Animas IR1250 User Guide

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 Note ... 8 Chapter 1 Important Information ... 9 Your User Guide ... 9 Warnings ... 9 Emergency Kit ... 9 Indications for Use... 10 Contraindications ... 10 Warnings and Precautions... 10 Radiology Quick Reference Chart ... 11 Safety Information ... 13 Chapter 2 Package Contents ... 17 Chapter 3 Explanation of Symbols ... 19 Chapter 4 Introduction to Your IR 1250 Pump ... 21 Get to Know Your IR 1250... 21 Main Programming Buttons... 21 Programming Basics ... 21 Display Screen ... 21 Backlight 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 Feature ... 23 Basic Display Screens... 23 Home Screen... 23 Main Menu Screen... 23 Status... 24 Chapter 5 Getting Your Pump Ready ... 25 Battery Insertion... 25 Setup – Basics ... 27 Setting/Changing the Time and Date... 27 Daylight Saving Time (applicable in certain states/countries only) ... 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 Setting a Basal Program... 37 Adding/Changing Segments in an Existing Basal Program ... 39 Reviewing Basal Programs ... 40 Clearing Basal Programs... 40 Page 3

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 Status Screen 7 – Personal Information ... 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 – Insulin to Carb (I:C) Ratios ... 58 Setup Advanced 8 – Insulin Sensitivity Factor (ISF) ... 59 Setup Advanced 9 – BG Target Ranges ... 59 Setup Advanced 10– Insulin on Board Setting ... 60 Setup Advanced 11– Sick Day Guidelines ... 61 Chapter 12 Using Advanced Features... 63 Audio Bolus and ezBolus... 63 ezBolus™... 65 Advanced Bolus Feature... 58

Page 4

The Vents ... 79 Battery Cap with O-ring and Vent ... 79 Cleaning ... 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 S...

Page 5

Page 6

Welcome and Congratulations! You have begun a new way of life with your Animas IR 1250 insulin pump. Your choice of pump therapy is a sign that you are committed to taking excellent care of yourself. The IR 1250 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. It delivers two ways: a continuo

Page 7

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

Page 8

Chapter 1

Important Information

1

Your User Guide 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

Page 9

1

Indications for Use Your Animas IR 1250 insulin pump is indicated for use for the control of insulin-requiring diabetes. It is intended for use by one person. 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 IR 1250 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.

Page 10

1

Radiology Quick Reference Chart

Page 11

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. 

Page 12

1

 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 13

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 IR 1250 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 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.

Page 14

 Animas insulin pumps and insulin pump cartridges are latex free.

1

 To avoid risk of explosion, do not use the pump in the presence of explosive gases.  Your IR 1250 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 put your pump in a microwave oven or baking oven to dry it. Use a soft towel.

Page 15

Page 16

Chapter 2

Package Contents

Take a minute to check your IR 1250 Pump Kit box. It should include: • • • •

2

Your Animas IR 1250 One Energizer Lithium L91 AA battery (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 aD0 Tc0 c Ty will b a uD0 Tcosatial y taciveaed wahD0 Tenyou

Page 17

Page 19

Page 19

Page 20