Insulet OmniPod User manual

Contacts and Important Information
o
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
OmniPod System Start Date:______________________
PDM Model: CAT 35 E 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
Use the spaces below to record important health and product information.
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Copyright © 2011 Insulet Corporation. All rights reserved.
Copyright © 2011 GlaxoSmithKline Inc. All rights reserved.
OmniPod
®
is a registered trademark of Insulet Corporation, used under license by GlaxoSmithKline Inc.
FreeStyle
®
is a registered trademark of Abbott Laboratories.
Third-party trademarks used here in are the trademarks of their respective owners.
14737-AW Rev C
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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
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Automatic priming, safety checks, and insertion. . . . . . . . . . . . . . 8
Rapid occlusion detection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Alerts and alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Set Up the Personal Diabetes Manager (PDM) . . . . . . . . . . . . . . 9
Turn on the PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
The OmniPod Setup Wizard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
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
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Enter minimum BG allowed for use in bolus calculation . . . . 13
Enter insulin-to-carbohydrate ratio . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Enter correction factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Set reverse correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Enter the duration of insulin action . . . . . . . . . . . . . . . . . . . . . . 14
Select bolus increment and enter maximum bolus . . . . . . 14
Set extended bolus doses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Set low reservoir advisory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Set expiration notification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3 Understanding and Adjusting Basal Rates . . . . . . . . . . . . 16
What Is a Basal Rate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Personalized Basal Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Create a basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Enable an existing basal program. . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Change, rename, copy, or delete a basal program. . . . . . . . 20
Temporary Basal Rates and Presets . . . . . . . . . . . . . . . . . . . . . . . . 22
What is a temporary basal rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Enable a one-time temporary basal rate. . . . . . . . . . . . . . . . . . . . . 23
Cancel a one-time temporary basal rate. . . . . . . . . . . . . . . . . . . . . 24
Create a temporary basal preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Enable an existing temporary basal preset . . . . . . . . . . . . . . . . . . 25
Cancel an active temporary basal preset . . . . . . . . . . . . . . . . . . . . 26
Change, rename, or delete a temporary basal preset . . . . . . . 26
Maximum Basal Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
What is the maximum basal rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Change the maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4 Understanding and Delivering Bolus Doses . . . . . . . . . . . 28
What Is a Bolus? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Bolus Dose Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Suggested Bolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
How a suggested bolus is calculated. . . . . . . . . . . . . . . . . . . . . . . . . 29
Deliver a Normal Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Deliver a bolus when suggested bolus calculator is On . . . . . 30
Deliver a bolus manually (suggested bolus calc is Off) . . . . . . 33
Deliver an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Deliver an extended bolus instead of a normal bolus . . . . . . . 33
Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Replace an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
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5 Using the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
The Pod Change Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Gather equipment and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Deactivate the current Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Fill a new Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Select the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Prepare the infusion site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Apply the new Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Insert cannula and begin insulin delivery. . . . . . . . . . . . . . . . . . . . 51
Check Pod Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Suspend Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Resume Insulin Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Avoid Infusion Site Infections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Get the Most From Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Avoid extreme temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Water and your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Safe storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6 Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . 57
The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Insulin gauge and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
PDM settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
The System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Reset the time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Reset the date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Change Bolus and Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Bolus calcs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Ratios/factors/targets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Temp basal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Bolus increment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Alert and Reminder Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Set alert and reminder notifications. . . . . . . . . . . . . . . . . . . . . . . . . . 66
Change Blood Glucose Meter Settings . . . . . . . . . . . . . . . . . . . . . 68
Change BG goal limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Manage the blood glucose tags list . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Change BG sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Customize the Personal Diabetes Manager . . . . . . . . . . . . . . . . 70
Set PDM options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Set Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Diagnostic options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Set a Notification to Vibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Get the Most from Your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Keep it handy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Communicating with the Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Water and your PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
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Avoid extreme temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Electrical interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
7 Checking Your Blood Glucose. . . . . . . . . . . . . . . . . . . . . . . . . 75
The Built-in FreeStyle® Blood Glucose Meter . . . . . . . . . . . . . . . 75
The FreeStyle® Blood Glucose Test Strips. . . . . . . . . . . . . . . . . . . 76
