Animas 115 User Manual

Download

OneTouch

™

Symphony

Insulin Delivery and

Blood Glucose Monitoring

System

Owner’s Booklet

Draft. 410-106-00 Rev.A

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Welcome

Congratulations. You have chosen one of the most advanced diabetes management systems available

today. Your OneTouch

Symphony™Insulin Delivery and Blood Glucose Monitoring System will play an integral part in the blood glucose management and continuous insulin delivery regimen that you have established with your health care professional.

Your OneTouch OneTouch

Symphony™System combines the functionality of an Animas®Insulin Pump and a

Meter Remote through radio frequency (RF) communication. Both devices will work independently of one another, but using them together can provide you with options to help make insulin delivery more discreet and flexible.

Your Animas

Insulin Pump uses the latest advanced technology, providing continuous insulin delivery to help maintain your blood glucose targets as recommended by your health care professional. It delivers insulin in two ways: 1) continuous “basal” insulin delivery and 2) “bolus” insulin delivery to cover foods eaten and/or reduce a high blood glucose level.

Your OneTouch

Meter Remote combines the accuracy expected from OneTouch®products with features designed to make testing and tracking more convenient. These include a meter remote memory that serves as an electronic logbook for storing all your glucose test results along with other diabetes-related health records. Another new feature is a Food Database which can be easily accessed on your meter remote. The Food Database helps take the guesswork out of carb counting.

When the devices are used together, your OneTouch to insulin delivery functions available with the Animas also allows your most recent blood glucose results from the OneTouch

Meter Remote gives you convenient remote access

Insulin Pump. Your OneTouch®Symphony™System

Meter Remote to be automatically entered into bolus insulin calculations to cover carbohydrates in food or to correct for a high blood glucose level.

This Owner’s Booklet is designed to provide the information that you are looking for, when you need it. We hope you keep it handy.

Of course you may still have questions. If you do, our customer service representatives will be happy to answer your call. You can reach them at Customer Service at 999-999-9999. You can also obtain information at www.animascorp.com.

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TABLE OF CONTENTS

BEFORE YOU BEGIN I

SECTION I : ANIMAS

CHAPTER 1 - Important Information 3

CHAPTER 2 - Explanation of symbols 9

CHAPTER 3 - Introduction to your Animas

CHAPTER 4 - Getting your pump ready 15

CHAPTER 5 - Using the Normal Bolus feature 27

CHAPTER 6 - Using Basal Program features 29

INSULIN PUMP

Insulin Pump 11

CHAPTER 7 - Suspend/Resume feature 37

CHAPTER 8 - History feature 39

CHAPTER 9 - Status feature 45

CHAPTER 10 - Advanced features/Setup and activation 49

CHAPTER 11 - Using Advanced features 59

CHAPTER 12 - Care and maintenance 73

CHAPTER 13 - Safety system and alarms 75

CHAPTER 14 - Troubleshooting guidelines 85

CHAPTER 15 - Sick day guidelines 91

CHAPTER 16 - Lifestyle issues 93

CHAPTER 17 - My information 95

CHAPTER 18 - Warranty and other technical information 99

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SECTION II : ONETOUCH®METER REMOTE

CHAPTER 1 - Setting up your OneTouch

CHAPTER 2 - Setting up and using the Food Database 121

CHAPTER 3 - Estimating bolus insulin amounts with the bolus calculator 123

CHAPTER 4 - Testing your blood glucose 125

CHAPTER 5 - Adding comments to glucose test results 139

CHAPTER 6 - Making logbook entries 143

CHAPTER 7 - FastFacts

/ Using your meter remote logbook 149

CHAPTER 8 - Control solution testing 159

CHAPTER 9 - Caring for your meter remote and test strips 163

Meter Remote 105

CHAPTER 10 - Understanding meter remote error and other messages 167

CHAPTER 11 - Detailed information about your meter remote and test strips 171

SECTION III: ONETOUCH

AND ANIMAS

CHAPTER 1 - Overview of your OneTouch

CHAPTER 2 - Establishing communication between your

meter remote and your insulin pump 175

CHAPTER 3 - Pump Home and Meter Home screens on your meter remote 185

CHAPTER 4 - Insulin delivery functions on your meter remote 187

CHAPTER 5 - Checking the status of your OneTouch

CHAPTER 6 - Troubleshooting your OneTouch

CHAPTER 7 - OneTouch

SYMPHONY™SYSTEM/USING YOUR ONETOUCH®METER REMOTE

INSULIN PUMP TOGETHER

Symphony™System 173

Symphony™System 203

Symphony™System 207

Symphony™System Communication Technical Specifications 217

Appendix A: Glossary 219

Index 223

BEFORE YOU BEGIN

EFORE YOU BEG I N

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Before using your OneTouch®Symphony™System to deliver insulin, you must complete training with a

certified Animas

Insulin Pump trainer on the insulin pump and on the meter remote.

As part of your training, your health care professional will assist you in making the appropriate selections for your insulin pump and meter remote settings. Your insulin pump must be programmed for your own personal use. Your insulin pump settings impact the calculations for insulin delivery using either your meter remote or insulin pump. Be comfortable with using your insulin pump before you activate the RF feature on your insulin pump and meter remote. See the appropriate chapters in Section I, pages 1–104 for the steps on setting up and using your insulin pump.

Many people also find it helpful to practice the blood glucose test process with control solution before testing with blood for the first time. See Chapter 8 in Section II, pages 159–162.

For best results the use of your insulin pump, or your meter remote to access pump functions, is recommended for people with diabetes who are willing to:

Test their blood glucose levels four to six times per day or as recommended by their health care team.

•

Demonstrate adequate carbohydrate counting skills.

•

Maintain good diabetes self-care skills.

•

See their health care professional regularly.

•

Have adequate vision and hearing to recognize the pump alerts.

•

You should carefully read this Owner’s Booklet and any inserts that come with your OneTouch

Symphony™System. These include inserts for:

OneTouch®Ultra®Test Strips

•

Food Database Reference Guide

•

OneTouch®Ultra®Control Solution

•

and Instructions for Use for:

Animas®2000 Series Insulin Pump Cartridges

•

Infusion Sets

•

ezManager®Software

•

While reading this Owner’s Booklet, please note the following:

Display screens throughout the Owner’s Booklet are examples only. They should not be considered

•

suggestions for individual programming and may not be representative of current health states.

“Blood Glucose” is often abbreviated as BG in both instructional copy as well as in example display

•

screens.

Your Animas®Insulin Pump will often be referred to as simply “your pump”. Similarly, your

•

OneTouch be used when referring to both the Animas

Meter Remote will often be referred to as “your meter remote”. “The devices” will often

Insulin Pump and OneTouch®Meter Remote.

Take special note of Warnings and Cautions throughout this Owner’s Booklet, which are identified with

.

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EFORE YOU BEG I N

Intended use

Your OneTouch®Symphony Insulin Delivery and Blood Glucose Monitoring System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood.

Your Animas treatment of insulin-requiring diabetes.

Your OneTouch quantitative measurement of glucose in fresh capillary whole blood. When used together with the Animas pump. Your OneTouch self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Your OneTouch finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.

Insulin Pump is indicated for continuous subcutaneous infusion of insulin for the

Meter Remote Blood Glucose Monitoring System is intended to be used for the

Insulin Pump, it also functions as a wireless (RF) remote control to deliver insulin from the

Meter Remote Blood Glucose Monitoring System is specifically indicated for use on the

Meter Remote Blood Glucose Monitoring System is intended for use for

About radio frequency (RF) communication

Your meter remote and pump have built-in RF capability. RF is a type of wireless communication. Cell phones use RF technology, as do many other devices. RF is how your meter remote and pump communicate and share data.

The RF feature on your meter remote and pump will be deactivated when you first receive them. In order to begin using your meter remote and pump together as a system, RF must be activated on both devices and they must be paired (synchronized). Activating RF opens a line of communication on both devices and pairing ensures communication will take place only between one meter remote and one pump.

RF communication between your meter remote and pump will work up to a distance of about 10 feet and will transmit through clothing. Direct line of sight is not required for RF communication. As long as you have a good RF signal and are within range, you can use your meter remote to access pump functions.

When conditions or distance cause RF communication to be lost or interrupted, you will not be able to use your meter remote to access pump functions. This also means that data transfer between the two devices will stop temporarily. As soon as the problem is resolved, RF communication will resume. Any status records stored in your pump during the RF interruption will then be sent to your meter remote.

Your meter remote and pump are subject to and comply with U.S. Federal regulations, Part 15 of the Federal Communications Commission (FCC) Rules regarding devices with RF capability. From these regulations, the two conditions of operation specific to your device are given in the following FCC required statement:

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation.

BEFORE YOU BEGIN

Draft. 410-106-00 Rev. A

Compliance with these guidelines means that under normal day-to-day circumstances your OneTouch Symphony™System should not affect the operation of other devices. Additionally, your OneTouch

Symphony™System should operate normally in the presence of other devices in a normal household environment. In the event there is interference from another device, it is recommended that you

increase distance between your system and that device, or turn off the interfering device. Alternatively, you may turn off RF communication between the meter remote and pump and perform insulin delivery functions directly from your pump (see Chapter 2 in Section III, pages 180-182).

Changes or modifications not expressly approved by the manufacturer (Animas Corporation) could void the user’s authority to operate the equipment.

There are environments where it is recommended that you not use the RF communication feature linking your meter remote and pump. When you are in radiology and MRI departments and around radiology equipment, it is recommended you first deactivate the RF communication feature on both your meter remote and your pump. Then you must remove both devices and leave them outside the

MRI room. Any metal needle infusion sets should also be removed and left outside the MRI room.

Likewise, during air travel your airline may have specific restrictions about using your System with RF communication activated. It is recommended that you deactivate the RF feature on your pump and meter remote during flights, or check with your airline’s RF restrictions when making your travel plans. To learn more about deactivating the RF feature on your pump and meter remote, see Chapter 2 in Section III, pages 175–184.

Your pump has additional environmental restrictions. See Chapter 1 in Section I, pages 3–8 for recommendations regarding the use of pumps in the presence of radiology equipment.

Using your meter remote and pump together as a system

Once you have established communication between your meter remote and pump, you can access certain pump functions directly from your meter remote. These include delivering a bolus, monitoring pump status, and confirming many pump alarms and warnings.

Your pump has its own set of display screens and buttons to provide stand-alone insulin delivery without the use of your meter remote. Some of the buttons work the same way as the buttons on your meter remote. One example is the button on your pump. Like the button on your meter remote, the button on your pump is used to confirm entries. Be sure you know how the buttons workon both your pump and meter remote before you begin using the devices together as a system.

When you use your meter remote to access pump functions, your meter remote display screens will closely resemble your pump display screens.

III

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EFORE YOU BEG I N

OneTouch®Symphony™System Carton Contents

Your OneTouch®Symphony™System carton includes your insulin pump, your meter remote, and other accessories you will need to begin using both devices. Your meter remote and BG testing supplies are included within a separate kit within the carton. Check the contents of your carton to make sure all items are included. If any items are missing call Customer Service at 999-999-9999.

Your OneTouch

The Animas®Insulin Pump and pump accessories:

•

Symphony™System carton includes:

a. Animas®Insulin Pump

b. One Energizer Lithium L91 AA battery (1.5V) for your pump

c. Owner’s Booklet

d. Envelope that includes Instructions for Use for IR 1200/2000 series cartridges

e. Sample Animas

IR 1200/2000 series (200 U/2ml) cartridge

f. Sample infusion sets

g. Sample skin prep

h. Leather Case

i. Low Profile Clip

j. Extra Battery Cap

k. Battery Cap Tool

l. ezManager

Software and download/upload cable

EFORE YOU BEG I N

The OneTouch®Meter Remote kit which includes:

•

Draft. 410-106-00 Rev. A

a. OneTouch®Meter Remote

b. OneTouch

Ultra®Control Solution

c. OneTouch

Lancing Device

If another type of lancing device is included, see the separate instructions for that lancing device.

d. OneTouch®AST™Clear Cap

e. OneTouch

UltraSoft®Sterile Lancets

f. Carrying Case

g. Two 1.5V AAA Alkaline Batteries* (batteries included but not installed)

h. OneTouch

Ultra®Test Strips

i. USB Cable

A warranty card for your meter remote is also included.

* See Chapter 9 in Section II, pages 163–166, for important information on the correct way to install the batteries in your meter remote.

 WARNING: Keep the pump, meter remote, and accessories away from young children. Small

items such as the battery door, batteries, battery cap, clip, test strips, lancets, protective disks on the lancets, and control solution vial cap are choking hazards.

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EFORE YOU BEG I N

Supply Reordering

You can place orders for cartridges, infusion sets, skin prep, test strips, batteries and many meter remote and 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, you may also call 1-999-999-9999.

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

•

BG monitoring supplies including meter, strips, lancing device, lancets, meter remote batteries

•

(2 AAA alkaline)

Blood or urine ketone testing supplies

•

Rapid-acting and other insulin as recommended by your health care team

•

Extra infusion sets and IR 1200/2000 series cartridges

•

Dressing and adhesive, if used

•

An extra Energizer Lithium L91 AA battery for your pump

•

An extra pump battery cap

•

An extra pump cartridge cap (In the U.S., Canada and Puerto Rico, call 1-999-999-9999 to order

•

an extra cartridge cap. All other customers contact your local Animas

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.

distributor.)

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Animas®Insulin Pump

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Welcome and Congratulations

You have begun a new way of life with your Animas®Insulin Pump.

Your choice of pump therapy is a sign that you are committed to taking excellent care of yourself. Your 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 (BG) targets as recommended by your health care 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 BG. 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: ______________________________________

Animas

Insulin Pump

Serial Number (S/N)

Technical and Clinical Help

If there is anything you do not understand in the Owner’s Booklet or if you have a question or need assistance with your pump, our Customer Service Department is available to you every minute of every day.

In the United States, Canada and Puerto Rico, call 1-999-999-9999 for assistance every minute of every day. For non-urgent technical questions, please email pumpsupport@anmus.jnj.com.

We understand that you may have questions and concerns when using a new product. Please do not hesitate to call for assistance!

Important Note

Your pump comes with a transparent plastic film covering the display lens for protection during shipping. Be sure to remove this protective covering before using your pump.

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Insulin Pump

Animas

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CHAPTER 1 - IMPORTANT INFORMATION

This section of the Owner’s Booklet 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 Owner’s Booklet handy for reference. Warnings, cautions and safety tips are found throughout this Owner’s Booklet, indicated by a

 WARNING:

Do Not attempt to connect to your pump before you have been trained on your pump or unless

•

your certified Animas

Incorrect use of your pump, failure to follow the instructions in this Owner’s Booklet 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 health care team or call our Customer Service representatives at 1-999-999-9999.

Your pump is designed to deliver insulin reliably but because your 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 BG, you must be prepared to give yourself an injection of insulin if delivery is interrupted for any reason.

 symbol.

Insulin Pump trainer is present.

Animas

Insulin Pump

Your 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.

Warnings and Precautions

 Radiology Equipment

Your pump 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, your 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.

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CHAPTER 1 - I M P O R TANT INFORMAT I O N

 Medical Procedures and Equipment

Procedure

Patient is Pumper

Health Care

Professional/Technician

is Pumper

Pacemaker/

Automatic Implantable

Cardioverter-

Defibrillator (AICD)

EKG No need to disconnect. No need to disconnect.

Insulin Pump

Cardiac

Animas

Catheterization

Nuclear Stress Test

Colonoscopy No need to disconnect. No need to disconnect.

Laser Surgery

Disconnect pump and leave outside room during insertion of device and reprogramming. Infusion set can remain in place.

Disconnect pump and leave outside room during procedure.

Disconnect pump and leave outside room during scan. Can remain connected during injection of radioisotope.

Pump and infusion set can be worn; however some lasers can create interference and cause pump to alarm.

Follow normal safety practices and proceed to the designated safe area while each X-ray is taken and during reprogramming.

Follow normal safety practices and proceed to the designated safe area while each X-ray is taken.

Pump and infusion set can be worn; however some lasers can create interference and cause pump to alarm.

General Anesthesia

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) 1-999-999-9999 in the U.S., Canada and Puerto Rico.

HAPTER 1 - I M P O R TANT INFORMAT I O N

 Medical Procedures and Equipment

Draft. 410-106-00 Rev. A

Procedure

Dental X-Rays

Ultrasound

Mammogram

and Bone

Density Test

Body X-Rays,

Flouroscopy (chest,neck,

abdomen,

torso, etc.)

Patient is Pumper

No need to disconnect.

•

Pump should remain covered by lead apron

•

placed on the patient by the dentist or technician.

No need to disconnect.

•

Transducer should not be pointed directly

•

at pump or site. If site is directly in range of transducer, site should be removed.

Do Not expose pump to test.

•

Disconnect pump prior to test and leave pump

•

in locked dressing room.

Infusion set can remain in place during test.

•

Do Not expose pump to X-ray beam.

•

Disconnect pump prior to exam and leave

•

pump in locked dressing room.

Infusion set can remain in place during X-ray.

•

Health Care Professional/Technician

is Pumper

No need to disconnect.

•

Follow normal X-ray safety practices and

•

proceed to the designated safe area when each X-ray is taken.

No need to disconnect.

•

Transducer should not be pointed

•

directly at pump or site.

