Animas IR1000 User Guide Rev F

Table of Contents *

Your ANIMAS Pump: A New Beginning Congratulations! ... 7 Your User Guide ... 7 Getting Help or Information ... 8 An Important Safety Note ... 8 Ordering Accessories... 9 Package Contents ... 9

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Getting to Know Your ANIMAS Pump Insulin Pump Therapy... 12 Introduction to Your ANIMAS Pump ... 12 Front Panel ... 12 Back Panel ... 13 End Panel... 14

2 Getting Started with Your ANIMAS Pump The Display Screen ... 16 Using the Main Menu ... 16 Moving Through Menu Layers ... 16 Editing Settings ... 17 Using the SETUP Feature ... 17 Time of Day... 18 Calendar Date... 19 Daylight Saving Time ... 21 Sound... 21 P/N: 410-025-00 Rev. F

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3 Preparing to Use Your ANIMAS Pump Filling the Cartridge ...24 Inserting the Cartridge ...25 Preparing and Connecting the Infusion Set to the Cartridge...27 Using the Prime Feature ...28 Selecting the Infusion Site and Inserting the Infusion Set ...29 Changing the Cartridge and Infusion Set...29

4 Your ANIMAS Pump BOLUS Feature Using the BOLUS Feature ...32 Setting a Normal Bolus ...32 Setting an Extended Bolus ...34 Setting an Audio Bolus ...35

5 Your ANIMAS Pump: Other Programming

Features Using the SUSPEND Feature ...38 Suspending Insulin Delivery ...38 Restarting Insulin Delivery ...39 Using the HISTORY Feature ...39 Bolus Review ...40 Alarm History ...40 Daily Total History ...41 Using the STATUS Feature ...42 Using the BASAL Feature ...42 Creating a New Basal Program...43 Reviewing Your Current Basal Program...45 Activating Your Basal Program ...46

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Editing an Active Basal Program ...46 Editing a Non-Active Basal Program...48 Clearing Your Basal Program ...49 Using the TEMP BASAL Feature ...49 Setting a Temporary Basal Program ...50 Clearing a Temporary Basal Program ...51

6 Your ANIMAS Pump: Advanced Options Advanced Setup Menu ...54 Extended Bolus Setup ...54 Audio Bolus Setup ...54 Insulin Limit Setup ...55 Language Setup...57 Display Timeout Setup ...57 Audio Bolus Delivery Step ...58 Auto Off Setup ...58 Cartridge Warning Setup...59 Clock Setup...60 Occlusion Limits ...61 Tamper Resistant Feature...62 Download Feature (not available as of this printing) ..62

7 Taking Care of Your ANIMAS Pump General Care...64 Cleaning Your Pump ...65 Changing the Batteries ...65 Battery Removal Procedure ...65 Removing Battery with Tool ...66 Battery Insertion Procedure ...67 Battery Door “O” Ring Replacement ...69 The Vents ...69-70 P/N: 410-025-00 Rev. F

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MRIs, X-Rays and Hazards ...70 Pump Disposal ...70

8 Your ANIMAS Pump: Warnings and Alarms

Warnings: Low Battery ...72 Low Insulin Remaining ...73 Insulin Limits Exceeded ...73 No Delivery Cartridge Low ...74 Not Primed ...74 Pump Suspended ...74 Bolus Delivery Cancelled by User ...75 Bolus Delivery Cancelled by Low Battery ...75 Archive Clear ...75 Active Basal Program Clear ...76 Alarms: Dead Battery ...76 Pump Malfunction ...76 Empty Cartridge ...77 Occlusion...77 Call Service ...78 Alarm Code Description ...78

9 Living with Your ANIMAS Pump

Pump Survival Skills Daily Check List ...80 Using the Clip ...81 Lifestyle Issues Sleeping ...82 Intimacy...82 Bathing and Swimming ...82 Exercise and Sports ...83

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Traveling ...83 Attaching and Removing a Fashion Cover ...84 Using the Leather Case ...85 Troubleshooting: Emergency Supplies ...86 Hypoglycemia ...86 Hyperglycemia ...89 Diabetic Ketoacidosis (DKA) ...92 Sick Day Guidelines...93 Medication ...93 Blood and Urine Testing ...94 Fluids and Diet ...94 Problems with Infusion Sets and Sites ...94 Frequently Asked Questions ...95

