Insulet 041 User Guide

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Omnipod DASH™ Insulin Management System User Guide

Contacts and Important Information

Customer Care

1-800-591-3455 — 24 hours/7 days

1-978-600-7850 when calling from outside the United States of America

Customer Care Fax: 877-467-8538

Website: myomnipod.com Address: Insulet Corporation, 600 Technology Park Drive, Ste 200

Billerica, MA, 01821, USA

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

PDM Model PDM-USA1-D001-MG-USA1

Serial Number __________________________________________________

Omnipod DASH™ Insulin Management System Start Date _______________

Healthcare Provider Omnipod® System Trainer

Name Name Address Address

Phone Phone Email Email

Health Insurance Pharmacy

Name Name Address Address

Draft

Phone Phone Policy Number Email

Patent information at www.insulet.com/patents.

All other trademarks are the property of their respective owners. e use of third party trademarks does not constitute an endorsement or imply a relationship or other aliation.

USA-18296-ENG-mg-AW Rev 3 12/17

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xi

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

Indications and Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

Working with Your Healthcare Provider. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv

Getting Started

1 Your Omnipod DASH™ Insulin Management System . . . . . . . . . . . . . . . . . . . 1

Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

The Pod and PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Navigating Screens and Entering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Touchscreen Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Entering Numbers and Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Navigation Icons and Navigation Shorthand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

The Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

The PDM's Lock and PIN Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

The PDM's Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Dashboard tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Basal tab / Temp Basal tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Pod Info tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Last BG section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Last bolus section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Bolus button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

The Home Page's Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

PDM Messages to You . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Noti cations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Con rmation Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

2 Initial PDM Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

The Starter Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Preparing for Your Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

General PDM Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Turning on and personalizing the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Enter a PIN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

iii

Contents

Set the time zone and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

Set the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Basal Insulin Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Maximum Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Create a Basal Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Temp basal con guration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

Blood Glucose Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Upper and lower limits for BG Goal Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Pair to a BG meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

Bolus Calculator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

Turn the Bolus Calculator on or o . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

Target BG and Correct Above values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

Minimum BG for Calcs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

IC Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

Correction Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Reverse Correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Duration of Insulin Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Other Bolus Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

Maximum Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

Extended bolus setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

PDM Setup Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

User Guide

3 Changing Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Beginning the Pod Change Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

First Time Activating a Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

Deactivate an Active Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

No Active Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

Preliminary Pod Change Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

Fill the Syringe with Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Fill, Pair, and Apply the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

Fill the Pod with insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

Pair the PDM and Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

Prepare the Pod site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

Remove the Pod's blue cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

Apply the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

Begin insulin delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

Check the Infusion Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

Avoid Infusion Site Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

More Information about Pod Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

Contents

4 Entering Blood Glucose Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

About Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

Entering Your Blood Glucose Reading from a Paired BG Meter . . . . . . . . . . . . . . .49

Entering Your Blood Glucose Reading Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50

Tagging Your Blood Glucose Reading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52

How Blood Glucose Readings are Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52

5 Delivering a Bolus of Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Bolusing with the Bolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55

Enter your meal information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55

Enter your blood glucose reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56

Delivering an immediate or extended bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57

Manually-calculated Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

Tracking the Progress of a Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61

Altering a Bolus in Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62

Using the Food Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63

Add carbs to the Bolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64

Search for a food on the BROWSE list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66

Create a list of favorite foods on the MY FOODS list . . . . . . . . . . . . . . . . . . . . . . . . .67

Removing foods from the MY FOODS list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70

6 Modifying Basal Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Using Temporary Basal Rates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71

Activate a temp basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71

Activate a temp basal preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

Cancel a temp basal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

Switching to a Di erent Basal Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74

Suspending and Resuming Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74

7 Managing Programs and Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77

Create a new Basal Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77

Review all Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78

Edit or rename a Basal Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79

Delete a Basal Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

Temp basal presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

Create a new temp basal preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81

Edit or rename a temp basal preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

Delete a temp basal preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

Bolus presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

Create a new bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

Edit or rename a bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

Delete a bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84

Contents

8 Browsing Your PDM Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Noti cations & Alarms Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

Overview of the Insulin and BG History Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

Date Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

Summary Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88

Details Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90

Blood glucose details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91

Bolus details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91

Carbs details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92

Basal rate details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

Pod details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

Insulin suspended and resumed details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

Time change details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94

Date change details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94

9 Adjusting Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

PDM Device Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95

Network connectivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95

Screen display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96

Lock screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97

Date and time, and language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97

Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99

Software update (Wireless update) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Pod Sites Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Reminder Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Pod expiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Low reservoir level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Pod Auto-o . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Check BG after Bolus reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Missed bolus reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Con dence reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Program reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Custom reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Blood Glucose Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

BG Goal Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Pairing, unpairing, or renaming a BG meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Basal and Temp Basal Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Maximum Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Temp basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Bolus Delivery Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Maximum Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Extended bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Bolus Calculator settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Contents

Reference

10 Alarms, Noti cations, and Communication Errors . . . . . . . . . . . . . . . . . . . .115

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Responding to Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Responding to Noti cations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

Priority and Predictability of Alarms and Noti cations . . . . . . . . . . . . . . . . . . . . . . 117

Sounds and Vibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Hazard Alarm List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Advisory Alarm List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Noti cations List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Informational Signals List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

Communication Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Error when canceling a bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Error when sending insulin delivery instructions . . . . . . . . . . . . . . . . . . . . . . . . . 126

Error when activating a Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Error when deactivating a Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Silencing an Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

Pod alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

PDM alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

11 Taking Care of Your PDM and Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129

Pod and Insulin Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Pod and insulin storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Pods and the environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Cleaning your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

PDM Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

PDM storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

PDM and the environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Cleaning your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

If you drop the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

PDM Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Safe use of the PDM battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Charging the PDM battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Inserting or replacing the PDM battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

12 Understanding PDM and Pod Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137

PDM and Pod Interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Pod actions controlled by the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

What the Pod can do between PDM instructions . . . . . . . . . . . . . . . . . . . . . . . . . 140

Auto-o . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

PDM and Paired BG Meter Interaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Basal Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Temporary basal rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

vii

Contents

Methods to temporarily stop insulin delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Immediate and Extended Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Manually-calculated Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

The Bolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Bolus Calculator boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

When the Bolus Calculator does not work . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Factors used in the Bolus Calculator's calculations . . . . . . . . . . . . . . . . . . . . . . . . 149

Bolus Calculator equations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Bolus Calculator examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Bolus Calculator rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Calculations for History Summaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Blood glucose summaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Insulin delivery summaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

13 Living with Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .163

Daily Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Infusion site checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Check your blood glucose frequently . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Prepare for Emergencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Traveling and Vacations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Keep supplies accessible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Plan for changing time zones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Airports and  ying . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Avoid Lows, Highs, and DKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

General precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Hypoglycemia (low blood glucose) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Hyperglycemia (high blood glucose) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

Diabetic ketoacidosis (DKA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Handling Special Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Sick days . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Exercising, playing sports, or working hard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

X-rays, MRIs, and CT scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Surgery or hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177

Summary of Settings and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Pod Speci cations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

PDM Speci cations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

Protection from Over-infusion or Under-infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

Omnipod DASH™ System Label Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182

Omnipod DASH™ System Notice Concerning Interference . . . . . . . . . . . . . . . . . 182

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

Customer's Bill of Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Limited Express Warranty, Disclaimer, and

Limitation of Remedies for the PDM and Pods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

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Contents

HIPAA Privacy Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201

 is page intentionally le blank.

Introduction

About This User Guide

Caution: is User Guide is intended for use only with Personal Diabetes Manager (PDM) model PDM-USA1-D001-MG-USA1. To learn which version of the PDM you have, turn it over. If you see "PDM-USA1-D001-MG-USA1" on the back of the PDM, this is the correct User Guide. If you do not see it, call Customer Care.

Note: Screen images shown in this User Guide are examples only and are not suggestions for user settings. Always consult with your healthcare provider to determine the appropriate settings for you.

Healthcare and treatment are complex subjects requiring the services of qualied healthcare providers. is User Guide is informational only and not intended as medical or healthcare advice or recommendations to be used for diagnosis, treatment, or for any other individual needs. is User Guide is not a substitute for medical or healthcare advice, recommendations, and/or services from a qualied healthcare provider. is User Guide may not be relied upon in any way in connection with your personal healthcare, related decisions, and treatment. All such decisions and treatment should be discussed with a qualied healthcare provider who is familiar with your individual needs.

is User Guide is periodically updated. Visit www.myomnipod.com to see the most recent version and to nd other helpful information.

For instructions about how to use the CONTOUR® NEXT ONE Blood Glucose Monitoring System, see the CONTOUR® NEXT ONE Blood Glucose Monitoring System User Guide.

Term Meaning

Warning Alerts you to the possibility of injury, death, or other serious adverse

reactions associated with the use or misuse of the device.

Caution Alerts you to the possibility of a problem with the device associated

with its use or misuse. Such problems include device malfunctions, device failure, damage to the device, or damage to other property.

Note Provides helpful information.

Tip O ers a suggestion for successful use of the device.

Introduction

Indications and Contraindications

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

Indications for use

e Omnipod DASH™ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Additionally, the Omnipod DASH™ System is interoperable with a compatible blood glucose monitoring system to receive and display blood glucose measurements.

Contraindications

Insulin pump therapy is NOT recommended for people who are:

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

• Unable to maintain contact with their healthcare provider

• Unable to use the Omnipod DASH™ System according to instructions

General Warnings

Warnings:

Rapid-acting U-100 insulin: e Omnipod DASH™ System is designed to

use rapid-acting U-100 insulin. e following U-100 rapid-acting insulin analogs have been tested and found to be safe for use in the Pod: NovoLog®, Humalog®, or Apidra®. NovoLog, Humalog, and Apidra are compatible with the Omnipod DASH™ System for use up to 72 hours (3 days). Before using a dierent insulin with the Omnipod DASH™ System, check the insulin drug label and consult your healthcare provider. Refer to the insulin labeling and follow your healthcare provider’s directions for how oen to replace the Pod.

Read all the instructions provided in this User Guide before using the Omnipod DASH™ System. Monitor your blood glucose with the guidance of your healthcare provider. Undetected hyperglycemia or hypoglycemia can result without proper monitoring.

Not recommended for individuals with hearing loss. Always verify your ability to hear Pod/PDM alarms and notications.

xii

Introduction

Warnings:

If you are unable to use the Omnipod DASH™ 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 Omnipod DASH™ System properly.

Parts of the device are considered biohazardous and can potentially transmit infectious diseases.

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

e Omnipod DASH™ System should NOT be used at low atmospheric pressure (below 700 hPA). You could encounter such low atmospheric pressures at high elevations, such as when mountain climbing or living at elevations above 10,000 feet (3,000 meters).

e Omnipod DASH™ System should NOT be used in oxygen rich environments (greater than 25% oxygen) or at high atmospheric pressure (above 1060 hPA), both of which can be found in a hyperbaric chamber. Hyperbaric, or high pressure, chambers are sometimes used to promote healing of diabetic ulcers, or to treat carbon monoxide poisoning, certain bone and tissue infections, and decompression sickness.

Working with Your Healthcare Provider

Insulin pump therapy requires substantial caregiver involvement, especially with children. Work with your healthcare provider to establish diabetes management guidelines and settings that best t your, or your child’s, needs. ese may include:

Insulin-to-Carbohydrate (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 15 grams of carbohydrate you eat.

Correction (or Sensitivity) Factor: How much one unit of insulin lowers your blood glucose. For example, if your Correction Factor is 50, one unit of insulin lowers your blood glucose by 50 mg/dL.

Target Blood Glucose (Target BG): e blood glucose level you want to achieve. For example, you may want to keep your blood glucose close to 100 mg/dL.

xiii

Introduction

Duration of Insulin Action: e length of time that insulin remains active and available in your body aer a correction or meal bolus.

Your healthcare provider is a valuable resource. You will rely on him or her for critical information about your Omnipod DASH™ System, especially during the rst few weeks and months. When you have questions about diabetes management aer starting on the Omnipod DASH™ System, do not hesitate to talk with your healthcare provider.

For technical questions about your Omnipod DASH™ System setup or operation, or to order Omnipod DASH™ System products and supplies, you can call Customer Care 24 hours a day, 7 days a week. See the rst page of this User Guide for your Customer Care contact information.

For technical questions about your CONTOUR® NEXT ONE Blood Glucose Monitoring System setup or operation, or to order CONTOUR® NEXT ONE BG meter products or supplies, see the CONTOUR® NEXT ONE instructions for use for Customer Service contact information.

Your healthcare provider will give you all the tools and training you need to be successful with the Omnipod DASH™ System. As you become actively involved in your diabetes management, you can enjoy the control and exibility that is possible with the Omnipod DASH™ System.

Being actively involved means to frequently monitor your blood glucose levels, to learn how to operate your Omnipod DASH™ System, to practice proper techniques, and to visit your healthcare provider regularly.

Safety Features

e Omnipod DASH™ System’s safety features include:

Automatic priming, safety checks, and insertion

When you activate a new Pod, the Omnipod DASH™ System automatically primes and performs safety checks on the Pod, then inserts and primes the cannula (a small, thin tube). ese safety checks take only a few seconds.

e Omnipod DASH™ System also performs safety checks on the Personal Diabetes Manager (PDM) whenever the PDM is awake. If it detects any problems in the PDM or the Pod—or in the communication between them—it informs you with vibrations or beeps and on-screen messages.

Alarms and noti cations

For your safety, the Omnipod DASH™ System provides a range of alarms and notications to tell you that your attention is needed or to warn you of hazardous situations. For a description of the PDM's alarms and notications, see "Alarms, Notications, and Communication Errors" on page 115.

xiv

Introduction

Note: Brief alarm and noti cation messages appear on the Lock screen. You must unlock the screen and enter your personal identi cation number (PIN) to see the full alarm messages.

Note: Wake up your PDM periodically to con rm that there are no noti cation or alarm messages that require a response.

Warning: Do NOT attempt to use the Omnipod DASH™ System before you receive training. Inadequate training could put your health and safety at risk.

Software updates

Occasionally, a security update may be provided for the PDM soware. e PDM periodically checks for soware updates if Wi-Fi is on. For information about checking for and installing soware updates, "Soware update (Wireless update)" on page 101.

 is page intentionally le blank.

xvi

CHAPTER 1

Your Omnipod DASH™ Insulin Management System

Welcome

e Omnipod DASH™ Insulin Management System is a continuous insulin delivery system that provides all the proven benets of continuous subcutaneous insulin infusion (CSII) therapy.