No need to disconnect.

•

Follow normal safety practices and

•

proceed to the designated safe area while each test is being performed.

No need to disconnect.

•

Follow normal X-ray safety practices

•

and proceed to the designated safe area when each X-ray is taken.

Animas

Insulin Pump

Therapeutic

Radiation/

Oncology

(cancer treatment radiation)

CT Scans and

MRI’s (Magnetic

Resonance

imaging)

Electro-cautery

surgery

Do Not expose pump to radiation treatment.

•

Disconnect pump prior to radiation treatment

•

and leave pump in locked dressing room.

If the infusion set doesn’t interfere with the

•

area being treated, the set can remain in place during radiation.

Do Not bring pump into the exam

•

room at any time.

Disconnect pump and metal needle

•

infusion set prior to exam and leave in a locked dressing room.

Soft cannula infusion sets can remain in place.

•

If pump is accidently allowed in the exam

•

room disconnect pump immediately and contact Customer Service for instructions.

Disconnect from pump during surgery.

•

Disconnect prior to surgery and leave pump

•

in locked dressing room.

If the infusion set doesn’t interfere with the

•

area being treated, the set can remain in place during surgery.

No need to disconnect.

•

Follow normal radio-protection practices

•

and proceed to the designated safe area while the patient is undergoing treatment.

MRI: Do Not bring pump into the

•

same room as the MRI machine at any time.

If pump is accidently allowed in

•

the MRI room disconnect pump immediately and contact Customer Service for instructions.

CT Scan: No need to disconnect.

•

Follow normal CT Scan safety practices

•

and proceed to the designated safe area when each Scan is performed.

No need to disconnect.

•

When in doubt, disconnect and leave pump in locked dressing room.

Follow usual instructions for bolusing to cover any missed basal insulin when you reconnect.

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CHAPTER 1 - I M P O R TANT INFORMAT I O N

 Amusement Parks

Very powerful electromagnets are sometimes used on “free-fall” amusement park rides. 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) your 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) pump.

Precautions

Your pump is a sealed device that should be opened ONLY by the manufacturer. If your pump seal

Insulin Pump

Animas

•

is broken by anyone other than an authorized Animas your pump is no longer waterproof. If the back label on your pump is removed or damaged, the warranty is voided and your pump is no longer waterproof.

When using your 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 your pump and the infusion site should be no more than 12 inches (30 cm). If your pump is placed at a vertically lower position than the infusion site, this condition is eliminated.

factory technician, the warranty is voided and

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 your 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

•

™

connector. Efficacy of pump cannot be guaranteed if cartridges other than those manufactured

Luer by Animas

Always dispose of used cartridges and infusion sets following the regulations in your community.

•

Failure to follow these guidelines may pose health hazards.

Prior to replacing the battery cap, make sure the o-ring fits securely and is not damaged. A damaged

•

o-ring may impact the battery contact and/or the waterproof feature of your pump. See Chapter 4 in Section I, pages 15–26.

Prior to inserting a cartridge into your pump, check the o-rings on the cartridge to be sure they are not

•

damaged. Damaged cartridge o-rings can result in under or over delivery of insulin.

Occasionally check the vents to be sure they are clear of debris. See Chapter 12 in Section I, pages

•

73–74.

Occasionally check that your pump personal settings are correct.

•

Corporation are used or if cartridges are used more than once.

Occasionally check to make sure your pump emits audible tones that are easily detectable and that

•

the vibrate feature is working correctly. For example, audible tones should be heard and the vibration pulse felt every time you replace the battery.

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HAPTER 1 - I M P O R TANT INFORMAT I O N

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

NOTE: Your pump uses battery power to notify you of alerts, warnings, and alarms. If you do not confirm the notification, your pump will continue to use battery power as the notifications repeat and progress. This will result in reduced battery life and the Replace Battery Alarm screen appearing sooner than expected.

distributor for information on ezManager®Software and IR Accessory Kit.

Additionally, certain warnings (e.g., Low Cartridge Warning, Occlusion Alarm) take precedence over less critical ones (e.g., Low Battery Warning). This means if you do not confirm the more critical warning, battery life will be reduced and your pump may skip the Low Battery Warning and go directly to the Replace Battery Alarm, or battery life will end before a Replace Battery Alarm is displayed.

 Safety Information

Your pump is designed only for Continuous Subcutaneous Insulin Infusion (CSII). It is not intended

•

for use with any other delivery substance.

This section of the Owner’s Booklet gives instruction on how to program and operate your pump.

•

Animas diabetes care program. Consult your health care team for instructions specific to your treatment plan.

Corporation does not make any recommendations on specific programming related to your

Consult your health care team before using your 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 health care team will give you specific training on programming and using your pump.

Use of Extended Bolus, Combo Bolus, ezCarb (carb calculator), Insulin on Board (IOB) and ezBG (BG correction calculator) all require input from your health care 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.

Animas

Insulin Pump

Only your health care team can determine your Insulin to Carbohydrate (I:C) ratios, Insulin

Sensitivity Factors (ISFs), BG Target ranges and duration of Insulin on Board (IOB).

Basal rates that are too high or too low can adversely affect BG levels. Work with your health care

team to fine-tune basal rates.

The way your body uses insulin can be affected by many things. Contact your health care 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 your pump if you are ill. Even when you’re sick, your body still needs insulin. See

•

Chapter 15 in Section I, pages 91–92.

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 health care team.

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CHAPTER 1 - I M P O R TANT INFORMAT I O N

Before Bedtime

•

Try to arrange infusion set changes at meals or one to two hours before bedtime. If a change

is needed at bedtime, then check BG in one to two hours. Always check BG one to two hours after infusion set change.

Always check that your cartridge has enough insulin to last through the night before going to bed.

Insulin Pump

Unless otherwise recommended by your health care 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 your pump electronics by cell phones can occur if worn in close proximity. It is

•

recommended that you wear your pump and cell phone at least 6 inches apart. When RF is turned on and you are using your pump and meter remote together as a system, RF interference is possible. See Chapter 7 in Section III, pages 217–218.

Animas

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 your 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 your pump may impact the battery contact and/or the waterproof feature of your pump. Call our Customer Service representatives at 1-999-999-9999 if you identify or suspect your pump has been damaged. They will help determine if your pump should be replaced.

Your pump is designed to operate in conditions where temperatures are between 40˚F and 104˚F.

•

If your pump is exposed to temperatures outside these parameters, extra care should be taken to protect it from extreme temperatures.

Your pump and pump cartridges are latex free.

•

To avoid risk of explosion, Do Not use your pump in the presence of explosive gases.

•

Your 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 your 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 your pump and voids its warranty.

Do Not use household cleaners, chemicals, solvents, bleach, scouring pads or sharp instruments to

•

clean your 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.

•

 WARNING: Your pump and pump accessories include small component pieces that could

pose a choking hazard for small children.

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MRI

HAPTER 2 - E X P L A N ATION O F SYMBOLS

CH A PT ER 2 - EX P LAN AT IO N OF SY MB O LS

Shown below are symbols you will find on your Animas®Insulin Pump and its packaging.

On the front of your pump:

Up Arrow button

Down Arrow button

OK button

On the top of your pump:

Contrast button

On the back of your pump:



S/N Serial Number

IPX8 Water-Tight Equipment (protected against the effects of submersion; tested to 12 feet/3.6 meters

Important Information (See Owner’s Booklet for Instructions for Use)

Date of Manufacture

for 24 hours)

Animas

Insulin Pump

Type BF Medical Equipment (patient isolated, not defibrillator protected)

Rx Only CAUTION: Federal (U.S.) law restricts this device to sale by, or on the order of a physician.

Consult Owner’s Booklet

Do Not wear or operate around MRI devices. Remove and leave outside MRI room before entering.

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CHAPTER 2 - E X P L A N ATION O F SYMBOLS

Insulin Pump

Animas

Draft. 410-106-00 Rev. A

CH A PT ER 3 - IN T ROD U CT I ON TO YO UR A NIM A S®IN S UL I N PU M P

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 level (basal rate), 24 hours a day. You program delivery of an immediate dose (bolus) of insulin to cover food eaten or to correct high BG.

Your pump is 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 Animas®Insulin Pump

Contrast button

Up button

Down button

Audio bolus/ezBolus button

Display

Screen

OK button

Main Programming Buttons

There are 3 buttons for main programming functions. The and buttons allow you to move through screen selections and to scroll up and down to enter values such as a bolus amount. The button allows you to select an item or activate a function.

Animas

Insulin Pump

Programming Basics

Use the / buttons to scroll to the desired selection and then press the button to select.

•

If the cursor is flashing, it means your pump is in Edit Mode and by scrolling with the / buttons, you can edit the flashing field.

Once you have finished editing, press the 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.

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CHAPTER 3 - I N T R O D U C T I O N T O YOUR A N I M A S®INSULIN P U M P

Contrast Button

Pressing this button adjusts the contrast of your display. There are three contrast levels: Dim, Default and Bright. To preserve battery life, your pump display will Auto-dim when a button is not pressed for half the time your display time-out is set. While in Auto-dim mode, you can restore the default contrast level you have set by pressing the button on top of your pump. Pressing a function button while in

Auto-dim mode will restore the default contrast level as well as perform the function of the key. To adjust contrast during a Call Service alarm, you must use the button. See Chapter 10 in Section I, pages 49–58.

NOTE: When viewing your pump display in bright sunlight, it is recommended you shade the screen or move to a shady area for best visibility.

Insulin Pump

Animas

Audio Bolus/ezBolus

This button allows you to program a bolus without looking at your 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.

NOTE: 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. See Chapter 10 in Section I, pages 49–58.

Battery Cap/Vent

This cap unscrews easily with a coin or the battery cap tool to replace and secure your battery. There is an o-ring around the cap, which prevents water from entering. The battery cap also is equipped with a built-in vent to allow air to enter your pump to maintain pressurization but prevent water from entering. Be careful not to over tighten the battery cap. See Chapter 4 in Section I, pages 15–26.

Primary Vent

This vent is part of the redundant vent safety system, which allows air inside your pump to maintain equalized pressure but prevents water from getting inside.

Cartridge Cap

Primary Vent

Battery Cap/Vent

 WARNING: Under no circumstances should you introduce any kind of sharp object into the

vent openings to clean them. Doing so will compromise your pump’s waterproof capabilities. If at any time you suspect the vent openings are clogged, replace the battery cap or call Animas Customer Service for questions about the Primary Vent.

VERIFY

Confirm

Mode Month Day

Year ENGLISH Battery = Lith

2:27PM

12 Hr

2007

Jan

2 : 27

Status

Basal Rate

0.025U/Hr

Insulin: 105U

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HAPTER 3 - I N T R O D U C T I O N T O YOUR A N I M A S

NSULIN P U M P

Cartridge Compartment Cap

This cap secures your cartridge and infusion set in your pump.

 WARNING: Never tighten the cartridge cap when your infusion set is attached to your body.

Tightening the cartridge cap while your infusion set is attached to your body may result in unwanted insulin delivery, which can result in serious injury or death.

IR Window for Download

The IR window is framed in blue. This is the infrared communication window used for downloading your pump data.

IR Window

Sounds

Your pump allows you to customize the volume level or use the vibrate function to notify you of warnings and alarms and to confirm certain deliveries. With ezManager tunes to play as your initial audible notification for some Alerts, Reminders, Warnings and Alarms. Refer to your ezManager

User Guide included with the software.

Software, you can also add

Animas

Insulin Pump

Tamper Resistant (Locked) Feature

You can use the tamper resistant feature to prevent accidental button pressing. Simply wake up your pump and press and hold the and buttons at the same time until the screen reads “(LOCKED)”. This locks your pump buttons. To unlock your pump, wake up your pump so the screen reads “(LOCKED)” and press and hold the and buttons at the same time until the screen display wakes up.

Basic Display Screens

Verify Screen

When you insert a battery, an all-black screen with an hourglass symbol will appear followed by the VERIFY screen. From here you should verify the settings for time, date, language and battery type. With “Confirm” highlighted, press to confirm the settings and go to the Home screen.

NOTE: If you do not confirm the settings on the VERIFY screen, you will be notified with an alarm beep sequence on your pump. If not confirmed after 1 hour, the sequence will progress to 3 chirps/vib and then 4 long tones/vib within an hour.

Home Screen

Once you have your pump set up, the Home screen is the first screen that is displayed when you “wake up” your pump. Press any button to wake up your pump. The Home screen shows the time of day, a battery life indicator, if you have an extended bolus or temp basal currently active, current basal rate, and how much insulin remains in your cartridge. You access the Main Menu from here or you can take a shortcut to the Status menu. The battery life indicator is shaded to show approximate battery life remaining.

MAIN MENU

Home

Bolus

Suspend/Resum History Basal Setup Prime/Rewind Status

2 : 27

Status

Basal Rate

0.025U/Hr

Insulin: 105U

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CHAPTER 3 - I N T R O D U C T I O N T O YOUR A N I M A S®INSULIN P U M P

OTE: When the RF feature is activated on your pump, an RF ( ) symbol will

appear on the top left of your pump Home screen.

After a set amount of time with no button presses, your pump display screen will “time out” to conserve battery life. When your pump times out, the screen display is blank.

Main Menu Screen

This screen shows all Main Menu options.

Insulin Pump

Animas

Bolus

This selection takes you to the Normal Bolus screen. If you have activated Advanced Bolus features, the Bolus Menu will be displayed. From the Bolus Menu you can select the bolus type, program and deliver the bolus dose.

Suspend/Resume

The Suspend function stops all insulin deliveries and Resume restarts basal delivery.

History

This option allows you to review history of boluses, total daily dose (TDD), alarms, primes, suspend and basal information.

Basal

The Basal Menu allows you to access and program your basal rate. This continuous rate maintains your blood glucose between meals. This rate will be determined by your health care team. The default Basal Menu will display one basal program and the Temp Basal option. You can activate additional basal program options with the Setup Advanced menu.

Setup

This menu allows you to personalize the settings and features of your pump, as well as add advanced features to the menu. Your health care team will advise you on which features are best suited for your plan of treatment, as well as train you to achieve the best results.

Prime/Rewind

This function enables you to properly align the cartridge and piston rod as well as prime your infusion set tubing and fill your cannula or needle before connecting to your pump.

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CH A PT ER 4 - GE T TI N G YOU R PU M P RE A DY

Status

This feature allows you to quickly see your current/most recent settings and pump deliveries.

 WARNING: Before proceeding with this chapter, you should have completed your pump

training and/or watched your training video.

To complete this section, you will need the following items:

Animas®Insulin Pump

•

Energizer Lithium L91 AA battery (1.5V)

•

Battery cap tool or coin

•

Infusion set with standard Luer connector

•

Animas®IR 1200/2000 series (200/2ml unit) cartridge

•

Alcohol wipe (to clean top of insulin vial)

•

Vial of U100 insulin (rapid-acting) at room temperature

•

Skin prep such as IV Prep™(to clean and prepare site for infusion set insertion)

•

 CAUTION: Under no circumstances should you use an alcohol wipe or skin prep to clean your

pump. See Chapter 12 in Section I, pages 73–74.

Battery Type

Your pump is designed to achieve optimum performance and battery longevity with an Energizer Lithium L91 AA battery (1.5V).

Animas

Insulin Pump

 CAUTION: It is possible to safely power your pump with a conventional AA Alkaline battery

(1.5V), but battery life is significantly reduced. Be sure you select the correct Battery Type on the VERIFY screen when you change the battery to ensure accuracy of battery life indicator.

If you must use an AA Alkaline battery, the following is recommended:

Energizer E91 (labeled as Energizer MAX)

•

 WARNING:

Rechargeable batteries and Carbon-Zinc batteries do not have the necessary characteristics

•

to power your pump and must not be used. Use of these batteries voids your pump warranty.

Under no circumstances should you attempt to power your pump with a high-energy 3.6V AA

•

Lithium battery. Use of these batteries could permanently damage your pump and voids its warranty.

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CHAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

battery life will be reduced and your pump may skip the Low Battery Warning and go directly to the Replace Battery Alarm, or battery life will end before a Replace Battery Alarm is displayed.

Changing the Battery

Each time you change the battery

A full rewind and prime sequence is required. See Priming your Pump and Infusion Set, pages 22–24

•

Insulin Pump

Animas

in this chapter.

The Insulin on Board (IOB) calculation starts over at zero.

•

The Combo bolus returns to the factory set default duration and split.

•

You should review your basal program settings.

•

 WARNING: Low Battery Warning means battery life will only last a minimum of 30 minutes.

1. Use a coin or the battery cap tool to unscrew the battery cap with a counter-clockwise motion.

2. Check your battery cap for damage such as cracks or missing threads, and be sure the colored

o-ring fits securely and is not torn or damaged.

3. Check the vent hole on the top of the battery cap to

be sure it is clear of debris. This vent maintains pressurization while preventing water from entering the compartment.

NOTE: The battery cap should be replaced once each year or sooner if the o-ring or cap is damaged or the vent is clogged. See Chapter 12 in Section I, pages 73–74.

4. Insert the Energizer Lithium L91 AA (1.5V)

battery into the battery compartment with the positive (+) end going in first.

Battery Cap Vent HoleO-ring

Energizer Lithium L91 AA battery

5. Replace the cap by turning clockwise until you cannot see

the o-ring but Do Not over tighten.