A Glossary of Terms B Symbols Used on Your ANIMAS Pump C Technical Specifications D Your Basal Programs Chart E Animas Supplier Standards F Patients’ Rights Information G Pump Cautions H Declaration of Conformance I Index P/N: 410-025-00 Rev. F

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Your ANIMAS Pump: A New Beginning

Congratulations! You have begun a new way of life with your ANIMAS insulin pump from Animas Corporation. Insulin therapy by an insulin infusion pump closely approximates normal physiological insulin delivery by continuously delivering a basal rate of rapid-acting insulin and allowing bolus insulin administration at mealtime. For many people with diabetes, insulin pump therapy allows a more relaxed and confident lifestyle. Your choice of pump therapy is a sign that you are committed to taking excellent care of yourself. The ANIMAS pump has been specially designed to help you better manage your diabetes, using advanced technology. It is important to remember that successful pump therapy is a partnership of advanced technology and responsible self-care.

Your User Guide This booklet includes information about how to use, program, and maintain your new ANIMAS pump. It is important to read it carefully. Even if you are an experienced “pumper,” it is a good idea to keep your User Guide handy until you become thoroughly familiar with your ANIMAS pump and how to use it. You may want to carry the User Guide with you for the first few weeks you use your pump, so you can refer to it if you need to. On the inside cover of this User Guide is a place for you to write down the serial number of your pump and the date you received it. This information may be helpful if you ever need to contact Animas about your pump (Animas Corporation in the U.S. or your local Animas distributor outside of the U.S). In addition to explaining how to use and care for your pump, this User Guide contains some other useful information and forms. Appendix A is a Glossary of certain medical and technical terms conP/N: 410-025-00 Rev. F

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cerning diabetes and insulin pump therapy. Appendix B lists and explains the symbols used on your pump and its packaging. Appendix C lists the technical specifications of your ANIMAS pump. Appendix D provides charts for you to write down your basal rate programs. You can use up to four different basal rate programs with your ANIMAS pump. For example, if you exercise on some days and not on others, you can create a basal rate program designed especially for your exercise days. Chances are you will use one or two of the programs most often. If some special scheduling need arises, you can check the charts in your manual to see if one of your other preset programs would be good to use. Appendix I is an index to the information contained in the User Guide.

Getting Help or Information If there is anything you don’t understand in the User Guide, or if you have a question or need assistance with your pump, a help line is available to you. In the United States, call 1-877767-7373 for assistance 24 hours a day, 7 days a week. Outside of the U.S., call your local Animas distributor. A trained staff is eager to help you. We understand that you may have questions and concerns when using a new product. Please do not hesitate to call for advice or assistance!

An Important Safety Note YOUR ANIMAS PUMP IS DESIGNED TO DELIVER INSULIN RELIABLY, BUT, BECAUSE THE PUMP USES ONLY SHORT-ACTING INSULIN,YOU WILL NOT HAVE LONG-ACTING INSULIN IN YOUR BODY. TO AVOID THE RISK OF DIABETIC KETOACIDOSIS (DKA) OR VERY HIGH BLOOD SUGAR,YOU MUST BE PREPARED TO GIVE YOURSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON! 8

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Ordering Accessories You can order the following accessories and items directly: In the U.S. from Animas Corporation at 1-877-YES-PUMP (937-7867). Outside the U.S. from your local Animas distributor at the number found on the back of your pump. Infusion sets Cartridges Dressings and tapes Pump supplies (batteries, O-rings, etc.) Leather case Fashion covers Accessories and clothing items for Pumpers Belt clip Books related to “pumping” In addition, information can be provided about a variety of accessories available from other sources.

Package Contents Your ANIMAS pump package includes the following items: The ANIMAS pump with batteries installed A belt clip for attaching your pump to your clothing A leather case A User Guide An “Important Documents” envelope that includes your Registration Card, Limited Warranty, and other documents. Your Warranty will be automatically activated when you return your Registration Card. In the U.S., the card is to be returned directly to Animas Corporation. Outside of the U.S., the card is to be returned to your local Animas distributor. A Starter Kit may include infusion sets, cartridges, dressings, and maintenance kit. This is customized to meet your country’s requirements. P/N: 410-025-00 Rev. F

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Getting to Know Your ANIMAS Pump

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Insulin Pump Therapy Introduction to Your Animas Pump Front Panel Back Panel End Panel

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Insulin Pump Therapy 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 around the clock. It can also deliver a high-level dose (bolus) of insulin at mealtime or to correct a high blood glucose. An insulin pump delivers insulin directly into the body through an infusion set. This infusion set consists of a long, thin plastic tube connected at one end to the pump, and, at the other end, to a small plastic or stainless steel needle that is placed under the skin and secured by an adhesive patch. After attaching your Animas pump, you must then program it to function properly with your body’s changing needs.

Introduction to Your ANIMAS Pump The ANIMAS IR 1000 pump has been engineered and manufactured to the highest standards of quality. Although it is a highly sophisticated medical device, it has been carefully designed to be easy to use and to fit your lifestyle. It is small, compact, and can be discreetly secured to your clothing with a specially designed clip. Alternatively, you can wear your pump inside your clothes or in a pocket.

Front Panel The front panel of your ANIMAS IR 1000 pump is simply designed. The four buttons and LCD display screen are all you need to program your pump. The display screen features black lettering against a white background and has a nine-line capacity. If you need to look at your display screen in low light, press the Backlight Button, and the screen will light up. The ANIMAS pump is “menu-driven.” The menus are shown on the display screen. To program and operate your pump, simply select items on various menus from the display screen. To select an item, simply press the up arrow button or down arrow button to move the black cursor bar to the item you want. Then press the enter button.

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Front panel of the Animas IR 1000 Pump

Back Panel The back panel of your ANIMAS IR 1000 pump lists the name of the manufacturer of your pump, Animas Corporation, its serial number (printed next to “S/N”), and several symbols that are explained in Appendix B. If you live in the U.S., contact phone numbers are listed for Animas Corporation. If you live outside the U.S., a contact phone number is listed for your local Animas distributor. The IR download port is framed in blue. This is the infrared communication window used for downloading your pump data.(Not available as of this printing) When you receive your pump, record the serial number on the inside cover of this User Guide. This information may be helpful if you lose your pump or experience a problem. IR port for download

Back panel of the Animas IR 1000 Pump (U.S. label) P/N: 410-025-00 Rev. F

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End Panel The end panel consists of a door which provides access to the pump’s batteries and the insulin cartridge. To open the door, simply pull down on the door latch, and swing the door open. Inside, you will see a smaller door that seals the battery compartment. Directions for inserting and changing batteries can be found in Chapter 7. Next to the battery compartment door you will see the access for the insulin cartridge. Directions for filling and changing the cartridge are given in Chapter 3.

End panel of the Animas Pump

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Getting Started with Your ANIMAS Pump

The Display Screen Using the Main Menu Moving Through the Menu Layers Editing Settings Using the SETUP Feature Time of Day Calendar Date Daylight Saving Time Sound

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Here are a few guidelines on how to operate your ANIMAS pump.

The Display Screen Since the ANIMAS pump is delivered to you in a "ship" mode, the display screen will be blank. Press any button on the front panel and the screen will display “WARNING, BASAL PROG CLEAR, NO BASAL”. The pump will beep twice and then display the Wake-up Screen. The warning screen is telling you that the basal program selected is set to zero. The Wake-up Screen will show the time; if an extended bolus is active; which basal program is active; the current basal rate; if a temporary basal program is active; if the pump is in suspend; and the amount of remaining insulin. The display screen will automatically shut off until activated by any button press. WARNING BASAL PROG CLEAR NO BASAL

AM

AM

10:37

10:37

1

1

AM

10:37

1

BOLUS E BOLUS E ACTPROG2 RATE U/H 1.00 280 MENU

SUSPEND RATE U/H 1.00 280 MENU

Wake-up Screen with extended bolus active

Wake-up Screen with pump in suspend

TEMP RATE U/H 280 MENU Wake-up Screen when extended bolus is active and temporary basal is active

Using the Main Menu The Main Menu displays seven functions: BOLUS, SUSPEND, HISTORY, BASAL, SETUP, PRIME, and STATUS. Each function contains its own menu layers.

Moving Through Menu Layers The ANIMAS pump is "menu-driven," much like a computer program. By making choices from the menus displayed on the screen, you can program and operate your pump to fit your lifestyle. To select an item, press the up (▲) and down (▼) arrow keys to move the cursor bar to the function 16

BOLUS SUSPEND HISTORY BASAL SETUP PRIME STATUS 12:00 AM Main Menu

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NOTE:

Throughout this User Guide, the word “select” means to move the cursor bar, using the up (▲) or down (▼) button, to the item you want and then pressing the enter (↵ ) button.

Step-by-step directions for programming are shown in detail for the first few menus. The method is the same for all menus.

↵) button. The next layer of you want, then press the enter (↵ menus is then displayed, and the process repeats itself. Chapter 3 explains in detail how to use the menus to program your pump. When you have finished programming your pump, move the cursor ↵) to return to the previbar to MENU RTN, and then press ENTER (↵ ous menu layer.

Editing Settings The ANIMAS pump allows you to adjust your insulin delivery and pump settings in accordance with your needs. The edit mode is used to adjust a setting, such as the time of day or a pump option, or to adjust the amount of insulin delivery in either basal or bolus delivery. To edit a setting, access the menu that contains the setting you wish to edit, move the cursor bar to that setting, and ↵) button. When you press ENTER, the curthen press the ENTER (↵ sor bar will change to an edit bar, a broken black bar that highlights the letter “E” (for “edit”) in the left area of the bar, and the setting in the right area of the bar ( ). Move the up and down arrow buttons (▼)(▲) to scroll through the available choices.

Using the SETUP Feature Before you use your ANIMAS pump, program the SETUP feature. To select SETUP, press ▲ or ▼ to move the cursor bar to SETUP and press ↵. The top layer of the SETUP menu will be displayed. From this menu, you can set the TIME and DATE that will be shown on your pump’s screen, and the SOUND menu allows you to move to ON/OFF, to turn the beeper on or off during a normal bolus and temporary basal. The ADVANCED menu P/N: 410-025-00 Rev. F

BOLUS SUSPEND HISTORY BASAL SETUP PRIME STATUS 12:00 AM Main Menu 17

provides additional programming options which are discussed in Chapter 6. The steps for setting each of these options are shown in the next few pages. Remember, to return to a previous menu, press the ▼ arrow to move the cursor bar to MENU RTN, and then press ↵.

SETUP TIME DATE SOUND ADVANCED

Time of Day MENU RTN To set the time of day that your pump will display, access the MAIN MENU. Move cursor bar to SETUP, SETUP Menu scroll to TIME, press ↵. The display will go to the SETUP TIME menu. If you want to set up your clock on a 24-hour day, see page 6.9, Clock Setup.

Hour. To set the hour, follow these steps: 1. 2. 3. 4.

Move the cursor bar to the hour setting. Press ↵. The cursor bar will change to an edit bar. Press ▲ or ▼ to scroll from 1 AM through 12 PM. Press ↵ when the correct hour is displayed. Your selection is

SETUP TIME HR

AM 12

MIN

SETUP TIME HR E MIN

AM 12

00

SETUP TIME HR E MIN

PM 03

00

SETUP TIME HR

PM 03

MIN 00

00

MENU RTN

MENU RTN

MENU RTN

MENU RTN

Hour Step 1

Hour Step 2

Hour Step 3

Hour Step 4

now set, and the edit bar will change back to a cursor bar. Minute. To set the minute, follow these steps: 1. 2. 3. 4. 18

Move the cursor bar to the minute setting. Press ↵. The cursor bar will change to an edit bar. Press ▲ or ▼ to scroll from 1 through 59. Press ↵ when the correct minute is displayed. Your selection is P/N: 410-025-00 Rev. F

SETUP TIME HR

AM

SETUP TIME HR E MIN E AM

MENU RTN

MENU RTN

3 MIN 00

Minute Step 1

SETUP TIME HR

SETUP TIME HR 3 00

MIN 17

17 AM MENU RTN

MENU RTN

Minute Step 2

3

3 MIN E AM

Minute Step 3

Minute Step 4

now set, and the edit bar will change back to a cursor bar. When you have finished, press MENU RTN to go back to layer 1 of the SETUP menu.

Calendar Date To set the date, select DATE on the SETUP menu. The display will now show the SETUP DATE menu. Day. To set the day, follow these steps: 1. 2. 3.

Move the cursor bar to the day setting. Press ↵. The cursor bar will change to an edit bar. Press ▲ or ▼ to display the settings: 01 through 31.

SETUP DATE DAY 01 MONTH

SETUP DATE DAY E MONTH

01

SETUP DATE DAY 23

YEAR

1 YEAR

99

99

23 MONTH

1

1 YEAR

SETUP DATE DAY E MONTH

1 YEAR

99

99

MENU RTN

MENU RTN

MENU RTN

MENU RTN

Day Step 1

Day Step 2

Day Step 3

Day Step 4

4.

Press ↵ when the correct day is displayed. Your selection is now set, and the edit bar will change back to a cursor bar.

Month. To set the month, follow these steps: P/N: 410-025-00 Rev. F

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