Insulet 001, 002 Users Manual

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Insulet Corporation

100 Cummings Center • Suite 239G • Beverly, MA 01915 USA

Customer Support: (800) 591-3455 (24 hours/7days) Sales/Supplies: (800) 591-9948 Web Site: www.insulet.com

i iXL™ Diabetes Management System User Guide: Contacts and Important Information

Use the spaces below to record important health and product information.

10776 Rev A

Contacts and Important Information

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

About This User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

Conventions and terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

Before You Get Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vii

Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

Your Important Role in Successful Pump Therapy . . . . . . . viii

Your Personal Diabetes Management Information . . . . . . . . ix

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

1: Your New iXL™ Diabetes Management System . . . . . . . . . . 1

Insulin-Delivery with the iXL™ System . . . . . . . . . . . . . . . . . . 1

How Does the iXL™ System Work? . . . . . . . . . . . . . . . . . . . . . 2

RediSet™ System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Wireless Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Data Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

The iXL™ Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

The iXL™ Remote Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Buttons that program and control the iXL™ System . . . . . 4

Entering and changing text . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Primary screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2: Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

The iXL™ Startup Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Set Up the iXL™ Remote Controller . . . . . . . . . . . . . . . . . . . . 10

Turn on the remote . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

The iXL™ Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3: Basal Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

What is a Basal Rate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Personalized Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . 15

Create a basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Enable an existing basal program . . . . . . . . . . . . . . . . . . . 19

Change or delete a basal program . . . . . . . . . . . . . . . . . . 20

Preset Temporary Basal Rates . . . . . . . . . . . . . . . . . . . . . . . . 22

What is a temporary basal rate? . . . . . . . . . . . . . . . . . . . . 22

Create a temporary basal preset . . . . . . . . . . . . . . . . . . . . 22

Enable an existing temporary basal preset . . . . . . . . . . . . 23

Cancel an active temporary basal preset . . . . . . . . . . . . . 23

Change or delete a temporary basal preset . . . . . . . . . . . 23

One-Time Temporary Basal Rates . . . . . . . . . . . . . . . . . . . . . 24

Enable a one-time temporary basal rate . . . . . . . . . . . . . . 24

Cancel a one-time temporary basal rate . . . . . . . . . . . . . . 25

Maximum Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

What is the maximum basal rate? . . . . . . . . . . . . . . . . . . . 25

Set a maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . 25

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

iXL™ Diabetes Management System User Guide: Contents ii

4: Bolus Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

What is a Bolus? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Bolus Dose Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Deliver Bolus Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Deliver a normal bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Deliver an extended bolus . . . . . . . . . . . . . . . . . . . . . . . . . 29

Deliver an iBolus™ (audio bolus) . . . . . . . . . . . . . . . . . . . . 31

Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

5: The iXL™ Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

The Pump Change Process . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Deactivate current pump . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Activate a new pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Fill the new pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Select the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Prepare the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Attach the new pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Insert cannula and begin insulin delivery . . . . . . . . . . . . . 42

Check Pump Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Suspend Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Resume Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Avoid Infusion Site Infections . . . . . . . . . . . . . . . . . . . . . . . . . 46

Get the Most From Your Pump . . . . . . . . . . . . . . . . . . . . . . . . 46

Avoid extreme temperatures . . . . . . . . . . . . . . . . . . . . . . . 46

Water and your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Safe storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

6: iXL™ Remote Controller Features . . . . . . . . . . . . . . . . . . . . . 49

The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Insulin Gauge and Display . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Reset the time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Reset the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Change Bolus and Basal Settings . . . . . . . . . . . . . . . . . . . . . 52

Set Alerts and Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Choose alerts and reminders . . . . . . . . . . . . . . . . . . . . . . . 54

Customize the Remote . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Set remote options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Set Diagnostic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Set diagnostic options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Get the Most from Your Remote . . . . . . . . . . . . . . . . . . . . . . . 58

Keep it handy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Communicating with the pump . . . . . . . . . . . . . . . . . . . . . . 58

Water and your remote . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Avoid extreme temperatures . . . . . . . . . . . . . . . . . . . . . . . 58

Electrical interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

iii iXL™ Diabetes Management System User Guide: Contents

Contents

7: My Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Insulin Delivery History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

View insulin delivery history . . . . . . . . . . . . . . . . . . . . . . . . 61

Alarm History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

User and Product Information . . . . . . . . . . . . . . . . . . . . . . . . 64

Add or change user information . . . . . . . . . . . . . . . . . . . . 64

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

8: Achieve Healthy, Safe Pumping . . . . . . . . . . . . . . . . . . . . . . 67

Your Role in Safe Pumping . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Automatic priming, safety checks, and insertion

with RediSet™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Continuous monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Rapid occlusion detection . . . . . . . . . . . . . . . . . . . . . . . . . 68

Alerts and advisory and hazard alarms . . . . . . . . . . . . . . . 68

Daily Diabetes Management Activities . . . . . . . . . . . . . . . . . 68

Check blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Inspect the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Water and Your Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Traveling and Vacationing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Plan for changing time zones . . . . . . . . . . . . . . . . . . . . . . . 69

Take enough supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Minimize airport security delays . . . . . . . . . . . . . . . . . . . . 70

Keep supplies accessible . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Avoid Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

General precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Hypoglycemia (low blood glucose) . . . . . . . . . . . . . . . . . . 72

Hyperglycemia (high blood glucose) . . . . . . . . . . . . . . . . . 75

Diabetic ketoacidosis (DKA) . . . . . . . . . . . . . . . . . . . . . . . . 78

Handling Special Situations . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Prepare for emergencies . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Sick days . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Exercising, playing sports, or working hard . . . . . . . . . . . 80

Short-term removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

X-rays, MRIs, and CT scans . . . . . . . . . . . . . . . . . . . . . . . . 81

Surgery or hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . 81

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

9: Be Aware: Hazard and Advisory Alarms . . . . . . . . . . . . . . . 83

Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Hazard Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Respond to hazard alarms . . . . . . . . . . . . . . . . . . . . . . . . . 87

Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Respond to advisory alarms . . . . . . . . . . . . . . . . . . . . . . . . 91

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

10:Troubleshoot Communication Failures . . . . . . . . . . . . . . . . . 93

The Communication Failure Sequences . . . . . . . . . . . . . . . . 93

Failure at start up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Failure during operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

iXL™ Diabetes Management System User Guide: Contents iv

Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

The iXL™ Pump Care and Maintenance . . . . . . . . . . . . . . . . 97

Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

The iXL™ Remote Controller Care and Maintenance . . . . . 97

Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Replacing batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

If the remote becomes submerged in water . . . . . . . . . . . 99

If you drop the remote . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Insulin and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Ordering supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Limited Warranty for the iXL™ Remote Controller . . . . . . . 101

Limited warranty coverage . . . . . . . . . . . . . . . . . . . . . . . . 101

Warranty claim procedure . . . . . . . . . . . . . . . . . . . . . . . . 101

Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

iXL™ System Options and Settings . . . . . . . . . . . . . . . . . . . 102

iXL™ Pump Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 103

iXL™ Remote Controller Specifications . . . . . . . . . . . . . . . . 103

iXL™ System Label Symbols . . . . . . . . . . . . . . . . . . . . . . . . . 104

iXL™ Remote Controller Icons . . . . . . . . . . . . . . . . . . . . . . . 104

iXL™ System Federal Communications Commission (FCC)

Notice Concerning Interference . . . . . . . . . . . . . . . . . . . . 105

Helpful Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

My Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

v iXL™ Diabetes Management System User Guide: Contents

Contents

Introduction

About This User Guide

Conventions and Terms

Convention/Term Meaning

Bold Names of buttons, soft keys, menus, and

screens are bold.

Italics Words in italics are defined in the Glossary

at the end of this User Guide.

Press Press and release a button or soft key. Hold Keep pressing a button until its function

is complete.

Menu A list of options on the remote.

Options allow you to perform tasks.

Screen Displays programming, operating, and

alarm/alert information.

Button A physical button on the remote, such as

the Power button.

Soft key A button on the remote whose label or

function appears on the screen directly above the button. The label changes depending on the task you are performing.

Icon An image on the remote screen that indicates

a menu option or item of information. A table of screen icons appears in the Appendices.

Symbols

Symbol Meaning

Warning Describes potential serious adverse

reactions, or indicates conditions that could cause death or serious injury.

Caution Indicates conditions that could cause

minor or moderate injury to you or damage to the device.

Note Provides helpful information.

Tip Offers a suggestion for successful

pumping.

iXL™ Diabetes Management System User Guide: Introduction vi

Before You Get Started

US Federal law restricts this device to sale by or on the order of a physician.

Indication

The Insulet iXL Diabetes Management System is intended for the continuous subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Contraindications

Insulin pump therapy is NOT recommended for people who are either:

• Unable to perform at least four (4) blood glucose checks per day.

• Unable to maintain contact with their healthcare provider.

• Unable to use the system according to instructions.

If you are unable to use the system according to instructions, you may be putting your health and safety at risk. Talk with your healthcare provider if you have questions or concerns about using the system properly.

Work with your healthcare provider to establish diabetes management guidelines that best fit your needs. These may include:

Insulin-to-Carbohydrate Ratio:

Number of grams of carbohydrate covered by one unit of insulin. For example, if your insulin-tocarbohydrate ratio is 1:10, then you need to deliver one unit of insulin to cover every ten grams of carbohydrate you eat.

Cor

rection Factor or Sensitivity Factor: How much one unit of

insulin will lower blood glucose. For example, if your sensitivity factor is 40, one unit of insulin will lower your blood glucose by 40mg/dl.

arget Blood Glucose Range: A range of blood glucose levels

that you are trying to achieve during a certain period of the day. For example, you may want one range before meals, a different range two hours after meals, and yet another range for bedtime.

Your individual needs influence the initial settings you and your healthcare provider will enter into the iXL’s Remote Controller during setup (see Chapter 2, Getting Started).

Although your healthcare provider must assist you in entering these initial settings, soon you will be entering and changing your own settings with confidence and ease. Don’t be intimidated by the new technology. The iXL System is more user-friendly than most electronic devices you use every day. In fact, technology is what makes the iXL System so easy to use.

vii iXL™ Diabetes Management System User Guide: Introduction

Introduction

Your healthcare provider is a valuable resource. You are going to rely on him/her for a lot of critical information about your iXL System, especially during the first few weeks and months. If you have questions about diabetes management after starting on the iXL System, do not hesitate to talk with your healthcare provider. You can call us 24 hours a day, 7 days a week for emergencies or for technical questions about iXL System setup or operation.

Customer Support: (24 hours/7 days) (800) 591-3455 Sales and Supplies: (800) 591-9948 Web Site: www.insulet.com

Do NOT attempt to use the iXL Diabetes Management System without first meeting with your healthcare provider to receive training.

Your Important Role in Successful Pump Therapy

Your healthcare provider will give you all the tools and training you need to be successful with insulin pump therapy. However, in the end, your success depends on YOU. You must become actively involved in your own diabetes management if you want to enjoy the outstanding control, freedom, and flexibility that is possible with the iXL System. Being actively involved means:

• Frequently monitoring and recording blood glucose levels.

• Learning how to operate your iXL System and practicing

proper pumping techniques.

• Regular visits with your healthcare provider.

iXL™ Diabetes Management System User Guide: Introduction viii

Your Personal Diabetes Management Information

Basal Programs

Name Time Segment Rate

______________ 12:00 am to _______ _______ U/hr

_______ to _______ _______ U/hr _______ to _______ _______ U/hr _______ to _______ _______ U/hr _______ to _______ _______ U/hr

______________ 12:00 am to _______ _______ U/hr

_______ to _______ _______ U/hr _______ to _______ _______ U/hr _______ to _______ _______ U/hr _______ to _______ _______ U/hr

______________ 12:00 am to _______ _______ U/hr

_______ to _______ _______ U/hr _______ to _______ _______ U/hr _______ to _______ _______ U/hr _______ to _______ _______ U/hr

Temp Basal Presets

Name Adjustment

______________ _______ U/hr ______________ _______ U/hr ______________ _______ U/hr

Insulin-to-Carbohydrate Ratio

1.0 unit of insulin covers _______ grams of carbohydrate

Correction (Sensitivity) Factor

1.0 unit of insulin lowers blood glucose by about _______ mg/dl

Target Blood Glucose Range

Before meals: Between _______ and _______ mg/dl 2 hours after meals: Less than _______ mg/dl Bedtime: Between _______ and _______ mg/dl 2–3am: More than _______ mg/dl

Hemoglobin A1c

Target: _________ Date: __________ Result: _________ Date: __________ Result: _________ Date: __________ Result: _________ Date: __________ Result: _________

ix iXL™ Diabetes Management System User Guide: Introduction

Introduction

My Notes:

iXL™ Diabetes Management System User Guide: Introduction x

My Notes:

xi iXL™ Diabetes Management System User Guide: Introduction

Introduction

Your New iXL™ Diabetes Management System 1

Insulin Delivery with the iXL™ System

The iXL System is more than just a pump. It is a complete diabetes management system.