NOTE: Over tightening the battery cap can cause your pump case to crack. Cracks, chips, or damage to your pump may impact the battery contact and/or the waterproof feature of your pump.

6. Each time you change the battery, your pump will run a series of self-tests which will last a few

seconds. An all black screen with an hourglass symbol will appear followed by the VERIFY screen. Your pump will give a beep to alert you to verify (or change) the time/date, language and battery type.

Alert

Confirm

Basal Menu

Your active

basal

program

is empty.

0.000U/Hr

2 : 27

Status

Basal Rate

0.025U/Hr

Insulin: 105U

MAIN MENU

Home

Bolus Suspend/Resum History Basal

Setup

Prime/Rewind Status

SETUP

Main Menu

Time/Date

Sound

Advanced

SETUP

Time/Date

Main Menu

Mode Month Day Year

2: 27PM

Hour: Minute

12 Hr

Jan

2007

2 : 27

Status

asal Rate

0.025U/Hr

Insulin: 105U

HAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

7. Check the displayed time/date, battery type and language. If correct, scroll

down to highlight “Confirm” and press the button. The Home screen will be displayed. For more details on changing the time and date, see Setup - Basics, Setting/Changing Time and Date, pages 17–18 in this chapter.

NOTE: The time and date must be programmed to confirm the VERIFY screen.

Draft. 410-106-00 Rev. A

8. To change the battery type, highlight the “Battery” field and press to

activate Edit mode (indicated by flashing cursor).

9. Use the / buttons to change battery type and press to confirm and exit Edit Mode.

NOTE: The correct battery type must be selected in order for your battery life indicator to be accurate. “Lith” = Lithium, “Alkl” = Alkaline.

10. Scroll to “Confirm” and press . The Home screen is displayed.

NOTE: Until you have programmed a basal rate, the Alert screen shown here will appear when your pump is awakened. Simply scroll to “Confirm” and press to move past this Alert screen.

Setup – Basics

You can use your computer, with ezManager®, to upload Time/Date and Sound settings. For instructions on uploading Time/Date Sound settings, refer to your ezManager

Setting/Changing the Time and Date

User Guide.

Animas

Insulin Pump

When you change your battery, the VERIFY screen allows you to edit the time and date.

You can also access the Time/Date SETUP screen by selecting “Setup” from the MAIN MENU.

1. From the Home screen,

press to select “Menu”. Scroll to “Setup” on the MAIN MENU. Press .

2. Scroll to Time/Date on

the SETUP menu. Press .

3. Press the button to activate Edit Mode (indicated by flashing cursor).

4. Use the / buttons to change to your desired settings. Press the

button to confirm your setting and exit Edit mode.

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CHAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

5. Use the / buttons to select the next field. Repeat the above process. Scroll to highlight

“Main Menu” and press button when finished. The MAIN MENU screen will be displayed.

NOTE:

• If you select the 12-hour time format, the AM/PM indicators will change as you scroll to set the time.

Be sure the desired AM or PM selection is correctly displayed when setting the time.

• If you select the 24-hour time format, the time will be shown in military time.

Daylight Saving Time (certain states and countries only)

“Spring Forward”

Insulin Pump

If you advance the hour on your pump clock after 11pm but before midnight, you must also manually forward the date by one day. If you change your pump clock after midnight, your pump date will have changed automatically to the appropriate date.

Animas

“Fall Back”

It is recommended that you set your clock back before midnight on Saturday or after 1am on Sunday. This keeps your pump set to the correct date. Your pump will register an additional hour in the Daily Totals History because the day has essentially been altered to consist of 25 hours. If you change the clock between midnight and 1am, you must also change the date. This will result in a duplicate date entry in your history. (This duplicate entry will contain up to one hour’s worth of insulin delivered.)

Sounds - Setting/Changing

Note that this menu only adjusts sounds. It does not activate the feature. For example, Audio Bolus Sound is adjusted in this menu, but to turn the Audio Bolus feature on, go to the Setup Advanced menu. See Chapter 10 in Section I, pages 49–58.

Your pump comes pre-loaded with a tune for most Alerts, Reminders and Alarms on medium and high volume settings. This tune plays only for the initial audible notification. If you do not confirm the initial notification, the next sound will be the factory default. If not confirmed, Warnings and Alarms will automatically progress to high volume and vibrate within one hour. With ezManager can change or add tunes to play as your initial notification for some Alerts, Reminders, Warnings and Alarms. Refer to your ezManager

The options from the first SETUP SOUND menu are listed below. The first three can be set to one of the following: Vibrate (Vib), Low volume (L) , Medium volume (M) , High volume (H) or can be shut off (OFF) completely. For safety reasons, some sounds cannot be turned off.

Normal Bolus Sound

Audio Bolus Sound (OFF is not an option for this sound setting)

Temp Basal Sound

Remote Bolus Sound (Vibrate and OFF are the only options for this sound)

User Guide included with the software.

Software, you

SETUP

Main Menu

Time/Date

Sound

Advanced

SETUP SOUND

Next Menu Main Menu

N-Bolus A-Bolus R-Bolus

T-Basal

L Vib

OFF

SETUP SOUND

Main Menu

Alert

Reminder

Warning

Alarm

Vib

MAIN MENU

Home

Bolus Suspend/Resum History Basal

Setup

Prime/Rewind Status

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HAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

The Remote Bolus Sound on your pump signals you when you use your meter remote to deliver a bolus from your pump. This setting applies only when you begin using your meter remote and pump together as a system (see Section III). Vibrate (Vib) is the default setting and OFF is the only other option for this sound setting.

The options from the second Setup Sound Menu are listed below. They can be set to one of the following: Vibrate (Vib), Low volume (L), Medium volume (M) or High volume (H). For safety reasons, some sounds cannot be turned off.

Alert Sound

Reminder Sound

Warning Sound (OFF is not an option for this sound setting)

Alarm Sound (OFF is not an option for this sound setting)

NOTE: If you download tunes from ezManager

Software to play on your initial audible notification,

they will not play for any sound set at the Low volume (L) level.

 CAUTION: Unless otherwise recommended by your health care professional, vibrate mode

should not be used during sleep. If you are a very sound sleeper, set the alarm volume to high before going to bed.

1. From the MAIN MENU, scroll to “Setup”. Press the button.

2. Scroll to “Sound”. Press the button to go to the SETUP SOUND screen.

3. Use the / buttons to scroll to your selection. Press the button.

4. The cursor will flash to indicate you can edit the selection. Use / buttons to change to desired

setting. Press the button to confirm.

Animas

Insulin Pump

5. Repeat for remaining selections.

6. Scroll to “Next Menu” to access second SETUP SOUND menu or scroll to “Main Menu” when

finished to return to the MAIN MENU.

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CHAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

The Cartridge

Filling the Cartridge

Refer to the Instructions for Use included with your cartridges.

Connecting the Tubing to the Cartridge

To complete this section, you will need the following:

Filled Animas®IR 1200/2000 series cartridge

•

Infusion set compatible with your Animas®Insulin Pump

•

Skin prep such as IV Prep

•

™

Insulin Pump

 WARNING: The efficacy of your pump cannot be guaranteed if cartridges other than those

manufactured by Animas

Corporation are used.

Animas

Only infusion sets marketed for use with insulin infusion pumps using insulin-compatible tubing and with a standard Luer lock can be used with your Animas of your pump cannot be guaranteed if infusion sets other than those specified are used.

Do Not connect infusion set to your body until after you have completed the Prime process.

1. Clean the workspace where you will be connecting the infusion set to the cartridge. Wash your

hands thoroughly with soap and water.

Insulin Pump. The efficacy

2. Open sterile infusion set package carefully. If the package is damaged or opened, use another set

and contact your supplier.

3. Unscrew the cartridge compartment

cap from your pump, using a counterclockwise motion.

Luer connector of infusion set

4. Remove infusion set tubing cap from

the Luer connector. (Not all infusion sets have these caps.)

Top of cartridge compartment cap

5. After removing protective cap, thread the Luer

connector of the infusion set through the top (smaller) opening of the cartridge compartment cap, being careful not to touch Luer tip with hands or work surface.

Correctly threaded through cap

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HAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

emove cap from the filled cartridge tip. To avoid

6. R

insulin spillage and introduction of air in the cartridge, it should never be filled beyond the 2.0 mL mark. The plunger is properly positioned for maximum fill when the black o-ring nearest the plunger tip is centered on the 2.0 mL mark. Attach infusion set Luer connector to cartridge tip using clockwise motion until finger tight and then twist

another quarter of a turn.

Connect infusion set to cartridge here

 WARNING: Be sure to twist the Luer connector an extra quarter of a turn to ensure a secure

connection. If the connection is not secure, insulin may leak around the cartridge, resulting in under delivery of insulin.

7. Put cartridge/tubing assembly aside.

Animas

Insulin Pump

NOTE:

• Check for leaks, cracks or damage each time you change your cartridge and infusion set. To avoid leakage, be sure to tighten the Luer connection securely. You can check for moisture periodically by wrapping a tissue around the Luer connection between the cartridge and infusion set.

• When handling the cartridge, take care not to twist or turn the plunger in the cartridge body. Maintaining straight alignment of the plunger keeps the o-rings properly seated, which minimizes the possibility of introducing air into the cartridge and will prevent insulin spillage.

Changing the Cartridge

1. Disconnect infusion set from your body.

2. Unscrew the cartridge cap, leaving tubing connected to the cartridge.

3. With the tubing connected to the cartridge, pull cartridge straight out of your pump.

4. Disconnect tubing from cartridge and discard. Proceed with filling the new cartridge as outlined

above.

MAIN MENU

Home

Bolus Suspend/Resum History Basal Setup

Prime/Rewind

Status

ezPrime

Main Menu

Rewind

Load Cart Prime Fill Cannula

o o o o

REWIND MOTOR

Cancel

Disconnect

infusion set

from your body!

Go Rewind

REWIND MOTOR

Cancel

Disconnect

infusion set

from your body!

Go Rewind

REWIND

ACTIVE

Position:

160U

Stop

<<------<<------<<------

REWIND

ACTIVE

Please wait.

Full rewind

required.

<<------<<------<<------

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CHAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

Priming your Pump and Infusion Set

NOTE: As each step is completed, the check box on the ezPrime menu will be shaded.

 WARNING: Never prime the tubing or tighten the cartridge cap while infusion set is

connected to your body. Priming the tubing or tightening the cartridge cap while the infusion set is connected to your body can result in serious injury or death.

1. Make sure you are disconnected from your pump.

Insulin Pump

2. From the MAIN MENU, select “Prime/Rewind”.

Animas

3. On the ezPrime menu, “Rewind” is highlighted.

Press . The REWIND MOTOR screen is displayed.

4. Scroll up to “Go Rewind”. Press . Your pump

will rewind the piston rod.

NOTE: Before starting the rewind, your pump will vibrate as it performs a self test.

5. When the rewind action is complete, the REWIND COMPLETE screen is displayed. Your pump will

beep once to let you know the rewind is complete.

NOTE: If using a partially filled cartridge, you can select Stop during the Rewind Active function to stop the rewind at the position desired. After every third rewind, your pump is required to do a Full Rewind and will not offer the option of selecting the “Stop” position. A Full Rewind is always required when a battery is inserted.

ezPrime

Main Menu

Rewind

Load Cart

Prime Fill Cannula

o o o

REWIND

COMPLETE

Cancel

Load U100

cartridge.

Attach cap

Select Continue.

Continue

PRIME

Cancel

Be sure set is disconnected

from your body.

Then select

Continue.

Continue

Insulin: 200U

LOAD

CARTRIDGE

ACTIVE

>>------>>------>>------

Please wait.

DELIVER

PRIME

Cancel

Press AND HOLD

OK button

while priming

tubing.

Go Prime

Insulin: 200U

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HAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

nsert your filled cartridge.

6. I

7. Secure cartridge compartment cap to pump by turning in a clockwise motion until finger tight but

Do Not over tighten.

 WARNING: Never tighten the cartridge cap while the infusion set is connected to your body.

Tightening the cartridge cap while the infusion set is connected to your body can result in serious injury or death.

NOTE: If screen display has timed out while loading your cartridge, select Prime/Rewind from the MAIN MENU and highlight “Load Cart” from the ezPrime menu. Press to display the REWIND COMPLETE screen. Continue with Step 8.

Animas

Insulin Pump

8. On the REWIND COMPLETE screen, “Continue” is

highlighted. Press . Your pump will align the piston rod with the cartridge. The LOAD CARTRIDGE ACTIVE screen is displayed, followed by the PRIME screen. Your pump will beep once to let you know the cartridge is aligned with the piston rod.

9. On the PRIME screen, “Continue” is highlighted. Press .

10. The DELIVER PRIME screen is displayed. Be sure the infusion set is not

connected to your body until the prime is complete.

 WARNING: Never prime while the infusion set is connected to your body. Priming while the

infusion set is connected to your body can result in serious injury or death.

ezPrime

Main Menu

Rewind Load Cart Prime

Fill Cannula

nn nn nn

PRIMING

ACTIVE

Press AND HOLD

OK button

while priming

tubing.

>>------>>------>>------

Insulin: 177U

PRIMING

DONE

23U

177U

Primed

Remaining

FILL CANNULA

Main Menu

Amount

0.00

ezPRIME

Home

Pump

suspended.

Priming

disabled.

Rewind

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CHAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

11. M

ake sure “Go Prime” is highlighted. Press

and hold the button until you see 5 drops of

insulin come out the end of your infusion set. This means your tubing is primed. The PRIMING ACTIVE screen is displayed, followed by the PRIMING DONE screen.

Refer to the Instructions for Use included with your infusion set for proper insertion guidelines. See Selecting the Infusion Site and Inserting the Infusion Set, page 25 in this chapter.

Insulin Pump

Animas

12. From the ezPrime menu, “Fill Cannula” is

highlighted. Press the button. The FILL CANNULA screen is displayed.

NOTE: This step is not necessary for needle sets.

13. Use the / buttons to enter the amount of insulin needed to fill the cannula. Refer to the

Instructions for Use included with your infusion set for details on how much insulin is required to fill the cannula.

NOTE: The maximum Fill Cannula amount is 1U at a time.

If your pump is suspended, the screen will alert you with the ezPrime “Pump suspended” screen. You must resume delivery of your pump in order to complete the Priming function.

NOTE: The Fill Cannula step is not required for your pump to operate. For example, when you prime your pump after a battery change and you are not inserting a new infusion set, this step is not necessary. Filling the cannula when not necessary can result in unwanted delivery of insulin.

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HAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

Selecting the Infusion Site and Inserting the Infusion Set

Your health care team will review appropriate site selections and techniques for insertion based on your body type. Refer to the Instructions For Use included with your infusion set for proper insertion guidelines.

 WARNING: Do Not attempt to insert the infusion set into your body until you have been

trained by your health care team. Improper insertion of your infusion set can lead to death or serious injury.

Changing the Cartridge and Infusion Set

Cartridges and infusion sets require replacement and are not to be reused. Infusion sets should be replaced approximately every 2–3 days or as directed by your health care team. Refer to the insulin labeling and follow the direction of your health care team for frequency of replacing the cartridge.

 CAUTION: Occasionally check the infusion set tubing for any damage, air bubbles, leaks or

kinking, which may restrict or stop insulin delivery and result in under infusion.

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Insulin Pump

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CHAPTER 4 - G E T T I N G Y O U R P U M P R E A D Y

Insulin Pump

Animas

MAIN MENU

Home

Bolus

Suspend/Resum History Basal Setup Prime/Rewind Status

NORMAL BOLUS

Main Menu

Amount

0.00

NORMAL BOLUS

Main Menu

Amount

2.35

NORMAL BOLUS

Main Menu

Amount

2.35

DELIVERING

2.00

Press any

function button

to Cancel

Warning

Confirm

Bolus

delivery canceled by user button

press.

Delivered:

2.00U of 2.35U

Draft. 410-106-00 Rev. A

CH A PT ER 5 - US I NG THE NOR M AL BO LU S F E ATUR E

This chapter covers the basics of a Normal bolus, which is used to cover food you have eaten and high BG.

Your pump also offers advanced bolus features. See Chapter 10 in Section I, pages 49–58.

1. From the MAIN MENU, select “Bolus”.

2. The cursor will flash over the amount field to

indicate that it can be edited. Use the / buttons to enter desired bolus amount. Press .

3. Go is highlighted. Press to deliver the bolus.

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Insulin Pump

4. The DELIVERING bolus screen is displayed. If you have activated the Normal

Bolus sound in the SETUP SOUND menu, your pump will beep to confirm start of delivery, as well as when delivery is complete.

NOTE: During a bolus delivery, you can stop delivery at any time by pressing any button on the front panel of your pump. The Warning screen shown here will be displayed. Confirm the Warning by pressing and check your Bolus History for the amount delivered.

NOTE: You can check when you last gave a bolus by looking in History or Status. These features are covered later. See Chapter 8, pages 39–44, and Chapter 9, pages 45–48, in Section I.

BOLUS MENU

Main Menu

Normal

ezCarb ezBG Combo Bolus Reminders

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CHAPTER 5 - U S I N G T H E N O R M A L B O L U S F E ATURE

NOTE: If you have Advanced Bolus and Reminders features turned on, the BOLUS MENU at right will be displayed when you select “Bolus” from the MAIN MENU. Select Normal and press . Follow steps 2 through 4 in this chapter.

