User Guide
100 Pages
Preview
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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 and Canada, 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 and Canada, call your local Animas distributor. Page 2
Table of Contents
Welcome and Congratulations! ... 7 Technical and Clinical Help ... 8 Supply Reordering... 8 Important Notes... 8 Chapter 1 Important Information... 9 Your User Guide... 9 Emergency Kit... 9 Indications for Use... 9 Contraindications... 10 Warnings and Precautions ... 10 Radiology Quick Reference Chart ... 11 Safety Information ... 13 Chapter 2 Package Contents... 15 Chapter 3 Explanation of Symbols... 17 Chapter 4 Introduction to Your IR 1200 Pump... 19 Get to Know Your IR 1200 ... 19 Main Programming Buttons... 19 Programming Basics... 19 Display Screen... 19 Backlight Button ... 19 Audio Bolus/ezBolus ... 20 Battery Cap/Vent... 20 Primary Vent ... 20 Cartridge Compartment Cap... 20 IR Window for Download... 20 Sounds... 20 Tamper Resistant Feature ... 20 Basic Display Screens... 21 Wake-up Screen ... 21 Main Menu Screen... 21 Bolus... 21 Suspend/Resume ... 21 History... 21 Basal... 21 Setup ... 21 Prime/Rewind... 21 Status... 21 Chapter 5 Getting Your Pump Ready ... 23 Battery Insertion ... 23 Setup – Basics ... 25 Setting/Changing the Time and Date ... 25 Daylight Saving Time (applicable in certain states/countries only)... 25 Sounds - Setting/Changing ... 26 The Cartridge ... 27 Filling the Cartridge... 27 Connecting the Tubing to the Cartridge ... 27 Changing the Cartridge... 28 Priming the Pump and Infusion Set... 29 Selecting the Infusion Site and Inserting the Infusion Set ... 31 Changing the Cartridge and Infusion Set ... 31 Page 3
Chapter 6 Using the Normal Bolus Feature ... 33 Chapter 7 Using Basal Program Features ... 35 Setting a Basal Program ... 35 Adding/Changing Segments in an Existing Basal Program... 37 Reviewing Basal Programs ... 38 Clearing Basal Programs ... 38 Temporary Basal Feature... 39 Canceling a Temporary Basal Program ... 40 Chapter 8 Suspend/Resume Feature ... 41 Suspending Delivery ... 41 Resuming Delivery ... 42 Chapter 9 History Feature ... 43 Bolus History ... 43 Total Daily Dose (TDD) History ... 44 Alarm History... 44 Prime History... 45 Suspend History... 45 Basal History ... 46 Chapter 10 Status Feature ... 47 Status Screen 1 – Active Basal ... 47 Status Screen 2 – Last Bolus ... 47 Status Screen 3 – Delivery Today ... 47 Status Screen 4 – Combo Bolus ... 48 Status Screen 5 – Temp Basal... 48 Status Screen 6 – Codes ... 49 Status Screen 7 – Personal Information... 49 Chapter 11 Advanced Features –Setup and Activation ... 51 Setup Advanced 1 – Audio Bolus Feature... 51 Setup Advanced 2 – Advanced Bolus Features and Multiple Basal Programs... 52 Setup Advanced 3 – Insulin Limits ... 52 Setup Advanced 4 – Language Setup, Display Timeout Setting and Battery Type ... 53 Setup Advanced 5 – Auto-OFF Feature ... 53 Setup Advanced 6 – Low Cartridge Warning Setting and Occlusion Sensitivity Setting... 54 Setup Advanced 7 – Insulin to Carb (I:C) Ratios ... 54 Setup Advanced 8 – Insulin on Board Setting ... 55 Chapter 12 Using Advanced Features... 57 Audio Bolus and ezBolus ... 57 ezBolus™... 58 Advanced Bolus Features ... 59 CarbSmart™... 59 Adding a BG Bolus to CarbSmart ... 60 ezBG... 62 Combo Bolus ... 64 Reminders... 65 Time of Day Reminders ... 65 BG Check Reminder ... 66 Delivery Speed - Bolus... 66 Multiple Basal Programs ... 67 Insulin on Board ... 67 Chapter 13 Care and Maintenance... 69 The Vents... 69 Page 4
Battery Cap with O-ring and Vent... 69 Cleaning ... 69 Chapter 14 Safety System and Alarms... 71 Alerts, Warnings and Alarms... 71 Chapter 15 Troubleshooting Guidelines ... 77 Hypoglycemia... 77 Hyperglycemia... 78 Problems with Infusion Sets and Sites ... 80 DKA (Diabetic Ketoacidosis) ... 80 Chapter 16 Sick Day Guidelines ... 81 Medication... 81 Blood and Urine Testing... 81 Fluids and Diet ... 81 Chapter 17 Lifestyle Issues ... 83 Exercise and Sports ... 83 Swimming... 83 Traveling ... 83 Intimacy... 84 Chapter 18 My Information ... 85 Frequently Asked Questions (FAQs) ... 90 Glossary ... 91 Tech Specs... 94 Patient’s Bill of Rights... 96 Supplier Standards ... 97 Index... 98
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Welcome and Congratulations! You have begun a new way of life with your Animas IR 1200 insulin pump. Your choice of pump therapy is a sign that you are committed to taking excellent care of yourself. The IR 1200 pump has been specially designed to help you manage your diabetes, using advanced technology and sophisticated safety systems. It is important to remember that successful pump therapy is a partnership of advanced technology and responsible self-care. 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) 2003-05 S/N: 49-00015-10 |||||||||||||||||||||||||| ||||| |||
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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 and Canada, 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 and Canada, call 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. In the United States and Canada, call 1-877-YES-PUMP (877-937-7867) Outside the United States and Canada, call your local Animas distributor.
Important Notes 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. The screen displays shown in this User Guide show blood glucose (BG) values as measured in milligrams per deciliter (mg/dL). Outside the US, your pump will show BG values either as measured in mg/dL or millimoles per liter (mmol/L), per local requirements.
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Chapter 1
Important Information
Your User Guide
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The 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 until you become thoroughly familiar with your pump and how to use it. Warnings, cautions and safety tips are found throughout this Guide, indicated by a symbol. Do not attempt to connect to the pump before you have been trained on the IR 1200 or unless your Certified IR 1200 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, 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 sugar, 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.
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: • Fast-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 operation • Extra infusion sets and IR 1200 cartridges • Dressing and adhesive, if used • An extra Energizer Lithium L91 AA battery • 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 IR 1200 insulin pump is indicated for use for the control of insulin requiring diabetes. It is intended for use by one person.
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1 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
Warnings and Precautions Radiology Equipment Your Animas IR 1200 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. X-rays, CT Scans, Fluoroscopy, Ultrasound, etc. do not emit the same kinds of strong electromagnetic fields; however, it is recommended that you remove the pump while undergoing these types of tests. Basic dental X-rays do not require removal of the pump, as long as it is covered by the lead safety apron.
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Radiology Quick Reference Chart
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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 take place. 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 set tubing for any damage and kinking while using the pump. Damaged or kinked tubing may restrict or stop insulin delivery and result in under infusion. Only use Animas IR 1200 (200 unit) 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. 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 (blue or 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. In addition to checking your blood sugar levels regularly, you should check that your pump is operating correctly and that your infusion set is properly placed and has no leaks. You should also 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. Page 12
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If using the download feature*, keep the communication window free of obstructions and refer to the Instructions for Use included with the IR Accessory Kit. *ezManager Plus Software and Accessory Kit each sold separately.
Safety Information The Animas IR 1200 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 be complete 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, CarbSmart (carb calculator), Insulin on Board and ezBG (BG 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 factor and duration of insulin on board. Basal rates that are too high or too low can adversely affect insulin delivery, including bolus amounts. Work with your healthcare team to fine-tune basal rates during the first weeks of pump therapy. 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. 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 IR 1200 and accessories include small component pieces that could pose a choking hazard to small children. Page 13
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Never prime tubing while infusion set is connected to your body. 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 sugar 1 to 2 hours after new set is placed. Always check that your cartridge has enough insulin to last through the night before going to bed. 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 and Canada, 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. 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 IR 1200 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. Under no circumstances should you use high-energy 3.6V AA Lithium batteries. Use of these batteries could permanently damage the pump and void the 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 put your pump in a microwave oven or baking oven to dry it. Use a soft towel.