The long-term health benefits of better blood glucose control are well known. Maintaining near-normal blood glucose can help you live a longer, healthier life with fewer diabetes-related complications. However, good health is not the only advantage enjoyed by people who use the iXL Diabetes Management System. There are many practical, everyday benefits having to do with convenience, freedom, and flexibility.

Continuous insulin delivery, possible only with an insulin pump, most closely mimics the insulin release of a healthy pancreas. Since the landmark 10-year Diabetes Control and Complications Trial (DCCT), the long-term health benefits of maintaining near-normal blood glucose levels have been widely recognized.

Continuous insulin delivery at preset rates eliminates the need for scheduled daily injections and the interruptions that come with them. Continuous delivery of rapid-acting, U-100 insulin also gives you the freedom to eat what you want and when you want. You don’t have to plan snacks or meals around when your insulin is peaking. In addition, with the iXL System, insulin delivery can be changed with the press of a button to adapt to snacks or unexpected changes in daily routine. The iXL System is ideal for all kinds of people, because it fits every lifestyle.

The iXL Diabetes Management System works much like the pancreas of a person without diabetes by delivering insulin in two ways:

• A small, constant background supply of insulin (called a basal rate) is delivered automatically at a programmed rate throughout the day and night.

• An extra dose of insulin (called a bolus) can be delivered when needed to match the carbohydrates (sugar content) in a meal or snack, or to correct a high blood glucose.

iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System 1

2 iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System

Your New iXL™ Diabetes Management System1

How does the iXL™ System Work?

The iXL Diabetes Management System is a two part system: a pump and a remote. The iXL Pump is small and has a low, thin profile. The pump is worn on the body and is comfortable to wear. An adhesive holds the pump against the skin. The pump can hold up to 200 units of deliverable insulin. Each time you activate a new pump, you fill it with the amount of insulin you need. The iXL System stores insulin right inside the pump. Insulin enters your body from the pump through a short thin tube (called a cannula). With the iXL Pump, there is no long tubing to get tangled or caught on things. Deactivate the used pump and

apply a new one every 48-72 hours or as instructed by your healthcare provider.

RediSet™ System

The iXL Pump uses the RediSet system, a built-in infusion set with an automatic inserter. With other systems, you have to either insert the infusion set manually or carry around a separate inserter. With the RediSet feature, once the iXL Pump is attached to your skin, you simply press a button on the remote and the automatic inserter does the rest.

Wireless Technology

The iXL System is wireless. The remote is small, lightweight, and not attached to the pump, so you can carry it inside an article of clothing or put it in a backpack, briefcase, or purse. All pump operations are programmed and controlled through the iXL Remote Controller. You use the remote to make insulin delivery adjustments, respond to alarms and alerts and obtain the pump status. The remote uses on-screen messages to guide you through menu options. The menu options are clear and easy to understand and there are only a few buttons on the remote to learn and use.

Data Storage

Another part of the iXL System’s convenience is data storage. Paper charts are useful, but sometimes they can be inconvenient to carry or use. The remote’s electronic data storage and retrieval system displays up to 90 days’ worth of information on the remote screen.

Your New iXL™ Diabetes Management System 1

The iXL™ Pump

The iXL Pump attaches to your skin with an adhesive backing, similar to a bandaid.

The iXL™ Remote Controller

All pump operations are programmed and controlled through the palm-sized iXL Remote Controller. The remote “talks” to the pump using wireless technology, similar to a mobile phone.

iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System 3

Up/Down Controller

Soft keys

iBolus

Fill port

Needle cap

User info/support

Status

Power

Adhesive backing

Viewing window

Your New iXL™ Diabetes Management System1

Buttons that program and control the iXL™ System

Button Action

Power Pressing turns the screen on and off. Holding

activates the backlight, which lets you read the screen in the dark. To preserve battery life, use the backlight only when necessary.

Status Brings you to the Status screen (shown later in

this chapter). Among other things, the Status screen tells you what basal rate or bolus dose is currently running, the time and amount of the last bolus delivered, how much insulin is in the pump reservoir, and how much power remains in the remote’s batteries.

User Info/ Brings you to the User Info/Support screen, Support which shows Insulet Corporation information,

product information, and–if you or your healthcare provider enter it–any personalized user information you want.

Button Action

Soft Keys Called “soft” because they do not have a “hard”

label or definite purpose. Soft key labels and functions depend on the menu or screen you are viewing. The label appears on the screen directly above the physical button you press. For example, when you are in the Main menu, the left soft key is labeled Status and pressing it brings you to the

Status screen. However, when you are in the Status screen, the same soft key is labeled Menu and pressing it brings you to the Main menu.

Up/Down Pressing scrolls through a list of available menu Controller options or numbers so you can pick the one you

want. Holding the button scrolls faster.

In some lists, the Up/Down Controller button cannot be used for scrolling, because it is being used for another purpose. In this case, press the soft key labeled More to go to the next screen.

iBolus™ Lets you easily and discreetly deliver a bolus dose

(Audio Bolus) “on the go,” without having to look at the screen.

4 iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System

Your New iXL™ Diabetes Management System 1

Entering and changing text

To enter text, numbers, or characters (for example, when entering your personal contact information), use the Up/Down Controller button to scroll to the character you want, and then press Select. Repeat for each character needed to spell the word or name you want to add.

To change a number, time, or date, select the number and use the Up/Down Controller button to increase or decrease it.

iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System 5

Your New iXL™ Diabetes Management System1

6 iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System

Primary Screens

Messages on the screen tell you how the system is operating, list menu choices, or explain how to perform certain tasks. The system’s two primary screens are:

Status Screen Action

View the system’s current operating status

• Date and time.

• Remote battery level.

• Insulin reservoir volume (how

much insulin is in the pump).

• When an

extended bolus is being delivered, how much insulin has been delivered.

• Name and rate of current

basal program, unless a bolus dose

is currently being delivered (see above).

• Whether a temporary basal program is in use. If a pump is in Suspend mode, the

Status screen displays “INSULIN SUSPENDED.” If a pump has not yet been activated (as during pump changes), the screen displays “No active pump. Would you like to activate a pump now?” (see Chapter 5, The iXL Pump, for details). You can go to the

Status screen at any time by pressing

the

Status button.

Main Menu Screen Action

Go to all the major submenus:

• Bolus menu to deliver bolus doses.

•

Temp basal menu to deliver temporary basal rates.

•

My records menu to review insulin delivery records, alarm records, and personal user information.

• Settings menu to customize system settings and to set and name basal and temporary basal programs that meet your personal needs.

•

Suspend menu to suspend, cancel, or resume insulin delivery programs.

Your New iXL™ Diabetes Management System 1

iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System 7

My Notes:

Your New iXL™ Diabetes Management System1

My Notes:

8 iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System

Getting Started

The iXL™ Startup Kit

Your kit contains:

• This User Guide

• One (1) iXL Remote Controller

• Ten (10) iXL Pumps (filling syringe and needle is provided

with each pump)

• Two (2) AAA alkaline batteries

• Registration card (postage paid)

If you are a first-time iXL System user, you need to meet with your healthcare provider for training and system setup before using it. To get a head start on learning about your new iXL System, review this User Guide before your first training session. Having a basic understanding of the System in advance will help you get more out of your training sessions.

After unpacking your startup kit, use the list above to make sure you have everything. Then, complete the registration card and promptly mail it to us. Returning the card allows us to contact you with important product updates or warranty information.

Do NOT use the iXL Diabetes Management System until you have been trained by your healthcare provider. He/she will initialize the system based on your individual needs.

iXL™ Diabetes Management System User Guide: Getting Started 9

Set Up The iXL™ Remote Controller

Chapter 6 describes the remote’s options in detail. The instructions in this chapter are simplified to help you get started.

Turn on the remote

1. Open the battery compartment on the back of the remote by gently pressing down on the ribbed side of the compartment door until it opens (Figure 2-1). No special tools are necessary.

2. Insert two (2) new AAA alkaline batteries into the compartment.

The diagram inside the compartment shows you which direction to insert the batteries.

Use only new AAA alkaline batteries to power the remote. Never use old or used batteries; the remote may not work properly.

3. Replace battery door.

4. Turn the remote face-up.

5. Press the Power button.

The iXL™ Setup Wizard

The first time you turn on the iXL Remote Controller, the Setup Wizard comes on automatically. Although setup is easy with the Wizard, if you are a first-time user, your healthcare provider must guide you through the process. Setup takes only a few minutes and is easy to do:

• Use the Up/Down Controller button to increase or decrease a number or to move up or down a list.

• Press the soft key labeled Next to continue to the next screen.

• Press the Back soft key to return to previous screens.

You can adjust these settings later as your needs change or you fine-tune your iXL System.

10 iXL™ Diabetes Management System User Guide: Getting Started

Getting Started2

Figure 2-1

Getting Started

The Wizard’s Welcome screen (Figure 2-2) gets you started. Press the Continue soft key to begin setting time and day, bolus and basal options, and indicators.

1. Use the Up/Down Controller button to increase or decrease the time. (If you prefer a 24-hour clock, press the 12hr/24hr soft key.) Then press Next.

2. Enter the current year, then press Next.

3. Choose the current month, then press Next.

4. Enter the current day, then press Next.

5. Choose the date format you prefer, then press Next.

6. Choose a bolus increment (how much each press of the Up/Down Controller button will increase or decrease a bolus delivery), either 0.10, 0.50, or 1.00 units of insulin, then press Next.

7. Choose the maximum bolus you can give at one time, up to 30 units in 0.10-unit increments, then press Next.

8. Choose the maximum basal rate you can set, up to 30 units per hour, then press Next.

9. Choose the initial basal rate to use, then press Next.

The initial basal program established with the Setup Wizard is named Basal 1. You can change the name in the Settings > Basal programs menu (see Chapter 3, Basal Rates).

10.Press Done to confirm the basal program shown on the screen. To add more basal segments to the program, or to change the rate shown, press Edit (see Chapter 3, Basal Rates, for details).

11.Press Confirm to confirm the basal program you have set. To see the basal program as a list, press List. To return to the graphic view, press Graph.

To avoid confusion, since “midnight” both begins and ends a 24-hour period, the end of the day is represented as 11:59 pm.

12.Choose the maximum daily dose of insulin you should take, from 0 to 200 units in 5-unit increments, then press Next.

13.Choose the level of insulin in the reservoir at which the remote should give you an alarm. Choose from 10 to 50 units in 5-unit increments, then press Next.

iXL™ Diabetes Management System User Guide: Getting Started 11

Figure 2-2

14.The remote now asks whether you want to activate a pump (Figure 2-3). You can:

• Press Yes if you are ready to activate a new iXL Pump.

• Press No if you do not want to activate a pump at this time.

The remote displays the Main menu.

You can press the Power button to turn off the remote at any time during setup. Otherwise, it turns off automatically after a screen time-out period you set (see Chapter 6, iXL Remote Controller Features). If you turn the remote on again within 5 minutes, you will return to the same Setup Wizard screen you last saw. If you turn it on after 5 minutes, you will return to the beginning of the Setup Wizard.

Your healthcare provider will help you fill and attach your first iXL Pump. The process is easy because on-screen messages walk you through every step. Please refer to Chapter 5, The iXL Pump, for detailed instructions.

12 iXL™ Diabetes Management System User Guide: Getting Started

Getting Started2

Figure 2-3

Getting Started

My Notes:

iXL™ Diabetes Management System User Guide: Getting Started 13

My Notes:

14 iXL™ Diabetes Management System User Guide: Getting Started

Getting Started2

Basal Rates

What is a Basal Rate?