Insulin Pump

Animas

MAIN MENU

Home

Bolus Suspend/Resum History

Basal

Setup Prime/Rewind Status

BASAL MENU

Main Menu

Total 0.00U

Temp

A1-WEEKDAY

BASAL MENU

Main Menu

Total 0.00U

Temp

A1-WEEKDAY 2-other

3-weekend 4-exercise

Draft. 410-106-00 Rev. A

CH A PT ER 6 - US I NG B ASAL PRO G RA M FEAT URE S

You can program your pump to display either 1 or 4 basal program options. Basal insulin is delivered continuously to help keep your BG in target between meals. Having more than one pre-set basal program makes it easy for you to switch based on your needs including weekends, weekdays, shiftwork, and menstruation. If you are new to pumping, your health care team may suggest you first become comfortable with one program before using multiple basal programs. The factory default displays one basal program and the temporary basal program. To display multiple basal options, see Chapter 10 in Section I, pages 49–58.

You can use your computer and ezManager rates. For instructions on uploading basal program information, refer to the ezManager included with the software.

Software to upload basal program names as well as basal

User Guide

Setting a Basal Program

Each basal program can be set with up to 12 different basal rates (doses) in a 24-hour period. These 12 start times can be set to accommodate your changing basal needs throughout the day. For example, your body may need more insulin in the early morning to compensate for the “dawn phenomenon.” You can program time segments to begin at any hour or half hour.

Animas

Insulin Pump

NOTE: The / buttons will move the cursor through fields when not in Edit mode. When in Edit mode, the / buttons will change the value of the field. If the cursor is flashing, that means you can edit the entry. Use the button to start/stop Edit mode.

Use the My Information chart in Chapter 17 in Section I, pages 95–98 to record and enter your basal program times and doses as recommended by your health care team.

1. From the MAIN MENU, select “Basal”.

The BASAL MENU displays the following:

Total basal insulin programmed for the 24-hour

•

period

Temp (if you wish to program a Temporary Basal rate)

•

The active basal program, designated by number

•

and by name, as well as an “A” to indicate the active program. (If you have activated multiple basal programs in the Setup Advanced menu, all 4 basal program options will be displayed as shown below, right.)

BASAL OPTIONS

Main Menu

A1-WEEKDAY Total 0.00U

Clear

Edit

Review Go

EDIT BASAL

Save/Review

Total 0.60U

12:00A

--:--

Start

U/Hr

0.025

--.---

EDIT BASAL

Save/Review

Total 13.60U

12:00A

4:00A

--:--

Start

U/Hr

0.025

0.675

--.---

EDIT BASAL

Save/Review

Total 0.60U

12:00A

4:00A

Start

U/Hr

0.025

--.---

EDIT BASAL

Save/Review

Total 0.00U

12:00A

--:--

Start

U/Hr

0.000

--.---

BASAL MENU

Main Menu

Total 0.00U

Temp

A1-WEEKDAY

Draft. 410-106-00 Rev. A

CHAPTER 6 - U S I N G B A S A L P R O G R A M F E ATURES

2. Scroll to select the program “1-WEEKDAY” and press .

NOTE: You do not have to Suspend your pump to edit an active program. When you select “Edit” from the BASAL MENU, your pump automatically suspends delivery. When you exit the Edit mode, the active program

delivery automatically resumes.

3. The BASAL OPTIONS screen is displayed. “Edit” is highlighted. Press

the button. From the EDIT BASAL screen, you can edit the basal segments of the selected program.

Insulin Pump

Animas

activate Edit mode (indicated by flashing cursor).

5. Use / buttons to set desired basal rate. Press to confirm

4. Scroll to the desired “U/Hr” field. Press to

and exit Edit mode for this field.

6. Scroll down to select the next “Start” time field. Press the button

to activate Edit mode (indicated by flashing cursor).

NOTE: The next available empty basal segment will appear automatically as you program the previous segment. If the next empty basal segment does not appear, you have programmed all 12 possible segments.

7. Change next “Start” time field as desired, press the button to exit Edit

mode. Segments can start on the hour or half hour.

NOTE: The 24-hour Total changes automatically as you change U/Hr settings.

BASAL OPTIONS

Main Menu

A1-WEEKDAY Total 13.60U

Clear Edit

Review

BASAL OPTIONS

Main Menu

A1-WEEKDAY Total 13.60U

Clear Edit Review

Warning

Edit Basal

Basal edit not saved.

Basal

delivery

suspended.

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HAPTER 6 - U S I N G B A S A L P R O G R A M F E ATURES

ontinue until basal segments have been set as recommended by your health care team.

8. C

9. When finished, scroll to “Save/Review” and press . If you have edited the active program, it is

now resumed automatically. The BASAL OPTIONS screen is displayed.

NOTE: If your screen display has timed out (gone to sleep) before you have selected Save/Review while editing, a Warning screen will remind you the basal edit has not been saved. See Chapter 13 in Section I, pages 75–84.

10. “Review” is highlighted. Press to review your entries for accuracy.

Your basal segment settings are shown (5 on first screen, 5 on second screen and 2 on last screen). If you have more than 5 segments programmed, scroll to “Next” to see second and third screens as desired.

11. “Options” is highlighted. Press . The BASAL OPTIONS screen is displayed.

a. If you’ve edited and saved/reviewed the active program, it is resumed

automatically. You can also select “Go” and the Home screen is displayed, which shows the current rate of delivery for the program that is active.

b. If you’ve edited an inactive program and wish to activate it, select “Go”

from the BASAL OPTIONS screen. When you select “Go”, the Home screen is displayed, which shows the current rate of delivery for the program that is active.

Animas

Insulin Pump

Adding/Changing Segments in an Existing Basal Program

1. From the BASAL MENU, select desired program.

2. “Edit” is highlighted. Press .

3. Scroll up to highlight the field you wish to change or to next available blank line to add a segment.

Press to activate Edit mode. (The cursor will flash to indicate Edit mode.)

4. Use / buttons to set Start times and U/Hr amounts.

5. Check that the AM/PM settings are correct.

BASAL OPTIONS

Main Menu

A1-WEEKDAY Total 13.60U

Clear Edit

Review

A1-WEEKDAY

Options

Total 13.60U

12:00A

4:00A

--:--

Start

U/Hr

0.025

0.675

--.---

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CHAPTER 6 - U S I N G B A S A L P R O G R A M F E ATURES

NOTE:

• If you program a segment to start at the same time as an existing segment, the previously entered segment is deleted.

• If you program a segment to start at a time that precedes an existing segment, the new segment is automatically inserted in the correct place. You must then scroll to the new segment, highlight the

corresponding U/Hr field and enter or change amount, if desired.

6. When finished, scroll to “Save/Review” and press . If you have edited the active program, it is

now resumed automatically. The BASAL OPTIONS screen is displayed.

a. Select “Review” from the BASAL OPTIONS screen to review your entries for accuracy. Your basal

segment settings are shown (5 on first screen, 5 on second screen and 2 on last screen). If you have

Insulin Pump

more than 5 segments programmed, scroll to “Next” to see second and third screens as desired.

b. If you’ve edited an inactive program, select the program from the BASAL MENU. Press . Select

“Go” from the BASAL OPTIONS screen to activate the program you’ve selected.

Animas

When you select “Go”, the Home screen is displayed, which shows the current rate of delivery for the program that is active. (Or you can simply wait for your pump display to time out. When you press any button, your active basal program rate information is displayed on the Home screen.)

 CAUTION: Always review changes to your basal program to be sure they are correct. Incorrect

basal rates can result in under or over delivery of insulin. See Reviewing Basal Programs, page 32 in this chapter.

Reviewing Basal Programs

1. From the BASAL MENU, scroll to highlight desired

program. Press .

2. Scroll to “Review” from the BASAL OPTIONS

screen. Press . Your basal segment settings are shown (5 on first screen, 5 on second screen and 2 on last screen). If you have more than 5 segments programmed, scroll to “Next” to see second and third screens as desired.

3. When finished, “Options” is highlighted. Press .

4. Scroll to “Main Menu” and press . The MAIN MENU screen is displayed. The active basal program

continues.

5. If reviewing an inactive program and you wish to activate it, select the program you wish to activate

from the BASAL MENU screen. Press .

6. Select “Go” from the BASAL OPTIONS screen to activate the program. The Home screen is displayed

to show the current rate per hour of the program you have activated.

Alert

Clear Program

Basal Options

Clear Program

deletes all

basal segments

in this program.

BASAL OPTIONS

Main Menu

A1-WEEKDAY Total 13.60U

Clear

Edit Review Go

Alert

Confirm

Basal Menu

Your active

basal

program

is empty

0.000U/Hr

BASAL MENU

Main Menu

Total 0.00U

Temp

A1-WEEKDAY

BASAL MENU

Main Menu

Total 0.00U

Temp

A1-WEEKDAY 2-other

3-weekend 4-exercise

HAPTER 6 - U S I N G B A S A L P R O G R A M F E ATURES

Clearing Basal Programs

This feature allows you to clear all information from a basal program.

1. From the BASAL MENU, scroll to desired program.

2. From the BASAL OPTIONS screen, scroll to “Clear”. Press .

If you press to select “Clear”, your pump will check to be sure you want to clear all the segments of the basal program selected. The Alert screen shown here is displayed. If you do wish to clear all the basal segments of the selected program, scroll to “Clear Program” and press .

If you do not wish to clear all the basal segments, scroll to “Basal Options” and press . The BASAL OPTIONS screen will be displayed.

Draft. 410-106-00 Rev. A

Animas

Insulin Pump

If all segments of your active basal program are set to 0.000U/Hr your pump will not deliver any basal insulin. Each time you wake up your pump, the Alert screen shown here is displayed. If you have turned on the sound for Alerts, you will also be notified by a beep or vibrate. This Alert screen does not progress to higher audible alarms. You have the option to either select “Confirm” to quickly go to the MAIN MENU screen or select “Basal Menu” to reset rates in your active program. For more information see Chapter 13 in Section I, pages 75–84.

Temporary Basal Feature

This feature allows you to increase your active basal delivery rate for events such as sick days or decrease for events such as exercise. You can decrease your basal rate by 90% (in 10% decrements) or increase your basal rate by 200% (in 10% increments). You can also set to OFF. You can set the duration up to 24 hours in half-hour increments. (If you have activated multiple basal programs in the Setup Advanced menu, all 4 basal program options will be displayed as shown on screen example below, right.)

 CAUTION: The lowest basal delivery amount possible is 0.025U/Hr. The highest basal

delivery amount possible is 25U/Hr or the Max Basal amount you set in the Setup Advanced menu in chapter 11.

1. From the BASAL MENU, scroll to “Temp”.

Press .

A1-WEEKDAY

Main Menu

TEMP BASAL

-40%

4.0Hr

Change:

Duration:

A1-WEEKDAY

Main Menu

TEMP BASAL

-40%

2.0Hr

Change:

Duration:

2 : 27

Status

TEMP BASAL

-40% 4.0 Hr

Time Left 1.2 Hr

Insulin: 105U

A1-WEEKDAY

Main Menu

TEMP BASAL

4.0Hr

Change:

Duration:

Alert

Temp Active

Minimum

Basal rate

limited to

0.025U/Hr

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CHAPTER 6 - U S I N G B A S A L P R O G R A M F E ATURES

he “Change” % field will flash to indicate Edit

2. T

mode. Use the / buttons to enter the percentage change desired. Press the button to exit Edit mode.

3. The “Duration” field is highlighted. Press to activate Edit mode.

Insulin Pump

Animas

4. Use the / buttons to enter the duration desired. Press to exit Edit mode.

5. “Go” is highlighted. Press to activate Temp Basal.

 CAUTION: The lowest basal delivery amount possible is 0.025U/Hr.

When you set a negative temporary basal rate, your pump will beep and display an Alert screen to remind you of the minimum delivery limit. This screen will display once for 5 seconds and give one audible alert (if you turned on Alert sounds in Setup).

6. The Home screen is displayed and shows your Temp Basal is active, the

percentage change, the duration and how much time is left. When the duration of time is complete, your pump will automatically resume the active basal program.

NOTE: If you turned on the Temp Basal sound in Setup, your pump will beep once every 30 minutes to remind you of Temp Basal status.

A1-WEEKDAY

Main Menu

TEMP ACTIVE

CANCEL

0.675 U/Hr

-40%

= 0.405 U/Hr

Time left

1.2 Hr

Alert

Pump Suspended

If active,

Temp Basal &

Combo Bolus

have been

canceled.

HAPTER 6 - U S I N G B A S A L P R O G R A M F E ATURES

Canceling a Temporary Basal Program

1. From the BASAL MENU, select “TEMP BASAL”. Press .

2. Details of the current active Temp Basal program will be displayed. Scroll up

to “CANCEL” and press .

Draft. 410-106-00 Rev. A

Your previously active basal program will be activated and the Home screen will be displayed to show the current rate per hour of the active basal program.

NOTE: If you Suspend your pump while a Temp Basal program is active, the Temp Basal program will be canceled and an Alert screen will notify you that the Temp Basal program has been canceled. This Alert is displayed once and gives an audible tone once (if you turned on Alert sounds in Setup). Temp Basal is also canceled when you change the battery and/or prime.

 CAUTION: When you switch to another basal program or set a Temp Basal, you will most

likely be changing the total insulin units delivered over a period of time. Be sure to review the total insulin units before you switch basal programs or set a Temp Basal. Units that are too high or too low may result in a hypoglycemic or hyperglycemic event.

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CHAPTER 6 - U S I N G B A S A L P R O G R A M F E ATURES

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2 : 27

Status

SUSPENDED

Basal Rate

0.675U/Hr

Insulin: 105U

MAIN MENU

Home

Bolus

Suspend/Resum

History Basal Setup Prime/Rewind Status

Pump

Delivery

Suspend

Main Menu

Alert

Pump Suspended

If active,

Temp Basal &

Combo Bolus

have been

canceled.

Warning

Confirm

No delivery.

Pump is

suspended.

Draft. 410-106-00 Rev. A

CH A PT ER 7 - S U SP E ND / RES UM E FE AT UR E

This feature allows you to stop and restart delivery quickly and easily.

It also cancels delivery of any Temp Basal or Bolus, including Combo Bolus that may be currently active. The Combo Bolus feature is covered in Chapter 10 in Section I, pages 49–58.

Suspending Delivery

1. From the MAIN MENU, scroll to “Suspnd/Resum” and press .

2. “Suspend” is highlighted. Press .

The screen will display a message reminding you that this mode not only suspends your active basal delivery but also cancels any Temp Basal or Combo Bolus that may be active.

Animas

Insulin Pump

NOTE: Periodically, your pump will beep (or vibrate if that is the setting you selected) to remind you of the Suspend status. If not confirmed, the beeps will progress to high volume in one hour. You can confirm the Warning to reset the audible sequence. See Chapter 13 in Section I, pages 75–84.

3. The Home screen is then displayed, showing that pump deliveries are

suspended.

MAIN MENU

Home

Bolus

Suspend/Resum

History Basal Setup Prime/Rewind Status

Pump

Suspended

at 1:13PM

Oct 2, 2007

Resume

Main Menu

2 : 27

Status

Basal Rate

0.025U/Hr

Insulin: 105U

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CHAPTER 7 - S U SPEND/RESUME FEATURE

Resuming Delivery

1. From the MAIN MENU, scroll down to “Suspnd/Resum” and press .

Insulin Pump

Resume” is highlighted. Press .

“

Animas

3. The Home screen is displayed to show you that your pump is no longer in

Suspend mode. Your previously active basal program is automatically resumed.

MAIN MENU

Home

Bolus Suspend/Resum

History

Basal Setup Prime/Rewind Status

HISTORY

Main Menu

Bolus

Total Daily

Dose (TDD) Alarm Prime Suspend Basal

BOLUS

History Menu

Record 1

NORMAL (P)

ezCarb

Mar 23, 2007

1:13PM

2.80U of 2.80U

COMPLETED

CH A PT ER 8 - HI S TO RY F EAT U RE

Draft. 410-106-00 Rev. A

Your pump stores important records for your review. You can access your pump’s history and view it directly on your pump screen or download it onto your computer using ezManager to the User Guide included with the software. Certain information on your pump history screens will include a “(P)” or “(M)”. This indicates if the action was initiated from your pump (P) or your meter remote (M) when you begin using the devices together as a system (see Chapter 1 in Section III, pages 173–174).

Your pump stores basal rates, boluses, alarms and settings. Your pump stores these records indefinitely, even when batteries are removed.

From the MAIN MENU, select “History”. The HISTORY menu is displayed.

Software. Refer

Bolus History

Your pump displays the last 500 Bolus records.

Animas

Insulin Pump

NOTE: BG values and carb values are not displayed on your pump. However, when you download your pump history with ezManager ezManager

1. From the HISTORY menu, select “Bolus”. This screen displays the following:

Bolus Record number

•

Date of bolus

•

Time of bolus

•

Type of bolus delivered and whether it was

•

initiated from your pump (P) or meter remote (M)

˚ ˚ ˚

Amount of bolus programmed and delivered

•

Status of bolus

•

˚ ˚ ˚

If the bolus was initiated from your pump(P) or meter remote(M)

•

If ezBG or ezCarb was used

•

Software reports.

