Insulet 010 User Manual

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Page 1

Contacts and Important Information

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

Doctor

Pharmacy

Name

Address

Telephon e and Fa x

Email Address

Nurse/Educator

Name

Address

Telephon e and Fa x

Email Address

Health Insurance

Name

Address

Telephone Number(s)

Policy Number

Name

Address

Telephon e a nd Fa x

Email Address

Prescriptions

Script # Name Dose Frequency

OmniPod System Start Date: __________________________ PDM Version: 2 Serial Number: SN __________________ Emergency Services

Dial 911 (USA only; not available in all communities)

Insulet Corporation

9 Oak Park Drive • Bedford, MA 01730 Customer Support (24 hours/7days): 800-591-3455

When calling from outside the United States: 781-457-5098

Customer Support Fax: 877-467-8538 Web Site: MyOmniPod.com

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Contents

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

Before You Get Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

Indication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

You and your healthcare provider . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Your Role: Safely Using the OmniPod System. . . . . . . . . . . . . . . . xi

About This User Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi

Conventions and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi

Conventions and Terms (continued). . . . . . . . . . . . . . . . . . . . . . . . . . xii

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

1 Your New OmniPod Insulin Management System. . . . . . . 1

Insulin Delivery with the OmniPod System. . . . . . . . . . . . . . . . . . 1

How Does the OmniPod System Work? . . . . . . . . . . . . . . . . . . . . . 2

No tubing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Automated cannula insertion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

A fully-integrated design with blood glucose monitoring . . . . 2

Suggested bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Reference food library and carb presets . . . . . . . . . . . . . . . . . . . . . . . 3

Record keeping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Personalizing your System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

The OmniPod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

The Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Buttons that program and control the OmniPod System. . . . . 5

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

Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Automatic priming, safety checks, and insertion. . . . . . . . . . . . . . 8

Rapid occlusion detection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Alerts and alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

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

The OmniPod Starter Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Set Up the Personal Diabetes Manager (PDM) . . . . . . . . . . . . . 10

Turn on the PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

The OmniPod Setup Wizard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Set date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Enter basal settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Enter blood glucose sound setting and BG goal . . . . . . . . . . . . . 12

Set the suggested bolus calculator . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Enter target blood glucose value . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

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Contents

Enter minimum BG allowed for use in bolus calculation . . . . 13

Enter insulin-to-carbohydrate ratio . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Enter correction factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Set reverse correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Enter the duration of insulin action . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Select bolus increment and enter maximum bolus . . . . . . . . . . 15

Set extended bolus doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Set low reservoir alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Set expiration alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3 Understanding and Adjusting Basal Rates . . . . . . . . . . . . 17

What Is a Basal Rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Personalized Basal Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Create a basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Enable an existing basal program. . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Change, rename, copy, or delete a basal program . . . . . . . . . . . 21

Temporary Basal Rates and Presets . . . . . . . . . . . . . . . . . . . . . . . . 23

What is a temporary basal rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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

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

Create a temporary basal preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Enable an existing temporary basal preset . . . . . . . . . . . . . . . . . . 26

Cancel an active temporary basal preset . . . . . . . . . . . . . . . . . . . . 27

Change, rename, or delete a temporary basal preset . . . . . . . 27

Maximum Basal Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

What is the maximum basal rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Change the maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

4 Understanding and Delivering Bolus Doses . . . . . . . . . . . 29

What Is a Bolus? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Bolus Dose Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Suggested Bolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

How a suggested bolus is calculated. . . . . . . . . . . . . . . . . . . . . . . . . 30

Deliver a Normal Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Deliver a bolus when suggested bolus calculator is On . . . . . 31

Deliver a bolus manually (suggested bolus calc is Off ) . . . . . . 34

Deliver an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Deliver an extended bolus instead of a normal bolus . . . . . . . 34

Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Replace an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Bolus Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Create a bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Enable an existing bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Change, rename, or delete a bolus preset. . . . . . . . . . . . . . . . . . . . 39

Cancel an active bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Carb Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Create a carb preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Change or edit a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Delete a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Reference Food Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Access the reference food library. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

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Contents

5 Using the OmniPod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

The OmniPod Change Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Gather equipment and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Deactivate the current OmniPod . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Fill a new OmniPod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Select the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Prepare the infusion site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Apply the new OmniPod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Insert cannula and begin insulin delivery. . . . . . . . . . . . . . . . . . . . 53

Check Pod Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Suspend Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Resume Insulin Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Avoid Infusion Site Infections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Get the Most From Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

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

Water and your OmniPod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Safe storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

6 Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . 59

The Status Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Insulin gauge and display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

PDM settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

The System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Reset the time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Reset the date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Change Bolus and Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Bolus calcs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Ratios/factors/targets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Temp basal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Bolus increment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Alerts and Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Set alerts and reminders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Change Blood Glucose Meter Settings. . . . . . . . . . . . . . . . . . . . . 70

Change BG limit goal or BG sound . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Manage the Blood Glucose Tags List . . . . . . . . . . . . . . . . . . . . . . . . . 71

Customize the Personal Diabetes Manager . . . . . . . . . . . . . . . . 72

Set PDM options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Set Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Diagnostic options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Set a Vibration Alert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Get the Most from Your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Keep it handy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Communicating with the Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Water and your PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Electrical interference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

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7 Checking Your Blood Glucose . . . . . . . . . . . . . . . . . . . . . . . . . 77

The Built-in FreeStyle® Blood Glucose Meter . . . . . . . . . . . . . . . 77

The FreeStyle® Blood Glucose Test Strips. . . . . . . . . . . . . . . . . . . 78

Important test strip information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

The FreeStyle® Control Solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

When to perform a control solution test. . . . . . . . . . . . . . . . . . . . . 79

Check that the meter and test strips are working . . . . . . . . . . . 79

Control solution expiration date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Ensure accurate control solution results . . . . . . . . . . . . . . . . . . . . . 79

Out-of-range control solution results. . . . . . . . . . . . . . . . . . . . . . . . 80

Performing a Control Solution Test . . . . . . . . . . . . . . . . . . . . . . . . 81

Performing a Blood Glucose Test. . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Prepare the lancing device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Insert the blood glucose test strip . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Set the blood glucose test strip code . . . . . . . . . . . . . . . . . . . . . . . . 88

Lance your finger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Lance your forearm, upper arm, hand, thigh, or calf. . . . . . . . . 90

Fill the blood glucose test strip with blood . . . . . . . . . . . . . . . . . . 91

Wait for the reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Remove the lancet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Blood Glucose Results and the Suggested Bolus Calculator 94

Entering Blood Glucose Readings Manually. . . . . . . . . . . . . . . . 95

Editing Tags. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Low and High Blood Glucose Readings . . . . . . . . . . . . . . . . . . . . 97

Low readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

High readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Important Health-Related Information . . . . . . . . . . . . . . . . . . . . . 98

8 Understanding Your Records . . . . . . . . . . . . . . . . . . . . . . . . . 99

Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Special symbols in record screens . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Insulin Delivery Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

View insulin delivery records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Blood Glucose Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

View single-day trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

View multiple-day trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Alarm Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Carbohydrate Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

All Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

User Information/Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Add or change user information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

9 Living with Diabetes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Your Role: Safely Using the OmniPod System. . . . . . . . . . . . . 107

Daily Diabetes Management Activities . . . . . . . . . . . . . . . . . . . 108

Check your blood glucose frequently. . . . . . . . . . . . . . . . . . . . . . . 108

Inspect the infusion site daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

Prepare for Emergencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Water and Your OmniPod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Traveling and Vacationing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

Plan for changing time zones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

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Contents

Take enough supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

Minimize airport security delays . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Keep supplies accessible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Avoid Lows, Highs, and DKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

General precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . . . . . . . . . . 112

Hyperglycemia (high blood glucose) . . . . . . . . . . . . . . . . . . . . . . . 116

Diabetic ketoacidosis (DKA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Handling Special Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Sick days . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Exercising, playing sports, or working hard. . . . . . . . . . . . . . . . . 121

X-rays, MRIs, and CT scans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Surgery or hospitalization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

10 Errors, Advisories, and Hazard Alarms . . . . . . . . . . . . . . . 123

Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Blood Glucose Meter Error Messages. . . . . . . . . . . . . . . . . . . . . . 123

Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Hazard Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

11 Communication Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

The Communication Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Failure During Pod Activation or Operation . . . . . . . . . . . . . . . 132

Failure During Pod Deactivation. . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Failure During Request for Status. . . . . . . . . . . . . . . . . . . . . . . . . . 135

Failure During Bolus Cancellation . . . . . . . . . . . . . . . . . . . . . . . . . 136

Failure During a Hazard Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

OmniPod Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 139

Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Personal Diabetes Manager Care and Maintenance. . . . . . . 139

Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Replacing batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

If the PDM becomes submerged in water . . . . . . . . . . . . . . . . . . 141

If you drop the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Storage and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Ordering supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Suggested Bolus Calculator Examples and Guidelines . . . . 143

Meal bolus calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Insulin-on-board (IOB) calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Examples of suggested bolus calculations. . . . . . . . . . . . . . . . . . 144

Calculator guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

OmniPod System Options and Settings. . . . . . . . . . . . . . . . . . . 147

OmniPod Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Personal Diabetes Manager Specifications. . . . . . . . . . . . . . . . 149

Blood Glucose Meter Specifications. . . . . . . . . . . . . . . . . . . . . . . 149

OmniPod System Label Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . 150

vii

Page 9

Contents

Personal Diabetes Manager Icons. . . . . . . . . . . . . . . . . . . . . . . . . 150

OmniPod System Federal Communications

Commission (FCC) Notice Concerning Interference . . . . . . . 151

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Customer Bill of Rights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Mission Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Scope of Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Supply Shipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Inquiries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Customer’s Bill of Rights and Responsibilities. . . . . . . . . . . . . . . 156

Limited Warranty for the Personal Diabetes Manager . . . . 158

HIPAA Privacy Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Uses and Disclosures of Medical Information. . . . . . . . . . . . . . . 159

Your Rights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Our Duties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

What To Do If You Have a Problem or Question. . . . . . . . . . . . . 164

Helpful Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

viii

Page 10

Introduction

■ Before You Get Started

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

Indication

The OmniPod Insulin Management System is intended for subcutaneous (below the skin) delivery of insulin at set and variable

rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro).

Contraindications

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

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

• Unable to maintain contact with their healthcare provider

• Unable to use the System according to instructions

Do not use the integrated FreeStyle® Blood Glucose Monitoring System for:

• Testing on newborns

• Testing arterial blood

• Diagnosing diabetes

This User Guide is intended for use only with the PDM2. To learn which version of the PDM you have, turn it over. On the battery door label, you will see “PDM2” if this is the correct User Guide. If you do not see “PDM2,” please call Customer Support immediately to receive the correct User Guide: 800-591-3455. When calling from outside the United States: 781457-5098.

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.

Page 11

Introduction

Please read all the instructions provided in this User Guide and practice the blood glucose testing proce-

dures before using the System. Monitor your blood glucose with the guidance of your healthcare provider. Undetected hyperglycemia or hypoglycemia can result without proper monitoring.

You and your healthcare provider

Work with your healthcare provider to establish diabetes management guidelines and settings 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- to-carbohydrate ratio is 1:15, then you need to deliver one unit of insulin to cover every fifteen grams of carbohydrate you eat.

Correction or Sensitivity Factor: How much one unit of insulin will lower blood glucose. For example, if your sensitivity factor is 50, one unit of insulin will lower your blood glucose by 50 mg/dL.

Target Blood Glucose Value: The blood glucose level you want to achieve. For example, you may want to keep your blood glucose close to 100 mg/dL.

Duration of insulin action: The length of time that insulin remains active and available in your body after a bolus.

Your individual needs influence the initial settings you and your healthcare provider will enter into the Personal Diabetes Manager (PDM) during setup (see Chapter 2, Getting Started).

Your healthcare provider must help you enter these initial settings. Soon you will enter and change your own settings with confidence and ease. The OmniPod System is more user-friendly than most electronic devices you use every day. In fact, technology is what makes the OmniPod System so easy to use.

Your healthcare provider is a valuable resource. You will rely on him or her for a lot of critical information about your OmniPod System, especially during the first few weeks and months. When you have questions about diabetes management after starting on the OmniPod System, do not hesitate to talk with your healthcare provider. For nonmedical emergencies or for technical questions about your OmniPod System setup or operation, you can call Insulet Corporation 24 hours a day, 7 days a week at:

Customer Support (24 hours/7 days): 800-591-3455

When calling from outside the United States: 781-457-5098

Customer Support Fax: 877-467-8538 Web site: www.MyOmniPod.com

This User Guide is periodically updated. Visit MyOmniPod.com to see the most recent version and to find other helpful information.