A basal rate is a small base or background amount of insulin that is delivered, at a preset rate, continuously for a specified period of time.

Even without eating, our bodies need a small, constant supply of insulin for normal cell activity. In people without diabetes, the pancreas continuously delivers this background supply of insulin. For people using the iXL Diabetes Management System, the iXL Pump mimics a healthy pancreas by delivering insulin at a programmed basal rate.

Approximately 50% of a pumper’s total daily dose comes from basal insulin delivery; the remaining 50% comes from bolus doses (see Chapter 4, Bolus Doses).

Personalized Basal Programs

Insulin needs vary throughout the day. Therefore, most people set their basal rates to deliver slightly more (or less) insulin at certain times. For example, one person may need to deliver a higher rate of insulin during the early morning and a lower rate during the late evening. A basal program describes the amount of insulin to be delivered during an entire 24-hour period.

A basal program contains at least one basal rate for the 24-hour period, but for most people it will be broken into several time segments, or basal segments, each delivering a different rate of insulin. A sample basal program with three basal segments might be:

Basal Segment Basal Rate Meaning

12:00am – 8:00am 0.60U/hr Between midnight and

8:00am, the pump delivers

0.60 units of insulin per hour.

8:00am – 3:00pm 0.80U/hr Between 8:00am and 3:00pm,

the pump delivers 0.80 units of insulin per hour.

3:00pm – 11:59pm* 0.70U/hr Between 3:00pm and 11:59pm

(midnight), the pump delivers

0.70 units of insulin per hour.

*To avoid confusion, the end of a day is represented as 11:59pm.

iXL™ Diabetes Management System User Guide: Basal Rates 15

In addition to normal daily changes, insulin needs can vary with different routines or days of the week. For example, regular school or workday routines may differ from weekend routines, and insulin needs may differ, too. With your healthcare provider, you will decide on the basal rates that best match your lifestyle and insulin needs. You will enter at least one basal program (your Basal 1 program) into your remote during the setup process (see Chapter 2, Getting Started). You can add other programs later as you fine-tune your system settings or when your needs change. You can preset basal rates to use for regular occasions when you need a different rate than the Basal 1 program provides, such as exercise times or school nights.

Create a basal program

The iXL Remote Controller can store up to seven different basal programs. Each program can contain 48 rates, programmed in half-hour increments. Once you enter a basal program into the remote, pressing a few buttons is all it takes to pick the program you want. The iXL Pump continues to deliver insulin at those rates until you change that program or switch to another one. For up to 72 hours, you get insulin delivery that’s customized to your personal needs.

1. In the Main menu, use the Up/Down Controller button to choose Settings (Figure 3-1); then press the soft key labeled Select.

16 iXL™ Diabetes Management System User Guide: Basal Rates

Basal Rates3

Figure 3-1

Basal Rates

2. Choose Basal programs (Figure 3-2), then press Select.

3. Choose [new program] (Figure 3-3), then press Create.

4. To use the iXL System’s default naming system, simply press Next.The default naming system automatically assigns program names in numerical order, such as Basal 1, Basal 2, Basal 3.

Or, to give a different name to the program: (a)Press the Up/Down Controller button to enter the

characters that spell the name you want. An underscore (_) on the screen indicates which character you are changing.

Press the soft key labeled with the arrow to move the underscore to the next character. For example, if you have

school three nights a week and eat early those nights, you might enter S, c, h, o, o, l, space, N, i, g, h, t (Figure 3-4).

(A blank character/space is the first and last option in the scrolling menu.)

(b)Press Next.

iXL™ Diabetes Management System User Guide: Basal Rates 17

Figure 3-2

Figure 3-3

Figure 3-4

As a safety feature, the words “Invalid basal program name” (Figure 3-5) appear if the name you entered does not have at least one character or if the name is being used by another basal program. Press OK to return to the previous screen and enter a different name.

5. Enter the rate, in U/hr, for the first basal segment (from Off to the maximum you entered during setup), then press Next.

6. Review the list showing your new basal program. New programs show the first basal rate during the time

period 12:00am-11:59pm. The end of the day is represented by 11:59pm.

To use the same basal rate for the entire 24-hour program, press Done and continue with step 7.

Or, to add basal segments and rates (for example, a higher basal rate between 8:00am and 3:00pm):

(a)Press Edit. (b) Enter the start time (for example, 8:00am), then press Next.

Basal segments are in 30-minute increments. (c)Enter the end time (for example, 3:00pm), then press Next. (d)Enter the rate for the new basal segment (for example,

0.80U/hr), then press Next. Basal rates outside the changed segment do not change.

(e) Repeat steps a-d for each new segment and rate you want. (f) Press Done.

18 iXL™ Diabetes Management System User Guide: Basal Rates

Basal Rates3

Figure 3-5

Basal Rates

7. Review the graph of the new basal program (Figure 3-6). To see the program as a list, press List (Figure 3-7). To see

the graph again, press Graph.

To add the program to the remote’s memory, press Save. Or press Cancel to cancel the newly entered program. Repeat the steps above for each basal program (up to 7) you

want to create.

Enable an existing basal program

1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

2. Choose Basal programs, then press Select.

3. Choose the program you want from the list (Figure 3-8), then press Enable.

To see a graph of the basal program, press Graph.

iXL™ Diabetes Management System User Guide: Basal Rates 19

Figure 3-6

Figure 3-7

Figure 3-8

4. Press Enable to start the selected basal program. The pump beeps to indicate that the chosen basal program is running.

Or press Cancel to return to the list and select a different program.

A diamond icon (♦) appears next to the program that is

currently running. You cannot select the current program to enable, because it is already running.

As a safety feature, you cannot enable a new basal program while a temporary basal preset is in process (see “Preset Temporary Basal Rates” later in this chapter); you must first cancel the current temporary basal preset. If you try to activate a new program before you cancel the temporary preset, the screen displays an error message (Figure 3-9). Press OK to return to the list of available basal programs.

Change or delete a basal program

1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

2. Choose Basal programs, then press Select.

3. Choose a program from the list, then press Edit.

4. Follow the steps below, then press Done.

To change a segment or rate in the basal program:

1. Choose Edit segment, then press Select (Figure 3-10). Or press Done to back out of this process.

2. To edit the program, press Edit.

3. Enter the start time for the segment you want to change then press Enter.

4. Enter an end time for this segment, then press Enter.

20 iXL™ Diabetes Management System User Guide: Basal Rates

Basal Rates3

Figure 3-9

Figure 3-10

Basal Rates

5. Enter a basal rate for the new segment, then press Enter.

6. To save the newly entered segment into the basal program, press Save. If you want to make additional edits, press Edit and repeat steps 3-5.

7. If this is the currently active basal program, press Confirm (Figure 3-11) to update. (The pump beeps to indicate that the active basal program has been updated.)

Press Save (Figure 3-12) for any other basal program. Or, press Cancel to ignore the edits you made to the basal

program and return to the edit screen.

To rename a basal program:

1. After choosing a program from the list, choose Rename and then press Select.

2. Press the Up/Down Controller button to enter the characters that spell out the name you want; then press Save.

Or press Back to back out of this process.

To delete a basal program:

1. After choosing a program from the list, choose Delete and then press Select.

2. Press Delete to permanently delete the program. Or press Cancel to back out of the deletion process.

As a safety feature, you cannot delete the current basal program. If you try to delete the current program, the screen displays an error message (Figure 3-13). Press OK to return to the list of editing options.

iXL™ Diabetes Management System User Guide: Basal Rates 21

Figure 3-11

Figure 3-12

Figure 3-13

Preset Temporary Basal Rates

What is a temporary basal rate?

A temporary basal rate lets you adjust your basal rate for a short period of time. If a temporary change later becomes permanent, you can create a new basal program for it. Some temporary changes are easy to predict and respond to; they happen routinely and you may know from experience how they affect your insulin needs. For example, you might take the same exercise class twice a week for eight weeks, or join a summer soccer league. For women, a monthly hormonal change that affects blood sugars is an example of predictable change. To easily handle predictable but short-term changes, you can preset a temporary basal rate, so it is ready whenever you need it. The remote can remember up to seven (7) temporary basal presets.

Create a temporary basal preset

1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

2. Choose Temp basal presets, then press Select.

3. Choose [new preset], then press Create.

4. To use the iXL System’s default naming system, simply press Next. The default naming system automatically assigns program names in numerical order, such as Temp basal 1, Temp basal 2, Temp basal 3.

Or, to give a different name to the program:

(a)Press the Up/Down Controller button to enter the

characters that spell the name you want. An underscore (_) on the screen indicates which character you are changing. Press the arrow key to move the underscore to the next character. For example, if you take an aerobics class two nights a week, you might enter a, e, r, o, b, i, c, s (Figure 3-14).

(b)Press Next.

5. Enter the new temporary basal rate, from Off to the maximum basal rate you entered during setup; then press Next.

22 iXL™ Diabetes Management System User Guide: Basal Rates

Basal Rates3

Figure 3-14

Basal Rates

6. Review the temporary basal name and rate; press Save to accept it.

Or press Back to return to the previous screen and enter a different rate.

Enable an existing temporary basal preset

1. In the Main menu, use the Up/Down Controller button to choose Temp basal (Figure 3-15); then press the soft key labeled Select.

2. Choose the temp basal preset you want to use from the list, then press Select.

3. Enter the duration for the temporary rate, in increments of 30 minutes, then press Enter.

4. Press Start to begin the temporary basal rate shown on the screen.

Or press Back to return to the previous screen if you want to enter a different duration.

Cancel an active temporary basal preset

1. In the Main menu, use the Up/Down Controller button to choose Suspend/cancel; then press the soft key labeled Select.

2. Choose Cancel temp basal, then press Select.

3. Press Confirm to cancel the currently running temporary basal preset.

Or press Back to back out of this process.

Change or delete a temporary basal preset

1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

2. Choose Temp basal presets, then press Select.

3. Choose a temporary program from the list, then press Edit.

4. Follow the steps in the next section, then press Done.

iXL™ Diabetes Management System User Guide: Basal Rates 23

Figure 3-15

To change a temporary basal preset:

1. Choose Edit rate, then press Select (Figure 3-16). Or press Done to back out of this process.

2. Enter a new rate for the program, then press Save.

To rename a temporary basal preset:

1. Choose Rename and then press Select.

2. Press the Up/Down Controller button to enter the characters that spell out the name you want; then press Save.

Or press Back to back out of this process.

To delete a temporary basal preset:

1. Choose Delete and then press Select.

2. Press Delete to permanently delete the preset. Or press Cancel to back out of this process.

One-Time Temporary Basal Rates

On occasion, you may need to change the current basal rate for a short time. For example, if you are going cross-country skiing for several hours, you may want to lower the basal rate during and after you exercise.

Enable a one-time temporary basal rate

1. In the Main menu, use the Up/Down Controller button to choose Temp basal; then press the soft key labeled Select.

2. Choose [enter manually] from the list of temp basal presets. (If you have not created any temp basal presets, the remote skips this step.)

3. Enter the temporary basal rate in units per hour, then press Enter.

4. Enter the length of time for the temporary rate, in increments of 30 minutes, then press Enter.

5. Press Start to start the temporary basal rate shown on the screen.

Or press Back to back out of this process.

24 iXL™ Diabetes Management System User Guide: Basal Rates

Basal Rates3

Figure 3-16

Basal Rates

Cancel a one-time temporary basal rate

1. In the Main menu, use the Up/Down Controller button to choose Suspend/cancel; then press the soft key labeled Select.

2. Choose Cancel temp basal (Figure 3-17); then press Select.

3. Press Confirm to cancel the temporary basal shown on the screen.

Or press Back to back out of this process.

Maximum Basal Rate

What is the maximum basal rate?

The maximum basal rate is a safety feature. It limits the basal rate (U/hr) that the iXL Pump can deliver. Once it is entered into the remote’s memory, the maximum applies to both regular basal programs and temporary basal rates.

You and your healthcare provider will enter an initial maximum basal rate into your remote during the setup process (see Chapter 2, Getting Started). You can change it later as you fine-tune your system settings or when your needs change.