Normal

Combo

Audio

ACTIVE

COMPLETED

CANCELED

Software, the BG and carb values (500 total) will be displayed on the

TDD

History Menu

Record 1

Temp Suspend

Bolus Basal

TOTAL

Mar 23, 2007

No No

6.200U

0.700U

6.900U

HISTORY

Main Menu

Bolus

Total Daily

Dose (TDD)

Alarm Prime Suspend Basal

BOLUS

History Menu

Record 2

NORMAL (P)

ezBG

Mar 23, 2007

2:13PM

0.80U of 3.80U

CANCELED (M)

Draft. 410-106-00 Rev. A

CHAPTER 8 - H I S TORY F E ATURE

2. Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing cursor).

3. Record 1 indicates the most recent record. Use the / buttons to scroll

to other records.

4. When finished reviewing, press to exit Review Mode.

Insulin Pump

History Menu” is highlighted. Press to return to the HISTORY menu.

“

Animas

Total Daily Dose (TDD) History

Your pump displays the last 120 TDD records.

1. From the HISTORY menu, select “TDD”. This

screen displays the following:

Record number

•

Date of record

•

If Temp Basal was active on that date

•

If Suspend was activated on that date

•

Total Bolus for the date

•

Total Basal for the date

•

Total dose for the date

•

NOTE: Each daily total is the total delivered since midnight.

2. Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing

cursor).

3. Record 1 indicates the most recent record. Use the / buttons to scroll to other records.

4. When finished reviewing, press to exit Review Mode.

5. “History Menu” is highlighted. Press to return to the HISTORY menu.

HISTORY

Main Menu

Bolus Total Daily

Dose (TDD)

Alarm

Prime Suspend Basal

ALARM

History Menu

Record 1

Code XXX-XXX

Mar 23, 2007

1:13PM

EMPTY CARTRIDGE

HISTORY

Main Menu

Bolus Total Daily

Dose (TDD) Alarm

Prime

Suspend Basal

PRIME

History Menu

Record 1

Fill Cannula Total 1.0U

Mar 23, 2007

01:15PM

PRIME

History Menu

Record 2

Primed Total 23.7U

Mar 23, 2007

01:13PM

HAPTER 8 - H I S TORY F E ATURE

Alarm History

Your pump displays the last 30 Alarm records.

1. From the HISTORY menu, select “Alarm”. The

screen displays the following:

Draft. 410-106-00 Rev. A

Record number

•

Date of alarm

•

Time of alarm

•

Alarm Code

•

Alarm Type

•

2. Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing

cursor).

3. Record 1 indicates the most recent record. Use the / buttons to scroll to other records.

4. When finished reviewing, press to exit Review Mode.

5. “History Menu” is highlighted. Press to return to the HISTORY menu.

Prime History

Your pump displays the last 60 Prime and Fill Cannula records. Prime and Fill Cannula records are stored as separate records.

Animas

Insulin Pump

1. From the HISTORY menu, select “Prime”.

The screen displays the following:

Record number

•

Date of prime

•

Time of prime

•

Amount of prime

•

2. Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing

cursor).

3. Record 1 indicates the most recent record. Use the / buttons to scroll

to other records.

HISTORY

Main Menu

Bolus Total Daily

Dose (TDD) Alarm Prime

Suspend

Basal

SUSPEND

History Menu

Record 1

Resumed

Mar 23, 2007

01:13PM

Mar 23, 2007

01:13PM

Suspended

HISTORY

Main Menu

Bolus Total Daily

Dose (TDD) Alarm Prime Suspend

Basal

BASAL

History Menu

Record 1

Rate = 0.670

Mar 23, 2007

01:13PM

Draft. 410-106-00 Rev. A

CHAPTER 8 - H I S TORY F E ATURE

4. When finished reviewing, press to exit Review Mode.

History Menu” is highlighted. Press to return to the HISTORY menu.

“

Suspend History

Your pump displays the last 30 Suspend records.

1. From the HISTORY menu, select “Suspend”. The

screen displays the following:

Record number

•

Date and time pump delivery was suspended

•

Insulin Pump

Animas

Date and time pump delivery was resumed

•

2. Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing

cursor).

3. Record 1 indicates the most recent record. Use the / buttons to scroll to other records.

4. When finished reviewing, press to exit Review Mode.

History Menu” is highlighted. Press to return to the HISTORY menu.

“

Basal History

Your pump displays the last 270 Basal delivery records.

1. From the HISTORY menu, select “Basal”. The

screen displays the following:

Record number

•

Date and time basal rate was adjusted

•

Basal rate adjustment

•

2. Scroll up to highlight the record field. Press to activate Review Mode (indicated by flashing

cursor).

3. Record 1 indicates the most recent record. Use the / buttons to scroll to other records.

4. When finished reviewing, press to exit Review Mode.

“

History Menu” is highlighted. Press to return to the HISTORY menu.

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HAPTER 8 - H I S TORY F E ATURE

NOTE: The History records each basal rate change. When no basal is being delivered, the Basal History Record will show 0 units delivered. This can happen for the following reasons:

Cartridge change

•

Battery change

•

Suspend

•

Alarm

•

Basal segment set to 0

•

Basal edit screen accessed

•

Prime menu accessed

•

Loss of prime

•

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CHAPTER 8 - H I S TORY F E ATURE

Insulin Pump

Animas

MAIN MENU

Home

Bolus Suspend/Resum History Basal Setup Prime/Rewind

Status

2 : 27

Status

Basal Rate

0.025U/Hr

Insulin: 105U

STATUS 1

Main Menu

ACTIVE BASAL

24-Hr Total

13.60U

0.675U/Hr

Insulin: 105U

A1-WEEKDAY

STATUS 2

Main Menu

IOB=1.70U

N 3.30U 9:55AM Jul 8, 2007

LAST BOLUS

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CH A PT ER 9 - S TATU S F E ATU R E

This feature gives you easy access to a summary of information about your pump’s current programming and performance. There are six Status screens.

1. From the MAIN MENU or from the Home screen, scroll to “Status” and press .

Status Screen 1 – Active Basal

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Insulin Pump

The screen displays the following information:

Which basal program is currently active

•

The 24-hour total for the active basal program

•

Units per hour currently being delivered

•

Insulin currently remaining in cartridge

•

The cursor is flashing on the STATUS 1 screen. Press the button to move to the STATUS 2 screen or press to highlight “Main Menu” and exit Status screens.

Status Screen 2 – IOB, Last Bolus

The screen displays the following information:

Amount of insulin currently “on board” (IOB). For more information on this feature, see Chapter 10 in

•

Section I, pages 49–58.

Type and amount of last completed bolus

•

N = Normal

C = Combo (normal portion only)

A = Audio

Time and date of last bolus

•

The cursor is flashing on the STATUS 2 screen. Press the button to move to the STATUS 3 screen or press to highlight “Main Menu” and exit Status screens.

STATUS 3

Main Menu

DELIVERY TODAY

Temp Suspend

Bolus Basal

TOTAL =

No No

9.400U 0

.200U

.600U

U100

STATUS 4

Main Menu

COMBO BOLUS

Start End

Delivered:

3.28/9.00U

CANCELLED

7:23AM 7:31AM

Mar 23, 2007

STATUS 5

Main Menu

TEMP BASAL

Start End Change:

ACTIVE

4:00PM 6:00PM

-50%

Mar 23, 2007

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CHAPTER 9 - STAT U S F E ATURE

Status Screen 3 – Delivery Today

The screen displays the following information since midnight and up to the current time:

Insulin type

•

If Temp Basal has been active

•

If Suspend has been active

•

Total bolus amount delivered

•

Total basal amount delivered

•

Total insulin delivered (excluding prime amounts)

•

Insulin Pump

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The cursor is flashing on the STATUS 3 screen. Press the button to move to the STATUS 4 screen or press to highlight “Main Menu” and exit Status screens.

Status Screen 4 – Combo Bolus

The screen displays the following information:

Most recent Combo Bolus status

•

Active or Completed or Canceled

Start date

Start time

End time

Amount delivered (if active, shows amount delivered as of current time)

For more information on Combo Bolus, see Chapter 10 in Section I, pages 49–58.

The cursor is flashing on the STATUS 4 screen. Press the button to move to the STATUS 5 screen or press to highlight “Main Menu” and exit Status screens.

Status Screen 5 – Temp Basal

The screen displays the following information:

•

The cursor is flashing on the STATUS 5 screen. Press the button to move to the STATUS 6 screen or press to highlight “Main Menu” and exit Status screens.

Most recent Temp Basal status

Active/Inactive

Start date

Start time

End time

% adjustment

STATUS 6

Main Menu

CODES

REV M=XXX.XX.XX D=XXX P=XXX S/N# 76543-21

HAPTER 9 - STAT U S F E ATURE

Status Screen 6 – Codes

The screen displays the following information:

Software revision

•

Last seven digits of the serial number of your pump

•

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Codes for manufacturer’s use

•

The cursor is flashing on the STATUS 6 screen. Press to highlight “Main Menu” and exit Status screens.

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Insulin Pump

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CHAPTER 9 - STAT U S F E ATURE

Insulin Pump

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MAIN MENU

Home

Bolus Suspend/Resum History Basal

Setup

Prime/Rewind Status

SETUP

Main Menu

Time/Date

Sound

Advanced

SETUP ADV 1

Home

AUDIO BOLUS

Enable OFF

Delivery

Step 0.1U

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CH A PT ER 10 - AD VA NC ED F E ATU R ES / SE T UP A ND A CTI VAT IO N

Now you’ve made it through the basics! Your pump offers many advanced features that you may find helpful in managing your diabetes. Consult with your health care team to determine which advanced features are appropriate for you.

This chapter tells you how to set up and turn on the advanced features. Chapter 11 in Section I, pages 59–72, covers how to use each advanced feature.

You can also use your computer and ezManager Refer to the ezManager

From the MAIN MENU screen, select “Setup”. Then select “Advanced” from the SETUP screen and press .

User Guide included with the software.

Software to upload settings for Advanced Setup.

Setup Advanced Screen 1 – Audio Bolus Feature

This screen allows you to:

Turn Audio Bolus on or off

•

Select the Audio Bolus delivery step size

•

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Insulin Pump

0.1, 0.5, 1.0, 5.0 Units

1. Use the / buttons to scroll to the desired field.

2. Press to change to flashing cursor for Edit mode.

3. Use the / buttons to change to desired setting.

4. Press when setting is made.

NOTE: If Audio Bolus is activated, you cannot use the side button as a shortcut to Normal Bolus. You can still give a Normal Bolus via the MAIN MENU.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press . For more information, see Chapter 11 in Section I, pages 59–72.

SETUP ADV 2

Home

BOLUS

Adv. Bolus Reminders Delivery

Programs 4

OFF OFF

NRML

BASAL

Alert

1-weekday

must be the

active program

to change the

basal display

setting.

Confirm

SETUP ADV 3

Home

Max LIMITS

Basal

Bolus

Daily

2Hr

25.00U/Hr

35.00U

600.00U

100.00U

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CHAPTER 10 - A D VANCED FEAT U R E S / S E T U P A N D ACTIVAT I O N

Setup Advanced Screen 2 – Advanced Bolus Features and Multiple Basal Programs

This screen allows you to:

Turn Advanced Bolus Features (ezCarb, ezBG, Combo Bolus) on or off

•

Turn personal Reminders feature on or off

•

Select bolus delivery speed (NRML (normal): 1U every second

•

or SLOW: 1U every 4 seconds)

NOTE: Users may experience a slight stinging sensation with normal bolus delivery. If this occurs changing the bolus delivery speed to “SLOW” may reduce the stinging sensation.

Select either 1 basal program or 4 basal programs to be displayed in the BASAL MENU

Insulin Pump

•

NOTE: If a program other than 1-Weekday is active, you cannot change this setting to display 1 basal program. The Alert screen shown here will be

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displayed to remind you.

1. Scroll to the desired field.

2. Press to change to flashing cursor for Edit mode.

3. Use the / buttons to change to desired setting.

4. Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press .

Setup Advanced Screen 3 – Insulin Limits

This screen allows you to:

Set maximum basal delivery per hour

•

Set maximum bolus amount

•

Set maximum daily (24-hour) delivery amount. Your pump checks that total

•

insulin delivery each 24-hour period (running from midnight of the previous day to midnight of the current day) does not exceed this limit.

Set maximum 2-hour delivery amount. Your pump checks that total insulin

•

delivery over each rolling 2-hour period does not exceed this limit.

1. Scroll to the desired field.

2. Press to change to flashing cursor for Edit mode.

3. Use the / buttons to change to desired setting.

4. Press when setting is made.

SETUP ADV 4

Home

Language ENGLISH Display Timeout in 60 secs Contrast

Battery Lith

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HAPTER 10 - A D VANCED FEATUR E S / S E T U P A N D ACTIVAT I O N

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press .

 CAUTION: Should you attempt a delivery that exceeds the limits you have set, your pump will

alert you and display a text message. See Chapter 13 in Section I, pages 75–84 for additional information.

Setup Advanced Screen 4 – Language Setup, Display Timeout, Contrast and Battery Type

This screen allows you to:

Select a different language

•

Set the length of time your display stays on before timing out to save

•

battery life

15, 30, 45 or 60 seconds

Select a contrast setting

•

Select Lithium (recommended) or Alkaline battery type. You can also change the battery type on the

•

VERIFY screen when you insert a new battery.

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Insulin Pump

1. Scroll to the desired field.

2. Press to change to flashing cursor for Edit mode.

3. Use the / buttons to change to desired setting.

4. Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press .

Contrast Button

Pressing the button on the top of your pump adjusts the contrast. There are three contrast levels: Dim, Default and Bright. To preserve battery life, your pump display will Auto-dim when a button is not pressed for half the time your display time out is set. While in Auto-dim mode, you can restore the default contrast level you have set by pressing the button on top of your pump. Pressing a function button while in Auto-dim mode will restore the default contrast level as well as perform the function of the key. If in Call Service Alarm mode, you must use the button to restore the default contrast level.

SETUP ADV 5

Home

AUTO OFF

Enable

OFF

hen enabled,

suspend in 12 Hr

if no buttons

are pressed.

SETUP ADV 6

Home

Low Cartridge

Warning 20U

Occlusion

Sensitivity L

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CHAPTER 10 - A D VANCED FEAT U R E S / S E T U P A N D ACTIVAT I O N

o return contrast setting to original factory default, press the button and button at the same

T time. When the word “Contrast” is displayed on the screen, press any button to return to the default contrast setting.

NOTE: When viewing your pump display in bright sunlight, it is recommended you shade the screen or move to a shady area for best visibility.

Setup Advanced Screen 5 – Auto-OFF Feature

This screen allows you to set your pump to automatically suspend basal delivery and sound an alarm if no buttons are pressed in a user-selected number of hours. This feature can be used as a safeguard in case the user is unconscious.

Insulin Pump

1. Scroll to the desired field.

2. Press to change to flashing cursor for Edit mode.

3. Use the / buttons to change to desired setting.

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4. Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight Next. Press .

To return to the Home screen, scroll to “Home” and press .

Setup Advanced Screen 6 – Low Cartridge Warning Setting and Occlusion Sensitivity Setting

This screen allows you to:

Set your low cartridge warning to alert you at 10, 20, 30, 40 or 50 units remaining

•

Set your occlusion detection sensitivity to High (more sensitive) or Low (less sensitive)

•

1. Use the / buttons to scroll to the desired field.

2. Press to change to flashing cursor for Edit mode.

3. Use the / buttons to change to desired setting.

4. Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press .

I:C Ratio

2 of 12

Done

Time:

6:00A

1U: 15g

Home

<<---- ---->>

Warning

Confirm

Low

cartridge.

10U or

ess left.

SETUP ADV 7

Home

I:C Ratio

ISF

BG Target

I:C Ratio

1 of 12

Done

Time:

12:00A

1U: 13 g

Home

<<---- ---->>

HAPTER 10 - A D VANCED FEATUR E S / S E T U P A N D ACTIVAT I O N

NOTE:

The Low Cartridge Warning only alerts you one time. For example, if you

•

have it set to 30U and receive an alert, and then change the setting to 20U, it will not alert at 20U until after the next cartridge has been primed.

If a bolus is delivered which causes a Low Cartridge Warning, your

•

remaining insulin may be less than the Warning screen displays.

Draft. 410-106-00 Rev. A

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Setup Advanced Screen 7 – Personal Settings - Insulin to Carb (I:C) Ratios

Your health care team may recommend you use different Insulin to Carb (I:C) ratios for different times of day. When you use the ezCarb feature, your pump will automatically select the I:C ratio for the current time of day.

 WARNING: Your health care team will determine your personal settings for the bolus calculator

feature. Use of incorrect personal settings can result in over or under delivery of insulin.

This screen allows you to:

Set different I:C ratios for 12 different time slots

•

NOTE: If you set only one ratio, it will be used for the entire 24-hour period.

From the SETUP ADV 7 screen, scroll up to “I:C Ratio”. Press .

1. The first segment always starts at midnight. The last time slot available

is 11:30pm. Use the / buttons to scroll to the “1U:” (grams) field.

Insulin Pump

2. Press to change to flashing cursor for Edit Mode.

3. Use the / buttons to change to desired setting.

4. Press when setting is made.

5. To move to the next I:C Ratio screen, scroll to “

6. Scroll up to the “Time” field and press to change to flashing cursor

for Edit Mode.

