OmniPod UST200 User manual

User Guide
MyOmniPod.com

Contacts and Important Information
Use the spaces below to record important health and product information.
Name
Address
Telephone and Fax
Email Address
Name
Address
Telephone and Fax
Email Address
Name
Address
Telephone Number(s)
Policy Number
Name
Address
Telephone and Fax
Email Address
Script # Name Dose Frequency
OmniPod System Start Date: __________________________
PDM Model: UST200 Serial Number: _________________
Emergency Services
Dial 911 (USA only; not available in all communities)
Insulet Corporation
9 Oak Park Drive •Bedford, MA 01730
Customer Care (24 hours/7days): 800-591-3455
When calling from outside the United States: 781-457-5098
Customer Care Fax: [phone]
Web Site: MyOmniPod.com
Doctor
Nurse/Educator
Health Insurance
Pharmacy
Prescriptions

User Guide
Model: UST200

© 2010 Insulet Corporation. All rights reserved.
OmniPod is a registered trademark of Insulet Corporation.
U.S. Patent No. 6,740,059.
FreeStyle is a registered trademark of Abbott Laboratories.
NovoLog is a registered trademark of Novo Nordisk A/S. Humalog is a registered trademark of Eli Lilly and Company. Apidra is a registered
trademark of Sanofi Aventis. Windows is a registered trademark of Microsoft Corporation.
13705-AW Rev E

iii
Contents
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Before You Get Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Indication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
You and your healthcare provider . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Your Role: Safely Using the OmniPod System. . . . . . . . . . . . . . . . xi
About This User Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Conventions and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
1 Your New OmniPod Insulin Management System. . . . . . . 1
Insulin Delivery with the OmniPod System . . . . . . . . . . . . . . . . . . 1
How Does the OmniPod System Work? . . . . . . . . . . . . . . . . . . . . . 2
No tubing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Automated cannula insertion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
A fully-integrated design with blood glucose monitoring . . . . 2
Suggested bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Reference food library and carb presets . . . . . . . . . . . . . . . . . . . . . . . 3
Record keeping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Personalizing your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
The Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
The Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Buttons that program and control the OmniPod System. . . . . 5
Primary screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Automatic priming, safety checks, and insertion. . . . . . . . . . . . . . 7
Rapid occlusion detection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Alerts and alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
The OmniPod Starter Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Set Up the Personal Diabetes Manager (PDM) . . . . . . . . . . . . . 10
Turn on the PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
The OmniPod Setup Wizard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Set date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Enter basal settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Enter blood glucose sound setting and BG goal . . . . . . . . . . . . . 12
Set the suggested bolus calculator . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Enter target blood glucose value . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Enter minimum BG allowed for use in bolus calculation. . . . . 13

Contents
iv
Enter insulin-to-carbohydrate ratio . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Enter correction factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Set reverse correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Enter the duration of insulin action . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Select bolus increment and enter maximum bolus . . . . . . . . . . 15
Set extended bolus doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Set low reservoir alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
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. . . . . . . . . . . . . . . . . . . . . 23
Cancel a one-time temporary basal rate. . . . . . . . . . . . . . . . . . . . . 24
Create a temporary basal preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Enable an existing temporary basal preset . . . . . . . . . . . . . . . . . . 26
Cancel an active temporary basal preset . . . . . . . . . . . . . . . . . . . . 26
Change, rename, or delete a temporary basal preset . . . . . . . 26
Maximum Basal Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
What is the maximum basal rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Change the maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4 Understanding and Delivering Bolus Doses . . . . . . . . . . . 29
What Is a Bolus? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Bolus Dose Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Suggested Bolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
How a suggested bolus is calculated. . . . . . . . . . . . . . . . . . . . . . . . . 30
Deliver a Normal Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Deliver a bolus when suggested bolus calculator is On . . . . . 31
Deliver a bolus manually (suggested bolus calc is Off) . . . . . . 34
Deliver an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Deliver an extended bolus instead of a normal bolus . . . . . . . 34
Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Bolus Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Create a bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Enable an existing bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Change, rename, or delete a bolus preset. . . . . . . . . . . . . . . . . . . . 38
Cancel an active bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Carb Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Create a carb preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Change or edit a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Delete a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Reference Food Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Access the reference food library. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5 Using the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
The Pod Change Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Contents
v
Gather equipment and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Deactivate the current Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Fill a new Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Select the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Prepare the infusion site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Apply the new Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Insert cannula and begin insulin delivery. . . . . . . . . . . . . . . . . . . . 52
Check Pod Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Suspend Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Resume Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Avoid Infusion Site Infections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Get the Most From Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Avoid extreme temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Water and your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Safe storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
6 Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . 58
The Status Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Insulin gauge and display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
PDM settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
The System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Reset the time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Reset the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Change Bolus and Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Bolus calcs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Ratios/factors/targets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Temp basal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Bolus increment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Alerts and Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Set alerts and reminders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Change Blood Glucose Meter Settings. . . . . . . . . . . . . . . . . . . . . 69
Change BG goal limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Manage the Blood Glucose Tags List . . . . . . . . . . . . . . . . . . . . . . . . . 70
Change BG sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Customize the Personal Diabetes Manager . . . . . . . . . . . . . . . . 71
Set PDM options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Set Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Diagnostic options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Get the Most from Your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Keep it handy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Communicating with the Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Water and your PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Electrical interference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
7 Checking Your Blood Glucose. . . . . . . . . . . . . . . . . . . . . . . . . 76
The Built-in FreeStyle® Blood Glucose Meter . . . . . . . . . . . . . . . 76

