OmniPod FreeStyle Blood Glucose MonitoringSystem, FreeStyle User Manual

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User Guide

GUIDE DE L’UTILISATEUR

Insulin Management System

Système de gestion de l’insuline

www.MyOmniPod.ca

www.MonOmniPod.ca

Insulin Management System

Système de gestion de l’insuline

Manufactured by / Fabriqué par: Insulet Corporation 9 Oak Park Drive Bedford, MA 01730 USA

Distributed by / Distribué par: GlaxoSmithKline Inc. 7333 Mississaugua Road Mississaugua, Ontario Canada L5N 6L4 1 855 POD INFO (1 855 763 4636) 647-788-3132 (Outside of Canada)

www.MyOmniPod.ca www.MonOmniPod.ca

OmniPod® is a registered trademark of Insulet Corporation, used under license by GlaxoSmithKline Inc. FreeStyle® is a registered trademark of Abbott Diabetes Care Inc. Third-party trademarks used herein are the trademarks of their respective owners.

PDM imagery is for illustrative purposes only. PDM screens may vary based on model or user settings. Model: CAT45E

15546-AW Rev. A

OmniPod® est une marque déposée d’Insulet Corporation, utilisée sous license par GlaxoSmithKline Inc. FreeStyle® est une marque deposee de Abbott Diabetes Care Inc. Les marques de commerce tierces utilisees dans cet ouvrage sont la propriete de leurs detenteurs respectifs.

Les images du GPD ne servent qu’à titre d’exemple. Les écrans du GPD peuvent varier selon le modèle ou les réglages de l’utilisateur. Model: CAT45F

User Guide/Guide de l’utilisateur

CAT45E / CAT45F

Contacts and Important Information

Name Address

Telep ho ne and Fax Email Address

Name Address

Telep ho ne and Fax Email Address

Name Address

Telephone Number(s) Policy Number

Name Address

Teleph on e and Fax Email Address

OmniPod System Start Date: ____________________________ PDM Model: CAT45E Serial Number: __________________

Distributor:

GlaxoSmithKline Inc. 7333 Mississauga Road, Mississauga, Ontario, Canada L5N 6L4

Customer Care:

Please call 1 855 POD INFO (1 855 763 4636). When outside of Canada, please call 647-788-3132. Visit www.myOmniPod.ca for additional information and resources.

Doctor

Nurse/Educator

Health Insurance

Pharmacy

, used under license by GlaxoSmithKline Inc. FreeStyle® is a registered trademark of Abbott Diabetes Care Inc. Apidra® is a registered trademark of Aventis Pharma S.A. Humalog® is a registered trademark of Eli Lily and Company Corp. Third-party trademarks used herein are the tr

ademarks of their respective owners.

15546-AW Rev A

iii

Contents

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Enter your PDM ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Select the ID screen color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

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

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

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

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

Enter target blood glucose value. . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

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

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

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

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

Enter the duration of insulin action. . . . . . . . . . . . . . . . . . . . . . . . . . 14

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

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

Set low reservoir advisory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Set expiration notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Contents

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How a suggested bolus is calculated . . . . . . . . . . . . . . . . . . . . . . . . 31

Deliver a Normal Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Deliver a bolus when suggested bolus calculator is On. . . . . . 32

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

Deliver an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Deliver an extended bolus instead of a normal bolus. . . . . . . . 35

Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

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

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

Create a bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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

Change, rename, or delete a bolus preset . . . . . . . . . . . . . . . . . . . 40

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

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

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

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

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

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

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

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

Deactivate the current Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

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

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

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

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

Suspend Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

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

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

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

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

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

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

Contents

6 Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . 61

The ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Insulin gauge and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

PDM settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

The System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

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

Reset the time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

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

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

Bolus calcs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

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

Temp basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Bolus increment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

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

Set alerts and reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Change Blood Glucose Meter Settings . . . . . . . . . . . . . . . . . . . . . . . . . 72

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

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

Change BG sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

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

Set PDM options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

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

Diagnostic options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Set a Reminder to Vibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

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

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

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

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

Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

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

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

The Built-in FreeStyle® Blood Glucose Meter . . . . . . . . . . . . . . . . . . . 79