7. Use the / buttons to change the segment start time. Press .

--->>

”

and press .

SETUP ADV 7

Home

I:C Ratio

ISF

BG Target

ISF

1 of 12

Done

Time:

12:00A

1U: 40

Home

<<---- ---->>

mg/dL

ISF

2 of 12

Done

Time:

6:00A

1U: 50

Home

<<---- ---->>

mg/dL

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CHAPTER 10 - A D VANCED FEAT U R E S / S E T U P A N D ACTIVAT I O N

8. Scroll to the “1U:” (grams) field and press to change to flashing cursor for Edit mode.

9. Use the / buttons to change the “1U:” (grams) field as desired. Press . Repeat to set

remaining segments per your health care team’s recommendations.

”

To review your settings, highlight “

times and setting values are correct.

and press to scroll through each segment. Confirm the

--->>

When finished, scroll to “Done” and press to return to the SETUP ADV 7 screen.

To return to the Home screen, scroll to “Home” and press .

Setup Advanced Screen 7 – Personal Settings - Insulin Sensitivity Factor (ISF)

Insulin Pump

Your health care team may recommend you use different Insulin Sensitivity Factors (ISFs) for different times of day. When you use the ezCarb or ezBG feature, your pump will automatically select the ISF for the current time of day.

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This screen allows you to:

Set different ISFs for 12 different time slots

•

NOTE: If you set only one ratio, it will be used for the entire 24-hour period.

From the SETUP ADV 7 screen, scroll up to “ISF”. Press .

1. The first segment always starts at midnight. The last time slot available is

11:30pm. Use the / buttons to scroll to the “1U:” (mg/dL) field.

2. Press to change to flashing cursor for Edit mode.

3. Use the / buttons to change to desired setting.

4. Press when setting is made.

5. To move to the next ISF screen, scroll to “

6. Scroll up to the “Time” field and press to change to flashing cursor for

Edit mode.

--->>

”

and press .

SETUP ADV 7

Home

I:C Ratio

ISF

BG Target

1 of 12

Done

Time:

12:00A

120

+/- 10

Home

<<---- ---->>

mg/dL mg/dL

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BG Target

1 of 12

Done

Time:

12:00A

120

+/- 5

Home

<<---- ---->>

mg/dL mg/dL

HAPTER 10 - A D VANCED FEATUR E S / S E T U P A N D ACTIVAT I O N

7. Use the / buttons to change the segment start time. Press .

8. Scroll to the “1U:” (mg/dL units) field and press to change to flashing cursor for Edit Mode.

9. Use the / buttons to change the “1U:” (mg/dL units) field as desired. Press . Repeat to set

remaining segments per your health care team’s recommendations.

”

To review your settings, highlight “

and press to scroll through each segment. Confirm the

--->>

times and setting values are correct.

When finished, scroll to “Done” and press to return to the SETUP ADV 7 screen.

To return to the Home screen, scroll to “Home” and press .

Setup Advanced Screen 7 – Personal Settings - BG Target Ranges

Your health care team may recommend you use different BG Target ranges for different times of day. When you use the ezCarb or ezBG feature, your pump will automatically select the BG Target range for the current time of day.

This screen allows you to:

Set different BG Targets and ranges for 12 different time slots

•

NOTE: If you set only one ratio, it will be used for the entire 24-hour period.

From the SETUP ADV 7 screen, scroll up to “BG Target”. Press .

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Insulin Pump

1. The first segment always starts at midnight. The last time slot available is

11:30pm. Use the / buttons to scroll to the BG Target field.

2. Press to change to flashing cursor for Edit mode.

3. Use the / buttons to change to desired setting.

4. Press when setting is made.

5. Scroll to the “+/-”(range) field. Press to change to flashing cursor for

Edit mode.

BG Target

2 of 12

Done

Time:

6:00A

120

+/- 10

Home

<<---- ---->>

mg/dL m

g/dL

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CHAPTER 10 - A D VANCED FEAT U R E S / S E T U P A N D ACTIVAT I O N

NOTE: By setting a range (+/-) your pump will not calculate a BG correction dose if your actual BG is within that range. If you prefer to correct to one target number rather than a range, simply set your range to +/- 0. This screen allows you to:

6. Use the / buttons to change the range as desired. Press .

7. To move to the next BG Target screen, scroll to “

--->>

”

and press .

8. Scroll up to the “Time” field and press to change to flashing cursor for

Edit mode.

9. Use the / buttons to change the segment start time. Press .

10. Scroll to the BG Target field. Press to change to flashing cursor for

Insulin Pump

Edit mode.

11. Use the / buttons to change to desired setting.

12. Press when setting is made.

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13. Scroll to the “+/-”(range) field. Press to change to flashing cursor for Edit mode.

14. Use the / buttons to change the range as desired. Press . Repeat to set remaining

segments per your health care team’s recommendations.

”

To review your settings, highlight “ times and setting values are correct.

When finished, scroll to “Done” and press to return to the SETUP ADV 7 screen.

and press to scroll through each segment. Confirm the

--->>

To return to the Home screen, scroll to “Home” and press .

Setup Advanced Screen 8 – Insulin on Board (IOB) Setting

This feature allows you to program the rate at which your body uses your bolus. Even with rapid-acting insulin, your body takes some time to use your entire bolus insulin. When this feature is activated and you give a bolus, your pump will tell you how much Insulin on Board (IOB) is currently remaining and will calculate a decreased bolus dose as an option. This helps to prevent “stacking” insulin and can help reduce your risk of hypoglycemia*. The duration of insulin action varies from person to person and can vary based on the infusion site you have selected and your activity level, among other factors. Your health care team will give you a recommended duration to program into your pump.

*Recommended reading for pump users includes:

Pumping Insulin, by John Walsh, PA, CDE and Ruth Roberts, MA

•

Smart Pumping, by Howard Wolpert, MD

•

 WARNING: This feature is intended for use only with U100 rapid-acting insulin analogs such

as Novolog Apidra result in serious injury or death.

, Humalog®or Apidra®. If you use an insulin other than Novolog®, Humalog®or

, Do Not use this feature. Use of any insulin with lesser or greater concentration can

SETUP ADV 8

Home

Insulin on Board

IOB-2

OFF

Duration

4.0 Hr

HAPTER 10 - A D VANCED FEATUR E S / S E T U P A N D ACTIVAT I O N

This screen allows you to:

Turn the IOB feature on or off

•

Select the duration

•

1. Use the / buttons to scroll to the desired field.

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2. Press to change to flashing cursor for Edit mode.

3. Use the / buttons to change to desired setting.

4. Press when setting is made.

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press .

NOTE: Your pump is constantly tracking IOB, so when you turn on the feature, your pump will immediately take into account the current amount remaining from previous bolus doses within the time frame you’ve selected during set up of the feature.

Points to remember about the IOB feature on your pump

A curvilinear algorithm is used, which more closely mimics the way drugs decay in the body versus a

•

straight line decay.

With BG below target, IOB amount is displayed and is subtracted from the carb portion of the bolus.

•

With BG within target, IOB amount is displayed for reference but not subtracted from bolus total.

•

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Insulin Pump

With BG above target, IOB amount is displayed and is subtracted from BG bolus.

•

ETUP ADV 9

Home

Sick days

BG over

240

Check ketones

every

4 Hrs

Check BG

every

2 Hrs

g/dL

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CHAPTER 10 - A D VANCED FEAT U R E S / S E T U P A N D ACTIVAT I O N

Setup Advanced Screen 9 – Sick Day Guidelines

During your pump training, your health care team will discuss guidelines to use when you’re sick. This is a convenient way to store your basic sick day guidelines as recommended by your health care team. For more information on sick day guidelines, refer to Chapter 16 in Section I, pages 93–94, and contact your health care team.

Insulin Pump

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This screen allows you to:

Set a BG limit as a reminder for testing when sick

•

Set the frequency of checking for ketones when sick

•

Set the frequency of checking your BG when sick

•

To move to the next Setup Advanced screen, scroll to the bottom of the screen and highlight “Next”. Press .

To return to the Home screen, scroll to “Home” and press .

NOTE: This screen is intended as a reference only. Alerts are NOT triggered based on values displayed on this screen.

Setup Advanced Screen 10 – Establishing Communication with Your Meter Remote

This screen allows you to activate the RF and pairing features on your pump. When you are ready to begin using your pump and meter remote together as a system, you will need to activate RF communication and pair the devices. See Chapter 2 in Section III, pages 175–184.

Audio bolus

Step size=

1.0U/Press

0.00

Enter

bolus amount

Press any other

key to CANCEL

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CH A PT ER 11 - US I NG A DVA N CE D FEAT URE S

 CAUTION: Using the features in this chapter requires an advanced understanding of insulin

pump therapy and should not be used without training and advice from your health care team. In order to achieve optimal results, some of these features should only be used once you have tested and fine-tuned your basal rates and your health care team has determined your individual targets and ratios.

NOTE:

Before using these features, you must turn them on in the Setup Advanced menu.

See Chapter 10 in Section I, pages 49–58.

Audio Bolus and ezBolus

The Audio Bolus feature of the Animas®Insulin Pump allows you to bolus without looking at the screen display. This is convenient if you wear your pump under your clothing. When first using the audio bolus feature, also check the display screen until you are comfortable with the programming steps. If you do not wish to use the Audio Bolus feature, this button serves as a shortcut to the Normal Bolus screen. See ezBolus, page 61 in this chapter.

 CAUTION: When you first use the Audio Bolus feature, you should always look at the screen

to confirm correct programming until you are comfortable with the feature.

1. Turn on Audio Bolus in the Setup Advanced menu and select your preferred step size. See Chapter

10 in Section I, pages 49–58.

2. The Audio Bolus button is the soft rubber button on the end of your pump. Press it once. Your pump

will beep (or vibrate) to indicate you’ve accessed Audio Bolus mode as well as indicate the step size you’ve set up.

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Insulin Pump

The number of beeps (or vibrate pulses) reminds you of the step size you’ve set.

1 indicates 0.1U step size

•

2 indicates 0.5U step size

•

3 indicates 1.0U step size

•

4 indicates 5.0U step size

•

3. Press the Audio Bolus button once for each step size you’ve programmed to

reach the desired total amount. For example, if you are using 1.0U step size and you wish to bolus 4 units, press the button 4 times. You will hear a beep tone or vibrate for each button press. If you are using 0.5U step size and you wish to bolus 4 units, press the button 8 times.

4. Within 5 seconds, your pump will respond with a number of confirmation beeps equal to the

number of times you pressed the Audio Bolus button.

NOTE: Do Not press any of the function buttons at this time unless you wish to cancel delivery.

Audio bolus

Confirm

3.00

Press any other

key to CANCEL

DELIVERING

3.00

Press any

function button

to Cancel

Warning

Confirm

Bolus

delivery canceled by user button

press.

Delivered:

2.00U of 3.00U

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CHAPTER 11 - U S I N G A D VANCED FEATURES

ithin 5 seconds, your pump will beep twice to “ask” you to confirm that

5. W

you wish to activate delivery and “Confirm” is displayed on the Audio Bolus screen.

6. Within 5 seconds, press the button again to activate delivery. Your pump

will beep twice to confirm your delivery command. The DELIVERING bolus

Insulin Pump

screen is displayed and your pump will beep once to signal the start of delivery and once to signal end of delivery (if you turned on Normal Bolus Sounds in Setup).

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If you wish to cancel the Audio Bolus, press any function button (not the contrast button).

If you cancel a bolus delivery after you’ve activated it, the screen at right will be displayed. See Chapter 13 in Section I, pages 75–84.

NOTE: If during a bolus delivery your low cartridge level is reached, your pump will not display the warning until after the bolus is completed. So you could possibly have less insulin available than your low cartridge setting.

Example: Your low cartridge warning is set to 10 (units). You have 20 units of insulin remaining and you deliver a 15 unit bolus. The Low cartridge warning appears after bolus is completed and you have only 5 units left – not 10 units. The Wake up screen will show the remaining insulin amount.

The maximum number of Audio Bolus button presses is 20. Therefore, if you’ve set the step size to

0.1U, the maximum audio bolus amount is 2U. If you’ve set the step size at 0.5U, the maximum audio bolus amount is 10U and if your step size is 1.0U, the maximum audio bolus amount is 20U. With a

5.0U step size, the maximum cannot be greater than 35U, which is the maximum amount for any type of bolus.

BOLUS MENU

Main Menu

Normal

ezCarb ezBG Combo Bolus Reminders

NORMAL BOLUS

Main Menu

Amount

0.00

HAPTER 11 - U S I N G A D VANCED FEATURES

ezBolus

If you do not have your Audio Bolus feature turned on, the button on the end of your pump will function as a short cut to the Normal Bolus screen.

1. Press the button on the end once. The Normal Bolus screen is displayed.

Program a Normal Bolus as usual.

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Advanced Bolus Features

ezCarb

•

ezBG

•

Combo Bolus

•

Reminders

•

All Advanced Bolus features are activated in the Setup Advanced Menu. See Chapter 10 in Section I, pages 49–58. When the Advanced Bolus features and Reminders are activated, the full BOLUS MENU is displayed.

 WARNING: Be sure to review all the values used in bolus calculations to make sure they

are correct. You may always adjust the insulin units up or down before you decide to administer your bolus. If you dose an insulin amount that is too high or too low, this may result in a hypoglycemic or hyperglycemic event. Please discuss the bolus calculator feature and all relevant personal settings with your health care professional before using the calculator for the first time.

Animas

Insulin Pump

ezCarb

This feature allows you to manually enter the number of carbs eaten, and your pump will automatically calculate your bolus dose, based on the I:C ratio, ISF and BG Target range you have entered for the current time of day. Consult your health care team for your personal I:C ratios, ISFs and BG Target ranges. See Chapter 10 in Section I, pages 49–58.

If the IOB feature is activated, your pump will calculate a reduced amount for high BG correction boluses and for Carb Boluses if you entered a below-target BG value.

When you use your meter remote to deliver an ezCarb Bolus, you may also select the number of carbs eaten directly from a Food Database stored in your meter remote, see Chapter 4 in Section III, pages 187–202. The Food Database is available through an upload to your meter remote from ezManager Software. For instructions on uploading the Food Database, refer to the ezManager®User Guide included with the software.

ezCarb Home

Main Menu

Carbs: 34g

I:C 1U: 15g

Add BG

Show Result

Bolus Total

Main Menu

Carb BG + IOB Total =

2.26U

0.00U

--.--U

2.25U

0.00 U

Go Type Normal

Bolus Total

Main Menu

Carb BG + IOB Total =

2.26U

0.00U

--.--U

2.25U

2.25 U

Go Type Normal

ezCarb Home

Main Menu

Carbs: 34g

I:C 1U: 15g

Add BG Show Result

BOLUS MENU

Main Menu

Normal

ezCarb

ezBG Combo Bolus Reminders

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CHAPTER 11 - U S I N G A D VANCED FEATURES

Entering Carbs Manually

1. From the BOLUS MENU, scroll to “ezCarb”. Press . The ezCarb Home

screen is displayed.

2. The cursor will flash on the “Carbs” field to indicate that you can edit the

Insulin Pump

total number of carbs eaten. Use the / buttons to enter the number of carbs. Press . “Add BG” is highlighted. (See Adding a BG Bolus to ezCarb, pages 63–64 in this chapter.)

Animas

NOTE: The max limit for ezCarb Total is 999g.

3. Check that the grams of carb entered and your I:C ratio at the top of the screen are correct.

a. If the entries are correct, scroll to “Show Result”. Press and go to Step 5.

b. If not correct, scroll up to highlight the field and press to activate Edit

Mode. Use / buttons to enter your I:C ratio and/or change the carb entry. Press .

4. Scroll down to “Show Result”. Press .

5. The Bolus Total screen is displayed. The bolus

amount field is highlighted and flashing to indicate you can enter the total amount as shown or adjust as needed. Enter your bolus amount. Press .

NOTE: Calculated total units will be rounded to the nearest .05 units.

Bolus Total

Main Menu

Carb B

G + IOB Total =

2.26U

0.00U

--.--U

2.25U

Type Normal

DELIVERING

2.25

Press any

unction button

o Cancel

Bolus Total

Main Menu

Carb BG + IOB Total =

2.26U

0.00U

--.--U

2.25U

Go Type Combo

ezCarb Home

Main Menu

Carbs: 34g

I:C 1U: 15g

Add BG

Show Result

Draft. 410-106-00 Rev. A

HAPTER 11 - U S I N G A D VANCED FEATURES

6. “Go” is highlighted. If you wish to give a Normal

Bolus, press to deliver.

7. If you wish to give a Combo Bolus, scroll to the “Type” field and press

to edit.

8. Use the / buttons to select bolus type: “Normal” (default) or “Combo”. Press .

9. “Go” is highlighted. Press .

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Insulin Pump

NOTE: If you select the Combo Bolus option, the Combo Bolus screen will be displayed. See Combo Bolus, pages 67–68 in this chapter for instructions on delivering the Combo Bolus.

Entering Carbs Using the Food Database

This feature is only available on your meter remote, and can be accessed when delivering an ezCarb Bolus from your meter remote. See Chapter 4 in Section III, pages 187–202.

Adding a BG Bolus to ezCarb

1. On the ezCarb Home screen, enter the number of carbs. Press .

2. “Add BG” is highlighted. Press . The BG CORRECT screen is displayed.