Contents
vi
The FreeStyle® Blood Glucose Test Strips. . . . . . . . . . . . . . . . . . . 77
Important test strip information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
The FreeStyle® Control Solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
When to perform a control solution test. . . . . . . . . . . . . . . . . . . . . 78
Check that the meter and test strips are working . . . . . . . . . . . 78
Control solution expiration date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Ensure accurate control solution results . . . . . . . . . . . . . . . . . . . . . 78
Out-of-range control solution results. . . . . . . . . . . . . . . . . . . . . . . . 79
Performing a Control Solution Test . . . . . . . . . . . . . . . . . . . . . . . . 80
Performing a Blood Glucose Test. . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Prepare the lancing device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Insert the blood glucose test strip . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Set the blood glucose test strip code . . . . . . . . . . . . . . . . . . . . . . . . 86
Lance your finger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Lance your forearm, upper arm, hand, thigh, or calf. . . . . . . . . 88
Fill the blood glucose test strip with blood . . . . . . . . . . . . . . . . . . 89
Wait for the reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Remove the lancet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Blood Glucose Results and the Suggested Bolus Calculator 92
Entering Blood Glucose Readings Manually. . . . . . . . . . . . . . . . 93
Editing Tags. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Low and High Blood Glucose Readings . . . . . . . . . . . . . . . . . . . . 95
Low readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
High readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Important Health-Related Information. . . . . . . . . . . . . . . . . . . . . 96
8 Understanding Your Records . . . . . . . . . . . . . . . . . . . . . . . . . 97
Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Special symbols in record screens . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Insulin Delivery Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
View insulin delivery records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Blood Glucose Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
View single-day trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
View multiple-day trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Alarm Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Carbohydrate Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
All Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
User Information/Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Add or change user information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
9 Living with Diabetes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Your Role: Safely Using the OmniPod System. . . . . . . . . . . . . 105
Daily Diabetes Management Activities . . . . . . . . . . . . . . . . . . . 106
Check your blood glucose frequently. . . . . . . . . . . . . . . . . . . . . . . 106
Inspect the infusion site daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Prepare for Emergencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Water and Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Traveling and Vacationing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Plan for changing time zones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Take enough supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Minimize airport security delays . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Contents
vii
Keep supplies accessible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Avoid Lows, Highs, and DKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
General precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . . . . . . . . . . 110
Hyperglycemia (high blood glucose) . . . . . . . . . . . . . . . . . . . . . . . 114
Diabetic ketoacidosis (DKA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Handling Special Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Sick days . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Exercising, playing sports, or working hard. . . . . . . . . . . . . . . . . 119
X-rays, MRIs, and CT scans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Surgery or hospitalization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
10 Errors, Advisories, and Hazard Alarms . . . . . . . . . . . . . . . 121
Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Blood Glucose Meter Error Messages. . . . . . . . . . . . . . . . . . . . . . 121
Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Hazard Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
11 Communication Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
The Communication Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Failure During Pod Activation or Operation . . . . . . . . . . . . . . . 129
Failure During Pod Deactivation. . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Failure During Request for Status. . . . . . . . . . . . . . . . . . . . . . . . . . 132
Failure During Bolus Cancellation . . . . . . . . . . . . . . . . . . . . . . . . . 133
Failure During a Hazard Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Pod Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Personal Diabetes Manager Care and Maintenance. . . . . . . 136
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Replacing batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
If the PDM becomes submerged in water . . . . . . . . . . . . . . . . . . 138
If you drop the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Storage and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Ordering supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Suggested Bolus Calculator Examples . . . . . . . . . . . . . . . . . . . . 140
Meal bolus calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Insulin-on-board calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Examples of suggested bolus calculations. . . . . . . . . . . . . . . . . . 141
Calculator guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
OmniPod System Options and Settings. . . . . . . . . . . . . . . . . . . 143
Pod Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Accuracy Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Flow rate from startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Flow rate error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Personal Diabetes Manager Specifications. . . . . . . . . . . . . . . . 146

Contents
viii
Blood Glucose Meter Specifications. . . . . . . . . . . . . . . . . . . . . . . 146
OmniPod System Label Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . 147
Personal Diabetes Manager Icons. . . . . . . . . . . . . . . . . . . . . . . . . 147
OmniPod System Federal Communications
Commission (FCC) Notice Concerning Interference. . . . . . . 148
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Customer Bill of Rights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Mission Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Scope of Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Supply Shipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Inquiries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Customer’s Bill of Rights and Responsibilities. . . . . . . . . . . . . . . 153
Limited Warranty for the Personal Diabetes Manager . . . . 155
HIPAA Privacy Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Uses and Disclosures of Medical Information. . . . . . . . . . . . . . . 156
Your Rights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Our Duties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
What To Do If You Have a Problem or Question. . . . . . . . . . . . . 161
Helpful Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

ix
Introduction
■ Before You Get Started
Indication
The OmniPod Insulin Management System is intended for sub-
cutaneous (below the skin) delivery of insulin at set and variable
rates for the management of diabetes mellitus in persons requir-
ing insulin and for the quantitative measurement of glucose in
fresh whole capillary blood (in vitro).
Contraindications
Insulin pump therapy is NOT recommended for people who are
either:
• Unable to perform at least four (4) blood glucose tests per day
• Unable to maintain contact with their healthcare provider
• Unable to use the System according to instructions
Do not use the integrated FreeStyle® Blood Glucose Monitoring
System for:
• Testing on newborns
• Testing arterial blood
• Diagnosing of or screening for diabetes mellitus
US Federal law restricts this device to sale by or on
the order of a physician.
This User Guide is intended for use only with PDM
model UST200. To learn which version of the PDM
you have, turn it over. On the back of the PDM, look
for the symbol. If you see “UST200” to the right
of it, this is the correct User Guide. If you do not see
“UST200,” please call Customer Care immediately to
receive the correct User Guide: 800-591-3455. When
calling from outside the United States: 781-457-5098.
This User Guide is periodically updated. Visit the Cus-
tomer Care section of MyOmniPod.com to see the
most recent version and to find other helpful infor-
mation.

Introduction
x
You and your healthcare provider
Work with your healthcare provider to establish diabetes man-
agement guidelines and settings that best fit your needs. These
may include:
Insulin-to-Carbohydrate Ratio: Number of grams of carbohy-
drate covered by one unit of insulin. For example, if your insulin-
to-carbohydrate ratio is 1:15, then you need to deliver one unit of
insulin to cover every fifteen grams of carbohydrate you eat.
Correction or Sensitivity Factor: How much one unit of insulin
will lower blood glucose. For example, if your sensitivity factor is
50, one unit of insulin will lower your blood glucose by 50 mg/dL.
Target Blood Glucose Value: The blood glucose level you want
to achieve. For example, you may want to keep your blood glu-
cose close to 100 mg/dL.
Duration of insulin action: The length of time that insulin
remains active and available in your body after a correction
bolus.
Your individual needs influence the initial settings you and your
healthcare provider will enter into the Personal Diabetes
Manager (PDM) during setup (see Chapter 2, Getting Started).
If you are unable to use the System according to
instructions, you may be putting your health and
safety at risk. Talk with your healthcare provider if
you have questions or concerns about using the
System properly.
The OmniPod System is designed to use rapid-act-
ing U-100 insulin. The following U-100 rapid-acting
insulin analogs have been tested and found to be
safe for use in the Pod: NovoLog®, Humalog® , or
Apidra®. Before 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 healthcare provider’s
directions for how often to replace the Pod.
Please read all the instructions provided in this User
Guide and practice the blood glucose testing proce-
dures before using the System. Monitor your blood
glucose with the guidance of your healthcare pro-
vider. Undetected hyperglycemia or hypoglycemia
can result without proper monitoring.
Screen displays shown in this User Guide are for illustra-
tive purposes only and should not be considered
suggestions for user settings. Consult with your health-
care provider to determine the appropriate settings for
you.

