Insulet 017 Usr Manual
Contacts and Important Information
Doctor
Nurse/Educator
Health Insurance
Pharmacy
Use the spaces below to record important health and product 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: UST
Emergency Services:
Dial 911 (USA only; not available in all communities)
Insulet Corporation
9 Oak Park Drive, Bedford, MA 01370
Customer Care (24 hours/7 days): 800-591-3455
When calling from outside the United States: 781-457-5098
Customer Care Fax: 877-467-8538
Web site: MyOmniPod.com
400 Serial Number: ____________________
© 2011 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.
Third-party trademarks used herein are the trademarks of their respective owners.
14421-AW Rev A
Contents
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
About This User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
Conventions and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Important Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
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
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Automatic priming, safety checks, and insertion . . . . . . . . . . . . . . 8
Rapid 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Set reverse correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
iii
Contents
Enter the duration of insulin action . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ect bolus increment and enter maximum bolus. . . . . . . . . . 14
Sel
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 . . . . . . . . . . . . . . . . . . . . . . . . 30
Deliver a Normal Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Deliver a bolus when suggested bolus calculator is On. . . . . . 31
Deliver a bolus manually (suggested bolus calc is Off). . . . . . . 33
Deliver an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Deliver an extended bolus instead of a normal bolus. . . . . . . . . . . 34
Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Replace an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Bolus Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Create a bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Enable an existing bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Change, rename, or delete a bolus preset . . . . . . . . . . . . . . . . . . . 39
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
Gather equipment and supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Deactivate the current Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Fill a new Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Select the infusion site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Apply the new Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Insert cannula and begin insulin delivery. . . . . . . . . . . . . . . . . . . . 52
Check Pod Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
iv
Contents
Suspend Insulin Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
ume Insulin Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Res
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 ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Insulin gauge and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
PDM settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
The System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Reset the time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Reset the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Change Bolus and Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Bolus calcs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Ratios/factors/targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Temp basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Bolus increment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Alerts and Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Set alerts and reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Change Blood Glucose Meter Settings . . . . . . . . . . . . . . . . . . . . . . . . . 69
Change BG goal limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Manage the blood glucose tags list . . . . . . . . . . . . . . . . . . . . . . . . . 69
Change BG sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Customize the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . 70
Set PDM options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Set Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Diagnostic options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Set a Reminder to Vibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
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
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 reading . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Prepare the lancing device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
v
Contents
Insert the blood glucose test strip . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
the blood glucose test strip code . . . . . . . . . . . . . . . . . . . . . . . . 86
Set
Lance your finger. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Lance your forearm, upper arm, or hand. . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Entering Blood Glucose Readings Manually . . . . . . . . . . . . . . . . . . . . 92
Editing Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Low and High Blood Glucose Readings. . . . . . . . . . . . . . . . . . . . . . . . . 94
Low readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
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
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
Water and Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Traveling and Vacationing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Plan for changing time zones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Take enough supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Minimize airport security delays. . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Travel preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Screening procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Keep supplies accessible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Avoid Lows, Highs, and DKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
General precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . . . . . . . . . . 109
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 Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Blood Glucose Meter Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
vi
Contents
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
isory Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Adv
Hazard Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Manual Shut-off of a Hazard Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
11 Communication Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
The Communication Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Failure During Pod Activation or Operation . . . . . . . . . . . . . . . . . . . 131
Failure During Pod Deactivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Failure During Request for Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Failure During Bolus Cancellation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Pod Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Personal Diabetes Manager Care and Maintenance . . . . . . . . . . . 137
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Cleaning and disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Replacing batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
If the PDM becomes submerged in water . . . . . . . . . . . . . . . . . . 139
If you drop the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Storage and Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Suggested Bolus Calculator Examples and Guidelines . . . . . . . . 141
Meal bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Insulin-on-board (IOB) calculation. . . . . . . . . . . . . . . . . . . . . . . . . . 141
Examples of suggested bolus calculations . . . . . . . . . . . . . . . . . 142
Calculator guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
OmniPod System Options and Settings . . . . . . . . . . . . . . . . . . . . . . . 145
Pod Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Accuracy Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Flow rate from startup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Flow rate error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Personal Diabetes Manager Specifications . . . . . . . . . . . . . . . . . . . . 148
Blood Glucose Meter Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . 148
OmniPod System Label Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Personal Diabetes Manager Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
OmniPod System Notice Concerning Interference . . . . . . . . . . . . 150
Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Customer Bill of Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Mission Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Scope of Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Supply Shipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Inquiries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
CHAP Accredited. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Customer’s Bill of Rights and Responsibilities. . . . . . . . . . . . . . . 156
Limited Warranty for the Personal Diabetes Manager . . . . . . . . . 157
HIPAA Privacy Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Uses and Disclosures of Medical Information. . . . . . . . . . . . . . . 158
Your Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Our Duties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
What To Do If You Have a Problem or Question . . . . . . . . . . . . 163
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
vii
Introduction
■
About This User Guide
Symbols
Symbol Term Meaning
Warning
Caution
Describes potential serious adverse
reactions, or indicates conditions that
could cause death or serious injury.
Indicates conditions that could cause
minor or moderate injury to you or
damageto the device.
This User Guide is intended for use only with PDM
model UST400. To learn which version of the PDM
you have, turn it over. On the back of the PDM, look
for “UST400.” If you see it, this is the correct User
Guide. If you do not see “UST400” on the back of the
PDM, please call Customer Care.
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 information.
viii
Note
Tip
Provides helpful information.
Offers a suggestion for successful use
of the OmniPod
ment System.
®
Insulin Manage-
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 healthcare provider to determine the appropriate settings for
you.
Conventions and Terms
Introduction
Convention/Term Meaning
Bold
Italics
Press
Hold
Menu
Screen
Button
Names of buttons, soft keys, menus, and
screens are in bold.
Words in italics are defined in the
Glossary at the end of this User Guide.
Press and release a button or soft key.
Keep pressing a button until its function is
complete.
A list of options on the PDM. Options allow
you to perform tasks.
Displays programming, operating, and
alarm/alert information.
A physical button on the PDM, such as the
Home/Power button.
Convention/Term Meaning
Icon
Soft keys
An image on the PDM screen that indicates a menu option or item of information. A table of screen icons appears in the
Appendices.
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.
Important Information
US Federal law restricts this device to sale by or on
the order of a physician.
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 requir-
ing insulin and for the quantitative measurement of glucose in
fresh whole capillary blood (in vitro).
ix
Introduction
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
Systemfor:
• Testing on newborns
• Testing arterial blood
• Diagnosing of or screening for diabetes mellitus
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: Novolog®/NovoRapid®,
Humalog®, or Apidra®. Novolog® is compatible with
the OmniPod System for use up to 72 hours (3 days).
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.
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.
The glucose meter and lancing device are for single
patient use. Do not share the device with anyone
including other family members. Do not use on multiple patients.
Parts of the device are considered biohazardous and
can potentially transmit infectious diseases, even
after you have performed cleaning and disinfection.
x
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 provider. Undetected hyperglycemia or hypoglycemia
can result without proper monitoring.
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.
This device is intended for self-testing by the user.
If you are having symptoms that are not consistent
with your blood glucose test and you have followed
all instructions described in this User Guide, call your
healthcare professional.
Introduction
■
Your Role: Safely Using the OmniPod System
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: 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 glucose close to 100 mg/dL.
Duration of Insulin Action: The length of time that insulin
remains active and available in your body after a correction or
meal bolus.
xi
Introduction
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 settings. 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, technology 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 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 (24 hours/7 days): 800-591-3455
When calling from outside the United States: 781-457-5098
Customer Care Fax: 877-467-8538
Web site: MyOmniPod.com
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.
xii
CHAPTER 1
Your New OmniPod Insulin Management System
■ Insulin Delivery with the OmniPod System
The OmniPod® Insulin Management System is an innovative
continuousinsulin 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 innovative 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 diabetesrelated 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 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 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.
1
Your New OmniPod Insulin Management System
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.
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.
2
Your New OmniPod Insulin Management System
1
You can also enter your own favorite foods, snacks, or entire
ls as “carb presets.” Presets contain the grams of carbohy-
mea
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.
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, 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
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.
Record keeping
Another convenient part of the OmniPod System is record keeping. Paper charts are useful, but sometimes they can be
inconvenient to carry or use. The data storage system in the
Personal Diabetes Manager (PDM) displays up to 90 days’ worth
of information. This includes blood glucose readings, basal rates
and bolus doses, carbohydrates, and alarms.
Personalizing your System
You can personalize your 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
3
Your New OmniPod Insulin Management System
Top
Bottom
Needle cap
Viewing window
Fill port
Figure 1-1
Adhesive
backi
ng
Housing vent
Figure 1-2
Up/Down
Controller
User Info/
Support
Soft Key
Label
Soft Keys
Home/
Power
USB Port
Test Strip Port
LCD Screen
1
■ 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).
4
Your New OmniPod Insulin Management System
Buttons that program and control the OmniPod System
1
Button Action
Home/
Power
Up/Down
Controller
Soft Keys
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).
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 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/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.
5
Your New OmniPod Insulin Management System
Figure 1-3
Figure 1-4
1
Primary screens
sages on the screen either:
Mes
• Let you identify your PDM
• Tell you how the System is operating
• List menu choices
• Explain how to perform certain tasks
The System’s primary screens are the ID screen (Figure 1-3), the
Status screen (Figure 1-4), and the Home screen (Figure 1-6 on
the next page).
ID screen
The System displays an ID screen to make the PDM easy to iden-
tify when you first turn it on. You can personalize the ID screen by
adding your name and choosing its color. (See Chapter 6, Using
the Personal Diabetes Manager, for details on customizing your
PDM.) You must acknowledge the ID screen before you can use
the PDM. It is important that you always identify the PDM as
yours before you use it.
Status screen
Lists the System’s current operating status (Figure 1-4).
From top to bottom, the Status screen displays:
• Time, date, and result of last blood glucose checked or
entered manually
• Time, date, and total amount of last bolus delivered
• Amount of Insulin on Board (IOB) will be displayed on
Status screen (if calculator in use)
• Name and rate of active basal program or temp basal
program
• “Ext bolus,” the amount of insulin, and the delivery time
remaining if an extended bolus is being delivered
• “INSULIN SUSPENDED” if insulin delivery has been
suspended
• Time and date of when the Pod will expire
6
Your New OmniPod Insulin Management System
Figure 1-5
Figure 1-6
1
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.)
Status support screen
m the Status screen, press the User Info/Support button to
Fro
see details about the current insulin on board (IOB) in your
body (Figure 1-5). See page 30, for additional information
describing insulin on board (IOB).
Home screen
Lists all the major menus (Figure 1-6).
• Bolus menu to deliver bolus doses
• More actions menu to change the Pod, manually enter
blood glucose readings, and assign and edit tags for BG readings that are less than 2 hours old.
• Temp basal menu to deliver temporary basal rates (This
submenu does not appear if temp basal is turned Off in
Settings.)
• My records menu to review insulin delivery, blood glucose
history, alarm history, carb history, and personal user 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
You can go to the Status screen at any time by
pressing Status from the Home screen.
7
Your New OmniPod Insulin Management System
1
■ 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 onscreen messages.
Rapid 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).
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.
Confirm on ID screen - alerts/alarms do not show on
PDM until after ID screen is confirmed.
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.
8
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 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 and complete the Pre-
Training section of OmniPod’s online Interactive Training Program, found in the Customer Care section of MyOmniPod.com. 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. Then complete the Warranty card and promptly mail it to us. Returning the
card allows us to contact you with important product updates or
Warranty information.
You can also complete the Warranty form online at
MyOmniPod.com. 4 year limited Warranty.
Do NOT use the OmniPod
System until you have been trained by your healthcare
provider. He or she will initialize the System based on
your individual needs. Inadequate training or improper
setup could put your health and safety at risk.
Prepare and keep an emergency kit with you at all times
to quickly respond to any diabetes emergency. For
details, see Chapter 9, Living with Diabetes.
■ Set Up the Personal Diabetes Manager (PDM)
Chapter 6 describes the PDM options in detail. The instructions
in this chapter are simplified to help you get started.
®
Insulin Management
9
Getting Started
Figure 2-1
Figure 2-2
Hard
Reset
2
Turn on the PDM
pen the battery compartment on the back of the PDM
1. O
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.
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
alkaline batteries to power the PDM. Never use old
or used batteries; the PDM may not work properly.
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
few minutes and is easy to do:
• Use the Up/Down Controller buttons to increase or
decrease a number, or to move up or down a list.
Initial settings are “---” [blank] for target blood glucose
value, insulin-to-carbohydrate ratio, correction factor,
and duration of insulin action.
• Press the Soft Key labeled Next, Select, Done, or Save to con-
tinue to the next screen.
• Press Back to return to the previous screen.
10
Getting Started
2
You can adjust these settings later as your needs
change or as you fine-tune your OmniPod System.
To get started, press Nex
begin setting up your PDM.
t on the Wizard's Welcome Screen to
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 bu
press Next.
Your ID and the chosen color will be displayed on an
identification (ID) screen that you must acknowledge
every time you turn on the PDM. Always be sure you
properly identify your PDM before using it.
ttons to choose a color, then
Set date and time
1. Use the Up/D
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.
own Controller buttons to increase or
Enter basal settings
1. Choose a maximum basal rate, then press Next. (The default
maximum basal rate is 3 U/hr.)
2. Choose the initial basal rate to use, then press Next.
The initial basal program created with the Setup Wizard is
named basal 1. You can change the name in the Settings >
Basal Programs menu (see Chapter 3, Understanding and
Adjusting Basal Rates).
3. Press Done to confirm the basal program shown on the
screen. To add more basal segments to the program, or to
change the rate shown, see Chapter 3, Understanding and
Adjusting Basal Rates.
4. To see the basal program as a list, press List. To return to the
graphic view, press Graph.
5. Press Save to accept the basal program you have set.
11
Getting Started
2
6. Choose a tem
% 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.
porary basal feature, then press Next. Choose
You can add up to 7 basal programs and set 24
segments per program.
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.
The lower and upper BG limits are only used when
viewing BG History (see Chapter 8, Understanding
Your Records).
4. Press Save to accept the BG goal.
Check with your healthcare provider before adjusting these settings.
Set the suggested bolus calculator
1. To set the suggested bolus calculator feature, choose On or
Off, then press Next.
If the suggested bolus calculator is set to On, perform
the following steps. If set to Off, you will be prompted
to “Select bolus increment” and “Enter maximum
bolus.”
Enter target blood glucose value
1. Use the Up/Down Controller button to enter a target blood
glucose (BG) value, then press Next.
2. Use the Up/Down Controller buttons to enter the “correct
above” value or correction threshold (the BG value above
which you want the PDM to suggest a correction bolus), then
press Next.
If the suggested bolus calculator is On, a correction
bolus will be suggested only when your BG is above
the value shown in brackets on the screen.
3. To save the target BG value, press Done. To change these set-
tings, select the segment you wish to change and press Edit.
You can define up to 8 target BG time segments. To enter
additional segments, choose [add new], then:
a. Press New.
12
Getting Started
2
b. Enter a start time for the target BG segment, then press
er.
Ent
c. Enter an end time for the target BG segment, then press
Next.
d. Enter a target blood glucose value, then press Next.
Use the Up/Down Controller buttons to enter the “cor-
rect above” value or “correction threshold” (the BG value
above which you want the PDM to suggest a correction
bolus), then press Next.
e. When you have finished entering segments, press Done.
4. To see the segments as a list, press List. To return to the
graphic view, press Graph.
5. Press Save to accept the target BG profile you have set.
Enter minimum BG allowed for use in bolus calculation
1. Use the Up/Down Controller buttons to enter a minimum
blood glucose value, below which the System will not calculate a suggested bolus. The values are in 1 mg/dL increments
and range from 50 to 70 mg/dL.
2. Press Next.
Enter insulin-to-carbohydrate ratio
1. Use the Up/D
to-carbohydrate ratio, then press Next. (Insulin-to-carbohy-
drate ratio is the number of carbs covered by 1 unit of insulin.)
own Controller buttons to enter your 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.
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/D
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:
own Controller buttons to enter how much
13
Getting Started
2
a. Press New.
Enter a start time for the segment, then press Next.
b.
c. Enter an end time for the segment, then press Next.
d. Enter the correction factor, then press Next.
e. To save the new correction factor segment, press Done.
3. To see the factors as a list, press List. To return to the graphic
view, press Graph.
4. Press Save to accept the correction factors you have set.
Set reverse correction
1. To set reverse correction, use the Up/Down Controller
buttons to choose On or Off, then press Next.
If you enter carbs and reverse corrections are On, the
System will subtract insulin from the suggested meal
bolus to compensate for a low blood glucose (below
the BG target you set). With reverse corrections Off,
the System will not subtract insulin from the suggested meal bolus dose due to a low BG. Follow your
healthcare provider’s recommendation to set
reverse correction On or Off.
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.
The duration-of-insulin-action setting is used to
calculate the amount of insulin on board (IOB) from a
previous correction bolus or meal bolus when you
use the suggested bolus calculator.
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.
The maximum bolus default is 10 units. Check with
your healthcare provider before adjusting these settings.
Set extended bolus doses
1. To set the units for an extended bolus dose, choose % f
cent of the total bolus, or choose Units for units of insulin. To
turn off the extended bolus feature, choose Off. Then press
Next.
or per-
14
Getting Started
2
Set low reservoir advisory
hoose the level of insulin in the reservoir at which the
1. C
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 Yes if you are ready to activate a new Pod. See Chapter
5, Using the Pod, to learn how to activate a new Pod.
• Press No if you do not want to activate a Pod at this time. The
PDM displays the Home screen.
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.
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.
15
CHAPTER 3
Understanding and Adjusting Basal Rates
■ What Is a Basal Rate?
A basal rate is a small base or background amount of insulin that
is delivered, at a preset rate, continuously for a specified period of
time.
Even without eating, our bodies need a small, constant supply
of insulin for normal daily living. In people without diabetes, the
pancreas continuously delivers this basal insulin. For people
using the OmniPod® Insulin Management System, the Pod mimics a healthy pancreas by delivering insulin at the rate that you’ve
programmed into the Personal Diabetes Manager (PDM).
Approximately 50% of a person’s total daily insulin dose
typically comes from basal insulin delivery; the remaining 50% typically comes from bolus doses (see Chapter 4,
Understanding and Delivering Bolus Doses).
■ Personalized Basal Programs
Insulin needs vary throughout the day. Therefore, most people
set their basal rates to deliver slightly more or less insulin at
16
certain times. For example, one person may need to deliver a
higher rate of insulin during the early morning and a lower rate
during the late evening. A basal program describes the amount
of insulin to be delivered during an entire 24-hour period.
A basal program contains at least one basal rate for the 24-hour
period, but for most people it will be broken into several time
segments, or basal segments, each delivering a different rate of
insulin. A sample basal program with three basal segments
might be:
12:00 am–8:00 am 0.60 U/hr Between 12:00 am (midnight)
and 8:00 am, the Pod delivers
0.60 units of insulin per hour.
8:00 am–3:00 pm 0.80 U/hr Between 8:00 am and 3:00 pm,
the Pod delivers 0.80 units of
insulin per hour.
3:00 pm–12:00 am 0.70 U/hr Between 3:00 pm and 12:00 am
(midnight), the Pod delivers 0.70
units of insulin per hour.
Understanding and Adjusting Basal Rates
Figure 3-1
Figure 3-2
3
In addition to normal daily changes, insulin needs can vary with
ferent routines or days of the week. For example, regular
dif
school or workday routines may differ from weekend routines,
and insulin needs may differ, too. With your healthcare provider,
you will decide on the basal rates that best match your lifestyle
and insulin needs. You will enter at least one basal program (your
Basal 1 Program) into your PDM during the setup process (see
Chapter 2, Getting Started). You can add other programs later as
you fine-tune your System settings or when your needs change.
You can also create temporary basal presets to use on occasions
when you need to adjust your basal rate for a short period of
time. See “Temporary Basal Rates and Presets” later in this
chapter.
Create a basal program
The Personal Diabetes Manager can store up to 7 different basal
programs. Each program can contain 24 rates, programmed in
half-hour increments. Once you enter a basal program into the
PDM, you only need to press a few buttons to pick the program
you want. The Pod continues to deliver insulin at those rates until
you change that program or switch to another one.
Check with your healthcare provider before adjusting these settings.
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings; then press Select.
2. Choose Basal programs (Figure 3-1), then press Select.
3. Choose [add new] (Figure 3-2), then press New.
4. To use the default naming system, simply press Next. The
default naming system automatically assigns program
names in numerical order, such as basal 1, basal 2, basal 3.
If you want to give a different name to the program:
a. Press the Up/Down Controller buttons to scroll through
the list of characters. An up-and-down arrow symbol on
the screen indicates the character you are changing.
17
Understanding and Adjusting Basal Rates
Figure 3-3
Figure 3-4
3
b. Press the middle Sof
move the underscore to the next character.
c. Enter each character one at a time. For example, if your
weekend schedule is different from your weekday schedule, you might enter W, e, e, k, e, n, d (Figure 3-3). (A blank
character or space is the first and last option in the scrolling menu.)
d. Press Next.
t Key (labeled with the right arrow) to
As a safety feature, the words “Invalid basal program
name” (Figure 3-4) appear if the name you entered
does not have at least one character or if the name is
being used for another basal program. Capitals and
lowercase letters are considered the same. Press OK
to return to the previous screen and enter a different
name.
5. Enter the rate, in U/hr, for the first basal segment (from 0.05 to
the maximum you entered during setup), then press Next.
6. Review the list showing your new basal program.
To use the same basal rate for the entire 24-hour program,
press Done and continue with step 7.
Or, to add basal segments and rates (for example, a higher
basal rate between 8:00 am and 3:00 pm):
a. Choose an existing basal segment, then press Edit.
Or, choose [add new], then press New.
b. Enter the start time (for example, 8:00 am), then press
Next. Basal segments are in 30-minute increments.
c. Enter the end time (for example, 3:00 pm), then press
Next.
d. Enter the rate for the new basal segment (for example,
0.80U/hr), then press Next.
18