Important test strip information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
The FreeStyle® Control Solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
When to perform a control solution test. . . . . . . . . . . . . . . . . . . . . 77
Check that the meter and test strips are working . . . . . . . . . . . 77
Control solution expiration date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Ensure accurate control solution results . . . . . . . . . . . . . . . . . . . . . 77
Out-of-range control solution results. . . . . . . . . . . . . . . . . . . . . . . . 78
Performing a Control Solution Test . . . . . . . . . . . . . . . . . . . . . . . . 79
Performing a blood glucose reading. . . . . . . . . . . . . . . . . . . . . . . 82
Prepare the lancing device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Insert the blood glucose test strip . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Set the blood glucose test strip code. . . . . . . . . . . . . . . . . . . . . 85
Lance your finger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Lance your forearm, upper arm, hand, thigh, or calf. . . . . . . . . 87
Fill the blood glucose test strip with blood . . . . . . . . . . . . . . . . . . 88
Wait for the reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Remove the lancet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Blood Glucose Results and the Suggested Bolus Calculator 91
Entering Blood Glucose Readings Manually. . . . . . . . . . . . . . . . 92
Editing Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Low and High Blood Glucose Readings. . . . . . . . . . . . . . . . . . . . . 93
Low readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
High readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Important Health-Related Information . . . . . . . . . . . . . . . . . . . . . 95
8 Understanding Your Records . . . . . . . . . . . . . . . . . . . . . . . . . 96
Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Special symbols in record screens . . . . . . . . . . . . . . . . . . . . . . . . 96
Insulin Delivery Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
View insulin delivery records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Blood Glucose Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
View single-day trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
View multiple-day trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Alarm Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Carbohydrate Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
All Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
User Information/Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Add or change user information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
9 Living with Diabetes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Your Role: Safely Using the OmniPod System. . . . . . . . . . . . . 104
Daily Diabetes Management Activities . . . . . . . . . . . . . . . . . . . 105
Check your blood glucose frequently. . . . . . . . . . . . . . . . . . . . . . . 105
Inspect the infusion site daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Prepare for Emergencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
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Water and Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Traveling and Vacationing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Plan for changing time zones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Take enough supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Minimize airport security delays . . . . . . . . . . . . . . . . . . . . . . . . . 108
Keep supplies accessible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Avoid Lows, Highs, and DKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
General precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . . . . . . . . . . 109
Hyperglycemia (high blood glucose) . . . . . . . . . . . . . . . . . . . . . . . 113
Diabetic ketoacidosis (DKA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Handling Special Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Sick days . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Exercising, playing sports, or working hard. . . . . . . . . . . . . . . . . 118
X-rays, MRIs, and CT scans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Surgery or hospitalization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
10 Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Blood Glucose Meter Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Hazard Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Manual Shutoff of a Hazard Alarm. . . . . . . . . . . . . . . . . . . . . . . . . 129
11 Communication Failures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
The Communication Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Failure During Pod Activation or Operation . . . . . . . . . . . . . . . 130
Failure During Pod Deactivation . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Failure During Request for Status . . . . . . . . . . . . . . . . . . . . . . . . . 133
Failure During Bolus Cancellation . . . . . . . . . . . . . . . . . . . . . . . . . 134
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Pod Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Personal Diabetes Manager Care and Maintenance. . . . . . . 136
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Replacing batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
If the PDM becomes submerged in water . . . . . . . . . . . . . . . . . . 139
If you drop the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Storage and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Ordering supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Suggested Bolus Calculator Examples and Guidelines . . . . 140
Meal bolus calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Insulin-on-board (IOB) calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Examples of suggested bolus calculations. . . . . . . . . . . . . . . . . . 141
Calculator guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
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Contents
viii
OmniPod System Options and Settings. . . . . . . . . . . . . . . . . . . 144
Pod Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Accuracy Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Flow rate from startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Flow rate error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Personal Diabetes Manager Specifications. . . . . . . . . . . . . . . . 147
Blood Glucose Meter Specifications. . . . . . . . . . . . . . . . . . . . . . . 147
OmniPod System Label Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . 148
Personal Diabetes Manager Icons. . . . . . . . . . . . . . . . . . . . . . . . . 148
OmniPod System Notice Concerning Interference . . . . . . . 149
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Limited Warranty for the Personal Diabetes Manager. . . . . 154
Privacy Code. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
You and Your Healthcare Provider . . . . . . . . . . . . . . . . . . . . . . . . 155
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
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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
This User Guide is intended for use only with PDM
model CAT35E. To learn which version of the PDM
you have, turn it over. On the back of the PDM, look
for “CAT35E.” If you see it, this is the correct User
Guide. If you do not see “CAT35E” on the back of the
PDM, please call Customer Care at 1 855 POD INFO
(1 855 763 4636). When outside of Canada,
please call 647-788-3132.
This device is intended for self-testing by the user.
This User Guide is periodically updated. Visit
www.MyOmnipod.ca and www.MonOmniPod.ca to
see the most recent version.
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Introduction
x
You and Your Healthcare Provider
The contents of the OmniPod®user manual are not intended to
replace or substitute the advice of your physician or other quali-
fied healthcare professionals. You should speak to your own
healthcare professional, who is the best source of information
regarding your own health related questions. Absolutely no
information contained in the OmniPod® user manual should be
construed as taking the place of your physician’s or other quali-
fied healthcare professional's advice.
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
2.8, one unit of insulin will lower your blood glucose by 2.8
mmol/L.
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-
acting U-100 insulin. The following U-100 rapid-
acting insulin analogs have been tested and found
to be safe for use in the Pod: NovoRapid®, Humalog®,
or Apidra®. 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
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.
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.
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Introduction
xi
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 5.6 mmol/L.
Duration of insulin action: The length of time that insulin
remains active and available in your body after a bolus.
Your individual needs influence the initial settings you and your
healthcare provider will enter into the Personal Diabetes
Manager (PDM) during setup (see Chapter 2, Getting Started).
Your healthcare provider must help you enter these initial 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 Customer Care 24 hours a day, 7 days a week.
Customer Care:
Please call customer care at 1 855 POD INFO (1 855 763
4636). When outside of Canada, please call 647-788-
3132.This user guide is periodically updated. Please visit
www.MyOmniPod.ca and www.MonOmniPod.ca to see the
most recent version and to find other helpful information.
■ 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.
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Introduction
xii
■ About This User Guide
Conventions and Terms
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.
Convention/Term Meaning
Soft keys A row of three unlabeled buttons on the
PDM whose label or function appears on
the screen directly above the button. The
label changes depending on the task you
are performing.
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.
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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 unprecedentedfreedom, 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 prac-
tical, everyday benefits, including convenience, freedom,
flexibility, and ease of use.
Continuous insulin delivery most closely mimics the insulin
release of ahealthy pancreas. Since the landmark 10-year
Diabetes Control and Complications Trial (DCCT), the long-
term health benefitsof 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.
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Your New OmniPod Insulin Management System
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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. 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
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.
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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 car-
bohydrate 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 pre-
set 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
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Your New OmniPod Insulin Management System
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■ 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).
Top
Bottom
Needle cap
Viewing window
Fill port
Figure 1-1
Adhesive
backing
Up/Down
Controller
User Info/
Support
Soft Key
Label
Soft Keys
Home/
Power
USB Port
Test Strip Port
Figure 1-2
LCD Screen
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Your New OmniPod Insulin Management System
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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 dis-
plays 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 physi-
cal button you press. Select, Save, and Back are
just three examples of the soft key labels on your
PDM.
Button Action
User Info/
Support Pressing opens a User Info/Support screen that
displays additional information about the cur-
rent screen you are viewing. The User Info/Sup-
port icon appears when additional information
can be viewed. It may be displayed at the top of
the screen, to the right of an event detail (such as
a suggested bolus), or to the right of a record
item (such as a BG history record). (See “Personal
Diabetes Manager Icons” in the Appendix.)
In addition, pressing and holding this button for
2 seconds enables a “bright mode” on the PDM
screen.
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Your New OmniPod Insulin Management System
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Primary screens
Messages on the screen either:
• Tell you how the System is operating
•Listmenuchoices
• 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
•Amountofinsulin on board (IOB), if suggested bolus calcu-
lator is in use
• Name and rate of active basal program or temp basal
program
• “Ext bolus,” the amount of insulin, and the delivery time
remaining if an extended bolus is being delivered
• “INSULIN SUSPENDED” if insulin delivery has been
suspended
• Time and date when the Pod will expire
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.)
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Your New OmniPod Insulin Management System
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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).
Home screen
Lists all the major menus (Figure 1-4 on previous page).
•Bolus menu to deliver bolus doses
•More actions menu to change the Pod, manually enter
blood glucose readings, and assign and edit tags for BG read-
ings that are less than 2 hours old.
•Temp basal menu to deliver temporary basal rates (This
submenu does not appear if Temp basal is turned Off in
Settings.)
•My records menu to review insulin delivery, blood glucose
history, alarm history, carb history, and personal user informa-
tion
•Settings menu to edit, enter, and name basal programs,
temp basal, carbohydrate, and bolus presets, and to custom-
ize System settings
•Suspend menu to suspend, cancel, or resume insulin
delivery programs
Figure 1-5
You can go to the Status screen at any time by
pressing Status from the Home screen.
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