Animas IR 1250 User manual

Page 1

Page 2
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 3
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 4
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 Features ......................................................................................................... 65
CarbSmart™ ......................................................................................................................... 65
Entering Carbs Manually (no food database) ....................................................................... 66
Adding a BG Bolus to CarbSmart ........................................................................................ 67
Entering Carbs Using the Food Database............................................................................. 68
Editing CarbSmart Total Entries........................................................................................... 71
ezBG ..................................................................................................................................... 72
Combo Bolus ........................................................................................................................ 74
Reminders............................................................................................................................. 75
Bolus Reminders................................................................................................................... 75
BG Check Reminder............................................................................................................. 76
Delivery Speed - Bolus......................................................................................................... 76
Multiple Basal Programs........................................................................................................... 76
Insulin on Board........................................................................................................................ 77
Sick Day Guidelines ................................................................................................................. 77
Chapter 13 Care and Maintenance............................................................................................ 79

Page 5
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
Swimming................................................................................................................................. 95
Traveling................................................................................................................................... 95
Intimacy .................................................................................................................................... 96
Chapter 18 My Information................................................................................................. 97
Frequently Asked Questions (FAQs).......................................................................................... 103
Glossary ...................................................................................................................................... 105
Tech Specs.................................................................................................................................. 108
Patient’s Bill of Rights................................................................................................................ 110
Supplier Standards...................................................................................................................... 111

Page 6

Page 7
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 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.
Please take a moment to look at the back of your pump and write down the serial number.
My pump serial number is: ___________________
2003-05
S/N: 49-00015-XX
|||||||||||||||||||||||||| ||||||||
Serial Number
(S/N)

Page 8
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 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.

Page 9
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 your pump and how to use it. 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 IR 1250 or
unless your Certified IR 1250 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.
Never prime tubing while infusion set is connected to your body. Priming the tubing
while the infusion set is connected to your body 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 series 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.

Page 10
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 11
Radiology Quick Reference Chart 1

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.
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 series (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 (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 13
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.
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.
*ezManager Plus Software and IR Accessory Kit each sold separately.
Safety Information
The Animas IR 1250 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 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 factors, blood glucose target ranges 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.

Page 14
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 15
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 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 16

Page 17
Chapter 2 Package Contents 2
Take a minute to check your IR 1250 Pump Kit box. It should include:
•Your Animas IR 1250
•One Energizer Lithium L91 AA battery (1.5V)
•A User Guide
•An envelope that includes
oYour registration card. (In the US, send the card directly to Animas Corporation.
Outside the US, send the card to your local Animas representative.)
oLimited warranty terms. Your warranty will be automatically activated when you
return your registration card.
oInstructions for Use for infusion sets and IR 1250 cartridges
•Training DVD*
•One Comfort infusion set*
•One Inset infusion set*
•One Animas IR 1200 series (200 U) cartridge
•IV Prep*
•Leather Case
•Holster Accessory
•Battery Cap Tool
•An ezManager Plus User Guide*
•An ezManager Plus CD*
*U.S. only

Page 18

Page 19
Chapter 3 Explanation of Symbols 3
Shown below are symbols you will find on your IR 1250 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:
Backlight 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 – contact your local Animas distributor for disposal
!

Page 20