Introduction
xi
Your healthcare provider must help you enter these initial set-
tings. Soon you will enter and change your own settings with
confidence and ease. The OmniPod System is more user-friendly
than most electronic devices you use every day. In fact, technol-
ogy is what makes the OmniPod System so easy to use.
Your healthcare provider is a valuable resource. You will rely on
him or her for a lot of critical information about your OmniPod
System, especially during the first few weeks and months. When
you have questions about diabetes management after starting
on the OmniPod System, do not hesitate to talk with your health-
care provider. For nonmedical emergencies or for technical
questions about your OmniPod System setup or operation, you
can call Insulet Corporation 24 hours a day, 7 days a week at:
Customer Care (24 hours/7 days): 800-591-3455
When calling from outside the United States: 781-457-5098
Customer Care Fax: [phone]
Web site: MyOmniPod.com
■ Your Role: Safely Using the OmniPod System
Your healthcare provider will give you all the tools and training
you need to be successful with the OmniPod Insulin Manage-
ment 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 practic-
ing proper techniques
• Visiting your healthcare provider
If you are having symptoms that are not consistent
with your blood glucose test and you have followed
all instructions described in this User Guide, call your
healthcare professional.
Do NOT attempt to use the OmniPod Insulin
Management System before you receive training
from your healthcare provider. Inadequate training
could put your health and safety at risk.

Introduction
xii
■ About This User Guide
Conventions and Terms
Symbols
Convention/Term Meaning
Bold Names of buttons, soft keys, menus, and
screens are in bold.
Italics Words in italics are defined in the
Glossary at the end of this User Guide.
Press Press and release a button or soft key.
Hold Keep pressing a button until its function is
complete.
Menu A list of options on the PDM. Options allow
you to perform tasks.
Screen Displays programming, operating, and
alarm/alert information.
Button A physical button on the PDM, such as the
Home/Power button.
Icon An image on the PDM screen that indi-
cates a menu option or item of informa-
tion. A table of screen icons appears in the
Appendices.
Soft keys A row of three unlabeled buttons on the
PDM whose label or function appears on
the screen directly above the button. The
label changes depending on the task you
are performing.
Symbol Term Meaning
Warning Describes potential serious adverse
reactions, or indicates conditions that
could cause death or serious injury.
Caution Indicates conditions that could cause
minor or moderate injury to you or
damage to the device.
Note Provides helpful information.
Tip Offers a suggestion for successful use
of the OmniPod Insulin Management
System.
Convention/Term Meaning

1
CHAPTER 1
Your New OmniPod Insulin Management System
■ Insulin Delivery with the OmniPod System
The OmniPod Insulin Management System is an innovative
continuous insulin delivery system that provides all the proven
benefits of continuous subcutaneous insulin infusion (CSII) therapy
in a way no conventional insulin pump can. The System’s innova-
tive design and features allows you to live your life—and
manage your diabetes—with unprecedented freedom, comfort,
convenience, and ease.
The long-term health benefits of better blood glucose control
are well known. Maintaining near-normal blood glucose levels
can help you live a longer, healthier life with fewer diabetes-
related complications. The OmniPod System also has many
practical, everyday benefits, including convenience, freedom,
flexibility, and ease of use.
Continuous insulin delivery most closely mimics the insulin
release of a healthy pancreas. Since the landmark 10-year
Diabetes Control and Complications Trial (DCCT), the long-
term health benefits of maintaining near-normal blood
glucose levels have been widely recognized.
Continuous insulin delivery at preset rates eliminates the need
for injections and the interruptions that come with them. In addi-
tion, with the OmniPod System, insulin delivery can be changed
with the press of a button to adapt to snacks or unexpected
changes in daily routine. The OmniPod System is a great option
for people with diabetes who require insulin.
The OmniPod System works much like the pancreas of a person
without diabetes by delivering insulin in two ways:
• A small, constant, background supply of insulin (called a basal
rate) is delivered automatically at a programmed rate, all day
and night.
• An extra dose of insulin (called a bolus) can be delivered
when you need it to match the carbohydrates in a meal or
snack or to correct a high blood glucose.

Your New OmniPod Insulin Management System
2
1
■ 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 that:
• Programs the Pod with your personalized insulin-delivery
instructions
• Wirelessly monitors the Pod’s operation
• Incorporates a FreeStyle® blood glucose meter
With just two parts, you’ll enjoy all the functionality and benefits
of continuous insulin delivery and blood glucose monitoring.
Plus you’ll enjoy the safety, convenience, and freedom of:
No tubing
There is no tubing connecting the 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.
Automated cannula insertion
With the OmniPod System, you don’t have to insert the infusion
set manually or carry around a separate inserter. You simply press
a button on the PDM and the Pod’s automated insertion system
safely and consistently inserts the cannula beneath the skin, vir-
tually pain free.1It 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
separate 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.
1. Data on file at Insulet Corporation.

Your New OmniPod Insulin Management System
3
1
Suggested bolus calculation
Calculating bolus doses has never been easier. After you check
your blood glucose, enter the carbs for your snack or meal. Based
on your individual settings, the System displays a suggested
bolus dose. You can accept the suggestion, change it, or cancel it.
Reference food library and carb presets
To make carbohydrate counting easier, the OmniPod System
includes a reference food library. You can look up the carbs and
other values for many standard food items. Foods are organized
alphabetically and by category.
You can also enter your own favorite foods, snacks, or entire
meals as “carb presets.” Presets contain the grams of carbohy-
drate in the food item or meal. Next time you eat this same food,
you don’t have to count the carbs; just select your carb preset
and the System does the calculating for you. The System stores
up to 36 carb presets.
Record keeping
Another convenient part of the OmniPod System is record keep-
ing. Paper charts are useful, but sometimes they can be
inconvenient to carry or use. The data storage system in the
Personal Diabetes Manager (PDM) displays up to 90 days’ worth
of information. This includes blood glucose readings, basal rates
and bolus doses, carbohydrates, and alarms.
Personalizing your System
You can personalize your OmniPod System in other ways, too:
• Enter and name basal programs
• Name and save temporary basal presets
• Add your own customized reminders
• Enter your name, phone number, doctor’s names and
numbers, and other emergency information

Your New OmniPod Insulin Management System
4
1
■ The Pod
The Pod (Figure 1-1) is applied to your skin with an adhesive
backing, similar to a Band-Aid®.
■ The Personal Diabetes Manager
All Pod operations are programmed and controlled through the
palm-sized Personal Diabetes Manager (PDM; Figure 1-2).
Top
Bottom
Needle cap
Viewing window
Fill port
Figure 1-1
Adhesive
backing
Figure 1-2
Up/Down
Controller
User Info/
Support
Soft Key
Labels
Soft Keys
Home/
Power
USB Port
Test Strip Port
LCD Screen

Your New OmniPod Insulin Management System
5
1
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
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 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 phys-
ical 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 infor-
mation can be viewed. It may be displayed at
the top of the screen, to the right of an event
detail (such as a suggested bolus), or to the
right of a record item (such as a BG history
record). (See “Personal Diabetes Manager
Icons” in the Appendices.)
In addition, pressing and holding this button
for 2 seconds enables a “bright mode” on the
PDM screen.

Your New OmniPod Insulin Management System
6
1
Primary screens
Messages on the screen either:
• Tell you how the System is operating
• List menu choices
• Explain how to perform certain tasks
The System’s primary screens are the Status screen (Figure 1-3)
and the Home screen (Figure 1-4).
Status screen
Lists the System’s current operating status.
From top to bottom, the Status screen displays:
• Time, date, and result of last blood glucose checked or
entered manually
• Time, date, and total amount of last bolus delivered
• Name and rate of active basal program or temp basal
program
• “Ext bolus,” the amount of insulin, and the delivery time
remaining if an extended bolus is being delivered
• “INSULIN SUSPENDED” if insulin delivery has been
suspended
• Time and date when the Pod will expire
Figure 1-3
Figure 1-4
If a Pod has not yet been activated (as during Pod
changes), the screen displays “No active Pod. Would you
like to activate a Pod now?” (See Chapter 5, Using the Pod,
for details on activating a Pod.)