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Chapter 2
Package Contents
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Take a minute to check your IR 1200 Pump Kit box. It should include: • • • •
• • • • • • •
Your Animas IR 1200 Two Energizer Lithium L91 AA batteries (1.5V)* A User Guide An envelope that includes o Your registration card. (In the US, send the card directly to Animas Corporation. Outside the US, 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 infusion sets and IR 1200 cartridges Training DVD* Sample infusion sets, in various tubing lengths and cannula lengths. Consult with your healthcare team to determine which cannula length is best for your body type.* Sample Animas IR 1200 (200 U) cartridge IV Prep* Leather Case Holster Accessory Battery Cap Tool
*U.S. Only
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Chapter 3
Explanation of Symbols
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Shown below are symbols you will find on your IR 1200 insulin pump and its packaging. On the front of the pump: Up Arrow button
Down Arrow button
Enter button OR
On the top of the pump:
your pump may have an OK button instead
Backlight 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/3.6 meters for 24 hours) Type BF Medical Equipment (patient isolated, not defibrillator protected)
Rx Only
For sale by or on the order of a physician only (US).
CE Mark (conforms to the directives of the European Community)
Hazardous waste – contact your local Animas distributor for disposal
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Chapter 4
Introduction to Your IR 1200 Pump
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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).
Animas pumps are 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.
Get to Know Your IR 1200 Backlight button Up button
Down button Display screen
Audio Bolus/ezBolus button
OK button Enter button
Main Programming Buttons There are 3 buttons for main programming functions. The Up and Down buttons allow you to move through screen selections and to scroll up and down to enter values such as bolus amount. Your IR 1200 will either have an OK button or an Enter button. The OK/Enter button allows you to select an item or activate a function.
Programming Basics • •
•
Your Animas pump is menu-driven, much like an ATM machine. Use the Up/Down buttons to scroll to the desired selection and then press the OK/Enter button to select. If the cursor is flashing, it means the pump is in Edit Mode and by scrolling with the Up/Down buttons, you can edit the flashing field. Once you’ve finished editing, press the OK/Enter button to confirm your entry and to exit the Edit Mode.
Display Screen All programming, operations, warnings and alarms are shown on the display screen.
Backlight Button This button turns the backlight on and off. If you forget to turn the backlight off, it will automatically be turned off when the pump display screen times out. See Chapter 11, Advanced Features, Setup Advanced 4 – Display Timeout Setting.
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4 Audio Bolus/ezBolus This button allows you to program a bolus discreetly, without looking at the pump, by using audible tones to confirm programming and delivery*. If you choose not to activate the Audio Bolus feature, this button provides a shortcut to the Normal Bolus screen. *When you first use the Audio Bolus feature, you should always look at the screen to confirm correct programming until you are comfortable with using audio feedback to program a bolus.
Battery Cap/Vent This cap unscrews easily with a coin or the battery cap tool to replace and secure your battery. There is a colored (blue or yellow) o-ring around the cap, which prevents water from entering. The battery cap also is equipped with a vent built in to allow air to enter the pump to maintain pressurization but prevent water from entering.
Primary Vent This vent is part of the redundant vent safety system, which allows air inside the pump to maintain equalized pressure but prevents water from getting inside. Under no circumstances should you introduce any kind of sharp object into the vent openings to clean them. Doing so will compromise the pump’s waterproof capabilities. If at any time you suspect the vent openings are clogged, replace the battery cap or call Animas for questions about the Primary Vent.
Cartridge Cap
Primary Vent
Battery Cap/Vent
Cartridge Compartment Cap This cap secures your cartridge and infusion set in the pump.
IR Window for Download The IR window is framed in blue. This is the infrared communication window used for downloading* your pump data. *ezManager Plus software and accessory kit sold separately. Outside the U.S., check with your local Animas Distributor. IR Window
2003-05 S/N: 49-00015-10 |||||||||||||||||||||||||| |||||
Sounds Your IR 1200 allows you to customize the volume level or use the vibrate function to notify you of warnings and alarms and to confirm certain deliveries.
Tamper Resistant Feature You can use the tamper resistant feature to prevent accidental button pressing. Simply wake up the pump and press the Up and Down arrow buttons at the same time. This locks the pump programming. To unlock the pump, wake up the pump so the screen reads “Locked” and press the up and down buttons at the same time again. Page 20