Features of the Omnipod DASH™ System include:

No tubing: ere is no tubing connecting the Pod to the Personal Diabetes Manager (PDM). You can wear the Pod under your clothes and carry the PDM separately. You can swim wearing the Pod and leave the PDM on dry land. e Pod is waterproof to 25 feet (7.6 meters) for up to 60 minutes (IP28).

Bolus Calculator: If your blood glucose is high or if you are planning to eat, the PDM's Bolus Calculator can suggest a bolus dose based on your individual settings.

Blood glucose readings: Your PDM can pair to and record BG readings from the CONTOUR® NEXT ONE BG meter via Bluetooth (BLE). You can also manually enter blood glucose readings into the PDM.

Record keeping: e PDM displays up to 90 days of information, including basal rates, bolus doses, carbohydrates, alarms, and blood glucose entries.

e Getting Started section of this book gives an overview of the basic operation and setup of the Omnipod DASH™ System. e User Guide section gives step-by- step instructions for using the Omnipod DASH™ System. e Reference section explains how the Omnipod DASH™ System works.

Terms and conventions used in this User Guide

Screen Area of the PDM that displays menus, instructions, and messages.

Menu List of options on the screen.

Icon An image on the screen that indicates a menu option or that

provides information.

Button Physical buttons on the PDM, such as the Power button. Also, areas

of the screen that you can tap to perform an action.

Field  e area of a screen where you enter information.

1 Omnipod DASH™ Insulin Management System

The Pod and PDM

e Omnipod DASH™ System is made up of two parts: e Pod, which delivers insulin to your body, and the Personal Diabetes Manager (PDM), which lets you control the Pod.

 e Pod

e Pod is a lightweight device that you ll with insulin and wear directly on your body. e Pod receives insulin delivery instructions from the PDM. e Pod then delivers insulin into your body through a small, exible tube called a cannula.

e Pod is applied to your skin with an adhesive, similar to an adhesive bandage.

e Pod that is used with the Omnipod DASH™ System has a blue needle cap.

To p

Viewing window

Bottom

Adhesive backing

Fill port

Air vent

Paper cover for adhesive backing

Blue needle cap

Omnipod DASH™ Insulin Management System 1

 e Personal Diabetes Manager (PDM)

e PDM is a handheld device that controls and monitors the Pod's operations using wireless technology.

Micro-B USB port:

Used for charging the battery and exporting data

Sound/vibrate button

Power button: Used for

Touchscreen

wake/sleep and on/o

Back button

Not used

1 Omnipod DASH™ Insulin Management System

Navigating Screens and Entering Information

is section explains how to use the touchscreen, how to enter numbers or text into the PDM, and how this User Guide describes moving between PDM screens.

Touchscreen Basics

e PDM displays messages and options for you on its touchscreen. You communicate with the PDM by tapping or swiping your nger on the touchscreen.

Tapping and swiping

e basic instructions for interacting with the touchscreen are explained here.

Tap Touch the screen, then li your  nger up.

Swipe Touch a starting point and move your  nger up,

down, le , or right.

Note: Scrolling and swiping are related actions. When you swipe up, the screen display scrolls up to show items that are currently o -screen.

Note: A screen protector may decrease the touchscreen sensitivity.

Screen time-out and brightness

e PDM screen turns black, called timing-out, aer a set period of use. To control the screen time-out and brightness settings, see "Screen display" on page

96. e PDM screen dims 6-10 seconds before it times out. If the screen dims, touch the screen briey to prevent the screen from timing out.

Entering Numbers and Text

Tapping  elds to enter data

Fields allow you to specify values to be used by the PDM. Tapping an editable eld (which is either framed by a box or underlined) opens a keypad, number pad or scroll wheel. Tap the letters or numbers or scroll the wheel to enter data for use in that eld.

Editable elds are underlined or framed by a box.

Non-editable elds are not underlined nor framed by a box.

Omnipod DASH™ Insulin Management System 1

Tapping blue and underlined text brings up an explanatory screen or a screen that can be used for data entry.

Using a keypad

Tapping in an editable eld brings up a built-in keypad. To bring up a dierent keypad, tap the ?123, ABC, or =\< in the lower le of a keypad.

Tap a character to add it to the text eld.

Touch a letter in the top row for a second to display other options such as a number or an accented letter such as é.

Using a number pad

Tap the up-arrow ( uppercase and lowercase letters. Tap the up-arrow twice in rapid succession to type in ALL CAPITALS mode. Tap the up-arrow one more time to exit ALL CAPITALS mode.

Tap the spacebar icon ( between characters.

Tap the backspace icon ( most recent entry from the entry eld.

Tap the green checkmark ( keypad when you have nished entering your text.

Note:  e PDM considers capital and lowercase letters to be the same. In other words, the PDM considers "myFavoriteFood" and "myfavoritefood" to be the same name.

) to toggle between

) to add a space

) to delete the

) to close the

Tap a number to add it to the entry eld. Tap the period (.) to add a decimal point. Tap the backspace icon ( to delete the most recent entry from the entry eld. e comma (,), dash (-), and underscore (_) are not used.

Tap the green checkmark ( number. You can also tap outside the number pad to accept the entered number.

) to accept the entered

)

1 Omnipod DASH™ Insulin Management System

Using a scroll wheel

Place your nger on the scroll wheel. Move your nger up to select a smaller number and down to select a larger number. e faster you move your nger, the faster the wheel will scroll.

When your desired selection is shown in the center of the wheel, select the value by tapping it or by tapping outside the scroll wheel.

Using a slider

Use sliders to select a value from a scale. Place your nger on the small open circle and move your nger until your desired value is displayed. Depending on the on-screen graphic, you may move your nger vertically or in a circle to move the slider. Move your nger up or clockwise for a larger number and down or counterclockwise for a smaller number. Li your nger when the desired value is displayed.

Move slider around the circle

Move slider up or down

Selecting, Adding, and Deleting Items

Toggles

Tap a toggle to change the selection from one side to the other.

Toggles allow you to choose between two options or to turn a feature on or o. e toggle is on the right side and blue when a feature is on, and on the le and gray when a feature is o.

Checkboxes, radio buttons, and drop-down lists

Checkboxes are squares. Tap a checkbox to check or uncheck it. You can check more than one checkbox in a list.

Radio buttons are circles. Tap a radio button to select it. A dot appears inside the selected radio button. You can select only one radio button at a time. To deselect a radio button, tap the radio button next to a dierent option.

Omnipod DASH™ Insulin Management System 1

Drop-down lists are indicated by a down or up arrow next to an item. e currently selected setting appears to the le of the drop-down arrow. To select a dierent option, tap the down arrow to show the drop-down list of options. To replace the currently selected option at the top, tap the desired option from the drop-down list.

Tap the up arrow to hide the list of options.

A plus symbol in a circle indicates that you can add an item to a list. Tap the plus symbol to add the item to the list.

A red x in a circle indicates that you can remove an item from a list. To remove the item, tap the red x.

Navigation Icons and Navigation Shorthand

e PDM has buttons below the screen that can be used for navigation. In addition, some screen icons can be used for navigation.

Back arrow and back button

Many screens display a "back" arrow icon in the upper le corner. Tapping the back arrow returns to the previous screen.

Tapping the le-hand button below the PDM screen generally also returns to the previous screen.

Note:  e middle and right-hand buttons below the PDM screen have no function.

Options Icon

e Options icon ( side of certain lists. Tapping the Options icon brings up a list of options relevant to the item on that row.

) appears on the right-

1 Omnipod DASH™ Insulin Management System

Navigation shorthand

e User Guide uses the ">" symbol to indicate navigating from one screen to another. For example, the following notation:

• Menu icon (

tells you to:

1. Tap the Menu icon (

2. Tap Pod to open the Pod screen.

3. Tap CHANGE POD.

• Menu icon

tells you to:

1. Tap the Menu icon (

2. Expand the History entry, if it is collapsed, by tapping anywhere in the row with the word "History."

When expanded, selections for the Notications & Alarms history screen and the Insulin & BG History screen appear.

3. Tap Insulin & BG History.

• Settings icon (

tells you to:

1. Tap the Settings icon (

2. Tap Reminders.

3. Tap Pod Expiration.

) > Pod > CHANGE POD

) in the upper le of the Home screen.

> History : Insulin & BG History

)in the upper le of the Home screen.

) > Reminders > Pod Expiration

) in the upper right of the Home screen.

Omnipod DASH™ Insulin Management System 1

The Status Bar

Most screens have a status bar that shows you:

• e Pod status, including how much insulin is le in an active Pod

• Whether a temp basal rate is running

• Whether the PDM will vibrate for selected notications

• e Bluetooth Low Energy (BLE) icon

• If Wi-Fi is on, the strength of the Wi-Fi signal

• e status of the PDM's battery

• e current time

Status bar icon denitions:

More than 50 units in Pod Airplane mode on

Between 50 to 26 units in Pod Vibration mode on

Between 25 to 5 units in Pod Bluetooth Low Energy (BLE) on

Less than 5 units in Pod Wi-Fi on: strong signal

No active Pod Wi-Fi on: good signal

PDM unable to communicate with Pod

Temp basal rate active Wi-Fi on: low signal

e PDM's rechargeable battery icons, during normal operation and while charging, are:

100% to 31% charge

30% to 16% charge

15% to 0% charge

For charging instructions, see"Charge the battery" on page 20.

Wi-Fi on: fair signal

Wi-Fi on: no signal

1 Omnipod DASH™ Insulin Management System

The PDM's Lock and PIN Screens

Aer you set up your PDM, the Lock and PIN screens appear whenever you wake up your PDM. e Lock and PIN screens help conrm that you are using the correct PDM.

e Lock screen displays:

• Your selected background image

• Your customized message

• e amount of insulin on board, if the Bolus Calculator is on

• Today's date

• Any alarm or notication messages

Warning: Always identify the PDM as yours before using it. Using someone else's PDM can result in incorrect insulin delivery for both of you.

Unlock your PDM

In the remainder of this User Guide, instructions to "wake up" or "unlock" the PDM mean to do the following:

1. Press the Power button briey. See the PDM image on page 3 for the location of the Power button.

2. Unlock the Lock screen by either swiping le to right or by swiping up from the bottom. e PIN screen appears.

3. Tap the four numbers of your PIN, one at a time. e PIN screen helps avoid unintended screen taps.

4. Tap the checkmark. e Home screen or your most recent screen appears.

Note: If a hazard alarm or an advisory alarm is occurring, the alarm message appears instead of the Home screen.

Lock your PDM

To lock your PDM when you are nished using it:

1. Press the Power button briey. is locks the PDM by putting it to sleep.

2. Store your PDM in a safe, accessible location.

Omnipod DASH™ Insulin Management System 1

Caution: Only press the Power button briey. If the PDM asks if you would like to "Power o," tap outside the message to cancel the instruction. Once you begin using your PDM, do not turn the power o unless you are replacing the PDM's battery, as that would prevent the PDM from sounding an alarm.

Forgot your PIN?

You can use the last four digits of the PDM's serial number as an alternate PIN:

1. Find the serial number next to the

icon on the back of your PDM.

2. Note the last four digits of the serial number.

3. Enter those four digits on the PIN screen and tap the checkmark.

If you have problems with your PIN, call Customer Care.

The PDM's Home Screen

e Home screen provides information about recent boluses, blood glucose values, the active basal rate, and the active Pod. It also provides access to the PDM functions, alarm information, and settings.

e Home screen also has a Bolus button to give quick access to the bolus screen.

Today's date

Status bar

Menu icon

Tab labels: The name of the visible tab is blue and underlined.

Settings icon

Notications & Alarms icon

Tab area The Dashboard tab is visible in this image.

Amount and time of most recent bolus

Bolus button

Value and time of most recent blood glucose reading

1 Omnipod DASH™ Insulin Management System

e tab area of the Home screen can display bolus information on the Dashboard, basal information, or Pod information. To change which information is displayed:

• Tap on the word Dashboard, Basal, or Pod Info to display each tab.

• Swipe right or swipe le in the middle section to move between the tabs.

Note: If an immediate bolus is running, a bolus progress bar is shown on the Home screen, and the Bolus button and three tabs are not visible (see "Immediate bolus progress" on page 61). A button to cancel the bolus is visible.

Dashboard tab

e Dashboard tab is available if the Bolus Calculator is on and is usually not available if the Bolus Calculator is o.

When the Bolus Calculator is on

When the Bolus Calculator is on, the Dashboard tab displays:

• Insulin on board (IOB), when IOB is available.

• "IOB is Not Available," when the Bolus Calculator is disabled. Tap the of reasons for the Bolus Calculator to be disabled.

icon for a list

A progress bar appears when a bolus is in progress (see "Tracking the Progress of a Bolus" on page 61).

When the Bolus Calculator is o

When the Bolus Calculator is o, there are only two tabs: Basal and Pod Info. e Dashboard tab displays only when an extended bolus is running (see "Tracking the Progress of a Bolus" on page 61).

Omnipod DASH™ Insulin Management System 1

Basal tab / Temp Basal tab

is tab is labeled Basal or Temp Basal, depending on whether a Basal Program or temp basal is active.

Basal Program

By default, the Basal tab shows the name and graph of the active Basal Program.

A label below the Basal Program's name indicates whether the listed Basal Program is:

• Active—is program is running on the active Pod.

• Suspended —is program will resume when you resume insulin delivery.

• Current—ere is no active Pod. is program will be sent to your next Pod during activation.

When there is an active Basal Program, a green line marks the current time. e numbers above the graph indicate the basal rate for each time segment.

e total daily amount of basal insulin is shown beneath the graph. is total is the amount of insulin that the active Basal Program is scheduled to deliver in a 24hour period. is total does not account for temp basals or boluses. To see the total amount of insulin that your Pod has actually delivered, including temp basals and boluses, see "Summary Section" on page 88.

Ta p VIEW to see details about other Basal Programs (see page 77).

Temp basal

If a temp basal is running, the Basal tab is labeled Temp Basal and is highlighted in green. It displays the temp basal graph and allows you to cancel the temp basal.

1 Omnipod DASH™ Insulin Management System

Pod Info tab

e Pod Info tab shows whether there is an active Pod, and, if so, how much insulin is le in a Pod and when the Pod will expire. If there is an active Pod, tap VIEW POD DE TAILS to bring up a screen that lets you deactivate or change your Pod. e VIEW POD DETAILS screen shows:

• Amount of insulin in the Pod.

• Time of the last successful communication between the PDM and Pod.

• Date and time of the Pod's expiration.

• Any active reminders.

