Insulet 019 UST500 PDM User Manual

Insulet Corporation UST500 PDM

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Users manual

Contacts and Important Information

Name

Address

Telephone and Fax

Email Address

Name

Address

Telephone and Fax

Email Address

Name

Address

Telephone Number(s)

Policy Number

Name

Address

Telephone and Fax

Email Address

mylife OmniPod System Start Date: ______________________

PDM Model: ENT500 Serial Number: _____________________

Distributor:

Customer Care:

Doctor

Nurse/Educator

Health Insurance

Pharmacy

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

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

mylife OmniPod is a registered trademark of Insulet Corporation.

U.S. Patent No. 6,740,059.

OneTouch® Verio™ is a registered trademark of Johnson & Johnson.

Third-party trademarks used herein are the trademarks of their respective owners.

15858-AW Rev A

iii

Contents

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

About This User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

Conventions and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

Important Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

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

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

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

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

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

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

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

Suggested bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Carb presets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

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

A fully integrated design with blood glucose monitoring . . . . 3

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

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

The Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

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

Buttons that program and control the mylife OmniPod

System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

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

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

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

Occlusion detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Table 1:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

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

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

Set Up the Personal Diabetes Manager (PDM). . . . . . . . . . . . . . . . . . . 9

Turn on the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

The mylife OmniPod Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Enter your PDM ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Select the ID screen color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

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

Enter basal settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Enter blood glucose sound setting and BG goal. . . . . . . . . . . . . 11

Enter minimum BG allowed for use in bolus calculation. . . . . 12

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

Enter correction factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Set reverse correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Set low reservoir advisory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Set Pod expiration notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Contents

3 Understanding and Adjusting Basal Rates . . . . . . . . . . . . . . . . 16

What Is a Basal Rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Personalized Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Create a basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

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

Temporary Basal Rates and Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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

Enable a one-time temporary basal rate. . . . . . . . . . . . . . . . . . . . . 23

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

Create a temporary basal preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Enable an existing temporary basal preset . . . . . . . . . . . . . . . . . . 25

Cancel an active temporary basal preset . . . . . . . . . . . . . . . . . . . . 26

Change, rename, or delete a temporary basal preset . . . . . . . . 26

Maximum Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

What is the maximum basal rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Change the maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

4 Understanding and Delivering Bolus Doses. . . . . . . . . . . . . . . 28

What Is a Bolus? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Bolus Dose Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Suggested Bolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

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). . . . . . . 33

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

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

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

Replace an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Bolus Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Enable an existing bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

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

Cancel an active bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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

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

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

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

5 Using the Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

The Pod Change Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Gather equipment and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Fill a new Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Select the infusion site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Prepare the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Apply the new Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

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

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

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

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

Avoid Infusion Site Infections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

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

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

Water and your Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Safe storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

6 Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . 60

The ID Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Contents

The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

The System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Reset the time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Reset the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Change Bolus and Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Bolus calcs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Ratios/factors/targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Temp basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Bolus increment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Alerts and Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Set alerts and reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Change Blood Glucose Meter Settings . . . . . . . . . . . . . . . . . . . . . . . . . 71

Change BG goal limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Manage the blood glucose tags list . . . . . . . . . . . . . . . . . . . . . . . . . 72

Change BG sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Customize the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . 73

Set PDM options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Set ID screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Set PDM lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Set the Screen time-out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Set Diagnostic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Diagnostic options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Set a Reminder to Vibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Get the Most from Your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Keep it handy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Communicating with the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Water and your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Electrical interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

7 Checking Your Blood Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

The Built-in OneTouch® Verio™ Blood Glucose Meter . . . . . . . . . . . 79

The OneTouch® Verio™ Blood Glucose Test Strips. . . . . . . . . . . . . . . 80

Important test strip information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

The OneTouch® Verio™ Control Solution. . . . . . . . . . . . . . . . . . . . . . . . 81

When to perform a control solution test. . . . . . . . . . . . . . . . . . . . . 81

Check that the meter and test strips are working. . . . . . . . . . . . 81

Control solution expiration date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Ensure accurate control solution results . . . . . . . . . . . . . . . . . . . . . 82

Performing a Control Solution Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Performing a Blood Glucose Reading . . . . . . . . . . . . . . . . . . . . . . . . . . 85

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

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

Fill the blood glucose test strip with blood . . . . . . . . . . . . . . . . . . 88

Remove the lancet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Blood Glucose Results and the Suggested Bolus

Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Entering Blood Glucose Readings Manually. . . . . . . . . . . . . . . . . . . . 92

Editing Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Low and High Blood Glucose Readings . . . . . . . . . . . . . . . . . . . . . . . . 94

Low readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Contents

High readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Important Health-Related Information . . . . . . . . . . . . . . . . . . . . . . . . . 95

8 Understanding Your Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Insulin Delivery Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

View insulin delivery records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Blood Glucose Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

View single-day trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

View multiple-day trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Alarm Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Carbohydrate Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

All Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

User Information/Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

9 Living with Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Your Role: Safely Using the mylife OmniPod System . . . . . . . . . . . 104

Daily Diabetes Management Activities . . . . . . . . . . . . . . . . . . . . . . . . 105

Check your blood glucose frequently. . . . . . . . . . . . . . . . . . . . . . . 105

Inspect the infusion site daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Prepare for Emergencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Water and Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Traveling and Vacationing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Plan for changing time zones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Take enough supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Keep supplies accessible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Avoid lows, highs, and DKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

General precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Hypoglycemia (Low Blood Glucose) . . . . . . . . . . . . . . . . . . . . . . . . 109

Symptoms of hypoglycemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

To avoid hypoglycemia (low blood glucose) . . . . . . . . . . . . . . . . 110

To treat hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . . 111

How much is 15 grams of carbohydrate? . . . . . . . . . . . . . . . . . . . 112

Hyperglycemia (high blood glucose) . . . . . . . . . . . . . . . . . . . . . . . 114

Diabetic ketoacidosis (DKA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Handling Special Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Sick days. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Exercising, playing sports, or working hard . . . . . . . . . . . . . . . . . 120

X-rays, MRIs, and CT scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Surgery or hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

10 Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Blood Glucose Meter Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

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

Hazard Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Manual Shut-off of a Hazard Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

11 Communication Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

The Communication Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Failure During Pod Activation or Operation . . . . . . . . . . . . . . . . . . . 136

Failure During Pod Deactivation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Failure During Request for Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Failure During Bolus Cancellation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142

Pod Care and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

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

Contents

vii

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Personal Diabetes Manager Care and Maintenance . . . . . . . . . . . 142

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

Cleaning and disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Replacing batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

If the PDM becomes submerged in water. . . . . . . . . . . . . . 145

If you drop the PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Storage and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Suggested Bolus Calculator Examples and Guidelines . . . . . . . . 147

Meal bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Insulin-on-board (IOB) calculation. . . . . . . . . . . . . . . . . . . . . . . . . . 147

Examples of suggested bolus calculations . . . . . . . . . . . . . . . . . 148

Calculator guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

mylife OmniPod System Options and Settings . . . . . . . . . . . . . . . . 151

Pod Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Accuracy Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

Flow rate error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

Personal Diabetes Manager Specifications . . . . . . . . . . . . . . . . . . . . 154

Blood Glucose Meter Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

mylife OmniPod System Label Symbols . . . . . . . . . . . . . . . . . . . . . . . 155

Personal Diabetes Manager Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Medical Device Directive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

mylife OmniPod System Notice Concerning Interference . . . . . 157

Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

viii

n About This User Guide

Symbols

Symbol Term Meaning

Warning Describes potential serious adverse

reactions, or indicates conditions that

could cause death or serious injury.

Caution Caution: Consult accompany in docu-

ments. Indicates conditions that could

cause minor or moderate injury to

you or damage to the device.

Note Provides helpful information.

Tip Offers a suggestion for successful use

of the mylife OmniPod® Insulin Man-

agement System.

This User Guide is intended for use only with PDM

model ENT500. To learn which version of the PDM

you have, turn it over. On the back of the PDM, look

for “ENT500.” If you see it, this is the correct User

Guide. If you do not see “ENT500” on the back of the

PDM, please call Customer Care.

This User Guide is periodically updated. Visit the Cus-

tomer Care section of mylife-omniPod.com to see

the most recent version and to find other helpful

information.

Screen displays shown in this User Guide are for illustra-

tive purposes only and should not be considered

suggestions for user settings. Consult with your health-

care provider to determine the appropriate settings for

you.

Introduction

Conventions and Terms

Important Information

Indication

The mylife 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 glu-

cose in fresh whole capillary blood (in vitro).

Convention/Term Meaning

Bold Names of buttons, soft keys, menus, and

screens are in bold.

Italics Words in italics are defined in the

Glossary at the end of this User Guide.

Press Press and release a button or soft key.

Hold Keep pressing a button until its function is

complete.

Menu A list of options on the PDM. Options allow

you to perform tasks.

Screen Displays programming, operating, and

alarm/alert information.

Button A physical button on the PDM, such as the

Home/Power button.

Convention/Term Meaning

Icon An image on the PDM screen that indi-

cates a menu option or item of informa-

tion. A table of screen icons appears in the

Appendices.

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.

This device is for prescription use only.

Introduction

OneTouch® Verio™ test strips are used with the built-in One-

Touch® Verio™ meter for the quantitative measurement of blood

glucose in fresh whole capillary blood from the finger, upper arm

and palm. OneTouch® Verio™ Control Solutions are used to verify

that the meter and test strips are working together properly and

that the test is performed correctly.

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 OneTouch® Verio™ Blood Glucose

Monitoring System for:

• Testing on newborns

• Testing arterial blood

• Diagnosing of or screening for diabetes mellitus

The mylife OmniPod System is designed to use

rapid-acting U-100 insulin. The following U-100

rapid-acting insulin analogs have been tested and

found to be safe for use in the Pod: NovoRapid®,

Humalog®, or Apidra®. NovoRapid® is compatible

with the mylife OmniPod System for use up to 72

hours (3 days). Before using different insulins with

the mylife OmniPod System, check the insulin drug

label to make sure it can be used with a pump. Refer

to the insulin labeling and follow your healthcare

provider’s directions for how often to replace the Pod.

Not recommended for individuals with hearing

loss. Always verify ability to hear Pod/PDM alerts

and alarms.

The Pod and PDM may be affected by strong radi-

ation or magnetic fields. Before having an X-ray, MRI,

or CT scan (or any similar test or procedure), remove

your Pod and put it and the PDM outside the treat-

ment area. Check with your healthcare provider for

Pod removal guidelines.

Introduction

n Your Role: Safely Using the mylife OmniPod

System

Work with your healthcare provider to establish diabetes man-

agement guidelines and settings that best fit your needs. These

may include:

Insulin-to-Carbohydrate (IC) Ratio: Number of grams of carbo-

hydrate 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 Factor: How much one unit of insulin will lower

blood glucose. For example, if your correction 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 glu-

cose close to 100 mg/dL.

Duration of Insulin Action: The length of time that insulin

remains active and available in your body after a correction or

meal bolus.

The glucose meter and lancing device are for single-

patient use. Do not share the device with anyone

including other family members. Do not use on mul-

tiple patients.

Parts of the device are considered biohazardous and

can potentially transmit infectious diseases, even

after you have performed cleaning and disinfection.

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.

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 pro-

vider. Undetected hyperglycemia or hypoglycemia

can result without proper monitoring.

This device is intended for self-testing by the user.

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.

Introduction

xii

Your individual needs influence the initial settings you and your

healthcare provider will enter into the Personal Diabetes Man-

ager (PDM) during setup (see Chapter 2, Getting Started).

Your healthcare provider must help you enter these initial set-

tings. Soon you will enter and change your own settings with

confidence and ease. The mylife OmniPod System is more user-

friendly than most electronic devices you use every day. In fact,

technology is what makes the mylife 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 mylife

OmniPod System, especially during the first few weeks and

months. When you have questions about diabetes management

after starting on the mylife OmniPod System, do not hesitate to

talk with your healthcare provider. For nonmedical emergencies

or for technical questions about your mylife OmniPod System

setup or operation, you can call Customer Care 24 hours a day, 7

days a week.

Customer Care:

Your healthcare provider will give you all the tools and training

you need to be successful with the mylife OmniPod Insulin Man-

agement 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 mylife OmniPod System.

Being actively involved means:

• Frequently monitoring blood glucose levels

• Learning how to operate your mylife OmniPod System and

practicing proper techniques

• Visiting your healthcare provider

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

Do NOT attempt to use the mylife OmniPod® Insulin

Management System before you receive training

from your healthcare provider. Inadequate training

could put your health and safety at risk.

CHAPTER 1

Your New mylife OmniPod Insulin Management System

n Insulin Delivery with the mylife OmniPod

System

The mylife OmniPod® Insulin Management System is an innova-

tive continuous insulin delivery system that provides all the

proven benefits of continuous subcutaneous insulin infusion (CSII)

therapy. The System’s innovative design and features allows you

to live your life—and manage your diabetes—with unprece-

dented 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 diabetes-

related complications. The mylife OmniPod System also has

many practical, everyday benefits, including convenience, free-

dom, 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 long-

term health benefits of maintaining near-normal blood

glucose levels have been widely recognized.

Continuous insulin delivery at preset rates eliminates the need

for injections and the interruptions that come with them. In addi-

tion, with the mylife OmniPod System, insulin delivery can be

changed with the press of a button to adapt to snacks or unex-

pected changes in daily routine.

The mylife 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 carbohydrates in a meal or

snack or to correct a high blood glucose.

Your New mylife OmniPod Insulin Management System

n How Does the mylife OmniPod System Work?

The Pod is a small, lightweight, self-adhesive device that you fill

with insulin and wear directly on your body. The Pod 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 Pod.

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

device that:

• Programs the Pod with your personalized insulin-delivery

instructions

• Wirelessly monitors the Pod’s operation

• Includes a OneTouch® Verio™ 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 Pod to the PDM. You wear the

Pod comfortably and discreetly under your clothes. You can carry

the PDM separately in a backpack, briefcase, or purse. With the

mylife OmniPod Insulin Management System, you don’t have to

worry about snagging, tangling, or feeling tethered by tubing.

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.

Carb presets

To make carbohydrate counting easier, the mylife OmniPod Sys-

tem includes “carb presets.” You can enter your 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.

Automated cannula insertion

With the mylife OmniPod System, you don’t have to insert the

infusion set manually or carry around a separate inserter. You sim-

ply press a button on the PDM and the Pod’s automated

insertion system safely and consistently inserts the cannula

beneath the skin, virtually pain free. It then begins delivering

insulin according to your programmed basal rate.

Your New mylife OmniPod Insulin Management System

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 Pod. With the PDM, you can check your blood glucose

level using OneTouch® Verio™ blood glucose test strips, but with-

out 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.

Record keeping

Another convenient part of the mylife 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 mylife 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 name and

number, and other emergency information

Your New mylife OmniPod Insulin Management System

n The Pod

The Pod (Figure 1-1) is applied to your skin with an adhesive

backing, similar to an adhesive bandage.

n The Personal Diabetes Manager

All Pod operations are programmed and controlled through the

palm-sized Personal Diabetes Manager (PDM; Figure 1-2).

Top

Bottom

Needle Cap

Viewing Window

Fill Port

Figure 1-1

Adhesive

Backing

Housing Vent

Figure 1-2

Up/Down

Controller

User Info/

Support

Soft Key

Label

Soft Keys

Home/

Power

USB Port

Test Strip Port

LCD Screen

Your New mylife OmniPod Insulin Management System

Buttons that program and control the mylife OmniPod

System

Button Action

Home/

Power Pressing and holding turns the PDM on and off.

When the PDM is on, pressing this button

(quickly/briefly) displays the Home screen, from

which you can choose a menu item or view the

Status screens (shown later in this chapter).

Up/Down

Controller Pressing and releasing scrolls through a list of

available menu options or numbers, so you can

pick the one you want. Holding the button

scrolls faster.

Soft Keys Soft key labels and functions depend on the

menu or screen you are viewing. The label

appears on the screen directly above the physi-

cal 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 cur-

rent screen you are viewing. The User Info/Sup-

port 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 Appendix).

In addition, pressing and holding this button for

2 seconds enables a “bright mode” on the PDM

screen.

Your New mylife OmniPod Insulin Management System

Primary screens

Messages on the screen either:

• Let you identify your PDM

• Tell you how the System is operating

• List menu choices

• Explain how to perform certain tasks

The System’s primary screens are the ID screen (Figure 1-3), the

Status screen (Figure 1-4), and the Home screen (Figure 1-6 on

the next page).

ID screen

The System displays an ID screen to make the PDM easy to iden-

tify when you first turn it on. You can personalize the ID screen by

adding your name and choosing its color. (See “The mylife Omni-

Pod Setup Wizard” on page 10, for details on customizing your

PDM.) You must acknowledge the ID screen before you can use

the PDM. It is important that you always identify the PDM as

yours before you use it.

Status screen

Lists the System’s current operating status (Figure 1-4).

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 (IOB) will be displayed on Status

screen (if calculator 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 of when the Pod will expire

Figure 1-3 Figure 1-4

Your New mylife 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). See page 30 for additional information

describing insulin on board (IOB).

Home screen

Lists all the major menus (Figure 1-6).

•Bolus menu to deliver bolus doses

•More actions menu to change the Pod, manually enter

blood glucose readings, and assign and edit tags for BG

readings that are less than 2 hours old

•Temp basal 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 informa-

tion

•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

If a Pod has not yet been activated (during Pod changes),

the screen displays “No active Pod. Would you like to acti-

vate a Pod now?” (See Chapter 5, Using the Pod, for details

on activating a Pod.)

Figure 1-5 Figure 1-6

You can go to the Status screen at any time by

pressing Status from the Home screen.

Your New mylife OmniPod Insulin Management System

n Safety Features

The mylife 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 you activate a new Pod, the System automatically

primes and performs a safety check on the Pod, then inserts

and primes the cannula (see Chapter 5, Using the Pod). Micro-

processor technology makes it possible to complete thousands

of safety checks in only a few seconds.

The mylife OmniPod System also performs safety checks on the

PDM. If it detects any problems in the PDM or the Pod—or in

communication between them—it informs you with beeps and

on-screen messages.

Occlusion detection

An occlusion is a blockage or interruption in insulin delivery. If

the mylife OmniPod System detects an occlusion, it sounds a

hazard alarm and prompts you to deactivate and change your

Pod (see Chapter 5, Using the Pod).

A hazard alarm sounds when an average of 3 to 5 units of missed

insulin occurs. This table depicts occlusion detection for 3 differ-

ent situations when using U100 insulin (Table 1). If an occlusion is

cleared, a volume of insulin could be released. That volume

would not exceed 3.9 U.

If an occlusion is detected during an immediate bolus, the Pod

will alarm at the conclusion of the bolus.

Table 1:

Alerts and alarms

For your safety, the mylife 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 notifications and how to set them. See Chapter 10,

Alerts and Alarms, for a list of safety alarms built into the mylife

OmniPod System and how to respond to them.

At very low flow rates checking your blood glucose

frequently may give you an early indication of an

occlusion (refer to Chapter 9, page 107).

Confirm on ID screen - alerts/alarms do not show on

PDM until after ID screen is confirmed.

5.00 U Bolus

1.00 U/hr basal

0.05 U/hr basal

200 seconds

2.4 hr

48 hr

Minimum

time

202 seconds

3.7 hr

74 hr

Typical

time

300 seconds

5.0 hr

80 hr

Maximum

time

(Pod expiration)

CHAPTER 2

Getting Started

n Set Up the Personal Diabetes Manager (PDM)

If you are a first-time mylife 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 mylife OmniPod System, review this User Guide. If you have

a basic understanding of the System in advance, you will get

more out of your training sessions.

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.

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

ment.

Do NOT use the mylife OmniPod

Insulin Management

System until you have been trained by your health-

care 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.

Figure 2-1 Figure 2-2

Getting Started

3. Replace the battery door.

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

matically.

n The mylife 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 pro-

vider 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.

• 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.

To get started, press Next on the Wizard's Welcome Screen to

begin setting up your PDM.

Enter your PDM ID

1. 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 that can be changed.

2. Press the middle Soft Key (labeled with the right arrow) to

move the underscore to the next character.

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

to enter your name, you might enter J, a, n, e, [space], S, m, i, t,

h. (A blank character or space is the first and last option in the

scrolling menu.)

4. Press Next.

Select the ID screen color

1. Use the Up/Down Controller buttons to choose a color, then

press Next.

The diagram inside the compartment shows you which

direction to insert the batteries (Figure 2-2 on the previous

page).

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.

Initial settings are “---” [blank] for target blood glucose

value, insulin-to-carbohydrate ratio, correction factor,

and duration of insulin action.

Getting Started

Set date and time

1. Use the Up/Down Controller buttons to increase or

decrease the time. (Press 12/24hr if you prefer a different

time format.) Then press Next.

2. Enter the current year, then press Next.

3. Choose the current month, then press Next.

4. Enter the current day of the month, then press Next.

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

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 tem-

porary 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.

Your ID and the chosen color will be displayed on an

identification (ID) screen that you must acknowledge

every time you turn on the PDM. Always be sure you

properly identify your PDM before using it.

You can add up to 7 basal programs and set 24

segments per program.

The lower and upper BG limits are only used when

viewing BG History (see Chapter 8, Understanding

Your Records).

Getting Started

4. Press Save to accept the BG goal.

Set the suggested bolus calculator

1. To set the suggested bolus calculator feature, choose On or

Off, then press Next.

Enter target blood glucose value

1. Use the Up/Down Controller button 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.

3. To save the target BG value, press Done. To change these set-

tings, select the segment you wish to change and press Edit.

You can define up to 8 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.

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.

e. 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 calcu-

late a suggested bolus. The values are in 0.1 mmol/L incre-

ments and range from 2.8 to 3.9 mmol/L.

2. Press Next.

Check with your healthcare provider before adjust-

ing these settings.

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.”

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.

Getting Started

Enter insulin-to-carbohydrate ratio

1. Use the Up/Down Controller buttons to enter your insulin-

to-carbohydrate ratio, then press Next. (Insulin-to-carbohy-

drate ratio is the number of carbs in grams covered by 1 unit

of insulin.)

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 8 insulin-to-carbohydrate time seg-

ments. 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 8 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 corrections Off,

the System will not subtract insulin from the sug-

gested meal bolus dose due to a low BG. Follow your

healthcare provider’s recommendation to set

reverse correction On or Off.

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.

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 unit of insu-

lin—then press Next.

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

press Next.

Set extended bolus doses

1. To set the units for an extended bolus dose, choose % for per-

cent 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 advisory

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 Pod expiration notification

1. Choose the number of hours before a Pod expires when the

PDM should give you a notification, then press Next. The

values are in 1-hour increments and range from 1 to 24 hours.

(The default is 4 hours.)

The PDM asks whether you want to activate a Pod.

• Press Yes if you are ready to activate a new Pod. See Chapter

5, Using the Pod, 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.

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.

The maximum bolus default is 10 units. Check with

your healthcare provider before adjusting these set-

tings.

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.

Getting Started

Your healthcare provider will help you fill and apply your first

Pod. The process is easy because on-screen messages walk you

through every step. Please refer to Chapter 5, Using the Pod, for

detailed instructions.

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. If you

ever need to reset or replace your PDM, having

these settings handy will make setup very easy.

CHAPTER 3

Understanding and Adjusting Basal Rates

n 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 mylife OmniPod® Insulin Management System, the

Pod mimics a healthy pancreas by delivering insulin at the rate

that you’ve programmed into the Personal Diabetes Manager

(PDM).

n 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:

Approximately 50% of a person’s total daily insulin dose

typically comes from basal insulin delivery; the remain-

ing 50% typically comes from bolus doses (see Chapter 4,

Understanding and Delivering Bolus Doses).