Page 12

Introduction

■ Your Role: Safely Using the OmniPod System

Your healthcare provider will give you all the tools and training you need to be successful with the OmniPod Insulin Management System. However, in the end, your success depends on YOU. You must become actively involved in your own diabetes management to enjoy the outstanding control, freedom, and flexibility that is possible with the OmniPod System.

Being actively involved means:

• Frequently monitoring blood glucose levels

• Learning how to operate your OmniPod System and practicing proper techniques

• Visiting your healthcare provider

If you are having symptoms that are not consistent with your blood glucose test and you have followed all instructions described in this User Guide, call your healthcare professional.

Do NOT attempt to use the OmniPod Insulin Management System before you receive training from your healthcare provider. Inadequate training could put your health and safety at risk.

■ About This User Guide

Conventions and Terms

Convention/Term Meaning

Bold

Italics

Press

Hold

Screen

Button

Icon

Names of buttons, soft keys, menus, and screens are in bold.

Words in italics are defined in the Glossary at the end of this User Guide.

Press and release a button or soft key.

Keep pressing a button until its function is complete.

A list of options on the PDM. Options allow you to perform tasks.

Displays programming, operating, and alarm/alert information.

A physical button on the PDM, such as the Home/Power button.

An image on the PDM screen that indicates a menu option or item of information. A table of screen icons appears in the Appendices.

Page 13

Introduction

Conventions and Terms (continued) Symbols

Convention/Term Meaning

Soft keys

A row of three unlabeled buttons on the PDM whose label or function appears on the screen directly above the button. The label changes depending on the task you are performing.

Symb ol Te r m Meaning

War nin g

Caution

Note

Tip

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

Indicates conditions that could cause minor or moderate injury to you or damage to the device.

Provides helpful information.

Offers a suggestion for successful use of the OmniPod Insulin Management System.

xii

Page 14

CHAPTER 1

Your New OmniPod Insulin Management System

■ Insulin Delivery with the OmniPod System

The OmniPod Insulin Management System is an innovative continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy in a way no conventional insulin pump can. The System’s innovative design and features allows you to live your life—and manage your diabetes—with unprecedented freedom, comfort, convenience, and ease.

The long-term health benefits of better blood glucose control are well known. Maintaining near-normal blood glucose levels can help you live a longer, healthier life with fewer diabetesrelated complications. The OmniPod System also has many practical, everyday benefits, including convenience, freedom, flexibility, and ease of use.

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

Continuous insulin delivery at preset rates eliminates the need for injections and the interruptions that come with them. In addition, with the OmniPod System, insulin delivery can be changed with the press of a button to adapt to snacks or unexpected changes in daily routine. The OmniPod System is a great option for people with diabetes who require insulin.

The OmniPod 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, all day and night.

• An extra dose of insulin (called a bolus) can be delivered when you need it to match the carb ohydrates in a meal or snack or to correct a high blood glucose.

Page 15

Your New OmniPod Insulin Management System

■ How Does the OmniPod System Work?

The OmniPod is a small, lightweight, self-adhesive insulin Pod that you fill with insulin and wear directly on your body for up to three days, then replace. The OmniPod delivers precise, personalized doses of insulin into your body through a small flexible tube (called a cannula), based on instructions that you program into its wireless companion, the Personal Diabetes Manager. The cannula is inserted only once with each OmniPod.

The Personal Diabetes Manager (PDM) is a wireless, handheld device that:

• Programs the OmniPod with your personalized insulindelivery instructions

• Wirelessly monitors the OmniPod’s operation

• Incorporates a FreeStyle® blood glucose meter

With just two parts, you’ll enjoy all the functionality and benefits of continuous insulin delivery and blood glucose monitoring. Plus you’ll enjoy the safety, convenience, and freedom of:

No tubing

There is no tubing connecting the OmniPod to the PDM. You wear the OmniPod comfortably and discreetly under your clothes. You can carry the PDM separately in a backpack, briefcase, or purse. With the OmniPod Insulin Management System, you don’t have to worry about snagging, tangling, or feeling tethered by tubing.

Automated cannula insertion

With the OmniPod System, you don’t have to insert the infusion set manually or carry around a separate inserter. You simply press

a button on the PDM and the OmniPod’s automated insertion system safely and consistently inserts the cannula beneath the skin, virtually pain free. ing to your programmed basal rate.

It then begins delivering insulin accord-

A fully-integrated design with blood glucose monitoring

With a fully integrated two-part design, there’s no need to carry separate infusion sets, reservoirs, or inserters. It’s all integrated into the OmniPod. With the PDM, you can check your blood glucose level using FreeStyle® blood glucose test strips, but without the hassle of carrying a separate blood glucose meter.

If you prefer to use another blood glucose meter, you can enter the readings manually into the PDM.

1. Data on file at Insulet Corporation.

Page 16

Your New OmniPod Insulin Management System

We recommend that you test on your fingers if you are checking for hypoglycemia (low blood glucose) or if you suffer from hypoglycemia unawareness. Blood from the fingertips may show changes in blood glucose sooner than blood from other sites.

Only use FreeStyle® test strips and FreeStyle® control solution with the OmniPod System. Using other brands of test strips and control solutions with the OmniPod System can produce inaccurate results.

Blood glucose monitoring should be done with the guidance of a healthcare professional.

Suggested bolus calculation

Calculating bolus doses has never been easier. After you check your blood glucose, enter the carbs for your snack or meal. Based on your individual settings, the System displays a suggested bolus dose. You can accept the suggestion, change it, or cancel it.

Reference food library and carb presets

To make carbohydrate counting easier, the OmniPod System includes a reference food library. You can look up the carbs and other values for many standard food items. Foods are organized alphabetically and by category.

You can also enter your own favorite foods, snacks, or entire meals as “carb presets.” Presets contain the grams of carbohydrate in the food item or meal. Next time you eat this same food, you don’t have to count the carbs; just select your carb preset and the System does the calculating for you. The System stores up to 36 carb presets.

Record keeping

Another convenient part of the OmniPod System is record keeping. Paper charts are useful, but sometimes they can be inconvenient to carry or use. The data storage system in the Personal Diabetes Manager (PDM) displays up to 90 days’ worth of information. This includes blood glucose readings, basal rates and bolus doses, carbohydrates, and alarms.

Personalizing your System

You can personalize your OmniPod System in other ways, too:

• Enter and name basal programs

• Name and save temporary basal presets

• Add your own customized reminders

• Enter your name, phone number, doctor’s names and numbers, and other emergency information

Page 17

Your New OmniPod Insulin Management System

■ The OmniPod

The OmniPod (Figure 1-1) is applied to your skin with an adhesive backing, similar to a Band-Aid®.

Figure 1-1

To p

Bottom

Fill port

Viewing window

Adhesive backing

■ The Personal Diabetes Manager

All OmniPod operations are programmed and controlled through the palm-sized Personal Diabetes Manager (PDM; Figure 1-2).

Figure 1-2

USB Port

LCD Screen

Soft Key Label

Soft Keys

Home/ Power

User Info/ Support

Needle cap

Test Strip Por t

Up/Down Controller

Page 18

Your New OmniPod Insulin Management System

Buttons that program and control the OmniPod System

Button Action

Home/ Power

Up/Down Controller

Soft Keys

Pressing and holding turns the PDM on and off. When the PDM is on, pressing this button displays the Home screen, from which you can choose a menu item or view the Status screens (shown later in this chapter).

Pressing scrolls through a list of available menu options or numbers, so you can pick the one you want. Holding the button scrolls faster.

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. Select, Save, and Back are just three examples of the soft key labels on your PDM.

Button Action

User Info/ Support

Pressing opens a User Info/Support screen that displays additional information about the current screen you are viewing. The User Info/ Support icon appears when additional information can be viewed. It may be displayed at the top of the screen, to the right of an event detail (such as a suggested bolus), or to the right of a record item ( such as a BG history record). (See “Personal Diabetes Manager Icons” in the Appendices.)

In addition, pressing and holding this button for 2 seconds enables a “bright mode” on the PDM screen.

Page 19

Your New OmniPod Insulin Management System

Primary screens

Messages on the screen either:

• Tell you how the System is operating

• List menu choices

• Explain how to perform certain tasks The System’s primary screens are the Status screen (Figure 1-3)

and the Home screen (Figure 1-4).

Figure 1-3 Figure 1-4

Status screen

Lists the System’s current operating status. From top to bottom, the Status screen displays:

• Time, date, and result of last blood glucose checked or entered manually

• Time, date, and total amount of last bolus delivered

• Amount of insulin on board, if suggested bolus calculator is in use

• Name and rate of active basal program or temp basal program

• “Ext bolus,” the amount of insulin, and the delivery time remaining if an extended bolus is being delivered

• “INSULIN SUSPENDED” if insulin delivery has been suspended

• Time and date when the Pod will expire

If an OmniPod has not yet been activated (as during Pod changes), the screen displays “No active Pod. Would you like to activate a Pod now?” (See Chapter 5, Using the OmniPod, for details on activating a Pod.)

Page 20

Your New OmniPod Insulin Management System

Status support screen

From the Status screen, press the User Info/Support button to see details about the current insulin on board (IOB) in your body (Figure 1-5).

Figure 1-5

Home screen

Lists all the major menus (Figure 1-4 on previous page).

• Bolus menu to deliver bolus doses

• More actions menu to change the Pod, manually enter blood glucose readings, assign and edit tags for BG readings that are less than 2 hours old, and view the food library.

• Te mp ba sa l menu to deliver temporary basal rates (This submenu does not appear if Temp basal is turned Off in Settings.)

• My records menu to review insulin delivery, blood glucose history, alarm history, carb history, and personal user information

• Settings menu to edit, enter, and name basal programs, temp basal, carbohydrate, and bolus presets, and to custom- ize System settings

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

You can go to the Status screen at any time by pressing Status from the Home screen.

Page 21

Your New OmniPod Insulin Management System

■ Safety Features

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

Automatic priming, safety checks, and insertion

Every time a new OmniPod is activated, the System automatically primes and performs a safety check on the Pod, then inserts and primes the cannula (see Chapter 5, Using the OmniPod). Microprocessor technology makes it possible to complete thousands of safety checks in only a few seconds.

The OmniPod System also performs safety checks on the PDM. If it detects any problems in the PDM or the OmniPod—or in communication between them—it informs you with beeps and on-screen messages.

Rapid occlusion detection

An occlusion is a blockage or interruption in insulin delivery. If the OmniPod System detects an occlusion, it sounds a hazard alarm and prompts you to deactivate and change your Pod (see Chapter 10, Errors, Advisories, and Hazard Alarms).

An occlusion may result from a blockage, Pod 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. Hyperglycemia could result if appropriate actions are not taken.

Alerts and alarms

For your safety, the OmniPod System provides a range of alerts and alarms to tell you that your attention is needed, or to warn you of hazardous situations.

See Chapter 6, Using the Personal Diabetes Manager, for a description of alerts and reminders and how to set them. See Chapter 10, Errors, Advisories, and Hazard Alarms, for a list of safety alarms built into the OmniPod System and how to respond to them.

Page 22

CHAPTER 2

Getting Started

■ The OmniPod Starter Kit

Your Starter Kit contains everything you need to begin using the OmniPod System.

Please refer to the Starter Kit for a complete list of package contents.

If you are a first-time OmniPod 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 OmniPod System, review this User Guide and the Interactive Training CD before your first training session. If you have a basic understanding of the System in advance, you will get more out of your training sessions.

After you unpack the Starter Kit, use the “Contents” list to make sure you have everything. Then complete the warranty card and promptly mail it to us. Returning the card allows us to contact you with important product updates or warranty information.

You can also complete the warranty form online at MyOmniPod.com/warranty.

Do NOT use the OmniPod Insulin Management System until you have been trained by your healthcare provider. He or she will initialize the System based on your individual needs. Inadequate training or improper setup could put your health and safety at risk.

Prepare and keep an emergency kit with you at all times to quickly respond to any diabetes emergency. For details, see Chapter 9, Living with Diabetes.

Page 23

Getting Started

■ Set Up the Personal Diabetes Manager (PDM)

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

Turn on the PDM

1. Open the battery compartment on the back of the PDM by pushing the compartment latch and lifting upward (Figure 2-1). No special tools are necessary.

Figure 2-1 Figure 2-2

The diagram inside the compartment shows you which direction to insert the batteries (Figure 2-2).

Do not use any other type of batteries than AAA alkaline batteries to power the PDM. Never use old or used batteries; the PDM may not work properly.

3. Replace the battery door.

4. Turn the PDM face-up. The PDM has begun to power on automatically.

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

Page 24

Getting Started

■ The OmniPod Setup Wizard

The first time you turn on the Personal Diabetes Manager, 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 buttons to increase or decrease a number or to move up or down a list.

Initial settings are “---” [blank] for target blood glucose value, insulin-to-carbohydrate ratio, correction factor, and duration of insulin action.