If the PDM cannot communicate with an active Pod, the Pod Info tab says "No Pod Communication." Tap the reasons why the PDM may not be able to communicate with the Pod.

If there is no active Pod, the Pod Info tab says "No Active Pod." To set up a new Pod, see "Changing Your Pod" on page 35.

When your Pod will expire soon, a yellow Change Pod soon banner appears on the Pod Info tab. e yellow banner appears 12 hours before Pod expiration or at the time of your Pod expiration reminder, whichever is earlier.

icon for a list of

At six hours before Pod expiration, a red Change Pod banner appears on the Pod Info tab.

When less than ve units of insulin remain in the Pod, a red Low Reservoir banner appears on the Pod Info tab. If the Pod will expire soon and there are less than ve units of insulin in the Pod, the red Low Reservoir banner is displayed on the Pod Info tab.

Note: If you change the date or time, the Pod expiration date and time are adjusted to match the new date and time.

Last BG section

e right side of the Home screen below the rotating tabs displays the value and time of your most recent blood glucose reading.

Omnipod DASH™ Insulin Management System 1

Last bolus section

e le side of the Home screen below the rotating tabs displays bolus information.

Between boluses

When a bolus is not being delivered, the section is labeled LAST BOLUS and shows the amount and time of the most recent bolus.

During a bolus when the Bolus Calculator is on

When a bolus is being delivered and the Bolus Calculator is on, the last bolus information is replaced by an estimate of the Insulin on Board (IOB):

• During an immediate bolus, the IOB estimate is updated every ten seconds.

• During an extended bolus, the IOB estimate includes IOB from previous boluses, an estimate of the amount already delivered from the ongoing bolus, and the amount projected to be delivered within the time period dened by your Duration of Insulin Action setting.

During a bolus when the Bolus Calculator is o

When a bolus is being delivered and the Bolus Calculator is o, the lower le of the screen shows the amount of the preceding bolus (not the ongoing bolus).

Bolus information if the PDM cannot communicate with the Pod

If the Pod is out of range of the PDM, and the PDM cannot conrm the recent bolus amount, an estimated bolus amount is shown. Once the Pod is in range again and the bolus delivery is conrmed, the conrmed bolus amount is shown.

Estimated and uncon rmed bolus amounts

e PDM estimates bolus amounts during an ongoing bolus and when the Pod is out of range. A gray icon ( (

) marks unconrmed bolus amounts (see "When the Pod has not conrmed

bolus delivery" on page 92).

) marks estimated bolus amounts. A yellow icon

Bolus button

e Bolus button provides access to the bolus screen. e Bolus button does not appear while an immediate bolus is being delivered, or when the Bolus Calculator is o and there is no active Pod.

1 Omnipod DASH™ Insulin Management System

The Home Page's Menu

e Menu on the Home page lets you access most of the PDM's functions. To display the Menu:

• Tap the Menu icon ( corner of the Home screen.

• Place your nger on the far le of the PDM, and swipe right across the screen. Swipe le to hide the Menu.

Tap an option on the Menu to bring up the related screen.

Tip: e Menu extends beyond the bottom of the screen. Swipe up or down to see all parts of the Menu.

Frequent tasks

e rst section of the Menu gives access to frequent tasks: activating a temp basal, changing your Pod, entering a blood glucose reading, and suspending or resuming insulin.

Special situations:

• Set Temp Basal is grayed-out if there is no active Pod, insulin is suspended, or a temp basal is already running.

• Set Temp Basal does not appear if the temp basal setting is turned o.

) in the upper le

• Suspend Insulin changes to Resume Insulin if insulin delivery is suspended.

• Suspend Insulin is grayed-out if there is no active Pod.

Manage Programs & Presets

e next section allows you to create or activate Basal Programs, temp basal presets, and bolus presets (see "Managing Programs and Presets" on page 77).

Omnipod DASH™ Insulin Management System 1

Special situations:

• Temp Basal Presets is only visible if the temp basal setting is on.

• Bolus Presets is only visible if the Bolus Calculator setting is o.

Food library

e Food Librar y option allows you to look up the carbohydrate content of various foods and to create food favorites (see "Using the Food Library" on page

63).

History menu

Tap the down arrow (  ) next to History to reveal the submenu:

• Notications & Alarms history (see page 85)

• Insulin & BG History (see page 86)

Tip: Tap the bell icon (

Notications & Alarms history screen.

Settings Menu

Tap the down arrow (  ) next to Settings to reveal the submenu:

• PDM Device

• Pod Sites

• Reminders

• Blood Glucose

• Basal & Temp Basal

• Bolus

Tip: Tap the Settings icon ( portion of the Menu.

ese settings allow you to change the time and date, turn Wi-Fi on or o, create or remove reminders, pair to a BG meter, turn the Bolus Calculator on or o, and much more. For more information, see "Adjusting Settings" on page 95.

About screen

e About screen displays details about your PDM, such as the soware revision number, the Customer Care phone number, the PDM serial number, the Pod version number, the time of the most recent PDM-Pod communication, and other device and legal information.

or ) at the top-right of many screens to open the

) at the top of the Home screen to open the Settings

Note: You can also  nd the PDM's serial number next to the back of your PDM.

icon on the

1 Omnipod DASH™ Insulin Management System

PDM Messages to You

e PDM can deliver alarm messages, notications, and conrmation messages.

Alarms

Hazard alarms and advisory alarms require your immediate attention (see "Alarms, Notications, and Communication Errors" on page 115). If you ignore an alarm, you could develop hypoglycemia or hyperglycemia.

Hazard alarms ( interrupt anything else the PDM is doing except another hazard alarm. For example, a hazard alarm is issued if the Pod runs out of insulin.

Advisor y alarms ( your attention in the near future. For example, if the level of insulin in your Pod is getting low, the PDM issues an advisory alarm.

) are accompanied by a continuous vibration or tone and

) alert you to some aspect of the PDM or Pod that needs

Noti cations

Notications ( ) remind you about actions you may want to perform (see "Notications List" on page 122). For example, you can set a reminder to tell you to measure your blood glucose aer a specied amount of time.

Con rmation Messages

e PDM conrms that an instruction was successful by displaying a green banner with a conrmation message. e conrmation message disappears aer several seconds.

Tip: Swipe to the right on the message to dismiss it sooner.

If an instruction is not successful, then the PDM displays a communication error message (see "Communication Errors" on page 125).

CHAPTER 2

Initial PDM Setup

is chapter guides you through setting up your rst PDM or a replacement PDM.

If you are setting up a to your old PDM before setting up your new PDM (see "Pairing, unpairing, or renaming a BG meter" on page 109). en go to "Charge the battery" on page 20.

replacement PDM, be sure to unpair any BG meters paired

The Starter Kit

Your initial shipment contains the Starter Kit and other items needed to begin using the Omnipod DASH™ Insulin Management System.

Aer you unpack the Starter Kit, use the "Contents" label on the side of the box to make sure you have everything.

e Starter Kit contains:

• PDM & rechargeable battery • Carrying case

• USB cable & charger • Quick Start Guide

• User Guide

You can obtain Pods by contacting Customer Care (see the rst page of this User Guide for contact information).

Preparing for Your Training

If you are a rst-time Omnipod DASH™ System user, you need to meet with your Omnipod DASH™ System Trainer to set up your Personal Diabetes Manager

(PDM) and rst Pod.

If you have used an Omnipod® Insulin Management System in the past and are upgrading to the Omnipod DASH™ System, review the online training module before setting up your new system.

To get a head start on learning about the Omnipod DASH™ System, review this User Guide, including the "Introduction" on page xi, "Your Omnipod DASH™

2 Initial PDM Setup

Insulin Management System" on page 1, and "Taking Care of Your PDM and Pod" on page 129.

Warnings:

Do NOT use the Omnipod DASH™ System before you have been trained. Inadequate training could put your health and safety at risk.

Follow your healthcare provider's instructions for initializing the PDM. Improper setup could put your health and safety at risk.

Note: Keep an emergency kit with you at all times to quickly respond to a diabetes emergency (see "Prepare for Emergencies" on page 164).

Charge the battery

It is important to charge the PDM's rechargeable battery before setting up your Omnipod DASH™ System:

1. Install the rechargeable battery in the PDM, if necessary (see "Inserting or replacing the PDM battery" on page 135).

2. Assemble the charger by plugging the charger cable's USB Type A plug into the charger's wall adapter.

Caution: Only use the micro-USB charger that came with the PDM.

3. Plug the charger into a wall outlet.

4. Plug the charger cable's USB Micro-B plug into the PDM's Micro-B USB port.

5. Charge the PDM until the battery level icon shows 100% charge (see "e Status Bar" on page 9).

6. Disconnect the charger from the PDM and the wall outlet.

Caution: Only use the rechargeable battery that came with your PDM or an equivalent replacement. Contact Customer Care if you have questions.

Items needed when you meet with your Omnipod DASH™ System Trainer

• Your PDM

• Two Pods

• is User Guide

• e blood glucose meter that came with your PDM(recommended) or another blood glucose meter

• Test strips and a lancing device (available from many pharmacies)

• Vial of U-100 insulin

• Alcohol prep swabs

Initial PDM Setup 2

• Instructions from your healthcare provider with PDM settings tailored to your needs. ese settings include Basal Program, IC Ratio, Correction Factor, Target BG values, and Duration of Insulin Action.

General PDM Settings

Although PDM setup is easy, if you are a rst-time user, your trainer must guide you through the setup process. You can adjust these settings later as needed.

Avoid taking a long break during the setup process. If the PDM is idle for 60 minutes during the setup process, you must begin the setup process from the beginning.

Tip: Use the pages at the end of this User Guide to write down all of your settings. is list will be helpful if you ever need to reset or replace your PDM.

Note: Tapping the back arrow ( tapping the CANCEL button in any of these setup steps takes you to the  rst screen of each section and erases any entries in that section. A popup screen warns you that you could lose these entries.

) returns you to the previous screen. However

Turning on and personalizing the PDM

1. Turn on the PDM by pressing and holding the Power button on the right side until the Omnipod logo appears. e PDM runs through a series of checks.

Caution: Once you begin using your PDM, do not turn the power o when you are not using it, as that would prevent the PDM from sounding an alarm. In other words, if you press the Power button too long, a 'Power O ' option appears. Do NOT tap 'Power O.' Instead, tap somewhere else on the screen to close the popup message while keeping the PDM on.

Note: You can, however, press the Power button brie y to toggle the PDM between the wake and sleep modes. Alarms cause the PDM to wake up if it is in sleep mode.

2. When a gray screen with the Omnipod DASH™ logo appears, use your nger to swipe from le to right across the screen.

3. Tap ALLOW to turn on Blu etoot h.

4. Tap a language to select your preferred language for the PDM screens. en tap the arrow (>).

5. Review the terms and conditions as follows:

a. Tap HIPAA Privacy Policy, EULA, ToU, and Warranty to read the Omnipod

DASH™ System's legal notices and privacy policy.  en tap AGREE.

2 Initial PDM Setup

b. Tap the box to add a checkmark.

c. Tap CONTINUE.

Note: If you are under 18, your parent or guardian must accept for you.

6. Tap BEGIN SETUP.

7. Tap letters on the keypad to enter a personalized screen message (see "Selecting, Adding, and Deleting Items" on page 6). en tap the checkmark.

Note: You must enter at least one character.

8. Tap CONTINUE.

A screen appears showing several background images.

9. Swipe right or le to see more images. Tap on your preferred image, then tap CONTINUE.

Note: When you wake up your PDM, you will see your personalized screen message and background image. Always con rm that the PDM is yours before using it.

Enter a PIN

To protect against unintentional screen touches, you must create a 4-digit personal identication number or PIN.

1. Choose four numbers to be your PIN. You will use this PIN number every time you wake up your PDM. You may want to record the PIN in a safe place.

Tip: To keep the PIN visible, tap the eye icon located to the right of the PIN entry elds. To hide the number, tap the eye icon again.

2. On the number pad, tap each number of your PIN. en tap the checkmark.

Initial PDM Setup 2

3. Enter the same four numbers again to conrm your PIN. Tap the checkmark.

If the second PIN entry does not match the rst, you must repeat the above steps.

Set the time zone and time

To set the current time zone and time:

1. Tap Select One to show the list of time zones.

2. Tap your time zone. You may need to swipe up or down to nd your time zone.

3. Tap CONTINUE.

4. Tap the 12 hr / 24 hr toggle to choose your preferred time display. For example, six hours before midnight is:

• 6:00 PM in 12 hr display

• 18:00 in 24 hr display

5. Place your nger on the Hour scroll wheel. Slide your nger up or down to scroll the wheel up or down. Stop scrolling when the correct hour appears in the center of the wheel.

6. Scroll the Minute scroll wheel up or down until the correct minute appears in the center of the scroll wheel.

7. If using 12 hr time, scroll the rightmost eld to select AM or PM.

8. Review the time and tap CONTINUE.

Caution: Check that you have set the time correctly. e time setting aects the operation of several Omnipod DASH™ System features and can impact your insulin delivery.

2 Initial PDM Setup

Set the date

On the Set Current Date screen:

1. Tap MM/DD/YY to display a list of date

formats. Tap the desired date format.

2. Set the Month, Day, and Year elds by

scrolling their respective wheels one at a time.

3. Review the date and date format, then

tap CONTINUE.

4. Review the time and date. If correct,

tap CONTINUE.

Basal Insulin Settings

Maximum Basal Rate

e Maximum Basal Rate sets the upper limit of any basal insulin rate that you can use.

1. Tap SET UP PROFILE.

2. Review the description of basal insulin, then tap the arrow (>).

3. Tap the Max Basal Rate eld.

4. Scroll to your desired Maximum Basal Rate. When the correct number is in the center of the scroll wheel, tap the number to select it.

Tip: Alternatively, tapping outside of the scroll wheel selects the value in the center of the scroll wheel.

5. Tap NEXT.

You can adjust your Maximum Basal Rate later, if your needs change.

Initial PDM Setup 2

Create a Basal Program

e next step is to dene a Basal Program. For a description of basal rates, basal segments, and Basal Programs, see "Basal Insulin Delivery" on page 141.

Name and tag the Basal Program

1. Review the description of Basal Programs, then tap NEXT.

2. e default name for the Basal Program is Basal 1. To change the name, tap the Program Name eld and enter the new name (see "Selecting, Adding, and Deleting Items" on page 6) and then tap the checkmark.

3. Optional: To add a visual icon to your Basal Program, tap one of the tags. Tap the tag a second time to deselect it.

4. Tap NEXT.

De ne the  rst segment

1. e Start Time for the rst segment is always midnight. Tap the End Time eld and scroll to select the desired end time.

2. Tap the Basal Rate eld and scroll to select the basal rate for the segment.

e Maximum Basal Rate that you entered earlier is displayed under the Basal Rate text. You cannot enter a basal rate greater than this number.

2 Initial PDM Setup

Note:  e two vertical blue lines on the graph near the top of the screen show the start and end time for the basal segment.  e selected basal rate for the segment is shown between the two vertical lines.

3. Check the values of your start and end times and the basal rate. en tap

NEXT.

De ne additional segments

If the Basal Program does not cover 24-hours, you must add additional segments:

1. Tap the End Time eld to dene the duration of the next segment.

2. Tap the Basal Rate eld and select the basal rate for the segment.

3. Review the segment details and the graph.

4. Tap NEXT to move to the next segment.

5. Repeat the preceding steps as needed until your nal segment ends at midnight.

Aer specifying a basal rate for the nal segment, your Basal Program is complete.

Review the Basal Program

e next screen summarizes the start and end times, duration, and basal rate for each segment of the Basal Program.

1. Check that the graph and the individual segment values are correct.

e total daily amount of basal insulin to be delivered by this Basal Program is listed below the graph.

2. To change an end time or basal rate for a segment:

a. Tap the row containing the

segment you would like to change.

b. Tap the End Time  eld, and enter

the new end time for the segment.

c. Tap the Basal Rate  eld, and enter

the desired basal rate.

d. Tap NEXT.

e.  en de ne the end time and basal

rate for any following segments, as needed.

Initial PDM Setup 2

3. To add a new segment:

a. Tap the row containing the start time of the new segment.

b. Tap the End Time  eld, and enter the start time of the new segment as the

end time of this segment.

c. Change the basal rate, if necessary.

d. Tap NEXT.

e.  en de ne the end time and basal rate for any following segments, as

needed.

4. To delete a segment:

a. Note the end time of the segment you want to delete.

b. Tap the segment that precedes the segment you want to delete.

c. Tap the End Time  eld, and enter the end time of the segment you want to

delete.  is 'overwrites' the segment you want to delete.

d. Tap NEXT.

e.  en de ne the end time and basal rate for any following segments, as

needed.

5. When the Basal Program is correct, tap SAVE.

Note: If the basal rate for a segment is 0 U/hr, the PDM displays a message calling this to your attention. Tap OK if the 0 U/hr rate is correct. Otherwise, tap CANCEL and edit the segment with the 0 U/hr rate.

Note: To create additional Basal Programs a er setup is complete, see page 77.

Temp basal con guration

For a description of temporary basal rates, also called temp basals, see page 143.

1. If you want the ability to use temp basals, tap the toggle to the "on" position. e toggle is in the "on" position when it is in the right-hand position and is blue.

If you turn temp basals on, percentages are used by default. To specify temp basals as a at rate (U/hr), see "Temp basal" on page 111.

2. Tap NEXT.

2 Initial PDM Setup

Blood Glucose Settings

e blood glucose settings dene what blood glucose readings are considered in range and allow you to pair to a CONTOUR® NEXT ONE BG meter.

Upper and lower limits for BG Goal Range

You can set the upper and lower limits of your BG Goal Range by using the number pad or the slider:

1. Review the description of blood glucose levels, then tap the arrow (>).

2. To dene the lower limit, tap the Lower Limit eld and type the number using the number pad.

Tip: Alternatively, you can touch the lower (red) circle with your nger and slide it up or down.

3. To dene the upper limit, tap the Upper Limit eld or slide the upper (yellow) circle.

4. Review your upper and lower limits, and tap NEXT to save them.

Initial PDM Setup 2

Pair to a BG meter

If desired, you can pair your PDM to a CONTOUR® NEXT ONE BG meter (BG meter). Once paired, blood glucose readings can be transmitted via Bluetooth (BLE) from your BG meter to your PDM.

Note: If you do not want to pair to a BG meter, tap SKIP.  en go to "Bolus Calculator Settings" on page 30

1. To pair a BG meter, tap BG Meter Pairing Instructions and follow the pairing process:

a. Turn o your BG meter, if

necessary, and keep it within six feet of your PDM.

b. Press and hold the OK button on

the BG meter. First you will see a white light and then a  ashing blue light. Continue to hold until the light is blue.

Note: Swipe up or down as necessary to see the full set of instructions.

2. On the PDM, tap START SEARCH.

e PDM displays the model and serial number of any CONTOUR® NEXT ONE BG meters that are in range and available for pairing.

3. Turn your BG meter over to nd its seven digit serial number. Verify that this number matches the one on the PDM screen.

4. On the PDM, tap PAIR below your BG meter's serial number.

A Successfully Paired message appears.

Note: If the BG meter is paired to another PDM, see "Pairing, unpairing, or renaming a BG meter" on page

109.

5. Tap OK. Verify that your BG meter is listed as paired.

2 Initial PDM Setup

6. Optional: Rename your paired BG meter:

a. Tap the Options icon (

b. Tap the Name  eld and use the keypad to enter a new name for your BG

meter, then tap the checkmark.

c. Tap SAVE.

7. Tap NEXT.

Caution: Aer pairing, the PDM controls the date and time on your paired BG meter. To avoid mislabeling of history records, make all changes to date and time on your PDM, not on your BG meter.

) next to the paired BG meter.  en tap Edit.

Bolus Calculator Settings

e Bolus Calculator suggests boluses based on your current blood glucose value and any food you are about to eat (see "e Bolus Calculator" on page 148).

Turn the Bolus Calculator on or o

1. Review the description of insulin boluses, then tap the arrow (>).

2. Toggle the Bolus Calculator setting on or o:

• Select the On position (blue and to the right) to have the Bolus Calculator suggest boluses.

• Select the O position (gray and to the le) to turn o the Bolus Calculator. You will have to calculate your own bolus amounts.

3. Tap NEXT.

4. If you turned the Bolus Calculator o, skip to "Other Bolus Settings" on page

34.

Initial PDM Setup 2

Target BG and Correct Above values

e Bolus Calculator aims to bring your blood glucose to the Target BG value if your current blood glucose level is above the Correct Above value. You can establish up to eight dierent blood glucose targets for dierent times of day.

De ne the segments

Setting values for each segment follows the same pattern that you used to create your Basal Program:

1. Review the description of Target BG

and Correct Above, then tap NEXT.

2. Tap the End Time eld to enter an end

time for the segment.

3. Tap the Target BG eld to specify the

Target BG for that segment.

4. Tap the Correct Above eld to specify

the Correct Above value for that segment.

5. Tap NEXT.

6. Repeat the above steps as needed until you have specied values for the segment that ends at midnight.

Review the Target BG and Correct Above values

1. Review the segments for the full 24 hour prole.

2. To change any of the entries:

a. Tap the row containing the entry to

be changed and enter the corrected value.

b. Review and correct as needed any

remaining segments.

3. When the segments and values are correct, tap SAVE.

2 Initial PDM Setup

Minimum BG for Calcs

If your blood glucose level is below the Minimum BG for Calcs that you specify, the Bolus Calculator is disabled (see "e Bolus Calculator" on page 148).

1. To enter your Minimum BG for Calcs,

tap the Min BG for Calc eld and enter the number on the number pad.

Tip: Alternatively, touch the blue circle and drag it to the desired number.

2. Tap NEXT.

IC Ratio

Your Insulin-to-Carbohydrate Ratio, or "IC Ratio," denes how many carbohydrates are covered by one unit of insulin. e Bolus Calculator uses the IC Ratio to calculate the meal portion of a suggested bolus. You can create up to eight IC Ratio segments per day.

1. Review the description of IC Ratio,

then tap NEXT.

2. Enter the end time.

3. Enter the IC Ratio value in the 1 Unit of Insulin Covers box.

4. Tap NEXT.

5. Add additional segments as necessary until the nal end time is midnight.

6. Review your 24-hour IC Ratio segments. Tap any entry to correct it.

7. When the segments and values are correct, tap SAVE.

Correction Factor

Your Correction Factor denes how much one unit of insulin lowers your blood glucose level. e Bolus Calculator uses the Correction Factor to calculate the correction portion of a suggested bolus. You can create up to eight Correction Factor segments per day.

1. Review the description of Correction

Factor, then tap NEXT.

2. Enter the end time.

3. Enter the Correction Factor in the 1 Unit of Insulin Decreases BG by eld.

4. Tap NEXT.

5. Add additional segments as necessary until the nal end time is midnight.

6. Review your Correction Factor segments. Tap any entry to correct it.

Initial PDM Setup 2

7. When the segments and values are correct, tap SAVE.

Reverse Correction

ere may be times when you are about to eat and your blood glucose level is below your Target BG level. If Reverse Correction is on, the Bolus Calculator decreases a suggested meal bolus to help counteract your low blood glucose.

1. Toggle the Reverse Correction button on or o:

• Select the On position if you want the Bolus Calculator to reduce the suggested meal bolus when your blood glucose is below your Target BG.

• Select the O position if you do not want the Bolus Calculator to adjust the suggested meal bolus based on a low blood glucose value.

2. Tap NEXT.

Duration of Insulin Action

e Duration of Insulin Action is the length of time that insulin stays active in your body. e Bolus Calculator uses this setting to determine how much insulin remains in your body from previous boluses (called insulin on board or IOB).

1. Tap the Duration of Insulin Action eld and use the scroll wheel to specify

your Duration of Insulin Action.

2 Initial PDM Setup

2. Tap NEXT.

Other Bolus Settings

e remaining bolus settings are used whether the Bolus Calculator is on or o.

Maximum Bolus

e PDM will not let you request a manually-calculated bolus above the Maximum Bolus setting. You will see a message if the Bolus Calculator calculates a bolus that is above this amount.

1. Tap the Max Bolus eld and use the number pad to specify your Maximum

Bolus. Tap the checkmark to close the number pad.

2. Tap NEXT.

Extended bolus setting

Extending a bolus means that a meal bolus can be delivered over a prolonged period of time. For a description of the extended bolus feature, see page 147.

1. Toggle the Extended Bolus button to turn the extended bolus feature on or

o.

2. Tap NEXT.

PDM Setup Complete

Congratulations! Your PDM is now ready for use. When you are ready to activate your rst Pod, go to "First Time Activating a Pod" on page 36.

Tip: To adjust the PDM screen time-out or screen brightness, see "Screen display" on page 96.

Note: Con dence reminders and program reminders are turned on by default.  ese reminders cause the PDM or Pod to beep at the beginning and end of boluses and temp basals, and also once an hour during a long-lasting bolus or temp basal. For more information, see "Con dence reminders" and "Program reminders" on page 107.

CHAPTER 3

Changing Your Pod

Beginning the Pod Change Process

Changing your Pod consists of deactivating your current Pod and activating a new Pod.

Your Pod should be changed at least once every 72 hours (3 days) or aer delivering 200 units of insulin. Consult with your healthcare provider and refer to the insulin labeling to determine if you should change your Pod more oen.

Warnings:

Do NOT use a Pod if you are sensitive to or have allergies to acr ylic adhesives, or have fragile or easily damaged skin.

Because the Pod uses only rapid-acting U-100 insulin, you are at increased risk for developing hyperglycemia if insulin delivery is interrupted. Severe hyperglycemia can quickly lead to diabetic ketoacidosis (DKA). DKA can cause symptoms such as breathing di culties, shock, coma, or death. If insulin delivery is interrupted for any reason, you may need to replace the missing insulin. Ask your healthcare provider for instructions for handling interrupted insulin delivery, which may include an injection of rapid-acting insulin.

Keep the Pod and its accessories, including the needle cap, away from young children, as they contain small parts that may be dangerous if swallowed.

e steps for deactivating or activating a Pod depend on whether you have an active Pod or not:

• If this is your rst time activating a Pod, go to "First Time Activating a Pod" on page 36.

• If you currently have an active Pod, go to "Deactivate an Active Pod" on page

36.

• If you have already deactivated your most recent Pod, go to "No Active Pod" on page 37.

Tip: Soware updates require that you deactivate your Pod. Connect to Wi-Fi periodically so the PDM can check for soware updates. If there is a "Wireless Update" message on the Lock screen, be sure to install the soware update aer you deactivate your Pod (see "Soware update (Wireless update)" on page 101).

3 Changing Your Pod

First Time Activating a Pod

Your Omnipod DASH™ System trainer will help you set up your rst Pod.

1. Aer completing the PDM setup ow, the Home screen displays "No Active

Pod." Tap SET UP NEW POD.

2. Tap SET UP NEW POD again.

3. Go to "Preliminary Pod Change Steps" on page 38.

Deactivate an Active Pod

To deactivate and remove an active Pod:

1. Navigate to the Pod change screen:

Home > Pod Info tab > VIEW POD DETAILS

or Menu icon (

) > Pod

2. Tap CHANGE POD, then tap DEACTIVATE POD.

If a temp basal or extended bolus was running, it is canceled now.

If you see a communication error message, see "Error when deactivating a Pod" on page 127.

Warning: Do NOT apply a new Pod until you have deactivated and removed the old Pod. A Pod that has not been deactivated properly can continue to deliver insulin as programmed, putting you at risk of over infusion and possible hypoglycemia.

Changing Your Pod 3

3. When the green banner tells you to remove your Pod, remove the deactivated Pod from your body:

a. Gently li the edges of the adhesive tape from

your skin and remove the entire Pod.

Tip: Remove the Pod slowly to help avoid possible skin irritation.

b. Use soap and water to remove any adhesive that remains on the skin, or, if

necessary, use an adhesive remover.

c. Check the infusion site for signs of infection (see "Avoid Infusion Site

Infections" on page 47).

d. Dispose of the used Pod according to local waste disposal regulations.

4. To activate a new Pod, tap SET UP NEW POD.

5. Go to "Preliminary Pod Change Steps" on page 38.

No Active Pod

If you have no active Pod and are ready to activate a new Pod:

1. Navigate to the Pod change screen:

Home > Pod Info tab > SET UP NEW POD

Menu icon ( SET UP NEW POD

2. Tap SET UP NEW POD.

3. Go to "Preliminary Pod Change Steps" on page 38.

) > Pod >

3 Changing Your Pod

Preliminary Pod Change Steps

Warnings:

NEVER use insulin that is cloudy; it may be old or inactive. Always follow the insulin manufacturer’s instructions for use. Failure to use rapid-acting U-100 insulin, or using insulin that has expired or is inactive, could put your health at risk.

Do NOT apply or use a Pod if the sterile packaging is open or damaged, or if the Pod has been dropped a er removal from the package, as this may increase the risk of infection. Pods are sterile unless the packaging has been opened or damaged.

Do NOT apply or use a Pod that is damaged in any way. A damaged Pod may not work properly.

Do NOT use a Pod if it is past the expiration date on the package.

To minimize the possibility of site infection, do NOT apply a Pod without  rst using aseptic technique.  is means to:

• Wash your hands.

• Clean the insulin vial with an alcohol prep swab.

• Clean the infusion site with soap and water or an alcohol prep swab.

• Keep sterile materials away from any possible germs.

1. Gather the necessary supplies:

• A vial of rapid-acting U-100 insulin cleared for use in the Omnipod DASH™ System

• An unopened DASH™ Pod (look for the Omnipod DASH™ logo on the Pod tray lid)

• Alcohol prep swabs

• Your Omnipod DASH™ PDM

2. Wash your hands before starting and keep them clean throughout the Pod change process.

3. Check the insulin for signs of deterioration according to the manufacturer's instructions for use.

4. Check the Pod's packaging for damage. If undamaged, open it and inspect the Pod for signs of damage.

5. If the insulin or Pod is below 50°F (10°C), allow it to warm up to room temperature before proceeding.

Changing Your Pod 3

Fill the Syringe with Insulin

e next step is to ll the syringe that came with the Pod (the "ll syringe") with insulin:

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

2. Securely twist the ll needle onto the ll syringe.

3. Pull outward to remove the protective cap from the needle. Save the cap; you will need it later.

4. Determine how much insulin you will put into the Pod. For example, to use the Pod for 48 hours, determine how much insulin you will use over the next 48 hours. Your healthcare provider can help you determine the correct amount.

Note:  e Pod requires a minimum of 85 units of U-100 insulin to begin operation.  e Pod can deliver up to 200 units of U-100 insulin.

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

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

7. Turn the vial of U-100 insulin and the ll syringe upside down. Pull down on the plunger to withdraw the desired amount of insulin from the vial into the ll syringe.

• Fill the syringe at least to the MIN (minimum) ll line.

• To ll the Pod with enough insulin to deliver 200 units, pull the plunger down until it stops. is will be below the 200 mark.

Pull apart

MIN ll line

8. With the needle still in the vial, ick the side of the syringe with your ngertip to dislodge any air bubbles so they collect at the top of the syringe. en push in the plunger to expel any air bubbles out of the syringe and into the insulin vial. Pull down on the plunger again, if necessary, to rell the ll syringe to the desired amount of insulin.

Warning: Make sure there are no air bubbles or pockets of air in the  ll syringe before  lling a Pod with insulin. Air transferred from the  ll syringe into the Pod may result in interrupted insulin delivery.

9. Remove the needle from the vial.

3 Changing Your Pod

Fill, Pair, and Apply the Pod

Warning: Before  lling a Pod, ensure that no other Pods are being activated within 5 feet (1.5 m) of your PDM.

Caution: Be sure to insert the ll syringe into the ll port and not any other location on the Pod. Do not insert the ll syringe more than once into the ll port. Only use the ll syringe and needle that came with your Pod. e ll syringe is intended for single use only and should only be used with the Omnipod DASH™ System.

Fill the Pod with insulin

To ll the Pod with insulin (screen step ):

1. Locate the arrow on the underside of the Pod. e arrow points to the insulin ll port.

Tip: You can leave the Pod in its tray during lling and pairing.

2. Insert the ll syringe straight down— not at an angle—into the ll port.

3. Depress the ll syringe plunger to transfer the insulin into the Pod.

4. Listen for two beeps from the Pod during the lling process. Be sure to completely empty the ll syringe, even aer hearing the two beeps.

Note:  e Pod must contain a minimum of 85 units of insulin in order to function.  e Pod beeps twice a er it has been  lled with 85 units of insulin. If you have  lled the Pod with more than 85 units and still do not hear the two beeps, please call Customer Care.

Note: A er  lling the Pod, continue to the next step immediately. If two hours pass before pairing the  lled Pod to the PDM, the Pod becomes unusable.

Changing Your Pod 3

Warnings:

NEVER use a Pod if you feel resistance when you depress the plunger. is condition can result in interrupted insulin delivery.

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

5. Remove the needle from the insulin ll port. e port is self-sealing; insulin will not leak aer the needle is removed.

6. Place the protective cap back on the syringe needle and remove the needle from the ll syringe.

Pair the PDM and Pod

To pair the PDM and Pod (screen step ):

1. Place the PDM next to the Pod so they are touching. e Pod should be in its plastic tray during this process.

2. Tap NEXT.

• If more than one lled DASH Pod is in range, the PDM informs you of this. Move at least ve feet (1.5 m) away from any other DASH Pod and tap TRY AGAIN.

• If only one Pod is in range, the Omnipod DASH™ System performs a series of safety checks and primes the Pod.

3. Listen for the tone from the PDM that indicates that the Pod is paired to the PDM and is ready to be applied.

Note: A er pairing, the PDM should always be able to communicate with a Pod that is up to 5 feet (1.5 m) away. Depending on the location, the PDM may be able to communicate with a Pod that is as much as 50 feet (15 meters) away.

Note: A er pairing, the Pod beeps every 5 minutes until you apply it. If you do not apply it within 60 minutes a er pairing, the Pod becomes unusable.

If you see a communication error message when you attempt to pair your Pod, see "Communication Errors" on page 125.

3 Changing Your Pod

Prepare the Pod site

Select the Pod infusion site (screen step

Guidelines for Pod site selection

Discuss suitable Pod placement sites with your healthcare provider using the following guidelines:

• Ideal sites have a layer of fatty tissue.

• Ideal sites oer easy access and

• e site should be at least 1 inch

• e site should be at least two inches

• Avoid sites where belts, waistbands,

viewing.

(2.5 cm) away from the previous site to avoid skin irritation.

(5 cm) away from your navel.

or tight clothing may rub against or dislodge the Pod.

• Avoid sites where the Pod will be aected by folds of skin.

• Avoid placing the Pod over a mole, tattoo, or scar, where insulin absorption may be reduced.

• Avoid areas of the skin with an active infection.

Pod site map (optional)

e Pod site map is an optional feature that helps you track your current and recent Pod site locations. is option only appears if the Pod Sites setting is turned on (see "Pod Sites Settings" on page 103).

Front Back

Front

Back

Changing Your Pod 3

1. Tap RECORD POD SITE to bring up the Record Pod Site screen.

2. Tap the FRONT or BACK tab to select an area of your body for your Pod. To

help you avoid recent Pod sites, the screen indicates the two most recent dates that each site was selected.

3. Tap a circle to indicate the location on your body where you will place your new Pod. A blue circle appears inside the selected circle. Tap again to deselect the location.

4. Tap the DETAILS tab to add a detail about the placement of this Pod. For example, you could add a detail that says "Facing up" or "Facing down" to describe the Pod's orientation.

a. To add a new detail, tap ADD NEW and type in the new detail. Tap ADD

when done.  e new detail is added to the list.

Note:  e PDM considers uppercase letters and lowercase letters to be identical. For example, you can only use one of the following details: "Facing up," "FACING UP," or "facing Up," because the PDM considers these to be identical entries.

b. Select a detail for the new Pod by tapping the circle next to that detail. You

may only add one detail for each Pod. Tap again to deselect the detail.

Note: To delete a site detail, tap the

5. Tap DONE when nished to return to the Change Pod screen.

next to the detail.

3 Changing Your Pod

Prepare the infusion site

To reduce the risk of infection at the infusion site:

1. Wash your hands with soap and water.

2. Wash your selected infusion site with soap and water.

Note: Antibacterial soap may irritate skin, especially at the infusion site. Ask your healthcare provider how to treat any skin irritation.

3. Dry the infusion 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 infusion site air-dry thoroughly. Do not blow on the site to dry it.

Remove the Pod's blue cap

Remove the Pod's blue needle cap (screen step

1. Turn the Pod so the blue needle cap is

up and facing you.

2. Place your thumb on the bottom (at edge) of the blue cap and pull the cap upwards. e cap snaps o. row the cap away.

When you remove the blue cap, a drop of insulin may be visible at the end of the cannula or in the well.

3. If any of the following apply, tap CANCEL, and then dispose of the Pod and begin again with a new Pod:

• e Pod is accidentally dropped, as this may compromise sterility.

• e Pod or its adhesive pad is wet, dirty, or damaged.

• e cannula extends beyond the adhesive backing when the blue needle cap is removed.

Warning: Verify that the cannula does not extend beyond the adhesive backing once the Pod's blue needle cap is removed.

4. Using the pull tabs, remove and discard the white paper backing from the adhesive pad. Do not allow the adhesive to fold back on itself.

Changing Your Pod 3

Apply the Pod

Inspect and apply the Pod (screen step ):

1. Examine the Pod. Tap CANCEL and dispose of the Pod if the adhesive pad is

folded, torn, or damaged, and begin again with a new Pod.

2. Orient the Pod so it is:

• Horizontal or diagonal on your abdomen, hip, lower back, or buttocks.

• Up and down or at a slight angle on your upper arm or thigh.

Up, down, or slight angle

3. Apply the Pod to the selected infusion site, pressing down rmly to secure the Pod to your skin.

e adhesive is designed for onetime use. Once a Pod is placed on your body, you cannot move that Pod to another infusion site.

Note:  e Pod’s adhesive keeps it securely in place for up to three 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 as these products may loosen the adhesive.

Front

Horizontal or diagonal

Up, down, or slight angle

Back

Begin insulin delivery

Begin insulin delivery (screen step ):

Warning: If you are applying a Pod in a place that does not have a lot of fatty tissue, squeeze the skin around the Pod throughout the next step. Occlusions may result if you do not use this technique for lean areas.

1. If you applied the Pod to a lean area, squeeze the skin around the Pod.

2. Tap START.

3 Changing Your Pod

3. Conrm that the Pod is securely attached to your body, then tap CONFIRM.

4. If you are squeezing your skin, stop squeezing when the PDM asks if the cannula is properly inserted.

Once the cannula is inserted, the Pod automatically lls the cannula with insulin. e Pod then begins delivering the basal rate of insulin according to the active Basal Program.

e cannula can be inserted only once with each Pod.

Caution: Be sure to check the alarm function at every Pod change (see "Check alarms" on page 99).

Check the Infusion Site

Following insertion of the cannula, check the Pod and infusion site:

1. Look through the viewing window on the edge of the Pod to verify that the cannula is inserted into the skin. e cannula is tinted light blue.

2. Verify that there is a pink color in the area indicated in the gure. is is an additional check that the cannula was inserted.

3. Verify that there is no wetness or scent of insulin

Check here for light blue cannula

Check here for pink color

at the infusion site. e presence of either may indicate that the cannula has dislodged.

Warning: Check the infusion site a er insertion to ensure that the cannula was properly inserted. If the cannula is not properly inserted, hyperglycemia may result.

4. If the cannula is not properly inserted, tap NO. en tap DEACTIVATE POD. Restart the process with a new Pod.

5. If the cannula is properly inserted, tap YES.

A green banner noties you that the Pod setup is complete. e screen shows details about the Pod and a list of reminders.

6. Review the list of active reminders, then tap CLOSE.

Note: A Check BG reminder prompts you to check your blood glucose level and infusion site 90 minutes a er Pod activation.  is additional safety feature helps ensure that the cannula was properly inserted.

Changing Your Pod 3

Warning: Never inject insulin (or anything else) into the  ll port while the Pod is on your body. Doing so may result in unintended or interrupted insulin delivery.

Avoid Infusion Site Infections

Check the infusion site at least once a day:

• Be aware of signs of infection, including pain, swelling, redness, discharge, or heat at the infusion site. If you suspect an infection, immediately remove the Pod and apply a new Pod in a dierent location. en contact your healthcare provider.

• If you observe any problems with the Pod, replace it with a new Pod.

Warnings:

Check o en to make sure the Pod and so cannula are securely attached and in place. A loose or dislodged cannula may interrupt insulin delivery. Verify that there is no wetness or scent of insulin, which may indicate that the cannula has dislodged.

If an infusion site shows signs of infection:

• Immediately remove the Pod and apply a new Pod at a dierent infusion site.

• Contact your healthcare provider. Treat the infection according to instructions from your healthcare provider.

3 Changing Your Pod

More Information about Pod Use

Tip: Develop a routine so you can change your Pod at a convenient time. If you know of an upcoming event that could interfere with changing your Pod, you can change your Pod early to avoid a disruption in insulin delivery.

For additional information on using your Pods as eectively as possible, see the following sections:

• For care of your Pod, see "Pod and Insulin Care" on page 129.

• To learn about the Pod alarms, see "Alarms, Notications, and Communication Errors" on page 115.

• If a Pod alarm is sounding, rst attempt to silence it with your PDM. If that is not successful, you can manually turn o the Pod alarm (see "Silencing an Alarm" on page 128).

• To understand the Pod's informational and notication beeps, including which beeps are optional, see "Notications List" on page 122 and "Informational Signals List" on page 124.

• To understand how to handle situations where the PDM cannot communicate with your Pod, see "Communication Errors" on page 125.

• If the Home: Pod Info tab says "No Pod Communication:"

• To nd the last time the PDM successfully communicated with the Pod

navigate to: Menu icon (

• If you are unable to restore communication with the Pod and want to

change to a new Pod, navigate to: Menu icon (

POD.

• For a description of the how the PDM communicates with the Pod, see "PDM and Pod Interactions" on page 137.

) > Pod.

) > Pod > CHANGE

CHAPTER 4

Entering Blood Glucose Readings

About Blood Glucose Testing

Warning: Follow the guidance of your healthcare provider for proper blood glucose monitoring.

You may want to test for low blood glucose when:

• You feel symptoms such as weakness, sweating, nervousness, headache, or confusion.

• You have delayed a meal aer taking insulin.

• Your healthcare provider advises you to do so.

To enter your blood glucose reading into the PDM:

• From a paired BG meter, go to the following section.

• When not using a paired BG meter, go to page 50.

To pair to a new BG meter, go to "Pairing, unpairing, or renaming a BG meter" on page 109.

Entering Your Blood Glucose Reading from a Paired BG Meter

To record a blood glucose reading from a paired BG meter:

1. Check your blood glucose following the CONTOUR® NEXT ONE BG meter's instructions for use.

2. Turn on your BG meter and place it next to your PDM (no more than six feet away).

3. Go to the Enter BG screen on your PDM: Menu icon (

) > Enter BG

4 Blood Glucose Readings

4. Tap SYNC BG METER.

e PDM imports all new blood glucose readings and saves them in your history records.

For the meaning of the screen's colors and messages, see "How Blood Glucose Readings are Displayed" on page 52.

Note: You cannot edit the value or time of blood glucose readings from a paired BG meter.

5. Optional: To add one or more informational tags to the blood glucose reading shown in the circle, see "Tagging Your Blood Glucose Reading" on page 52.

6. Aer the blood glucose reading and any tags are entered, do one of the following:

• Tap ADD TO CALCULATOR to save any tags and enter the blood glucose

reading into the Bolus Calculator. en go to "Bolusing with the Bolus Calculator" on page 55. If the Bolus Calculator is o or disabled or if insulin is suspended, ADD TO CALCULATOR does not appear.

• Tap SAVE to save any tags in the history records. If you accessed this screen

from the Bolus Calculator, SAVE does not appear.

• Tap CANCEL to exit the screen without saving the tags. Any imported

blood glucose readings have already been saved.

Entering Your Blood Glucose Reading Manually

To manually enter your blood glucose reading:

1. Check your blood glucose following the BG meter's instructions for use.

2. Go to the Enter BG screen on your PDM: Menu icon (

) > Enter BG

Blood Glucose Readings 4

3. Manually enter or edit a blood glucose value as follows:

a. Tap the box inside the circle.

b. Use the number pad to enter your

blood glucose reading.

c. Tap the checkmark to close the

number pad.

Note: Alternatively, you can enter a blood glucose reading using the circular slider (see "Using a slider" on page 6). When using the slider, "+" and "-" buttons appear brie y. Tap these buttons to make small adjustments to the blood glucose number.

Note: To enter a blood glucose reading above 600 mg/dL, use the slider to slide the indicator clockwise until HI appears. To enter a reading below 20 mg/dL, move the slider counterclockwise until LO appears.  e PDM stores readings above 600 mg/dL as "HI" and below 20 mg/dL as "LO."

For the meaning of the screen's colors and messages, see "How Blood Glucose Readings are Displayed" on page 52.

4. Optional: To add one or more informational tags to the blood glucose reading shown in the circle, see "Tagging Your Blood Glucose Reading" on page 52.

5. Aer the blood glucose reading and any tags are entered, do one of the following:

• Tap ADD TO CALCULATOR to save any tags and enter the blood glucose

• Tap SAVE to save the blood glucose reading and any tags in the history

records. If you accessed this screen from the Bolus Calculator, SAVE does not appear.

• Tap CANCEL, then YES, to exit the screen without saving the blood

glucose reading or tags.

e PDM records the current time as the time of the blood glucose reading.

4 Blood Glucose Readings

Tagging Your Blood Glucose Reading

Tag a blood glucose reading

You can add informational tags to your blood glucose reading for future reference. For example, you may tag the blood glucose reading as pre-meal.

To add a tag to the current blood glucose reading or to a control solution reading:

1. Tap ADD TAGS.

2. Tap a tag to select it. You can add up to four tags.

3. To remove a tag, tap the tag again to deselect it.

You can add or remove tags for LO and HI blood glucose readings just as you would for any other reading.

Control solution readings

As a rule, a control solution reading from a paired BG meter is automatically tagged as a control solution. In the rare case when it is not tagged automatically, you must add a "Control" tag. Readings tagged as Control are not included in history averages.

Do not manually enter control solution readings from a non-paired BG meter. You cannot tag manually-entered readings with a Control tag, which means you cannot prevent them from being averaged into your blood glucose history records.

How Blood Glucose Readings are Displayed

e PDM displays the blood glucose reading inside a colored circle. e circle is:

• Yellow if your blood glucose is above your BG Goal Range.

• Green if your blood glucose is within your BG Goal Range.

• Red if your blood glucose is below your BG Goal Range.

Blood Glucose Readings 4

To change your BG Goal Range, see "BG Goal Range" on page 109.

e PDM adds a warning message for high and low blood glucose readings.

Blood glucose reading Screen display Screen warning message

Above 600 mg/dL or HI HI Treat your high BG! If it remains

high, seek medical advice.

251-600 mg/dL <BG reading> Treat your high BG! If it remains

high, seek medical advice.

70-250 mg/dL <BG reading>

20-69 mg/dL <BG reading> Treat your low BG!

0-19 mg/dL or LO LO Treat your low BG!

If the blood glucose is HI or above 600 mg/dL, the PDM records "HI" in the history. is indicates severe hyperglycemia (high blood glucose). If the blood glucose reading is LO or below 20 mg/dL, the PDM records "LO" in the history. is indicates severe hypoglycemia (low blood glucose). HI and LO readings are saved in your blood glucose history, but are not used in averages.

4 Blood Glucose Readings

Warnings:

Blood glucose readings below 70 mg/dL may indicate hypoglycemia (low blood glucose). Blood glucose readings above 250 mg/dL may indicate hyperglycemia (high blood glucose). Follow your healthcare provider's suggestions for treatment.

If you get a “Treat your low BG!” message and feel symptoms such as weakness, sweating, nervousness, headache, or confusion, follow your healthcare provider’s recommendation to treat hypoglycemia.

If you get a “Treat your high BG! If it remains high, seek medical advice” reading message and feel symptoms such as fatigue, thirst, excess urination, or blurry vision, follow your healthcare provider’s recommendation to treat hyperglycemia.

"LO" or "HI" blood glucose readings can indicate potentially serious conditions requiring immediate medical attention. If le untreated, these situations can quickly lead to diabetic ketoacidosis (DKA), shock, coma, or death.

CHAPTER 5

Delivering a Bolus of Insulin

A bolus of insulin is used to lower a high blood glucose level and to cover the carbohydrates in a meal. Bolus insulin is delivered in addition to insulin from a Basal Program or temp basal. For more information about boluses, see page 147.

Warning: When using the extended bolus function, check your blood glucose levels more frequently to avoid hypoglycemia or hyperglycemia.

Caution: Always measure your blood glucose prior to delivering a bolus.

If the Bolus Calculator is set to 'o ' or is temporarily disabled, go to "Manuallycalculated Bolus" on page 59.

Bolusing with the Bolus Calculator

e Bolus Calculator calculates a suggested bolus amount of insulin to correct an elevated blood glucose level (a correction bolus) or to cover carbohydrates in a meal (a meal bolus). For details about how the Bolus Calculator works, see page

148.

If you enter a blood glucose value but not carbs, the Bolus Calculator calculates a correction bolus only. If you enter carbs but not a blood glucose value, the Bolus Calculator calculates a meal bolus only.

To change your personal settings used by the Bolus Calculator, or to turn the Bolus Calculator on or o, see "Bolus Calculator settings" on page 112.

Enter your meal information

To enter the carbohydrates, or "carbs," for your meal:

1. On the Home screen, tap the Bolus icon (

Tip: If you already know the amount of the bolus you want to deliver, tap the

Total Bolus eld to bring up the number pad. Enter the bolus amount and tap the checkmark. en go to "Delivering an immediate or extended bolus" on page

57.

5 Delivering a Bolus of Insulin

2. To enter carbs manually, tap the Enter Carbs eld. Enter the grams of carbs

and tap the checkmark.

Note: Consult your healthcare provider about how to calculate the grams of carbs.

3. Optional: To look up carbs in the Food Library, tap FOOD LIBRARY and select the food for your meal (see "Add carbs to the Bolus Calculator" on page 64).

Note: Even though the Food Library may list grams of  ber in addition to grams of carbs, the Bolus Calculator does not subtract  ber from the carb value. Consult your healthcare provider about whether you should make an adjustment for  ber.

4. Review the suggested meal bolus, which is shown next to the grams of carbs. e meal bolus has been adjusted for any insulin on board (IOB) from a previous correction bolus.

Enter your blood glucose reading

To enter a blood glucose reading:

1. Tap ENTER BG.

If the PDM has a blood glucose reading from within the past 10 minutes, that value automatically appears in the BG eld. In this case, skip the next step.

2. Enter your blood glucose reading:

• To use a paired BG meter—Aer measuring your blood glucose on

the paired BG meter, tap SYNC BG METER. e blood glucose reading appears on the PDM screen.

• To manually enter a blood glucose reading—Tap the box in the circle and enter the blood glucose reading. Alternatively, slide the indicator along the circle to enter the blood glucose reading.

For the meaning of the colors and messages displayed on the Enter BG screen, see "How Blood Glucose Readings are Displayed" on page 52.

3. Optional: To tag the blood glucose reading, tap ADD TAGS and tap a tag. Tap

again to deselect a tag. You can add up to four tags.

4. Tap ADD TO CALCULATOR. e Bolus Calculator screen reappears.

Delivering a Bolus of Insulin 5

5. Review the suggested correction bolus, which is shown next to the blood glucose value. e correction bolus has been adjusted for any insulin on board (IOB).

Delivering an immediate or extended bolus

e Total Bolus eld shows the proposed bolus. e amount of any IOB adjustment appears below the Total Bolus eld.

To review and deliver the bolus:

1. Review the suggested bolus. To adjust it, tap the Total Bolus eld and enter a revised bolus.

Tip: To review the Bolus Calculator's calculations, tap CALCULATIONS. You may need to swipe up or down to see all of the calculations. Tap CLOSE when done (see "Bolus Calculator equations" on page 152 for details).

2. To deliver the entire bolus immediately, tap CONFIRM and skip to step 4.

3. To extend some or all of a meal bolus:

a. Tap EXTEND BOLUS.

Note:  e EXTEND BOLUS option is available when there is a meal bolus and the extended bolus setting is enabled.

b. Tap the Now  eld and type in the

percentage of the bolus to be delivered immediately. Alternatively, tap the Extended  eld and enter the percentage to be extended.

e number of units to be delivered now and over the extended period appear below the percentage (%).

5 Delivering a Bolus of Insulin

Note: You can only extend the meal portion of the bolus. A correction portion of the bolus, if any, is always delivered immediately.

c. Tap the Duration  eld and enter the duration for the extended portion of

the bolus.

d. Tap CONFIRM.

4. Review the bolus details on the Conrm Bolus screen.

e screen for an immediate bolus is shown on the le. e screen for an extended bolus is shown on the right.

Warning: If the suggested bolus exceeds your Maximum Bolus, the PDM asks if you'd like to override the Maximum Bolus limit. Allowing a temporary override does not change your Maximum Bolus setting. Giving too much insulin can cause hypoglycemia.

5. Optional: Set up a reminder to check your blood glucose:

a. Tap CREATE BG REMINDER.

b. Tap the Check BG in  eld and enter the time for the reminder.

c. Tap SAVE.

Note:  e CREATE BG REMINDER button does not appear if the "Check BG a er Bolus" reminder setting is turned o . To turn this setting on or o , see "Check BG a er Bolus reminders" on page 105.

Delivering a Bolus of Insulin 5

6. Tap START to begin the bolus.

e Home screen tracks the delivery of an immediate or extended bolus (see "Tracking the Progress of a Bolus" on page 61).

Manually-calculated Bolus

A manually- calculated bolus is a bolus that you calculate yourself. If the Bolus Calculator is set to 'o' or is temporarily disabled, you must enter a manuallycalculated bolus.

A manually-calculated bolus cannot be greater than your Maximum Bolus setting (see "Maximum Bolus" on page 112).

To deliver a manually-calculated bolus:

1. On the Home screen, tap the Bolus icon (

e Bolus screen appears.

Note: A di erent screen appears if the Bolus Calculator is active (see page

56).

2. Enter the bolus amount using one of the following methods:

• Tap the Total Bolus eld and enter the bolus amount. en tap the

checkmark.

• Tap SELECT FROM PRESETS and select the desired preset from the list.

is option is only available if the Bolus Calculator is turned o. To create or edit a bolus preset, see "Bolus presets" on page 82.

3. To deliver the entire bolus immediately, tap CONFIRM. en skip to step 5.

5 Delivering a Bolus of Insulin

4. To extend the bolus:

a. Tap EXTEND BOLUS.

Note:  e EXTEND BOLUS option is only available if extended boluses are enabled (see page 112).

b. Tap the Now  eld and type in the

percentage of the bolus to be delivered now. Alternatively, tap the Extended  eld and enter the percentage to be extended.

e number of units to be delivered now and over the extended period appear below the percentage (%).

Note: You can extend the entire bolus.

c. Tap the Duration  eld and enter

the duration for the extended portion of the bolus.

d. Tap CONFIRM.

5. Review the bolus details on the Conrm Bolus screen.

6. Optional: Set up a reminder to check your blood glucose as follows:

a. Tap CREATE BG REMINDER.

b. Tap the Check BG in  eld and enter the time for the reminder.

c. Tap SAVE.

7. Review the bolus details, then tap START to begin the bolus.

e bolus amount and details about the bolus preset, if a preset was used, are stored in your history records. e Home screen tracks the delivery of an immediate or extended bolus (see "Tracking the Progress of a Bolus" on page 61).

Delivering a Bolus of Insulin 5

Tracking the Progress of a Bolus

During a bolus, the Home screen displays a progress bar.

Immediate bolus progress

During an immediate bolus, the Home screen displays a Bolus in Progress message along with a progress bar and details.

If the Bolus Calculator is on, an estimate of the IOB is displayed in the lower le of the screen.

If the Bolus Calculator is o (not shown), the amount of the last completed bolus is displayed in the lower le of the screen.

You cannot use your PDM during an immediate bolus.

To cancel or replace a bolus, see "Altering a Bolus in Progress" on page 62.

Extended bolus progress

During an extended bolus, the Home screen's Dashboard tab displays an Extended Bolus in Progress message along with a progress bar and other details.

Note: If the Bolus Calculator is o , the Dashboard tab only appears when an extended bolus is in progress.

If the Bolus Calculator is on, the displayed IOB is updated with estimated amounts from the ongoing bolus.

If the Bolus Calculator is o (not shown), the amount of the last completed bolus is displayed in the lower le of the screen.

You can use your PDM for most actions during an extended bolus.

Unless you cancel the bolus, the Pod nishes delivering a bolus whether or not it is in range of the PDM. To cancel or replace a bolus, see "Altering a Bolus in Progress" in the next section.

5 Delivering a Bolus of Insulin

Altering a Bolus in Progress

When an immediate bolus is in progress, you must cancel it before performing any other action.

During an extended bolus, you can:

• Cancel the bolus.

• Deliver a new immediate bolus and continue the extended bolus in progress.

• Replace the bolus in progress with another bolus.

If you get a communication error message when canceling a bolus, see "Error when canceling a bolus" on page 126.

Cancel a bolus

To cancel an immediate or extended bolus:

1. From the Home screen (immediate bolus) or the Home screen's Dashboard tab (extended bolus), tap CANCEL.

2. Tap YES to conrm canceling the bolus. e Pod beeps to conrm that the bolus is canceled.

Deliver a new bolus during an extended bolus

To deliver an immediate bolus while an extended bolus is in progress:

1. From the Home screen, tap the Bolus button.

2. Enter the carbs and BG reading information. en tap CONFIRM.

3. Tap START.

e new bolus is delivered, and the extended bolus continues.

Replace an extended bolus

To replace an extended bolus in progress with a new extended bolus, you must cancel the ongoing bolus rst.

1. On the Home screen, tap the Bolus icon (

2. Enter the amount of the new bolus (see "Bolusing with the Bolus Calculator" on page 55 or "Manually-calculated Bolus" on page 59).

3. Tap EXTEND BOLUS. A screen appears telling you that an extended bolus is already active.

Delivering a Bolus of Insulin 5

4. Tap CANCEL & CREATE NEW to cancel the active bolus. e PDM tells you

how much of the bolus was undelivered.

5. Select how to handle the undelivered bolus amount:

• If you want to add the undelivered bolus amount to the new extended

bolus, tap ADD TO TOTAL BOLUS. Verify that the new total bolus is correct. en tap EXTEND BOLUS.

Note:  e Bolus Calculator considers this added amount to be a user adjustment to the new bolus.  is added amount will be delivered over the same duration as the new extended bolus.

• If you do not want to add the undelivered bolus amount to the new

extended bolus, tap NO.

6. Return to the extended bolus ow:

• If the Bolus Calculator is on, go to step 3 on page 57.

• If the Bolus Calculator is o, go to step 4 on page 60.

Using the Food Library

e Food Library has a MY FOODS list and a BROWSE list.

e BROWSE list contains thousands of common foods. You can create a smaller list of your favorite foods on the MY FOODS list.

When you are about to eat, you can use the MY FOODS list or the BROWSE list to transfer the number of carbs in a meal to the Bolus Calculator.

To access the Food Library, do one of the following:

• From the Home screen, tap:

Menu icon (

• From the Bolus Calculator screen, tap

FOOD LIBRARY.

Ta p MY FOODS or BROWSE to switch between the lists. A blue underline indicates whether the MY FOODS or BROWSE list is showing.

) > Food Library

5 Delivering a Bolus of Insulin

All individual food items on the BROWSE list are marked with a heart. If the heart is an outline ( on the MY FOODS list. If the heart is solid (

), you have added that food to the MY

FOODS list. Foods with a solid heart ( are considered "favorite" foods.

e back (< ) arrow takes you to the previous screen in the Food Library.

Note:  e total grams of carbs on the BROWSE list includes grams of  ber.  e Bolus Calculator does not automatically subtract  ber from a carbs value when importing carbs from the Food Library. Consult your healthcare provider about how to account for  ber when calculating a bolus.

), that food does not appear

)

Add carbs to the Bolus Calculator

Add carbs to the Bolus Calculator from the BROWSE list

To add carbs to the Bolus Calculator from a food listed on the BROWSE list:

1. Locate the food you are going to eat (see "Search for a food on the BROWSE list" on page 66).

2. Tap Quantity to specify how many servings of the food you will eat.

3. If the food has multiple serving sizes, tap Servings to specify the serving size and measurement units.

4. Tap ADD to add the number of carbs in the food to the total carbs displayed in the Food Carbs banner.

Note:  e ADD button is disabled if you have not speci ed a serving size.

To remove the food from the Food Carbs total, tap REMOVE.

Delivering a Bolus of Insulin 5

5. Optional: Add additional foods:

a. Tap the back (< ) arrow or use the search function to navigate to the next

food item.  en tap to select the food item.

b. Tap ADD.  is adds the carbs from the new selection to the total carbs in

the Food Carbs banner.

c. Repeat this step until the Food Carbs banner shows the total carbs for

your entire meal.

Tip: Tap the Food Carbs banner to see the foods that are included in the total.

6. Tap ADD TO CALCULATOR. e Bolus Calculator screen appears with the

total number of carbs entered in the Enter Carbs eld.

Note:  e ADD TO CALCULATOR option does not appear if the Bolus Calculator is o or disabled.

Add carbs to the Bolus Calculator from the MY FOODS list

To add carbs to the Bolus Calculator from a food listed on the MY FOODS list:

1. Open the MY FOODS list:

Menu icon (

2. Tap the MY FOODS list.

3. Optional: To lter the MY FOODS list:

a. Tap the down arrow beneath the

MY FOODS heading. A dropdown list of food tags appears.  e number of food items with each tag is shown in parentheses.  e default category is All, which shows the entire MY FOODS list.

b. Tap a tag.  e list is  ltered to

show only food items with that tag.

4. Tap the plus sign (+) next to the food's name to add that food's carbs to the total in the Food Carbs banner. A checkmark replaces the plus (+) sign to show that the food's carbs have been added.

Tip: If you want to view the food details before adding its carbs, tap the name of the food instead of tapping the plus sign (+). en tap ADD to add the number of carbs to the total in the Food Carbs banner.

) > Food Library

5 Delivering a Bolus of Insulin

To remove a food from the Food Carbs total, tap the checkmark next to that food.

5. Repeat the preceding steps until the Food Carbs banner shows the total carbs for your entire meal.

Tip: Tap the Food Carbs banner to see the foods that are included in the total.

6. To transfer the total carbs from the Food Carbs banner to the Bolus Calculator, tap ADD TO CALCULATOR. e Bolus Calculator screen appears with the total number of carbs entered in the Enter Carbs eld.

Note:  e screen reads REPLACE CALCULATOR CARBS instead of ADD TO CALCULATOR if you had already entered carbs into the Bolus Calculator.

Note:  e ADD TO CALCULATOR option does not appear if the Bolus Calculator is o or disabled.

Search for a food on the BROWSE list

Search using the search icon

To search for a specic food:

1. Open the Food Library:

Menu icon (

2. Tap the search icon ( upper right of the screen.

Note:  e search function only searches for foods from the BROWSE list. It does not search the MY FOODS list.

3. Type in a search word.

Aer three letters are entered, the screen shows a list of foods that begin with those letters. To narrow down a long list, you can continue typing your word.

Note: Tap the "x" next to the search term to exit the search.

4. Tap the checkmark to close the keypad. e screen displays food items matching your search term.

5. Swipe up or down as needed to locate the desired food. en tap to select it.

) > Food Library

) on the

Delivering a Bolus of Insulin 5

Search by browsing the food categories

e BROWSE list displays food categories listed in alphabetic order.

To browse food categories:

1. Open the Food Library's BROWSE list:

Menu icon (

2. Tap the BROWSE list.

3. Swipe up or down as needed and tap the desired category of food.

4. Continue selecting sub-categories until a list of individual foods is displayed.

5. Swipe up or down as needed to locate the desired food. en tap to select it.

) > Food Library

Create a list of favorite foods on the MY FOODS list

Foods on the MY FOODS list are considered "favorites." is section explains how to create food favorites on the MY FOODS list by:

• Adding foods from the BROWSE list.

• Creating a meal by combining two or more foods from the BROWSE tab.

• Creating a custom food by entering a name and number of carbs.

Add foods from the BROWSE list

To add a food item from the BROWSE list to the MY FOODS list:

1. Navigate to the BROWSE list:

Menu icon (

2. Tap the BROWSE list.

3. On the BROWSE list, locate the food you would like to add to MY FOODS (see "Search for a food on the BROWSE list" on page 66).

) > Food Library

4. Tap the outline of a heart ( the food.

5. To change the name of the food on the MY FOODS list:

a. Tap the checkmark next to Keep

existing name.  e checkmark disappears.

b. Tap Enter New Name and type in a

descriptive name. Tap the checkmark on the keypad.

) next to

5 Delivering a Bolus of Insulin

6. Optional: Tap Quantity to specify how many portions of the food you will

eat.

7. If the food has multiple serving sizes, tap Servings to specify the serving size

and measurement units.

8. Optional: To help locate the food in the future, tap one or more tags. Swipe up as necessary to view the tags. Tap a tag again to deselect it.

9. Tap SAVE TO MY FOODS. e food is marked with a solid heart ( indicating that the food is a "favorite" and appears in both the BROWSE and MY FOODS lists.

Create a meal by combining foods from the BROWSE list

To combine two or more foods into a meal on the MY FOODS list, you must rst create a new meal containing only one food. Once you have an existing meal, you can add additional foods to that meal.

To create a new meal or to add foods to an existing meal:

1. Navigate to the BROWSE list:

Menu icon (

2. Tap the BROWSE list.

3. On the BROWSE list, locate the rst food you would like to add to the meal (see "Search for a food on the BROWSE list" on page 66).

4. Tap the outline of a heart (

5. Optional: Tap Quantity to specify how many portions of the food you will eat.

6. If the food has multiple serving sizes, tap Servings to specify the serving size and measurement units.

7. To create a new meal:

) > Food Library

) next to the food.

)

a. Tap Create a new meal.

b. Tap the Create A New Meal  eld. Type in a descriptive name for the meal.

Tap the checkmark when  nished.

c. Optional: Add one or more tags to help you  nd the food in the future.

d. Tap SAVE TO MY FOODS to save this new meal.

e food is marked with a solid heart ( "favorite" and was added to the MY FOODS list.

8. To add a new food to an existing meal:

a. Repeat steps 1 - 6 above.

b. Tap the Add To A Meal (optional)  eld and tap the name of the desired

meal.

) indicating that the food is a

Delivering a Bolus of Insulin 5

c. Optional: Add one or more tags to help you  nd the food in the future.

d. Tap SAVE TO MY FOODS to add the food to the meal.

e. Repeat this step to add additional food items to the meal.

Note:  e food items that make up the meal are shown immediately below the meal in the MY FOODS list. To remove a food item from a meal, see "Removing foods from the MY FOODS list" on page 70.

Create a custom food

Use the custom food feature to add carb information about any food. You can add up to 50 custom foods.

To add a custom food:

1. Navigate to the MY FOODS list:

Menu icon (

2. Tap the MY FOODS list.

3. Tap Add custom foods.

4. Tap the Food Title eld and type in

a descriptive name for your custom food.

) > Food Library

5. Tap the Carbs eld and enter the total

number of carbs for the food item(s).

6. Optional: Tap the Fiber eld and enter

the amount of ber for the food item.

Note: Consult your healthcare provider about how to enter the carbs and  ber values.  e Bolus Calculator does not subtract  ber from the carb value.

7. To add one or more tags to your custom food, tap the desired tags.

Note: You may need to swipe up to see additional tags.  e Custom tag is automatically added to a custom food. Tap any selected tag to remove it.

Tip: Tags are a quick way to lter your MY FOODS list. Select multiple tags for any foods that belong to more than one food category.

8. To create a dierent custom food, tap ADD ANOTHER ITEM. Swipe up to see a

new set of name and carb elds. Repeat the preceding steps.

9. When done, tap SAVE TO MY FOODS. Your custom foods are displayed on

the MY FOODS list for quick access in the future.

5 Delivering a Bolus of Insulin

Removing foods from the MY FOODS list

To delete a food or meal from the MY FOODS list:

1. Navigate to the MY FOODS list: Menu icon (

2. Tap the MY FOODS list.

3. Tap EDIT.

4. Locate the food or meal you would like to remove, and tap the red x (

) next to its name.

5. Tap YES to remove the food item from MY FOODS.

If the food was originally added from the BROWSE list, it remains listed on the BROWSE list with an open heart icon (

If a deleted food is also part of a meal, deleting the individual food also deletes the food from that meal and subtracts the carbs from a meal's total carbs.

) > Food Library

Note: When on the BROWSE list, if you tap the  lled heart icon ( (

).  at food is removed from the MY FOODS list. If the food is also part of a

meal on the MY FOODS list, this action also removes the food from the meal and subtracts the food's carbs from a meal's total carbs.

Note: You cannot delete or edit foods listed on the BROWSE list.

) and tap YES, the icon changes to an open heart

CHAPTER 6

Modifying Basal Insulin Delivery

is chapter describes how to modify your basal insulin delivery by using temporary basal rates or by switching to a dierent Basal Program (see "Temporary basal rates" on page 143).

To create a new Basal Program, see page 77. To edit an existing Basal Program, see page 79.

Using Temporary Basal Rates

Use a temporary basal rate, or “temp basal,” to handle a temporary change in your routine. For example, a temp basal can be used when you are exercising or when you are sick. When a temp basal ends, the PDM automatically reverts to delivering the scheduled Basal Program.

You cannot activate a temp basal during an immediate bolus, but you can activate a temp basal while an extended bolus is running.

To create a temp basal preset for a frequently used temp basal, see "Create a new temp basal preset" on page 81.

To activate a temp basal preset, see "Activate a temp basal preset" on page 73.

Tip: By default, the PDM or Pod sounds a tone at the beginning and end of a temp basal and every 60 minutes while a temp basal is running. To turn these on or o, see "Informational Signals List" on page 124.

Activate a temp basal

If the temp basal setting is turned o, you cannot activate a temp basal. To turn on the temp basal setting, see "Temp basal" on page 111.

To dene and activate a temp basal:

1. Navigate to: Menu icon (

e screen shows a graph of the active Basal Program.

Note: To activate a temp basal preset, tap SELECT FROM PRESETS and go to step 2 of "Activate a temp basal preset" on page 73.

) > Set Temp Basal.

6 Modifying Basal Insulin Delivery

2. Tap the Basal Rate eld to enter the desired change in the basal rate:

• If temp basals are congured as

a percent (%) change, scroll the wheel up or down to dene the percent change to the active Basal Program. An up arrow indicates increasing the basal rate above that of the active Basal Program. A down arrow indicates decreasing the basal rate below that of the active Basal Program.

• If temp basals are congured as a at rate (U/hr), scroll the wheel to select the basal rate for the entire temp basal period.

To change whether temp basals are congured as percent (%) or U/hr, see "Temp basal" on page 111.

Note:  e number wheel will not scroll above your Maximum Basal Rate. To adjust your Maximum Basal Rate, see "Maximum Basal Rate" on page 111.

Tip: You can turn o insulin deliver y for the duration of the temp basal by setting a decrease of 100% or setting the temp basal to 0 U/hr. For more information, see "Temp basal limitations" on page 145 and "Methods to temporarily stop insulin delivery" on page 146.

3. Tap the Duration eld and enter the temp basal duration (between 30

minutes and 12 hours).

Examine the temp basal graph at the top of the screen. e proposed temp basal is superimposed on the active Basal Program.

• e lighter blue shaded area shows the proposed temp basal rate for each segment.

• If you set a decrease, the active Basal Program is shown as a dotted line.

4. Tap CONFIRM to continue.

5. Review the temp basal details. If corrections are needed, tap on the row that you would like to change. en enter your corrections and conrm them.

Note: If necessary, the PDM limits the basal rate of any segment that would exceed your Maximum Basal Rate setting.  is is indicated by a red line on the graph and the word "Max."

6. To activate the temp basal, tap ACTIVATE. en tap ACTIVATE again.

Modifying Basal Insulin Delivery 6

Aer activation, the Home screen's Basal tab, renamed Temp Basal, indicates that the temp basal is running and how much time remains. At the end of the temp basal time period, the Pod automatically resumes the active Basal Program.

Activate a temp basal preset

A temp basal preset stores the details of a temp basal that you use frequently. To create or modify a temp basal preset, see "Temp basal presets" on page 80.

To activate a temp basal preset:

1. Navigate to:

Menu icon (

2. Swipe to scroll up or down, and tap the temp basal preset you want to activate.

3. To change the duration of the temp basal, tap EDIT.

4. To activate the temp basal, tap ACTIVATE, and then tap ACTIVATE again.

) > Temp Basal Presets

Cancel a temp basal

A temp basal stops automatically at the end of its time period and the last active Basal Program resumes. To cancel a temp basal before the end of its time period:

1. Navigate to the Home screen's Temp Basal tab.

2. Tap CANCEL.

3. Tap YES to conrm cancellation. e PDM cancels the temp basal and restarts the active Basal Program.

6 Modifying Basal Insulin Delivery

Switching to a Di erent Basal Program

Dierent days can have dierent routines. e PDM lets you create dierent Basal Programs for your dierent routines. For example, you may use one Basal Program on weekdays and a dierent one on weekends.

To create, edit, or delete a Basal Program, see "Basal Programs" on page 77.

To switch to a dierent Basal Program:

1. Navigate to: Menu icon (

A list of Basal Programs appears with the current Basal Program at the top.

2. Select a dierent Basal Program in one of the following ways:

• To see a graph of an inactive Basal Program prior to activating it, tap on

the name of that Basal Program. en tap ACTIVATE.

Tip: Double-tap the graph to see an expanded view of the Basal Program. Swipe horizontally to view basal rates for later or earlier times.

• Tap the Options icon (

tap Activate.

3. Tap ACTIVATE again to replace the current Basal Program with the newly

selected one.

Note: You must cancel a running temp basal prior to switching to a di erent Basal Program (see "Cancel a temp basal" on page 73). You can, however, switch Basal Programs when an extended bolus is running.

Note: If one or more segments are set to deliver 0 U/hr, the PDM noti es you that insulin delivery will stop during those segments.

) > Basal Programs.

) to the right of an inactive Basal Program, then

Suspending and Resuming Insulin Delivery

Sometimes you may need to stop insulin delivery briey. For example, you must suspend insulin delivery prior to editing an active Basal Program or resetting the time or date. e Omnipod DASH™ System lets you suspend all insulin delivery for up to two hours.

For the dierence between stopping insulin delivery using the suspend feature or the temp basal feature, see "Methods to temporarily stop insulin delivery" on page

146.

Modifying Basal Insulin Delivery 6

Suspend insulin delivery

To suspend insulin delivery :

1. Navigate to: Menu icon ( Suspend Insulin.

2. Tap the Suspend Insulin for eld. Scroll the number wheel to specify the duration of insulin suspension. e suspension can last 30 minutes, 1 hour, 1.5 hours, or 2 hours.

3. Tap SUSPEND INSULIN.

4. Tap YES to conrm that you want to stop all insulin delivery.

e basal insulin delivery is suspended.

e Home screen displays a yellow banner stating that "Insulin delivery is suspended."

Note:  e Pod beeps every 15 minutes throughout the suspension period. At the end of the suspension period, insulin delivery does not automatically resume.  e Pod and PDM notify you every minute for three minutes, and repeat this noti cation every 15 minutes until you have resumed insulin delivery.

Note: Temp basals or extended bolus are automatically canceled when you suspend insulin delivery.

) >

6 Modifying Basal Insulin Delivery

Resume insulin delivery before the suspension period ends

1. Navigate to:

Menu icon (

If the Bolus Calculator is on, tap the large circle showing the IOB on the Home screen's Dashboard tab.

2. Tap RESUME INSULIN to conrm

restarting the Basal Program scheduled for the current time.

e PDM beeps to conrm that insulin delivery has resumed.

Resume insulin delivery after the suspension period ends

1. Wake up your PDM, if necessary.

2. Tap RESUME INSULIN to resume

insulin delivery.

) > Resume Insulin

e PDM activates the Basal Program that is scheduled for the current time and beeps to alert you that insulin delivery has resumed.

If you do not resume insulin delivery immediately, this screen reappears and the PDM and Pod beep every 15 minutes until insulin delivery is resumed.

Warning: Insulin delivery does not automatically resume at the end of the suspension period. You must tap RESUME INSULIN to resume insulin delivery. If you do not resume insulin delivery, you could develop hyperglycemia.

CHAPTER 7

Managing Programs and Presets

is chapter describes how to create, edit, and delete Basal Programs, temp basal presets, and bolus presets. Once set up, you can activate these quickly at a later time.

Basal Programs

You can create up to 12 Basal Programs. Each Basal Program can contain from one to 24 basal rates.

Caution: Check with your healthcare provider before adjusting these settings.

Create a new Basal Program

To create a new Basal Program:

1. Navigate to the Create Basal Program screen:

Menu icon (

2. Tap CREATE NEW.

Note: If you already have 12 Basal Programs, CREATE NEW does not appear. If necessary, you can delete an existing Basal Program.

3. Optional: Tap the Program Name eld and enter a descriptive name for your new Basal Program. Tap the checkmark to save the name. e default name for the Basal Program is "Basal" followed by a number.

4. Optional: Tap a tag to appear next to the name of the new Basal Program. Tap a second time to deselect the tag. If you do not select a tag, a default tag is used.

5. Tap NEXT.

) > Basal Programs

7 Managing Programs and Presets

6. Dene the basal segments one at a time. For each segment:

a. Tap the End Time  eld and select

the end time for the segment.

b. Tap the Basal Rate  eld and select

the desired basal rate for the segment.

c. Tap NEXT.

d. Repeat these steps until your  nal

segment ends at midnight.

7. When your Basal Program covers 24 hours, tap CONTINUE.

8. A screen appears showing the full Basal Program as a graph and as a list. Review the Basal Program to be sure all the values are correct.

Tip: Double-tap the graph to see an expanded view of the Basal Program. Swipe horizontally to view basal rates for later or earlier times.

To edit any of the segments in the Basal Program, see steps 6-8 under "Edit or rename a Basal Program" on page 79.

9. Tap SAVE to store the new Basal Program.

10. If you have an active Pod and you want to use the new Basal Program now, tap ACTIVATE to start using the new Basal Program. If you do not want to use the new Basal Program now, tap NOT NOW.

Review all Basal Programs

1. Navigate to the list of Basal Programs:

Menu icon (

2. A graph of the current Basal Program is shown at the top of the screen (see "Basal tab / Temp Basal tab" on page 13 for details about the graph).

3. Swipe to scroll up or down if the list of Basal Programs is long.

4. Tap on the name of a non-active Basal Program to see its graph and basal rates. Tap outside the graph to close that graph.

) > Basal Programs

Managing Programs and Presets 7

Edit or rename a Basal Program

To edit a Basal Program:

1. Navigate to the list of Basal Programs:

Menu icon (

2. Swiping up or down as necessary, select the Basal Program to edit:

• To edit the active Basal Program,

tap EDIT beneath the graph of the active program. en tap SUSPEND INSULIN.

• To edit an inactive Basal Program, tap the Options icon ( the Basal Program you would like to edit. en tap Edit.

3. To rename the Basal Program, tap the

Program Name eld and enter the new name.

4. To change the tag, tap a dierent tag. Tap again to deselect a tag.

5. Tap NEXT.

6. To change an end time or basal rate for a segment:

a. Tap the row containing the segment you would like to change.

b. Tap the End Time  eld, and enter the new end time for the segment.

) > Basal Programs

) next to

c. Tap the Basal Rate  eld, and enter the desired basal rate.

d. Tap NEXT.

e.  en de ne the end time and basal rate for any following segments, as

needed.

7. To add a new segment:

a. Tap the row containing the start time of the new segment.

b. Tap the End Time  eld, and enter the start time of the new segment as the

end time of this segment.

c. Change the basal rate, if necessary.

d. Tap NEXT.

e.  en de ne the end time and basal rate for any following segments, as

needed.

7 Managing Programs and Presets

8. To delete a segment:

a. Note the end time of the segment you want to delete.

b. Tap the segment that precedes the segment you want to delete.

c. Tap the End Time  eld, and enter the end time of the segment you want to

delete.  is 'overwrites' the segment you want to delete.

d. Tap NEXT.

e.  en de ne the end time and basal rate for any following segments, as

needed.

9. When the Basal Program is correct, tap SAVE.

10. To activate the newly edited Basal Program:

• If you edited the current Basal Program, tap RESUME INSULIN.

• If you edited an inactive Basal Program and you have an active Pod, tap

ACTIVATE.

11. If you do not want to activate this Basal Program, tap NOT NOW.

Delete a Basal Program

You can only delete a Basal Program that is not running; you cannot delete an active or suspended Basal Program. To delete a Basal Program:

1. Navigate to the list of Basal Programs:

Menu icon (

2. Tap the Options icon (

3. Tap Delete.

4. Tap DELETE to conrm deletion of the Basal Program.

) > Basal Programs

) next to the Basal Program you want to delete.

Temp basal presets

If there is a temp basal that you use oen, you can create a "Temp basal preset" for rapid activation in the future. To activate a temp basal preset, see page 73. To turn on or o the ability to activate temp basals, or to change between specifying the temp basal as a percentage or in U/hr, see page 111. You can create up to 12 temp basal presets.

Managing Programs and Presets 7

Create a new temp basal preset

To create a new temp basal preset:

1. Navigate to the Temp Basal Presets screen:

Menu icon (

2. Tap CREATE NEW.

Note: If you already have 12 temp basal presets, CREATE NEW does not appear. If necessary, you can delete an existing preset.

3. Optional: Tap the Preset Name eld and enter a descriptive name for your preset. e default name for the preset is "Temp Basal Presets" followed by a number.

4. Optional: Tap a tag to appear next to the name of the new preset. Tap a second time to deselect the tag. If you do not select a tag, a default tag is used.

5. Tap NEXT.

6. Tap the Basal Rate eld and scroll to the desired value.

7. Tap the Duration eld and enter a duration for the preset. e temporary change to the Basal Program is shown on the graph.

Note: You will be able to modify the duration of a temp basal preset when you activate it.

8. Tap CONFIRM.

) > Temp Basal Presets

9. Tap SAVE to sav e this a s a temp ba sal preset.

10. If you would like to start this temp basal now, tap ACTIVATE. Otherwise, tap NOT NOW. is choice does not appear if a temp basal is already running.

7 Managing Programs and Presets

Edit or rename a temp basal preset

Note: You cannot edit a temp basal preset that is actively running.

1. Navigate to the Temp Basal Presets screen:

Menu icon (

2. Swipe up or down as needed to nd the preset that you want to edit. en tap the Options icon (

3. To rename the preset, tap the Preset Name eld and enter the new name.

4. To change the tag, tap a dierent tag. Tap again to deselect a tag.

5. Tap NEXT.

6. Change the basal rate and duration as desired.

7. Tap CONFIRM.

8. Tap SAVE to save your changes.

9. If you would like to start this temp basal now, tap ACTIVATE. Otherwise, tap NOT NOW. is choice does not appear if a temp basal is already running.

) > Temp Basal Presets

) and tap Edit.

Delete a temp basal preset

Note: You cannot delete a temp basal preset that is running.

To delete a temp basal preset:

1. Navigate to the Temp Basal Presets screen:

Menu icon (

2. Tap the Options icon (

) > Temp Basal Presets

) next to the preset you want to delete.

3. Tap Delete.

4. Tap DELETE to conrm deletion of the preset.

Bolus presets

Use bolus presets to store commonly used bolus amounts for quick retrieval in the future. Bolus presets are only available if the Bolus Calculator is o.

A bolus preset stores the units of insulin in a bolus. You can choose to extend some or all of the bolus preset when you activate it.

You can set up to seven bolus presets. A bolus preset cannot exceed your Maximum Bolus.

Managing Programs and Presets 7

Create a new bolus preset

To create a new bolus preset:

1. Navigate to the Bolus Presets screen:

On the Home screen, tap the Bolus icon (

)

Menu icon (

2. Tap SELECT FROM PRESET.

3. Tap CREATE NEW.

Note: If you already have seven bolus presets, CREATE NEW does not appear. If necessary, you can delete an existing preset.

4. Optional: Tap the Preset Name eld

and enter a descriptive name for your preset. e default name for the preset is "Bolus Preset" followed by a number.

5. Optional: Tap a tag to appear next to the name of the new preset. Tap a second time to deselect the tag. If you do not select a tag, a default tag is used.

6. Tap NEXT.

7. Tap the Total Bolus eld and enter the units of insulin for the bolus preset.

8. Tap SAVE to save the new bolus preset.

) > Bolus Presets

Edit or rename a bolus preset

To edit or rename a bolus preset:

1. Navigate to the Bolus Presets screen:

Menu icon (

2. Tap the Options icon (

3. Tap Edit.

4. To rename the preset, tap the Preset Name eld and enter the new name.

5. To change the tag, tap a dierent tag. Tap again to deselect a tag.

6. Tap NEXT.

7. To change the bolus amount, tap the Total Bolus eld and enter the units of insulin.

) > Bolus Presets

) next to the name of the preset you want to edit.

7 Managing Programs and Presets

8. Tap SAVE to save your changes.

Delete a bolus preset

To delete a bolus preset:

1. Navigate to the Bolus Presets screen:

Menu icon (

2. Tap the Options icon (

3. Tap Delete.

4. Tap DELETE to conrm deletion of the preset.

) > Bolus Presets

) next to the name of the preset you want to delete.

Insulet 041 User Guide

Specifications and Main Features

Frequently Asked Questions

User Manual