00:00–08:00 0.60 U/hr Between 00:00 (midnight) and

08:00, the Pod delivers 0.60

units of insulin per hour.

08:00–15:00 0.80 U/hr Between 08:00 and 15:00, the

Pod delivers 0.80 units of insulin

per hour.

15:00–24:00 0.70 U/hr Between 15:00 and 24:00

(midnight), the Pod delivers

0.70 units of insulin per hour.

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 Pod continues to deliver insulin at those rates until

you change that program or switch to another one.

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.

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 that can be changed.

Check with your healthcare provider before adjust-

ing these settings.

Figure 3-1 Figure 3-2

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 sched-

ule, 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 scroll-

ing menu.)

d. Press Next.

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 08:00 and 15:00):

a. Choose an existing basal segment, then press Edit.

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

b. Enter the start time (for example, 08:00), then press Next.

Basal segments are in 30-minute increments.

c. Enter the end time (for example, 15:00), then press Next.

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

0.80 U/hr), then press Next.

Figure 3-3 Figure 3-4

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.

Basal rates outside the changed segment do not

change.

Understanding and Adjusting Basal Rates

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

want, then press Done.

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

programs) you want to create.

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.

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.

Figure 3-5 Figure 3-6

Understanding and Adjusting Basal Rates

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

press Enable.

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.

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.

A diamond icon (u) appears next to the program that

is active. You cannot select the active program to

enable it, because it is already running.

Figure 3-7

As a safety feature, you cannot enable a new basal

program while a temporary basal program is in pro-

cess (see “Temporary Basal Rates and Presets” later in

this chapter); you must first cancel the active tempo-

rary basal program.

Understanding and Adjusting Basal Rates

To view the segments of the basal program

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

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

1. Choose Edit, then press Select.

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.

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

press Graph.

As a safety feature, you must suspend insulin delivery

before editing an active basal program (see Chapter

5, Using the Pod). Remember to resume delivery after

the edits are made.

Figure 3-8 Figure 3-9

Figure 3-10

Understanding and Adjusting Basal Rates

To rename a basal program

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 under-

score to the next character, then press Save.

To copy a basal program

1. After choosing a program from the list, press Copy to accept

this change, 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, fol-

low the steps under “To edit or add a segment or rate in the basal

program” earlier in this chapter.

To delete a basal program

After choosing a program from the list, press Delete to accept

this change and then press Select.

4. Press Delete to permanently delete the program.

n Temporary Basal Rates and Presets

What is a temporary basal rate?

A temporary basal rate lets you adjust your basal rate for a pre-

determined 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 tempo-

rary basal rate.”

Some temporary changes are easy to predict and plan for. 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 join a

summer soccer league. For women, a monthly hormonal change

that affects blood glucose is an example of predictable

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.

As a safety feature, you cannot delete the active basal

program.

Understanding and Adjusting Basal Rates

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 System automati-

cally returns to the active basal program.

When using units per hour, the mylife 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 “Off” to +95% of your active rate, as long as the tem-

porary rate is less than or equal to your max basal rate. Another

limit on the temp basal rate when configured in % is that the rate

cannot be decreased such that the resultant flow rate will be less

than 0.05 U/hr. Example – if flow rate is 0.10 U/hr, you can’t create

a temp basal of -60%.

See the sections below on creating, enabling, cancelling, 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 basal, 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 choose to show the rates, then press Enter.

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.

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.

Figure 3-11 Figure 3-12

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.

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 mylife 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 which character can be changed.

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 on the next page). (A blank

character or space is the first and last option in the scroll-

ing menu.)

Figure 3-13

Capitals and lowercase letters are considered the

same.

Understanding and Adjusting Basal Rates

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.

3. If you want, change the duration for the temporary rate, in

half-hour increments, then press Enter (Figure 3-16).

4. Press Confirm to begin the temporary basal rate shown on

the screen. The Pod beeps to indicate that the chosen tempo-

rary basal preset is running.

Figure 3-14

Figure 3-15 Figure 3-16

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.

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.

To change a temporary basal preset

1. Choose Edit, then press Select (Figure 3-17).

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.

If you suspend insulin delivery while a temp basal is

running, the temp basal will be cancelled when you

suspend.

You cannot edit, change, or delete a temporary basal

preset that is actively running.

Figure 3-17

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 charac-

ters 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.

n 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 Pod can deliver. Once you enter it into the

PDM memory, the maximum applies to both regular basal pro-

grams 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.

CHAPTER 4

Understanding and Delivering Bolus Doses

n 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 through-

out the day and night (see Chapter 3, Understanding and

Adjusting Basal Rates).

The size of a bolus dose depends on the current factors at the

time you deliver the bolus:

• Your blood glucose level

• Your insulin-to-carbohydrate ratio

• Your correction factor

• Your target blood glucose and correct above threshold

• The amount of insulin on board (IOB) (active insulin) from pre-

vious 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 mylife OmniPod System, it is easy to adapt to any situa-

tion. 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 adjust-

ing these settings.

Understanding and Delivering Bolus Doses

n Bolus Dose Options

So that you can fully enjoy freedom and flexibility in your life, the

mylife 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 carbohy-

drate (“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).

n Suggested Bolus Calculator

The suggested bolus calculator lets the mylife OmniPod System

recommend your bolus based on your personal settings. To

review or adjust these settings—including turning the sug-

gested 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.

When using the extended bolus function the user

should check their blood glucose levels more fre-

quently to avoid hypoglycemia or hyperglycemia.

The bolus features in the mylife 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.

The suggested bolus calculator will display a sug-

gested bolus dose based on the settings you have

programmed into the PDM. Check with your health-

care provider before using this feature or adjusting

these settings.

If a suggested bolus exceeds the max bolus you

have set, the suggested bolus screen displays

“Exceeds max bolus.” (Figure 4-1 on next page.) If you

select Extend or Enter, the following confirmation is

displayed “WARNING: Exceeds max bolus of nn.nn U.

Accept this bolus and temporarily override your

limit?” (Figure 4-2 on next page). Consult your

healthcare provider before changing the setting.

Understanding and Delivering Bolus Doses

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.

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 carbohy-

drates you enter into the System.

Insulin on board (IOB): Insulin on Board (IOB) the amount of

insulin still working in your body from previous meal and correc-

tion boluses. The amount of time the 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 calcula-

tion, detailed examples, and additional guidelines of how the

suggested bolus calculator works, see the Appendix.

Figure 4-1 Figure 4-2

The mylife OmniPod System can only subtract insulin on

board (IOB) from a suggested bolus when the current BG

is known.

Understanding and Delivering Bolus Doses

n 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 4-3; see the end of Chapter 7, Checking Your

Blood Glucose). Press Next.

Figure 4-3

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 Yes 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 Read-

ing. See the end of Chapter 7, Checking Your Blood

Glucose.

Understanding and Delivering Bolus Doses

2. If you are not going to eat now, press No (Figure 4-4). The

Suggested Bolus screen appears (Figure 4-5). 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.

3. If you are going to eat now:

a. Press Yes (Figure 4-4), 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 num-

ber 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.

b. Press Enter to accept the suggested bolus (Figure 4-6 on

the following page).

Or press the User Info/Support (?) button to view calcula-

tion information used for this suggested bolus. Press

Close to return to the Suggested Bolus screen, then

press Enter.

In the Suggested Bolus screen (Figure 4-5), “adjusted

for IOB” appears only when Insulin on Board (IOB) is a

factor in the calculation.

Figure 4-4 Figure 4-5

To view detailed information about the calcula-

tions used for this suggested bolus, press the User

Info/Support button and scroll through the infor-

mation screens. Press Close to return to the

Suggested Bolus screen.

Understanding and Delivering Bolus Doses

4. If you have set the blood glucose reminder option to On and

you want to add a reminder:

a. Press Yes.

b. 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.

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.

If the reverse correction setting is turned Off, the

System does not subtract anything for a blood glu-

cose level below your target.

Figure 4-6

As a safety feature, the mylife 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 reset-

ting your maximum bolus dose. If suggested bolus

calc is On, you can enter a temporary manual over-

ride to make an adjustment above your max bolus

limit (Figure 4-1 and Figure 4-2). Consult your health-

care provider before changing this setting.

Understanding and Delivering Bolus Doses

n Deliver an Extended Bolus

The extended bolus feature lets the mylife 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 4-7).

2. Enter the units of insulin or percentage of the bolus that you

want to take immediately (Figure 4-8), then press Enter.

Figure 4-7

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.

To learn how to set extended boluses in percentages

or units, see Chapter 6, Using the Personal Diabetes

Manager.

Figure 4-8

Understanding and Delivering Bolus Doses

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 4-9). In Figure 4-10 you can see a detailed view of the

extended bolus.

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.

Figure 4-9 Figure 4-10

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

correction bolus 1 unit

meal bolus 1 unit

Extend = 3 units

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 36). You

can deliver a normal bolus while an extended bolus is

being delivered.

Understanding and Delivering Bolus Doses

n Cancel Active Boluses

The mylife 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. To check the Pod status, refer to Page 54 for detailed instruc-

tions. The ID screen must be confirmed before you can check

Pod status. An on-screen message appears for as long as a

normal bolus is being delivered (Figure 4-11).

2. Press Cancel.

The Pod beeps to confirm the bolus is cancelled. An on-screen

message tells you how much insulin was delivered before

you cancelled the bolus (Figure 4-12).

3. Press OK to return to the Status screen.

n 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 4-7 on Page 34).

Figure 4-11 Figure 4-12

If the bolus has already been completely delivered,

the “Delivering bolus” message and Cancel do not

appear, but the Status screen does appear.

If your suggested bolus contains both a correction

bolus and a meal bolus, the correction bolus is always

delivered first.

Understanding and Delivering Bolus Doses

2. Press Yes to cancel the active extended bolus (Figure 4-13).

Or press Back to return to the Suggested Meal Bolus screen.

3. Press Confirm (Figure 4-14).

4. The screen displays the amount of the old extended bolus

that has yet to be delivered (Figure 4-15). Press Next to return

to the Suggested Meal Bolus screen.

n 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.”

You can add what remained of the old extended

bolus to the new one.

Figure 4-13 Figure 4-14

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 pre-

sets. See “Carb Presets” on Page 39.)

Figure 4-15

Understanding and Delivering Bolus Doses

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 mylife 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.

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. The up and down

arrow symbol on the screen indicates which character can

be changed.

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 4-16).

d. Press Next.

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, then 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

4-17), then press Select.

3. Press Enter to confirm the bolus preset amount, or, if neces-

sary, use the Up/Down Controller buttons to adjust the

bolus amount.

Figure 4-16 Figure 4-17

Understanding and Delivering Bolus Doses

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.

Rename a bolus preset

1. Choose Rename, then press Select.

2. Press the Up/Down Controller buttons to enter the charac-

ters 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 (To

check the Pod status, refer to Page 54 for detailed instruc-

tions. The ID screen must be confirmed before you can check

Pod status.), 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 cancelled. An on-screen

message tells you how much insulin was delivered before

you cancelled the bolus.

3. Press OK to return to the Status screen.

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

chapter.

Understanding and Delivering Bolus Doses

n 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 carb amounts 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: (Favorites, Snacks,

or Meals), then press Select.

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

6. To use the mylife OmniPod System’s default naming system,

simply press Next. The default naming system automatically

assigns program names in numerical order, such as carb pre-

set 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 down

arrow symbol on the screen indicates the character that

can be changed.

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 consisting 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 4-18 on

the next page).

d. Press Next.

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

8. For American food label enter the fiber. For European food

label do not enter the fiber, because it is already counted off

the carbohydrate. Press Next.

9. If you want, enter the grams of 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 skip

through the screens.

Understanding and Delivering Bolus Doses

10. 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 4-19).

To change the category for a carb preset

1. Choose the carb preset you want to move to another cate-

gory, then press Tag (Figure 4-20).

2. Choose a new category, then press Select.

If you do include grams of fiber in step 8 to the left, the

suggested bolus calculator uses carbs minus fiber. Alter-

natively, in step 7, you can enter the total grams of carbs

minus the fiber yourself. Your healthcare provider can

best advise you on how to make this entry.

Figure 4-18

Figure 4-19 Figure 4-20

Understanding and Delivering Bolus Doses

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 gives you the option to

choose a blank space.

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

5. For American food label enter the fiber. For European food

label do not enter the fiber, because it is already counted off

the carbohydrate. Press Next.

6. If you want, enter the grams of fat and protein in the meal,

and the total calories. Press Next after each entry.

7. 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.

These additional units are not required. If you prefer

not to enter them, simply press Next repeatedly to

skip through the screens.

CHAPTER 5

Using the Pod

n The Pod Change Process

Replace the Pod at least once every 72 hours or up to 200

units of insulin (3 days). Refer to the insulin labeling and follow

your healthcare provider’s directions for how often to replace

your Pod. If you like, you can set the Personal Diabetes Manager

(PDM) to notify you when it is time to replace the Pod (see Chap-

ter 6, Using the Personal Diabetes Manager).

WARNINGS!

• Do NOT apply or use a Pod if the sterile packaging is open or

damaged, or if the Pod has been dropped after removal from

the package as this may increase the risk of infection. Pods

are sterile unless packaging has been opened or damaged.

• Do NOT apply or use a Pod if it is damaged in any way. A dam-

aged Pod may not work properly.

• To minimize the possibility of site infection, do NOT apply a

Pod 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 a Pod if you are sensitive to or have allergies to

acrylic adhesives, or have fragile or easily damaged skin.

• Check often to make sure the Pod and soft cannula are

securely attached and in place. A loose or dislodged cannula

may interrupt insulin delivery. Verify there is no wetness or

scent of insulin, which may indicate the cannula has dis-

lodged.

• Do NOT apply a new Pod until you have deactivated and

removed the old Pod. A Pod that has not been deactivated

properly may continue to deliver insulin as programmed, put-

ting you at risk of over infusion and possible hypoglycemia.

Using the Pod

• 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 symptoms such as breathing difficul-

ties, shock, coma, or death. If insulin delivery is interrupted for

any reason, you may need to replace the missing insulin usu-

ally with an injection of rapid-acting insulin. Ask your health-

care provider for instructions on handling interrupted insulin

delivery.

Gather equipment and supplies

Gather the following before you begin:

• A vial of rapid-acting U-100 insulin (See the warning on

page 8 of the Introduction for a list of insulins approved for

use in the mylife OmniPod System.)

• An unopened Pod

• An alcohol prep swab

Deactivate the current Pod

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.

NEVER use insulin that is cloudy; it may be old or inac-

tive. Failure to use rapid-acting U-100 insulin, or using

insulin that is expired or inactive, may lead to hyper-

glycemia or diabetic ketoacidosis (DKA).

If you are a first-time mylife 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 a Pod 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.

Figure 5-1 Figure 5-2

Using the Pod

4. If an extended bolus or temporary basal or both are actively

running, you will see a message similar to that shown in Fig-

ure 5-3. Press Confirm to accept the cancellation.

Or press Back to return to the More actions menu.

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).

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

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

c. Discard the used Pod according to local waste disposal

regulations or contact Customer Care for more informa-

tion about how to dispose of your used Pod.

6. After removing the old Pod, press Next.

7. Press Yes to fill and activate a new Pod (Figure 5-6).

Removing the Pod slowly will help to avoid

possible skin irritation.

Figure 5-3 Figure 5-4

Check the infusion site for signs of infection.

See “Avoid Infusion Site Infections” later in this

chapter.

Figure 5-5 Figure 5-6

Using the Pod

Fill a new Pod

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).

3. Pull outward to remove the protective cap from the needle

(Figure 5-8). Save the cap; you will need it later.

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.

Before filling a Pod, ensure that no other Pods are

being activated within 61 cm (24 inches) of your

PDM.

Before filling a Pod with insulin, ensure that the Pod

is above 10° Celsius. If the Pod has been exposed to

temperatures below 10° C, then allow the Pod to be

brought back to room temperature before filling it

with insulin.

Use care after removing the needle cap and

exposing the fill needle.

Only use room temperature insulin when filling

the Pod.

The Pod requires a minimum of 85 units of insulin to

begin operation.

The Pod can deliver up to 200 units of insulin.

Figure 5-7 Figure 5-8

Using the Pod

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.

7. Turn the vial and syringe upside down. Withdraw insulin from

the vial into the syringe, expelling any and all air or air bub-

bles. Fill at least to the MIN (minimum) fill line (Figure 5-9).

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).

Any air bubbles present in the fill syringe could be

transferred into the reservoir during the fill process.

The pod does not purge air that is introduced into the

reservoir by way of customer fill.

Failure to expel air bubbles from the fill syringe

may result in interrupted insulin delivery.

Make sure there is no air in the syringe before

attempting to fill a Pod with insulin. Be sure to only insert the fill syringe into the fill

port. Attempting to inject insulin into any other

location on the Pod may result in damage to the

Pod or loss of insulin.

To ensure proper fill, do not insert the fill syringe

at an angle into the fill port.

Figure 5-9 Figure 5-10

Fill

port

Using the 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.

10. Remove the needle from the insulin fill port. The port is self-

sealing; insulin will not leak after the needle is removed.

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

needle from the syringe.

12. After you fill the Pod, it will beep twice. After hearing the

beeps, PDM and pod should be adjacent and touching,

either in or out of tray to ensure proper communication

during priming (Figure 5-11on the next page). Press Next.

13. 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, please call Customer Care.

14. The System performs a series of safety checks and automati-

cally primes the Pod (Figure 5-12 on next page). Once com-

plete, the PDM beeps, letting you know that the priming and

safety checks were successful.

Do not use any other type of needle or filling

device besides the syringe provided with each

Pod.

NEVER use a Pod if you hear a crackling noise or

feel resistance when you depress the plunger.

These conditions can result in interrupted deliv-

ery of insulin.

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 deliv-

ery.

The fill syringe is intended for single use only and

should be used only with the mylife OmniPod

System.

As a safety feature, the communication distance be-

tween the Pod and PDM is reduced during activation.

Once a Pod is primed and communicates with the

PDM, the full communication range is restored and

the Pod can receive commands only from that PDM.

Using the Pod

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 poten-

tial 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 on the next page).

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.

Figure 5-11 Figure 5-12

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 2.5 cm (1 inch)

away from the last site. (Using the same location

repeatedly may reduce insulin absorption.)

Do NOT apply the Pod within 5 cm (2 inches) of your

navel or over a mole, a tattoo, or scar, where insulin

absorption may be reduced.

Using the Pod

Prepare the infusion site

You can reduce the risk of infection at the infusion site by follow-

ing 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.

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.

Figure 5-13: Pod placement options

Front

Back

To help avoid condensation from occurring in the

viewing window, make sure both your Pod and your

insulin are at room temperature.

Antibacterial soap may irritate skin, especially at the

infusion site. Ask your healthcare provider how to

treat any skin irritation.

Using the Pod

Apply the new Pod

Prepare the Pod for applying to your infusion site:

1. To remove the needle cap on the underside of the Pod, place

your thumb on the bottom (flat edge) of the needle cap and

pull it upwards (Figure 5-14). The needle cap will snap off.

2. Verify that the Pod is ready to be applied:

• Pod is clean and dry.

• Adhesive pad is intact and undamaged.

• Pod is intact and in its original condition

• If Pod is accidentally dropped, discard it; sterility may be

compromised.

If you are unsure the Pod is ready to be applied to the site,

press “Discard” and do not use it (Figure 5-17 on the next

page). Select a new Pod.

3. Using the pull tabs, remove and discard the white paper

backing from the adhesive tape (Figure 5-14).

4. Apply the Pod to the prepared infusion site. Press firmly to

secure it to your skin.

Figure 5-14 Figure 5-15

Verify cannula does not extend

beyond adhesive backing once

needle cap is removed.

Do not remove the needle cap until you are

instructed to do so by the PDM. When you remove

the needle cap, a drop of insulin may be visible at the

end of the cannula or in the well.

Using the Pod

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

For the Pod to work best, apply it:

a. Crosswise or at a slight angle on your abdo-

men, hip, or buttocks (in Figure 5-16)

b. Up and down or at a slight angle on your

upper arm or thigh (in Figure 5-16)

c. At least 2.5 cm (1 inch) away from the last site

Figure 5-13

Figure 5-16 Figure 5-17

The Pod’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.

The adhesive is designed for one-time use. Once

removed, a Pod cannot be reapplied.

Using the Pod

Insert cannula and begin insulin delivery

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

The Pod automatically inserts the soft cannula below your

skin. It takes a few seconds to complete this process. Once the

cannula is inserted, the Pod delivers a prime bolus to fill the

cannula with insulin (Figure 5- 20).

Once the soft cannula is inserted, the PDM indicates that the Pod

is active (Figure 5-21).

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.

The soft cannula is tinted light blue.

Figure 5-18 Figure 5-19

You will hear a click when the cannula inserts.

Figure 5- 20 Figure 5-21

Using the Pod

Figure 5-21 on the previous page 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.

When you see the pink slide insert in this position, it means

that the cannula is inserted (Figure 5-22).

2. Press Yes if you can see that the cannula is properly inserted.

The PDM returns to the Status screen.

Press No if you see a problem with the cannula. The PDM

instructs you to deactivate the new Pod (Figure 5-23 on

the next page). Press Discard to restart the process with

a new Pod.

Check the infusion site after insertion to ensure

that the cannula was properly inserted. You

should check your blood glucose 1.5 to 2 hours

after each Pod change and check the infusion site

periodically. If the cannula is not properly

inserted, hyperglycemia may result. Verify there is

no wetness or scent of insulin, which may indi-

cate the cannula has dislodged.

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.

To help avoid condensation from occurring in the

viewing window, make sure both your Pod and your

insulin are at room temperature.

Condensation may occur in the viewing window, due

to perspiration.

Figure 5-22

Using the Pod

Or press Back to return to the previous screen.

n Check Pod Status

To check Pod status, if the PDM is turned Off, press and hold the

Power button to display the ID screen, then press Confirm 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 but-

ton, 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 insulin reservoir volume, PDM battery

level, last blood glucose value, last bolus dose, active basal pro-

gram, and any alarm conditions. See Chapter 6, Using the

Personal Diabetes Manager, for details of what you see on the

Status screen.

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 on the Pod. See the end of Chapter 10, Alerts and

Alarms, for instructions.

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.

Figure 5-19

Figure 5-23

Once a Pod is activated and communicates with the

PDM, it can only receive commands from that PDM,

not from any other.

Using the Pod

n 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 mylife 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 deliv-

ery is suspended.

1. On the Home screen, use the Up/Down Controller buttons

to choose Suspend; then press Select.

2. Enter how long you want to stop all insulin delivery, from 30

minutes to 2 hours, in 30-minute increments (Figure 5-24),

then press Enter.

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 now sus-

pended (Figure 5-25).

The Pod beeps every 15 minutes until the end of the suspen-

sion period. The Status screen shows INSULIN SUSPENDED

until you resume insulin delivery (see “Resume Insulin Deliv-

ery” on the next page).

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 can-

celled when you suspend insulin delivery.

If a temporary basal or extended bolus is in process, the

menu item will read Suspend/cancel instead, and

options for cancelling these programs also appear in the

menu. If these options appear, choose Suspend insulin

delivery.

Figure 5-20

Figure 5-24 Figure 5-25

Using the Pod

4. At the end of the suspend time, a Pod Advisory alarm occurs

(Figure 5-26).

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

n Resume Insulin Delivery

1. On the Home screen, use the Up/Down Controller buttons

to choose Resume (Figure 5-27), then press Select.

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

ment.

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).