Set a maximum basal rate

1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

2. Choose System setup, then press Select.

3. Choose Bolus/basal setup, then press Select.

4. Choose Max basal rate, then press Select.

5. Enter a new maximum basal rate, then press Enter.

6. You can press Back at any screen to back out of this process.

iXL™ Diabetes Management System User Guide: Basal Rates 25

Figure 3-17

My Notes:

26 iXL™ Diabetes Management System User Guide: Basal Rates

Basal Rates3

Bolus Doses

What is a Bolus?

A bolus is an extra dose of insulin, delivered when needed to match the carbohydrates (sugar content) in a meal or snack, or to lower blood glucose when it gets too high. This extra dose is in addition to the basal rate delivered throughout the day and night (see Chapter 3, Basal Rates).

The size of a bolus dose depends on many variables. These variables include your blood glucose level, insulin-to- carbohydrate ratio, activity level, and the type and amount of food you eat. With the iXL System, it is easy to adapt to any situation, because – with the press of a few buttons – you can adjust to unexpected or changing insulin needs.

During setup, you enter bolus dose settings in the remote (see Chapter 2, Getting Started). However, you can adjust these settings as you fine-tune your system settings or when your needs change (see Chapter 6, iXL Remote Controller Features).

Bolus Dose Options

So you can fully enjoy the freedom of eating what and when you want, the iXL System offers the following bolus dose options:

Nor

mal Bolus: When you need a dose of insulin right way (to

cover a meal or snack you are about to eat or to reduce a high blood glucose level).

Extended Bolus:

When you are eating high-fat or high-protein foods (which take longer to digest and are slower to affect blood glucose) or when you are eating for an extended period (for example, at a party or during a holiday meal).

iBolus™ (Audio Bolus):

When you want to give yourself a bolus “on the go,” without looking at the remote screen. This feature is especially handy if you want to give yourself a bolus discreetly or without having to stop what you are doing (for example, when attending classes or meetings, eating out, or entertaining).

The bolus features in the iXL System are designed for flexibility and convenience. You can easily transition from a normal to an extended bolus simply by pressing a few buttons.

Although you cannot deliver an extended bolus while another extended bolus is active, you can deliver a normal or an iBolus while an extended bolus is being delivered.

iXL™ Diabetes Management System User Guide: Bolus Doses 27

Deliver Bolus Doses

Deliver a normal bolus

1. In the Main menu, use the Up/Down Controller button to choose Bolus (Figure 4-1); then press the soft key labeled Select.

2. Enter the number of units you want to deliver.

3. Press Enter. As a safety feature, the remote only allows you to give a

bolus at or below your maximum bolus dose.

If the dose you enter would put you over your maximum total daily dose, an on-screen message appears (Figure 4-2). Press OK and request a smaller amount; or increase the system setting for maximum daily dose (see Chapter 6, iXL Remote Controller Features).

28 iXL™ Diabetes Management System User Guide: Bolus Doses

Bolus Doses4

Figure 4-1

Figure 4-2

Bolus Doses

4. If you have set the blood glucose reminder option to Audible or Vibrate (see Chapter 6, iXL Remote Controller Features), the remote asks whether you want to schedule a reminder (Figure 4-3). Reminders that have been set previously appear at the bottom of this screen.

If you want to set a reminder: (a)Press Ye s. (b)Enter the time for the reminder. (c)Press OK. If you do not want to set a reminder, press No. If you have set the blood glucose reminder to Off, the remote

will not ask you to set a reminder.

5. Press Start to begin the bolus delivery. Or press Back if you decide not to deliver the bolus.

Deliver an extended bolus

1. In the Main menu, use the Up/Down Controller button to choose Bolus; then press the soft key labeled Select.

2. Enter the number of units you want to deliver.

3. Press Extended.

4. Enter the units of insulin (if any) that you want to take immediately, then press Enter.

5. Enter the time (up to 8 hours, in 30-minute increments) over which to deliver the remainder of the bolus (the amount shown on the screen, Figure 4-4); then press Enter.

iXL™ Diabetes Management System User Guide: Bolus Doses 29

Figure 4-3

Figure 4-4

6. If you have set the blood glucose reminder option to Audible or Vibrate (not Off) and you want to add a reminder:

(a)Press Ye s. (b)Enter the time for the reminder. (c)Press OK. If you do not want to set a reminder, press No. If you have set the blood glucose reminder to Off, the remote

will not ask you to set a reminder.

7. Press Start to begin the bolus delivery. Or press Back if you decide not to deliver the bolus.

As a safety feature, if you try to set an extended bolus while another extended bolus is being delivered, an on-screen message appears (Figure 4-5). Press OK and wait until the extended bolus is complete, or cancel the extended bolus (see “Cancel Active Boluses” later in this chapter). You can deliver a normal bolus while an extended bolus is being delivered.

30 iXL™ Diabetes Management System User Guide: Bolus Doses

Bolus Doses4

Figure 4-5

Bolus Doses

Deliver an iBolus™ (audio bolus)

The iXL System’s exclusive iBolus feature lets you deliver a bolus conveniently and discreetly, without having to look at the remote screen. The iBolus button is located on the right side of the remote (Figure 4-6).

The iBolus increment depends on the bolus increment that you select during setup. For example, if your normal bolus increment is 1.0 unit, the iBolus increment will be the same.

When delivering an iBolus dose, the blood glucose check reminder feature defaults to Off.

1. Press the iBolus button. The remote beeps once to confirm that the iBolus feature is

active.

2. Press the iBolus button once for each increment of insulin to deliver. For example, if you want to deliver 3 units and your increment is set to 1 unit, press the iBolus button 3 times .

3. After a brief pause, the remote beeps once for each increment entered, so you can confirm the dose by counting the number of beeps.

If you press the iBolus button during the counting period, the remote cancels the operation and returns to the Status screen.

4. Within 3 seconds of hearing the final beep, press Start to confirm the dose (Figure 4-7).

If you do not press Start within 3 seconds, the remote automatically cancels the iBolus and returns to the Main menu.

5. After you confirm the dose, the pump beeps once to signal that bolus delivery has begun.

iXL™ Diabetes Management System User Guide: Bolus Doses 31

Figure 4-6

Figure 4-7

iBolus button

Cancel Active Boluses

The iXL System is extremely flexible and can respond almost immediately to your changing insulin needs. It is easy to cancel an active bolus (one that is currently being delivered), even after insulin delivery has started.

1. Press the Power button to turn on the remote, if it is not already on. An on-screen message appears as long as a bolus is being delivered (Figure 4-8).

2. Press the soft key labeled Cancel. The pump beeps to confirm the bolus is canceled. An

on-screen message tells you how much insulin was delivered before you canceled the bolus (Figure 4-9).

If the bolus has already been completed, the “Delivering bolus” message and the Cancel soft key label do not appear.

3. Press OK to return to the Status screen.

32 iXL™ Diabetes Management System User Guide: Bolus Doses

Bolus Doses4

Figure 4-8

Figure 4-9

Bolus Doses

My Notes:

iXL™ Diabetes Management System User Guide: Bolus Doses 33

My Notes:

34 iXL™ Diabetes Management System User Guide: Bolus Doses

Bolus Doses4

The iXL™ Pump

The Pump Change Process

You should replace the pump at least once every 48-72 hours, or as instructed by your healthcare provider. (You can also choose to have the remote alert you when you need to replace the pump (see Chapter 6, iXL Remote Controller Features and Chapter 9, Hazard and Advisory Alarms).

WARNINGS!

• Do NOT attach or use a pump if its sterile packaging is open or damaged, as this may increase the risk of infection. Pumps are sterile unless packaging has been opened or damaged.

• Do NOT attach or use a pump if it is damaged in any way. A damaged pump may not work properly.

• Do NOT attach a pump without first using aseptic technique to clean the infusion site.

• Do NOT use the iXL Pump if you are sensitive to or have allergies to acrylic adhesives or have fragile or easily damaged skin.

• Check often to make sure the pump and soft cannula are securely attached and in place. A loose or dislodged cannula may interrupt insulin delivery.

IMPORTANT!

Because insulin pumps use rapid-acting insulin, pump users are at increased risk for developing hyperglycemia (high blood glucose) if insulin delivery is interrupted. If it is untreated, severe hyperglycemia can quickly lead to diabetic ketoacidosis (DKA), which can cause coma, shock, breathing difficulties, or death. If insulin delivery is interrupted for any reason, you may need to replace the missing insulin–usually with an injection of rapid-acting insulin. Ask your healthcare provider for instructions on handling interrupted insulin delivery.

Gather the following equipment and supplies:

• Vial of rapid-acting U-100 insulin Use ONLY rapid-acting U-100 insulin with iXL Pumps.

NEVER use insulin that is cloudy; it may be old or inactive. Failure to use rapid-acting U-100 insulin, or using insulin that is old or inactive may lead to hyperglycemia or diabetic ketoacidosis (DKA).

• An unopened iXL Pump (including filling syringe and needle

provided with each pump)

• Alcohol prep swab

If you are a first-time iXL System user, your healthcare provider will guide you through the steps for system setup, including steps for initializing and attaching your first pump. Do NOT attempt to attach or use an iXL Pump until you have been trained by your healthcare provider.

iXL™ Diabetes Management System User Guide: The iXL™ Pump 35

Deactivate current pump

1. In the Main menu of the remote, select Settings (Figure 5-1).

2. In the Settings menu, select Pump change (Figure 5-2).

3. In the Confirm Pump change screen, press Confirm (Figure 5-3).

36 iXL™ Diabetes Management System User Guide: The iXL™ Pump

The iXL™ Pump5

Figure 5-1

Figure 5-2

Figure 5-3

The iXL™ Pump

4. At the message, “Pump deactivated. Remove and discard the pump, and then press Continue” (Figure 5-4), remove the old pump.

(a)Lift the edges of the adhesive tape from your skin and

remove the entire pump (Figure 5-5).

(b)Use soap and water to remove any adhesive that remains

on the skin or, if necessary, use an adhesive remover.

(c)Discard used pump according to local waste disposal

regulations.

5. After removing the old pump, press Continue.

iXL™ Diabetes Management System User Guide: The iXL™ Pump 37

Figure 5-4

Figure 5-5

Activate a new pump

1. Remove the new pump from its sterile package.

2. Place the remote against the new pump (Figures 5-6A/5-6B).

3. Press Activate (Figure 5-7).

After you press Activate, the pump beeps, indicating that the remote has successfully activated the pump. The iXL System safety features ensure that the remote works only with the newly activated pump.

38 iXL™ Diabetes Management System User Guide: The iXL™ Pump

The iXL™ Pump5

Figure 5-6A

Figure 5-7

Figure 5-6B

The iXL™ Pump

Fill the new pump

1. Use an alcohol prep swab to clean the top of the insulin vial; discard the prep swab.

2. Lock the filling needle onto the syringe by turning it clockwise (Figure 5-8).

3. Remove protective cap from needle.

Use care after removing the needle cap and exposing the fill needle.

4. Draw air into syringe equal to the amount of insulin being withdrawn.

5. Insert needle into vial and inject the air. This makes it easier

to draw the insulin out of the vial.

6. Withdraw insulin from vial, expelling any air bubbles. Fill syringe with enough insulin for 72 hours, or at least to the MIN (minimum) fill line (Figure 5-9).

Avoid using insulin from more than one vial, which may introduce air into the syringe.

iXL™ Diabetes Management System User Guide: The iXL™ Pump 39

Figure 5-8

Figure 5-9

7. Remove needle from vial and insert into the insulin fill port on the underside of the pump body (Figure 5-10).

8. Depress syringe plunger to completely empty syringe into the pump.

9. Remove needle from insulin fill port. Port is self-sealing; insulin will not leak after needle is removed.

Do NOT insert the fill syringe into the fill port more than once.

10.Place protective cap on needle and remove needle from

syringe.

11.Place capped needle in sharps container. Dispose of used needles according to local waste disposal regulations.

The fill syringe is intended for single use only and should be used only with iXL Pumps.

12.After you fill the pump, press Continue (Figure 5-11). The

pump’s RediSet system performs a series of safety checks and automatically primes the pump. Once complete, the remote beeps, letting you know that the priming and safety checks were successful.

40 iXL™ Diabetes Management System User Guide: The iXL™ Pump

The iXL™ Pump5

Figure 5-10

Figure 5-11

The iXL™ Pump

Select the infusion site

Before attaching a new pump, you must first select an appropriate infusion site. Due to ease of access, viewing, and reliable insulin absorption, the abdomen is often preferred. Your healthcare provider may suggest other potential sites, including the hip or upper thigh.

• Avoid sites where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the pump.

• Rotate infusion sites with each pump change. A new infusion site should be at least 1“ away from the last site. (Using the same location can lead to scarring, which reduces insulin absorption.)

• Do NOT attach the pump within 2“ of your navel or over a mole or scar, where insulin absorption may be reduced.

Prepare the infusion site

You can reduce the risk of infusion site infection by following aseptic technique and disinfecting the infusion site. Before attaching a new pump, always:

1. Wash hands with soap and water.

2. Use soap to wash the infusion site.

Antibacterial soap may irritate skin, especially at the infusion site. Consult with your healthcare provider on guidelines for treating any skin irritation.

3. Dry the site with a clean towel.

4. Use an alcohol prep swab to disinfect the infusion site. Start at the center of the site and move outward in a circular motion.

5. Let the site air-dry thoroughly. Do NOT blow on the site to dry it.

Attach the new pump

1. Prepare the pump for attaching to your infusion site. Using the pull tabs, remove and discard the white paper backing from the adhesive tape (Figure 5-12). The protective needle cap will come off in this process.

When the needle cap comes off, a few drops of insulin may escape from the needle.

iXL™ Diabetes Management System User Guide: The iXL™ Pump 41

Figure 5-12

Figure 5-14 Figure 5-15

2. Attach pump to the prepared infusion site; press firmly to secure it to your skin.

Under normal conditions, the iXL Pump’s adhesive keeps it securely in place for up to 3 days. A variety of products

are available to help secure the pump to the skin. Ask

your healthcare provider about these products. Avoid getting body lotion, creams, or oils near the infusion site; these products may loosen the adhesive.

3. After you securely attach the pump, press

Continue

(Figure 5-13).

The adhesive is designed for one-time use. Once removed, a pump cannot be reattached.

Insert cannula and begin insulin delivery

1. To insert the soft cannula, press Start (Figure 5-14). The pump’s RediSet system automatically inserts the soft

cannula and delivers a

prime bolus to fill the cannula with

insulin (Figure 5-15).

42 iXL™ Diabetes Management System User Guide: The iXL™ Pump

The iXL™ Pump5

Figure 5-13

The iXL™ Pump

The remote will alert every 5 minutes until the pump change process is complete. You must complete the

pump change process within one hour.

Once the soft cannula is inserted and the prime bolus has filled

the cannula, the pump will beep, indicating that it is active and

delivering insulin at the programmed basal rate (Figure 5-16).

2. Press OK to return to the Status screen.

Check Pump Status

To check pump status:

• From the Main menu, press Status. The remote automatically checks the status of the pump. The remote then displays the current reservoir volume, basal and bolus rates, and any alarm conditions. (See Chapter 6, iXL Remote Controller Features, for details of what you see on the Status screen.)

Suspend Insulin Delivery

Sometimes you may need to briefly stop insulin delivery (for example, during exercise). The iXL System lets you suspend insulin delivery for up to 2 hours. While in suspension, the pump beeps once every 15 minutes, reminding you of the pump’s suspend status.

At any time during a suspension period, press Resume to resume the basal program that was running when you suspended insulin delivery.

iXL™ Diabetes Management System User Guide: The iXL™ Pump 43

Figure 5-16

Figure 5-18

1. In the Main menu, use the Up/Down Controller button to choose

Suspend (Figure 5-17); then press the soft key

labeled Select.

If a temporary or

extended bolus is in process, the menu item

will be

Suspend/cancel instead, and cancel options for these

programs will also appear in the menu.

2. Choose

Suspend insulin delivery.

3. Enter how long you want to stop all insulin delivery, from 30 minutes to 2 hours in 30-minute

increments.

4. Press

Enter.

5. Press

Suspend to confirm that you want to halt all insulin delivery (basal and bolus). The pump beeps and an on-screen message lets you know that insulin delivery is indeed suspended (Figure 5-18).

Or press

Back to enter a different time period or to cancel

the suspension.

The pump beeps every 15 minutes until the end of the suspension period. The

Status screen shows “INSULIN SUSPENDED” until you resume insulin delivery (see Resume Insulin Delivery on the next page).

44 iXL™ Diabetes Management System User Guide: The iXL™ Pump

The iXL™ Pump5

Figure 5-17

The iXL™ Pump

At the end of the suspend period, a pump Advisory alarm will occur.

To resume your programmed basal rate, press OK (Figure 5-19).

The Advisory alarm will repeat every 15 minutes until you

press OK.

Resume Insulin Delivery

1. In the Main menu, use the Up/Down Controller button to choose Resume (Figure 5-20); then press the soft key labeled Select.

2. Press Resume to restart the basal program that was previously running. Or press Back if you want to continue the suspension.

iXL™ Diabetes Management System User Guide: The iXL™ Pump 45

Figure 5-19

Figure 5-20

Avoid Infusion Site Infections

• Always wash your hands and use aseptic technique to prepare the infusion site before attaching a pump.

• Do not apply a pump to any area of skin with an active infection. If you are unsure whether to use a specific site, consult your healthcare provider.

• At least once a day, use the pump’s infusion site viewing

window to check the site for signs of infection and to confirm

that the soft cannula is securely in place.

• Be aware of the signs of infection, including pain, swelling, redness, discharge, or heat at the site. If you suspect an infection, immediately remove the pump and attach a new one in a different location. Then contact your healthcare provider.

• Change the pump at least once every 48-72 hours, or as instructed by your healthcare provider.

Get the Most From Your Pump

Avoid extreme temperatures

Do NOT expose the iXL Pump to extreme operating temperatures. Exposing pumps to temperatures below 41°F (5°C) or above 104°F (40°C) can cause pump malfunction. Do NOT expose your pump to direct sunlight for extended durations. It is recommended that you remove your pump prior to using hot tubs, whirlpools, or saunas. These conditions would expose the pump to extreme temperatures and may also affect the insulin inside the pump.

Remember to check your blood glucose levels frequently before and after removing the pump. Check with your healthcare provider for guidelines on removing the pump for extended periods.

Insulin degrades at high temperatures and will freeze near 32°F (0°C). Check the insulin manufacturer’s instructions for use.

46 iXL™ Diabetes Management System User Guide: The iXL™ Pump

The iXL™ Pump5

The iXL™ Pump

Water and your pump

The iXL Pump is watertight to a depth of 8 feet for up to 30 minutes (IPX8). After exposure to water, rinse off the pump with clean water and dry it with a towel.

Do NOT expose your iXL Pump to water at depths greater than 8 feet or for durations exceeding 30 minutes.

Check often to make sure the pump and soft cannula are securely attached and in place.

The iXL Remote Controller is not waterproof. Do NOT place it in or near water.

Safe Storage

Store unopened iXL Pumps in a cool, dry place. Extreme heat or cold can damage pumps and cause them to malfunction. If pumps are exposed to extreme temperatures, inspect them carefully before use. Do NOT attach or use pump if its sterile

packaging is opened or damaged. Pumps are sterile unless packaging is opened or damaged.

iXL™ Diabetes Management System User Guide: The iXL™ Pump 47

My Notes:

48 iXL™ Diabetes Management System User Guide: The iXL™ Pump

The iXL™ Pump5

iXL™ Remote Controller Features

The Status Screen

The top of the iXL Remote Controller Status screen (Figure 6-1) displays the “communicating” icon, an icon showing how full the battery is, and the current date and time. The center of the screen provides information on current insulin delivery (or suspension). The bottom of the screen shows an insulin gauge and the soft key for the Main menu.

Insulin Gauge and Display

One of the important icons on the Status screen is the insulin gauge in the lower lefthand corner. It indicates how much insulin is left in the pump’s reservoir. As the reservoir empties, the icon changes to indicate the amount of insulin remaining.

Next to the insulin gauge, the remote displays the number of units remaining in the pump. As long as more than 50 units remain, the gauge displays “50+ U.” Once the reservoir volume drops to 50 units, the gauge counts down unit by unit. When the volume falls below 5 units, the display changes to “Low Reservoir.”

Regularly checking the insulin gauge enables you to plan pump changes easily. For example, if you know you will need approximately 20 units during your work day and the insulin gauge shows only 17 units remaining, you can either take a new pump with you or change it before you leave for the day.

iXL™ Diabetes Management System User Guide: iXL™ Remote Controller Features 49

Figure 6-1

System Setup Menu

The System setup menu lets you personalize the settings that control the iXL System. These include:

• Date and time

• Bolus doses and basal rates

• Alerts and reminders

• Remote options: remote lock, screen time-out, and backlight

time-out

• Diagnostics: check alarms and reset remote

You and your healthcare provider entered initial system settings using the Setup Wizard (see Chapter 2, Getting Started). After setup, however, you can use the System setup menu to customize or change those settings, as described in this chapter.

Reset the Date or Time

Occasionally, you need to change date and time settings (for example, to adjust for daylight savings time or after resetting the remote). As a safety feature, you can change date and time settings only when the pump is deactivated or when insulin delivery is suspended (see Chapter 5, The iXL Pump).

1. Either suspend insulin delivery or deactivate the pump.

2. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

3. Choose System setup, then press Select (Figure 6-2).

4. Choose Date/time, then press Select.

5. Choose either Time or Date, then press Edit.

6. Follow the steps below, then press Done.

50 iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features

iXL™ Remote Controller Features6

Figure 6-2

iXL™ Remote Controller Features

Reset the time

1. Enter the current time.

2. Choose either a 12-hour or 24-hour clock, then press Enter.

3. Press Confirm to accept the new time (Figure 6-3). Or press Cancel to back out of this process.

Reset the date

1. Enter the current year, then press Enter.

2. Choose the current month, then press Enter.

3. Enter the current day, then press Enter.

4. Choose the date format to be displayed by the remote, then press Select.

5. Press Confirm to accept the new date and format. Or press Cancel to back out of this process.

Remember to resume insulin delivery or activate a new pump after changing the date or time.

iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features 51

Figure 6-3

Change Bolus and Basal Settings

You can reset the bolus increment, the maximum bolus dose, the maximum basal rate, and the maximum daily dose.

1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

2. Choose System setup, then press Select.

3. Choose Bolus/basal setup, then press Select.

4. Choose one of the following (Figure 6-4) and then press Select:

• Bolus increment

• Max bolus

• Max basal rate

• Max daily dose

5. Use the Up/Down Controller button to enter a value, then press Select.

Some settings have preset defaults, but all settings are changeable. See the Appendices for a list of system specifications, including preset default settings.

6. Repeat steps 4 and 5 for each setting you want to change.

For details on basal rate and bolus dose settings, see Chapter 3, Basal Rates, and Chapter 4, Bolus Doses.

If the remote’s clock becomes corrupted and the clock is reset, then the max daily dose checks will only apply moving forward. If a clock reset is required due to a Remote error, the max daily dose will be reset and the max daily dose checks will only apply to insulin deliveries moving forward from this point in time (see Chapter 9, Hazard and Advisory Alarms).

52 iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features

iXL™ Remote Controller Features6

Figure 6-4

iXL™ Remote Controller Features

Set Alerts and Reminders

In addition to automatic safety alarms (see Chapter 9, Hazard and Advisory Alarms), the iXL System offers a number of alerts and reminders that you can set to help you manage your diabetes. These features are optional. You can turn alerts and reminders on or off at any time. They include:

BG (blood glucose) r

eminder: Reminds you to check your blood

glucose. Choose from Off, Audible, or Vibrate. The default setting

is Off. When the reminder is on, the remote reminds you each time you enter a bolus dose, and you can then choose a time interval.

Expiration:

Alerts you when a pump is nearing expiration (72 hours). Choose an alert period from 3 to 18 hours before expiration in 1-hour increments, or choose Off. The default setting is Off. (This optional alert is in addition to two advisory alarms, at 2 and 1 hours before expiration, and a hazard alarm at actual expiration time, as described in Chapter 9, Hazard and Advisory Alarms.)

Low r

eservoir: Alerts you when insulin in the pump reaches a

certain level, so you can plan ahead to change the pump. Choose a level from 10 to 50 units, in 5-unit increments. The default setting is 10 units.

Auto of

f: Alerts you if no buttons have been pressed within a

certain time period. This alert can be especially reassuring for users who are prone to hypoglycemia unawareness. Choose a time period from 1 to 24 hours, in 1-hour increments, or choose Off. Choose from an audio-only or an audio-plus-vibration alert. The default setting is Off.

Reminders:

Pump beeps when a program is in process (see Chapter 3, Basal Rates, and Chapter 4, Bolus Doses, for details). These include:

• Temporary basal in process

• Extended bolus in process

Choose On or Off. The default setting is On.

Confidence aler

ts: Pump beeps in response to your instructions,

so you become familiar with the operation of the iXL System and feel confident that you are getting the insulin you need. These alerts include:

• Bolus delivery started

• Bolus delivery completed

• Extended bolus started

• Extended bolus completed

• Temporary basal rate started

• Temporary basal completed

Choose On or Off. The default setting is On.

iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features 53

Choose alerts and reminders

1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

2. Choose System setup, then press Select.

3. Choose Alerts/reminders, then press Select.

4. Choose the reminder or alert you want to set (Figure 6-5), then press Select.

5. Choose the desired option or set the desired value and press Select or Enter.

Repeat steps 1-5 to set more alerts or reminders.

Customize the Remote

Additional options let you customize how the iXL Remote Controller operates:

Remote lock:

“Locks” the buttons on the remote. The default setting is Off. This safety feature can help avoid accidentally changing basal rates or giving boluses.

Scr

een time-out: The screen goes blank after a time interval

that you set, during which you have not pressed any buttons on the remote. This setting preserves battery power by turning off the screen when you are not using it. Choose an interval of 15, 30, or 60 seconds. Set it at the lowest setting (15 seconds) to maximize battery life. The default is 30 seconds.

Press the Power button to turn the screen back on. If it has been less then 5 minutes since the screen timed out, pressing the Power button returns you to the same screen you were using. If it has been longer than 5 minutes, the remote brings you to the Status screen.

Backlight time-out:

The backlight allows you to see the screen in the dark and remains on while you are using the remote. To turn it on, hold the Power button for three seconds. This setting turns off the backlight when you have not used it for a time interval that you set. Choose an interval of 15, 30, or 60 seconds. Set at the lowest setting (15 seconds) to maximize battery life. The default is 30 seconds.

54 iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features

iXL™ Remote Controller Features6

Figure 6-5

iXL™ Remote Controller Features

Set remote options

1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

2. Choose System setup, then press Select.

3. Choose Remote options (Figure 6-6), then press Select.

4. Choose one of the following, then press Select:

• Remote lock

• Screen time-out

• Backlight time-out

To set Remote lock:

1. Choose Off or On, then press Select. If you choose On, other remote options and most other

soft keys are locked (Figure 6-7) and will not respond to button presses. To use them, you must first set Remote lock to Off.

To set time-outs:

1. Choose a time interval of 15, 30, or 60 seconds, then press

Select.

iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features 55

Figure 6-6

Figure 6-7

Set Diagnostic Functions

The Diagnostics screen allows you to instantly confirm how the system is working or to completely update settings entered during setup (see Chapter 2, Getting Started). They include:

Check alar

ms: Confirms that all alarms work properly when

needed. When you select this function, the remote beeps, then vibrates, and then the pump beeps.

If the remote fails to beep and/or vibrate, call Insulet immediately at (800) 591-3455. If a pump is active and fails to beep, change pump immediately (see Chapter 5, The iXL Pump).

Reset r

emote (soft reset): Restores all settings in the remote to

the factory defaults.

Resetting the remote deletes all history records, basal programs, temporary basal presets, and user information from memory. Before using this feature, be sure you have a written record of the information you need before it is deleted.

As a safety feature, you cannot reset the remote from the Diagnostics screen when a pump is active. You must first deactivate the pump.

Set diagnostic options

1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select.

2. Choose System setup, then press Select.

3. Choose Diagnostics, then press Select (Figure 6-8).

To check alarms:

1. Choose Check alarms, then press Select.

2. Press Confirm. The remote beeps three times, then vibrates. If a pump is active, it then beeps three times.

Check the alarm function at every pump change.

56 iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features

iXL™ Remote Controller Features6

Figure 6-8

iXL™ Remote Controller Features

To reset the remote:

1. Choose Reset remote.

2. If the pump is deactivated, the screen shows what information will be deleted. Press Confirm to reset the remote.

If the pump is still active, you will be unable to reset the remote (Figure 6-9). Press OK to return to the diagnostics menu.

iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features 57

Figure 6-9

Get the Most from Your Remote

Keep it handy

Wireless communication technology means you don’t have to keep the remote right next to the pump for the pump to work. Once you set your basal rate, the pump continues to deliver insulin at that rate until you decide to change it or until you give yourself a bolus dose. Meanwhile, since the remote is small, lightweight, and is not attached to the pump, you can store it conveniently inside an article of clothing (like a shirt pocket) or put it discreetly into a drawer, briefcase, or purse.

Communicating with the pump

When you enter or change programs, hold the remote within 12” (30.5cm) of the pump. If you wear the pump on your abdomen, holding the remote in your hands when pressing the buttons should be close enough.

Water and your remote

The remote is not waterproof. Do NOT place it in or near water.

Avoid extreme temperatures

Extreme operating temperatures can affect remote batteries and interfere with system operation. Avoid using the remote in temperatures below 41°F (5°C) or above 104°F (40°C).

Do NOT store or leave the remote where it may be exposed to extreme temperatures, such as inside a car. Extreme heat or cold can cause the device to malfunction.

Electrical interference

The remote is designed to withstand normal radio interference and electromagnetic fields. However, as with all wireless communication technology, certain operating conditions can interrupt communication. For example, electric appliances such as microwave ovens and electric machinery located in manufacturing environments may cause interference. In most cases, interruptions are easy to resolve (see Chapter 10, Troubleshooting Communication Failures).

58 iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features

iXL™ Remote Controller Features6

iXL™ Remote Controller Features

My Notes:

iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features 59

My Notes:

60 iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features

iXL™ Remote Controller Features6

My Records

Record Keeping

Record keeping is an important part of successful diabetes management. The iXL Remote Controller helps simplify this task. It automatically stores insulin-delivery records, alarm records, and personal information.

If the remote batteries run out, data in the remote’s memory is at risk. Information will be lost if the batteries are not changed within 2 hours. Do NOT remove the batteries until you have new ones at hand; the longer the batteries are removed, the more the memory is at risk.

Insulin Delivery History

The remote stores:

• Basal rates (including any rate changes and temporary basals)

• Bolus doses (normal, extended, and iBolus)

• Dates, times, and how long insulin delivery was suspended

and dates and times when it was resumed

• Total daily doses (total daily bolus + total daily basal) by date

The remote can store up to 2400 insulin-delivery events (basal and bolus), or approximately 90 days of information. Information older than 90 days is automatically deleted as new information is added.

View insulin delivery history

1. In the Main menu, use the Up/Down Controller button to choose My records; then press the soft key labeled Select.

2. Choose Insulin delivery, then press Select. The remote displays today’s information first (from 12:00am

to the current time), including the total daily dose delivered, total of boluses delivered, and total basal amount delivered (Figure 7-1). The date appears in the second line of the screen.

To see information for a different date, press the Up/Down

Controller button.

iXL™ Diabetes Management System User Guide: My Records 61

Figure 7-1

3. Press Basal (Figure 7-2). The display indicates the time of day and whether a basal

was suspended, the pump was deactivated, or a temp basal rate was delivered. If a temp basal rate is currently running,

a diamond icon (♦) appears next to it. If a temp basal rate

was cancelled, the screen shows how long it ran before being cancelled.

Press the Up/Down Controller button for different dates. If not all the information fits onto one screen, a page icon

appears at the bottom center of the screen. Press More to go to the next screen of information. Continue to press More until you return to the first screen.

4. Press Bolus (Figure 7-3). The display indicates whether the bolus was normal, extended

(ext), or an iBolus (i). (Normal and extended boluses are displayed separately even if they were programmed at the same time.) Extended boluses are shown with time and duration. If an extended bolus is currently running, a diamond

icon (♦) appears next to it. If a bolus was cancelled, only the

amount delivered before cancellation is shown.

The amount shown after cancellation may be in 0.05 unit increments, even though the smallest dose you can program is 0.10 units.

Press the Up/Down Controller button for different dates. Press

More for additional screens.

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My Records7

Figure 7-2

Figure 7-3

My Records

Alarm History

The remote lists the entire alarm history for the device, from the current date to when the remote was first activated. The remote can store up to 128 alarm records.

1. In the Main menu, use the Up/Down Controller button to choose My records; then press the soft key labeled Select.

2. Choose Alarm history, then press Select. The remote displays the type, date, and time of each alarm.

3. Press the shift key labeled More for additional screens.

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User and Product Information

You or your healthcare provider may have entered your personal contact information (name, address, telephone numbers, and email address) during your pump-start visit. To view that information, press the User Info/Support button (?) in the upper

right corner of the remote. You can add or change user information at any time (see below).

The user information screen also displays contact information for Insulet Corporation and product information for your iXL System (make, model, serial number). The factory enters the corporate and product information and you cannot change it.

Add or change user information

1. In the Main menu, use the Up/Down Controller button to choose My records; then press the soft key labeled Select.

2. Choose My info, then press Select.

3. Choose name, address1, address2, phone1, phone2, or email, then press Select.

4. Press the Up/Down Controller button to enter the characters that spell the name, address, phone number, or email address. An underscore (_) on the screen indicates which character you are changing. Press the arrow key to move the underscore to the next character. For example, if you live at 1234 Main Street, you might enter 1, 2, 3, 4, space, M, a, i, n, space, S, t., (Figure 7-4).

5. Press Done.

6. Repeat steps 3 through 5 for each line of personal information you want to enter.

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Figure 7-4

My Records

My Notes:

iXL™ Diabetes Management System User Guide: My Records 65

My Notes:

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Achieve Healthy, Safe Pumping

Your Role in Safe Pumping

Before deciding on the iXL Diabetes Management System, you and your healthcare provider discussed the advantages and benefits of the iXL System, as well as the responsibilities that come with insulin pump therapy. Remember: Safe pumping begins and ends with you. If you have questions or doubts about being able to safely use the iXL System at any time, consult your healthcare provider immediately.

Most pump problems are easily avoided by:

• Learning all you can about successful diabetes management.

• Being actively involved in your treatment.

• Checking your blood glucose frequently.

• Washing your hands and disinfecting infusion sites to reduce

the possibility of infection.

• Being aware of the signs of hypoglycemia (low blood

glucose), hyperglycemia (high blood glucose), and DKA

(see “Avoid Adverse Reactions” later in this chapter).

• Keeping a diabetes emergency kit with you at all times (see “Prepare for Emergencies” later in this chapter).

• Knowing how to contact your healthcare provider in case of

an emergency.

Safety Features

The iXL System’s state-of-the-art design includes the latest safety technology. Its built-in safety features include:

Automatic priming, safety checks, and insertion with RediSet™

Every time a new iXL Pump is activated, the exclusive RediSet system automatically primes and performs a safety check on the pump, then inserts and primes the cannula (see Chapter 5, The iXL Pump). Micro-processor technology makes it possible to complete thousands of safety checks in only a few seconds.

Continuous monitoring

The iXL System checks the operation of the remote and pump and informs you if any problems are detected. For example, during setup, you entered a maximum daily dose. If you try to give a bolus that would put you over the maximum for the day, the remote alerts you. This automatic safeguard protects you from unintended overdelivery of insulin. The system checks communication between the remote and the pump as well as functions within each device.

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Rapid occlusion detection

An occlusion is a blockage or interruption in insulin delivery. The iXL System can detect an occlusion as small as 2 units, which may lower your risk for hyperglycemia or DKA.

An occlusion may result from a blockage, pump malfunction, or from using old or inactive insulin. If insulin delivery is interrupted by an occlusion, check your blood glucose level and follow the treatment guidelines established by your healthcare provider (see “Avoid Adverse Reactions” later in this chapter).

Alerts and advisory and hazard alarms

For your safety, the iXL System provides a range of alerts and alarms to notify you of continuing functions, tell you that your attention is needed, or warn you of hazardous situations. For example, the Auto off advisory alarm alerts you when you have not used the remote to communicate with the pump within a time period that you set. You can set a time period between 1 and 24 hours, in 1-hour increments. If you do not respond to an

Auto off advisory alarm within 15 minutes, the pump and remote

go into a hazard alarm state. See Chapter 6, iXL Remote Controller Features, for a description

of alerts and reminders and how to set them, and Chapter 9, Hazard and Advisory Alarms, for a list of safety alarms built into the iXL System and how to respond to them.

Daily Diabetes Management Activities

To ensure proper iXL System operation and your continued good health, you should perform these activities every day:

Check blood glucose

Routine blood glucose checks allow you to identify and treat high or low blood glucose before it becomes a problem (see “Avoid Adverse Reactions” later in this chapter).

• Check your blood glucose at least 4 to 6 times a day: when you wake up, before every meal, and before going to bed. In addition, check:

• Whenever you feel nauseated or sick.

• Before driving a car.

• Whenever your blood glucose has been running unusually

high or low.

• If you suspect that your blood glucose is high or low.

• Before, during, and after exercise.

• As directed by your healthcare provider.

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Inspect the infusion site

At least once a day, use the iXL Pump’s viewing window to inspect the infusion site. Check the site for signs of infection, such as pain, swelling, redness, discharge, or heat.

If an infusion site shows signs of infection:

1. Immediately remove the pump and attach a new one at a different site (see Chapter 5, The iXL Pump).

2. Contact your healthcare provider.

3. Treat the infection according to instructions from your healthcare provider. (Refer to Chapter 5, The iXL Pump, for detailed information on site care and preparation.)

Consider making infusion site checks a part of your regular daily routine (like showering or brushing your teeth). That way, it’s easy to remember.

Water and Your Pump

The iXL Pump is watertight to a depth of 8 feet for up to 30 minutes (IPX8). After exposure to water, rinse off the pump with clean water and dry it with a towel.

Do NOT expose your iXL Pump to water at depths greater than 8 feet or for durations exceeding 30 minutes. Check the infusion site often to make sure the pump and soft cannula are securely attached and in place.

The iXL Remote Controller is not waterproof. Do NOT place it in or near water.

Traveling and Vacationing

Plan for changing time zones

If you’re planning a business trip or vacation to a different time zone, you may need to adjust your basal rate programs. For changes of just a few hours, basal rate adjustments are minor and easy to calculate. For long-distance travel, however, figuring out the correct program can be more challenging. Your healthcare provider can help with these adjustments.

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Take enough supplies

Keeping your emergency kit with you during trips or vacations is especially important (see “Prepare for emergencies” later in this chapter). It may be difficult or impossible to get insulin or supplies in an unfamiliar place. If traveling by air, be sure to pack your supplies in your carry-on luggage. When packing for travel, be sure to include the following and take more than you think you’ll need:

• Diabetes emergency kit packed in your carry-on luggage

• Enough pumps for your trip, plus a backup supply

• Extra remote batteries

• Insulin syringes or pens in case you need injections

• Several vials of insulin or insulin cartridges if you use a pen

• Glucagon kit (make sure any person you are traveling with

knows how to give the injection)

• Alcohol prep swabs

• Written prescriptions for all medications and supplies

(generic medications may be easier to find than brand names outside the US)

When traveling outside the country or for long periods of time, consider taking a backup remote. Call (800) 591-9948 to order additional pump supplies for your trip.

Minimize airport security delays

Contact the airlines in advance for information on their current security requirements. To make airport security checks go smoothly, be sure you have the following easily accessible:

• A signed letter from your healthcare provider explaining that you need to carry insulin supplies and pump equipment

• An emergency kit (see “Prepare for emergencies” later in this chapter)

• A list of the supplies you must carry, including the contents of your emergency kit

• Prescriptions for insulin and all supplies, clearly marked with their original pharmacy labels

If the detector goes off, tell the security screener that you have diabetes and wear an insulin pump.

iXL Pumps and Remote Controllers can safely pass through airport X-ray machines (see the FCC notice in the Appendices).

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Keep supplies accessible

On airplanes and trains, keep these items in your carry-on luggage, rather than checking them:

• iXL Remote Controller

• An emergency kit

• Extra vials of insulin (cargo area temperatures may affect

insulin)

• A copy of your healthcare provider’s letter (see “Minimize airline security delays”)

• Prescriptions for insulin and supplies

• Snacks (in case food is not available)

• Bottled water (especially on planes) to prevent dehydration

• The name and phone number of a physician at your final

destination, in case of emergency

Avoid Adverse Reactions

Most risks related to insulin pump therapy can be avoided by practicing good pumping techniques and by acting promptly at the first sign of trouble. You can avoid potential problems by being aware of the signs of hypoglycemia (low blood glucose), hyperglycemia (high blood glucose), and DKA. The easiest and most reliable way to avoid these conditions is to check your blood glucose often.

General precautions

• Keep careful records and discuss changes and adjustments with your healthcare provider.

• Tell your healthcare provider if you have extreme highs or lows, or if highs or lows are occurring more often than usual.

• If you have technical difficulties with your iXL System and are unable to resolve them, do not hesitate to contact us. Our 24-hour technical support hotline is (800) 591-3455.

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Hypoglycemia (low blood glucose)

Hypoglycemia can occur even when a pump is working properly. Never ignore the signs of low blood glucose (no matter how mild). If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness. If you suspect or feel that your blood glucose level is low, check your blood glucose level to confirm.

For users who are prone to hypoglycemia unawareness, a condition in which people do not realize when their blood glucose levels are low, the iXL System’s blood glucose reminder can be especially useful.

Symptoms of hypoglycemia

Never ignore these symptoms:

• Shakiness

• Fatigue

• Sweating

• Cold, clammy skin

• Weakness

• Blurred vision or a headache

• Sudden hunger

• Rapid heart rate

• Confusion

• Tingling in the lips or tongue

• Anxiety

To avoid hypoglycemia (low blood glucose)

• Make sure your blood glucose is at least 100 mg/dl before driving or working with dangerous machinery or equipment. Besides the risk of hypoglycemia while driving or operating dangerous equipment, focusing on a task may cause you to miss symptoms you might notice otherwise.

• Work with your healthcare provider to establish individualized blood glucose targets and guidelines.

• Keep a fast-acting carbohydrate (such as glucose tablets, hard candies, or juice) with you at all times to respond quickly to low blood glucose.

• Teach your friends, family members, and colleagues to recognize the signs of hypoglycemia, so they can help if you develop hypoglycemia unawareness or a severe adverse reaction.

• Keep a glucagon injection kit with your emergency supplies. Teach friends and family members how to give a glucagon injection in case you have severe hypoglycemia and become unconscious.

Periodically check the expiration date of your glucagon kit to make sure it has not expired.

Always carry medical identification and wear an emergency medical necklace or bracelet such as the Medic Alert tag.

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Again, frequent blood glucose checks are the key to avoiding potential problems. Detecting low blood glucose early lets you

treat it before it becomes a problem. Check with your healthcare provider for guidance in any and all

areas listed above.

To treat hypoglycemia (low blood glucose)

Any time your blood glucose is low, treat it immediately. Check it every 15 minutes while you are treating, to make sure you don’t over-treat the condition and cause blood glucose levels to rise too high.

Even if you cannot check your blood glucose, do NOT wait to treat symptoms of hypoglycemia, especially if you are alone.

1. If blood glucose is 80 mg/dl or below, eat or drink 15 grams of fast-acting carbohydrate, such as glucose tablets, juice, or hard candy (see “How much is 15 grams of carbohydrate?”).

Do NOT use chocolate or candy bars to treat low blood glucose. Their fat content slows down glucose absorption.

2. Check blood glucose again after 15 minutes.

3. If blood glucose remains low, take another 15 grams of carbohydrate.

4. Repeat steps 2 and 3 until blood glucose is within target range.

5. Investigate possible cause for hypoglycemia to avoid similar problems in the future (see “Possible causes of low blood glucose”).

How much is 15 grams of carbohydrate?

Examples of fast-acting foods:

• Three 5-gram glucose tablets, or four 4-gram tablets

• 4 ounces of orange juice

• 6 lifesavers or similar hard candy

• 1/2 can of regular (non-diet) soda

• 2 tablespoons of table sugar, honey, or corn syrup

Teach people you trust (like family members and close friends) how to give a glucagon injection. You will need to rely on them to give it to you if you have severe hypoglycemia and become unconscious. Include a copy of the glucagon instructions in your emergency kit and periodically review the procedure with family and friends.

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Possible causes of hypoglycemia (low blood glucose)

Possible cause of low Suggested action

Incorrect basal rate Check basal rate program. program

Pump time not set Reset time. correctly

Bolus too large Check bolus size and timing.

Do NOT over-correct for post-meal glucose levels.

Check carb intake (consult healthcare provider about carb counting).

Consult healthcare provider to refine insulin-to-carb ratio.

Wrong bolus timing Time bolus with food intake.

Check blood glucose before giving meal bolus; if necessary, adjust bolus.

Alcohol consumption Consult with your healthcare provider

for alcohol consumption guidelines. Check blood glucose before going to

bed (check with healthcare provider for guidance).

Unplanned activity If blood glucose is below 100 mg/dl, eat

a snack before activity.

Possible cause of low Suggested action

Prolonged or intense Adjust insulin delivery as instructed exercise by your healthcare provider.

Check blood glucose before, during, and after activity and treat as necessary.

Effects of exercise can last several

hours–even a full day–after activity

ends.

Low carbohydrate Consume carbohydrate before intake prior to activity activity, especially if you have not

decreased insulin beforehand.

Failure to use the Consult healthcare provider on setting temporary (temp) basal temp basal rates (see Chapter 3, Basal rate feature Rates).

Prone to severe Consult healthcare provider about hypoglycemia raising target blood glucose levels.

Hypoglycemia Consult healthcare provider about unawareness hypoglycemia unawareness and about

raising target blood glucose levels.

Incorrect target blood Consult healthcare provider about glucose levels raising target blood glucose levels.

Incorrect correction Consult healthcare provider about factor (sensitivity correction (sensitivity) factor; adjust it factor) if appropriate.

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Hyperglycemia (high blood glucose)

Insulin pumps use rapid-acting insulin; therefore, if there is an interruption in insulin delivery, pump users are at risk for developing hyperglycemia.

Symptoms of hyperglycemia (high blood glucose)

• Fatigue

• Frequent urination, especially during the night

• Unusual thirst or hunger

• Unexplained weight loss

• Blurred vision

• Slow healing of cuts or sores

Hyperglycemia symptoms can be confusing. Always check your blood glucose before you treat for hyperglycemia.

To avoid hyperglycemia (high blood glucose)

Check your blood glucose at least four 4-6 times a day (when you wake up, before each meal, and before going to bed). In addition, always check it:

• Whenever you feel nauseated or sick.

• Before driving a car.

• Whenever your blood glucose has been running unusually

high or low.

• If you suspect that your blood glucose is high or low.

• Before, during, and after exercise.

• As directed by your healthcare provider.

To treat hyperglycemia (high blood glucose)

Always check your blood glucose levels frequently when treating hyperglycemia to make sure you don’t over-treat the condition and cause blood glucose levels to drop too far.

1. Check your blood glucose level. The result will help you to find out how much insulin is needed to return your blood glucose to the target range.

2. If your blood glucose is over 250 mg/dl, check for ketones. If ketones are present, follow your healthcare provider’s guidelines.

3. If ketones are not present, take a correction bolus as prescribed by your healthcare provider.

4. Check blood glucose again after 2 hours.

iXL™ Diabetes Management System User Guide: Achieve Healthy, Safe Pumping 75

5. If blood glucose levels have not decreased, take a second bolus by injection, using a sterile syringe. Ask your healthcare provider whether to inject the same amount of insulin as in step 3.

6. If you feel nauseated at any point, check for ketones and call your healthcare provider immediately (see “Diabetic ketoacidosis” later in this chapter).

7. If blood glucose remains high after another 2 hours, replace the pump (fill the new pump using a new vial of insulin), then:

• Contact your healthcare provider for guidance.

• Drink eight ounces of water every 30 minutes until blood

glucose is within target range.

