Animas 2020 User Guide Rev D June 2006

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, our Pump Support Department is available to you 24/7. In the United States, Canada and Puerto Rico, call 1-877-767-7373 for assistance every minute of every day. For non-urgent technical questions, please email [email protected].

Outside the United States, Canada and Puerto Rico, call 1-610-644-8990 or contact your local Animas distributor. Page 2

Table of Contents Welcome and Congratulations... 7 Technical and Clinical Help ... 8 Supply Reordering... 8 Important Note ... 8 Chapter 1 Important Information ... 9 Warnings... 9 Emergency Kit ... 9 Indications for Use ...10 Contraindications ...10 Warnings and Precautions ...10 Radiology ...11 Safety Information ...13 Chapter 2 Package Contents...17 Chapter 3 Explanation of Symbols ...19 Chapter 4 Introduction to Your 2020 Pump...21 Get to Know Your 2020 ...21 Main Programming Buttons...21 Programming Basics ...21 Display Screen ...21 Contrast Button...21 Audio Bolus/ezBolus ...22 Battery Cap/Vent...22 Primary Vent ...22 Cartridge Compartment Cap...22 IR Window for Download ...22 Sounds ...22 Tamper Resistant (Locked) Feature ...23 Basic Display Screens...23 Verify Screen...23 Home Screen ...23 Main Menu Screen...23 Status...24 Chapter 5 Getting Your Pump Ready ...25 Battery Insertion ...25 Changing the Battery ...25 Setup – Basics...27 Setting/Changing the Time and Date ...27 Daylight Saving Time ...28 Sounds - Setting/Changing ...28 The Cartridge ...30 Filling the Cartridge ...30 Connecting the Tubing to the Cartridge...30 Changing the Cartridge...31 Priming the Pump ...32 Selecting the Infusion Site and Inserting the Infusion Set ...34 Changing the Cartridge and Infusion Set ...34 Chapter 6 Using the Normal Bolus Feature...35 Chapter 7 Using Basal Program Features ...37 Page 3

Setting a Basal Program ...37 Adding/Changing Segments in an Existing Basal Program...39 Reviewing Basal Programs ...40 Clearing Basal Programs ...40 Temporary Basal Feature ...41 Canceling a Temporary Basal Program ...43 Chapter 8 Suspend/Resume Feature ...45 Suspending Delivery ...45 Resuming Delivery...46 Chapter 9 History Feature...47 Bolus History...47 Total Daily Dose (TDD) History...48 Alarm History ...48 Prime History...49 Suspend History...49 Basal History ...50 Chapter 10 Status Feature...51 Status Screen 1 – Active Basal ...51 Status Screen 2 – Last Bolus...51 Status Screen 3 – Delivery Today ...52 Status Screen 4 – Combo Bolus ...52 Status Screen 5 – Temp Basal ...52 Status Screen 6 – Codes ...53 Chapter 11 Advanced Features – Setup and Activation...55 Setup Advanced 1 – Audio Bolus Feature ...55 Setup Advanced 2 – Advanced Bolus Features and Multiple Basal Programs ...56 Setup Advanced 3 – Insulin Limits ...56 Setup Advanced 4 – Language Setup, Display Timeout, Contrast and Battery Type ...57 Setup Advanced 5 – Auto-OFF Feature ...57 Setup Advanced 6 – Low Cartridge Warning Setting and Occlusion Sensitivity Setting ...58 Setup Advanced 7 – Personal Settings - Insulin to Carb (I:C) Ratios ...58 Setup Advanced 7 – Personal Settings - Insulin Sensitivity Factor (ISF) ...59 Setup Advanced 7 – Personal Settings - BG Target Ranges ...60 Setup Advanced 8 – Insulin on Board Setting...61 Setup Advanced 9 – Sick Day Guidelines ...62 Chapter 12 Using Advanced Features ...63 Audio Bolus and ezBolus ...63 ezBolus ...65 Advanced Bolus Features...65 ezCarb ...65 Entering Carbs Manually (no food database) ...66 Adding a BG Bolus to ezCarb ...67 Entering Carbs Using the Food Database ...68 Editing ezCarb Total Entries ...71 ezBG...72 Combo Bolus ...74 Reminders...75 Bolus Reminders ...75 BG Check Reminder ...76 Delivery Speed - Bolus...76 Page 4