BG CORRECT

Main Menu

Actual Target -

= +

ISF 37 mg/dL Show Result

mg/dL

220

120

100

BG CORRECT

Main Menu

Actual Target -

= +

ISF 37 mg/dL Show Result

mg/dL

220 120 100

Bolus Total

Main Menu

Carb BG + IOB Total =

2.26U

2.70U

--.--U

4.95U

4.95 U

Go Type Normal

Bolus Total

Main Menu

Carb BG + IOB Total =

2.26U

2.70U

--.--U

4.95U

Go Type Normal

0.00 U

Draft. 410-106-00 Rev. A

BG CORRECT

Main Menu

Actual Target -

= +

ISF 37 mg/dL

Show Result

g/dL

220 120 100

BG CORRECT

Main Menu

Actual Target -

= +

SF 37 mg/dL

Show Result

mg/dL

220

120 100

CHAPTER 11 - U S I N G A D VANCED FEATURES

3. The “Actual” field is highlighted and flashing to

indicate Edit mode. Use the / buttons to enter your BG value. Press . “Show Result” is highlighted.

4. Check that the BG Target range and ISF are correct.

a. If they are correct, press with “Show Result”

highlighted.

Insulin Pump

b. If they are not correct, scroll up to highlight the

fields and press . Use the / buttons to adjust the values. Press to exit Edit mode. Scroll down to “Show Result”. Press .

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5. The Bolus Total screen is displayed and shows the calculated bolus units

from your ezCarb Bolus. The bolus amount field is highlighted and flashing, and displays 0.00 units.

6. Enter the Bolus amount and press

deliver as a Normal Bolus or scroll to the “Type” field to select Combo Bolus, then select “Go”.

“Go” is highlighted. Press to

If you selected the Combo Bolus option, you will begin the steps for delivering the ezCarb units as a Combo Bolus (see Combo Bolus, pages 66–67 in this chapter). The bolus amount you entered on the Bolus Total screen in step 6 will appear in the “Total” field on the first Combo Bolus screen.

BOLUS MENU

Main Menu

Normal ezCarb

ezBG

Combo Bolus Reminders

Draft. 410-106-00 Rev. A

ezBG

Main Menu

Actual Target -

= +

ISF 37 mg/dL

mg/dL

224

120 104

Show Result

ezBG

Main Menu

Actual Target -

= +

ISF 37 mg/dL

mg/dL

224

120

104

Show Result

ezBG

Main Menu

Actual Target -

= +

ISF 37 mg/dL

mg/dL

224 120 104

Show Result

ezBG

Main Menu

Actual Target -

= +

ISF 37 mg/dL

mg/dL

224 120 104

Show Result

HAPTER 11 - U S I N G A D VANCED FEATURES

ezBG

This feature allows you to enter your BG reading and your pump will automatically calculate a BG correction bolus based on the ISF and BG Target range for the current time of day. If the IOB feature is activated, your pump will calculate a reduced dose for high BG correction boluses.

1. From the BOLUS MENU, select “ezBG”. Press the button.

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Insulin Pump

2. The “Actual” field will be highlighted and flashing

to indicate Edit mode. Use the / buttons to enter your actual BG reading. Press the button to confirm the entry and exit Edit mode.

3. Check to be sure the BG Target and Insulin Sensitivity Factor (ISF) are

correct. Your health care team will give you these values. If you need to edit these fields, scroll up to highlight the field and press to activate Edit mode. Use / buttons to change target. Press to confirm and to exit Edit mode.

4. “Show Result” is highlighted. Press .

Alert

LOW BG

Confirm

Treat low BG.

No bolus

recommended.

Monitor BG.

Alert

HIGH BG

Confirm

Treat high

BG.

Check site.

Check

ketones.

Monitor BG.

ezBG Total

Main Menu

BG + IOB

Total =

2.81U

--.--U

2.80U

0.00U

0.00 U

ezBG Total

Main Menu

BG + IOB

Total =

2.81U

--.--U

2.80U

DELIVERING

2.80

Press any

function button

to Cancel

ezBG Total

Main Menu

BG + IOB -

Total =

2.81U

1.00U

1.80U

Draft. 410-106-00 Rev. A

CHAPTER 11 - U S I N G A D VANCED FEATURES

5. The ezBG Total screen is displayed with a suggested bolus amount. The bolus amount field is

highlighted and flashing to indicate you can enter the total amount as shown or adjust as needed. Enter your bolus amount. Press to deliver.

Insulin Pump

NOTE: If the IOB feature is activated, your pump will calculate a reduced

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BG Bolus amount for your review.

NOTE: If you enter a BG amount below 70 mg/dL or above 250 mg/dL, your pump will alert you that you’ve entered an out of range BG. To confirm the Alert, press . Treat the out of range BG as recommended by your health care team.

BOLUS MENU

Main Menu

Normal ezCarb ezBG

Combo Bolus

Reminders

Combo Bolus

Main Menu

Total Duration

8.50U

0.5Hr

Extend

100%

0.00U

Normal:

0.00:

Combo Bolus

Main Menu

Total Duration

8.50U

4.0Hr

Extend

70%

5.95U

Normal:

30:

2.55:

Combo Bolus

Main Menu

Total Duration

8.50U

0.5Hr

Extend

70%

5.95U

Normal:

30:

2.55:

Draft. 410-106-00 Rev. A

HAPTER 11 - U S I N G A D VANCED FEATURES

Combo Bolus

The Combo Bolus feature is used to give both a Normal and Extended Bolus. This feature is useful for consumption of high fat meals such as pizza, if you will be “grazing” over a few hours or if you have gastroparesis. You can program part of your bolus amount to be delivered immediately and part of it to be delivered slowly over the course of up to 12 hours. Your health care team can help you determine the “split” of Normal to Extended insulin amounts, as well as the duration that is most appropriate for you.

1. From the BOLUS MENU, select “Combo Bolus”. If you used the ezCarb

Bolus option to calculate a bolus and chose to deliver it as a Combo Bolus, you will begin at the Combo Bolus screen in step 2.

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Insulin Pump

2. Use the / buttons to enter the Total bolus amount. Press . “Go” is

highlighted. The factory default setting for Duration is 30 minutes, and the Ratio is 0% Normal and 100% Extended. If these settings are appropriate, press to deliver.

3. To change either the Duration or Ratio, scroll up to the desired field and

press to activate Edit mode.

4. Use the / buttons to change settings. As you change the Ratio by

percentage, the amount in units is automatically changed. You cannot change the ratio by units, only by percentage.

5. When settings are correct, press to confirm and exit Edit Mode.

NOTE: Your pump is “smart”; it will remember your last duration and the ratio (as percentages) you programmed. So if you use the same duration and ratio for certain types of meals, you need only change the total bolus amount the next time you use this feature. However, the last programmed Combo Bolus settings will be cleared each time you change the battery.

Combo Bolus

Main Menu

Total Duration

8.50U

4.0Hr

Extend

70%

5.95U

Normal:

30:

2.55:

2 : 27

Status

Basal Rate

0.675U/Hr

Insulin: 105U

BOLUS ACTIVE

Combo Bolus

Main Menu

CANCEL

Duration

Delivered

0.0 : 4.0Hrs

2.55U : 8.50U

ACTIVE

BOLUS MENU

Main Menu

Normal ezCarb ezBG Combo Bolus

Reminders

REMINDERS

Main Menu

Reminder-1

Time =

Reminder-2

Time =

OFF

12:00PM

OFF

12:00PM

BG Check

After Bolus =

OFF

1 Hr

Draft. 410-106-00 Rev. A

CHAPTER 11 - U S I N G A D VANCED FEATURES

6. Scroll to “Go” and press to activate. The Home

screen shows Combo Bolus active.

To cancel an active Combo Bolus from the BOLUS MENU, select “Combo Bolus”. Details of the active Combo Bolus will be displayed.

Insulin Pump

Scroll to “CANCEL” and press to cancel the Combo Bolus.

NOTE: If you Suspend your pump, any active Combo Bolus will also be canceled and the screen display will alert you. Combo Bolus is also canceled

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when you change the battery and/or prime your pump.

Reminders

This feature allows you to set personal reminders. You can set two bolus reminders for times of day, and one reminder to check BG at a certain time after a bolus. Confirm the Reminder by pressing . Once you’ve confirmed the Reminder, you will not be alerted again.

Bolus Reminders for Time of Day

1. From the BOLUS MENU, select “Reminders”. Press .

2. The “Reminder-1” field will be highlighted with a flashing cursor to indicate

Edit mode. Use the / buttons to turn on or off. Press to confirm and exit Edit mode.

REMINDERS

Main Menu

Reminder-1

Time =

Reminder-2

Time =

OFF

12:00PM

OFF

12:00PM

BG Check

After Bolus =

OFF

1 Hr

REMINDERS

Main Menu

Reminder-1

Time =

Reminder-2

Time =

OFF

12:00PM

OFF

12:00PM

BG Check

After Bolus =

1 Hr

Confirm

Reminder

Check BG

1 Hr

Confirm

Check

Last bolus

12:15PM

Reminder

REMINDERS

Main Menu

eminder-1

Time =

Reminder-2

Time =

OFF

12:00PM

OFF

12:00PM

BG Check

After Bolus =

OFF

1 Hr

Confirm

Reminder

12:00PM

HAPTER 11 - U S I N G A D VANCED FEATURES

he “Time” field for this reminder will be

3. T

highlighted. Press to activate Edit mode. Use the

/ buttons to enter the time you wish a reminder to sound (or vibrate, if that is the setting you selected in the SETUP SOUND menu). Press to confirm your setting and exit Edit mode. When the feature is turned on, your pump will display the “Reminder” screen on the right at the selected time of day.

Draft. 410-106-00 Rev. A

4. Repeat for the Reminder 2.

BG Check Reminder

1. From the REMINDERS menu, select “BG Check”. Press to activate Edit

mode to turn this reminder on or off. Press to confirm and exit Edit mode.

2. Scroll down to highlight the “After Bolus” field. Press to select the field

and activate Edit mode. Use the / buttons to enter how long after a Normal Bolus you wish your pump to sound (or vibrate) to remind you to check your BG. You can select a reminder time of 1, 2, 3 or 4 hours.

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Insulin Pump

When this feature is turned on, your pump will display the “Check BG” screen at the reminder time you set. On this screen you can select a different reminder time (1,2,3, or 4 hours), or opt not to be reminded by entering 0.

NOTE: When you enter a time, your pump will sound a reminder and display this screen at that time after any Normal Bolus is programmed, including the Normal portion of a Combo Bolus. If you program an Extended Bolus only, the reminder will not sound.

3. When finished setting reminders, scroll to “Main Menu” to display the MAIN MENU.

BASAL MENU

Main Menu

Total 13.60U

Temp

A1-WEEKDAY

2-other

3-weekend

4-exercise

Alert

1-weekday

must be the

active program

to change the

basal display

setting.

Confirm

Bolus Total

Main Menu

Carb BG + IOB – Total =

2.25U

2.70U

1.00U

3.95U

Type Normal

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CHAPTER 11 - U S I N G A D VANCED FEATURES

Delivery Speed - Bolus

On rare occasions, usually with very large boluses, users may experience a slight stinging sensation with rapid bolus delivery. If this is a concern, you can set the bolus delivery speed to slow to accommodate your needs. If you use the slow setting, your pump will pause approximately 4 seconds in between delivery of each unit of insulin programmed.

Multiple Basal Programs

This feature allows 4 different Basal programs to show on your “Basal Menu” screen. Users find this feature beneficial if their activity level is different during the week than on weekends. Switching work shifts at work is another reason to use multiple basal programs. Some use a different basal program during

Insulin Pump

menstruation. An “A” will appear to the left of the basal program that is currently active.

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NOTE: If a program other than 1-Weekday is active, you cannot change this setting to display 1 basal program. The Alert screen shown here will pop up to remind you.

IOB

Even with rapid-acting insulin, your body takes some time to use the entire bolus amount. If you have activated this feature, your pump will track the bolus insulin remaining in your system - IOB - and calculate a suggested lower BG correction bolus dose. The lower dose is only recommended if you use the ezBG feature or if you add a BG bolus to an ezCarb bolus. For this feature to give optimal results, you should always use either ezBG or the Add BG feature during ezCarb programming when entering a BG correction bolus.

 CAUTION: Your health care team will give you recommendations specific to your plan of

treatment.

ezBG Total

Main Menu

BG + IOB -

Total =

2.81U

1.00U

1.80U

SETUP ADV 9

Home

Sick days

BG over

240

Check ketones

every

4 Hrs

Check BG

every

2 Hrs

mg/dL

Draft. 410-106-00 Rev. A

HAPTER 11 - U S I N G A D VANCED FEATURES

In the examples shown here, the IOB amount is subtracted from the BOLUS TOTAL screen and the ezBG Total screen.

NOTE:

• When you replace the battery, the IOB amount is cleared.

• Your pump constantly tracks IOB. If you’ve given a bolus before turning on the feature, your pump

will show the remaining amount from that bolus as IOB immediately.

Sick Day Guidelines

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Insulin Pump

To review your basic sick day guidelines, refer to this screen. For more information on sick day guidelines, refer to Chapter 15 in Section I, pages 91–92, and contact your health care team.

1. From the SETUP menu, select “Advanced”.

2. Scroll to the Setup Advanced Screen 9.

3. Enter or review the guidelines as recommended by your health care team.

Establishing Communication with your Meter Remote

When you are ready to begin using your pump and meter remote together as a system, you will need to activate RF communication and pair the devices. See Chapter 2 in Section III, pages 175–184.

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CHAPTER 11 - U S I N G A D VANCED FEATURES

Insulin Pump

Animas

Draft. 410-106-00 Rev. A

CH A PT ER 12 - CA R E A N D M A INT E NA N CE

The Vents

Your pump features a redundant Vent Safety System. Vents serve two purposes. First, they allow air to enter and exit your pump so that pressure is equalized under a variety of environmental circumstances, such as changes in altitude. Second, the vents are backed by a special membrane, which keeps water from entering your pump.

Battery Cap with O-ring and Vent

Your battery cap contains an o-ring and vent. There is a tiny hole backed by a membrane, which allows air to pass through but prevents water from entering. The o-ring helps to keep your pump waterproof. It is recommended that you change the battery cap/vent once a year. If you work in a dusty environment such as a construction site, mill, cement factory, etc., or if you are a frequent swimmer, you should change your battery cap every 6 months. You can call Animas

to order an extra battery cap.

Animas

Insulin Pump

Vent Hole

O-ring

 WARNING: Under no circumstances should you introduce any kind of sharp object into the

vent openings to clean them. Doing so could compromise your pump’s waterproof capabilities. If at any time you suspect the vent opening is clogged, replace the battery cap.

Cleaning

 CAUTION: Do Not use household or industrial cleaners, chemicals, solvents, bleach,

scouring pads or sharp instruments to clean your pump. Never put your pump in the dishwasher or use very hot water to clean it. Use only a very mild detergent (for example a drop of liquid soap in a glass of water) and a lint-free cloth.

Never put your pump in a microwave oven or baking oven to dry it. Use a soft towel.

Never clean the battery or insulin cartridge compartments.

General Wear and Tear

If you drop your 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 your pump may impact the battery contact and/or the waterproof feature of your pump. Call our Customer Service representatives at 1-999-999-9999 if you identify or suspect your pump is damaged. They will help determine if your pump should be replaced.

Draft. 410-106-00 Rev. A

CHAPTER 12 - C A R E A N D M A I N T E N A N C E

Disposal

International and US regulations require controlled disposal of devices such as insulin pumps.

Dispose of batteries according to your local environmental regulations.

Insulin Pump

Animas

Alert

Confirm

Basal Menu

Your active

basal

program

is empty.

0.000U/Hr

Draft. 410-106-00 Rev. A

CH A PT ER 13 - SAF ETY SYST E M A N D AL A RM S

Alerts, Warnings and Alarms

Your pump has a progressive warnings and alarms safety system. This means if you do not confirm the warning or alarm, it will progress to the sweep alarm with vibrate within one hour. At the high volume stage, if you do not confirm the warning or alarm, the sweep alarm will begin and will not stop until appropriate action is taken.

Alerts are automatically displayed to remind you of a function that you’ve set or a condition that exists. Warnings are triggered for a variety of reasons. They require you to confirm the warning by pressing and/or taking action to address the warning. Alarms are triggered by several conditions. All require you to address the alarm by taking appropriate action in order to clear the alarm condition.

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Insulin Pump

- Indicates that this alert, warning or alarm can play a tune as the initial notification for medium and high volume settings. The pump default for sounds at the low volume setting is a factory-set sound and cannot be modified with ezManager

IMPORTANT: Many of the following pump alerts, warnings and alarms will also sound and/or display on your meter remote, once you begin using the devices together as a system. See Chapter 6 in Section III, pages 207–216 for a complete list.

NOTE: Alarms, warnings and alerts will display actual insulin units during pump operation, rather than the “XX” or “XXX” units displayed on some of the screens in this list.

Alert: Active Basal Program Empty

Cause

Effect

Message

Action

Empty basal program activated.

No basal deliveries.

Displayed once until confirmed or until pump goes to sleep and each time manually awakened.

None required but can confirm or select Basal Menu.

Software.

Beeps/Vib

User selected, one time and each time manually awakened. No progression.

Alert

Pump Suspended

If active,

Temp Basal &

Combo Bolus

have been

canceled.

Alert

LOW BG

Confirm

Treat low BG.

No bolus

recommended.

Monitor BG.

Draft. 410-106-00 Rev. A

Alert

Temp Active

inimum

Basal rate

limited to

0.025U/Hr

CHAPTER 13 - SAFETY S Y STEM A N D A L A R M S

Alerts, Warnings and Alarms

Alert: Temp Basal Minimum Rate

Cause

Effect

Message

Action

Insulin Pump

Animas

Beeps/Vib

Alert: Suspend (Temp Basal/Combo Bolus Canceled)

Cause

Effect

Message

Negative Temp Basal activated.

Basal delivery will not go below 0.025U/Hr.

Displayed once for 3 seconds.

None required.

User selected, one time. No progression.

Pump suspended

Any active Temp Basal/Combo Bolus canceled.

Displayed once for 3 seconds.

Action

Beeps/Vib

Alert: Low BG

Cause

Effect

Message

Action

Beeps/Vib

None required.

User selected, one time. No progression.

BG entry below 70 mg/dL.

Requires user confirmation to continue.

Displayed until confirmed or until pump goes to sleep.

Press to confirm.

User selected, one time. No progression.

Alert

Clear Program

Basal Options

Clear Program

deletes all

basal segments

in this program.

Alert

1-weekday

must be the

active program

to change the

basal display

setting.

Confirm

Alert

HIGH BG

Confirm

Treat high

BG.

Check site.

Check

ketones.

Monitor BG.

HAPTER 13 - SAFETY S Y STEM A N D A L A R M S

Alerts, Warnings and Alarms

Alert: High BG

Draft. 410-106-00 Rev. A

Cause

Effect

Message

Action

Beeps/Vib

BG entry above 250 mg/dL.

Requires user confirmation to continue.

Displayed until confirmed or until pump goes to sleep.

Press to confirm.

User selected, one time. No progression.

Alert: Clear Program Basal Segments

Cause

Effect

Message

Clear command selected from BASAL OPTIONS screen.

Requires user confirmation to continue.

Displayed until one of the two options is selected or until pump goes to sleep.

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Insulin Pump

Action

Beeps/Vib

Select “Clear Program” or “Basal Options”.

User selected, one time.

Alert: Basal Program Display Change

Cause

Effect

Message

Action

Beeps/Vib

Changing display of basals from 4 to 1 but program 1 is not currently active.

Requires user confirmation to continue.

Displayed until confirmed or until pump goes to sleep.

Press to confirm.

User selected, one time.

Warning

Confirm

No delivery.

Pump is

suspended.

Warning

Confirm

No cartridge

detected.

Delivery

disabled.

Draft. 410-106-00 Rev. A

Warning

Edit Basal

Basal edit

not saved.

Basal

elivery

suspended.

CHAPTER 13 - SAFETY S Y STEM A N D A L A R M S

Alerts, Warnings and Alarms

Warning: Basal Delivery Suspended

Cause

Basal Edit was not saved.

Effect

Message

Action

Insulin Pump

Beeps/Vib

Animas

Warning: Suspend

Cause

Effect

Message

Basal delivery stopped.

Displayed when manually awakened until confirmed.

Press to select “Edit Basal”. Review basal edits and select “Save/Review”.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Pump suspended manually.

All deliveries stop.

Displayed each time pump is awakened until confirmed and once every 15 minutes until action is taken.

Action

Press to confirm. Resume delivery.

User selected, once every 15 min. No progression if

Beeps/Vib

confirmed each time displayed. Sweep/vibe within one hour if not confirmed.

Warning: No Cartridge Detected, Deliveries Disabled

Cause

Effect

Message

Action

No cartridge detected after “Load cartridge” step during Rewind/Prime.

No deliveries.

Displayed when manually awakened until confirmed.

Press to confirm. Be sure Rewind/Prime sequence is completed with cartridge properly in place.

User selected, once every 3 min. No progression if

Beeps/Vib

confirmed each time displayed. Sweep/vibe within one hour if not confirmed.

Warning

Confirm

Low

cartridge

XX U or

less left.

Warning

Confirm

Exceeds

max bolus

XX.XX U.

No bolus delivery.

Warning

Confirm

Low

battery.

HAPTER 13 - SAFETY S Y STEM A N D A L A R M S

Alerts, Warnings and Alarms

Warning: Low Battery

Draft. 410-106-00 Rev. A

Cause

Effect

Battery life will only last a minimum of 30 minutes.

Deliveries continue.

Displays when pump is awake until confirmed. Displays

Message

when triggered by event (such as bolus) & when manually awakened.

Action

Beeps/Vib

Press to confirm. Insert new battery.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning: Low Cartridge

Cause

Effect

Message

Low insulin level reached.

Deliveries may continue until Empty Cartridge alarm is triggered.

Displayed when manually awakened until confirmed.

Animas

Insulin Pump

Action

Beeps/Vib

Press to confirm. Replace with filled cartridge.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning: Exceeds Max Bolus

Cause

Effect

Message

Action

Audio bolus delivery exceeds user-set maximum.

Bolus delivery stops.

Displayed when manually awakened until confirmed.

Press to confirm. Reprogram max bolus amount in the Setup Advanced menu.

Beeps/Vib

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning

Confirm

Exceeds

max basal

XXX U/Hr.

No basal delivery.

Draft. 410-106-00 Rev. A

Warning

Confirm

Exceeds

max TDD

XXX U.

No delivery.

CHAPTER 13 - SAFETY S Y STEM A N D A L A R M S

Alerts, Warnings and Alarms

Warning: Exceeds Max TDD

Cause

Effect

Message

Bolus delivery exceeds user-set maximum.

All deliveries stop until action is taken. Any Combo Bolus or Temp Basal is temporarily suspended.

Displayed when manually awakened until confirmed.

Press to confirm. Reprogram max TDD amount in the Setup Advanced menu. If the Warning is not confirmed

Action

Insulin Pump

by the time your pump clock passes midnight, the message will continue to be displayed, but any Combo Bolus or Temp Basal that is currently suspended will resume.

Animas

Beeps/Vib

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning: Exceeds Max Basal

Cause

Basal delivery rate (or Temp Basal delivery) exceeds user-set maximum.

Effect

Message

Action

Beeps/Vib

Basal delivery stops.

Displayed when awakened (by basal delivery attempt every 3 min. or manually) until confirmed.

Press to confirm. Reprogram Max Basal amount in the Setup Advanced menu (or reprogram Temp Basal).

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning

Confirm

Pump is

not primed.

No delivery.

Warning

Confirm

Exceeds

max 2 Hr

XX U.

No delivery.

Warning

Confirm

Delivery

canceled

due to

low

cartridge.

HAPTER 13 - SAFETY S Y STEM A N D A L A R M S

Alerts, Warnings and Alarms

Warning: Exceeds Max 2-hour Delivery

Draft. 410-106-00 Rev. A

Cause

Effect

Message

Action

Combined basal and bolus delivery exceeds user-set 2-hour maximum.

Insulin delivery stops.

Displayed when manually awakened until confirmed.

Press to confirm. Reprogram Max 2-Hr amount in the Setup Advanced menu.

Beeps/Vib

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning: Delivery Canceled due to Low Cartridge

Cause

Effect

Message

Basal or Bolus delivery exceeds insulin remaining in cartridge.

Basal or Bolus delivery stopped.

Once per occurrence and each time awakened until confirmed.

Animas

Insulin Pump

Action

Beeps/Vib

Press to confirm. Replace with full cartridge.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Warning: No Prime, No Delivery

Cause

Effect

Message

Action

Beeps/Vib

Pump is not primed.

All deliveries stop.

Every 3 minutes or when awakened manually.

Press to confirm. Disconnect, reprime.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Draft. 410-106-00 Rev. A

ALARM

Confirm

OCCLUSION

DETECTED

No delivery.

Suspend

Warning

Confirm

Battery

change

requires

Rewind-Prime.

Warning

Confirm

Bolus

delivery

anceled by

user button

press.

Delivered:

.XX U of X.XX U

CHAPTER 13 - SAFETY S Y STEM A N D A L A R M S

Alerts, Warnings and Alarms

Warning: Bolus Delivery Canceled

Cause

User pressed function button on pump during bolus delivery.

Effect

Message

Action

Insulin Pump

Beeps/Vib

Animas

Warning: Battery Change Requires Rewind Prime

Cause

Effect

Message

Bolus delivery stopped.

Every 3 minutes.

Press to confirm. If button was pressed accidentally, repeat steps to deliver remaining insulin units.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Prime attempted without rewind.

All deliveries stopped.

Every 3 minutes or when awakened manually.

Action

Beeps/Vib

Alarm: Occlusion

Cause

Effect

Message

Action

Beeps/Vib

Press to confirm. Rewind and prime.

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour.

Occlusion detected.

All deliveries stop.

Continuous until confirmed.

Press to confirm. Disconnect and prime to clear occlusion. Option to select Suspend (see Suspend Warning screen, page 78).

User selected, every 3 minutes until confirmed. If not confirmed, progresses to sweep/vibe within one hour. (Once confirmed, No Prime warning triggered, see No Prime Warning screen, page 81.)

ALARM

REPLACE BATT ERY

Remove battery

to silence

the alarm.

No delivery.

ALARM

Confirm

EMPTY

CARTRIDGE

No delivery.

Replace

cartridge.

Suspend

HAPTER 13 - SAFETY S Y STEM A N D A L A R M S

Alerts, Warnings and Alarms

Alarm: Empty Cartridge

Draft. 410-106-00 Rev. A

Cause

Effect

Message

Cartridge empty.

All deliveries stop.

Continuous until confirmed.

Press to confirm. Replace with full cartridge. Option

Action

to select “Suspend” (see Suspend Warning screen, page 78).

User selected, every 3 minutes until confirmed. If not

Beeps/Vib

confirmed, progresses to sweep/vibe within one hour. (Once confirmed, No Prime warning triggered, see No Prime Warning screen, page 81.)

Alarm: Replace Battery

Cause

Effect

Battery either has minimum 3 minutes left or battery is dead.

All deliveries stop.

Animas

Insulin Pump

Message

Action

Beeps/Vib

Continuous until battery is removed.

Remove battery to silence alarm. Insert new battery.

MAX volume every 3 minutes until action taken. If not confirmed, will progress to 4 long tones/vib.

Draft. 410-106-00 Rev. A

ALARM

Confirm

AUTO-OFF

No button

presses in last

XX hours.

No delivery.

ALARM

CALL SERVICE

Remove battery

to silence

the alarm.

No delivery.

054-0108

CHAPTER 13 - SAFETY S Y STEM A N D A L A R M S

Alerts, Warnings and Alarms

Alarm: Call Service

Cause

Hardware or software problem detected.

Effect

Message

Action

Insulin Pump

Animas

Beeps/Vib

NOTE: Some Call Service Alarms have a unique sound/vibration sequence and cannot be silenced by pressing.

For these Alarms the usual progression is replaced by 3 chirps/vib repeated every 9 minutes for the first half hour. This is followed by 4 long tones/vib after that.

All deliveries stop.

Continuous until battery is removed.

Press to silence alarm for 30 minutes (alarm can only be silenced once). Call Customer Service at 1-999-999-

9999.

User-selected, every 3 minutes. If not confirmed, progresses to sweep/vibe within one hour.

Alarm: Auto-Off

Cause

Effect

Message

Action

Beeps/Vib

Suspended due to no key press in user-set time period.

All deliveries stop.

Continuous until confirmed.

Press to confirm. Adjust time period in the Setup Advanced menu.

MAX volume every 3 minutes. If not confirmed, progresses to sweep/vibe within one hour. (Once confirmed, No Prime warning triggered, see No Prime Warning screen, page 81.)

Draft. 410-106-00 Rev. A

CH A PT ER 14 - T R OU B LES HO OT I NG G U ID E LI N ES

It’s a good idea to set up a troubleshooting procedure to use anytime you suspect something might be wrong. Work with your health care team to establish guidelines* in the event of a problem.

Hypoglycemia

 WARNING: Low blood glucose is a risk for anyone using insulin therapy. You may experience

one or more of the following symptoms:

• Shakiness; rapid heart rate; nervousness; perspiration; cold, clammy skin; weakness; blurred or double vision; sudden hunger; tingling in your hands, lips, or tongue; headache and confusion.

• If you experience symptoms of hypoglycemia, you should immediately eat a quick-acting carbohydrate (glucose tablets, juice, or hard candy).

• If your BG is abnormally low, Do Not attempt to program your pump yourself. Get help.

• Treat hypoglycemia immediately

Rule of 15

1. Consume 15 grams of quick-acting carbohydrate

2. Wait 15 minutes

3. Recheck BG

4. If BG is < 70 mg/dL, repeat above

Animas

Insulin Pump

Troubleshooting hypoglycemia:

INSULIN PUMP

POSSIBLE CAUSE OF LOW BG SUGGESTED SOLUTION

Basal rate programmed incorrectly

Clock time incorrect

Pump exposed to MRI

* Walsh JA & Roberts R, Pumping Insulin. 2006. San Diego: Torrey Pine Press.

Check times and rates, remember to review basal programs when making any changes.

Reset clock to current time, being careful to check AM & PM.

Disconnect from pump. Call Customer Service at 1-999-999-9999

Draft. 410-106-00 Rev. A

CHAPTER 14 - T R O U B L ESHOOTING GUIDELINES

Troubleshooting hypoglycemia:

FOOD INTAKE

OSSIBLE CAUSE OF LOW BG SUGGESTED SOLUTION

Bolus too large

Low carbohydrate intake for bolus

Improper timing of bolus

Insulin Pump

Alcohol consumption

Animas

Check bolus amounts and times. Bolus only enough to lower your BG to normal level.

Measure carbohydrates accurately. See dietitian for carb counting review. May need recalculation of I:C ratio; consult with health care team.

Match timing of bolus with intake of food. Check BG prior to meal bolus and adjust accordingly.

May cause hypoglycemia. Eat food when drinking alcohol. Be cautious with bedtime bolus. Always check BG before going to bed. Check BG at 3 am. Consult health care team.

ACTIVITY

POSSIBLE CAUSE OF LOW BG SUGGESTED SOLUTION

Did not Suspend pump or activate Temp Basal

Low carbohydrate intake prior to exercise

Unplanned activity (shopping)

Long or intensive exercise

Consult health care team for guidelines for use of Temp Basal rate during exercise.

If not decreasing insulin prior to exercise, may need to eat foods containing carbohydrate prior to exercise.

If BG is <100 mg/dL, eat snack prior to exercise. Frequent BG testing before, during and after any activity.

Effects of exercise can be present for hours after activity has stopped. Consult with health care team for specific guidelines.

Draft. 410-106-00 Rev. A

HAPTER 14 - T R O U B L ESHOOTING GUIDELINES

Preventing hypoglycemia:

Check BG a minimum of four times a day, and more frequently with exercise.

•

Keep accurate track of carbohydrates in the foods you eat.

•

Consult your health care professional if you are experiencing frequent hypoglycemia.

•

If you experience frequent or severe episodes of hypoglycemia, contact your health care team. It may be necessary to adjust your basal rates, bolus doses, or review your BG Target goals, along with your daily regimen of food and exercise. If you have a low BG level (hypoglycemia), follow the routine established for you by your health care team.

It is important to monitor your BG frequently, including periodic checks at 3:00 AM.

•

Investigate the cause of hypoglycemia.

•

Hyperglycemia

Animas

Insulin Pump

Because your pump uses only rapid-acting insulin, you will not have a reserve of long-acting insulin in your body. This means that any interruption in the delivery of insulin by your pump can quickly result in a sharp rise of your BG levels.

Hyperglycemia (high BG) can occur within two to four hours after insulin delivery stops, and DKA (diabetic ketoacidosis) can develop within four to ten hours.

Several things can cause a high BG reading. The most common problems and causes of high BG are listed in the following table, as are some suggested solutions.

Draft. 410-106-00 Rev. A

CHAPTER 14 - T R O U B L ESHOOTING GUIDELINES

Troubleshooting hyperglycemia:

INFUSION SET

POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION

Redness, irritation, inflammation, swelling, discharge or discomfort

Change infusion set tubing and site. Contact health care team.

Bump or nodule at infusion site

Scar tissue

Catheter inserted in area of friction

Insulin Pump

Kink in tubing/catheter

Infusion set not primed (air in tubing)

Animas

POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION

Cloudy, clumpy, crystallized, expired or insulin exposed to extreme temperatures

Change infusion set and rotate sites. Avoid this area for site selection.

Avoid this area for site selection.

Avoid waistline and friction areas.

Change infusion set tubing and site.

Disconnect tubing from body. Prime tubing completely.

INSULIN

Remove infusion set and cartridge and discard. Use new insulin vial.

FOOD INTAKE

POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION

Bolus insufficient or omitted

High protein or fat intake

Long meal (holiday), continuous snacking, slowly absorbed food (high fiber), delayed digestion (gastroparesis)

Improper bolus timing

Review carbohydrate counting and I:C ratio settings.

Consult dietitian; may need to count protein and fat.

Consult health care team. May need to use extended bolus or combination bolus option.

Consult health care team.

Animas 115 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual