment is deleted. If you program a segment to start at a time that precedes an existing segment, the new segment is automatically inserted in the correct place. You must then scroll to the new segment, highlight the corresponding U/hr field and enter or change amount, if desired. 6. When finished, scroll to Save/Review and press OK.
Clearing Basal Programs This feature allows you to clear all information from a basal program. 7 1. From Basal Menu, scroll to desired program. 2. From Basal Options screen, scroll to Clear. Press OK. If you press OK to select Clear, your pump will check to be sure you want to clear all the segments of the basal program selected. The Alert screen shown here is displayed. If you do wish to clear all the basal segments of the selected program, scroll to Clear Program and press OK.
7 1. From Basal Menu, scroll to Temp. Press OK. 2. The Change % field will flash to indicate Edit mode. Use the Up/Down arrows to enter the percentage change desired. Press OK button to exit Edit mode. 3. Duration field is highlighted. Press OK to activate Edit mode. 4. Use the Up/Down arrows to enter the duration desired. Press OK to exit Edit mode. 5. Go is highlighted. Press OK to activate Temp Basal. The lowest basal delivery amount possible is 0.025 U/hr.
7 6. The Home screen is displayed and shows your Temp Basal is active, the percentage change, the duration and how much time is left. When the duration of time is complete, your pump will automatically resume the active basal program. Note: If you turned on the Temp Basal sound in Setup, the pump will beep once every 30 minutes to remind you of Temp Basal status. Canceling a Temporary Basal Program 1. From Basal Menu, select Temp Basal. Press OK. 2.
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Chapter 8 Suspend/Resume Feature 8 This feature allows you to stop basal insulin delivery quickly and easily. It also cancels delivery of any Temp Basal or Bolus, including Combo Bolus that may be currently active. The Combo Bolus feature is covered later in this User Guide. Suspending Delivery 1. From the Main Menu, scroll to Suspnd/Resum. 2. Suspend is highlighted. Press OK.
8 Resuming Delivery 1. From the Main Menu, scroll down to Suspnd/Resum. 2. Resume is highlighted. Press OK. 3. The Home screen is displayed to show you the pump is no longer in Suspend mode. Your previously active basal program is automatically resumed.
Chapter 9 9 History Feature Your Animas® 2020 stores important records for your review. You can access your pump’s history and view it directly on the pump screen or download it onto your computer using ezManager®. Refer to the User Guide included with the software. The pump stores these records indefinitely, even when batteries are removed. The pump stores basal rates, boluses, alarms and settings. From the Main Menu, select History. The History Menu is displayed.
9 Total Daily Dose (TDD) History Your Animas® 2020 displays the last 120 TDD records. 1. From the History Menu, select TDD. This screen displays the following: • • • • • • • Record number Date of record If Temp Basal was active on that date If Suspend was activated on that date Total Bolus for the date Total Basal for the date Total dose for the date 2. Scroll up to highlight the record field. Press OK to activate Review Mode (indicated by flashing cursor). 3. Record 1 indicates the most recent record.
Prime History Your Animas® 2020 displays the last 60 Prime records. 9 1. From the History Menu, select Prime. The screen displays the following: • Record number • Date of prime • Time of prime • Amount of prime 2. Scroll up to highlight the record field. Press OK to activate Review Mode (indicated by flashing cursor). 3. Record 1 indicates the most recent record. Use the Up/Down arrows to scroll to other records. 4. When finished reviewing, press OK to exit Review Mode. 5. History Menu is highlighted.
9 Basal History Your Animas® 2020 displays the last 270 Basal delivery records. 1. From the History Menu, select Basal. The screen displays the following: • Record number • Date and time basal rate was changed • Basal rate change 2. Scroll up to highlight the record field. Press OK to activate. Review Mode (indicated by flashing cursor). 3. Record 1 indicates the most recent record. Use the Up/Down arrows to scroll to other records. 4. When finished reviewing, press OK to exit Review Mode. 5.
Chapter 10 10 Status Feature This feature gives you easy access to a summary of information about your pump’s current programming and performances. There are 6 Status Screens. 1. From the Main Menu or from the Home screen, scroll to Status and press OK.
10 Status Screen 3 – Delivery Today The screen displays the following information: • Insulin type • If Temp Basal has been active between midnight and today’s current time • If Suspend has been active between midnight and today’s current time • Total bolus amount delivered since midnight and up to today’s current time • Total basal amount delivered since midnight and up to today’s current time • Total insulin delivered (excluding prime amounts) since midnight and up to today’s current time The cursor is fl
Status Screen 6 – Codes The screen displays the following information: • • • • • • 10 Software revision Serial number of pump Code for manufacturer’s use Code for manufacturer’s use Code for manufacturer’s use Code for manufacturer’s use The cursor is flashing on the Status Screen number 6. Press OK to highlight Main Menu and exit Status screens.
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Chapter 11 11 Advanced Features – Setup and Activation Now you’ve made it through the basics! Your Animas® 2020 offers many advanced features that you may find helpful in managing your diabetes. Consult with your healthcare team to determine which advanced features are appropriate for you. This chapter tells you how to set up and turn on the advanced features. Chapter 12 covers how to use each advanced feature. You can also use your computer and ezManager® software to upload settings for Advanced Setup.
11 Setup Advanced 2 – Advanced Bolus Features and Multiple Basal Programs This screen allows you to: • Turn Advanced Bolus Features on or off ○○ ezCarb Bolus ○○ ezBG Bolus ○○ Combo Bolus • Turn personal Reminders feature on or off • Select bolus delivery speed (normal: 1 U every second or slow: 1 U every 4 seconds) • Select either 1 basal program or 4 basal programs to be displayed in Basal Menu Note: If a program other than 1-Weekday is active, you cannot change this setting to display 1 basal program.
11 Setup Advanced 4 – Language Setup, Display Timeout, Contrast and Battery Type This screen allows you to: • Select a different language • Set the length of time your display stays on before timing out to save battery life ○○ 15, 30, 45 or 60 seconds • Select a contrast setting • Select Lithium (recommended) or Alkaline battery type 1. Scroll to the desired field. 2. Press OK to change to flashing cursor for Edit mode. 3. Use the Up/Down arrows to change to desired setting. 4.
11 Setup Advanced 6 – Low Cartridge Warning Setting and Occlusion Sensitivity Setting This screen allows you to: • Set your low cartridge warning to alert you at 10, 20, 30, 40 or 50 units remaining • Set your occlusion detection sensitivity to High (more sensitive) or Low (less sensitive) 1. Use the Up/Down arrows to scroll to the desired field. 2. Press OK to change to flashing cursor for Edit mode. 3. Use the Up/Down arrows to change to desired setting. 4. Press OK when setting is made.
11 5. To move to the next I:C Ratio screen, scroll to the forward arrows and press OK. 6. Scroll up to the time field and press OK to change to flashing cursor for Edit Mode. 7. Use the Up/Down arrows to change the segment start time. Press OK. 8. Scroll to the grams field and press OK to change to flashing cursor for Edit mode. 9. Use the Up/Down arrows to change the grams field as desired. Press OK. Repeat to set remaining segments per your healthcare team’s recommendations.
11 6. Scroll up to the time field and press OK to change to flashing cursor for Edit mode. 7. Use the Up/Down arrows to change the segment start time. Press OK. 8. Scroll to the BG units field and press OK to change to flashing cursor for Edit Mode. 9. Use the Up/Down arrows to change the BG units field as desired. Press OK. Repeat to set remaining segments per your healthcare team’s recommendations. To review your settings, highlight the forward arrows and press OK to scroll through each segment.
11 7. To move to the next BG Target screen, scroll to the forward arrows and press OK. 8. Scroll up to the time field and press OK to change to flashing cursor for Edit mode. 9. Use the Up/Down arrows to change the segment start time. Press OK. 10. Scroll to the BG Target field. Press OK to change to flashing cursor for Edit mode. 11. Use the Up/Down arrows to change to desired setting. 12. Press OK when setting is made. 13. Scroll to the range field. Press OK to change to flashing cursor for Edit mode.
11 To return to the Home screen, scroll to Home and press OK. Note: The pump is constantly tracking insulin on board, so when you turn on the feature, the pump will immediately take into account the current amount remaining from previous bolus doses within the time frame you’ve selected during set up of the feature.
Chapter 12 Using Advanced Features 12 Using the features in this chapter requires an advanced understanding of insulin pump therapy and should not be used without training and advice from your healthcare team. In order to achieve optimal results, some of these features should only be used once you have tested and fine-tuned your basal rates and your healthcare team has determined your individual targets and ratios. Note: Before using these features, you must turn them on in the Setup Advanced Menu.
12 4. Within 5 seconds, the pump will respond with a number of confirmation beeps equal to the number of times you pressed the audio bolus button. Note: Do NOT press any of the function buttons at this time unless you wish to cancel delivery. 5. Within 5 seconds, the pump will beep twice to “ask” you to confirm that you wish to activate delivery and the Confirm screen is displayed. 6. Within 5 seconds, press the button again to activate delivery. The pump will beep twice to confirm your delivery command.
ezBolus™ If you do not have your Audio Bolus feature turned on, the button on the end of the pump will function as a short cut to the Normal Bolus screen. 12 1. Press the button on the end once. The Normal Bolus screen is displayed. Program a Normal Bolus as usual. Advanced Bolus Features • ezCarb • ezBG • Combo Bolus • Reminders All Advanced Bolus features are activated in the Setup Advanced Menu. See Chapter 11, Advanced Features.
12 Entering Carbs Manually (no food database) 1. From the Bolus Menu, scroll to ezCarb. Press OK. The ezCarb Home screen is displayed. 2. The cursor will flash on the Carbs field to indicate that you can edit the total number of carbs eaten. Use the Up/Down arrows to enter the number of carbs. Press OK. Add BG is highlighted. (See next section, Adding a BG Bolus to ezCarb.) Note: The max limit for ezCarb Total is 999g. If your meal total is more than 999g, the pump display will show the actual total.
12 7. If you wish to give a Combo Bolus, scroll to the Type field and press OK to edit. 8. Use the Up/Down arrows to select bolus type: Normal (default) or Combo. Press OK. 9. Go is highlighted. Press OK. Note: If you select the Combo Bolus option, the Combo Bolus menu will be displayed. See this chapter, Combo Bolus. Adding a BG Bolus to ezCarb 1. On the ezCarb Home screen, enter the number of carbs. Press OK. 2. Add BG is highlighted. Press OK. The BG Correct screen is displayed. 3.
12 5. The Bolus Total screen is displayed and the Bolus amount field is highlighted and flashing. 6. Enter the Bolus amount. Go is highlighted. Press OK to deliver or scroll to Type field to select Combo Bolus. See this chapter, Combo Bolus. Entering Carbs Using the Food Database You can create a food database of up to 500 items and store them on your pump. Refer to your ezManager® User Guide included with the software. 1. From the Bolus Menu, select ezCarb. Press OK. 2.
12 6. Add Item is highlighted. If you wish to add an item to your meal, press OK. The Food List is displayed. Follow steps 2 through 5 until you have added all your meal items (maximum of 9 items can be entered for one meal). 7. When you enter the serving size for the last food item, press OK. Add Item is highlighted. Use the Down arrow to scroll to Total. Press OK. 8. The ezCarb Total screen is displayed. Review the items and carb amounts.
12 Note: The max limit for ezCarb Total is 999g. If your meal total is more than 999g, the pump display will show the actual total and the max amount. The ezCarb Home screen will use the max number for the calculator and will show the Actual total in parentheses. 9. Review the items and carb amounts. With Done highlighted, press OK. 10. The ezCarb Home screen is displayed, with the total carb amount displayed in the carbs field. Proceed as outlined in the two previous sections. 11.
12 ezBG This feature allows you to enter your BG reading and your Animas® 2020 will calculate a correction bolus based on the Insulin Sensitivity Factor and BG Target Range for the current time of day. If the Insulin on Board (IOB) feature is activated, your Animas® 2020 will calculate a reduced dose for high BG correction boluses that you can review. 1. From the Bolus Menu, select ezBG. Press the OK button. 2. The Actual field will be highlighted and flashing to indicate Edit mode.
12 5. The ezBG Total screen is displayed with a suggested bolus amount. The bolus amount field is highlighted and flashing to indicate you can enter the total amount as shown or adjust as needed. Enter your bolus amount. Press OK to deliver. Note: If Insulin on Board (IOB) feature is activated, your Animas® 2020 will calculate a reduced BG Bolus amount for your review. Note: If you enter a BG amount below 3.8 mmol/L or above 13.8 mmol/L, your pump will alert you that you’ve entered an out of range BG.
12 Combo Bolus The Combo Bolus feature is used to give both a Normal and Extended Bolus. This feature is useful for consumption of high fat meals such as pizza, if you will be “grazing” over a few hours or if you have gastroparesis. You can program part of your bolus amount to be delivered immediately and part of it to be delivered slowly over the course of up to 12 hours.
12 6. Scroll to Go and press OK to activate. The Home screen shows Combo Bolus active. To cancel an active Combo Bolus from the Bolus Menu, select Combo. Details of the active Combo Bolus will be displayed. Scroll to Cancel and press OK to cancel the Combo Bolus. Note: If you Suspend the pump, any active Combo Bolus will also be canceled and the screen display will alert you. Combo Bolus is also canceled when you change the battery and/or prime. Reminders This feature allows you to set personal reminders.
12 BG Check Reminder 1. From the Reminders Menu, select BG Check. Press OK to activate Edit mode to turn this reminder on or off. Press OK to confirm and exit Edit mode. 2. Scroll down to highlight the After Bolus field. Press OK to select the field and activate Edit mode. Use the Up/Down arrows to enter how long after a Normal Bolus you wish the pump to sound (or vibrate) to remind you to check your BG. You can select 1, 2, 3 or 4 hours after you give a bolus.
12 Note: If a program other than 1-Weekday is active, you cannot change this setting to display 1 basal program. The Alert screen shown here will pop up to remind you. Insulin on Board Even with rapid-acting insulin, your body takes some time to use the entire bolus amount. If you have activated this feature, your pump will track the bolus insulin remaining in your system – Insulin on Board (IOB) – and calculate a suggested lower correction bolus dose.
Chapter 13 13 Care and Maintenance The Vents Your Animas® 2020 features a redundant Vent Safety System. Vents serve two purposes. First, they allow air to pass through the pump so that pressure is equalized under a variety of environmental circumstances, such as changes in altitude. Second, the vents are backed by a special membrane, which keeps water from entering the pump. Battery Cap with O-ring and Vent Your battery cap contains a yellow o-ring and vent.
13 General Wear and Tear If you drop the pump or it has been hit against something hard, inspect it to be sure it is still working properly. Check that the display screen is working and clear, that the cartridge cap, battery cap and infusion set are properly in place. Check for leaks around the cartridge by wrapping a piece of tissue around the connection area. Cracks, chips or damage to the pump may impact the battery contact and/or the waterproof feature of your pump.
Chapter 14 Safety System and Alarms 14 Alerts, Warnings and Alarms Your Animas® pump has a progressive Warnings and Alarms safety system. This means if you do not confirm the Warning or Alarm, it will progress to the sweep alarm with vibrate within one hour. At the high volume stage, if you do not confirm the Warning or Alarm, the sweep alarm will begin and will not stop until appropriate action is taken.
14 Alerts, Warnings and Alarms Alert: Low BG ♪ Cause BG entry below 3.9 mmol/L. Effect Requires user confirmation to continue. Message Displayed until confirmed. Action Press OK to confirm. User selected, one time and each time manually Beeps/Vib awakened until confirmed. No progression. Alert: High BG ♪ Cause BG entry above 13.9 mmol/L. Effect Requires user confirmation to continue. Message Displayed until confirmed. Action Press OK to confirm.
14 Alerts, Warnings and Alarms Warning: Basal Delivery Suspended ♪ Cause Basal Edit was not saved. Effect Basal delivery stopped. Message Displayed when manually awakened until confirmed. Action Press OK to select Edit Basal. Review basal edits and select Save/Review. Beeps/Vib User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour. Warning: Suspend ♪ Cause Pump suspended manually. Effect All deliveries stop.
14 Alerts, Warnings and Alarms Warning: Low Battery ♪ Cause Battery life ends in minimum 1 hour. Effect Deliveries continue. Displays when pump is awake until confirmed. Message Displays when triggered by event (such as bolus) & when manually awakened. Action Press OK to confirm. Insert new battery. User selected, every 3 minutes until confirmed. If not Beeps/Vib confirmed, progresses to sweep/vibe within one hour. Warning: Low Cartridge ♪ Cause Low insulin level reached.
14 Alerts, Warnings and Alarms Warning: Exceeds Max Basal ♪ Basal delivery rate (or Temp Basal delivery) exceeds Cause user-set maximum. Effect Basal delivery stops. Displayed when awakened (by basal delivery attempt Message every 3 min. or manually) until confirmed. Press OK to confirm. Reprogram Max Basal amount in Action Setup Advanced (or reprogram Temp Basal). User selected, every 3 minutes until confirmed. If not Beeps/Vib confirmed, progresses to sweep/vibe within one hour.
14 Alerts, Warnings and Alarms Alarm: Empty Cartridge ♪ Cause Cartridge empty. Effect All deliveries stop. Message Continuous until confirmed. Action Press OK to confirm. Replace with full cartridge. Option to select Suspend (see Suspend). Beeps/Vib User-selected, every 3 minutes. If not confirmed, progresses to sweep/vibe within one hour. (Once confirmed, No Prime warning triggered, see No Prime.) Alarm: Replace Battery Battery either has minimum 3 minutes left or battery Cause is dead.
Chapter 15 Troubleshooting Guidelines 15 It’s a good idea to set up a troubleshooting procedure to use anytime you suspect something might be wrong. Work with your healthcare team to establish guidelines in the event of a problem. Hypoglycemia Low blood sugar is a risk for anyone using insulin therapy.
15 Possible Cause of Low BG Suggested Solution Alcohol consumption May cause hypoglycemia. Eat food when drinking alcohol. Be cautious with bedtime bolus. Always check BG before going to bed. Check BG at 3 am. Consult healthcare team. ACTIVITY Did not Suspend pump or activate Temp Basal Low carbohydrate intake prior to exercise Unplanned activity (shopping) Consult healthcare team for guidelines for use of Temp Basal rate during exercise.
15 Several things can cause a high BG reading. The most common problems and causes of high blood glucose are listed in the following table, as are some suggested solutions. Possible Cause of High BG Suggested Solution INFUSION SET Redness, irritation, inflammation, Change infusion set tubing and site. Contact healthcare team.
15 SMBG (Self-monitoring of BG) Insufficient BG testing Rebound high BG after low BG (Somogyi Effect) Elevated fasting BG Insulin sensitivity factor not correct or not used OTHER Medications (steroids, terbutaline, other hormone treatments) Infection, illness, virus Pre-menstrual cycle Check more often when BG is elevated. Check 3 am BG. May need to adjust basal rate during night. Consult healthcare team. May need to adjust basal rate. Consult healthcare team.
15 Problems with Infusion Sets and Sites A number of problems can occur with infusion sets and sites, the most common of which are listed in the following table, along with some suggested solutions. Infusion Sets and Sites Air bubbles in tubing Kinked tubing Dislodged needle or cannula Blood in tubing (insulin looks pink or red) Insulin leak Redness, tenderness, lumps, itching, warmth, discharge Cartridge Reused Suggested Solution Always fill your pump cartridge with room temperature insulin.
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Chapter 16 Sick Day Guidelines 16 During periods of short-term illness, it may be more difficult to maintain good control of your diabetes. Examples of minor illness are: dental surgery, colds, nausea/vomiting, sore throat, mild infections, diarrhea, fever. However, you should call your healthcare team if: • Illness persists without improvement for 24-48 hours. • Temperature rises above 100° Fahrenheit or 38° Celsius. • Vomiting or diarrhea continues longer than 4 hours.
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Chapter 17 17 Lifestyle Issues Exercise and Sports There are many options for wearing your pump during exercise and sports activities. During “low-contact” sport activities, such as walking, biking or aerobics, the pump can be clipped to the waistband, or for added security, placed in a “sport case.” During “contact” sports such as baseball, basketball or hockey, the pump can be disconnected for up to one hour.
17 Traveling, continued: • • • • Pack your insulin carefully so that it is not exposed to extreme temperatures or temperature changes Pack your pump supplies in carry-on luggage when traveling by air or train. Do not pack your supplies in checked luggage.
Chapter 18 18 My Information This chapter provides tables to record information needed for programming your personal settings into the pump. Consult your healthcare team for correct information for your personal treatment plan.
18 Temp Basal Rate Decrease for Activity Activity Type % Decrease Set Temp in advance of activity (yes or no) Minutes to set in advance Light (gardening, walking, shopping) Moderate (leisurely biking, golf {no cart}) Strenuous (basketball, jogging, swimming) Sustained (ice skating, rowing, hiking) My duration for Insulin on Board is: ______________ Basal Programming SEGMENT START TIME Date: ______________ Program 1 Program 2 Program 3 Program 4 Weekday Other Weekend Exercise ______________ ________
18 Basal Programming Date: ______________ SEGMENT START TIME Program 1 Program 2 Program 3 Program 4 Weekday Other Weekend Exercise ______________ _______________ ______________ _______________ Units/Hr Units/Hr Units/Hr Units/Hr Page 97
18 Basal Programming Date: ______________ SEGMENT START TIME Program 1 Program 2 Program 3 Program 4 Weekday Other Weekend Exercise ______________ _______________ ______________ _______________ Units/Hr Units/Hr Units/Hr Units/Hr Page 98
18 Basal Programming Date: ______________ SEGMENT START TIME Program 1 Program 2 Program 3 Program 4 Weekday Other Weekend Exercise ______________ _______________ ______________ _______________ Units/Hr Units/Hr Units/Hr Units/Hr Page 99
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Frequently Asked Questions (FAQs) 1. The Wake up screen shows my current basal rate delivery but doesn’t show which Basal Program is active. How do I find this information? From the Wake up screen, use the Up/Down arrows to highlight Status and press OK. Status Screen 1 shows the name of the active basal program. 2. When I go to Status Screen 2, there is an IOB (Insulin on Board) amount shown but I don’t use this feature.
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Glossary alpha cells – Alpha cells are found in the pancreas. They produce a hormone called glucagon, which raises blood glucose levels. basal rate – The basal rate is the amount of insulin that is continuously delivered by an insulin pump. It is measured in units per hour (U/hr). The basal rate usually provides about 40% to 60% of the daily total delivery of insulin. beta cells – Beta cells are found in the pancreas. They produce insulin, which lowers blood glucose levels.
gestational diabetes – Gestational diabetes is a form of diabetes that may develop during pregnancy. In some women, certain hormones normally produced by the body during pregnancy can result in unusually high blood glucose levels. If the body cannot produce enough insulin, this can lead to hyperglycemia and may require treatment with insulin. Gestational diabetes usually ends when the baby is born, but many mothers who experience gestational diabetes can later develop Type 2 diabetes.
insulin limits – Insulin limits are a programmable feature of the Animas® pump. After consulting with your healthcare team, you can use the advanced menu to program maximum limits for basal rate delivery, bolus delivery and total daily delivery. insulin pump – An insulin pump is a small, battery-powered device that mechanically pumps measured amounts of insulin through an infusion set into the body. THE PUMP IS NOT AUTOMATIC.
subcutaneous – Subcutaneous means beneath the skin. The infusion set needle is placed subcutaneously. Type 1 diabetes – Type 1 diabetes results from destruction of the beta cells in the pancreas. People with IDDM must use insulin to regulate their blood glucose levels. Type 2 diabetes – Type 2 diabetes develops as a result of insulin resistance and usually occurs in people 40 years old or older.
Tech Specs Note: When applicable, testing used 23" Comfort™ infusion set and temperature of 23°C +/- 1°C Number of Basal Segments: 12 per Program Number of Basal Programs: 4 Basal Delivery Frequency (minimum): every 3 minutes Temp Basal Range: -90% to +200%, in 10% increments, OFF Temp Basal Duration: 0.5 hrs to 24 hrs Extended Bolus Duration: 0.5 hrs to 12 hrs; 0.1 hr Battery Type: 1.5 Volt Energizer® AA L91 Lithium or 1.
Pump Disposal: Contact the Customer Care team at 1-866-406-4844 for pump disposal information. Infrared communication port Audio Bolus Range: • 0.1-2.0 U in 0.1 U step • 0.5-10.0 U in 0.5 U step • 1.0-20.0 U in 1.0 U step • 5.0-35.0 U in 5.0 U step Flow Rate Accuracy* Delivery Mode Accuracy Bolus +/- 5% 0.100 U/hr Basal and higher +/- 5% *Accuracy rate will be lower at basal rates less than 0.100 U/hr. Occlusion Detection time to alarm** Typical Maximum Bolus 3 units or more 8 sec 30 sec. 0.
Animas® Insulin Pump Warranty Animas warrants that the Animas® insulin pump will be free from defects in material and workmanship for a period of four (4) years from the date of purchase by the original purchaser. This limited warranty extends only to the original retail purchaser.
ANIMAS® INSULIN PUMP ACCESSORY WARRANTY LIMITED PRODUCT WARRANTY FOR INSULIN PUMP ACCESSORIES (Cases, Clips, Skins, etc.) Your Animas® insulin pump accessory is warranted against defects in materials and workmanship for a period of THREE (3) MONTHS from the date of original retail purchase.
Index active basal program empty alert 79 advanced bolus 36, 56, 65 advanced features 55 aicd 11 air bubbles 15 aircraft 13 alarm history 48 amusement parks 13 audio bolus 15, 22, 28, 55, 63, 108 audio bolus delivery step size 55 auto-dim 22 auto-off alarm 84 auto-off feature 57 basal delivery suspended warning 81 basal history 50 basal program features 37 battery 16, 27 battery cap 26, 77 battery cap/vent 22 battery insertion 25 bg check reminder 75 bg correction calculator.
rechargeable batteries 16, 25 reminders 65, 74 replace battery alarm 84 replacement pump 15 rf welders 10 roller-coasters 13 safety information 14 serial number 7 setting/changing the time and date 27 sounds – setting/changing 28 status feature 51 supply reordering 8 suspend history 49 suspending delivery 45 suspend (temp basal/combo bolus canceled) alert 79 suspend warning 81 swimming 93 tamper resistant feature 23 technical and clinical help 2 temp basal 42, 43, 45, 48, 52 temp basal minimum rate alert 7
Distributed in Canada by: 200 Whitehall Drive Markham, ON L3R 0T5, Canada Tel: 1 866 406-4844 Fax: 1 866 406-4033 Email: CustomerCare@animas.ca Animas has received ISO 13485:2003 (International Organization for Standardization) certification. By meeting these most rigorous standards, Animas is committed to superior quality and safety for its customers. Pump Support is available 24 hours a day, 7 days a week: 1 877 YES-PUMP (937-7867) Visit us at www.Animas.