If you need emergency attention, ask a friend or family member to take you to the emergency room or call an ambulance. Do NOT drive yourself.

8. Investigate possible cause for hyperglycemia to avoid similar problems in the future (see “Possible causes of hyperglycemia”).

Possible causes of hyperglycemia (high blood glucose)

Possible cause of high Suggested action

Expired insulin Deactivate and remove used pump.

Attach new pump filled with insulin from a new vial.

Insulin exposed to Deactivate and remove used pump. extreme temperatures Attach new pump filled with insulin

from a new vial.

Infusion site in or near Deactivate and remove used pump. a scar or mole Attach a new pump in a different

location.

Infected infusion site Deactivate and remove used pump.

Attach a new pump in a different location and consult your healthcare provider.

Dislodged cannula Deactivate and remove used pump.

Attach a new pump in a different location.

Avoid sites near a waistband, belt, or other area where friction may dislodge the cannula.

Empty pump Deactivate and remove used pump.

Attach a new pump in a different location.

Incorrect bolus dose Check carb intake (consult healthcare

provider about carb counting).

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Possible cause of high Suggested action

Incorrect bolus timing Time bolus with food intake.

Check blood glucose before giving meal bolus; if necessary, adjust bolus.

Incorrect basal rate Confirm that programmed basal rate is

correct.

Consult healthcare provider before making changes to your basal rate.

High-protein or Calculate protein/fat intake and high-fat meal account for it in your bolus timing and

bolus type. (Consult your healthcare provider for guidance.)

Less activity than Use temporary (temp) basal rate normal feature (see Chapter 3, Basal Rates).

Blood glucose greater Do NOT exercise when ketones are than 250 mg/dl present (blood glucose increases with (with ketones present) exercise when ketones are present). before exercise Consult healthcare provider about

exercise guidelines.

Infection or illness See “Sick days“ later in this chapter.

Consult healthcare provider about sick-day guidelines.

Possible cause of high Suggested action

Medication change Speak with your healthcare provider

about any medication changes or additions.

Weight loss or gain Consult your healthcare provider. Premenstrual cycle Program a temp basal preset for

premenstrual cycle (see Chapter 3, Basal Rates).

Pregnancy Consult your healthcare provider.

Check with your healthcare provider for guidance on any of the causes or suggested actions above.

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Diabetic ketoacidosis (DKA)

Insulin pumps use only rapid-acting insulin. Because there is no reserve of long-acting insulin in the body, any occlusion or interruption in insulin delivery can rapidly lead to diabetic ketoacidosis (DKA). DKA is a serious–but totally

preventable– emergency that can occur if you ignore high blood

glucose levels. If left untreated, DKA can cause breathing difficulties, shock,

coma, and eventually death.

Symptoms of DKA

• Nausea and vomiting

• Abdominal pain

• Dehydration

• Fruity-smelling breath

• Dry skin or tongue

• Drowsiness

• Rapid pulse

• Labored breathing

The symptoms of DKA are much like those of the flu. Before

assuming you have the flu, check your blood glucose and check for ketones to rule out DKA.

To avoid DKA The easiest and most reliable way to avoid DKA is by checking

your blood glucose at least 4 to 6 times a day. Routine checks

allow you to identify and treat high blood glucose before DKA develops.

To treat DKA

1. Once you have begun treatment for high blood glucose, check for ketones.

2. If ketones are negative or trace, continue treating for high blood glucose.

3. If ketones are positive, but you are not feeling nauseated or ill, replace the pump, using a new vial of insulin.

4. If ketones are present and you are feeling nauseated or ill, immediately call your healthcare provider for guidance.

5. Check blood glucose again after 2 hours. If blood glucose level has not declined, immediately call your healthcare provider for guidance. If you need to go to the emergency room for further treatment, do NOT drive yourself: either call an ambulance or have a friend or family member drive you.

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Handling Special Situations

Prepare for emergencies

Prepare and keep an emergency kit with you at all times to quickly respond to any diabetes emergency. The kit should include:

• Blood glucose meter and strips

• Lancet device and lancets

• Ketone strips

• Glucose tablets or another fast-acting source of carbohydrate

• Alcohol prep swabs

• A vial of rapid-acting U-100 insulin

• Syringes for injecting insulin

• Instructions from your healthcare provider about appropriate

injection doses if insulin delivery is interrupted

• Several iXL Pumps with their syringes and filling needles

• Extra remote batteries (at least two AAA alkaline)

• Extra blood glucose meter batteries

• A copy of the letter from your healthcare provider for airline

security

• Contact information for reaching your healthcare provider and/or doctor in case of an emergency

• Glucagon kit and written instructions for giving an injection if you are unconscious (see ”Avoid Adverse Reactions” earlier in this chapter).

Ask your healthcare provider to help you develop plans for handling emergency situations, including what to do if you cannot reach your healthcare provider.

Sick days

Any physical stress can cause your blood glucose to rise, and illness is a physical stress. Your healthcare provider can help you make a specific plan for sick days. The following are only general guidelines.

When you are ill, check your blood glucose more often (at least once every 2 hours) to avoid DKA. The symptoms of DKA are

much like those of the flu. Before assuming you have the flu,

check your blood glucose to rule out DKA (see ”Avoid Adverse Reactions” earlier in this chapter).

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To handle sick days:

• Treat the underlying illness to promote faster recovery.

• Eat as normally as you can.

• Adjust bolus doses, if necessary, to match changes in

carbohydrate/calorie intake.

• Always continue your basal insulin, even if you are unable to eat. Contact your healthcare provider for suggested basal rate adjustments during sick days.

• Check your blood glucose every two hours and keep careful records of results.

• Test for ketones when blood glucose is 250 mg/dl or higher.

• Follow your healthcare provider’s guidelines for giving

additional insulin on sick days.

• Drink plenty of noncaffeinated fluids to prevent dehydration.

If you are well enough to eat, drink sugar-free beverages. However, if you are too sick to eat solid foods, alternate between sugar-free beverages and those containing sugar.

• Call your healthcare provider immediately if you have any of the following: persistent nausea, vomiting for more than two hours, high blood glucose or ketones that stay elevated despite increased insulin, or low blood glucose with nausea or vomiting.

Exercising, playing sports, or working hard

Check your blood glucose levels before, during, and after exercising, playing sports, or doing unusually hard physical labor.

Under normal conditions the iXL Pump’s adhesive keeps it securely in place for up to three days. There are a variety of products available to help secure the pump to the skin. Ask your healthcare provider about these products.

For some contact sports, you may want to remove the iXL Pump (see “Short-term removal” below).

Short-term removal

The iXL Pump is designed to be discreet as well as comfortable. It should be worn at all times so that you can enjoy all the benefits of continuous insulin delivery. Occasionally, though, it may be necessary to temporarily remove the pump.

Be sure to check your blood glucose levels before removing the pump and after attaching a new one. Pumps are designed for one-time use. Do not attempt to reattach a used iXL Pump.

If possible, avoid wasting pumps by planning removal times that coincide with a scheduled pump replacement.

If you will need to remove the pump for more than 1 hour, ask your healthcare provider to recommend appropriate guidelines.

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X-rays, MRIs, and CT scans

The iXL Pump and Remote Controller may be affected by strong radiation or magnetic fields. Before having an X-ray, MRI, or CT scan (or any similar test or procedure), remove your pump and remote and put them outside the treatment area. Check with your healthcare provider on pump removal guidelines.

The pump and remote can tolerate common electromagnetic and electrostatic fields, including airport security and cellular phones.

Surgery or hospitalization

For scheduled surgeries or hospitalization, you should tell the doctor/surgeon or hospital staff about your insulin pump. It may be necessary to remove it for certain procedures or treatments

and replace the basal insulin that was missed while the pump was removed. Your healthcare provider can help you prepare

for these situations.

Always carry medical identification and wear an emergency medical necklace or bracelet such as the Medic Alert tag. (See the end of the Appendices for address, telephone, and web site information.)

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Notes:

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Be Aware: Hazard and Advisory Alarms

Safety Checks

A very important safety feature of the iXL System is its ability to check its own functions and to let you know when something needs attention. When you turn on the remote, the system automatically performs a series of safety checks. To make you aware of a serious or potentially serious condition, the system will sound an audible alarm and display an on-screen message with instructions for resolving the alarm. All alarms include a date and time indicating when the condition occurred. Alarm conditions are easy to handle, and will not be a problem if you attend to them promptly.

Check your blood glucose level frequently.

Hazard Alarms

Hazard alarms occur either when the pump is in a hazard condition or something is wrong with the remote. Hazard alarms are all continuous tones and each has an on-screen message (see the “Hazard Alarms” table on the following pages). Follow the instructions in the message to resolve the alarm situation.

If a bolus is being delivered when a hazard alarm occurs in the pump, the bolus is cancelled. (A hazard alarm in the remote, however, does not cancel a bolus delivery.) Before the system displays the alarm’s on-screen message, it tells you how much insulin was delivered before the bolus was cancelled. That information is stored in the system’s history records (see Chapter 7, My Records). After you resolve the alarm, you can check the amount of the last bolus displayed on the Status screen to see how much of the bolus was delivered.

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Hazard Alarms

Alarm Type Source Action to resolve Alarm Type Source Action to resolve

Empty reservoir

Pump Press OK to Pump expired Pump Press OK to

acknowledge. acknowledge. Change pump. Change pump.

Occlusion detected Pump Press OK to Auto Off Pump Press OK to

acknowledge. and acknowledge. Change pump. Remote Change pump.

Be Aware: Hazard and Advisory Alarms

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Hazard Alarms

Alarm Type Source Action to resolve Alarm Type Source Action to resolve

Pump change interruption

Pump Press OK to Stuck key detected Remote Press OK to

acknowledge. acknowledge. Change pump. Remove pump.

Call Insulet. (800) 591-3455

Remote error Remote Press OK to Remote error Remote Press OK to

acknowledge. acknowledge. Change pump. Remove pump.

Call Insulet. (800) 591-3455

86 iXL™ Diabetes Management System User Guide: Be Aware: Hazard and Advisory Alarms

Be Aware: Hazard and Advisory Alarms9

Alarm Type Source Action to resolve

Pump error

Pump Press OK to or acknowledge. Remote Change pump.

Hazard Alarms

Alarm Type Source Action to resolve

Remote error

Remote Press OK to

acknowledge.

System error Pump Press OK to

or acknowledge. Remote Change pump.

System error Press OK to

acknowledge. Remove pump. Call Insulet. (800) 591-3455

Respond to hazard alarms

Due to the serious nature of hazard alarms, you must act promptly to resolve them.

1. Acknowledge the alarm condition by pressing OK, which silences the alarm.

2. Deactivate and remove the current pump (see Chapter 5, The iXL Pump).

3. Activate and attach a new pump (see Chapter 5, The iXL

Pump).

For a hazard alarm caused by a stuck key, remote error, or system error that displays, “Call Insulet immediately,” remove the pump and call Insulet immediately for instructions. The 24-hour support line is (800) 591-3455.

Be Aware: Hazard and Advisory Alarms 9

Hazard Alarms

iXL™ Diabetes Management System User Guide: Be Aware: Hazard and Advisory Alarms 87

Alarm Type Source Beep pattern and escalation process Action to resolve

Low reservoir volume

Pump 3 sets of beeps every minute for 3 minutes. Press OK to acknowledge.

Repeats every 60 minutes until acknowledged. Escalates to hazard alarm when is empty.

(based on volume selected by user)

88 iXL™ Diabetes Management System User Guide: Be Aware: Hazard and Advisory Alarms

Advisory Alarms

Advisory alarms tell you about a condition that requires your attention. When you hear an advisory alarm, turn on the remote to display the

Status screen. The screen displays a message describing the alarm and how to resolve it.

Some advisory alarms are controlled by levels you set in the

Settings screen (for example, the insulin level at which the low-reservoir-volume alarm sounds). All advisory alarms are time-sensitive and require a response. Some advisory alarms escalate to hazard alarms if you do not respond within a certain time period (as noted in the table below).

Each advisory alarm beeps intermittently and displays an on-screen message once the remote

Status screen is

updated.

Be Aware: Hazard and Advisory Alarms9

Advisory Alarms

Insulet 001, 002 Users Manual

Specifications and Main Features

Frequently Asked Questions

User Manual