Figure 5-22

Figure 5-26

Figure 5-23

Figure 5-27

Using the Pod

n Avoid Infusion Site Infections

• Always wash your hands and use the aseptic technique to pre-

pare the infusion site before applying a Pod.

• Do not apply a Pod to any area of the 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 can-

nula 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 infec-

tion, immediately remove the Pod and apply a new one in a

different location. Then call your healthcare provider.

• Change the Pod as instructed by your healthcare provider.

n Get the Most From Your Pod

Avoid extreme temperatures

The Pod’s operating temperature is between 4.4°C and 40°C

(between 40°F and 104°F). Under normal circumstances, your

body temperature will keep the Pod well within this range.

Water and your Pod

The Pod is waterproof up to a depth of 7.6 meters (25 feet) for up

to 60 minutes (IPX8). After exposure to water, rinse off the Pod

with clean water and gently dry it with a towel.

Do NOT expose a Pod to direct sunlight for long peri-

ods 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 0°C (32°F). Follow the insulin manufac-

turer’s instructions for use.

Using the Pod

Safe storage

Store unopened Pods 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.

Do not expose your Pod to water at depths greater

than 7.6 meters or for more than 60 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. Verify

there is no wetness or scent of insulin, which may

indicate the cannula has dislodged.

The PDM is NOT waterproof. Do not place it in or

near water.

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, or if the Pod has

been dropped after removal from the package as

this may increase the risk of infection or serious

injury.

CHAPTER 6

Using the Personal Diabetes Manager

n The ID Screen

When you first turn on the PDM, it displays the identification (ID)

screen (Figure 6-1), which allows you to identify that the PDM is

yours. You can personalize the ID screen by adding your name

and choosing its color. You must acknowledge the ID screen

before you can use the PDM.

n The Status Screen

When a Pod is active and the PDM is turned on, the PDM estab-

lishes 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 expi-

ration. The information obtained is then displayed in the status

screen, which shows the System’s current operating status.

The Status screen (Figure 6-2) displays:

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

entered manually

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

It is important that you always identify the PDM as

yours before you use it.

Figure 6-1 Figure 6-2

Using the Personal Diabetes Manager

• Amount of insulin on board (IOB), if suggested bolus calcula-

tor 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

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.”

PDM settings

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

1. From the Status screen, 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 6-3 on the next page). Check with your health-

care provider before making any changes.

If a Pod has not yet been activated (as in during Pod

changes), the screen displays “No active Pod. Would you

like to activate a Pod now?” (See Chapter 5, Using the Pod,

for details on activating a Pod.)

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.

Using the Personal Diabetes Manager

n The System Setup Menu

The System setup menu lets you personalize the settings that

control the mylife OmniPod System. These include:

• Date and time

•Bolus doses, basal rates, and bolus calculator settings

• Alerts and reminders

• Blood glucose meter settings and 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.

Figure 6-3

Using the Personal Diabetes Manager

n 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 sus-

pended (see Chapter 5, Using the Pod).

1. Suspend insulin delivery.

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 Date or Time, 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.

2. Press 12/24 hr to choose either a 12-hour or 24-hour clock,

then press Enter (Figure 6-4).

3. Press Confirm to accept the new time (Figure 6-5).

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.

Figure 6-4 Figure 6-5

Using the Personal Diabetes Manager

Reset the date

1. Press the Up/Down Controller buttons to choose the cur-

rent 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.

n 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 mylife 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.

4. Choose one of the options (Figure 6-6a and Figure 6-6b), then

press Select. Each option is described below.

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 8.

If you suspended insulin delivery to change the

time or date, remember to resume insulin deliv-

ery. If you changed the time or date during the

Pod change process, remember to activate a new

Pod.

Figure 6-6a Figure 6-6b

Using the Personal Diabetes Manager

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 (smallest blood glucose value allowed for

calculating boluses)—Use the Up/Down Controller buttons

to enter a new minimum BG, then press Next.

3. Insulin-to-carb (IC) ratio—You can edit existing time seg-

ments and add segments, up to a total of 8.

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

ment, then press Edit (Figure 6-7 on next page). Use the

Up/Down Controller buttons 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.

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 8.

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 cor-

rection 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.

Figure 6-7

Using the Personal Diabetes Manager

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.

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 6-8a) or choose one setting from the menu, then press

Select (Figure 6-8b). The steps are the same whether you choose

all settings or individual ones.

1. Target BG and correct-above value—You can edit existing

segments and add segments, up to a total of 8.

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 (smallest 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—Number of grams of carbohy-

drate covered by one unit of insulin. You can edit existing

time segments and add segments, up to a total of 8.

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

segment, then press Edit. Use the Up/Down Controller

Figure 6-8a Figure 6-8b

When the suggested bolus calculator is turned Off, the

Ratios/factors/targets option does not appear in the

Bolus/basal/calcs menu.

Using the Personal Diabetes Manager

buttons 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.

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 8.

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 cor-

rection 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) or Insulin on Board (IOB)—Use

the Up/Down Controller buttons to choose a duration of

insulin action, then press Enter.

Temp basal

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 Appendix for a list of Sys-

tem 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 Deliver-

ing Bolus Doses.

Using the Personal Diabetes Manager

n Alerts and Reminders

In addition to automatic safety alarms (see Chapter 10, Alerts and

Alarms), the mylife OmniPod System offers a number of personal

settings to help you manage your diabetes. These features are

optional. You can turn them on or off at any time, except for the

alerts. Those you can set at levels that you find convenient to

remind you to change your Pod.

Notifications 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 30-minute increments.

Pod expiration: Reminds you when the Pod is nearing the 72-

hour expiration time. Choose a period from 1 to 24 hours before

expiration, in 1-hour increments. The default setting is 4 hours.

You will hear 2 sets of beeps every minute for 3 minutes. The

notification will repeat every 15 minutes until you press OK to

acknowledge it.

Low reservoir: Alerts you when insulin in the Pod reaches a cer-

tain 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 press-

ing and holding the PDM’s Power button. Choose a time period

from 1 to 24 hours, in 1-hour increments, or choose Off. The

default setting is Off. Refer to page 55 to check Pod status and to

Confirm ID.

This alert can be especially beneficial if you are prone to hypogly-

cemia unawareness. Ask your healthcare provider about using

this alert and where to set it.

The Low reservoir alert will escalate to an Empty res-

ervoir hazard alarm when insulin is depleted. Be sure

to respond to the alert when it occurs.

The Auto-off alert will escalate to a hazard alarm if

ignored and will result in the deactivation of your

active Pod. Be sure to respond to the alert when it

occurs.

Turning the PDM on by inserting a blood glucose

test strip does not send a Pod status to the PDM.

If you use the Auto-off feature, always turn on the

PDM with the Power button before using the system.

This allows the PDM to obtain a Pod status. Refer to

page 54 to check Pod status and to Confirm ID.

Using the Personal Diabetes Manager

Bolus reminders: Notifies 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.

Program reminders: 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.

Confidence reminders: The Pod or PDM beeps in response to

your instructions, so you become familiar with the operation of

the mylife OmniPod System and feel confident that you are get-

ting the insulin you need. These notifications 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 reminders: Displays text reminders that you enter, at

times that you select. You can choose to receive a notification

Daily, One time only, or Off. You can change or delete these

notifications 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 option you want to set (Figure 6-9), then press

Select.

Figure 6-9

Using the Personal Diabetes Manager

5. For all except Bolus reminders and Custom reminders,

choose the desired option or set the desired value, then press

Select or Enter.

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 reminders

• Use the Up/Down Controller buttons to choose [add

new], then press New.

• To use the mylife OmniPod System’s default naming sys-

tem, simply press Next. The default naming system

automatically assigns names in numerical order, such as

alert 1, alert 2, alert 3.

If you want to give a different name to the reminder:

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 that can

be changed.

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, for a

reminder to pick up a prescription, you might enter

R, x (Figure 6-10 on the next page). (A blank character

or space is the first and last option in the scrolling

menu.)

Using the Personal Diabetes Manager

d. Press Next.

• Enter the time of day for the reminder, in 30-minute incre-

ments, then press Next.

• Choose Daily, One time only, or Off, then press Select.

n Change Blood Glucose Meter Settings

You can adjust blood glucose (BG) meter settings:

• BG goal lower and upper limits (for BG history)

• Manage BG tags list

• BG sound—On or Off

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 6-11), then

press Select.

Custom reminders will repeat every 15 minutes until

acknowledged.

Figure 6-10

Figure 6-11

Using the Personal Diabetes Manager

Change BG goal limits

To change the BG goal limits, press Edit, change either or both

values, then press Save.

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 6-12a), followed by custom

tags, and then [add new] (Figure 6-12b). For more information

about tagging BG readings, see Chapter 7, Checking Your Blood

Glucose.

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 check marked; 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 buttons to choose letters

and numbers for a name, followed by the middle Soft Key

(the right arrow) 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.

Change BG sound

To change BG sound, choose On or Off, then press Select.

Figure 6-12a Figure 6-12b

Using the Personal Diabetes Manager

n Customize the Personal Diabetes Manager

Additional options let you customize how the PDM operates:

ID screen: Make your PDM unique by adding your name and

choosing a color. The options you set will be shown on the ID

screen every time you turn on the PDM.

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. Set it at the lowest setting to

maximize battery life. The ID screen must be confirmed before

you can check Pod status.

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. Set at the lowest setting to maximize

battery life.

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 6-13), then press Select.

4. Choose one of the options (Figure 6-14), then press Select.

Set ID screen

To change the ID:

1. Choose ID, then press Select.

2. 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 that can be changed.

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 lon-

ger than 5 minutes, the PDM brings you to the Status

screen. To check the Pod status, refer to page 55 for

detailed instructions.

For extra brightness on the PDM screen, press and

hold the User Info/Support button (?) for 2 seconds.

This enables a “bright mode.” The screen will remain

in this mode until the PDM times out or you turn it off.

To preserve battery life, use this feature only when

necessary.

Using the Personal Diabetes Manager

3. Press the middle Soft Key (labeled with the right arrow) to

move the underscore to the next character.

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

to enter your name, you might enter J, a, n, e, [space], S, m, i, t,

h. (A blank character or space is the first and last option in the

scrolling menu.)

5. Press Save.

To change the ID screen color:

1. Choose Screen color, then press Select.

2. Use the Up/Down Controller buttons to choose a color, then

press Select.

Set PDM lock

Choose On or Off, then press Select.

Set the Screen time-out

Choose a time interval, 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, then press Select.

When the screen dims, turn it on again by pressing any button.

The PDM will ignore the usual command and re-light the screen.

As a safety feature, an ID must be entered to enable

the PDM to be identified.

Figure 6-13 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.

The lowest setting will drain the battery the least.

Using the Personal Diabetes Manager

n 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 and

vibrates, then the Pod beeps. This function cannot be executed

unless insulin delivery is suspended.

Reset PDM (soft reset): Restores all settings in the PDM to the

factory defaults.

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 alarms

1. Choose Check alarms, then press Select.

2. Press OK. TThe PDM beeps three times and vibrates three

times. If the Pod is active, it beeps three times, then sounds

the alarm tone for 5 seconds.

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.

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.

If the PDM fails to beep, immediately call Customer

Care. If a Pod is active and fails to beep, change the

Pod immediately (see Chapter 5, Using the Pod).

Continuing to use the System in these situations

may put your health and safety at risk.

Resetting the PDM deletes all basal programs, temp

basal presets, carb presets, bolus presets, and all sug-

gested bolus settings. Before you use this feature, 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.

Be sure to check the alarm function at every Pod

change.

Using the Personal Diabetes Manager

n Set a Reminder to Vibrate

For certain reminders, you can choose vibration instead of beeps

or vibration followed by beeps, instead of only beeps. If you acti-

vate it, the PDM will vibrate for:

• Blood Glucose reminders

• Missed Bolus reminders

• Custom reminders

• “No active Pod” reminders

To change the type of notification

1. Use the Up/Down Controller buttons to choose Settings,

then press Select.

2. Choose Vibration, 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.

Use the form at the end of this User Guide to write

down all your settings from the Setup Wizard. If you

ever need to reset your PDM, having these settings

handy will make setup very easy.

Figure 6-15 Figure 6-16

The PDM cannot be set to vibrate for hazard or advisory

alarms.

Using the Personal Diabetes Manager

n 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, 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 Pod, hold the

PDM within 152 cm (60'') of the Pod.

Water and your PDM

Avoid extreme temperatures

Extreme operating temperatures can damage PDM batteries

and interfere with System operation. Avoid using the PDM in

temperatures below 4.4°C (40°F) or above 40°C (104°F).

Do NOT use IV Prep wipes, alcohol swabs, soap,

detergent, or solvents to clean the screen or any

other part of the PDM. The PDM is NOT waterproof.

Do NOT immerse it or place it in or near water.

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.

Using the Personal Diabetes Manager

Electrical interference

The PDM is designed to withstand normal radio interference and

electromagnetic fields. However, as with all wireless communica-

tion technology, certain operating conditions can interrupt

communication. For example, electric appliances such as micro-

wave ovens and electric machinery located in manufacturing

environments may cause interference. In most cases, interrup-

tions are easy to resolve (see Chapter 11, Communication

Failures).

Only connect a USB cable to your PDM when down-

loading 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 2.7 meters (9 feet)

in length.

CHAPTER 7

Checking Your Blood Glucose

n The Built-in OneTouch® Verio™ Blood Glucose

Meter

With the OneTouch® Verio™ blood glucose meter, checking your

blood glucose requires a very small sample size, 0.4 μL (microli-

ter) of blood. Refer to your OneTouch® Verio™ Test Strip Insert for

important test strip information.You may 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 system and the OneTouch® Verio™ accesso-

ries away from young children, as they contain small

parts that may be dangerous if swallowed.

Only use OneTouch® Verio™ test strips and One-

Touch® Verio™ control solution with the System.

Using other brands of test strips and control solutions

with the System can produce inaccurate results.

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.

This Device is intended for self-testing by the user.

Please read all the instructions provided in this User

Guide and practice the testing procedures before

using the system and OneTouch® Verio™ accessories.

Follow the guidance of a healthcare professional for

proper blood glucose monitoring.

Checking Your Blood Glucose

n The OneTouch® Verio™ Blood Glucose Test Strips

Important test strip information

• Store the test strip vial in a cool dry place between 41° and

86° F (5° and 30° C). Keep away from direct sunlight and heat.

Exposure to temperatures and/or humidity outside the stor-

age limits may cause inaccurate readings.

• The expiration date is printed on the vial.

• The discard date is 6 months after you first open a test strip

vial. When you open a new vial, write the discard date on the

label.

•Do Not use after the expiration or discard date, whichever

comes first.

• Store your test strips in the vial only. To avoid damage or

contamination, Do Not put test strips in any other container.

• Open the vial only when taking out a test strip for use.

• Close the vial lid tightly right away after removing a test strip.

Use each test strip as soon as you take it out of the vial.

•Do Not use test strips from a vial that is damaged or left open

to air.

•Do Not get dirt, food, or liquids on the test strip. You may

touch the test strip anywhere on its surface with clean, dry

hands.

•Do Not bend, cut, or alter test strips in any way.

• Test strips are for single use only.

•Never reuse a test strip that already has blood or control

solution on it.

• Operating temperature of the meter and strip is 6°- 44°C.

• Apply only OneTouch® Verio™ Control Solution or a blood

sample to the test strip.

•Do Not put the used test strip back in the vial after taking a

test.

• Used test strips may be considered biohazardous waste in

your area. Be sure to follow your health care professional’s

advice or local laws when throwing them away.

Complete information on the OneTouch® Verio™ test

strips (such as interferences and performance) can be

found in the test strip insert. Please read all instruc-

tions provided on the test strip insert before using the

OmniPod System and OneTouch® Verio™ accessories.

Keep the test strip vial away from children. Test strips

are a choking hazard. Do Not swallow test strips. The

test strip vial may contain drying agents that are

harmful if inhaled or swallowed and may cause skin

or eye irritation. Do Not ingest or swallow any items.

Checking Your Blood Glucose

n The OneTouch® Verio™ Control Solution

The OneTouch® Verio™ control solution (Fig-

ure 7-1) is a liquid that consists of a viscosity-

adjusting agent, a preservative, a dye, a buffer

and glucose in water and has two important

uses:

• To check that the meter and test strips are

working together properly and that the

test is performed correctly

• To practice testing without having to use

your own blood

Two levels of control solution are available:

Mid (Blue Cap: 102-138 mg/dL) and High (Red

Cap: 298-403 mg/dL). For information on how to obtain control

solution, call Insulet’s Customer Care (24 hours/7 days): 800-591-

3455. When calling from outside the United States: 781-457-

5098.

When to perform a control solution test

• Whenever you open a new vial of test strips

• If you suspect that the meter or test strips are not working

properly

• If you have had repeated unexpected blood glucose results

• If you drop or damage the meter

Check that the meter and test strips are working

A control solution test follows the same procedure as a blood

glucose reading, except that you use a sample of control solution

instead of a drop of blood. (See “Performing a Blood Glucose

Reading” 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

OneTouch® Verio™ control solution is good for 6 months after

opening the bottle, or until the expiration date printed on the

label, whichever comes first. Count forward 6 months from the

date you open a new bottle of control solution. This is your dis-

card 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 6 months to July 15. This is the discard date to

record on the bottle, as well as the date to discard it and begin

using a new bottle.

For detailed storage and usage information, refer to the

test strip insert.

Figure 7-1

Checking Your Blood Glucose

Ensure accurate control solution results

• Replace the cap on the control solution bottle immediately

after using it.

• Do not add water or any liquid to control solution.

• Control solution tests are specified to be accurate only when

performed between 43° and 111°F(6° and 44°C).

• The control solution test results should fall within the range

printed on the test strip vial label.

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

• Malfunction of the System

• Control solution test must be performed between 43° and

111°F (6° and 44°C).

If your control solution test results continue to fall outside the

range printed on the test strip vial:

1. The System may not be working properly.

2. Do not use the System to test your blood glucose.

3. Call Insulet’s Customer Care (24 hours/7 days): 800-591-3455.

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

n Performing a Control Solution Test

1. Grasp the bottom of the test strip with the gold side facing up

(Figure 7-2).

Use only OneTouch® Verio™ control solution with

the 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.

Results from OneTouch® Verio™ control solution

tests do not reflect your blood glucose level.

The control solution range is a target range for control

solution only. It is not a target range for your blood

glucose.

Checking Your Blood Glucose

2. Insert a test strip into the test strip port with the gold

side of the test strip and silver prongs facing you. (Figure

7-3) until it stops. This turns on the PDM on the screen. Refer

to page 57 to check Pod status and to Confirm ID.

Figure 7-2

Channel to apply sample

OneTouch® Verio™ test strip

Silver prongs, insert into test strip port

Always verify that you are using OneTouch®

Verio™ test strips with your PDM (Figure 7-4).

From some PDM screens, you cannot access the One-

Touch® Verio™ 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.

Figure 7-3 Figure 7-4

Checking Your Blood Glucose

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.

4. Wait for the PDM to display “Apply a blood sample to the

strip” on the screen (Figure 7-5).

5. Remove the vial cap and place it on a flat surface with

the top of the cap pointing up. Squeeze the vial to dis-

card the first drop. Then, wipe both the tip of the control

solution vial and the top of the cap with a clean, damp

tissue or cloth. Next, squeeze a drop into the small well

on the top of the cap or onto another clean, non-absor-

bent surface.

6. Gently touch only ONE SIDE of the test strip to the control

solution drop. Specifically, apply the control solution to the

test strip side next to the gold metallic channel (Figure 7-6 on

the previous page). If BG sound is set to On, the PDM beeps

when the test strip is full.

If you do not apply the sample within 10 seconds, the strip

port light turns off. To turn it on again, press Light.

The Countdown Screen appears while the sample is process-

ing (Figure 7-7). The strip port light turns off when the sample

is accepted.

Figure 7-5 Figure 7-6

Do not apply control solution to both sides of the test

strip.

Figure 7-7 Figure 7-8

Checking Your Blood Glucose

If BG sound is set to On, the PDM beeps twice. The PDM

automatically marks the result as a control solution test (Fig-

ure 7-8 on the previous page).

7. 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 Insulet’s Customer Care (24 hours/7 days):

800-591-3455. When calling from outside the United States:

781-457-5098.

8. 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.

n Performing a Blood Glucose Reading

Figure 7-9 shows the parts of the lancing device.

If the words Control solution do not show on

the screen, you MUST tag this result as a control

solution test.

If you do not mark this result as a control solution

result it will be included in your BG averages and

your averages may change, too. Repeat the test

with a new test strip. If the problem persists, con-

tact Insulet's Customer Care (24 hours/7days):

800-591-3455. When calling from outside the

United States: 781-457-5098.

Be sure to discard used test strips. (You can only use

test strips once.) Used test strips are considered bio-

hazardous material.

Release Button

Depth Wheel

Cocking Control

Figure 7-9

Lancing Device Cap

Depth Indicator

Ejection Control

Lancing device depicted in Figure 7-9 is representative only. Please follow

the instructions included with your specific lancing device.

Checking Your Blood Glucose

Prepare the lancing device

1. Remove the cap by turning it counterclockwise and

then pulling it straight off of the device. (Figure 7-10).

2. Insert a new lancet firmly into the white lancet holder cup

(Figure 7-11). 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 7-12).

4. Place the cap back onto the device; turn clockwise to

secure the cap (Figure 7-13). Be careful not to touch the

exposed needle on the lancet.

5. The lancing device has seven puncture depth settings, num-

bered 1 through 7. Smaller numbers are for a shallower punc-

ture and the larger numbers are for a deeper puncture.

(Figure 7-14 on the next page).

To ensure accurate results, wash your hands with

soap and water. Do not leave any cream or lotion on

your hands or fingers. Thoroughly dry your hands.

Figure 7-10 Figure 7-11

Figure 7-12 Figure 7-13

Lancing device depicted in Figures 7-10, 7-11, 7-12 and 7-13 is representative

only. Please follow the instructions included with your specific lancing

device.

Checking Your Blood Glucose

6. Pull out the cocking handle until it clicks (Figure 7-15). (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.

3. Insert only the bottom end of the strip into the test strip port

(Figure 7-16 and Figure 7-17).

Consult your lancing device instructions to ensure

proper usage.

Figure 7-14 Figure 7-15 From some PDM screens, you cannot access the One-

Touch® Verio™ 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.

Figure 7-16

Bottom

Top

Figure 7-17

Lancing device depicted in Figures 7-14 and 7-15 is representative only. Please follow the instructions included with your specific lancing device.

Checking Your Blood Glucose

Fill the blood glucose test strip with blood

1. Make sure that the strip is in the PDM and the PDM is pow-

ered on. Refer to page 55 to check Pod status and to Confirm

ID.

2. Hold the lancing device firmly against the side of your

finger. Press the release button. Remove the lancing

device from your finger.

3. Gently squeeze and/or massage your fingertip until a round

drop of blood forms on your fingertip.

4. Bring the strip to the blood sample at a slight angle

(Figure 7-18).

If you do not apply the sample within 10 seconds, the strip

port light turns off. To turn it on again, press Light.

Use only one edge of the blood glucose test strip per test. Do

not apply blood to both sides (Figure 7-19 on the next page).

Only use strips once. Discard used strips.

If you do not start the test within 2 minutes, the PDM

powers off. Refer to page 55 to check Pod status and to

Confirm ID.

If the blood smears or runs, DO NOT use that

sample. Dry the area and gently squeeze another

drop of blood, or puncture a new site.

Figure 7-18

Checking Your Blood Glucose

The test strip pulls the blood into the strip through the sides

(Figure 7-20).

1. Do not pull the test strip away from the sample until you hear

1 beep or see the countdown screen on the screen (Figure 7-

21 on the next page). This means you applied enough blood

and the meter is reading your glucose.

Figure 7-19

Side of test

strip, apply

blood here

Figure 7-20

The lancing device is intended for individual use and

should not be shared. If the device is being operated

by a second person who is providing testing assis-

tance to the user, the meter and lancing device

should be decontaminated prior to use by the sec-

ond person (see page 137 for PDM disinfection or

refer to lancing device instructions for use for

lancing device decontamination instructions).

Do not:

• Press the strip against the test site

• Share a lancing device with anyone.

• Scrape the blood onto the strip

• Apply blood to the flat side of the strip

• Apply blood to the strip when it is out of the meter

• Put blood or foreign objects into the test strip port

Checking Your Blood Glucose

2. If after 5 seconds the PDM does not display the countdown

screen, the sample may be too small.

The strip port light turns off when the blood sample is

accepted. The reading is complete when you hear 2 beeps (if

BG sound is turned On) and the PDM shows your reading on

the screen (Figure 7-22).

3. To mark the result as a pre- or post-meal test, to indicate a

level of exercise or to indicate other situations connected to

this blood glucose reading, press Tag. Then:

a. Use the Up/Down Controller buttons to select a tag,

then press Select. You can select a second tag for the

reading in the same way.

To learn how to manage your list of tags and to add

custom tags, see “Manage the blood glucose tags list” in

Chapter 6, Using the Personal Diabetes Manager.

b. Press OK to return to the reading screen (Figure 7-24),

then press Next.

4. If you do not want to mark the test, press Next instead of Tag.

5. Remove the test strip. If the strip-port light was turned on, it

now turns off.

Remove the lancet

6. When you have finished testing, place the lancet protec-

tive cover on a hard surface, then push the rounded top

into the cupped side of the cover. Then, remove the lan-

cet from the lancing device (Figure 7-23 on the next page).

Discard the used lancet properly in a puncture-resistant con-

tainer. Then wash your hands with soap and water.

If the words Control solution show on the

screen, repeat the test with a new test strip. If the

problem persists, contact Insulet's Customer

Care (24 hours/7days): 800-591-3455. When

calling from outside the United States: 781-457-

5098.

Figure 7-21 Figure 7-22

If the suggested bolus calculator feature is turned Off,

the Bolus soft key appears instead of Next.

Checking Your Blood Glucose

.n Blood Glucose Results and the Suggested Bolus

Calculator

If the suggested bolus calculator feature is turned On when you

check your blood glucose, the PDM will display the result. From

here, press Next to enter carbs (if eating) and have the System

calculate a suggested bolus. (See “Suggested Bolus Calculator” in

Chapter 4, Understanding and Delivering Bolus Doses.)

If the suggested bolus calculator feature is turned Off, the Next

soft key does not appear. Instead:

Press Bolus to open a screen where you can enter a bolus

manually.

Or press Done to return to the Status screen to see the most

recent BG result.

The BG result, either from the PDM or from manual entry, is

stored in the System’s history, whether suggested bolus calcula-

tor is turned On or Off. (See “Blood Glucose Records” in Chapter

8, Understanding Your Records.)

See “Cleaning and disinfecting” in the Appendix for

instructions on how to clean or disinfect your PDM.

Figure 7-23

If you use the suggested bolus calculator within 10

minutes after taking a blood glucose reading, or if you

store a BG reading (for example, one you enter manually)

within the same 10 minutes, that BG value will be used

automatically in the suggested bolus calculator process

(Figure 7-24 on the next page).

Lancing device depicted in Figure 7-23 is representative only.

Please follow the instructions included with your specific lancing device.

Checking Your Blood Glucose

n Entering Blood Glucose Readings Manually

You can enter blood glucose readings manually into the PDM.

This is particularly helpful if you use a separate blood glucose

meter.

1. On the Home screen, use the Up/Down Controller buttons

to choose More actions, then press Select.

2. Choose Add BG reading, then press Select.

3. Use the Up/Down Controller buttons to enter the BG read-

ing from your separate meter.

4. Press Tag to assign a tag to the reading. Press OK when fin-

ished. (For an explanation of entering tags, see page 90.)

5. Press Save to save the reading.

Or press Cancel to return to the More actions menu without

saving the reading.

The Bolus Entry screen does not open if:

• A regular bolus is currently in process

• The meter temperature is out of range

• The BG reading has been tagged as a Control

• The BG reading is less than your “Min BG for calcs”

• Insulin is suspended

Figure 7-24

To enter a “LOW” reading, press the Up/Down

Controller buttons down until you reach the mini-

mum value (20); then press down one more time.

To enter a “HIGH” reading, press up until you reach

the maximum value (600); then press up one more

time.

Checking Your Blood Glucose

n Editing Tags

Within 2 hours of a blood glucose reading, you can remove or

change a tag or add one. However, you cannot alter a Control tag.

1. On the Home screen, use the Up/Down Controller buttons

to choose More actions, then press Select.

2. Choose Assign/Edit BG tags, then press Select.

3. Use the Up/Down Controller buttons to choose a reading,

then press Tag (Figure 7-25). A User Info/Support icon (?) is

shown to the right of any reading to which you have already

assigned one or two tags.

Or press Done to return to the More actions menu.

4. Use the Up/Down Controller buttons to choose the first tag

you want, then press Select (Figure 7-26 on the next page). A

diamond icon appears next to selected tags, as in “Pre-meal” in

the figure. You can select up to two tags for each BG reading.

5. To remove a selected tag, highlight it and press Clear. (The

soft key changes from Select to Clear when you highlight

the tag.)

6. Press OK to return to the list of readings.

7. If no BG readings have been entered into the PDM within the

past 2 hours, you will see the screen in Figure 7-27. Press OK

to return to the More actions menu.

Figure 7-25

Figure 7-26 Figure 7-27

Checking Your Blood Glucose

To learn how to manage your list of tags and to add custom tags,

see “Manage the blood glucose tags list” in Chapter 6, Using the

Personal Diabetes Manager.

n Low and High Blood Glucose Readings

WARNINGS!

“LOW” or “HIGH” blood glucose readings can indicate a poten-

tially serious condition requiring immediate medical attention.

If left untreated, this situation can quickly lead to diabetic keto-

acidosis (DKA), shock, coma, or death.

Low readings

If your reading is below 20 mg/dL, the PDM displays: “LOW Treat

your low BG!” This indicates severe hypoglycemia (low blood

glucose).

Low reading with symptoms

If you get a “LOW Treat your low BG!” reading and feel symptoms

such as weakness, sweating, nervousness, headache, or confu-

sion, follow your healthcare provider’s recommendation to treat

hypoglycemia.

Low reading without symptoms

If you get a “LOW Treat your low BG!” reading, but have no symp-

toms of low blood glucose, then retest with a new test strip on

your fingers. If you still get a “LOW Treat your low BG!” reading,

perform a control solution test to ensure your system is working

properly. If the system is working properly, follow your health-

care provider's recommendation to treat hypoglycemia.

High readings

If your reading is above 600 mg/dL, the PDM displays “HIGH

Check for ketones!” This indicates severe hyperglycemia (high

blood glucose).

High reading with symptoms

If you get a “HIGH Check for ketones!” reading and feel symp-

toms such as fatigue, thirst, excess urination, or blurry vision,

follow your healthcare provider’s recommendation to treat

hyperglycemia.

High reading without symptoms

If you get a “HIGH Check for ketones!” reading, but have no

symptoms of high blood glucose, then retest with a new test

strip on your fingers. If you still get a “HIGH Check for ketones!”

reading, perform a control solution test to ensure your system is

working properly. If the system is working properly, follow your

healthcare provider's recommendation to treat hyperglycemia.

You can add and edit tags for LOW and HIGH BG readings

just as you would to any other reading. To add tags, see

page 90; to edit tags, see page 93.

Checking Your Blood Glucose

n Important Health-Related Information

For additional information, consult your test strip product infor-

mation sheet.

WARNINGS!

• Severe dehydration and excessive water loss may cause false

low results. If you believe you are suffering from severe dehy-

dration, consult your healthcare provider immediately.

• Test results below 70 mg/dL mean low blood glucose (hypo-

glycemia).

• Test results greater than 250 mg/dL mean high blood glu-

cose (hyperglycemia).

• If you get results below 70 mg/dL or above 250 mg/dL, but

do not have symptoms of hypoglycemia or hyperglycemia

(see Chapter 9, Living with Diabetes), repeat the test. If you

have symptoms or continue to get results that fall below 70

mg/dL or above 250 mg/dL, follow the treatment advice of

your healthcare provider.

• If you are experiencing symptoms that are not consistent

with your blood glucose reading and you have followed all

instructions described in this User Guide, call your healthcare

provider immediately.

• Do not use during xylose absorption testing.

• The lancing device is for individual use only and must not be

shared. Always use a new, sterile lancet; lancets are for single

use only.

• Objects that may be soiled with blood may then transmit

pathogens. See “Cleaning and disinfecting” in the Appendix

for instructions on how to clean or disinfect your PDM.

• “FDA Public Health Notification: Use of Fingerstick Devices on

More than One Person Poses Risk for Transmitting Blood-

borne Pathogens: Initial Communication” (2010) http://

www.fda.gov/MedicalDevices/Safety/AlertsandNotices/

ucm224025.htm.

• “CDC Clinical Reminder: Use of Fingerstick Devices on More

than One Person Poses Risk for Transmitting Bloodborne

Pathogens” (2010) http://www.cdc.gov/injectionsafety/

Fingerstick-DevicesBGM.html.

CHAPTER 8

Understanding Your Records

n Record Keeping

Record keeping is an important part of successful diabetes man-

agement. The Personal Diabetes Manager (PDM) helps simplify

this task. It automatically stores records of insulin delivery history,

blood glucose readings, alarms and carbohydrates. The PDM can

store over 5,000 records or approximately 90 days’ worth of infor-

mation. Once the memory is full, new information begins to

replace the oldest information.

Special symbols in record screens

In the record screens, you may encounter several special symbols:

If the PDM batteries run out, date and time are at risk.

Do NOT remove the old batteries until you have new

ones on hand. The PDM protects data in the mem-

ory for up to 2 hours after the batteries run out or are

removed.

Records with a question-mark symbol next to them have

additional information available. To see this information, use

the Up/Down Controller buttons to highlight the record,

then press the User Info/Support button to view details

about that record.

The record for this item has been “lost.”

If the PDM can no longer communicate with an

active Pod, then you must activate a new Pod. The

PDM may not be able to communicate with the

active Pod because of signal interference or because

you have discarded the Pod. If you change the Pod

without getting a Status update, any “unconfirmed”

records will be “lost.” If this occurs, the PDM will not

display insulin totals for any day containing “lost”

records.

Understanding Your Records

n Insulin Delivery Records

The PDM stores:

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

•Bolus doses (both normal and extended)

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

and dates and times when it was resumed

• Total daily doses (basal plus boluses) by date

View insulin delivery records

1. On the Home screen, use the Up/Down Controller buttons

to choose My records, then press Select.

2. Choose Insulin delivery, then press Select (Figure 8-1).

The PDM displays a summary of today’s information,

including total boluses delivered, total basal amount deliv-

ered and total daily dose delivered (Figure 8-2). Press the

Up/Down Controller buttons to view the summary for

previous days.

Wherever you see the ? symbol, press the User Info/Support

button to see additional information.

3. To review your basal history by day, press Basal.

The display shows the basal deliveries that have occurred for

the current day, most recent first (Figure 8-3 on the next

page). The active basal rate or program is indicated by a dia-

mond icon (u).

4The record for this item is “unconfirmed.”

When you power on the PDM, it will request a status

update from the active Pod and then update the

insulin history. If the PDM does not receive a status

update from the Pod, the PDM will update history

with “unconfirmed” records. The next time the PDM

receives a status update, it will update these records.

This insulin delivery item spans midnight. The date given

is the start date.

Figure 8-1 Figure 8-2

Understanding Your Records

For a temporary basal program, the display shows the %

adjustment that have been made to the default basal rate

(active or current). So, in Figure 8-3, “1.10 temp U/hr (+10%)”

means that you delivered a temporary basal of 1.10 units per

hour, which was 10% more than the default basal. (Notice

that two hours later, the basal rate returns to the default.)

Also, the “Pod activated” entry shows what time you applied

a new Pod.

Press the Up/Down Controller buttons for earlier or later

dates.

Press Event to use the Up/Down Controller buttons to scroll

through the list of information on the screen. Choose a

record, then press the User Info/Support button to view

details about that record. Record details may include insulin

delivery that was interrupted due to a Pod alarm, Pod deacti-

vation, or user cancellation. The screen shows the amount of

the bolus or basal that remained undelivered.

4. Press Day to return to dates.

5. To review your bolus history by day, press Bolus.

The display indicates whether the bolus was normal or

extended (marked “e” in Figure 8-4). Normal and extended

boluses are displayed separately even if they were pro-

grammed at the same time. Extended boluses are shown

with time and duration. If an extended bolus is active, a dia-

mond icon (u) appears next to it. If a bolus was cancelled,

only the amount delivered before cancellation is shown.

Press the Up/Down Controller buttons for different dates.

Press Event to use the Up/Down Controller buttons to scroll

through the list of information on the screen. Press Day to

return to dates.

Figure 8-3 Figure 8-4

The amount shown after cancellation may be in 0.05

unit increments, even though you may have pro-

grammed the bolus increment to be in 0.10 units.

Understanding Your Records

n Blood Glucose Records

The PDM stores blood glucose records for the past 90 days. You

can choose to view individual readings, single-day trends with

individual readings, or trends for the previous 7, 14, 30, 60 or 90

days.

View single-day trends

1. On the Home screen, use the Up/Down Controller buttons

to choose My records, then press Select.

2. Choose BG history, then press Select.

The PDM displays the current-day trends first (Figure 8-5),

including:

• Number of days and number of blood glucose

readings (n)

• Average blood glucose (Avg BG)

• Lowest and highest blood glucose (Min/max)

• The BG goal you have set

• Percentage of readings within the BG goal

• Percentage of readings above the BG goal

• Percentage of readings below the BG goal.

3. Press List to see a list of the current day’s readings

(Figure 8-6).

LOW and HIGH readings are included in the number

of BG readings (n), but not in calculations or averages.

Figure 8-5 Figure 8-6

Understanding Your Records

100

In the List view, press Event to select individual readings.

Readings with a question mark icon (?) next to them have

additional information available (Figure 8-7). To see this infor-

mation, use the Up/Down Controller buttons to choose the

reading. Then press the User Info/Support button to view

details about that reading (Figure 8-8).

4. Press Close to return to the List view.

5. Press Graph to see a graph of the data (Figure 8-9).

View multiple-day trends

1. On the Home screen, use the Up/Down Controller buttons

to choose My records, then press Select.

2. Choose BG history, then press Select.

3. Press Trends to display blood glucose data for the past 7

days.

4. Continue pressing the middle soft key to view trends for the

previous 14, 30, 60 and 90 days.

5. The PDM displays the same details for multiple days as for

single days, plus the average number of BG measurements

taken per day (Figure 8-10).

Figure 8-7 Figure 8-8

Figure 8-9 Figure 8-10

Understanding Your Records

101

For the 7-, 14- and 30-day trends, press Graph to see a graph

of the trends (Figure 8-11). Graphs are not available for 60- or

90-day trends. Press Stats to return to the detail view.

6. Press Back to return to the single-day trends.

n Alarm Records

The PDM lists the entire alarm history for the mylife OmniPod

System. The PDM can store over 90 days’ worth of alarm records.

1. On the Home screen, use the Up/Down Controller buttons

to choose My records, then press Select.

2. Choose Alarm history, then press Select.

The PDM displays the date, time, and type of each alarm

(Figure 8-12).

3. Press the Up/Down Controller buttons to see additional

screens.

4. Choose an alarm record, then press User Info/Support to

see more information.

n Carbohydrate Records

The PDM displays the records of carbohydrates you have

entered.

1. On the Home screen, use the Up/Down Controller buttons

to choose My records, then press Select.

2. Choose Carb history, then press Select.

The PDM displays the date, time and grams of carbohydrate

you have entered (Figure 8-13 on the following page).

3. Press the Up/Down Controller buttons to see additional

days.

Press Event to use the Up/Down Controller buttons to scroll

through the list of information on the screen. Press Day to

use the Up/Down Controller buttons for dates.

Figure 8-11 Figure 8-12

Understanding Your Records

102

n All Records

The PDM displays the combined insulin delivery, blood glucose,

alarm and carbohydrate records.

1. On the Home screen, use the Up/Down Controller buttons

to choose My records, then press Select.

2. Choose All history, then press Select.

The PDM displays all history for the most recent date (Figure

8-14).

3. Press the Up/Down Controller buttons to see additional

days.

Press Event to use the Up/Down Controller buttons to scroll

through the list of information on the screen. Press Day to

use the Up/Down Controller for dates.

n User Information/Support

You or your healthcare provider may have entered personal

contact information during your start-up visit. To view this infor-

mation, press the User Info/Support button (to the right of the

Power button) while on the Home screen. Or follow the steps

below to view the information. You can add or change the user

information at any time.

You may want to include your name, address, phone, email

address, emergency contact and phone, doctor’s or healthcare

provider’s name and phone, prescription numbers or other

information.

The user information screen also displays product information

for your mylife OmniPod System (make, model, serial number).

You cannot change this information.

Figure 8-13 Figure 8-14

Understanding Your Records

103

Add or change user information

1. On the Home screen, use the Up/Down Controller buttons

to choose My records, then press Select.

2. Choose My info, then press Select.

3. Choose an existing line or [My info] (Figure 8-15), then press

Edit.

4. 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 that can be changed.

5. Press the middle soft key to move the underscore to the next

character.

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

to enter your address, you might enter 5, 6, 5, [space], M, a, i, n,

[space], S, t, [period]. (A blank character or space is the first

and last option in the scrolling menu.)

For your healthcare provider and local phone number, you

might enter J, a, n, e, [space], S, m, i, t, h, [comma], [space], 5, 5,

5, [hyphen], 1, 2, 3, 4 (Figure 8-16).

7. Press Save.

8. Repeat steps 3–7 for each line of personal information you

want to enter or change. Twenty lines are available.

The User Info/Support icon is also displayed on

the suggested bolus screen. For information about

the support information displayed on these

screens, see Chapter 4, Understanding and Deliver-

ing Bolus Doses.

The first line of My Info displays the information that was

entered for the ID screen during your PDM setup. For

information on editing this line, see Chapter 6, Using the

Personal Diabetes Manager, “Customize the Personal

Diabetes Manager.”

Figure 8-15 Figure 8-16

104

CHAPTER 9

Living with Diabetes

n Your Role: Safely Using the mylife OmniPod

System

Before deciding on the mylife OmniPod® Insulin Management

System, you and your healthcare provider discussed the advan-

tages and benefits of the mylife OmniPod System, as well as the

responsibilities that come with insulin pump therapy. Remem-

ber: safe use begins and ends with you. If you have questions or

doubts about being able to safely use the mylife OmniPod Sys-

tem at any time, consult your healthcare provider immediately.

Most problems are easily avoided by:

• Learning all you can about successful diabetes management.

• Being actively involved in your treatment.

• Checking your blood glucose levels frequently.

• Washing your hands and disinfecting infusion sites to reduce

the possibility of infection.

• Being aware of the signs of hypoglycemia (low blood glu-

cose), hyperglycemia (high blood glucose), and diabetic keto-

acidosis (DKA). (See “Avoid Lows, Highs and DKA” later in this

chapter.)

• Keeping a diabetes emergency kit with you at all times. (See

“Prepare for Emergencies” later in this chapter.)

• Knowing how to contact your healthcare provider in case of

an emergency.

If you are unable to use the mylife OmniPod Insulin

Management 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 mylife OmniPod System.

Living with Diabetes

105

n Daily Diabetes Management Activities

To ensure proper mylife OmniPod System operation and your

continued good health:

• Check your blood glucose frequently

• Inspect the infusion site daily

Check your blood glucose frequently

When you routinely check your blood glucose level, you can iden-

tify and treat high or low blood glucose before it becomes a

problem (see “Avoid lows, highs, and DKA” later in this chapter).

Check your blood glucose (BG):

• At least 4 to 6 times a day: when you wake up, before every

meal, and before going to bed

• Whenever you feel nauseated or sick

• Before driving a car

• Whenever your blood glucose has been running unusually

high or low

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

• Before, during, and after exercise

• As directed by your healthcare provider

Inspect the infusion site daily

At least once a day, use the Pod’s viewing window to inspect the

infusion site. Check the site for signs of infection, such as pain,

swelling, redness, discharge or heat.

If an infusion site shows signs of infection:

1. Immediately remove the Pod and apply a new

one at a different site (see Chapter 5, Using the Pod).

2. Contact your healthcare provider.

Treat the infection according to instructions from

your healthcare provider. (Refer to Chapter 5, Using

the Pod, for how to prepare and care for infusion

sites.)

Consider making infusion site checks a part of your

regular daily routine (like showering or brushing your

teeth). That way, it’s easy to remember. Verify there is

no wetness or scent of insulin, which may indicate

the cannula has dislodged.

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.

Living with Diabetes

106

n Prepare for Emergencies

n Water and Your Pod

The Pod is waterproof to a depth of 7.6 meters (25 feet) for up to

60 minutes (IPX8). After the Pod gets wet, rinse it off with clean

water and dry it with a towel.

Keep an emergency kit with you at all times to

quickly respond to any diabetes emergency. The kit

should include:

• Several new, sealed Pods

• Extra new PDM batteries (at least two AAA alka-

line). Do not use rechargeable batteries.

• A vial of rapid-acting U-100 insulin (See the warn-

ing on page 8 of the Introduction for insulins

approved for use in the mylife OmniPod System.)

• Syringes for injecting insulin

• Instructions from your healthcare provider about

how much insulin to inject if delivery from the

Pod is interrupted

• Blood glucose test strips

• Ketone test strips

• Lancing device and lancets

• Glucose tablets or another fast-acting source of

carbohydrate

• Alcohol prep swabs

• A copy of the letter from your healthcare pro-

vider for airline security (see “Minimize airport

security delays” later in this chapter)

• Phone numbers for your healthcare provider

and/or doctor in case of an emergency

• Glucagon kit and written instructions for giving

an injection if you are unconscious (see “Avoid

Lows, Highs and DKA” later in this chapter)

Ask your healthcare provider to help you develop

plans for handling emergency situations, including

what to do if you cannot reach your healthcare

provider.

Do NOT expose your Pod to water at depths greater

than 7.6 meters (25 feet) or for longer than 60 min-

utes. Check the infusion site often to make sure the

Pod and soft cannula are securely applied and in

place. If the cannula is not properly inserted, hyper-

glycemia may result.

Living with Diabetes

107

n Traveling and Vacationing

Plan for changing time zones

If you’re planning a vacation or business trip to a different time

zone, you may need to adjust your basal rate programs. For

changes of just a few hours, basal rate adjustments are minor

and easy to calculate. For long-distance travel, however, figuring

out the correct program can be more challenging. Your health-

care provider can help with these adjustments.

Take enough supplies

Keeping your emergency kit with you during trips or vacations

is especially important (see “Prepare for Emergencies” on

page 106). It may be difficult or impossible to get insulin or

supplies in an unfamiliar place. If traveling by air, be sure to pack

your supplies in your carry-on luggage. When packing for travel,

take more supplies than you think you’ll need. Be sure to include:

• Diabetes emergency kit packed in your carry-on luggage

• Enough Pods for your trip, plus a backup supply

• Extra new PDM batteries. Do not use rechargeable batteries.

• Additional blood glucose meter

• Insulin syringes or pens in case you need injections

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

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

knows how to give the injection.)

The Personal Diabetes Manager (PDM) is not water-

proof. Do NOT place it near water and never immerse

it.

Living with Diabetes

108

• Alcohol prep swabs

• Written prescriptions for all medications and supplies.

(Generic medications may be easier to find than brand

names outside the country.)

Minimize airport security delays

With changing airport security checks and screening procedures,

you may have questions on how this impacts traveling with

your diabetes supplies. Below you will find more information on

prepping for travel and what you can expect when going

through security checkpoints.

Travel Preparation

• Review the airport websites for travel updates

• Pack extra supplies and hypoglycemia treatments

• Carry contact information for your physician

• Arrive at the airport 2-3 hours prior to your flight

To ensure airport security checks run smoothly, be sure you have

the following items easily accessible:

• All diabetes supplies in your carry-on luggage

• A signed letter from your healthcare provider explaining

you need to carry insulin supplies and mylife OmniPod

equipment

• Prescriptions for all medications and supplies with origi-

nal prescription labels

Screening Procedures

The airport may offer the option of requesting a visual inspection

of your medical supplies rather than putting them through the

X-ray. This must be requested before the screening process

begins. Your medical supplies should be ready in a separate bag

when you approach the Security Officer.

In order to prevent contamination or damage to your supplies,

you should be asked at the security checkpoint to display, han-

dle, and repack your own supplies during the visual inspection

process. Any medication and/or associated supplies that cannot

be cleared visually must be submitted for X-ray screening.

If you're concerned or uncomfortable about going through the

walk-through metal detector, you should notify the Security Offi-

cer that you're wearing a pump and would like a full-body pat-

down and a visual inspection of your pump instead. You should

also advise the Security Officer that the insulin pump cannot be

When you travel outside the country or for long peri-

ods of time, be sure to take extra Pod supplies. Call

Customer Care to order additional supplies for your

trip.

Living with Diabetes

109

removed because it is inserted with a catheter (needle) under

the skin.

Visit the airport websites if you have any further questions or

concerns.

If the security detector goes off, tell the security screener that you

have diabetes and wear an insulin Pod (pump).

Keep supplies accessible

On airplanes and trains, keep these items with you, rather than

checking them:

• Personal Diabetes Manager (PDM)

• An emergency kit

• Vials of insulin (cargo area temperatures may affect insulin)

• A copy of your healthcare provider’s letter (see “Minimize air-

port security delays”)

• Prescriptions for insulin and supplies

• Snacks, in case food is not available

• Bottled water (especially on planes) to prevent dehydration

The name and phone number of a physician at your final

destination, in case of emergency.

n Avoid lows, highs, and DKA

You can avoid most risks related to using the mylife OmniPod

System by practicing proper techniques and by acting promptly

at the first sign of trouble. You can avoid potential problems by

knowing the signs of hypoglycemia (low blood glucose), hyper-

glycemia (high blood glucose), and diabetic ketoacidosis (DKA).

The easiest and most reliable way to avoid these conditions is to

check your blood glucose often.

General precautions

• Keep careful records and discuss changes and adjustments

with your healthcare provider.

• Tell your healthcare provider if you have extreme highs or

lows, or if highs or lows are occurring more often than usual.

• If you have technical problems with your mylife OmniPod

System and cannot resolve them, do not hesitate to call Cus-

tomer Care.

Hypoglycemia (Low Blood Glucose)

Hypoglycemia can occur even when a Pod is working properly.

Never ignore the signs of low blood glucose (no matter how

mild). If left untreated, severe hypoglycemia can cause seizures

or lead to unconsciousness. If you suspect that your blood glu-

cose level is low, check it.

Pods and PDMs can safely pass through airport

X-ray machines (see the “mylife OmniPod System Notice

Concerning Interference” in the Appendix).

Living with Diabetes

110

Symptoms of hypoglycemia

Never ignore these symptoms:

• Shakiness

• Fatigue

• Unexplained sweating

• Cold, clammy skin

• Weakness

• Blurred vision or a headache

• Sudden hunger

• Rapid heart rate

• Confusion

• Tingling in the lips or tongue

• Anxiety

To avoid hypoglycemia (low blood glucose)

• Work with your healthcare provider to establish individual-

ized blood glucose targets and guidelines.

• Keep a fast-acting carbohydrate with you at all times to

respond quickly to low blood glucose. Examples of fast-

acting carbs are glucose tablets, hard candies or juice.

• Teach your friends, family members and colleagues to

recognize the signs of hypoglycemia, so they can help if you

develop hypoglycemia unawareness or a severe adverse

reaction.

• Keep a glucagon injection kit with your emergency supplies.

Teach friends and family members how to give a glucagon

injection in case you have severe hypoglycemia and become

unconscious.

Hypoglycemia unawareness is a condition in which

you do not realize when your blood glucose level is

low. If you are prone to hypoglycemia unawareness,

you may want to use the mylife OmniPod System’s

blood glucose reminder and check your blood glu-

cose more frequently. See “Alerts and Reminders” in

Chapter 6, Using the Personal Diabetes Manager, for

how to set the reminder.

Make sure your blood glucose is at least 100 mg/dL

before driving or working with dangerous machinery

or equipment. Hypoglycemia may cause you to lose

control of a car or dangerous equipment. Also, when

you focus intently on a task, you may miss the symp-

toms of hypoglycemia.

Periodically check the expiration date of your glucagon

kit to make sure it has not expired.

Living with Diabetes

111

Again, frequent blood glucose checks are the key to avoiding

potential problems. Detecting low blood glucose early lets you

treat it before it becomes a problem.

Check with your healthcare provider for guidance in any and all

areas listed above.

To treat hypoglycemia (low blood glucose)

Any time your blood glucose is low, treat immediately. Check it

every 15 minutes while you are treating, to make sure you don’t

overtreat the condition and cause blood glucose levels to rise

too high.

1. If blood glucose is below 70 mg/dL, eat or drink 15 grams of

fast-acting carbohydrate, such as glucose tablets, juice, or

hard candy (see “How much is 15 grams of carbohydrate?”).

2. Check blood glucose again after 15 minutes.

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

carbohydrate. Contact your healthcare provider as needed

for guidance.

4. Repeat steps 2 and 3 until blood glucose is within the BG goal.

5. Investigate possible cause for hypoglycemia to avoid similar

problems in the future (see “Possible causes of hypoglycemia

(low blood glucose)” on page 115).

Always carry medical identification (emergency

wallet card) and wear an emergency medical neck-

lace or bracelet such as the Medic Alert tag. (See the

end of the Appendix for address, telephone and

website information for obtaining these items.)

Even if you cannot check your blood glucose, do NOT

wait to treat symptoms of hypoglycemia, especially

if you are alone. Waiting to treat symptoms could

lead to severe hypoglycemia, which can quickly lead

to shock, coma or death.

Do NOT use chocolate or candy bars to treat low

blood glucose. Their fat content slows down glucose

absorption.

Living with Diabetes

112

How much is 15 grams of carbohydrate?

Examples of fast-acting foods:

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

118 milliliters of apple or orange juice

6 pieces of hard candy

1/2 can of regular (non-diet) soda

30 milliliters of table sugar or honey

Teach people you trust (like family members and

close friends) how to give a glucagon injection. You

will need to rely on them to give it to you if you have

severe hypoglycemia and become unconscious.

Include a copy of the glucagon instructions in your

emergency kit and periodically review the proce-

dure with family and friends.

Living with Diabetes

113

Possible causes of hypoglycemia (low blood glucose)

Possible cause of low

blood glucose

Suggested action

Incorrect basal

program

Confirm that correct basal program

is active.

Confirm that PDM time is set cor-

rectly.

Consult your healthcare provider

about adjusting your basal pro-

grams or using a temporary (temp)

basal rate.

Incorrect bolus

timing

Take bolus with food.

Check blood glucose before giving

meal bolus; if necessary, adjust

bolus.

Check bolus size and timing.

Do NOT overcorrect for post-meal

glucose levels.

Check carb intake.

Consult healthcare provider for

guidance.

Bolus too large

Possible cause of low

blood glucose

Suggested action

Incorrect target

blood glucose levels

Consult healthcare provider about

refining these settings as needed.

Incorrect correction

factor

Incorrect insulin-to-

carb ratio (IC)

Prone to severe hypo-

glycemia

Consult healthcare provider about

hypoglycemia unawareness and

about raising target blood glucose

levels.

Hypoglycemia

unawareness

Unplanned physical

activity

If blood glucose is below

100 mg/dL

eat a snack before activity.

Consult your healthcare provider

about using a temporary (temp)

basal rate.

Living with Diabetes

114

Hyperglycemia (high blood glucose)

Insulin Pods use rapid-acting insulin, so you have no long-acting

insulin in your body. If an occlusion (interruption of insulin deliv-

ery from the Pod) occurs, your blood glucose can rise rapidly.

Symptoms of hyperglycemia (high blood glucose)

• Fatigue

• Frequent urination, especially during the night

• Unusual thirst or hunger

• Unexplained weight loss

• Blurred vision

• Slow healing of cuts or sores

Possible cause of low

blood glucose

Suggested action

Prolonged or intense

exercise

Adjust insulin delivery as instructed

by your healthcare provider.

Check blood glucose before, during

and after activity and treat as

necessary.

Consult your healthcare provider

about adjusting your basal pro-

grams or using a temporary (temp)

basal rate.

Low carbohydrate

intake prior to

activity

Consume carbohydrate before

activity, especially if you have not

decreased insulin beforehand.

Alcohol consumption Check blood glucose before going

to bed.

Consult healthcare provider for

guidance.

Effects of exercise can last

several hours—even a full

day—after activity ends.

An occlusion may result from a blockage, Pod mal-

function 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.

Hyperglycemia symptoms can be confusing.

Always check your blood glucose before you

treat for hyperglycemia.

Living with Diabetes

115

To avoid hyperglycemia (high blood glucose)

Check your blood glucose at least 4–6 times a day (when you

wake up, before each meal, and before going to bed). In addi-

tion, always check it:

• If you feel nauseated or sick

• Before driving a car

• Whenever your blood glucose has been running unusually

high or low

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

• Before, during and after strenuous physical activities

• As directed by your healthcare provider

To treat hyperglycemia (high blood glucose)

Always check your blood glucose levels frequently while treating

hyperglycemia. You don’t want to over-treat the condition and

cause your BG level to drop too far.

1. Check your blood glucose level. The result will help you to

find out how much insulin is needed to return your blood

glucose to the BG goal.

2. If your blood glucose is 250 mg/dL or above, check for

ketones. If ketones are present, follow your healthcare

provider’s guidelines.

3. If ketones are not present, take a correction bolus as pre-

scribed by your healthcare provider.

4. Check blood glucose again after 2 hours.

5. If blood glucose levels have not decreased, take a second

bolus by injection, using a sterile syringe. Ask your healthcare

provider whether to inject the same amount of insulin as in

step 3.

6. If you feel nauseated at any point, check for ketones and call

your healthcare provider immediately (see “Diabetic ketoaci-

dosis (DKA)” later in this chapter).

7. If blood glucose remains high after another 2 hours (a total of

4 hours), replace the Pod. Use a new vial of insulin to fill the

new Pod. Then:

• Contact your healthcare provider for guidance.

• Drink eight ounces of water every 30 minutes until blood

glucose is within BG goal.

8. Investigate possible cause for hyperglycemia to avoid similar

problems in the future [see “Possible causes of hyperglyce-

mia (high blood glucose)“].

If you need emergency attention, ask a friend or

family member to take you to the emergency

room or call an ambulance. Do NOT drive yourself.

Living with Diabetes

116

Possible causes of hyperglycemia (high blood glucose)

Possible cause of high

blood glucose

Suggested action

Expired insulin Deactivate and remove used Pod.

Apply a new Pod filled from a new

vial of insulin.

Insulin exposed

to extreme

temperatures

Infusion site in or

near a scar or mole

Deactivate and remove used Pod.

Apply a new Pod in a different

location.

Infected infusion site Deactivate and remove used Pod.

Apply a new Pod in a different loca-

tion and consult your healthcare

provider.

Dislodged cannula Deactivate and remove used Pod.

Apply a new Pod in a different

location.

Possible cause of high

blood glucose

Suggested action

Avoid sites near a waistband,

belt, or other areas where fric-

tion may dislodge the cannula.

Living with Diabetes

117

Possible cause of high

blood glucose

Suggested action

Empty Pod Deactivate and remove used Pod.

Apply a new Pod in a different

location.

Incorrect basal

program

Confirm that correct basal program

is active.

Confirm that PDM time is set

correctly.

Consult your healthcare provider

about adjusting your basal pro-

grams or using a temporary (temp)

basal rate.

Incorrect bolus

timing

Check carb intake.

Take bolus with food.

Check blood glucose before giving

meal bolus; if necessary, adjust

bolus.

Consult healthcare provider for

guidance.

Bolus too small

High-protein or

high-fat meal

Calculate protein/fat intake and

account for it in your bolus timing

and bolus type.

Consult healthcare provider about

using the extended bolus option.

Less activity than

normal

Consult your healthcare provider

about adjusting your basal pro-

grams or using a temporary (temp)

basal rate.

Blood glucose value

greater than

250 mg/dL (with

ketones present)

before strenuous

activity

Do NOT exercise when ketones are

present. (Blood glucose increases

with exercise when ketones are

present.)

Consult healthcare provider for

guidance.

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

Consult your healthcare provider

about sick day guidelines and

about medication changes.

Medication change

Possible cause of high

blood glucose

Suggested action

Living with Diabetes

118

Diabetic ketoacidosis (DKA)

Insulin Pods use rapid-acting insulin, so you have no long-acting

insulin in your body. If insulin delivery from the Pod is interrupted

(an occlusion), your blood glucose can rise rapidly and lead to

diabetic ketoacidosis (DKA). DKA is a serious—but totally pre-

ventable—emergency that can occur if you ignore high blood

glucose levels.

Symptoms of DKA

• Nausea and vomiting

• Abdominal pain

• Dehydration

• Fruity-smelling breath

• Dry skin or tongue

• Drowsiness

• Rapid pulse

• Labored breathing

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

assuming you have the flu, check your blood glucose and check

for ketones to rule out DKA.

Weight loss or gain Consult your healthcare provider

for guidance.

Menstrual cycle

Pregnancy

Check with your healthcare provider for guidance on any

of the causes or suggested actions above.

Possible cause of high

blood glucose

Suggested action

If left untreated, DKA can cause breathing difficulties,

shock, coma, and eventually death.

Living with Diabetes

119

To avoid DKA

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

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

allow you to identify and treat high blood glucose before DKA

develops.

To treat DKA

• Once you have begun treatment for high blood glucose,

check for ketones. Check for ketones any time your blood

glucose is 250 mg/dL or above.

• If ketones are negative or trace, continue treating for high

blood glucose.

• If ketones are present, and you are feeling nauseated or ill,

immediately call your healthcare provider for guidance.

• If ketones are positive, but you are not feeling nauseated or ill,

replace the Pod, using a new vial of insulin.

• Check blood glucose again after 2 hours. If blood glucose

level has not declined, immediately call your healthcare

provider for guidance.

n Handling Special Situations

Sick days

Any physical stress can cause your blood glucose to rise, and ill-

ness is a physical stress. Your healthcare provider can help you

make a plan for sick days. The following are only general

guidelines.

When you are ill, check your blood glucose more often (at least

once every 2 hours) to avoid DKA. The symptoms of DKA are

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

check your blood glucose to rule out DKA (see “Diabetic ketoaci-

dosis (DKA)” earlier in this chapter).

To handle sick days

• Treat the underlying illness to promote faster recovery.

• Eat as normally as you can.

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

and snacks.

• Always continue your basal insulin, even if you are unable to

eat. Contact your healthcare provider for suggested basal

rate adjustments during sick days.

• Check your blood glucose every 2 hours and keep careful

records of results.

• Check for ketones when blood glucose is 250 mg/dL or

higher.

If you need emergency attention, ask a friend or

family member to take you to the emergency

room or call an ambulance. Do NOT drive yourself.

Living with Diabetes

120

• Follow your healthcare provider’s guidelines for taking addi-

tional insulin on sick days.

• Drink plenty of noncaffeinated fluids to prevent dehydration.

• Call your healthcare provider immediately if you have:

• Persistent nausea

• Vomiting for more than 2 hours

• High blood glucose or ketones that stay high even

though you take extra insulin

• Low blood glucose with nausea and vomiting

Exercising, playing sports, or working hard

Check your blood glucose levels before, during and after exercis-

ing, playing sports, or doing unusually hard physical labor.

The Pod’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.

For some contact sports, you may want to remove the Pod.

Be sure to check your blood glucose levels before removing the

Pod and after applying a new one. Pods are designed for one-

time use. Do not attempt to reapply a used Pod.

If you will need to remove the Pod for more than 1 hour, ask your

healthcare provider to recommend appropriate guidelines.

X-rays, MRIs, and CT scans

If you are well enough to eat, drink sugar-free bever-

ages. However, if you are too sick to eat solid foods,

alternate between sugar-free beverages and those

containing sugar.

If possible, avoid wasting Pods by planning removal

times that coincide with a scheduled Pod replace-

ment.

The Pod and PDM may be affected by strong radia-

tion or magnetic fields. Before having an X-ray, MRI, or

CT scan (or any similar test or procedure), remove

your Pod and put it and the PDM outside the treat-

ment area. Check with your healthcare provider on

Pod removal guidelines.

The Pod and PDM can tolerate common electromag-

netic and electrostatic fields, including airport security

and cellular phones.

Living with Diabetes

121

Surgery or hospitalization

For scheduled surgeries or hospitalization, you should tell the

doctor/surgeon or hospital staff about your insulin Pod. It may

be necessary to remove it for certain procedures or treatments.

Remember to replace the basal insulin that was missed while the

Pod was removed. Your healthcare provider can help you pre-

pare for these situations.

Always carry medical identification and wear an

emergency medical necklace or bracelet such as

the Medic Alert tag.

122

CHAPTER 10

Alerts and Alarms

n Safety Checks

The mylife OmniPod System has a very important safety feature:

It can check its own functions automatically and alert you when

something needs attention. When you turn on the Personal Dia-

betes Manager (PDM), the System automatically performs

a series of safety checks. (Refer to Page 54 for detailed instruc-

tions. The ID screen must be confirmed before you can check

Pod status.) To make you aware of a serious or potentially serious

condition, the System sounds an alarm and displays an on-

screen message. The message has instructions for taking care of

the alarm condition. Alarm conditions are easy to handle. They

are not a problem if you attend to them promptly.

n Blood Glucose Meter Alerts

These alerts let you know about an error in the blood glucose

meter, test strip, sample, or results. The PDM beeps and displays

an error message number, as in Figure 10-1.

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.

Figure 10-1

Alerts and Alarms

123

The following table explains what the message could mean and what you should do.

Alert error message Possible causes Action

BG Meter Error 1.

Meter problem.

For customer support

call 800.591.3455.

• There is a problem with the

meter.

1. DO NOT use the meter. Contact Customer Care.

BG Meter Error 2.

Meter or strip

problem.

Retest with a new

strip.

• Error message could be

caused either by a used

test strip or a problem

with the meter.

1. Repeat the test with a new test strip.

2. If the error persists, call Customer Care or repeat the blood test.

BG Meter Error 3.

Meter was not

ready.

Retest with a new

strip.

• The sample was applied

before the meter was

ready.

1. Be sure you see the Blood Drop and Test Strip symbols on the display

screen before you apply blood or control solution.

2. Conduct a control solution test using a new test strip. If the results of

the control solution test are within the range printed on the side of

the test strip vial, retest using blood and a new test strip.

3. If the control solution test does not work or the error persists, call

Customer Care or perform another blood test.

Alerts and Alarms

124

BG Meter Error 4.

Strip fill problem.

Retest with a new

strip.

• Not enough blood or

control solution was

applied or more was

added after the meter

began to count down.

• The test strip may have

been damaged or moved

during testing.

• The sample was improp-

erly applied.

• There is a problem with the

meter.

1. Retest using a new test strip. Do not press any buttons or Soft Keys

while applying blood or control solution to the test strip.

2. If the error persists, call Customer Care or perform another blood test.

BG Meter Error 5.

Strip problem.

Retest with a new

strip.

• The meter has detected a

problem with the test

strip, possible cause is

test strip damage.

1. Retest using a new test strip. Do not press any buttons or Soft Keys

while applying blood or control solution to the test strip.

2. If the error persists, call Customer Care.

Alert error message Possible causes Action

Alerts and Alarms

125

Temperature too

high. Out of operating

range.

For customer support

call 800.591.3455.

• Meter is too hot (above

111°F) to work correctly.

1. Move the meter and test strips to a cooler area. Insert a new test strip

when the meter and test strips are within the operating range (43–

111°F). If you do not get another Temperature too high message, you

can proceed with testing.

Temperature too low.

Out of operating

range.

For customer support

call 800.591.3455.

• Meter is too cold (below

43°F)to work correctly.

1. Move the meter and test strips to a warmer area. Insert a new test

strip when the meter and test strips are within the operating range

(43–111°F). If you do not get another Temperature too low message,

you can proceed with testing.

Alert error message Possible causes Action

Alerts and Alarms

126

n Alarms

The mylife OmniPod System provides alarms to make you aware

of serious or potentially serious conditions. When a condition

occurs that requires your attention an Advisory Alarm or a

Hazard Alarm will sound. Advisory alarms beep intermittently

and inform you about a condition that requires your attention.

Hazard alarms are continuous tones and occur when either the

Pod or PDM is in a serious condition. During an alarm the PDM

will display an on-screen message with instructions for taking

care of the alarm condition. Be sure to respond to all alarms

when they occur.

Details on how to handle an Advisory or a Hazard Alarm are

below:

Advisory Alarms

Advisory alarms tell you about a condition that requires your

attention. Each advisory alarm beeps intermittently. When you

hear an advisory alarm, first turn on the PDM to display the

Status screen. The PDM communicates with the Pod, if

necessary, and the screen displays a message describing the

alarm and how to resolve it. All advisory alarms are time sensitive

and require a response. Some advisory alarms escalate to hazard

alarms if you do not respond within a certain time period (as

noted in the following table).

Some advisory alarms are controlled by levels you set in the

Settings screen. One example is the level at which the Low

reservoir volume alarm sounds.

Hazard Alarms

Hazard alarms occur either when the Pod is in a very serious con-

dition or something is wrong with the PDM. Hazard alarms are

continuous tones and each has an on-screen message. Follow

the instructions in the message to fix the alarm situation. For

details, see the table on page 129.

Many alarms (such as Auto-off) will escalate and

result in deactivation of the active Pod if ignored. Be

sure to respond to all alarms when they occur.

Hazard alarms are continuous tones. If the alarm is NOT

acknowledged immediately, the Pod periodically gener-

ates an intermittent alarm tone and then returns to the

continuous tone.

Alerts and Alarms

127

When a hazard alarm occurs in the Pod, all insulin

delivery stops. Failing to address the situation could

result in hyperglycemia. If you had a temp basal or

extended bolus running when the hazard occurred,

the PDM will remind you of this.

Due to the serious nature of hazard alarms, you must

act promptly to resolve them.

1. Acknowledge the alarm condition by pressing

OK, which silences the alarm.

2. Deactivate and remove the active Pod (see Chap-

ter 5, Using the Pod).

3. Activate and apply a new Pod (see Chapter 5,

Using the Pod).

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.

Alerts and Alarms

128

Use the form at the end of this User Guide to write

down all your settings from the Setup Wizard. If you

ever need to reset your PDM, having these settings

handy will make setup very easy.

Alarm Type Source Beep Pattern Action

End of insulin suspend.

Press OK to resume basal

rate delivery.

Advisory

Alarm

Pod

and

PDM

2 sets of beeps every minute for 3

minutes.

Repeats every 15 minutes until

insulin delivery is resumed.

Press OK to resume insulin delivery at

programmed basal rate.

Auto-off alert Advisory

Alarm

Pod

and

PDM

2 sets of beeps every minute for 15

minutes.

Escalates to Auto-off hazard alarm

if not acknowledged within 15

minutes.

Press OK to acknowledge.

Insulin delivery will not resume

until you press OK. If you do not

press OK to resume insulin deli-

very, you could develop hyper-

glycemia (high blood glucose).

The Auto-off alert will escalate to

a hazard alarm if ignored and

will result in the deactivation of

your active Pod. Be sure to

respond to the alert when it

occurs.

Alerts and Alarms

129

Auto-off.

Remove Pod now.

Hazard

Alarm

Pod

and

PDM

Continuous tone. Pod has been deactivated. Insulin deliv-

ery has stopped. Press OK to acknowl-

edge.

Change Pod.

Check blood glucose.

Low reservoir.

Replace Pod soon.

(This is based on the vol-

ume level you selected.)

Advisory

Alarm

Pod

and

PDM

2 sets of beeps every minute for 3

minutes.

Repeats every 60 minutes until

acknowledged.

Escalates to Empty reservoir

hazard alarm when empty.

Press OK to acknowledge.

Empty reservoir.

Insulin delivery stopped.

Change Pod now.

Hazard

Alarm

Pod

and

PDM

Continuous tone. This alarm occurs when the Pod's

reservoir is out of insulin. Press OK to

acknowledge.

Change Pod.

Check blood glucose.

Alarm Type Source Beep Pattern Action

The Low reservoir alert will

escalate to an Empty reservoir

hazard alarm when insulin is

depleted. Be sure to respond to

the alert when it first occurs.

Alerts and Alarms

130

Pod expiration advisory.

Change Pod now.

Advisory

Alarm

Pod

and

PDM

2 sets of beeps repeat periodically.

Repeats every 15 minutes during

the last hour of the Pod’s life and is

independent of the Expiration noti-

fication that you can set. (See Using

the Personal Diabetes Manager in

Chapter 6.)

Escalates to Pod expired hazard

alarm.

Press OK to acknowledge.

Change Pod. (See Chapter 5, Using the

Pod.)

Pod expired.

Insulin delivery stopped.

Change Pod now.

Hazard

Alarm

Pod

and

PDM

Continuous tone. This alarm occurs when the Pod has

reached the end of its operating life.

Press OK to acknowledge.

Change Pod.

Check blood glucose.

Stuck key detected.

Check Home button to

resolve.

For technical support refer

to your User Guide.

Advisory

Alarm

PDM 2 sets of beeps every 5 minutes. Check the key described on the screen.

(In this example, the stuck key is the

Home button.) Press the key to unstick

it.

If this does not work, notify Customer

Care.

Alarm Type Source Beep Pattern Action

Alerts and Alarms

131

Occlusion detected.

Insulin delivery stopped.

Change Pod now.

Hazard

Alarm

Pod

and

PDM

Continuous tone. Press OK to acknowledge.

Change Pod.

Check blood glucose.

Pod Error.

Insulin delivery stopped.

Change pod now.

Hazard

Alarm

Pod

PDM

Continuous tone. This alarm occurs when the Pod detects

an unexpected error. Press OK to

acknowledge.

Change Pod.

Check blood glucose.

PDM Error.

Remove Pod now.

For customer support,

refer to your User Guide.

Hazard

Alarm

PDM Continuous tone. This alarm occurs if an unexpected error

is detected in the PDM. Press OK to

acknowledge.

Remove Pod.

Notify Customer Care immediately.

Check blood glucose.

Alarm Type Source Beep Pattern Action

Alerts and Alarms

132

PDM Error.

Memory corruption.

Press OK to reset PDM and

delete all user settings.

History records will not be

deleted.

Hazard

Alarm

PDM Continuous tone. This alarm occurs after the PDM is reset

and a memory corruption error occurs.

Press OK to acknowledge.

Change Pod.

Check blood glucose.

System Error.

Remove pod now.

For customer support,

refer to your User Guide.

Hazard

Alarm

Pod

PDM

Continuous tone. This alarm occurs if an unexpected error

is detected in the Pod or PDM. Press OK

to acknowledge.

Remove Pod.

Notify Customer Care immediately.

Check blood glucose.

PDM Error.

Press OK to reset clock.

Hazard

Alarm

PDM Continuous tone. This alarm occurs after the PDM is reset,

indicating that the time and date must

be reset. Press OK to acknowledge.

Reset clock.

Check blood glucose.

Alarm Type Source Beep Pattern Action

Alerts and Alarms

133

Pod deactivation required.

Press OK to deactivate.

Hazard

Alarm

PDM Continuous tone.

This alarm occurs after a PDM error

occurs that requires the user to reset the

date and time. Press OK to acknowledge.

Change Pod.

Check blood glucose.

Alarm Type Source Beep Pattern Action

Alerts and Alarms

134

n Manual Shut-off of a Hazard Alarm

If you respond to a hazard alarm but the PDM cannot communi-

cate with the Pod to acknowledge or shut off the alarm, you can

shut off the alarm manually.

1. Remove the Pod from your body if you have not already

done so.

2. Press the end of a paper clip or similar item straight down into

the manual alarm shut-off port (Figure 10-2) on the bottom

of the Pod. The port can be found by peeling back the adhe-

sive pad from the bottom of the Pod at the square end. The

alarm shut-off port is to the right of the fill port.

3. Press the paper clip straight down into the manual alarm shut

off port until the alarm stops and can no longer be heard.

Then discard the Pod according to local waste disposal regu-

lations.

4. The Reset Button is located in the PDM’s battery compart-

ment (Figure 10-3). The Reset Button allows the user to reset

the PDM (i.e. if the screen locks up and goes into an alarm).

The users PDM settings are not lost.

Figure 10-2

Manual

alarm shut-

off port

Fill

port

Figure 10-3

Reset

Button

Alerts and Alarms

135

136

CHAPTER 11

Communication Failures

n The Communication Process

When you turn on or use the Personal Diabetes Manager (PDM),

it establishes communication with the active Pod. Usually, com-

munication occurs quickly. Occasionally, communication takes

longer and the PDM displays the communication icon during

that time in the upper left-hand corner of the current screen.

However, if communication does not work, the PDM will walk

you through the necessary steps to re-establish communication.

Communication can fail if the PDM is:

• Too far from the Pod—The PDM and Pod should be side by

side while priming during activation.

• Interrupted by outside interference—See the “mylife Omni-

Pod System Notice Concerning Interference” in the Appen-

dix.

n Failure During Pod Activation or Operation

When you send an instruction from the PDM—such as Start to

begin bolus delivery or Enable to begin using a different basal

program—the Pod usually responds quickly. However, if the

PDM cannot send your instruction within a few seconds, it dis-

plays the “Communication error” screen (Figure 11-1 on the next

page).

1. Move the PDM closer to the Pod. The PDM will try to commu-

nicate with the Pod again. If communication still fails, you will

see the message in Figure 11-2 on the next page.

As a safety feature, the communication distance

between the Pod and PDM is reduced during activation.

Once a Pod is primed and communicates with the PDM,

the full communication range is restored and the Pod

can receive commands only from that PDM.

Communication Failures

137

2. Move across the room or to a different room. Then press

Retry.

a. If you press Retry within 2 minutes, the PDM tries to

communicate with the Pod again. If it cannot communi-

cate, it displays the same screen as in Figure 11-2,

then finally the “Communication time-out” screen

(Figure 11-3). Press OK to check the Pod status.

b. If the status check fails, you will see the screen in Figure

11-4. Press OK to try checking Pod status again or press

Discard to begin the deactivation process.

Figure 11-1 Figure 11-2 Figure 11-3 Figure 11-4

Communication Failures

138

3. If at any point in this process the PDM can communicate

again with the Pod, you will see either:

a. Figure 11-5, indicating that your original instruction or

command was successfully sent to the Pod. When you

press OK, or within 5 seconds, the System displays the next

screen in the command sequence you were entering.

b. Figure 11-6, indicating that your last command was not

sent to the Pod. Press OK.

If you were activating a Pod, the System returns to the pre-

vious screen where you can continue activation. If you

were issuing any other command, the System returns to

the Status screen, where you can reissue the command.

n Failure During Pod Deactivation

To review the deactivation process, see “Deactivate the current

Pod” in Chapter 5, Using the Pod.

If you press Confirm to deactivate the active Pod and the PDM

cannot send your instruction to the Pod, you will see the screen

in Figure 11-7.

Either:

1. Press Retry to try deactivating the Pod again. If the PDM still

cannot send the instruction, you will see Figure 11-7 again.

Follow step 2.

Figure 11-5 Figure 11-6

Figure 11-7

Communication Failures

139

2. Press Discard. The PDM will consider the Pod lost and ask

whether you want to activate a new Pod.

n Failure During Request for Status

If you turn on the PDM or press Status and the PDM cannot

communicate with the Pod, it displays a communication icon

(Figure 11-9). Below the icon is a soft key labeled Skip.

Either:

1. Wait until you see the “Pod status not available” screen

(Figure 11-10).

Or:

2. Press Skip to skip the communication process and immedi-

ately bring up Figure 11-10.

If you have an unconfirmed correction bolus when you

discard a Pod, then the bolus calculator will be temporar-

ily disabled. In this situation, the bolus calculator is dis-

abled until the duration-of-insulin-action period passes

(Figure 11-8). If you have any questions, call Customer

Care.

Figure 11-8

Figure 11-9 Figure 11-10

Communication Failures

140

At either “Pod status not available” screen, press Home to return

to the Home screen or press Status to send another status

request.

n Failure During Bolus Cancellation

When you instruct the PDM to cancel a bolus, if the PDM cannot

send your instruction to the Pod within a few seconds, it displays

the “Communication error” screen (Figure 11-12).

1. Move the PDM close to the Pod. The PDM tries to communi-

cate with the Pod again.

2. If the PDM still cannot communicate with the Pod, you will

see the “Bolus status unknown” message (Figure 11-13).

If the Pod has expired, you will see the screen in

“” on page 140 instead.

Figure 11-11

Figure 11-12 Figure 11-13

Communication Failures

141

3. Move across the room or to a different room. Then either:

a. Press Discard to begin the deactivation process.

b. Press Retry to repeat the attempts to communicate with

the Pod. The PDM tries to communicate with the Pod

again. If it cannot communicate, it displays the same

screen as in Figure 11-13, then finally a second “Bolus

status unknown” screen (Figure 11-14). Press OK to check

the Pod status or press Discard to begin the deactivation

process.

4. If at any point in this process the PDM can communicate

again with the Pod, you will see Figure 11-15. The message

indicates that your original instruction to cancel the bolus

was successful.

a. Press OK. The PDM displays the screen in Figure 11-16,

showing how much insulin was delivered before the

bolus was canceled.

b. Press OK again to return to the Status screen.

If your PDM is damaged or not working as

expected, call Customer Care for assistance. Be

sure to check your blood glucose frequently.

Remove your Pod and contact your healthcare

provider for treatment guidelines to follow after

you remove it.

Figure 11-14 Figure 11-15

Figure 11-16

142

Appendix

The mylife OmniPod® Insulin Management System has no user-serviceable parts. If you require assistance operating or main-

taining the System, please call Customer Care.

n Pod Care and Maintenance

Storage

Store unopened Pods in a cool, dry place. Extreme heat or cold

can damage Pods and cause them to malfunction. If Pods are

exposed to extreme temperatures, inspect them carefully before

use. Pods are sterile unless packaging is opened or damaged. Do

not apply or use a Pod if its sterile packaging is opened or

damaged.

Cleaning

Pods are waterproof. If you need to clean a Pod, you can gently

wash it with a clean, damp cloth. Or you can use mild soap and

water. However, do not use strong detergents or solvents. They

can damage the Pod’s casing or irritate the infusion site.

n Personal Diabetes Manager Care and Maintenance

Storage

When you are not actively using the Personal Diabetes Manager

(PDM) to enter or change programs, you can store it in a conve-

nient, nearby location. The storage location should be cool and

dry.

If the PDM is not safe from children or others who may press the

buttons by accident, consider using the optional PDM lock

safety feature to prevent accidental program changes (see

Chapter 6, Using the Personal Diabetes Manager).

Hold the Pod securely and take care while cleaning

it, so the cannula doesn’t kink and the Pod doesn’t

become detached from your skin.

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.

Appendix

143

Cleaning and disinfecting

Cleaning is to keep free from dirt, stains, or impurities; unsoiled.

Disinfecting is the process of destroying pathogenic organisms

or rendering them inert.

Keep your PDM test strip port and USB port free of debris and

liquids. Dirt, dust, blood, and control solution can impair the

functionality of your PDM or damage it.

If the battery compartment becomes soiled, gently shake out

the debris or use a dry, lint-free cloth to remove it.

You should clean and disinfect your PDM at least once a week.

You should also clean your PDM whenever it is visibly soiled. For

both cleaning and disinfecting the same process should be fol-

lowed. Therefore, if you are intending to complete weekly

cleaning and disinfection you should complete the process out-

lined to the right.

Use the guidelines below to clean or disinfect your PDM:

The PDM can be cleaned and disinfected up to twice a week over

the course of the life of the device (4 years).

1. Be sure to turn off your PDM before cleaning or disinfecting.

2. To clean and disinfect the outside surfaces of the PDM hous-

ing, use Dispatch® Hospital Cleaner Disinfectant Towels with

Bleach or its formula equivalent (available online through

major retailers).

3. Following the instructions on the label of the Dispatch® Hos-

pital Cleaner Disinfectant Towels with Bleach , wipe the out-

side surfaces of your PDM. Treated surfaces must remain wet

for a full two (2) minutes.

4. Let your PDM air dry completely before checking your BG

next. We recommend you perform a control solution test to

ensure the System functions properly. See ”Performing a

Control Solution Test” in Chapter 7, Checking Your Blood Glu-

cose.

5. If you see any signs of deterioration of the PDM (i.e. cracking,

separation, discolorations), please contact Customer Care.

Do NOT use IV Prep™ wipes, alcohol wipes, soap,

detergent, or solvents. Never put any liquid into the

battery compartment. The PDM is NOT waterproof.

Do NOT immerse it or place it in or near water.

It is recommended that the user pre-clean the device

prior to each disinfection cycle.

While cleaning, do NOT allow debris or liquid to get

into the test strip port, USB port, battery compart-

ment, or buttons (see Figure A-1 on the next page).

Appendix

144

Replacing batteries

The PDM uses two (2) AAA alkaline batteries. You can purchase

them at any grocery, hardware or convenience store.

On average, a pair of batteries powers the PDM for 3 weeks. The

battery life indicator on the PDM shows the battery power level.

See “Personal Diabetes Manager Icons” later in this Appendix for

the various battery power levels and their respective icons.

The PDM automatically alerts you when its battery power gets

low (see Figure A-2). When you see the “Low PDM battery” alert,

press OK to turn off the alert. Replace the batteries as soon as

you can.

AAA alkaline batteries are the required battery to

power the PDM. Do not use any other type of batter-

ies. Never use old or used batteries; the PDM may

not work properly. Using any kind of batteries other

than alkaline may reduce battery life and cause dam-

age to the PDM. Do no use rechargeable batteries.

Figure A-1

Test Strip Port (BG)

IR Port

USB Port

Battery

Compartment

(Reverse Side)

Buttons

Figure A-2 Figure A-3

Appendix

145

To replace batteries

1. Open the battery compartment on the back of the PDM by

pushing the compartment latch inward and then upward

(Figure A-2). No special tools are necessary.

2. Insert 2 new AAA alkaline batteries into the compartment.

3. Replace the battery door.

4. Turn the PDM face up. The PDM powers on automatically.

The PDM is now ready to use. Dispose of the old batteries in

accordance with local waste disposal regulations.

If the PDM becomes submerged in water

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

near water where it can accidentally fall in. If it becomes sub-

merged in water:

1. Dry the outside of the PDM with a clean, lint-free cloth.

2. Open the battery compartment; remove the batteries and

discard them.

3. Use a clean, lint-free cloth to gently absorb any water in the

battery compartment.

4. Leave the battery compartment door open until the PDM is

thoroughly dry.

5. Do not put in fresh batteries or attempt to use the PDM until

it has thoroughly air-dried.

When your PDM alerts you that battery power is getting

low, the PDM will maximize remaining battery life by:

• Turning off your vibration alert (if set)

• Disabling bright mode

• Disabling the test strip port light

Once the batteries are replaced, these functions resume.

If the batteries run out, date and time are at risk. DO

NOT remove the old batteries until you have new

ones at hand. The PDM protects data in the memory

for up to 2 hours after the batteries run out or are

removed.

The diagram inside the compartment shows you

which direction to insert the batteries.

Never use a blow dryer or hot air to dry the Pod or

PDM. Extreme heat can damage the electronics.

Appendix

146

If you drop the PDM

The PDM is built to withstand reasonable amounts of abuse, but

shock or a severe impact can damage it. If you drop the PDM or if

it is otherwise subjected to severe impact:

1. Inspect the outside of the PDM for visible signs of damage.

2. Press and hold the Power button to see whether the PDM

turns on and whether the LCD screen is damaged.

3. Inspect the inside of the battery compartment for visible

signs of damage.

4. Do NOT use the PDM if it appears damaged or is not working

as it should.

If you are unable to use your PDM to check your BG, have a back

up meter on hand to check your BG.

n Storage and Supplies

To order all mylife OmniPod System products and supplies, call

Customer Care.

If your PDM is damaged or not working as it

should, please call Customer Care for assistance.

Be sure to check your blood glucose frequently.

Remove your Pod and contact your healthcare

provider for treatment guidelines to follow after

you remove it.

If you require assistance, please call Customer Care.

Store all mylife OmniPod System products and sup-

plies (including unopened Pods) in a cool, dry place.

Products or supplies that have been exposed to

extreme temperatures may not function properly.

It is especially important to store your insulin in a well-

controlled environment. Inspect insulin before using

it; never use insulin that looks cloudy or discolored.

Insulin that is cloudy or discolored may be old, conta-

minated or inactive. Check the insulin manufacturer’s

instructions for use and expiration date.

Appendix

147

n Suggested Bolus Calculator Examples and

Guidelines

A suggested bolus is equal to the sum of a correction bolus and

meal bolus, then adjusted for insulin on board, if applicable.

Examples of each of these elements are shown below.

Example of correction bolus

Target BG: 100 mg/dL

Current BG: 200 mg/dL

Correction factor (CF): 50

200 mg/dL (current) – 100 mg/dL (target) = 100 mg/dL

100 mg/dL ÷ 50 (CF) = 2 units correction bolus

If the reverse correction feature is turned On and if your current

BG is below your target BG, the suggested bolus calculator sub-

tracts a correction amount from the meal bolus.

Example of reverse correction bolus:

Target BG: 100 mg/dL

Current BG: 75 mg/dL

Correction factor (CF): 50

75 mg/dL (current) – 100 mg/dL (target) = –25 mg/dL

–25 mg/dL ÷ 50 CF = –0.5 units reverse correction bolus

(reduces meal bolus)

Meal bolus calculation

Carbs entered ÷ insulin-to-carb (IC) ratio

Example of meal bolus

Carbs entered: 45 grams of carb

Insulin-to-carb ratio: 15

45 carbs ÷ 15 IC ratio = 3 units meal bolus

Insulin-on-board (IOB) calculation

(Duration of insulin action – time since your previous bolus) ÷

(duration of insulin action)  (previous bolus)

IOB from a previous correction bolus is called “correction IOB,”

and IOB from a previous meal bolus is called “meal IOB.”

Example of correction insulin-on-board (IOB)

Duration of insulin action: 3 hours

Time since previous correction bolus: 1 hour

Previous correction bolus: 3 units

3 hours – 1 hour = 2 hours

2 hours ÷ 3 hours = 2/3

2/3  3 units = 2 units correction IOB

In other words, one hour after your previous correction bolus,

you have received only 1 unit of insulin from it; 2 units of insulin

are still working to correct your BG. This feature prevents deliver-

ing too much insulin when correcting a high BG.

Appendix

148

Example of meal insulin-on-board IOB

Duration of insulin action: 3 hours

Time since previous meal bolus: 2 hours

Previous meal bolus: 4.5 units

3 hours – 2 hours = 1 hour

1 hours ÷ 3 hours = 1/3

1/3  4.5 units = 1.5 units meal insulin on board (IOB)

In other words, two hours after your previous meal bolus, you

have received 3 units of insulin from it; 1.5 units of insulin are still

working to cover your meal.

Examples of suggested bolus calculations

The examples below use these settings:

• Target BG: 100 mg/dL

• IC ratio: 1:15

• Correction factor (CF): 50

• Duration of insulin action: 3 hrs

Example 1

Current BG level: 150 mg/dL

Carb intake: 0 grams of carbohydrate (carbs)

Meal IOB: 1 unit

Correction IOB: 1 unit

Correction bolus: 150 mg/dL (current) – 100 mg/dL (target) = 50

50 ÷ 50 (CF) = 1 unit

Meal bolus: 0 (carbs) ÷ 15 (IC ratio) = 0 units

Suggested bolus dose = 1 (correction) + 0 (meal) – 2 (meal +

correction IOB) = 0 U

Example 2

Current BG level: 150 mg/dL

Carb intake: 45 carbs

Meal IOB: 0 units

Correction IOB: 0 units

Correction bolus: 150 mg/dL (current) – 100 mg/dL (target) = 50

50 ÷ 50 (CF) = 1 unit

Meal bolus: 45 (carbs) ÷ 15 (IC ratio) = 3 units

Suggested bolus dose = 1 (correction) + 3 (meal) – 0 (IOB) = 4 U

Meal IOB is used only to reduce a correction bolus,

and the correction bolus is only reduced until it

becomes 0 units.

Appendix

149

Example 3

Current BG level: 100 mg/dL

Carb intake: 45 carbs

Meal IOB: 1 unit

Correction insulin on board (IOB): 0 units

Correction bolus: 100 mg/dL (current) – 100 mg/dL (target) = 0

0 ÷ 50 (CF) = 0 units

Meal bolus: 45 (carbs) ÷ 15 (IC ratio) = 3 units

Suggested bolus dose = 0 (correction) + 3 (meal) – 0 (IOB) = 3 U

Example 4

Current BG level: 150 mg/dL

Carb intake: 60 carbs

Meal IOB: 0 units

Correction IOB: 1 unit

Correction bolus: 150 mg/dL (current) – 100 mg/dL (target) = 50

50÷ 50 (CF) = 1 unit

Meal bolus: 60 (carbs) ÷ 15 (IC ratio) = 4 units

Suggested bolus dose = 1 (correction) + 4 (meal) – 1 (IOB) = 4 U

Calculator guidelines

When the suggested bolus calculator is turned On, the mylife

OmniPod System applies these guidelines to the suggested

bolus doses:

• Suggested bolus doses are rounded down to the nearest

0.05 U.

• If the total of the suggested bolus calculation (correction

bolus plus meal bolus) is less than zero, the suggested bolus

dose is 0.00 U.

• The System will not suggest a bolus dose if your current

blood glucose (BG) reading is below the minimum BG you

have set for bolus calculation (see Chapter 2, Getting Started,

and Chapter 6, Using the Personal Diabetes Manager).

• The System suggests a correction bolus only when your BG

reading is above the correction threshold or correct-above

value you have set (see Chapter 2, Getting Started, and

Chapter 6, Using the Personal Diabetes Manager).

• Meal IOB, which is insulin on board from a previous meal

bolus, is subtracted first from the current correction bolus, if

any, until it is zero. However, any remaining meal IOB is never

subtracted from the current meal bolus.

Meal IOB is never subtracted from another meal

bolus – only from a correction bolus.

Appendix

150

• Correction IOB, which is insulin on board (active insulin) from

a previous correction bolus, is then subtracted from the cur-

rent correction bolus, if any remains, until it is zero. At that

point, any remaining correction IOB is subtracted from the

current meal bolus.

• The calculated insulin on board is rounded up to the nearest

0.05 U.

• A reverse correction only occurs if the meal bolus is greater

than 0.00 U.

• If your blood glucose value is below the target blood glucose

value and you have set reverse correction to On, the sug-

gested correction bolus is subtracted from the suggested

meal bolus. If you have set reverse correction to Off, the

System will not subtract insulin from the suggested meal

bolus dose.

If you manually increase or decrease the suggested bolus, the

following rules apply:

• If you increase a suggested bolus, the increase is applied to

the meal bolus unless there is no meal bolus, in which case it

is applied to the correction bolus.

• If you decrease a suggested bolus, the decrease is applied to

the meal bolus until it reaches zero; then it is applied to the

correction bolus. If there is no meal bolus, the decrease is

applied to the correction bolus.

Appendix

151

n mylife OmniPod System Options and Settings

Time 12-hour or 24-hour clock

Date MM/DD/YY

DD/MM/YY

MM.DD.YY

DD.MM.YY

YY.MM.DD

YY-MM-DD

Maximum basal rate 30 U/hr

Default is 3.00 U/hr

Basal programs 7

Basal rate segments 24 per program

Basal rate increment 0.05 units

Temp basal presets 7

Temp basal %, Units, or Off

30 minutes to 12 hours in

30-minute increments

Default is Off

Blood glucose (BG) goal for

BG history

Upper and lower limits; 70 to 200

mg/dL in 1 mg/dL increments

Blood glucose reminder On or Off; maximum of 4 active at

any one time. Created at time of

bolus entry; reminder can be set

for 30 minutes to 4 hours after

bolus is started, in 30-minute

increments. Default is Off.

Blood glucose meter sound On or Off

Default is On

Suggested bolus calculator On or Off

Default is On

Target BG value and

correction threshold

8 time segments; 70 to 200 mg/dL

in 1 mg/dL increments

Minimum BG allowed for

use by the suggested bolus

calculator

50 to 70 mg/dL in 1 mg/dL incre-

ments

Default is 70 mg/dL

Insulin-to-carb (IC) ratio 8 time segments; 1 to 150 g

carb/U in 1g carb/U increments

Correction factor 8 time segments; 1 to 300 mg/dL

in 1 mg/dL increments

Reverse correction On or Off

Default is On

Duration of insulin action 2 to 6 hours in 30-minute

increments

Bolus increment 0.05, 0.1, 0.5, or 1.0 units

Default is 0.1 units

Maximum bolus size 30 units

Default is 10 units

Extended bolus %, Units, or Off

30 minutes to 8 hours in

30-minute increments

Default is Off

Appendix

152

n Pod Specifications

Size: 3.9 cm x 5.2 cm x 1.45 cm

Weight (without insulin): 25 grams

Operating temperature range: 4.4°C to 40°C

Under normal circumstances, your body temperature will keep

the Pod well within this range.

Startup temperature: above 10°C

Storage temperature range: 0°C to 30°C

Reservoir volume (deliverable): 200 units

Cannula insertion depth: 6.5 mm

Waterproof rating: IPX8 (7.6 meters for up to 60 minutes)

Insulin concentration: U-100

Alarm type: Audible

Operating relative humidity range: 20–85%, non-condensing

Storage relative humidity range: 20–85%, non-condensing

Operating atmospheric pressure: 696 hPA to 1060 hPA

Storage atmospheric pressure: 696 hPA to 1060 hPA

Non-pyrogenic: Fluid pathway only

Type BF Medical Device: Protection from electrical shock

Flow Capability:

Basal: Programmable by the user in 0.05 U pulses

up to 30.0 U per hour

Bolus:

Rate: 1.5 units per minute

Range: 0.05 to 30.0 units

Delivery accuracy (tested per IEC 60601-2-24):

Basal: +/- 5% at rates > 0.05 U/hr

Bolus: +/- 5% for all set values > 0.05 units

Bolus presets 7

Carbohydrate presets 36

Suspend 30 minutes to 2 hours

Low reservoir volume

indicator

10 to 50 units in 5-unit increments

Default is 10.0 units

Pod expiration alert 1 to 24 hours in 1-hour increments

Default is 4 hours

Auto-off alert 1 to 24 hours or Off, in 1-hour

increments

Default is Off

PDM lock On or Off

Default is Off

History storage 5400 records/90 days

Language English

Appendix

153

n Accuracy Test Results

The following graph is designed to show flow accuracy of the

Pod against given time periods.

Flow rate error

The following trumpet curve shows the accuracy of the delivery

rate in relation to the observation period. The measurements

were made using a Pod with a basal rate of 0.05 U/h at high oper-

ating temperature. The overall mean percentage flow error was

1.40%.

Appendix

154

n Personal Diabetes Manager Specifications

Size: 6.21cm x 11.25cm x 2.5cm

Weight (with batteries): 125 grams

Screen: 3.6cm wide x 4.8cm long; 6.1cm diagonal screen LCD

Battery: Powered by (2) AAA alkaline batteries

Battery life: Approximately 3 weeks

Operating temperature range: 4.4°C to 40°C

Storage temperature range: -29°C to 60°C

Operating relative humidity range: 10% to 90% non-

condensing

Storage relative humidity range: 10% to 90% non-condensing

Operating atmospheric pressure: 696 hPA to 1062 hPA

Storage atmospheric pressure: 703 hPA to 1062 hPA

Communication distance: At start up the PDM and Pod should

be adjacent and touching, either in or out of tray to ensure proper

communication during priming. At least 152.40 cm during

normal operation.

Alarm type: Audible

Alert type: Audible and vibratory

Warranty: 4 Year Limited (PDM)

n Blood Glucose Meter Specifications

Assay method: Coulometric electrochemical sensor

Calibration: Plasma equivalent

Hematocrit: 15% to 65%

Measurement units: mg/dL

Result range: 20 to 500 mg/dL

Sample: Whole blood, capillary

Sample size: 300 nanoliters (0.3 microliters)

Test time: Results in as fast as 7 seconds

Appendix

155

n mylife OmniPod System Label Symbols

Symbol Meaning

Do not reuse this device; single-use only

Caution: Consult accompanying documents

Refer to Instruction Manual

Sterilized by ethylene oxide

Manufacture date: (year–month)

Lot number

Expiration date (use-by date): (year–month)

Reference/reorder number

Device serial number

Type BF medical device

(protection from electrical shock)

Manufacturer

Non-pyrogenic; fluid pathway only

Not MRI-safe

Waterproof to 7.6 meters for up to 60 minutes

Keep dry

Symbol Meaning

Storage temperature

Do not use if package is damaged

Authorized Representative in the European

Community

Product is designed and manufactured in accor-

dance with applicable standards/guidelines and

may be sold in the EU (European Union)

Do not throw away; contains mercury

Quantity of Pod(s), Needle(s) and Syringe(s) that

are packaged individually or as 10 packs.

Appendix

156

n Personal Diabetes Manager Icons

Icon Meaning Icon Meaning

Power More actions

Bolus Communication

Pod change Up/Down

Diagnostics/

settings Up/Down (on color)

Temp basal Status

Suspend/cancel Text entry right

My Records Submenu

Advisory alarm Home screen

(Alternating)

Hazard alarm Insulin gauge

Alert Apply blood sample/

Blood glucose records

PDM lock Setup Wizard

Battery 3/4 full Battery full

Battery 1/4 full Battery half full

Basal program Battery empty

“Lost” history

record

User Information/

Support

“Unconfirmed”

history record

Blood Glucose Meter -

Temperature out of

range

“Delivery Spans

Midnight”

history record

Active/default

program or selected

BG tag

Icon Meaning Icon Meaning

Appendix

157

n Medical Device Directive

This device complies with Medical Device Directive 93/42/EEC.

Contact Person: The Complaints Officer

Address: HealthLink Europe BV, Centaurusweg 123

NL-5015 TC TILBURG, The Netherlands

TEL: +31.13.5479300

FAX: +31.13.5479302

E-mail: complaints@HealthlinkEurope.com

Insulet Corporation complies with EU Directive, HIPAA, and rele-

vant provisions of PIPEDA.

n mylife OmniPod System Notice

Concerning Interference

The mylife OmniPod Insulin Management System (both the Pod

and the Personal Diabetes Manager or PDM) complies with Part

15 of the FCC Rules. Operation is subject to the following two

conditions:

1. These devices may not cause harmful interference.

2. These devices must accept any interference received, includ-

ing interference that may cause undesirable operation.

Changes or modifications not expressly approved by Insulet

could void the user’s authority to operate the equipment.

Both the Pod and the PDM generate, use, and can radiate radio

frequency energy, and may cause harmful interference to radio

communications. There are no guarantees that interference will

not occur in a particular installation. If the mylife OmniPod Sys-

tem does cause harmful interference to radio and television

reception, the interference may be corrected by one of the fol-

lowing measures:

• Move or reposition the mylife OmniPod System.

• Increase the distance between the System and the other

device that is emitting or receiving interference.

Insulet Corporation declares that the mylife OmniPod System is

in compliance with the essential requirements and other rele-

vant provisions of Directive 1999/5/EC. This ISM device complies

with Canadian ICES-003 and IC-RSS-210.

n Electromagnetic Compatibility

The information contained in this section (such as separation

distances) is, in general, specifically written with regard to the

mylife OmniPod System. The numbers provided will not guaran-

tee faultless operation but should provide reasonable assurance

of such. This information may not be applicable to other medical

electrical equipment; older equipment may be particularly sus-

ceptible to interference.

Appendix

158

General Notes

Medical electrical equipment requires special precautions

regarding electromagnetic compatibility (EMC) and needs to be

installed and put into service according to the EMC information

provided in this document and the instructions for use.

Portable and mobile RF communications equipment can affect

the function of medical electrical equipment.

Insulet Corporation declares that the mylife OmniPod Insulin

Management System is in compliance with the essential require-

ments and other relevant provisions of Directive 1999/5/EC.

Cables and accessories not specified within the instructions for

use are not authorized. Using other cables and/or accessories

may adversely impact safety, performance, and electromagnetic

compatibility (increased emission and decreased immunity).

Care should be taken if the System is used adjacent to other elec-

trical equipment; if adjacent use is inevitable, such as in work

environments, the System should be observed to verify normal

operation in this setting.

The System communicates by low level RF energy. As with all RF

receivers, the potential for disturbance exists, even with equip-

ment that complies with FCC and CISPR emissions requirements.

The mylife OmniPod System communicates with the following

characteristics:

Frequency: 433 MHz, FSK modulation, with an effective radi-

ated power of 13mW

The mylife OmniPod System greatly exceeds the immunity

requirements of the general standard for electromagnetic com-

patibility, IEC 60601-1-2.

Electromagnetic Emissions

This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure

that is used in such an environment.

Emissions Compliance according to Electromagnetic environment

RF Emissions (CISPR 11) Group 2 The Pod and the PDM emit low level electromagnetic energy (RF) in

order to communicate. Although unlikely, nearby electronic equip-

ment may be affected.

CISPR B

Emissions Classification

Class B The System is suitable for use in all establishments including domestic

establishments.

Appendix

159

Electromagnetic Immunity

The System is intended for use in the electromagnetic environment specified below. You should observe these requirements in the

use of the System.

Immunity against

IEC 60601-1-2

test level

Compliance level

(of this device) Electromagnetic environment

ElectroStatic Discharge,

ESD (IEC 61000-4-2)

contact discharge:

± 6 kV

air discharge: ± 8 kV

± 8 kV

± 15 kV

If floors are covered with synthetic material, try to avoid electro-

static discharges.

Power Frequency mag-

netic fields 50/60 Hz

(IEC 61000-4-8)

3 A/m 400 A/m Suitable for most environments. Magnetic field strengths in

excess of 400 A/m would be unlikely except in close proximity

to industrial magnetic devices.

Appendix

160

Radiated RF

(IEC 61000-4-3)

80 MHz–2.5 GHz 10 V/m Portable and mobile RF communications equipment should

be used no closer to any part of the System than the recom-

mended separation distance calculated from the equation

applicable to the frequency of the transmitter as below.

Recommended separation distance:

d=1.17 P 150 KHz to 80 MHz

d=0.35 P 80 MHz to 800 MHz

d=0.7 P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmit-

ter in watts (W) according to the transmitter manufacturer and

d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an

electromagnetic site survey,a should be less than the compli-

ance level in each frequency range.

Interference may occur in the vicinity of equipment marked

with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflections from struc-

tures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,

AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment

due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the

equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If

abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment.

Electromagnetic Immunity (Continued)

Appendix

161

Recommended Separation Distances Between Portable and

Mobile RF Communications Equipment and the System

You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communi-

cations equipment (transmitters) and the System, as recommended below, according to the maximum output power of the com-

munications equipment.

Rated maximum output power

of transmitter, in watts

Separation distance according to frequency of transmitter, in meters

150 kHz to 80 MHz, d = 1.17 P 80 MHz to 800 MHz, d = 0.35 P 800 MHz to 2.5 GHz, d = 0.7 P

0.01 0.12 0.035 0.070

0.1 0.37 0.11 0.22

1 1.17 0.35 0.7

10 3.70 1.11 2.21

100 11.7 3.5 7.0

For transmitters rated at a maximum output power not listed above, the recommended separation distances in meters (m) can be estimated

using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts

(W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from struc-

tures, objects, and people.

162

Glossary

A1c (see Hemoglobin A1c)

Advisory alarm

Notification by the PDM that a serious condition exists.

Aseptic technique

A method for maintaining sterilization and preventing

contamination.

Basal program

One or more basal rates that together cover a 24-hour period

from midnight to midnight.

Basal rate

A small base or background amount of insulin that is delivered, at

a preset rate, continuously for a specified period of time. Basal

rates are measured in units per hour (U/hr).

Basal segment (time segment)

The time period during which a specific basal rate is delivered.

BG goal

A range of blood glucose levels that you are trying to achieve

during a certain period of the day. For example, you may want

one BG goal before meals, a different BG goal two hours after

meals, and yet another BG goal for bedtime.

Blood glucose (see glucose)

Blood glucose level

The amount of glucose, or sugar, in the blood.

Blood glucose meter

A device used to check blood glucose content.

Bolus dose

A dose of insulin taken to correct an elevated blood glucose level

or to cover carbohydrates in a meal or snack.

Bolus preset

A bolus dose of insulin, in units, that can be assigned a custom

name and preprogrammed into the PDM.

Glossary

163

Calorie

A unit of measurement used to express the energy value of food.

Calories come from carbohydrate, protein, fat, and alcohol.

Cannula

A small, thin tube inserted below the skin, which serves to intro-

duce a liquid medication into the body.

Carbohydrate (carb)

One of the three main nutrients found in food. (The other two

are protein and fat.) Foods that contain carbohydrates include

starches, sugars, vegetables, fruits, and dairy products.

Carbohydrate counting

A method of meal planning based on counting the number of

grams of carbohydrate in a given food.

Carb preset

A favorite food item, snack, or entire meal that can be assigned a

custom name and preprogrammed into the PDM. You set the

carbohydrate value (and, optionally, the fat, protein, fiber, and

total calories) for each carb preset.

Complications (of diabetes)

Harmful effects of diabetes such as damage to the eyes, kidney,

heart, blood vessels, nervous system, teeth and gums, feet, and

skin.

Correction bolus

An amount of insulin taken to compensate for high blood glucose

levels. The mylife OmniPod System calculates the correction

bolus by taking the difference between your current blood glu-

cose level and your target blood glucose level, then dividing the

result by your correction factor.

Correction factor

A value that indicates how much one unit of insulin will lower

your blood glucose. For example, if your correction factor is 50,

one unit of insulin will lower your blood glucose by 50 mg/dL.

Correction threshold

The blood glucose level above which you would like to take

insulin to reduce an elevated blood glucose.

CSII (continuous subcutaneous insulin infusion)

Delivering insulin continuously under the skin (“subcutaneously”)

on a programmed schedule.

Dawn phenomenon

An early morning rise in blood glucose level caused by the normal

release of hormones that block insulin’s effect.

Glossary

164

Diabetes Control and Complications Trial (DCCT)

A study by the National Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK), conducted from 1983 to 1993 in

people with type 1 diabetes, which showed that good blood

glucose control significantly helped prevent or delay diabetes

complications.

Diabetes, diabetes mellitus

A condition characterized by hyperglycemia (high blood glucose)

resulting from the body’s inability to use blood glucose for energy.

In type 1 diabetes, the pancreas no longer makes insulin and

therefore blood glucose cannot enter the cells to be used for

energy. In type 2 diabetes, either the pancreas does not make

enough insulin or the body is unable to use insulin correctly.

Diabetic ketoacidosis (see Ketoacidosis)

Duration of insulin action

The length of time that certain types of insulin remain active and

available in your body after a bolus. This duration can vary greatly

depending on the type of insulin you take. Only use rapid-acting

insulin with the mylife OmniPod® Insulin Management System.

Extended bolus

A feature of the mylife OmniPod System that allows a meal bolus

dose to be given over an extended period of time.

Fat

One of the three main energy sources in food. (The other two are

carbohydrate and protein.) Fat is a concentrated source of energy,

providing 9 calories per gram. Foods high in fat include oils, mar-

garine, salad dressings, red meat, and whole-milk dairy foods.

Fiber

The indigestible part of plant foods. Foods that are high in fiber

include broccoli, beans, raspberries, squash, whole-grain bread,

and bran cereal or granola. Fiber is a type of carbohydrate but

does not raise blood glucose levels as other carbohydrates do.

Glucose

A simple sugar (also known as dextrose) used by the body for

energy. Without insulin, the body cannot use glucose for energy.

Hazard alarm

Notification by the PDM that a dangerous condition exists.

Healthcare provider

A professional who practices medicine or teaches people how to

manage their health. All healthcare providers are a resource for

valuable diabetes management information.

Glossary

165

Hemoglobin A1c (HbA1c)

A test that measures a person’s average blood glucose level over

the past 2 to 3 months. Also called glycosylated hemoglobin, the

test shows the amount of glucose that sticks to the red blood cell,

which is proportional to the amount of glucose in the blood.

Hyperglycemia (high blood glucose)

A higher-than-normal level of glucose in the blood; generally 180

mg/dL or higher.

Hypoglycemia (low blood glucose)

A lower-than-normal level of glucose in the blood; generally 70

mg/dL

or lower.

Hypoglycemia unawareness

A condition in which a person does not feel or recognize the

symptoms of hypoglycemia.

Infusing

Introducing a liquid substance under the skin into the body.

Infusion site

A place on the body where an infusion set or Pod is placed and

cannula is inserted.

Insulin

A hormone that helps the body use glucose for energy. The beta

cells of a healthy pancreas make insulin.

Insulin on board (IOB) (active insulin)

The amount of insulin that is still “active” in the body from a previ-

ous bolus dose. In the mylife OmniPod System, insulin on board

(IOB) is considered in two parts: the Insulin on Board (IOB) from a

previous correction bolus and the IOB from a previous meal bolus.

The amount of time insulin remains “on board” or “active”

depends on each individual’s duration of insulin action. Talk with

your healthcare provider to determine your duration of insulin

action.

The mylife OmniPod System continually calculates the Insulin on

Board (IOB) to help prevent “stacking” of bolus doses, which is a

major cause of hypoglycemia.

Insulin reaction (see hypoglycemia)

Insulin-to-carbohydrate ratio (IC 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.

Glossary

166

In vitro

Literally, “in glass.” Refers to a biological function taking place in a

laboratory dish rather than in a living organism.

Ketoacidosis (diabetic ketoacidosis or DKA)

A very serious condition in which extremely high blood glucose

levels and a severe lack of insulin cause the body to break down

fat for energy. The breakdown of fat releases ketones into the

blood and urine. DKA can take hours or days to develop, with

symptoms that include stomach pain, nausea, vomiting, fruity

breath odor, and rapid breathing.

Ketones

Acidic by-products that result from the breakdown of fat for

energy. The presence of ketones indicates that the body is using

stored fat and muscle (instead of glucose) for energy.

Meal bolus (also known as carbohydrate bolus)

An amount of insulin administered before a meal or snack to

ensure that blood glucose levels stay within the desired BG goal

after a meal. The mylife OmniPod System calculates a meal bolus

by dividing the grams of carbohydrates you are about to eat by

your insulin-to-carbohydrate ratio.

Multiple daily injections (MDIs)

Introducing insulin into the body with a syringe several times a

day.

Occlusion

A blockage or interruption in insulin delivery.

Prime bolus

An amount of insulin used to fill the cannula, preparing it to

begin delivering insulin under your skin.

Protein

One of the three main energy sources in food (the other two are

carbohydrate and fat). Protein is necessary for the growth, main-

tenance, and repair of body cells and tissues. Protein contains 4

calories per gram. Foods high in protein include meat, poultry,

fish, legumes and dairy products.

Reverse correction (negative correction)

Using an individual’s correction factor, the reverse correction is a

calculation that reduces a portion of a meal bolus dose when the

patient’s blood glucose level is below their blood glucose target.

This feature is an option in the mylife OmniPod® Insulin Manage-

ment System, which should be turned on or off according to the

advice of a healthcare provider.

It is important to rule out ketoacidosis when you

experience symptoms that might otherwise indicate

the flu.

Glossary

167

Sharps

Any medical item that may cause punctures or cuts to those

handling them. Sharps include needles, syringes, scalpel blades,

disposable razors, and broken medical glassware. Dispose of

used sharps according to local waste disposal regulations.

Sharps container

A puncture-proof container used for storage and disposal of

used sharps.

Soft Key

A button 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.

Subcutaneous

Under the skin.

Suggested bolus calculator

A feature that calculates bolus doses with user-specific settings

and inputs. The settings used to calculate a suggested bolus are

target BG, insulin-to-carbohydrate (IC) ratio, correction factor (CF)

and duration of insulin action. The inputs used to calculate a sug-

gested bolus are current BG, carbs entered, and insulin on board.

The bolus calculator can be turned Off or On in the PDM.

Target blood glucose (BG) level

The ideal number at which you would like your blood glucose

level to be. The mylife OmniPod System uses this number in cal-

culating bolus doses.

Temp basal

A basal rate that is used to cover predictable, short-term changes

in basal insulin need. Temporary rates are often used during exer-

cise and for sick-day insulin adjustments.

Temporary basal preset

An adjustment in a basal rate, in either % or U/hr, that can be

assigned a custom name and preprogrammed into the PDM.

Time segment (see basal segment)

Index

168

Index

activate a new Pod. . . . . . . . . . . . . . . 43–45

active insulin . . . . . . .See insulin on board

add

basal segment or rate . . . . . . . . . 17–21

bolus reminder. . . . . . . . . . . . . . . . . . . .70

custom reminders. . . . . . . . . . . . . . . . .70

user information . . . . . . . . . . . . . . . . 103

adhesive. . . . . . . . . . . . . . . . . . . . . . . . . . 4, 51

remover. . . . . . . . . . . . . . . . . . . . . . . . . . .45

advisory alarms . . . . . . . . . . 126–130, 162

airport security . . . . . . . . . . . . . . . . . . . . 108

alarms . . . . . . . . . . . . . . . . . . . . . . 8, 126–134

acknowledge . . . . . . . . . . . . . . . . . . . 127

advisory. . . . . . . . . . . . . . . . . . . . 126–130

hazard . . . . . . . . . . . . . . . . . . . . . 126–134

history records . . . . . . . . . . . . . . . . . . 101

alert escalation . . . . . . . . . . . . . . . . . . . . 126

alerts and reminders. . . . . . . . . . . . . 68–71

auto-off alert . . . . . . . . . . . . . . . . . . . . . .68

BG reminder . . . . . . . . . . . . . . . . . . . . . .68

bolus reminders. . . . . . . . . . . . . . . . . . .69

confidence reminders. . . . . . . . . . . . . 69

custom reminders . . . . . . . . . . . . . . . . 69

low reservoir alert . . . . . . . . . . . . . 14, 68

missed bolus . . . . . . . . . . . . . . . . . . . . . . 69

Pod expiration reminder . . . . . . . . . . 68

program reminders . . . . . . . . . . . . . . . 69

aseptic technique . . . . . . . . . . . . . . 58, 162

automated cannula insertion. . . . . 2, 53

auto-off alert . . . . . . . . . . . . . . . . . . . . . . . .68

backlight time-out. . . . . . . . . . . . . . . . . . .73

set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74

basal history . . . . . . . . . . . . . . . . . . . . . . . . .97

basal program . . . . . . . . . . 11, 16–22, 162

add segment or rate . . . . . . . . . . . . . .21

copy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

edit segment or rate . . . . . . . . . . . . . .21

enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

rename . . . . . . . . . . . . . . . . . . . . . . . . . . .22

basal rate . . . . . . . . . . . . . 1, 11, 16–27, 162

maximum. . . . . . . . . . . . . . . . . . . . . . . . . 27

temporary . . . . . . . . . . . . . . . . . . . . . . . . 22

basal segment. . . . . . . . . . . . . . 11, 16, 162

basal settings . . . . . . . . . . . . . . . . . . . . . . . . 11

batteries . . . . . . . . . . . . . . . . . . . . . .9, 96, 144

blood glucose

BG goal . . . . . . . . . . . . . . . . . . 11, 72, 162

BG reminder . . . . . . . . . . . . . . . . . . . . . . 68

checking . . . . . . . . . . . . . . . . . . . .9, 79–95

goal limit. . . . . . . . . . . . . . . . . . . . . . . . . . 72

history . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

level. . . . . . . . . . . . . . . . . . . . . . . . . . 28, 162

monitoring. . . . . . . . . . . . . . . . . . . . . . . 9, 3

sound . . . . . . . . . . . . . . . . . . . . . . . . . 11, 72

test strip . . . . . . . . . . . . . . . . . . . . . . . . . . 87

blood glucose meter . . . . .3, 79–95, 162

error messages. . . . . . . . . . . . . 122–124

readings . . . . . . . . . . . . . . . . . . . . . . . .3, 89

settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

specifications . . . . . . . . . . . . . . . . . . . .154

blood glucose readings

enter manually. . . . . . . . . . . . . . . . . . . . 92

low and high. . . . . . . . . . . . . . . . . . . . . . 94

bolus . . . . . . . . . . . . . . . . . . . . . . . 1, 3, 28–42

Index

169

cancel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

dose. . . . . . . . . . . . . . . . . . . . . . . . . . 28, 162

extended. . . . . . . . . . . . . . . . . . . . . . 29, 34

history . . . . . . . . . . . . . . . . . . . . . . . . . . . .98

manual delivery . . . . . . . . . . . . . . . . . . .33

normal . . . . . . . . . . . . . . . . . . . . . . . . 29, 31

presets . . . . . . . . . . . . . . . . . . . 37–39, 162

ratios/factors/targets. . . . . . . . . . . . . .66

reminders . . . . . . . . . . . . . . . . . . . . . 69, 70

settings . . . . . . . . . . . . . . . . . . . . . . . 64–67

suggested bolus calculator. . . 29–34,

147–150

bolus presets . . . . . . . . . . . . . . . 37–39, 162

cancel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

change. . . . . . . . . . . . . . . . . . . . . . . . . . . .39

create . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

enable . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

rename. . . . . . . . . . . . . . . . . . . . . . . . . . . .39

bolus reminder

add. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70

bolus reminders . . . . . . . . . . . . . . . . . . . . .69

Bolus/basal/calcs menu. . . . . . . . . . . . . .64

bright mode . . . . . . . . . . . . . . . . . . . . . . 5, 73

buttons

Home/Power. . . . . . . . . . . . . . . . . . . . . . . 5

Up/Down Controller . . . . . . . . . . . . . . . 5

User Info/Support . . . . . . . . . . . . . . . . . . 5

calorie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

cancel

bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

bolus preset. . . . . . . . . . . . . . . . . . . . . . .39

one-time temporary basal rate. . . .24

temporary basal presets . . . . . . . . . .26

cannula . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 163

automated insertion . . . . . . . . . . . 8, 53

carb presets . . . . . . . . . . . . . .2, 40–42, 163

change. . . . . . . . . . . . . . . . . . . . . . . . . . . .41

change category . . . . . . . . . . . . . . . . . .41

create . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

edit . . . . . . . . . . . . . . . . . . . . . . . . . . . 41, 42

rename . . . . . . . . . . . . . . . . . . . . . . . . . . .42

carbohydrate . . . . . . . . . . . . . . . . . . . . 1, 163

counting . . . . . . . . . . . . . . . . . . . . . . . . 163

history . . . . . . . . . . . . . . . . . . . . . . . . . . 101

carbohydrate bolus . . . . . See meal bolus

care and maintenance . . . . . . . . . . . . . 142

cellular phones . . . . . . . . . . . . . . . . . . . . 120

change

basal programs . . . . . . . . . . . . . . . . . . . 20

basal settings . . . . . . . . . . . . . . . . . . . . .64

bolus presets. . . . . . . . . . . . . . . . . . . . . .39

bolus settings . . . . . . . . . . . . . . . . . . . . . 64

carb presets . . . . . . . . . . . . . . . . . . . . . . .41

temporary basal presets . . . . . . . . . . 26

user information . . . . . . . . . . . . . . . . 103

check alarms. . . . . . . . . . . . . . . . . . . . . . . . . 75

check blood glucose. . . . . . . . . . . . . 79–95

cleaning . . . . . . . . . . . . . . . . . . . . . . .142, 143

clock

12-hour or 24-hour. . . . . . . . . . . . . . . .63

communication

distance to Pod . . . . . . . . . . . . . . 77, 154

interruption. . . . . . . . . . . . . . . . . . 78, 136

communication failure . . . . . . . 136–141

bolus cancellation. . . . . . . . . . . . . . . 140

Pod activation. . . . . . . . . . . . . . . . . . . 136

Pod deactivation . . . . . . . . . . . . . . . . 138

Pod operation. . . . . . . . . . . . . . . . . . . 136

Index

170

request for status . . . . . . . . . . . . . . . 139

complications, diabetes-related . .

1, 163

confidence reminders . . . . . . . . . . . . . . .69

contact information . . . . . . . . . . . . . . . 102

continuous subcutaneous insulin

infusion . . . . . . . . . . . . . . . . . . . . . . . . . 163

control solution

expiration . . . . . . . . . . . . . . . . . . . . . . . . .81

results. . . . . . . . . . . . . . . . . . . . . . . . . 82, 85

test. . . . . . . . . . . . . . . . . . . . . . . . . . . . 82–85

copy basal program . . . . . . . . . . . . . . . . .22

correct-above value . . . . .See correction

threshold

correction bolus . . . . . . . . . . . 30, 147, 163

correction factor . . . . . 13, 28, 65, 67, 163

correction IOB . . . . . . . . . . . . . . . . . . . . . 147

correction threshold . . . . .28, 65, 66, 163

create

basal program . . . . . . . . . . . . . . . . . . . .17

bolus preset. . . . . . . . . . . . . . . . . . . . . . .38

carb presets . . . . . . . . . . . . . . . . . . . . . . .40

temporary basal presets . . . . . . . . . .24

CSII . . . . . See continuous subcutaneous

insulin infusion

CT scans . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

custom reminders . . . . . . . . . . . . . . . 69, 70

customize PDM. . . . . . . . . . . . . . . . . . . . . .73

date and time. . . . . . . . . . . . . . . . . . . . 11, 63

dawn phenomenon . . . . . . . . . . . . . . . 163

deactivation . . . . . .See Pod deactivating

delete

basal program . . . . . . . . . . . . . . . . . . . .22

bolus presets. . . . . . . . . . . . . . . . . . . . . .39

bolus reminder. . . . . . . . . . . . . . . . . . . .70

carb presets . . . . . . . . . . . . . . . . . . . . . . .42

temporary basal presets . . . . . . . . . . 27

diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Diabetes Control and Complications Tri-

al (DCCT). . . . . . . . . . . . . . . . . . . . . . . . 164

diabetes emergency kit. . . . . . . . . . . . 106

diabetes mellitus . . . . . . . . . . . . . . . . . . . . . 7

diabetic ketoacidosis . . . . . . . . . . . See DKA

diagnostic functions . . . . . . . . . . . . . . . . . 75

check alarms . . . . . . . . . . . . . . . . . . . . . . 75

reset PDM. . . . . . . . . . . . . . . . . . . . . . . . . 75

disinfecting wipes . . . . . . . . . . . . . . . . . 143

DKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166

avoiding . . . . . . . . . . . . . . . . . . . . . . . . .119

symptoms . . . . . . . . . . . . . . . . . . . . . . .118

treating . . . . . . . . . . . . . . . . . . . . . . . . . .119

duration of insulin action . . . . . 9, 14, 30,

147–148, 164

edit

basal segment or rate . . . . . . . . . . . . .21

bolus reminder . . . . . . . . . . . . . . . . . . .70

carb presets. . . . . . . . . . . . . . . . . . . . . . . 42

electrical interference . . . . . . . . . . . . . . . 78

electrical safety . . . . . . . . . . . . . . . 157–161

electromagnetic compatibility 157–161

electromagnetic fields. . . . . . . . . . . . . . . 78

emergency kit . . . . . . . . . . . .104, 106, 107

empty reservoir hazard alarm . . . . . .129

enable

basal program . . . . . . . . . . . . . . . . . . . . 19

bolus preset. . . . . . . . . . . . . . . . . . . . . . . 38

one-time temporary basal rate. . . . 23

temporary basal presets . . . . . . . . . . 25

Index

171

enter

ID screen color . . . . . . . . . . . . . . . . . . . .10

tags . . . . . . . . . . . . . . . . . . . . . . . . . . . 72, 90

error messages, BG meter. . . . . 122–124

exercise . . . . . . . . . . . . . . . . . . . . . . . 114, 120

expiration

control solution . . . . . . . . . . . . . . . . . . .81

Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68

extended bolus . . . . . .14, 29, 34–35, 164

Extended option. . . . . . . . . . . . . . . . . . . . .67

extreme temperatures. . . . . . . . . . . . . . .77

failure . . . . . . . See communication failure

fat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

fiber . . . . . . . . . . . . . . . . . . . . . . . . . . . .41, 164

fill syringe. . . . . . . . . . . . . . . . . . . . . . . . 46–48

Flow accuracy

Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

Flow rate error . . . . . . . . . . . . . . . . . . . . . 153

glucagon . . . . . . . . . . . . . . . . . . . . . . . . . . 107

glucose . . . . . . . . . . . . . . . . . . . . . . . . . . 7, 164

hard work. . . . . . . . . . . . . . . . . . . . . . . . . . 120

hazard alarm, manual shut-off . . . . . 134

hazard alarms. . . . . . . . . . . . 126–134, 164

healthcare provider. . . . . . . . . . . . . . 9, 164

hemoglobin A1c (HbA1c). . . . . . . . . . 165

history

alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . 101

all . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97

blood glucose. . . . . . . . . . . . . . . . . . . . .99

bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98

carbohydrates. . . . . . . . . . . . . . . . . . . 101

insulin delivery . . . . . . . . . . . . . . . . 96, 97

Home screen . . . . . . . . . . . . . . . . . . . . . . 6–7

Home/Power button . . . . . . . . . . . . . . . . . 5

hospitalization. . . . . . . . . . . . . . . . . . . . . 121

hyperglycemia. . . . . . 104, 114–118, 165

avoiding . . . . . . . . . . . . . . . . . . . . . . . . 115

causes. . . . . . . . . . . . . . . . . . . . . . . . . . . 116

symptoms . . . . . . . . . . . . . . . . . . . . . . 114

treating . . . . . . . . . . . . . . . . . . . . . . . . . 115

hypoglycemia . . . . . . 104, 109–114, 165

avoiding . . . . . . . . . . . . . . . . . . . . . . . . 110

causes. . . . . . . . . . . . . . . . . . . . . . . . . . . 113

symptoms . . . . . . . . . . . . . . . . . . . 79, 109

treating . . . . . . . . . . . . . . . . . . . . . . . . . 111

hypoglycemia unawareness . . .110, 165

icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

insulin gauge . . . . . . . . . . . . . . . . . . . . .61

ID screen . . . . . . . . . . . . . . . . . . . . . . . . . . . .60

color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

illness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

infection . . . . . . . . . . . . . . . . . . . . . . . . 58, 105

infusion set, automated insertion. . . . . 2

infusion site. . . . . . . . . . . . 49, 58, 105, 165

infusion site, inspection. . . . . . . . . . . . 105

insulin . .16, 28, 43, 46, 48, 106, 146, 165

insulin action . . . See duration of insulin

action

insulin delivery

resume. . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

suspend. . . . . . . . . . . . . . . . . . . . . . . . . . . 56

insulin delivery records . . . . . . . . . . 96–98

insulin delivery, continuous. . . . . . . . . . . 1

Index

172

insulin gauge icon . . . . . . . . . . . . . . . . . . .61

insulin on board (IOB). .28, 30, 147–150,

165

insulin reservoir. . . . . . . . . . . . . . . . . . . . . .61

insulin, rapid-acting vs. long-acting

. 118

insulin-to-carb (IC) ratio9, 13, 28, 65, 66,

165

interruption in communication. . . . . .78

IV Prep wipes . . . . . . . . . . . . . . . . . . . 77, 143

ketoacidosis . . . . . . . . . . . . . . . . . . . . . . See DKA

ketones . . . . . . . . . . . . . . . . . . . . 94, 118, 166

lancing device . . . . . . . . . . . . . . . . . . . 85–87

long-acting insulin. . . . . . . . . . . . . . . . . 118

low battery alert . . . . . . . . . . . . . . . . . . . 144

low blood glucose . . See hypoglycemia

low reservoir advisory . . . . . . . . . . . . . 129

low reservoir alert . . . . . . . . . . . . . . . 14, 68

lows, highs, and DKA, avoid. . . . . . . . 109

manual shut-off of hazard alarm. . . 134

maximum basal rate. . . . . . . . . . . . . 27, 67

maximum bolus . . . . . . . . . . . . . . . . . 14, 67

meal bolus. . . . . . . . . . . . 30, 147–150, 166

meal IOB. . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Medic Alert tag . . . . . . . . . . . . . . . . . . . . 121

medical electrical equipment. 157–161

Bolus/basal/calcs. . . . . . . . . . . . . . . . . . 64

More actions . . . . . . . . . . . . . . . . . . . 7, 31

My records . . . . . . . . . . . . . . . . . . . . . . . . . 7

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Suspend/resume. . . . . . . . . . . . . . . . . . . 7

System setup . . . . . . . . . . . . . . . . . . . . .62

Temp basal. . . . . . . . . . . . . . . . . . . . . . . . . 7

microwave ovens . . . . . . . . . . . . . . . . . . . .78

Min BG for calcs. . . . . . . . . . . . . . .12, 65, 66

missed bolus reminder . . . . . . . . . . 69–70

More actions menu . . . . . . . . . . . . . . . . . .31

MRIs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

multiple daily injections (MDIs) . . . . 166

multiple-day trends, BG history. . . . 100

normal bolus . . . . . . . . . . . . . . . . . . . . 29, 31

occlusion . . . . . . . . . . . . . . . . .114, 118, 166

occlusion detected hazard alarm . . .131

OmniPod label symbols . . . . . . . . . . . .155

OmniPod System . . . . . . . . . . . . . . . . . . . . . 2

one-time temporary basal rate . . . . . . 23

cancel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

operating temperatures . . . 77, 152, 154

options

Bolus calcs . . . . . . . . . . . . . . . . . . . . . . . . 64

Extended . . . . . . . . . . . . . . . . . . . . . . . . . 67

Max basal rate . . . . . . . . . . . . . . . . . . . .67

Max bolus. . . . . . . . . . . . . . . . . . . . . . . . . 67

Ratios/factors/targets . . . . . . . . . . . . . 66

Temp basal. . . . . . . . . . . . . . . . . . . . . . . . 67

Options and settings . . . . . . . . . . . . . . .151

PDM . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 60–78

backlight time-out . . . . . . . . . . . . . . . . 73

batteries . . . . . . . . . . . . . . . . . . . . . . 9, 144

BG goal . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

blood glucose sound . . . . . . . . . . . . . 72

Index

173

cleaning. . . . . . . . . . . . . . . . . . . . . . . . . 143

communication with Pod . . 136–141

customize . . . . . . . . . . . . . . . . . . . . . 73–74

disinfecting wipes. . . . . . . . . . . . . . . 143

dropped . . . . . . . . . . . . . . . . . . . . . . . . 146

icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

ID screen . . . . . . . . . . . . . . . . . . . . . . . . . .60

PDM lock. . . . . . . . . . . . . . . . . . . . . . 73–74

repair or replacement . . . . . . . . . . . 127

screen time-out . . . . . . . . . . . . . . . . . . .73

settings . . . . . . . . . . . . . . . . . . . . . . . . . . .61

specifications . . . . . . . . . . . . . . . . . . . 154

Status screen. . . . . . . . . . . . . . . . . .60–61

storage. . . . . . . . . . . . . . . . . . . . . . . . . . 142

submerged in water. . . . . . . . . . . . . . .77

version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

PDM error hazard alarm . . . . . . . . . . . 132

PDM lock . . . . . . . . . . . . . . . . . . . . . . .73, 142

set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74

PDM options, System setup. . . . . . . . . .73

personal contact information. . . . . . 102

Personal Diabetes Manager . . .See PDM

physical exertion. . . . . . . . . . . . . . . . . . . 120

playing sports . . . . . . . . . . . . . . . . . . . . . 120

Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 43–45

applying . . . . . . . . . . . . . . . . . . . . . . . . . .51

change process . . . . . . . . . . . . . . . . . . .43

check status. . . . . . . . . . . . . . . . . . . . . . .55

cleaning. . . . . . . . . . . . . . . . . . . . . . . . . 142

deactivating . . . . . . . . . . . . . . . . . . . . . .44

expiration reminder. . . . . . . . . . . . . . .68

filling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

flow accuracy . . . . . . . . . . . . . . . . . . . 153

flow rate error . . . . . . . . . . . . . . . . . . . 153

inserting cannula . . . . . . . . . . . . . . . . .53

priming . . . . . . . . . . . . . . . . . . . . . . . . . . .48

removal . . . . . . . . . . . . . . . . . . 44–45, 120

safety checks. . . . . . . . . . . . . . . . . . . . . .48

specifications . . . . . . . . . . . . . . . . . . . 152

storage. . . . . . . . . . . . . . . . . . . . . . . . . . 142

Pod error hazard alarm . . . . . . . . . . . . 131

Pod expiration advisory. . . . . . . . . . . . 130

Pod expired hazard alarm. . . . . . . . . . 130

Pod occlusion hazard alarm . . . . . . . 131

prescriptions. . . . . . . . . . . . . . . . . . . . . . . 109

for travel . . . . . . . . . . . . . . . . . . . . . . . . 108

prime bolus. . . . . . . . . . . . . . . . . . . . . 53, 166

priming, automatic . . . . . . . . . . . . . . . . . . . 8

program reminders. . . . . . . . . . . . . . . . . . 69

protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

radio interference . . . . . . . . . . . . . . . . . . .78

rapid-acting insulin . . . . . . . . . . . . . . . . 118

Ratios/factors/targets option . . . . 66–67

record keeping . . . . . . . . . . . . . . 3, 96–103

record screens . . . . . . . . . . . . . . . . . .96–103

alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . 101

all . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

blood glucose. . . . . . . . . . . . . . . . . . . . . 99

carbohydrates . . . . . . . . . . . . . . . . . . 101

combined records . . . . . . . . . . . . . . 102

insulin delivery. . . . . . . . . . . . . . . . . . . .97

personal contact information . . . 102

special symbols . . . . . . . . . . . . . . 96, 100

User Info/Support. . . . . . . . . . . . . . . 102

remove a Pod. . . . . . . . . . . . . . . 44–45, 120

rename

basal program . . . . . . . . . . . . . . . . . . . .22

bolus presets. . . . . . . . . . . . . . . . . . . . . .39

custom reminders . . . . . . . . . . . . . . . . 70

temporary basal presets . . . . . . . . . . 27

Index

174

replace batteries . . . . . . . . . . . . . . . . . . . 145

reset

date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64

PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63

resume insulin delivery . . . . . . . . . . . . . .57

reverse correction . . . . . . . 13, 33, 66, 67,

147, 166

safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 104

alerts and alarms. . . . . . . . . . . . . . . . . . . 8

automatic priming . . . . . . . . . . . . . . . . . 8

automatic safety checks. . . . . . . . . . . . 8

electrical . . . . . . . . . . . . . . . . . . . 157–161

safety checks . . . . . . . . . . . . . . . . . . . . . . 122

screen time-out. . . . . . . . . . . . . . . . . . . . . .73

set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74

set

backlight time-out . . . . . . . . . . . . . . . .74

ID screen . . . . . . . . . . . . . . . . . . . . . . . . . .73

PDM lock. . . . . . . . . . . . . . . . . . . . . . . . . .74

screen time-out . . . . . . . . . . . . . . . . . . .74

settings, BG meter . . . . . . . . . . . . . . . . . . .71

Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . .10

sharps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

sharps container. . . . . . . . . . . . . . . . . . . 167

shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

shut-off, manual . . . . . . . . . . . . . . . . . . . 134

sick days . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

soap, solvent. . . . . . . . . . . . . . . 77, 142, 143

soft keys . . . . . . . . . . . . . . . . . . . . . . . 7, 5, 167

soft reset . . . . . . . . . . . . . . . . . . . See reset PDM

special symbols in record screens. . . .96

specifications

BG meter. . . . . . . . . . . . . . . . . . . . . . . . 154

PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

sports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Status screen . . . . . . . . . . . . . . . 6–7, 60–61

storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

storage temperatures. . . . . . . . . .152, 154

stuck key advisory . . . . . . . . . . . . . . . . . 130

suggested bolus calculator . . . . . . . 2, 12,

29–33, 91, 167

examples . . . . . . . . . . . . . . . . . . 147–149

guidelines. . . . . . . . . . . . . . . . . . . . . . . 149

supplies

packing for travel . . . . . . . . . . . . . . . .107

surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121

suspend insulin delivery . . . . . . . . . . . . . 56

symbols

in history records. . . . . . . . . . . . . . . . . . 96

on screen . . . . . . . . . . . . . . . . . . . . . . . .156

System labels . . . . . . . . . . . . . . . . . . . .155

symptoms

DKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118

hyperglycemia . . . . . . . . . . . . . . . . . . .114

hypoglycemia. . . . . . . . . . . . . . . . 79, 109

System options and settings. . . . . . . .151

System setup menu . . . . . . . . . . . . . . . . . 62

Insulet 019 UST500 PDM User Manual

Insulet Corporation UST500 PDM

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