The FreeStyle® Blood Glucose Test Strips . . . . . . . . . . . . . . . . . . . . . . . 80

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

The FreeStyle® Control Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

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

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

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

Ensure accurate control solution results. . . . . . . . . . . . . . . . . . . . . 81

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

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

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

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

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

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

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

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

Blood Glucose Results and the Suggested Bolus

Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

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

Contents

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Daily Diabetes Management Activities . . . . . . . . . . . . . . . . . . . . . . . . 107

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

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

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

Water and Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

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

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

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

Minimize airport security delays . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

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

Avoid lows, highs, and DKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

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

Hypoglycemia (Low Blood Glucose) . . . . . . . . . . . . . . . . . . . . . . . . 112

Symptoms of hypoglycemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

To avoid hypoglycemia (low blood glucose) . . . . . . . . . . . . . . . . 112

To treat hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . . 113

Examples of fast-acting foods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

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

Diabetic ketoacidosis (DKA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Handling Special Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Sick days. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

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

X-rays, MRIs, and CT scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

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

10 Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

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

Blood Glucose Meter Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

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

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

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

Manual Shut-off of a Hazard Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

11 Communication Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

The Communication Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Failure During Pod Activation or Operation . . . . . . . . . . . . . . . . . . . 133

Failure During Pod Deactivation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Contents

vii

Failure During Request for Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Failure During Bolus Cancellation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Pod Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

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

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

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

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

Cleaning and disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Replacing Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

If the PDM becomes submerged in water . . . . . . . . . . . . . . . . . . 143

If you drop the PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Storage and Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Ordering Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Suggested Bolus Calculator Examples and Guidelines . . . . . . . . 144

Meal bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Insulin-on-board (IOB) calculation. . . . . . . . . . . . . . . . . . . . . . . . . . 145

Examples of suggested bolus calculations . . . . . . . . . . . . . . . . . 145

Calculator guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

OmniPod System Options and Settings . . . . . . . . . . . . . . . . . . . . . . . 148

Pod Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Accuracy Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Flow rate error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Personal Diabetes Manager Specifications . . . . . . . . . . . . . . . . . . . . 150

Blood Glucose Meter Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

OmniPod System Label Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Personal Diabetes Manager Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

OmniPod System Notice Concerning Interference . . . . . . . . . . . . 153

Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

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

Privacy Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

You and Your Healthcare Provider. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

viii

■ About This User Guide

Symbols

Symb ol Te rm Meaning

War nin g

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

Caution

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

Note

Provides helpful information.

Tip

Offers a suggestion for successful use of the OmniPod

Insulin

Management System.

This User Guide is intended for use only with PDM model CAT45E. To learn which version of the PDM you have, turn it over. On the back of the PDM, look for “CAT45E.” If you see it, this is the correct User Guide. If you do not see “CAT45E” on the back of the PDM, please call Customer Care.

This User Guide is periodically updated. Visit www.myomnipod.ca to see the most recent version and to find other helpful information.

Screen displays shown in this User Guide are for illustrative purposes only and should not be considered suggestions for user settings. Consult with your healthcare provider to determine the appropriate settings for you.

Introduction

Conventions and Terms

Important Information

Indication

The OmniPod® Insulin Management System is intended for subcutaneous (below the skin) delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro).

Contraindications

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

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

• Unable to maintain contact with their healthcare provider

• Unable to use the System according to instructions

Convention/Term Meaning

Bold

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

Italics

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

Press

Press and release a button or soft key.

Hold

Keep pressing a button until its function is complete.

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

Screen

Displays programming, operating, and alarm/alert information.

Button

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

Convention/Term Meaning

Icon

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

Soft keys

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

This device is for prescription use only.

Convention/Term Meaning

Introduction

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

• Testing on newborns

•

Testing arterial blood

• Diagnosing of or screening for diabetes mellitus

The OmniPod System is designed to use rapidacting U-100 insulin. The following U-100 rapidacting insulin analogs have been tested and found to

be safe for use in the Pod: NovoRapid, Humalog®,

or Apidra®. NovoRapid is compatible with the OmniPod System for use up to 72 hours (3 days). Bef

ore using a different insulin with the OmniPod

System, check the insulin drug label to make sure it can be used with a pump. Refer to the insulin labeling and follow your health

care provider's

directions for how often to replace the Pod.

Not recommended for individuals with hearing loss.

Always verify ability to hear Pod/PDM alerts

and alarms.

The Pod and PDM may be affected by strong radiation or magnetic fields. Before having an X-ray, MRI, or CT scan (or any similar test or procedure), remove your Pod and put it and the PDM outside the treatment area. Check with your healthcare provider for Pod removal guidelines.

Please read all the instructions provided in this User Guide

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

If you are unable to use the System according to in

structions, you may be putting your health and

safety at risk. Talk with your healthcare provider if you have questions or concerns about using the System properly.

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

If you are having symptoms that are not consistent with y

our blood glucose test and you have followed all instructions described in this User Guide, call your healthcare professional.

Introduction

■ You r R ole : S af el y U sin g t he Om ni Po d Sy ste m

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

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

grams of carbohydrate covered by one unit of insulin. For example, if your insulin-to-carbohydrate ratio is 1:15, then you need to deliver one unit of insulin to cover every fifteen grams of carbohydrate you eat.

Correction or Sensitivity Factor: Ho

w much one unit of insulin

will lower blood glucose. For example, if your sensitivity factor is

2.8, one unit of insulin will lower your blood glucose by

2.8 mmol/L. Target Blood Glucose Value: The

blood glucose level you want to achieve. For example, you may want to keep your blood glucose close to 5.6 mmol/L.

Duration of Insulin Action: The

length of time that insulin remains active and available in your body after a correction or meal bolus.

Your individual needs influence th

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

Your healthcare provider must help you enter these initial s

ettings. Soon you will enter and change your own settings with confidence and ease. The OmniPod System is more userfriendly than most electronic devices you use every day. In fact, technology is what makes the OmniPod System so easy to use.

Your healthcare provider is a valuable resource. You will rely on h

im or her for a lot of critical information about your OmniPod System, especially during the first few weeks and months. When you have questions about diabetes management after starting on the OmniPod System, do not hesitate to talk with your healthcare provider. For nonmedical emergencies or for technical questions about your OmniPod System setup or operation, you can call Customer Care 24 hours a day, 7 days a week.

Customer Care:

Please call customer care at 1 855 POD INFO (1 855 7634636). When

outside of Canada, please call 647-788-3132.This user guide is periodically updated. Please visit www.MyOmniPod.ca to see the most recent version and to find other helpful information.

Introduction

xii

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

Being actively involved means:

• Frequently monitoring blood glucose levels

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

• Visiting your healthcare provider

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

CHAPTER 1

Your New OmniPod Insulin Management System

■ Insulin Delivery with the OmniPod System

The OmniPod® Insulin Management System is an innovative continuous insulin delivery system that provides all the proven benefits of c

ontinuous subcutaneous insulin infusion (CSII) therapy

in a way no conventional insulin pump can. The System’s innovative design and features allows you to live your life— and manage your diabetes—with unprecedented freedom, co

mfort, convenience, and ease.

The long-term health benefits of better blood glucose control ar

e well known. Maintaining near-normal blood glucose levels

can help you live a longer, healthier life with fewer diabetesrelated complications. The OmniPod System also has many practical, everyday benefits, including convenience, freedom, flex

ibility, and ease of use.

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

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

The OmniPod System works much like the pancreas of a person without diabet

es by delivering insulin in two ways:

• A small, constant, background supply of insulin (called a basal

te) is delivered automatically at a programmed rate, all day

and night.

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

Your New OmniPod Insulin Management System

■ How Does the OmniPod System Work?