• Press the soft key labeled Next, Select, Done, or Save to con- tinue to the next screen.

• Press Back to return to the previous screen.

You can adjust these settings later as your needs change or you fine-tune your OmniPod System. See “OmniPod System Options and Settings” in the Appendices.

The Wizard’s Welcome screen (Figure 2-3) gets you started. Press

Next to begin setting up your PDM.

Figure 2-3

Set date and time

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

Page 25

Getting Started

Enter basal settings

1. Choose a maximum basal rate, then press Next. (The default maximum basal rate is 3 U/hr.)

2. Choose the initial basal rate to use, then press Next. The initial basal program created with the Setup Wizard is

named basal 1. You can change the name in the Settings > Basal programs menu (see Chapter 3, Understanding and Adjusting Basal Rates).

3. 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, see Chapter 3, Understanding and Adjusting Basal Rates.

4. To see the basal program as a list, press List. To return to the graphic view, press Graph.

5. Press Save to accept the basal program you have set.

6. Choose a temporary basal feature, then press Next. Choose % to show temporary basal rates as a percent increase or decrease of your current basal rate. Choose U/hr to show temporary basal rates in units per hour. Or choose Off to turn off the temporary basal feature. For details about setting temporary basals, see Chapter 3, Understanding and Adjusting Basal Rates.

Enter blood glucose sound setting and BG goal

1. To set the sound for the blood glucose meter, choose On or Off, then press Next.

2. Use the Up/Down Controller buttons to enter the lower limit for your blood glucose (BG) goal, then press Next.

3. Enter the upper limit for your BG goal, then press Next.

The lower and upper BG limits are only used when viewing BG History (see Chapter 8, Record Keeping).

4. Press Save to accept the BG goal.

Check with your healthcare provider before adjusting these settings.

Set the suggested bolus calculator

1. To set the suggested bolus calculator feature, choose On or Off, then press Next.

If the suggested bolus calculator is set to On, perform the following steps. If set to Off, you will be prompted to “Select bolus increment” and “Enter maximum bolus.”

You can add up to 7 basal programs and set 24 segments per program

Page 26

Getting Started

Enter target blood glucose value

1. Use the Up/Down Controller buttons to enter a target blood glucose (BG) value, then press Next.

2. Use the Up/Down Controller buttons to enter the “correct above” value or correction threshold (the BG value above which you want the PDM to suggest a correction bolus), then press Next.

If the suggested bolus calculator is On, a correction bolus will be suggested only when your BG is above the value shown in brackets on the screen.

3. To save the target BG value, press Done. To change these settings, select the segment you wish to change and press Edit.

You can define up to 4 target BG time segments. To enter additional segments, choose [add new], then:

a. Press New. b. Enter a start time for the target BG segment, then press

Enter.

c. Enter an end time for the target BG segment, then press

Next.

d. Enter a target blood glucose value, then press Next.

e. Use the Up/Down Controller buttons to enter the “cor-

rect above” value or correction threshold (the BG value above which you want the PDM to suggest a correction bolus), then press Next.

f. When you have finished entering segments, press Done.

4. To see the segments as a list, press List. To return to the graphic view, press Graph.

5. Press Save to accept the target BG profile you have set.

Enter minimum BG allowed for use in bolus calculation

1. Use the Up/Down Controller buttons to enter a minimum blood glucose value, below which the System will not calculate a suggested bolus. The values are in 1 mg/dL increments and range from 50 to 70 mg/dL.

2. Press Next.

Enter insulin-to-carbohydrate ratio

1. Use the Up/Down Controller buttons to enter your insulinto-carbohydrate ratio, then press Next. (Insulin-to-carbohy-

drate ratio is the number of carbs covered by 1 unit of insulin.)

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Getting Started

2. To save the ratio, press Done. To change the ratio, select the segment you wish to change and press Edit.

You can define up to 4 insulin-to-carbohydrate time segments. To enter additional ratios, choose [add new], then:

a. Press New. b. Enter a start time for the segment, then press Next. c. Enter an end time for the segment, then press Next. d. Enter the insulin-to-carb ratio for the new time segment,

then press Next.

e. To save the new ratio, press Done.

3. To see the ratios as a list, press List. To return to the graphic view, press Graph.

4. Press Save to accept the ratios you have set.

Enter correction factor

1. Use the Up/Down Controller buttons to enter how much one unit of insulin decreases your blood glucose, then press Next.

2. To save the correction factor, press Done. To change the factor, select the segment you wish to change and press Edit.

You can define correction factors for up to 4 time segments. To enter additional correction factors, choose [add new], then:

a. Press New. b. Enter a start time for the segment, then press Next. c. Enter an end time for the segment, then press Next. d. Enter the correction factor, then press Next. e. To save the new correction factor segment, press Done.

3. To see the factors as a list, press List. To return to the graphic view, press Graph.

4. Press Save to accept the correction factors you have set.

Set reverse correction

1. To set reverse correction, use the Up/Down Controller buttons to choose On or Off, then press Next.

If you enter carbs and reverse corrections are On, the System will subtract insulin from the suggested meal bolus to compensate for a low blood glucose (below the BG target you set). With reverse correction Off, the System will not subtract insulin from the suggested meal bolus dose due to a low BG. Follow your healthcare provider’s recommendation to set reverse correction On or Off.

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Getting Started

Enter the duration of insulin action

1. Use the Up/Down Controller buttons to enter the duration of insulin action (how long insulin lasts in your body), then

press Next.

The duration-of-insulin-action setting is used to calculate the amount of insulin on board (IOB) from a previous correction bolus or meal bolus, when you use the suggested bolus calculator.

Select bolus increment and enter maximum bolus

1. Choose a bolus increment (how much each press of the Up/Down Controller buttons will increase or decrease a bolus amount)—either 0.05, 0.10, 0.50, or 1.00 units of insulin—then press Next.

2. Choose the maximum bolus you can give at one time, then press Next.

The maximum bolus default is 10 units. Check with your healthcare provider before adjusting these settings.

Set extended bolus doses

1. To set the units for an extended bolus dose, choose % for percent of the total bolus, or choose Units for units of insulin. To turn off the extended bolus feature, choose Off. Then press

Next.

Set low reservoir alert

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

Set expiration alert

1. Choose the number of hours before a Pod expires when the PDM should give you an alert, then press Next. The values are in 1-hour increments and range from 1 to 24 hours. (The default is 4 hours.)

The PDM now asks whether you want to activate a Pod (Figure 2-4).

Figure 2-4

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Getting Started

• Press Ye s if you are ready to activate a new OmniPod. See Chapter 5, Using the OmniPod, to learn how to activate a new Pod.

• Press No if you do not want to activate a Pod at this time. The PDM displays the Home screen.

You can press and hold the Power button to turn off the PDM at any time during setup. Otherwise, it turns off automatically after 5 minutes. If you do not complete the entire setup within 60 minutes, when you turn on the PDM again you will return to the beginning of the Setup Wizard.

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

If you ever need to return the PDM for repair or replacement, contact your healthcare provider for instructions on going back to treatment by injections.

You may want to adjust the PDM screen time-out and backlight time-out. For more information on how to do this, see Chapter 6, Using the Personal Diabetes Manager.

Use the form at the end of this User Guide to write down all your settings from the Setup Wizard. You can also attach a copy of the CSII orders that you used during your training session. If you ever need to reset your PDM, having these settings handy will make setup very easy.

Resources for OmniPod users are available from the Customer Support tab on our Web site:

MyOmniPod.com/support/resources

Among these resources are an online copy of this User Guide and the My OmniPod System Information form, which you will also find at the end of this guide.

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CHAPTER 3

Understanding and Adjusting 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 daily living. In people without diabetes, the pancreas continuously delivers this basal insulin. For people using the OmniPod Insulin Management System, the OmniPod mimics a healthy pancreas by delivering insulin at the rate that you’ve programmed into the Personal Diabetes Manager (PDM).

Approximately 50% of a person’s total daily insulin dose typically comes from basal insulin delivery; the remaining 50% typically comes from bolus doses (see Chapter 4, Understanding and Delivering 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:

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

and 8:00 am, the Pod delivers

0.60 units of insulin per hour.

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

the Pod delivers 0.80 units of insulin per hour.

3:00 pm–12:00 am 0.70U/hr Between 3:00 pm and 12:00 am

(midnight), the Pod delivers 0.70 units of insulin per hour.

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Understanding and Adjusting Basal Rates

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 PDM 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 also create temporary basal presets to use on occasions when you need to adjust your basal rate for a short period of time. See “Temporary Basal Rates and Presets” later in this chapter.

Create a basal program

The Personal Diabetes Manager can store up to 7 different basal programs. Each program can contain 24 rates, programmed in half-hour increments. Once you enter a basal program into the PDM, you only need to press a few buttons to pick the program you want. The OmniPod continues to deliver insulin at those rates until you change that program or switch to another one.

Check with your healthcare provider before adjusting these settings.

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Basal programs (Figure 3-1), then press Select.

Figure 3-1 Figure 3-2

3. Choose [add new] (Figure 3-2), then press New.

4. To use the 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.

If you want to give a different name to the program: a. Press the Up/Down Controller buttons to scroll through

the list of characters. An up-and-down-arrow symbol on the screen indicates the character you are changing.

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Understanding and Adjusting Basal Rates

b. Press the middle soft key (labeled with the right arrow) to

move the underscore to the next character.

c. Enter each character one at a time. For example, if your

weekend schedule is different from your weekday schedule, you might enter W, e, e, k, e, n, d (Figure 3-3). (A blank character or space is the first and last option in the scrolling menu.)

Figure 3-3 Figure 3-4

d. Press Next.

As a safety feature, the words “Invalid basal program name” (Figure 3-4) appear if the name you entered does not have at least one character or if the name is being used for another basal program. Capitals and lowercase letters are considered the same. 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 0.05 to the maximum you entered during setup), then press Next.

6. Review the list showing your new basal program. 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 8:00 am and 3:00 pm): a. Choose an existing basal segment, then press Edit.

Or, choose [add new], then press New.

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

Next. Basal segments are in 30-minute increments.

c. Enter the end time (for example, 3:00 pm), then press

Next.

d. Enter the rate for the new basal segment (for example,

0.80U/hr), then press Next.

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Understanding and Adjusting Basal Rates

Basal rates outside the changed segment do not change.

e. Repeat steps a–d for each new segment and rate you

want, then press Done.

Press and hold the Power button to turn the screen back on. In some cases, if it has been less than 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 PDM brings you to the Status screen.

7. Review the graph of the new basal program (Figure 3-5).

8. To see the program as a list, press List (Figure 3-6). To see the graph again, press Graph.

The total daily basal that will be delivered is shown at the bottom of each “Basal programs” graph and list.

9. To add the program to the PDM’s memory, press Save.

Repeat steps 1 through 9 above for each basal program (up to 7) you want to create.

Figure 3-5 Figure 3-6

Enable an existing basal program

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Basal programs, then press Select.

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Understanding and Adjusting Basal Rates

3. Choose the program you want from the list (Figure 3-7), then press Enable.

Figure 3-7

A diamond icon (♦) appears next to the program that is active. You cannot select the active program to enable it, because it is already running.

4. Press Enable again to start the selected basal program. If a Pod is active, the PDM beeps to indicate that the chosen basal program is running.

As a safety feature, you cannot enable a new basal program while a temporary basal preset is in process (see “Temporary Basal Rates and Presets” later in this chapter); you must first cancel the active temporary basal preset.

Change, rename, copy, or delete a basal program

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Basal programs, then press Select.

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

To view the segments of the basal program

1. Choose View, then press Select (Figure 3-8).

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Understanding and Adjusting Basal Rates

Figure 3-8 Figure 3-9

To edit or add a segment or rate in the basal program

1. Choose Edit, then press Select.

As a safety feature, you must suspend insulin delivery before editing an active basal program (see Chapter 5, Using the OmniPod.) Remember to resume delivery after the edits are made.

2. Choose the segment to change, then press Edit (Figure 3-9). Or, choose [add new], then press New.

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

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

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 (Figure 3-10). If you want to make additional edits, repeat steps 2–5.

Figure 3-10

7. To see the program as a list, press List. To see the graph again, press Graph.

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Understanding and Adjusting Basal Rates

To rena me a b as al p ro gra m

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

2. Press the Up/Down Controller buttons to enter the charac- ters that spell out the new name you want. Press the middle soft key (labeled with the right arrow) to move the underscore to the next character, then press Save.

To copy a basal pro gram

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

2. Press the Up/Down Controller buttons to enter the charac- ters that spell out the name you want for the copied file. Press the middle soft key (labeled with the right arrow) to move the underscore to the next character, then press Next.

3. To use the same basal program for the entire 24-hour period, press Save.

To edit or add segments to the newly copied basal program, follow the steps under “To edit or add a segment or rate in the basal program” earlier in this chapter.

Instead of suspending, changing, and then resuming the active basal program, try this: Copy the active program, rename it, make the changes, save it, then enable it.

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.

As a safety feature, you cannot delete the active basal program.

■ Temporary Basal Rates and Presets

What is a temporary basal rate?

A temporary basal rate lets you adjust your basal rate for a predetermined period of time.

On occasion, you may need to change the active basal rate for only 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. This is called a “one-time temporary basal rate.”

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 a few weeks or months, or

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Understanding and Adjusting Basal Rates

join a summer soccer league. For women, a monthly hormonal change that affects blood glucose is an example of predictable change. To easily handle predictable, short-term changes, you can “preset” a temporary basal rate, so it is ready whenever you need it. The PDM can remember up to 7 temporary basal presets.

You can set a temporary basal rate for a duration of 30 minutes to 12 hours. Once the time limit is reached, the PDM returns to the active basal program.

When using units per hour, the OmniPod System allows you to set temporary basal rates from 0.0 U/hr, up to your max basal rate. When using percent rate, you can set temporary basal rates from -100% to +95% of your active rate, as long as the temporary rate is less than or equal to your max basal rate.

See the sections below on creating, enabling, canceling, and changing temporary basal presets.

Enable a one-time temporary basal rate

1. On the Home screen, use the Up/Down Controller buttons to choose Temp ba sa l; then press Select.

2. If you have created temp basal presets, choose [enter manu- ally] from the list, then press Select.

If you have not created any temp basal presets, the PDM skips this step.

3. Enter the temporary basal rate in either units per hour (Figure 3-11) or percent change (Figure 3-12), depending on how you chose to show the rates; then press Enter.

Figure 3-11 Figure 3-12

During initial setup, you and your healthcare provider either turned Off temporary basal rates or chose to show the rates as % or U/hr. To change this setting, see Chapter 6, Using the Personal Diabetes Manager.

4. Enter the duration for the temporary rate, then press Enter.

5. Press Confirm to start the temporary basal rate shown on the screen. The Pod beeps to indicate that the temporary basal rate is running.

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Understanding and Adjusting Basal Rates

Cancel a one-time temporary basal rate

1. On the Home screen, use the Up/Down Controller buttons to choose Suspend/cancel; then press Select.

2. Choose Cancel temp basal (Figure 3-13), then press Select.

Figure 3-13

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

Create a temporary basal preset

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Presets, then press Select.

3. Choose Temp basal presets, then press Select.

4. Choose [add new], then press New.

5. To use the OmniPod 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 buttons to scroll through

the list of characters. An up-and-down-arrow symbol on the screen indicates the character you are changing.

b. Press the middle soft key to move the underscore to the

next character.

c. Enter each character one at a time. 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). (A blank character or space is the first and last option in the scrolling menu.)

Capitals and lowercase letters are considered the same.

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Understanding and Adjusting Basal Rates

Figure 3-14

d. Press Next.

6. Enter the new temporary basal rate (or percent change), then press Next.

7. Enter the duration of the temporary basal rate, from 0.5 hours to 12 hours, then press Next.

8. Review the temporary basal name, rate, and duration, then press Save to accept it.

Enable an existing temporary basal preset

1. On the Home screen, use the Up/Down Controller buttons to choose Temp basal; then press Select.

2. Choose the temporary basal preset you want to use from the list (Figure 3-15), then press Select.

Figure 3-15

3. If you want, change the duration for the temporary rate, in half-hour increments, then press Enter.

4. Press Confirm to begin the temporary basal rate shown on the screen. The Pod beeps to indicate that the chosen temporary basal preset is running.

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Understanding and Adjusting Basal Rates

Cancel an active temporary basal preset

1. On the Home screen, use the Up/Down Controller buttons to choose Suspend/cancel; then press Select.

2. Choose Cancel temp basal, then press Select.

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

If you suspend insulin delivery while a temp basal is running, the temp basal will be cancelled when you resume.

Change, rename, or delete a temporary basal preset

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Presets, then press Select.

3. Choose Temp basal presets, then press Select.

4. Choose a temporary preset from the list, then press Edit.

You cannot edit, change, or delete a temporary basal preset that is actively running.

5. Follow the steps below.

To change a temporary basal preset

1. Choose Edit, then press Select (Figure 3-16).

Figure 3-16

2. Enter a new rate (or new percent change), for the preset, then press Next.

3. Enter a new duration for the preset, then press Save.

4. Press Done.

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Understanding and Adjusting Basal Rates

To rename a temporary basal preset

1. Choose Rename, then press Select.

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

3. Press Done.

To delete a temporary basal preset

1. Choose Delete, then press Select.

2. Press Delete to permanently delete the preset.

■ Maximum Basal Rate

What is the maximum basal rate?

The maximum basal rate is a safety feature that limits the basal rate (U/hr) that the OmniPod can deliver. Once you enter it into the PDM 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 PDM 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.

Change the maximum basal rate

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose System setup, then press Select.

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

4. Choose Max basal, then press Select.

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

Page 42

CHAPTER 4

Understanding and Delivering 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— also known as a meal bolus

•Lower blood glucose when it gets too high—also known as a correction bolus

This extra dose is in addition to the basal rate delivered throughout the day and night (see Chapter 3, Understanding and Adjusting Basal Rates).

The size of a bolus dose depends on the factors current at the time you deliver the bolus:

•Your blood glucose level

•Your insulin-to-carbohydrate ratio

•Your correction factor

• Your target blood glucose

• The amount of insulin on board (active insulin) from previous meal and correction boluses

•Your correction threshold, the BG level above which you would like to take insulin to reduce an elevated blood glucose

•Your activity level

• The type and amount of food you eat

With the OmniPod System, it is easy to adapt to any situation. With just a few button presses, you can adjust to unexpected or changing insulin needs.

During setup, you entered bolus dose settings in the PDM (see Chapter 2, Getting Started). You can adjust these settings as you fine-tune your System or when your needs change (see Chapter 6, Using the Personal Diabetes Manager).

Check with your healthcare provider before you adjust these settings.

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Understanding and Delivering Bolus Doses

■ Bolus Dose Options

So that you can fully enjoy freedom and flexibility in your life, the OmniPod System offers the following bolus dose options:

Suggested bolus calculator: When you want the System to calculate your suggested bolus, based on your personal settings, your current blood glucose, the amount of insulin still active in your body from previous boluses, and the grams of carbohydrate (“carbs” for short) you are about to eat

Normal bolus: When you need a dose of insulin right away, 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)

The bolus features in the OmniPod System are designed for flexibility and convenience. You can easily transition from a normal to an extended bolus with just a few button presses.

■ Suggested Bolus Calculator

The suggested bolus calculator lets the OmniPod System recommend your bolus based on your personal settings. To review or adjust these settings—including turning the suggested bolus calculator On or Off—see Chapter 6, Using the Personal Diabetes Manager.

If the suggested bolus calculator is turned On, the System automatically calculates a bolus dose. If the suggested bolus calculator is turned Off, you must enter a bolus amount manually.

The suggested bolus calculator will display a suggested bolus dose based on the settings you have programmed into the PDM. Check with your healthcare provider before using this feature or adjusting these settings.

How a suggested bolus is calculated

The suggested bolus calculator estimates the suggested amount for each bolus portion based on your personal settings and inputs.

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Understanding and Delivering Bolus Doses

The settings used to calculate a suggested bolus are:

•target BG

• insulin-to-carbohydrate (IC) ratio

• correction factor (CF)

• duration of insulin action The inputs used to calculate a suggested bolus are:

• current BG

•carbs entered

• insulin on board (IOB) A suggested bolus can have a correction bolus only, a meal bolus

only, or both. Correction bolus: The correction bolus, as the name suggests,

“corrects” for a blood glucose (BG) level above your target BG level.

Meal bolus: The meal bolus provides insulin for the carbohydrates you enter into the System.

Insulin on board (IOB): IOB is the amount of insulin still working in your body from previous boluses. The amount of time insulin remains “on board” or “active” depends on what you set for your duration of insulin action.

For formulas for each element of the suggested bolus calculation, detailed examples, and additional guidelines of how the suggested bolus calculator works, see the Appendices.

■ Deliver a Normal Bolus

Deliver a bolus when suggested bolus calculator is On

1. After you check your blood glucose, the PDM displays the results (Figure 4-1; see the end of Chapter 7, Checking Your Blood Glucose). Press Next.

Figure 4-1

The OmniPod System can only subtract insulin on board from a suggested bolus when the current BG is known.

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Understanding and Delivering Bolus Doses

A blood glucose value is current for up to 10 minutes after it is tested. So you can wait up to 10 minutes, restart the bolus process, and not have to retest your blood glucose in order to include it in the suggested bolus calculator.

When your blood glucose result reads “HIGH” or “LOW,” the suggested bolus calculator will be disabled.

If you use a separate blood glucose meter—not the Personal Diabetes Manager (PDM)—you will need to enter your blood glucose manually. On the Home screen, choose Bolus, then press Select. Use the Up/ Down Controller buttons to enter your current BG value, then press Ye s if you want this value to be used by the suggested bolus calculator.

You can also enter a BG manually by choosing the

More actions menu, then choosing Add BG Reading. See the end of Chapter 7, Checking Your Blood

Glucose.

2. If you are not going to eat now, press No (Figure 4-2). The Suggested Bolus screen appears (Figure 4-3). Press Enter to accept the suggested bolus.

Or, if you wish, press the Up/Down Controller buttons to increase or decrease the suggested bolus. Then press Enter to accept the bolus.

Figure 4-2 Figure 4-3

In the Suggested Bolus screen, “adjusted for IOB” appears only when IOB is a factor in the calculation.

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Understanding and Delivering Bolus Doses

To view detailed information about the calculations used for this suggested bolus, press the User Info/Support button and scroll through the information screens. Press Close to return to the Suggested Bolus screen.

3. If you are going to eat now: a. Press Ye s (Figure 4-2 on previous page), enter the number

of carbohydrates you are about to eat, then press Enter. If you’ve previously entered a carb preset, then either:

• Use the Up/Down Controller buttons to choose [enter manually], then press Select. Enter the number of carbohydrates that you are going to eat, then press Enter.

• Use the Up/Down Controller buttons to choose favorites, snacks, or meals. From there, select a carb preset you have previously entered (see “Carb Presets” later in this chapter), then press Select.

The OmniPod System includes a reference food library. For more information, see “Reference Food Library” at the end of this chapter.

Figure 4-4

Or press the User Info/Suppor t button to view calculation information used for this suggested bolus. Press Close to return to the Suggested Bolus screen, then press Enter.

If the reverse correction feature is turned On and if your blood glucose level is below your target, the System subtracts a correction amount from the meal portion of the bolus.

b. Press Enter to accept the suggested bolus (Figure 4-4).

If the reverse correction setting is turned Off, the System does not subtract anything for a blood glucose level below your target.

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Understanding and Delivering Bolus Doses

4. If you have set the blood glucose reminder option to On and you want to add a reminder:

c. Press Ye s . d. Enter the time for the reminder, then press OK.

5. Press Confirm to begin the bolus delivery.

Deliver a bolus manually (suggested bolus calc is Off)

1. On the Home screen, use the Up/Down Controller buttons to choose Bolus; then press Select.

2. Enter the number of units you want to deliver, then press Enter.

3. If the blood glucose reminders feature is turned On, you can now set a blood glucose reminder.

4. Press Confirm to begin the bolus delivery.

As a safety feature, the OmniPod System only allows you to give a bolus at or below the maximum bolus dose you have set. See Chapter 6, Using the Personal Diabetes Manager, for information on resetting your maximum bolus dose. Consult your healthcare provider before changing this setting.

Once a Pod is activated and communicates with the PDM, it can only receive commands from that PDM, not from any other.

■ Deliver an Extended Bolus

The extended bolus feature lets the OmniPod System deliver some (or no) insulin now and the remainder over a period of time you choose.

Deliver an extended bolus instead of a normal bolus

1. After you get your suggested bolus, press Extend instead of Enter (see Figure 4-5).

Figure 4-5

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Understanding and Delivering Bolus Doses

If you have set the Extended bolus option to Off, the PDM will not display the Extend soft key. For information on turning this feature on and off, see Chapter 6, Using the Personal Diabetes Manager.

2. Enter the units of insulin or percentage of the bolus that you want to take immediately (Figure 4-6), then press Enter.

Figure 4-6

To learn how to set extended boluses in percentages or units, see Chapter 6, Using the Personal Diabetes Manager.

3. Enter the time (up to 8 hours, in 30-minute increments) over which to deliver the remainder of the bolus, then press Enter (Figure 4-7). In Figure 4-8 you can see a detail of the extended bolus.

Figure 4-7 Figure 4-8

4. If the blood glucose reminders feature is turned On, you can now set a blood glucose reminder.

5. Press Confirm to begin the bolus delivery.

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As a safety feature, the correction bolus is always delivered first and cannot be extended. Only the meal bolus can be extended. For example:

Total bolus = 5 units

Correction bolus 1 unit Meal bolus 4 units

Deliver now = 2 units

100% of correction bolus 1 unit 25% of meal bolus 1 unit

Extend = 3 units

75% of meal portion 3 units

As a safety feature, you cannot deliver two extended boluses at the same time. You can, however, cancel the first extended bolus and replace it with another (see “Replace an Extended Bolus” on page 37). And you can deliver a normal bolus while an extended bolus is being delivered.

■ Cancel Active Boluses

The OmniPod System is extremely flexible, so you can use it to respond 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 and hold the Power button to turn on the PDM, if it is not already on. An on-screen message appears as long as a normal bolus is being delivered (Figure 4-9).

Figure 4-9

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Understanding and Delivering Bolus Doses

If the bolus has already been completely delivered, the “Delivering bolus” message and Cancel do not appear, but the Status screen does appear.

2. Press Cancel. The Pod beeps to confirm the bolus is canceled. An on-screen

message tells you how much insulin was delivered before you canceled the bolus (Figure 4-10).

Figure 4-10

3. Press OK to return to the Status screen.

If your suggested bolus contains both a correction bolus and a meal bolus, the correction bolus is always delivered first.

■ Replace an Extended Bolus

You can replace one extended bolus with another. The System tells you how much of the first bolus has not yet been delivered.

1. After you see your suggested bolus, press Extend instead of Enter (see Figure 4-5 on page 34).

2. Press Ye s to cancel the active extended bolus (Figure 4-11). Or press Back to return to the Suggested Meal Bolus screen.

Figure 4-11

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Understanding and Delivering Bolus Doses

3. Press Confirm (Figure 4-12).

Figure 4-12 Figure 4-13

4. The screen displays the amount of the old extended bolus that remained to be delivered (Figure 4-13). Press Next to return to the Suggested Meal Bolus screen.

You can add what remained of the old extended bolus to the new one.

■ Bolus Presets

Bolus presets are bolus amounts that you program for frequent use. For example, if you often take the same bolus at lunchtime, you can create a bolus preset for that amount and name it “Lunch.”

Bolus presets are available only when the suggested bolus calculator feature is turned Off. (If the suggested bolus calculator is turned On, you can still use carb presets. See “Carb Presets” on page 40.)

Create a bolus preset

1. On the Home screen use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Presets, then press Select.

3. Choose Bolus presets, then press Select.

4. Choose [add new], then press New.

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

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Understanding and Delivering Bolus Doses

Or, to give a different name to the program: a. Press the Up/Down Controller buttons to enter the char-

acters that spell the name you want. An up- and downarrow symbol on the screen indicates which character you are changing.

b. Press the middle soft key (labeled with the right arrow) to

move the underscore to the next character.

c. Enter each character one at a time. For example, if you

frequently take the same bolus at lunchtime, you might enter L, u, n, c, h (Figure 4-14).

d. Press Next.

Figure 4-14 Figure 4-15

6. Enter the new bolus preset amount, up to the maximum bolus you entered during setup; then press Next.

7. Review the bolus preset name and amount; press Save to accept it.

Enable an existing bolus preset

1. On the Home screen, use the Up/Down Controller buttons to choose Bolus; then press Select.

2. Choose the bolus preset you want to use from the list (Figure 4-15), then press Select.

3. Press Enter to confirm the bolus preset amount, or, if necessary, use the Up/Down Controller buttons to adjust the bolus amount.

4. Press Confirm to deliver the bolus shown on the screen.

Change, rename, or delete a bolus preset

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Presets, then press Select.

3. Choose Bolus presets, then press Select.

4. Choose a preset from the list, then press Edit.

Change a bolus preset

1. Choose Edit, then press Select.

2. Enter a new insulin amount for the bolus, then press Save.

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Rename a bolus preset

1. Choose Rename, then press Select.

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

Delete a bolus preset

1. Choose Delete and then press Select.

2. Press Delete to permanently delete the preset.

Cancel an active bolus preset

1. Press and hold the Power button to turn on the PDM, if it is not already on. An on-screen message appears as long as a bolus is being delivered.

2. Press Cancel. The Pod beeps to confirm the bolus is canceled. An on-screen

message tells you how much insulin was delivered before you canceled the bolus.

3. Press OK to return to the Status screen.

For more details, see “Cancel Active Boluses” earlier in this chapter.

■ Carb Presets

Carb presets are favorite food items, snacks, or meals that you eat frequently. After you enter these items, you can quickly select one when entering carbs during the suggested bolus calculator process.

Create a carb preset

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Presets, then press Select.

3. Choose Carb presets, then press Select.

4. Choose the category for this carb preset: Favorit es, Snacks, or Meals, then press Select.

5. Choose [add new], then press New.

6. To use the OmniPod System’s default naming system, simply press Next. The default naming system automatically assigns program names in numerical order, such as carb preset 1, carb preset 2, carb preset 3.

Or, to give a different name to the program: a. Press the Up/Down Controller buttons to enter the char-

acters that spell the name you want. An up-and-downarrow symbol on the screen indicates the character you are changing.

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Understanding and Delivering Bolus Doses

b. Press the middle soft key (the right arrow) to move the

underscore to the next character.

c. Enter each character one at a time. For example, if you

frequently eat a breakfast of plain low-fat yogurt with blueberries, sweetener, and cinnamon, you might enter B, l, u, e, [space], Y, o, g, u, r, t (Figure 4-16).

Figure 4-16 Figure 4-17

d. Press Next.

7. Enter the grams of carbohydrate in the meal, then press Next.

8. If you want, enter the grams of fiber, fat, and protein in the meal, and the total calories. Press Next after each entry.

These additional units are not required. If you prefer not to enter them, simply press Next repeatedly to step through the screens.

If you do include grams of fiber in step 8 above, the suggested bolus calculator uses carbs minus fiber. Alternatively, in step 7, you can enter the total of carbs minus fiber yourself. Your healthcare provider can best advise you how to make this entry.

9. Press Save to add the preset to the category.

Change or edit a carb preset

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Presets, then press Select.

3. Choose Carb presets, then press Select.

4. Choose the category of the preset you want to change, then press Select (Figure 4-17).

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Understanding and Delivering Bolus Doses

To change the category for a carb preset

1. Choose the carb preset you want to move to another category, then press Tag (Figure 4-18).

Figure 4-18

2. Choose a new category, then press Select.

To edit a carb preset

1. Choose the carb preset you want to change, then press Edit.

2. Press Edit again on the next screen.

3. To rename the carb preset, press the Up/Down Controller buttons to enter the characters that spell out the name you want, then press Next.

To “erase” characters, press either Up or Down until you reach the end of the characters, which is a blank.

4. Enter the grams of carbohydrate in the meal, then press Next.

5. If you want, enter the grams of fiber, fat, and protein in the meal, and the total calories. Press Next after each entry.

These additional units are not required. If you prefer not to enter them, simply press Next repeatedly to step through the screens.

6. Press Save to update the preset.

Delete a carb preset

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose Presets, then press Select.

3. Choose Carb presets, then press Select.

4. Choose the category of the preset you want to change, then press Select.

5. Choose the carb preset you want to delete, then press Edit.

6. Press Delete.

7. Press Delete again to permanently delete the preset.

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Understanding and Delivering Bolus Doses

■ Reference Food Library

The OmniPod System includes a reference library of over 1,000 common food items. The library shows each item’s carbohydrate, fat, protein, fiber, and calories for a single portion. You can use this information to determine the carbs for a meal or snack you are going to eat. You can also use it to help you create carb presets for your favorite meals.

The items in the food library are derived from the USDA database, USDA National Nutrient Database for Standard Reference, Release 16, published by the U.S. Department of Agriculture, Agricultural Research Service, in 2004.

Access the reference food library

1. On the Home screen, use the Up/Down Controller buttons to choose More actions; then press Select.

2. Choose View food library, then press Select. The screen displays a list of main food categories (Figure 4-

19a and Figure 4-19b).

3. To choose directly from the food categories, use the Up/ Down Controller buttons to choose a main category, then press Select. Choose a subcategory, then press Select. Choose a food item from the subcategory, then press View.

Figure 4-19a Figure 4-19b

4. To choose from an alphabetical list of foods, press Index. Enter the first letter of the food item, then press Select. Choose a food item from the alphabetical list, then press View.

The screen displays the food item’s:

•Name

•Serving size

• Grams of carbohydrate, fiber, fat, and protein

•Total calories

5. Press OK to return to the list of main food categories.

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CHAPTER 5

Using the OmniPod

■ The OmniPod Change Process

You should replace the OmniPod at least once every 48–72 hours (2–3 days), or as instructed by your healthcare provider. You can also choose to have the PDM alert you when it is time to replace the Pod (see Chapter 6, Using the Personal Diabetes Manager).

WAR NI NG S!

• Do NOT apply or use an OmniPod if its sterile packaging is open or damaged, as this may increase the risk of infection. OmniPods are sterile unless packaging has been opened or damaged.

• Do NOT apply or use an OmniPod if it is damaged in any way. A damaged Pod may not work properly.

• To minimize the possibility of site infection, do NOT apply an OmniPod without first using aseptic technique. This means to:

• Wash your hands.

• Clean the insulin vial with an alcohol prep swab.

• Clean the infusion site with soap and water.

• Keep sterile materials away from any possible germs.

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

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

• Do NOT apply a new OmniPod until you have deactivated and removed the old Pod. A Pod that has not been deactivated properly may continue to deliver insulin as programmed, putting you at risk of overinfusion and possible hypoglycemia.

• Because insulin Pods use only rapid-acting insulin, 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 ketoacido- sis (DKA). DKA can cause breathing difficulties, shock, coma, or death. If insulin delivery is interrupted for any reason, you

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Using the OmniPod

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 equipment and supplies

Gather the following before you begin:

• Vial of rapid-acting U-100 insulin

Use ONLY rapid-acting U-100 insulin with the OmniPod. 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 OmniPod

• Alcohol prep swab

If you are a first-time OmniPod System user, your healthcare provider will guide you through the steps for initializing and applying your first Pod. Do NOT attempt to apply or use an OmniPod until you have been trained by your healthcare provider. Use of the System with inadequate training or improper setup could put your health and safety at risk.

Deactivate the current OmniPod

1. On the Home screen, use the Up/Down Controller buttons to choose More actions, then press Select.

2. Choose Change Pod (Figure 5-1), then press Select.

3. Press Confirm (Figure 5-2) to deactivate the current Pod.

Figure 5-1 Figure 5-2

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Using the OmniPod

4. If an extended bolus or temporary basal or both are actively running, you will see the message in Figure 5-3. Press Con- firm to accept the cancellation.

Or press Back to return to the More actions menu.

Figure 5-3 Figure 5-4

5. After you press Confirm, you will see the message in Figure 5-4. To remove the old Pod:

a. Gently lift the edges of the adhesive tape from your skin

and remove the entire Pod (Figure 5-5).

Removing the Pod slowly will help to avoid possible skin irritation.

Figure 5-5 Figure 5-6

b. Use soap and water to remove any adhesive that remains

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

Check the infusion site for signs of infection. See “Avoid Infusion Site Infections” later in this chapter.

c. Discard the used Pod according to local waste disposal

regulations.

6. After removing the old Pod, press Next (Figure 5-4).

7. Press Ye s to fill a new Pod (Figure 5-6).

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Using the OmniPod

Fill a new OmniPod

Before filling an OmniPod with insulin, ensure that the Pod is above 50° Fahrenheit. If the Pod has been exposed to temperatures below 50°, then allow the Pod to be brought back to room temperature before filling it with insulin.

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

2. Securely twist the fill needle onto the syringe (Figure 5-7).

Figure 5-7 Figure 5-8

3. Pull outward to remove the protective cap from the needle (Figure 5-8). Save the cap; you will need it later.

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

Only use room temperature insulin when filling the OmniPod.

4. Determine the amount of insulin you need to insert into the Pod. For example, if you will use this Pod for 72 hours, you need enough insulin to last you 72 hours. Your healthcare provider will help you determine the correct amount.

The Pod requires a minimum of 85 units of insulin to begin operation.

5. Draw air into the syringe up to the amount of insulin you want.

6. Insert the needle into the insulin vial and inject the air. This makes it easier to withdraw insulin from the vial.

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Using the OmniPod

7. Turn the vial and syringe upside down. Withdraw insulin from the vial into the syringe, expelling any air bubbles. Fill at least to the MIN (minimum) fill line (Figure 5-9).

Figure 5-9 Figure 5-10

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

8. Remove the needle from the vial and insert it straight down into the insulin fill port on the underside of the Pod (Figure 5-10).

To ensure proper fill, do not insert fill syringe at an angle into the fill port.

Do not use any other type of needle or filling device besides the syringe provided with each Pod.

9. Depress the syringe plunger to completely empty the insulin into the Pod. The Pod will beep, indicating that the System is ready to proceed to the next step.

NEVER use a Pod if you hear a crackling noise or feel resistance when you depress the plunger. These conditions can result in underdelivery of insulin.

10. Remove the needle from the insulin fill port. The port is selfsealing; insulin will not leak after the needle is removed.

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

NEVER inject air into the fill port. Doing so may result in unintended or interrupted insulin delivery.

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NEVER inject insulin (or anything else) into the fill port while the Pod is on your body. Doing so may result in unintended or interrupted insulin delivery.

11. Place the protective cap back on the needle and remove the needle from the syringe.

12. Place the capped needle in a 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 the OmniPod System.

13. After you fill the OmniPod, the Pod will beep twice. After you hear the beeps, press Next (Figure 5-11).

The Pod will only beep if you have filled it with at least 85 units of insulin.

If you have filled the Pod with more than 85 units and still do not hear the 2 beeps, call Customer Support, 800-591-3455 (from outside the United States, 781-457-5098).

14. The System performs a series of safety checks and automatically primes the Pod (Figure 5-12). Once complete, the PDM beeps, letting you know that the priming and safety checks were successful.

Using the OmniPod

Figure 5-11 Figure 5-12

After filling the Pod with insulin, you should complete the Pod-change process within 60 minutes. As a reminder that the Pod has been filled, it will beep every 5 minutes to indicate that time is passing. If you do not set up the Pod within 60 minutes, you must deactivate and discard it.

Once a Pod is activated and communicates with the PDM, it can only receive commands from that PDM, not from any other.

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Select the infusion site

Before applying a new Pod, you must first select an appropriate infusion site. Due to ease of access and viewing, the abdomen is often used. Your healthcare provider may suggest other potential sites that, like the abdomen, typically have a layer of fatty tissue, such as the hip, back of upper arm, upper thigh, or lower back (Figure 5-13, and Figure 5-14 on the following page).

Avoid sites where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the Pod. Also avoid sites where the Pod will be affected by folds of skin.

Change the site each time you apply a new Pod. A new infusion site should be at least 1" away from the last site. (Using the same location repeatedly may reduce insulin absorption.)

Do NOT apply the Pod within 2" of your navel or over a mole or scar, where insulin absorption may be reduced.

To help avoid condensation from occurring in the viewing window, make sure both your Pod and your insulin are at room temperature.

Figure 5-13

Front

Back

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Using the OmniPod

Figure 5-14

Prepare the infusion site

You can reduce the risk of infection at the infusion site by following aseptic technique and disinfecting the infusion site. Before applying a new Pod, 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. Ask your healthcare provider how to treat 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 gently rub outward in a circular motion.

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

Front

Back

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Using the OmniPod

Apply the new OmniPod

Prepare the Pod for applying to your infusion site:

1. To remove the needle cap on the underside of the Pod, pull it upward (Figure 5-15).

When you remove the needle cap, a few drops of insulin should be visible at the end of the needle.

Figure 5-15 Figure 5-16

2. Using the pull tabs, remove and discard the white paper backing from the adhesive tape (Figure 5-16).

3. Apply the Pod to the prepared infusion site. Press firmly to secure it to your skin.

For the Pod to work best, apply it:

1. Crosswise or at a slight angle on your abdomen, hip, upper back, or buttocks (see A)

2. Up and down or at a slight angle on your upper arm or thigh (see B)

3. At least one inch away from the last site

The OmniPod’s adhesive keeps it securely in place for up to 3 days. However, if necessary, several products are available to enhance adhesion. Ask your healthcare provider about these products. Avoid getting body lotion, creams, or oils near the infusion site; these products may loosen the adhesive.

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Using the OmniPod

4. After you securely apply the Pod, press Next (Figure 5-17).

Figure 5-17

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

Insert cannula and begin insulin delivery

1. To insert the soft cannula, press Start (Figure 5-18).

Figure 5-18 Figure 5-19

If you are applying a Pod in a place that does not have a lot of fatty tissue or is very lean, pinch the skin around the Pod (Figure 5-19) after you press Start , and hold it until the cannula inserts. Occlusions may result in lean areas if you do not use this technique.

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Using the OmniPod

The OmniPod automatically inserts the soft cannul a below your skin. It takes a few seconds to complete the insertion process. Once the cannula is inserted, the Pod delivers a prime bolus to fill the cannula with insulin (Figure 5-20).

Figure 5-20 Figure 5-21

You will hear a click when the cannula inserts.

Check the infusion site after insertion to ensure that the cannula was properly inserted. It is also a good idea to check your blood glucose about two hours after after each Pod change and to check the infusion site periodically. If the cannula is not properly inserted, hyperglycemia may result.

If you observe blood in the cannula, check your blood glucose more frequently to ensure insulin delivery has not been affected. If you experience unexpected elevated blood glucose levels, change your Pod.

Once the soft cannula is inserted, the PDM indicates that the Pod is active (Figure 5-21).

Figure 5-21 also displays a reminder to check the infusion site and cannula. Make sure the Pod is securely attached to your skin. You can see the cannula through the small viewing window on the Pod.

To help avoid condensation from occurring in the viewing window, make sure both your Pod and your insulin are at room temperature.

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Using the OmniPod

2. Press Ye s if you can see that the cannula is properly inserted. The PDM returns to the Status screen.

Or press No if you see a problem with the cannula. The PDM instructs you to deactivate the new Pod (Figure 5-22). Press

Discard to restart the process with a new Pod.

Figure 5-22

Or press Back to return to the previous screen.

NEVER inject insulin (or anything else) into the fill port while the Pod is on your body. Doing so may result in unintended or interrupted insulin delivery.

■ Check Pod Status

To check Pod status, if the PDM is turned off, press and hold the Power button to display the Status screen. If the PDM is on, press Back until you reach the Status screen. (If you press and hold the Power button, you will turn off the PDM instead.) Or, from the Home screen, press Status.

The PDM automatically checks the status of the Pod. The PDM then displays the current reservoir volume, PDM battery level, last blood glucose, last bolus dose, active basal program, and any alarm conditions. See Chapter 6, Using the Personal Diabetes Manager, for details of what you see on the Status screen.

Once a Pod is activated and communicates with the PDM, it can only receive commands from that PDM, not from any other.

If the Pod goes into hazard alarm condition and the PDM is unable to communicate with it to turn off the alarm, you can turn it off manually. See the end of Chapter 11, Communication Failures, for instructions.

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■ Suspend Insulin Delivery

Sometimes you may need to briefly stop insulin delivery (for example, when editing an active basal program or changing the time or date). The OmniPod System lets you suspend all insulin delivery for up to 2 hours. While in suspension, the Pod beeps once every 15 minutes, reminding you that insulin delivery is suspended.

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

Extended boluses and temporary basal rates will be cancelled when you suspend insulin delivery.

1. On the Home screen, use the Up/Down Controller buttons to choose Suspend; then press Select.

If a temporary basal or extended bolus is in process, the menu item is Suspend/cancel instead, and options for canceling these programs also appear in the menu. If these options appear, choose Suspend insulin delivery.

2. Enter how long you want to stop all insulin delivery, from 30 minutes to 2 hours in 30-minute increments (Figure 5-23), then press Enter.

Figure 5-23 Figure 5-24

3. Press Confirm to confirm that you want to halt all insulin delivery (basal and bolus). The PDM beeps and an on-screen message lets you know that insulin delivery is indeed suspended (Figure 5-24).

The Pod 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” below).

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At the end of the suspend time, a Pod Advisory alarm occurs (Figure 5-25).

Figure 5-25 Figure 5-26

4. To resume your programmed basal rate, press OK.

The Advisory alarm repeats every 15 minutes until you press OK.

Insulin delivery will not resume until you press OK. If you do not press OK to resume insulin delivery, you could develop hyperglycemia (high blood glucose).

■ Resume Insulin Delivery

1. On the Home screen, use the Up/Down Controller buttons to choose Resume (Figure 5-26); then press Select.

2. Press Confirm to restart the basal program for that time segment.

■ Avoid Infusion Site Infections

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

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

• At least once a day, use the Pod’s 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 Pod and apply a new one in a different location. Then call your healthcare provider.

• Change the Pod at least once every 2–3 days, or as instructed by your healthcare provider.

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Using the OmniPod

■ Get the Most From Your Pod

Avoid extreme temperatures

The OmniPod’s operating temperature is between 40°F and 104°F (between 5°C and 40°C). Under normal circumstances, your body temperature will keep the Pod well within this range.

Do NOT expose a Pod to direct sunlight for long periods of time. It is recommended that you remove your Pod prior to using hot tubs, whirlpools, or saunas. These conditions could expose the Pod to extreme temperatures and may also affect the insulin inside the Pod.

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

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

Water and your OmniPod

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

Do not expose your OmniPod to water at depths greater than 8 feet or for more than 30 minutes. Check often to make sure the Pod and soft cannula are securely attached and in place. If the cannula is not properly inserted, hyperglycemia may result.

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

Safe storage

Store unopened OmniPods in a cool, dry place. Extreme heat or cold can damage Pods and cause them to malfunction. If Pods are exposed to extreme temperatures, allow them to return to room temperature before use.

Pods are sterile unless their packaging is opened or damaged. Do NOT apply or use a Pod if its sterile packaging is opened or damaged, as this may increase the risk of infection or serious injury.

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CHAPTER 6

Using the Personal Diabetes Manager

■ The Status Screens

When a Pod is active and the PDM is turned on, the PDM establishes communication with the Pod to obtain a status check. During the status check, the PDM collects information from the Pod about bolus deliveries, active basal programs, and Pod expiration. The information obtained is then displayed in the status screen, which shows the System’s current operating status.

The Status screen (Figure 6-1) displays:

• Time, date, and result of last blood glucose checked or entered manually

• Time, date, and total amount of last bolus delivered

• Amount of insulin on board, if suggested bolus calculator is in use

• Name and rate of active basal program or temp basal program

• “Ext bolus,” the amount of insulin, and the delivery time remaining if an extended bolus is being delivered

Figure 6-1

• “INSULIN SUSPENDED” if insulin delivery has been suspended

• Time and date when the Pod will expire

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Insulin gauge and display

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

Next to the insulin gauge, the PDM displays the number of units remaining in the Pod. 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.”

Regularly checking the insulin gauge enables you to plan Pod 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 Pod with you or change it before you leave for the day.

PDM settings

You can adjust the PDM settings to meet your individual needs.

1. From the Status screens, press Home.

2. Use the Up/Down Controller buttons to choose Settings; then press Select.

3. Choose System setup, then press Select.

4. Choose an option from the System setup list, then press Select (Figure 6-2). Check with your healthcare provider before making any changes.

Figure 6-2

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Using the Personal Diabetes Manager

■ The System Setup Menu

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

• Date and time

• Bolus doses, basal rates, and bolus calculator settings

• Alerts and reminders

• Blood glucose meter settings

• Blood glucose tags

• PDM options

• Diagnostics You and your healthcare provider entered initial System settings

using the Setup Wizard (see Chapter 2, Getting Started). After setup, 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 PDM). As a safety feature, you can change date and time settings only when the Pod is deactivated or when insulin delivery is suspended (see Chapter 5, Using the OmniPod).

1. Suspend insulin delivery.

If you are changing the Pod, you can reset the date or time without suspending by changing the date or time before activating the new Pod.

2. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

3. Choose System setup, then press Select.

4. Choose Date/time, then press Select.

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

Reset the time

1. To enter the current time, press the Up/Down Controller buttons. Press and hold the button to increase or decrease the time faster.

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2. Press 12/24 hr to choose either a 12-hour or 24-hour clock, then press Enter (Figure 6-3).

Figure 6-3 Figure 6-4

3. Press Confirm to accept the new time (Figure 6-4).

Reset the date

1. Press the Up/Down Controller buttons to choose the current year, then press Next.

2. Choose the current month, then press Next.

3. Choose the current day, then press Next.

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

5. Press Confirm to accept the new date and format.

If you suspended insulin delivery to change the time or date, remember to resume insulin delivery. If you changed the time or date during the Pod change process, remember to activate a new Pod.

■ Change Bolus and Basal Settings

You and your healthcare provider entered initial bolus and basal System settings using the Setup Wizard. Using the System setup menu, you can edit all the OmniPod System bolus and basal settings as your needs change. Check with your healthcare provider before making any changes.

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose System setup, then press Select.

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

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4. Choose one of the options (Figure 6-5a and Figure 6-5b), then press Select. Each option is described below.

Figure 6-5a Figure 6-5b

Bolus calcs

When the suggested bolus calculator is turned Off and you want to turn it On, press On and follow these steps:

1. Target BG and correct-above value—You can edit existing time segments and add segments, up to a total of four.

a. To edit an existing target BG time segment, choose the

segment, then press Edit. Use the Up/Down Controller buttons to choose a new start time, end time, target BG value, and correct-above value (correction threshold). Press Next after each entry.

b. To add a segment, choose [add new], then press New.

Use the Up/Down Controller buttons to choose a start time, end time, target BG value, and correct-above value (correction threshold). Press Next after each entry.

c. When you have completed all the time segments you

want, press Done, then Save.

2. Min BG for calcs (minimum blood glucose value allowed for calculating boluses)—Use the Up/Down Controller buttons to enter a new minimum BG, then press Next.

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3. Insulin to carb (IC) ratio—You can edit existing time segments and add segments, up to a total of four.

a. To edit an existing IC ratio time segment, choose the seg-

ment, then press Edit (Figure 6-6). Use the Up/Down Controller buttons to choose a new start time, end time, and IC ratio. Press Next after each entry.

Figure 6-6

b. To add a segment, choose [add new], then press New.

Use the Up/Down Controller buttons to choose a start time, end time, and IC ratio. Press Next after each entry.

c. When you have completed all time segments, press

Done, then Save.

4. Correction factor—You can edit existing time segments and add segments, up to a total of four.

a. To edit an existing correction factor time segment, choose

the segment, then press Edit. Use the Up/Down Control- ler buttons to choose a new start time, end time, and correction factor. Press Next after each entry

b. To add a segment, choose [add new], then press New.

Use the Up/Down Controller buttons to choose a start time, end time, and correction factor. Press Next after each entry.

c. When you have completed all time segments, press

Done, then Save.

5. Reverse correction—Choose On or Off, then press Next.

6. Insulin action (duration)—Use the Up/Down Controller buttons to choose a duration of insulin action, then press Done.

7. Press OK.

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Ratios/factors/targets

When the suggested bolus calculator is turned On, you can view and change all the settings using the Ratios/factors/targets menu option. Choose Review all settings, then press Select (Figure 6-7a ). Or choose one setting from the menu, then press Select (Figure 6-7b). The steps are the same whether you choose all settings or individual ones.

When the suggested bolus calculator is turned Off, the

Ratios/factors/targets option does not appear in the Bolus/basal/calcs menu.

Figure 6-7a Figure 6-7b

1. Target BG and correct-above value—You can edit existing segments and add segments, up to a total of four.

a. To edit an existing target BG time segment, choose the

segment, then press Edit. Use the Up/Down Controller buttons to choose a new start time, end time, target BG value, and correct-above value (correction threshold). Press Next after each entry.

b. To add a segment, choose [add new], then press New.

Use the Up/Down Controller buttons to choose a start time, end time, target BG value, and correct-above value (correction threshold). Press Next after each entry.

c. When you have completed all the time segments you

want, press Done, then Save.

2. Min BG for calcs (minimum blood glucose value allowed for calculating boluses)—Use the Up/Down Controller buttons to enter a new minimum BG, then press Enter.

3. Insulin to carb (IC) ratio—You can edit existing time segments and add segments, up to a total of four.

a. To edit an existing IC ratio time segment, choose the seg-

ment, then press Edit. Use the Up/Down Controller but- tons to choose a new start time, end time, and IC ratio. Press Next after each entry.

b. To add a segment, choose [add new], then press New.

Use the Up/Down Controller buttons to choose a start time, end time, and IC ratio. Press Next after each entry.

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c. When you have completed all time segments, press

Done, then Save.

4. Correction factor—You can edit existing time segments and add segments, up to a total of four.

a. To edit an existing correction factor time segment, choose

the segment, then press Edit. Use the Up/Down Control- ler buttons to choose a new start time, end time, and correction factor. Press Next after each entry.

b. To add a segment, choose [add new], then press New.

Use the Up/Down Controller buttons to choose a start time, end time, and correction factor. Press Next after each entry.

c. When you have completed all time segments, press

Done, then Save.

5. Reverse correction—Choose On or Off, then press Select.

6. Insulin action (duration)—Use the Up/Down Controller buttons to choose a duration of insulin action, then press

Enter.

Temp ba sa l

Choose %, U/hr , or Off to set the mode for temporary basal rates and presets, then press Select.

Extended

Choose %, Units, or Off to set the mode for extended boluses, then press Select.

Bolus increment

Choose 0.05, 0.10, 0.50, or 1.00 units for bolus increments, then press Select.

Max bolus

Use the Up/Down Controller buttons to enter the maximum bolus dose you can take, then press Enter.

Max basal rate

Use the Up/Down Controller buttons to enter the maximum basal rate you can choose, then press Enter.

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

For additional details on bolus and basal settings, see Chapter 3, Understanding and Adjusting Basal Rates, and Chapter 4, Understanding and Delivering Bolus Doses.

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■ Alerts and Reminders

In addition to automatic safety alarms (see Chapter 10, Errors, Advisories, and Hazard Alarms), the OmniPod 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.

Alerts and reminders you can use are: BG (blood glucose) reminder: Reminds you to check your blood

glucose. Choose from On or Off. The default setting is Off. When the reminder is on, the PDM asks you each time you enter a bolus dose whether you want to set a BG reminder, and you can then choose a time interval, in 1/2-hour increments.

Expiration: Alerts you when the Pod is nearing the expiration time. Choose an alert period from 1 to 24 hours before expiration, in 1-hour increments. The default setting is 4 hours.

Low reservoir: Alerts you when insulin in the Pod reaches a certain level, so you can plan ahead to change the Pod. Choose a level from 10 to 50 units, in 5-unit increments. The default setting is 10 units.

Auto-off: Alerts you if the PDM does not receive a Pod status within a predefined period of time. Obtain Pod status by pressing and holding the PDM’s Power button. This alert can be especially reassuring if you are prone to hypoglycemia unawareness. Choose a time period from 1 to 24 hours, in 1-hour increments, or choose Off. The default setting is Off.

Turning the PDM on by inserting a blood glucose test strip does not send a Pod status to the PDM.

Many hazard alarms (such as Auto-off) will cause alert escalation and deactivation of the active Pod if you ignore them. Be sure to respond to all alerts and alarms when they occur.

Bolus reminders: Alerts you if you have not delivered a meal bolus, manually or using the suggested bolus calculator, between the times you specify. Choose On or Off and choose up to 6 time segments.

Reminder alerts: Pod beeps when a program is in process (see Chapter 3, Understanding and Adjusting Basal Rates, and Chapter 4, Understanding and Delivering Bolus Doses, for details). These include:

• Temporary basal in process

• Extended bolus in process Choose On or Off. The default setting is On.

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Confidence alerts: The OmniPod or PDM beeps in response to your instructions, so you become familiar with the operation of the OmniPod 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. Custom alerts: Displays text reminders that you enter, at times

that you select. You can choose to receive an alert Daily, One time only, or Off. You can change or delete these custom alerts at any time.

Set alerts and reminders

1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press 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 6-8a and Figure 6-8b), then press Select.

Figure 6-8a Figure 6-8b

5. For all except Bolus reminders and Custom alerts, choose the desired option or set the desired value, then press Select or Enter.

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6. For Bolus reminders

• Use the Up/Down Controller buttons to choose On or Off, then press Select.

•If you chose On, you are taken to a new screen where you can add, edit or delete reminders:

To add a Bolus reminder

a. Use the Up/Down Controller buttons to choose [add

new], then press New.

b. Choose a start time, then press Next. c. Choose an end time, then press Save.

To edit a Bolus reminder

a. Choose the bolus reminder you wish to edit, then

press Edit. b. Choose Edit, then press Select. c. Enter a new start time, then press Next. d. Enter a new end time, then press Save.

To delete a Bolus reminder

a. Choose the bolus reminder you wish to delete, then

press Edit. b. Choose Delete then press Select. c. Press Delete to remove the bolus reminder.

7. For Custom alerts

• Use the Up/Down Controller buttons to choose [add new], then press New.

• To use the OmniPod System’s default naming system, simply press Next. The default naming system automatically assigns alert names in numerical order, such as alert 1, alert 2, alert 3.

If you want to give a different name to the custom alert: a. Use the Up/Down Controller buttons to scroll

through the list of characters. An up-and-down-arrow symbol on the screen indicates the character you are changing.

b. Press the middle soft key to move the underscore to

the next character.

c. Enter each character one at a time. For example, for a

reminder to pick up a prescription, you might enter R, x (Figure 6-9 on next page). (A blank character or space is the first and last option in the scrolling menu.)

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Figure 6-9 Figure 6-10

d. Press Next.

• Enter the time of day for the alert, in 30-minute increments, then press Next.

• Choose Daily, One time only, or Off, then press Select.

Custom alerts will repeat every 15 minutes until acknowledged.

You can change or delete alerts and reminders at any time.

■ Change Blood Glucose Meter Settings

You can adjust blood glucose (BG) meter settings:

• BG lower and upper limit goals (for BG history)

• BG sound—On or Off

• Manage BG tags list

1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.

2. Choose System setup, then press Select.

3. Choose BG meter, then press Select.

4. Choose the setting you want to change (Figure 6-10), then press Select.

Change BG limit goal or BG sound

1. To change the BG limit goal, press Edit, change either or both values, then press Save.

2. To change BG sound, choose On or Off, then press Select.

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Manage the Blood Glucose Tags List

You can create up to 15 custom blood glucose tags and hide any of the standard tags you do not plan to use. Standard BG tags are shown first on the screen (Figure 6-11a), followed by custom tags, then [add new] (Figure 6-11b). For more information about tagging BG readings, see Chapter 7, Checking Your Blood Glucose.

Figure 6-11a Figure 6-11b

1. To hide or show a standard BG tag, choose the tag, and press Show (if it is marked as hidden) or Hide.

Tags you choose to show will be checkmarked; hidden ones will not be.

2. To add a custom tag, choose [add new] at the end of the list of custom tags, then press New.

In the Edit name screen, either: a. Press Save to save the new tag with the default name,

custom tag1, custom tag2, and so on; or

b. Use the Up/Down Controller key to choose letters and

numbers for a name, followed by the middle soft key to move forward one space. Then press Save.

3. To delete a custom tag, choose the tag, press Delete, then press Delete again. Or press Cancel to leave the tag unchanged.

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■ Customize the Personal Diabetes Manager

Additional options let you customize how the PDM operates: PDM lock: “Locks” the buttons on the PDM. The default setting is

Off. This safety feature can help avoid accidentally changing basal rates or giving boluses.

Screen time-out: The screen turns off after a time interval that you set, which occurs if you have not pressed any buttons on the PDM. This setting preserves battery power by turning off the screen when you are not using it. Choose an interval of 10, 20, or 30 seconds. Set it at the lowest setting (10 seconds) to maximize battery life. The default is 20 seconds.

Backlight time-out: The backlight is on by default while you are using the PDM. The time-out setting dims the backlight and causes the screen to dim when you have not used it within the time interval that you set. Choose an interval of 5, 10, or 20 seconds. Set at the lowest setting (5 seconds) to maximize battery life. The default is 10 seconds.

Set PDM options

1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press Select.

2. Choose System setup, then press Select.

3. Choose PDM options (Figure 6-12), then press Select.

Figure 6-12 Figure 6-13

4. Choose one of the PDM (Figure 6-13), then press Select.

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Set PDM lock

Choose On or Off, then press Select (Figure 6-14).

If you choose On, other PDM options and most other soft keys are locked and will not respond to button presses. To use them, you must first set PDM

lock to Off.

Figure 6-14

Set the Screen time-out

Choose a time interval of 10, 20, or 30 seconds, then press Select.

When the screen times out and goes black, turn it on again by pressing the Home/Power button.

Set the Backlight time-out

Choose a time interval of 5, 10, or 20 seconds, then press Select. When the screen dims, turn it on again by pressing any button.

The PDM will ignore the usual command and relight the screen.

The lowest setting, 5 seconds, will drain the battery the least.

■ 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). Options include:

Check alarms: Confirms that all alarms work properly when needed. When you select this function, the PDM beeps, then the Pod beeps.

If the PDM fails to beep, immediately call Customer Support at 800-591-3455 (from outside the United States, 781-457-5098). If a Pod is active and fails to beep, change the Pod immediately (see Chapter 5, Using the OmniPod). Continuing to use the System in these situations may put your health and safety at risk.

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Reset PDM (soft reset): Restores all settings in the PDM to the factory defaults.

Resetting the PDM deletes all basal programs, temp basal presets, carb presets, bolus presets, and all suggested bolus settings. Before you use this feature and delete these settings, be sure you have a written record of the information you need. History records will not be deleted.

As a safety feature, you cannot reset the PDM when a Pod is active. You must first deactivate the Pod.

Diagnostic options

1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press Select.

2. Choose System setup, then press Select.

3. Choose Diagnostics, then press Select.

To check alarm s

1. Choose Check alarms, then press Select.

2. Press OK. The PDM beeps three times and vibrates three times. If a Pod is active, it then beeps three times.

To reset the PDM

1. Choose Reset PDM, then press Select.

2. If the Pod is deactivated, the PDM asks for confirmation and reminds you that you will lose all user settings (Figure 6-15). Press Confirm to reset the PDM.

Figure 6-15 Figure 6-16

If the Pod is still active, you will be unable to reset the PDM (Figure 6-16). Press OK to return to the Diagnostics menu.

Check the alarm function at every Pod change.

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These forms are also available on Insulet’s Web site, MyOmniPod.com/support/resources.

■ Set a Vibration Alert

For certain reminders and alerts, you can choose vibration instead of beeps or vibration followed by beeps, instead of only beeps. If you set the vibration alert, the PDM will vibrate for:

• Blood Glucose reminders

• Missed Bolus reminders

•Custom Alerts

• “No active Pod” reminders

To change the type of alert

1. Use the Up/Down Controller button to choose Settings; then press Select.

2. Choose Vibration alert, then press Select.

3. Choose Vibrate, Vibrate then beep, or Off (beep only), then press Select. (Vibrate then beep means the PDM will repeat the reminder twice using vibration. After that, it uses beeps.)

Or press Back to return to the Settings menu.

■ Get the Most from Your PDM

Keep it handy

Wireless communication technology means you don’t have to keep the PDM right next to the Pod for the Pod to work. Once you set your basal program, the Pod continues to deliver your basal program 24 hours a day, regardless of the location of the PDM. However, you still need the PDM to deliver a bolus, change the basal rate, reference a food item, and so on. You can store the PDM conveniently inside an article of clothing (like a shirt pocket) or put it discreetly into a drawer, briefcase, or purse.

Communicating with the Pod

When you use the PDM to communicate with the OmniPod, hold the PDM within 24'' (61 cm) of the Pod. If you wear the Pod on your abdomen, holding the PDM in your hands when pressing the buttons should be close enough.

Water and your PDM

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

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Do NOT use IV Prep wipes, alcohol swabs, soap, detergent, or solvents to clean the screen or any other part of the PDM.

Avoid extreme temperatures

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

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

Never attempt to test your blood glucose while your PDM is connected via USB cable to a computer. Doing so could result in electrical shock.

Electrical interference

The PDM 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 11, Communication Fai lure s).

Only connect a USB cable to your PDM when downloading data to a computer. Other PDM functions are disabled while a USB cable is connected, and the PDM cannot communicate with the Pod.

When you connect a USB cable to the PDM, only use a cable that is less than or equal to 9 feet in length.

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CHAPTER 7

Checking Your Blood Glucose

■ The Built-in FreeStyle® Blood Glucose Meter

With the FreeStyle® blood glucose meter, you can check your

blood glucose on your finger, hand, forearm, upper arm, thigh, or calf (Figure 7-1).

Checking with the FreeStyle® blood glucose meter requires a very small sample size, just 1/3 or 0.3 microliter of blood— about the size of a pinhead.

Most healthcare providers rec- ommend checking on your hand, arm, or leg when blood glucose values are stable: before meals and before bedtime. However, when blood glucose is changing, it is best to test on your fingers. Blood from the fingertips may show these changes sooner than blood from other sites.

Figure 7-1

Illustration of test areas on the body

We recommend that you test on your fingers if you are testing for hypoglycemia (low blood glucose) or if you suffer from hypoglycemia unawareness.

You may also want to test for low blood glucose:

• When you feel symptoms such as weakness, sweating, nervousness, headache, or confusion

• When you have delayed a meal after taking insulin

• When your healthcare provider advises you to do so

Keep the OmniPod Insulin Management System and the FreeStyle® accessories away from young children, as they contain small parts that may be dangerous if swallowed.

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Please read all the instructions provided in this User Guide and practice the testing procedures before

using the OmniPod System and FreeStyle® accessories. Follow the guidance of a healthcare professional for proper blood glucose monitoring.

Never attempt to test your blood glucose while your PDM is connected via USB cable to a computer. Doing so could result in electrical shock.

■ The FreeStyle® Blood Glucose Test Strips

Important test strip information

• Store the blood glucose test strip package in a cool, dry place between 37° and 86° F (3° and 30° C).

• Use test strips only when the System is within its operating temperature range, between 40° and 104° F (5° and 40° C).

• Keep test strips away from direct sunlight and heat.

• Store test strips in their original vial only; never transfer them to another vial or any other container.

• Never store individual test strips outside the vial.

• After removing a blood glucose test strip from the vial, immediately replace the vial cap and close it tightly.

• With clean, dry hands, you can gently touch the test strip anywhere when removing it from the vial or inserting it into the test strip port.

• Do not bend, cut, or alter blood glucose tests strips in any way.

Do not use strips beyond the expiration date printed on the package, as this may cause inaccurate results.

For detailed storage and usage information, refer to the package insert in the box containing the test strip vial.

Keep the test strip vial away from children. The cap is a choking hazard. The cap or vial contains drying agents that may be harmful if inhaled or swallowed and may cause skin or eye irritation.

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■ The FreeStyle® Control Solution

The FreeStyle® control solution (Figure 7-2) is a red liquid that contains a fixed amount of glucose and has three important uses:

• To ensure that your meter and test strips are working together properly

• To check that you are following the correct testing procedure

• To practice testing without having to use your own blood

Figure 7-2

When to perform a control solution test

You should perform a control solution test:

• When you first get your OmniPod System, before doing a blood glucose test

• When you open and begin using a new vial of test strips

• When you suspect that your meter or test strips are not working properly

• When you think your test results are not accurate, or if your test results are not consistent with how you feel

• When you drop or damage your PDM or expose it to liquids

• When your healthcare provider advises you to do so

Check that the meter and test strips are working

A control solution test follows the same procedure as a blood glucose test, except that you use a sample of control solution instead of a drop of blood. (See “Performing a Blood Glucose Test” later in this chapter.)

When you perform a control solution test, if the reading is within the control solution acceptable range, the meter is working properly.

Control solution expiration date

FreeStyle® control solution is good for 3 months after opening the bottle, or until the expiration date printed on the label, whichever comes first. Count forward 3 months from the date you open a new bottle of control solution. This is your discard date. Write this date on the side of the control solution bottle. For example, if you open the control solution on January 15, count forward 3 months to April 15. This is the discard date to record on the bottle, and the date to discard it and begin using a new bottle.

Ensure accurate control solution results

• Replace the cap on the control solution bottle immediately after using it.

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Use only FreeStyle® control solution with the OmniPod System. Other brands of control solution may produce inaccurate results with this System.

Do not use control solution past the expiration date or you may get inaccurate results.

• Do not add water or any liquid to control solution.

• Control solution tests are specified to be accurate only when performed between 59° and 104° F (15° and 40° C).

Results from FreeStyle® control solution tests do not reflect your blood glucose level.

• The control solution test results should fall within the range printed on the test strip vial label.

The control solution range is a target range for control solution only. It is not a target range for your blood glucose.

If control solution results are out of this range, REPEAT THE TEST.

Out-of-range control solution results

Out-of-range test results may be caused by:

• Expired or bad control solution

• Expired or bad test strip

• Error in performing test

• Watered-down control solution

• Code on test strip vial does not match code set in the PDM

• Malfunction of the OmniPod System

• Control solution test done outside 59º to 104ºF (15º to 40ºC) If your control solution test results continue to fall outside the

range printed on the test strip vial:

1. The OmniPod System may not be working properly.

2. Do not use the System to test your blood glucose.

3. Call Customer Support, 800-591-3455, 24 hours/7 days (from outside the United States, 781-457-5098).

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■ Performing a Control Solution Test

1. Grasp the bottom of the test strip with the name “FreeStyle®” facing up (Figure 7-3).

Figure 7-3

Top, to insert into meter

FreeStyle® test strip

Bottom edges, for blood sample

2. Insert the top of the test strip into the test strip port (Figure 7-4) until it stops. This turns on the PDM and displays the code number on the screen.

Be ready to adjust the code on the PDM to match the code number on the test strip vial (Figure 7-5).

If you need to adjust the code number after the PDM has moved to the next screen, just press the Up/Down Controller buttons. The code screen reappears and you can adjust the number.

The code number remains on the PDM screen for your reference until you have completed the control test.

Figure 7-4 Figure 7-5

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From some PDM screens, you cannot access the Freestyle® blood glucose meter. For example, you cannot use the meter while you are activating a Pod or when an alert, alarm, or communication error screen is displayed. In these cases, if you insert a test strip, the PDM beeps to alert you.

3. To help you see the test strip port in reduced lighting, when you insert a test strip into the PDM, you can turn on the port light. Press the middle soft key labeled Light. To turn the light off, press Light again.

The code number on the screen should match the code number on the side of your test strip vial (Figure 7-5 on previous page). They must always match, or your results will be inaccurate. (See “Set the blood glucose test strip code” later in this chapter.)

4. Wait for the PDM to display “Apply a blood sample to the strip” on the screen (Figure 7-6).

Figure 7-6

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5. Gently touch only ONE EDGE of the test strip to the control solution. Specifically, apply the control solution to the test strip edge next to one of the dark-colored half-circles (Figure 7-7). If BG sound is set to On, the PDM beeps when the test strip is full.

Figure 7-7 Figure 7-8

If you do not apply the sample within 10 seconds, the stripport light turns off. To turn it on again, press Light.

The “Checking” screen appears while the sample is processing (Figure 7-8). The strip-port light turns off when the sample is accepted.

Do not apply control solution to both edges.

If BG sound is set to On, the PDM beeps twice. The result appears on the screen in about 7 seconds, on average.

6. To mark the result as a control solution result rather than a blood glucose test:

a. Press Ta g. b. Use the Up/Down Controller buttons to select Control

(Figure 7-9 on the next page), then press Select. You can select a second tag for the test result in the same way.

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Figure 7-9

You can select a maximum of 2 tags.

c. Press Done.

7. If you do not want to mark the test as a control solution test, press Next instead of Ta g.

If the suggested bolus calculator feature is turned Off, the Bolus soft key appears instead of Next.

If you mark a test as a control solution test by mistake, you can unmark it: Press Tag, select Control, then press Clear.

8. Compare the control solution test result to the range printed on the test strip vial label. If the result does not fall within the range, repeat the test. If the result still does not fall within the range, call Customer Support, 800-591-3455, 24 hours/ 7 days (from outside the United States, 781-457-5098).

9. Remove the test strip. If the strip-port light was turned on, it now turns off.

If you remove the test strip before this step, you will still see the available soft keys.

Be sure to discard used test strips. (You can only use test strips once.)

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Checking Your Blood Glucose

■ Performing a Blood Glucose Test

Figure 7-10 shows the parts of the FreeStyle® lancing device.

To ensure accurate results, wash your hands and the test site (for example, your forearm) with soap and water. Do not leave any cream or lotion on the test site. Thoroughly dry your hands and the test site.

Figure 7-10

Cocking handle

Depth settings dial

Depth indicator window

Release button

Clear cap, for testing sites other than the finger

Gray cap, for finger testing

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Checking Your Blood Glucose

Prepare the lancing device

1. Snap off the cap on the lancing device at an angle (Figure 7-11).

Figure 7-11 Figure 7-12

2. Insert a new FreeStyle® lancet firmly into the white lancet holder cup (Figure 7-12). Pushing the device into the cup may cock the device, which is fine.

3. Hold the lancet firmly in place with one hand. With your other hand, twist off the rounded top (Figure 7-13).

4. Replace the cap until it snaps or clicks into place (Figure 7-14). Be careful not to touch the exposed needle on the lancet.

Figure 7-13 Figure 7-14

Use the clear cap to lance at the following test sites: forearm, upper arm, hand, thigh, and calf. Use the gray cap for finger tests only.

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Checking Your Blood Glucose

5. The lancing device offers four different depth settings. Level 1 is the shallowest depth; level 4 is the deepest. Move the dial to the desired setting as shown in the depth indicator window (Figure 7-15). We recommend that you start at level 2 for most sites except the finger.

Figure 7-15 Figure 7-16

To lance your finger, we recommend that you start at level 1, the shallowest. Be sure to use the gray cap.

6. Pull out the dark gray cocking handle until it clicks (Figure 7-

16). (You may have already cocked the handle in step 2. This is okay.)

You are now ready to perform a blood glucose test.

Insert the blood glucose test strip

1. Insert a new blood glucose test strip into the test strip port until it stops. The test strip port is at the bottom of the PDM.

2. To help you see the test strip port in reduced lighting, press the middle soft key labeled Light. To turn the light off, press Light again.