Multiple Basal Programs ...76 Insulin on Board ...77 Sick Day Guidelines ...77 Chapter 13 Care and Maintenance...79 The Vents ...79 Battery Cap with O-ring and Vent...79 Cleaning...79 General Wear and Tear ...79 Disposal ...79 Chapter 14 Safety System and Alarms ...81 Chapter 15 Troubleshooting Guidelines ...87 Hypoglycemia ...87 Hyperglycemia ...88 Problems with Infusion Sets and Sites ...90 DKA (Diabetic Ketoacidosis) ...91 Chapter 16 Sick Day Guidelines ...93 Medication ...93 Blood and Urine Testing...93 Fluids and Diet ...93 Chapter 17 Lifestyle Issues ...95 Exercise and Sports ...95 Swimming ...95 Traveling...95 Intimacy ...96 Chapter 18 My Information...97 Frequently Asked Questions (FAQs) ...103 Glossary...105 Tech Specs ...109 Patient’s Bill of Rights...111 Supplier Standards...112

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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 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. You program it to deliver two ways: a continuous, 24 hour “basal” rate and “bolus” insulin deliveries to accommodate for immediate doses to cover foods eaten and high blood glucose. It is important to remember that successful pump therapy is a partnership of advanced technology and responsible self-care. Your pump is covered by a limited warranty for 4 years. Review the warranty card in your pump kit for details. Some circumstances that void the warranty are: • If the pump is taken apart by anyone other than an authorized Animas factory technician • Use of any battery other than those specified in Chapter 5 of this User Guide Please take a moment to look at the back of your pump and write down the serial number. My pump serial number is: ___________________

Serial Number (S/N) 2006-12 S/N: 49-00015-XX |||||||||||||||||||||||||| ||||| |||

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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 Department is available to you 24/7. In the United States, Canada and Puerto Rico, call 1-877-767-7373 for assistance every minute of every day. For non-urgent technical questions, please email [email protected]. Outside the United States, Canada and Puerto Rico, call 610-644-8990 or contact your local Animas distributor. We understand that you may have questions and concerns when using a new product. Please do not hesitate to call for assistance!

Supply Reordering You can place orders for cartridges, infusion sets, skin prep, batteries and many pump accessories by calling our Reorder Department or by visiting our eStore at https://estore.animascorp.com/ In the United States, Canada and Puerto Rico, call 1-877-YES-PUMP (877-937-7867). Outside the United States, Canada and Puerto Rico, contact your local Animas distributor.

Important Note The screen displays shown in this User Guide are examples only and should not be considered suggestions for individual programming. Your Animas pump comes with a transparent plastic film covering the display lens for protection during shipping. Be sure to remove this protective covering before using the pump. Blood Glucose is abbreviated throughout this User Guide with BG.

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Chapter 1

Important Information

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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 2020 or unless your Certified 2020 Pump Trainer is present. Incorrect use of your pump, failure to follow the instructions in this User Guide or improper/inadequate self-care and troubleshooting techniques can lead to death or serious injury. If you do not understand something or have questions, ask your healthcare team or call our 24/7 Pump Support Department at 1-877-767-7373. (Outside the US, Canada and Puerto Rico, contact your local Animas distributor.) Your Animas pump is designed to deliver insulin reliably but because the pump uses only rapid-acting insulin, you will not have long-acting insulin in your body. To avoid the risk of Diabetic Ketoacidosis (DKA) or very high blood glucose (BG), you must be prepared to give yourself an injection of insulin if delivery is interrupted for any reason. Your Animas pump is designed and calibrated to deliver U100 insulin. Use of any insulin with lesser or greater concentration can result in serious injury or death. 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. Emergency Kit Keep an emergency kit with you at all times to make sure you always have necessary supplies. This kit should include but is not limited to: • Quick-acting glucose tablets or gel • Blood glucose monitoring supplies including meter, strips, lancing device, lancets, meter batteries • Blood or urine ketone testing supplies • Rapid-acting insulin and syringe with directions from your healthcare team regarding how much insulin to take in the event of interruption of pump therapy • Extra infusion sets and IR 1200/2000 series cartridges • Dressing and adhesive, if used • An extra Energizer Lithium L91 AA battery • An extra pump battery cap • An extra pump cartridge cap (In the US, Canada and Puerto Rico, call 877-937-7867 to order an extra cartridge cap. All other customers contact your local Animas distributor.) • 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. Page 9

1 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 a prescription device. Contraindications The pump is not indicated for anyone unable or unwilling to: • Test BG levels at least 4 – 6 times per day or as recommended by healthcare team • Demonstrate adequate carbohydrate counting skills • Maintain good diabetes self-care skills • See his/her healthcare team regularly Adequate vision or hearing is required to recognize the pump alerts.

Warnings and Precautions Radiology Equipment Your Animas 2020 has been designed to operate in the presence of common sources of electrostatic and electromagnetic interference, including airport and store security systems. However, like all portable electronic devices, the pump should not be exposed to very strong electromagnetic fields, such as in MRI’s, RF welders or magnets used to lift automobiles. Very strong magnetic fields, such as in an MRI, can re-magnetize the portion of the motor that regulates insulin delivery. If you plan to undergo an MRI, remove your pump beforehand and keep it outside the room during the procedure. Medical Procedures Procedure

Patient is Pumper

Pacemaker / AICD

Disconnect pump and leave outside room during insertion of device and reprogramming. Infusion set can remain in place. No need to disconnect. Disconnect pump and leave outside room during procedure.

EKG Cardiac Catheter

Nuclear Stress test

Colonoscopy Laser Surgery

General anesthesia

Disconnect pump and leave outside room during scan. Can remain connected during injection of radioisotope. No need to disconnect. The pump and infusion set can be worn; however some lasers can create interference and cause the pump to alarm. Determination based on what medical equipment is being used in the procedure.

Healthcare Professional/Technician is Pumper Follow normal safety practices and proceed to the designated safe area while each Xray is taken and during reprogramming. No need to disconnect. Follow normal safety practices and proceed to the designated safe area while each Xray is taken. Follow normal safety practices and proceed to the designated safe area while each Xray is taken. No need to disconnect. The pump and infusion set can be worn; however some lasers can create interference and cause the pump to alarm. Determination based on what medical equipment is being used in the procedure.

For procedures not included above or on the chart on the following page, call (in advance of your procedure) 1-877-767-7373 in the US, Canada and Puerto Rico. Outside the US, Canada and Puerto Rico, contact your local Animas distributor. Page 10

Radiology (X-rays) and Medical Procedure Quick Reference Chart

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1

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. Aircraft without Cabin Pressurization If flying in aircraft without cabin pressurization or flying in aircraft used for aerobatics or combat simulation (pressurized or not), it is recommended that you disconnect (NOT suspend) the pump. Precautions The Animas pump is a sealed device that should be opened ONLY by the manufacturer. If the pump seal is broken by anyone other than an authorized Animas factory technician, the warranty is voided and the pump is no longer waterproof. If the back label on the pump is removed or damaged, the warranty is voided and the pump is no longer waterproof. When using an insulin pump, if the pump is placed at a vertically higher position than the infusion site, a very small amount of additional insulin infusion may occur. To minimize this condition and maintain pump delivery accuracy, the vertical distance between the pump and the infusion site should be no more than 12 inches (30 cm). If the pump is placed at a vertically lower position than the infusion site, this condition is eliminated. Occasionally check the infusion site for proper placement and leaks. Improperly placed infusion sites or leaks around the infusion site can result in under infusion. Occasionally check the infusion set tubing for any damage, leaks or kinks while using the pump. Damaged, leaking or kinked tubing may restrict or stop insulin delivery and result in under infusion. Only use Animas 1200/2000 series (200 unit/2ml) cartridges and infusion sets with a standard Luer™ connector. Efficacy of pump cannot be guaranteed if cartridges other than those manufactured by Animas Corporation are used or if cartridges are used more than once. Always dispose of used cartridges and infusion sets following the regulations in your community. Insulin can be absorbed through the skin. Minimize any contact with insulin and wash hands thoroughly after handling any devices that contain insulin. Failure to follow these guidelines may pose health hazards. Prior to replacing the battery cap, make sure the o-ring (yellow) fits securely and is not damaged. See Chapter 5, Getting Your Pump Ready. Prior to inserting a cartridge into the pump, check the o-rings on the cartridge to be sure they are not damaged. Occasionally check the vents to be sure they are clear of debris. See Chapter 13, Care and Maintenance. Page 12

Occasionally check that your pump personal settings are correct.

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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 local Animas distributor for information on ezManager Software and IR Accessory Kit. To find out if your pump model is compatible with your ezManager software, go to the pump download feature on ezManager and check the drop down box for your pump model number. If your model number is not an option, call Customer Support at 1877-767-7373. Safety Information The Animas 2020 is designed only for Continuous Subcutaneous Insulin Infusion (CSII). It is not intended for use with any other delivery substance. This User Guide gives instruction on how to program and operate the pump. Animas Corporation does not make any recommendations on specific programming related to your diabetes care program. Consult your healthcare team for instructions specific to your treatment plan. Consult your healthcare team before using the pump to determine which programming features are appropriate for you. Some features require a greater knowledge of insulin pumping and advanced self-care skills. Additionally, some advanced programming features require that testing and fine-tuning of basic settings be completed in order to achieve the best possible results. Your healthcare team will give you specific training on programming and using your pump. Use of Extended Bolus, Combo Bolus, ezCarb (carb calculator), Insulin on Board and ezBG (blood glucose correction calculator) all require input from your healthcare team. Do not attempt to use these features until you have specific information for your treatment plan and have had specific training on each programming feature. Only your healthcare team can determine your insulin to carbohydrate ratios, correction factors, blood glucose target ranges and duration of insulin on board. Basal rates that are too high or too low can adversely affect blood glucose levels. Work with your healthcare team to fine-tune basal rates. The way your body uses insulin can be affected by many things. Contact your healthcare team about lifestyle changes such as starting/stopping your exercise program or significant weight loss/gain. Your basal rates may need to be modified.

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1 DO NOT stop using the pump if you are ill. Even when you’re sick, your body still needs insulin. See Chapter 16, Sick Day Guidelines. 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. The Animas 2020 and accessories include small component pieces that could pose a choking hazard to small children. Before Bedtime To ensure proper delivery, do not change your infusion set just before bedtime or if you will not be able to test your blood glucose 1 to 2 hours after a new set is placed. Always check that your cartridge has enough insulin to last through the night before going to bed. Unless otherwise recommended by your healthcare team, do not use the vibrate feature during sleep. It is recommended that you set the volume to high for all warnings and alarms before going to sleep. Always remove all air bubbles from cartridge and tubing before beginning insulin delivery. Air bubbles can compromise accuracy of delivery. Refer to the Instructions for Use included with your cartridge packaging. Interference with the pump electronics by cell phones can occur if worn in close proximity. It is recommended that you wear the pump and cell phone at least 6 inches apart. If you return your pump for service and a replacement pump is sent, do not use the replacement pump until all the settings specific to your treatment plan have been programmed. 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. Call our 24/7 Pump Support Department at 877-767-7373 if you identify or suspect your pump has been damaged. They will help determine if your pump should be replaced. (Outside the US, Canada and Puerto Rico, contact your local Animas distributor.) The pump is designed to operate in conditions where temperatures are between 40º and 104ºF (5 – 40C). If your pump is exposed to temperatures outside these parameters, extra care should be taken to protect it from extreme temperatures. Page 14

1 Animas insulin pumps and insulin pump cartridges are latex free. To avoid risk of explosion, do not use the pump in the presence of explosive gases. Your 2020 pump is designed to achieve optimum performance and battery life with an Energizer Lithium L91 AA battery (1.5V). Rechargeable batteries and Carbon-Zinc 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 1.5V battery could permanently damage the pump and voids its warranty. Do not use household cleaners, chemicals, solvents, bleach, scouring pads or sharp instruments to clean the pump. Never put your pump in the dishwasher or use very hot water to clean it. Never use a hair dryer, microwave oven or baking oven to dry your pump. Use a soft towel.

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Chapter 2

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Package Contents

Take a minute to check the contents of your 2020 shipping box. It should include: • • • •

• • • • • • • •

Your Animas 2020 One Energizer Lithium L91 AA battery (1.5V) A User Guide An envelope that includes o Your registration card. (In the US, Canada and Puerto Rico, send the card directly to Animas Corporation. Outside the US, Canada and Puerto Rico, send the card to your local Animas representative.) o Limited warranty terms. Your warranty will be automatically activated when you return your registration card. o Instructions for Use for IR 1200/2000 series cartridges Sample Animas IR 1200/2000 series (200 U/2ml) cartridge* Sample infusion sets* Sample skin prep* Leather Case Low Profile Clip Extra Battery Cap Battery Cap Tool ezManager software and download/upload cable*

*US only Outside the US, contact your local Animas distributor for information on ezManager software and download/upload cable

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Chapter 3

Explanation of Symbols

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Shown below are symbols you will find on your 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:

!

Important Information (See User Guide for Instructions for Use)

S/N Serial Number Date of Manufacture

IPX8 Water-Tight Equipment (protected against the effects of submersion; tested to 12 feet/3.6 meters for 24 hours) Type BF Medical Equipment (patient isolated, not defibrillator protected)

CE Mark (conforms to the directives of the European Community)

Rx Only

For sale by or on the order of a physician only (US)

Hazardous waste – Residents of US, Canada and Puerto Rico, dispose of in accordance with federal, state and local regulations. All other customers contact your local Animas distributor for disposal.

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