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

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

• Programs the Pod with your personaliz

ed insulin-delivery

instructions

• Wirelessly monitors the Pod’s operation

• Incorporates a FreeStyle® blood glucose meter With just two parts, you’ll enjoy all the func

tionality and benefits of continuous insulin delivery and blood glucose monitoring. Plus you’ll enjoy the safety, convenience, and freedom of:

No tubing

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

Suggested bolus calculation

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

Carb presets

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

Your New OmniPod Insulin Management System

Automated cannula insertion

With the OmniPod System, you don’t have to insert the infusion set ma

nually or carry around a separate inserter. You simply press a button on the PDM and the Pod’s automated insertion system safely and consistently inserts the cannula beneath the skin, virtually pain free. It then begins delivering insulin according to your programmed basal rate.

A fully-integrated design with blood glucose monitoring

With a fully integrated two-part design, there’s no need to carry separ

ate infusion sets, reservoirs, or inserters. It’s all integrated into the Pod. With the PDM, you can check your blood glucose level using FreeStyle® blood glucose test strips, but without the hassle of carrying a separate blood glucose meter.

If you prefer to use another blood glucose meter, you can enter the

readings manually into the PDM.

Record keeping

Another convenient part of the OmniPod System is record ke

eping. Paper charts are useful, but sometimes they can be

inconvenient to carry or use. The data storage system in the Personal Diabetes Manager (PDM) displ

ays up to 90 days’ worth of information. This includes blood glucose readings, basal rates and bolus doses, carbohydrates, and alarms.

Personalizing your System

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

•Enter and name basal programs

•

Name and save temporary basal presets

• Add your own customized reminders

• Enter your name, phone number, doctor’s name and

number, and other emergency information

Your New OmniPod Insulin Management System

■ The Pod

The Pod (Figure 1-1) is applied to your skin with an adhesive backing, similar to an adhesive bandage.

■ The Personal Diabetes Manager

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

To p

Bottom

Needle cap

Viewing window

Fill port

Figure 1-1

Adhesive backing

Housing vent

Figure 1-2

Up/Down Controller

User Info/ Support

Soft Key Label

Soft Keys

Home/ Power

USB Port

Test Strip Por t

LCD Screen

Your New OmniPod Insulin Management System

Buttons that program and control the OmniPod System

Button Action

Home/ Power

Pressing and holding turns the PDM on and off. When the PDM is on, pressing this button (quickly/briefly) displays the Home screen, from which you can choose a menu item or view the

Status screens (shown later in this chapter).

Up/Down Controller

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

Soft Keys

Soft key labels and functions depend on the menu or screen you are viewing. The label appears on the screen directly above the physical button you press. Select, Save, and Back are just three examples of the soft key labels on your PDM.

Button Action

User Info/ Support

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

In addition, pressing and holding this button for 2 seconds

enables a “bright mode” on the PDM

screen.

Your New OmniPod Insulin Management System

Primary screens

Messages on the screen either:

• Let you identify your PDM

•

Tell you how the System is operating

• List menu choices

• Explain how to perform certain tasks The System’s primary screens are the ID scr

een (Figure 1-3), the

Status s

creen (Figure 1-4), and the Home screen (Figure 1-6).

ID screen

The System displays an ID screen to make the PDM easy to identify when you first turn it on. You can personalize the ID screen by adding your name and choosing its color. (See , for details on customizing your PDM.) You must acknowledge the ID screen before you can use the PDM. It is important that you always identify the PDM as yours before you use it.

Status screen

Lists the System’s current operating status (Figure 1-4). From top to bottom, the Status scr

een displays:

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

ered manually

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

• Amount of Insulin on Board (IOB) will be displayed on Status screen (if calculator in use)

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

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

• “INSULIN SUSPENDED” if insulin delivery has been suspended

• Time and date of when the Pod will expire

Figure 1-3

Figure 1-4

Your New OmniPod Insulin Management System

Status support screen

From the Status screen, press the User Info/Support button to see details about the current insulin on board (IOB) in your body (Figure 1-5). See page 30, for additional information describing insulin on board (IOB).

Home screen

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

• Bol

us menu to deliver bolus doses

• More actions menu to change the Pod, manually enter

blood glucose readings, and assign and edit tags for BG readings that are less than 2 hours old.

• Tem p b as al menu to deliver temporary basal rates (This submenu does not appear if temp basal is turned Off in Settings.)

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

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

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

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

Figure 1-5

Figure 1-6

You can go to the Status screen at any time by pressing St

atus from the Home screen.

Your New OmniPod Insulin Management System

■ Safety Features

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

Automatic priming, safety checks, and insertion

Every time you activate a new Pod, the System automatically primes and performs a safety check on the Pod, then inserts and primes the cannula (see Chapter 5, Using the Pod). Microprocessor technology makes it possible to complete thousands

of safety checks in only a few seconds.

The OmniPod System also performs safety checks on the PDM. If it

detects any problems in the PDM or the Pod—or in communication between them—it informs you with beeps and on-screen messages.

Occlusion detection

An occlusion is a blockage or interruption in insulin delivery. If the OmniPod System detects an occlusion, it sounds a hazard alarm and prompts you to deactivate and change your Pod (see Chapter 5, Using the Pod).

A hazard alarm sounds when an average o

f 3 to 5 units of missed insulin occurs. This table depicts occlusion detection for 3 different situations when using U100 insulin. If an occlusion is cleared, a volume of insulin could be released. That volume would not exceed 3.9 U.

Alerts and alarms

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

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

At very low flow rates checking your blood glucose fr

equently may give you an early indication of an

occlusion (refer to Chapter 9).

Confirm on ID scr

een - alerts/alarms do not show on

PDM until after ID screen is confirmed.

5.00 U Bolus

1.00 U/hr basal

0.05 U/hr basal

200 seconds

2.4 hr

48 hr

Minimum time

202 seconds

3.7 hr

74 hr

Typ ica l time

300 seconds

5.0 hr

80 hr

Maximum time

(Pod expiration)

CHAPTER 2

Getting Started

■ The OmniPod Starter Kit

Your initial shipment contains everything you need to begin using the OmniPod System.

If you are a OmniPod System user, you need to meet with your healthcar

e provider for training and System setup before using it.

To get a head start on learning about your new OmniPod System, review this User Guide and

complete the Pre-Training

section of OmniPod's online Interactive Training Program, found in the Customer Care section of www.MyOmnipod.ca.

If you have a basic understanding of the System in advance, you will

get more out of your training sessions.

After you unpack the Starter Kit, use the “Contents” label on the sided

of the box to make sure you have everything.

■ Set Up the Personal Diabetes Manager (PDM)

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

You can complete the Warranty form online at www.MyOmniPod.ca. 5 year limited Warranty.

Do NOT use the OmniPod® Insulin Management System until you have been trained by your healthcare pr

ovider. He or she will initialize the System based on your individual needs. Inadequate training or improper setup could put your health and safety at risk.

Prepare and keep an emergency kit with you at all times t

o quickly respond to any diabetes emergency. For

details, see Chapter 9, Living with Diabetes.

Getting Started

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

Turn on the PDM

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

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

compartment.

3. Replace the battery door.

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

■ The Setup Wizard

The first time you turn on the Personal Diabetes Manager, the Setup Wizard comes on automatically. Although setup is easy with the Wizard, if you are a first-time user, your healthcare provider must guide you through the process. Setup takes only a f

ew minutes and is easy to do:

• Use the Up/Do

wn Controller buttons to increase or

decrease a number, or to move up or down a list.

Figure 2-1

Figure 2-2

Hard

Reset

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

Do not use any other type of batteries than AAA alk

aline batteries to power the PDM. Never use old

or used batteries; the PDM may not work properly.

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

, insulin-to-carbohydrate ratio, correction factor,

and duration of insulin action.

Getting Started

• Press the Soft Key labeled Next, Select, Done, or Save to

continue to the next screen.

• Press Back to return to the previous screen.

To get started, press Next on the Wizard's Welcome Screen to begin setting up your PDM.

Enter your PDM ID

1. Use the Up/Down Controller buttons to scroll through the

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

2. Press the middle Soft Key (labeled with the right arrow) to move the underscore to the next character.

3. Enter each character one at a time. For example, if you want to enter your name, you might enter J, a, n, e, [space], S, m, i, t, h. (A blank character or space is the first and last option in the scrolling menu.)

4. Press Next.

Select the ID screen color

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

Set date and time

1. Use the Up/Down Controller buttons to increase or decrease the time. (Press 12/24hr if you prefer a different time format.) Then press Next.

2. Enter the current year, then press Next.

3. Choose the current month, then press Next.

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

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

Enter basal settings

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

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

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

You can adjust these settings la

ter as your needs change

or as you fine-tune your OmniPod System.

Your ID and the chosen color will be displayed on an identification (ID) screen that you must acknowledge every time you turn on the PDM. Always be sure you properly identify your PDM before using it.

Getting Started

3. Press Done to confirm the basal program shown on the

screen. To add more basal segments to the program, or to change the rate shown, see Chapter 3, Understanding and Adjusting Basal Rates.

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

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

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

Enter blood glucose sound setting and BG goal

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

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

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

4. Press Save to accept the BG goal.

Set the suggested bolus calculator

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

Enter target blood glucose value

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

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

The lower and upper BG limits are only used when viewing BG History (see

Chapter 8, Understanding

Your Records).

Check with your healthcare provider before adjustin

g these settings.

If the suggested bolus calculator is set to On, pe

rform

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

Getting Started

2. Use the Up/Down Controller buttons to enter the “correct

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

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

You can define up to 8 target BG time segments. To enter additional segments, choose [add new], then:

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

Enter.

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

Next.

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

Use the Up/D

own Controller buttons to enter the “cor-

rect above” value or “correction threshold” (the BG value abov

e which you want the PDM to suggest a correction

bolus), then press Next.

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

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

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

Enter minimum BG allowed for use in bolus calculation

1. Use the Up/Down Controller buttons to enter a minimum

blood glucose value, below which the System will not calculate a suggested bolus. The values are in 0.1 mmol/L increments and range from 2.8 to 3.9 mmol/L.

2. Press Next.

Enter insulin-to-carbohydrate ratio

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

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

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

You can define up to 8 insulin-to-carbohydrate time segments. To enter additional ratios, choose [add new], then:

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

then press Next.

If the suggested bolus calculator is On, a c

orrection bolus will be suggested only when your BG is above the value shown in brackets on the screen.

Getting Started

e. To save the new ratio, press Done.

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

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

Enter correction factor

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

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

You can define correction factors for up to 8 time segments. To enter additional correction factors, choose [add new], then:

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

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

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

Set reverse correction

1. To set reverse correction, use the Up/Down Controller

buttons to choose On or Off, then press Next.

Enter the duration of insulin action

1. Use the Up/Down Controller buttons to enter the duration

of insulin action (how long insulin lasts in your body), then

press Next.

If you enter carbs and reverse corrections are On, the S

ystem will subtract insulin from the suggested meal

bolus to compensate for a low blood glucose (below the BG target you set). With reverse corrections Off, the System will not subtract insulin from the suggested meal bolus dose due to a low BG. Follow your health

care provider’s recommendation to set

reverse correction On or Off.

The duration-of-insulin-action setting is used to calculate the amount of insulin on board (IOB) from a pr

evious correction bolus or meal bolus when you

use the suggested bolus calculator.

Getting Started

Select bolus increment and enter maximum bolus

1. Choose a bolus increment (how much each press of the

Up/Down Controller buttons will increase or decrease a bolus amount)—either 0.05, 0.10, 0.50, or 1.00 units of insulin—then press Next.

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

press Next.

Set extended bolus doses

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

Next.

Set low reservoir advisory

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

Set expiration notification

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

PDM should give you a notification, then press Next. The values are in 1-hour increments and range from 1 to 24 hours. (The default is 4 hours.)

The PDM asks whether you want to activate a Pod.

• Press Ye

s if you are ready to activate a new Pod. See Chapter

5, Using the Pod, to learn how to activate a new Pod.

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

The maximum bolus default is 10 units. Check with y

our healthcare provider before adjusting these set-

tings.

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

Getting Started

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

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

Use the form at the end of this User Guide to

write down all your settings from the Setup Wizard. If you ever need to reset or replace your PDM, having these settings handy will make setup very easy.

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OmniPod FreeStyle Blood Glucose MonitoringSystem, FreeStyle User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual