Insulet 019 OmniPod PDM User Manual OmniPod UST400

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Mirror Download [FCC.gov]
Document ID	1529165
Application ID	vRacpdPbdl8fgDQA38hPmQ==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	460.82kB (5760197 bits)
Date Submitted	2011-08-24 00:00:00
Date Available	2011-08-24 00:00:00
Creation Date	2011-05-04 15:41:17
Producing Software	GPL Ghostscript 8.70
Document Lastmod	2011-05-10 12:23:32
Document Title	OmniPod UST400.book
Document Creator	PDFCreator Version 1.0.2
Document Author:	c_sullivan

Contacts and Important Information
Use the spaces below to record important health and product information.
Doctor
Health Insurance
Name
Name
Address
Address
Telephone and Fax
Telephone Number(s)
Email Address
Policy Number
Pharmacy
Nurse/Educator
Name
Name
Address
Address
Telephone and Fax
Telephone and Fax
Email Address
Email Address
OmniPod System Start Date: ____________________________
PDM Model: UST400 Serial Number: ____________________
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
© 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 . . . . . . . . . .
Insulin Delivery with the OmniPod System. . . . . . . . . . . . . . . . . . . . . .
How Does the OmniPod System Work? . . . . . . . . . . . . . . . . . . . . . . . . .
No tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Automated cannula insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A fully-integrated design with blood glucose monitoring . . . .
Suggested bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reference food library and carb presets . . . . . . . . . . . . . . . . . . . . . .
Record keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Personalizing your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Personal Diabetes Manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Buttons that program and control the OmniPod System . . . . .
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 . . . . . . . . . . . . . . . . . . . . . . . . . .
Select bolus increment and enter maximum bolus . . . . . . . . . .
Set extended bolus doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set low reservoir advisory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set expiration notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14
14
14
15
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
iv
Deliver a Normal Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deliver a bolus when suggested bolus calculator is On. . . . . .
Deliver a bolus manually (suggested bolus calc is Off). . . . . . .
Deliver an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deliver an extended bolus instead of a normal bolus. . . . . . . . . . .
Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Replace an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bolus Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Create a bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Enable an existing bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Change, rename, or delete a bolus preset . . . . . . . . . . . . . . . . . . .
Cancel an active bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Carb Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Create a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Change or edit a carb preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Delete a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reference Food Library. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Access the reference food library . . . . . . . . . . . . . . . . . . . . . . . . . . . .
31
31
33
34
34
36
36
37
38
38
39
39
39
39
40
41
42
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
Contents
Suspend Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Resume Insulin Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Avoid Infusion Site Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Get the Most From Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Water and your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safe storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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6 Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . .
The ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Insulin gauge and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PDM settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reset the time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reset the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Change Bolus and Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bolus calcs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ratios/factors/targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Temp basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bolus increment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alerts and Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set alerts and reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Change Blood Glucose Meter Settings . . . . . . . . . . . . . . . . . . . . . . . . .
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Change BG goal limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manage the blood glucose tags list . . . . . . . . . . . . . . . . . . . . . . . . .
Change BG sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Customize the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . .
Set PDM options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnostic options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set a Reminder to Vibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Get the Most from Your PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Keep it handy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Communicating with the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Water and your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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73
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75
7 Checking Your Blood Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Built-in FreeStyle® Blood Glucose Meter . . . . . . . . . . . . . . . . . . .
The FreeStyle® Blood Glucose Test Strips . . . . . . . . . . . . . . . . . . . . . . .
Important test strip information. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The FreeStyle® Control Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
When to perform a control solution test. . . . . . . . . . . . . . . . . . . . .
Check that the meter and test strips are working. . . . . . . . . . . .
Control solution expiration date. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ensure accurate control solution results. . . . . . . . . . . . . . . . . . . . .
Out-of-range control solution results. . . . . . . . . . . . . . . . . . . . . . . .
Performing a Control Solution Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Performing a blood glucose reading . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepare the lancing device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Contents
Insert the blood glucose test strip . . . . . . . . . . . . . . . . . . . . . . . . . . .
Set the blood glucose test strip code . . . . . . . . . . . . . . . . . . . . . . . .
Lance your finger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lance your forearm, upper arm, or hand. . . . . . . . . . . . . . . . . . . . .
Fill the blood glucose test strip with blood . . . . . . . . . . . . . . . . . .
Wait for the reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Remove the lancet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood Glucose Results and the Suggested Bolus
Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Entering Blood Glucose Readings Manually . . . . . . . . . . . . . . . . . . . .
Editing Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Low and High Blood Glucose Readings. . . . . . . . . . . . . . . . . . . . . . . . .
Low readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
High readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Important Health-Related Information . . . . . . . . . . . . . . . . . . . . . . . . .
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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
vi
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
Contents
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advisory Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hazard Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manual Shut-off of a Hazard Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . .
124
124
124
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accuracy Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flow rate from startup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flow rate error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Personal Diabetes Manager Specifications . . . . . . . . . . . . . . . . . . . .
Blood Glucose Meter Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . .
OmniPod System Label Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Personal Diabetes Manager Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OmniPod System Notice Concerning Interference . . . . . . . . . . . .
Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Customer Bill of Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mission Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Scope of Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply Shipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inquiries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAP Accredited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Customer’s Bill of Rights and Responsibilities. . . . . . . . . . . . . . .
Limited Warranty for the Personal Diabetes Manager . . . . . . . . .
HIPAA Privacy Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Uses and Disclosures of Medical Information. . . . . . . . . . . . . . .
Your Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Our Duties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
What To Do If You Have a Problem or Question . . . . . . . . . . . .
146
147
147
147
148
148
149
149
150
151
155
155
155
155
155
155
155
156
157
158
158
161
163
163
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
vii
Introduction
■ About This User Guide
Symbols
Symbol
viii
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.
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 Customer Care section of MyOmniPod.com to see the
most recent version and to find other helpful information.
Screen displays shown in this User Guide are for illustrative purposes only and should not be considered
suggestions for user settings. Consult with your healthcare provider to determine the appropriate settings for
you.
Introduction
Conventions and Terms
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.
Convention/Term Meaning
Icon
An image on the PDM screen that indicates a menu option or item of information. A table of screen icons appears in the
Appendices.
Soft keys
A row of three unlabeled buttons on the
PDM whose label or function appears on
the screen directly above the button. The
label changes depending on the task you
are performing.
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 requiring 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
System for:
• 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.
Introduction
Please read all the instructions provided in this User
Guide and practice the blood glucose testing procedures before using the System. Monitor your blood
glucose with the guidance of your healthcare provider. Undetected hyperglycemia or hypoglycemia
can result without proper monitoring.
If you are unable to use the System according to
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.
■ 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
xii
Your healthcare provider will give you all the tools and training
you need to be successful with the OmniPod Insulin Management System. However, in the end, your success depends on
YOU. You must become actively involved in your own diabetes
management to enjoy the outstanding control, freedom, and
flexibility that is possible with the OmniPod System.
Being actively involved means:
• Frequently monitoring blood glucose levels
• Learning how to operate your OmniPod System and practicing proper techniques
• Visiting your healthcare provider
Do NOT attempt to use the OmniPod® Insulin Management System before you receive training from
your healthcare provider. Inadequate training could
put your health and safety at risk.
CHAPTER 1
Your New OmniPod Insulin Management System
■ Insulin Delivery with the OmniPod System
The OmniPod® Insulin Management System is an innovative
continuous insulin delivery system that provides all the proven
benefits of 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 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.
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.
1 Your New OmniPod Insulin Management System
■ How Does the OmniPod System Work?
The Pod is a small, lightweight, self-adhesive device that you fill
with insulin and wear directly on your body. The Pod delivers
precise, personalized doses of insulin into your body through a
small flexible tube (called a cannula), based on instructions that
you program into its wireless companion, the Personal Diabetes
Manager. The cannula is inserted only once with each Pod.
The Personal Diabetes Manager (PDM) is a wireless, handheld
device 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.
Your New OmniPod Insulin Management System
You can also enter your own favorite foods, snacks, or entire
meals as “carb presets.” Presets contain the grams of carbohydrate in the food item or meal. Next time you eat this same food,
you don’t have to count the carbs; just select your carb preset
and the System does the calculating for you. The System stores
up to 36 carb presets.
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
1 Your New OmniPod Insulin Management System
■ The Pod
■ The Personal Diabetes Manager
The Pod (Figure 1-1) is applied to your skin with an adhesive
backing, similar to an adhesive bandage.
All Pod operations are programmed and controlled through the
palm-sized Personal Diabetes Manager (PDM; Figure 1-2).
Figure 1-1
Figure 1-2
USB Port
Top
LCD Screen
Bottom
Fill port
Soft Key
Label
Housing vent
Soft Keys
Viewing window
Adhesive
backing
User Info/
Support
Home/
Power
Needle cap
Test Strip Port
Up/Down
Controller
Your New OmniPod Insulin Management System
Buttons that program and control the OmniPod System
Button
Action
Home/
Power
Pressing and holding turns the PDM on and off.
When the PDM is on, pressing this button
(quickly/briefly) displays the Home screen, from
which you can choose a menu item or view the
Status screens (shown later in this chapter).
Up/Down
Controller
Pressing and releasing scrolls through a list of
available menu options or numbers, so you can
pick the one you want. Holding the button
scrolls faster.
Soft Keys
Soft key labels and functions depend on the
menu or screen you are viewing. The label
appears on the screen directly above the physical button you press. Select, Save, and Back are
just three examples of the soft key labels on your
PDM.
Button
User Info/
Support
Action
Pressing opens a User Info/Support screen that
displays additional information about the current screen you are viewing. The User Info/Support icon appears when additional information
can be viewed. It may be displayed at the top of
the screen, to the right of an event detail (such as
a suggested bolus), or to the right of a record
item (such as a BG history record). (See “Personal
Diabetes Manager Icons” in the Appendix).
In addition, pressing and holding this button for
2 seconds enables a “bright mode” on the PDM
screen.
1 Your New OmniPod Insulin Management System
Primary screens
Messages on the screen either:
• Let you identify your PDM
• Tell you how the System is operating
• List menu choices
• Explain how to perform certain tasks
The System’s primary screens are the ID screen (Figure 1-3), the
Status screen (Figure 1-4), and the Home screen (Figure 1-6 on
the next page).
Figure 1-3
Figure 1-4
ID screen
The System displays an ID screen to make the PDM easy to identify when you first turn it on. You can personalize the ID screen by
adding your name and choosing its color. (See 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
Your New OmniPod Insulin Management System
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
From the Status screen, press the User Info/Support button to
see details about the current insulin on board (IOB) in your
body (Figure 1-5). See page 30, for additional information
describing insulin on board (IOB).
Figure 1-5
Figure 1-6
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.
1 Your New OmniPod Insulin Management System
■ Safety Features
The OmniPod System’s state-of-the-art design includes the latest
safety technology. Its built-in safety features include:
Automatic priming, safety checks, and insertion
Every time you activate a new Pod, the System automatically
primes and performs a safety check on the Pod, then inserts
and primes the cannula (see Chapter 5, Using the Pod). Microprocessor technology makes it possible to complete thousands
of safety checks in only a few seconds.
The OmniPod System also performs safety checks on the PDM.
If it detects any problems in the PDM or the Pod—or in communication between them—it informs you with beeps and 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.
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 PreTraining 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® Insulin Management
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.
2 Getting Started
Turn on the PDM
1. Open the battery compartment on the back of the PDM
by pushing the compartment latch and lifting upward
(Figure 2-1). No special tools are necessary.
Figure 2-1
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.
Figure 2-2
■ The Setup Wizard
Hard
Reset
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.
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).
•
•
10
Press the Soft Key labeled Next, Select, Done, or Save to continue to the next screen.
Press Back to return to the previous screen.
Getting Started
You can adjust these settings later as your needs
change or as you fine-tune your OmniPod System.
To get started, press Next on the Wizard's Welcome Screen to
begin setting up your PDM.
Enter your PDM ID
1. Use the Up/Down Controller buttons to scroll through the
list of characters. An up-and-down-arrow symbol on the
screen indicates the character you are changing.
2. Press the middle Soft Key (labeled with the right arrow) to
move the underscore to the next character.
3. Enter each character one at a time. For example, if you want
to enter your name, you might enter J, a, n, e, [space], S, m, i, t,
h. (A blank character or space is the first and last option in the
scrolling menu.)
4. Press Next.
Select the ID screen color
1. Use the Up/Down Controller buttons to choose a color, then
press Next.
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.
Set date and time
1. Use the Up/Down Controller buttons to increase or
decrease the time. (Press 12/24hr if you prefer a different
time format.) Then press Next.
2. Enter the current year, then press Next.
3. Choose the current month, then press Next.
4. Enter the current day of the month, then press Next.
5. Choose the date format you prefer, then press Next.
Enter basal settings
1. Choose a maximum basal rate, then press Next. (The default
maximum basal rate is 3 U/hr.)
2. Choose the initial basal rate to use, then press Next.
The initial basal program created with the Setup Wizard is
named basal 1. You can change the name in the Settings >
Basal Programs menu (see Chapter 3, Understanding and
Adjusting Basal Rates).
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
2 Getting Started
6. Choose a temporary basal feature, then press Next. Choose
% to show temporary basal rates as a percent increase or
decrease of your current basal rate. Choose U/hr to show
temporary basal rates in units per hour. Or choose Off to turn
off the temporary basal feature. For details about setting temporary basals, see Chapter 3, Understanding and Adjusting
Basal Rates.
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.
12
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 settings, select the segment you wish to change and press Edit.
You can define up to 8 target BG time segments. To enter
additional segments, choose [add new], then:
a. Press New.
Getting Started
b. Enter a start time for the target BG segment, then press
Enter.
c. Enter an end time for the target BG segment, then press
Next.
d. Enter a target blood glucose value, then press Next.
Use the Up/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.
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/Down Controller buttons to enter your insulinto-carbohydrate ratio, then press Next. (Insulin-to-carbohydrate ratio is the number of carbs covered by 1 unit of insulin.)
2. To save the ratio, press Done. To change the ratio, select the
segment you wish to change and press Edit.
You can define up to 8 insulin-to-carbohydrate time segments. To enter additional ratios, choose [add new], then:
a. Press New.
b. Enter a start time for the segment, then press Next.
c. Enter an end time for the segment, then press Next.
d. Enter the insulin-to-carb ratio for the new time segment,
then press Next.
e. To save the new ratio, press Done.
3. To see the ratios as a list, press List. To return to the graphic
view, press Graph.
4. Press Save to accept the ratios you have set.
Enter correction factor
1. Use the Up/Down Controller buttons to enter how much
one unit of insulin decreases your blood glucose, then press
Next.
2. To save the correction factor, press Done. To change the
factor, select the segment you wish to change and press Edit.
You can define correction factors for up to 8 time segments.
To enter additional correction factors, choose [add new],
then:
13
2 Getting Started
a. Press New.
b. Enter a start time for the segment, then press Next.
c. Enter an end time for the segment, then press Next.
d. Enter the correction factor, then press Next.
e. To save the new correction factor segment, press Done.
3. To see the factors as a list, press List. To return to the graphic
view, press Graph.
4. Press Save to accept the correction factors you have set.
Set reverse correction
1. To set reverse correction, use the Up/Down Controller
buttons to choose On or Off, then press Next.
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.
14
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 % for percent of the total bolus, or choose Units for units of insulin. To
turn off the extended bolus feature, choose Off. Then press
Next.
Getting Started
Set low reservoir advisory
1. Choose the level of insulin in the reservoir at which the
PDM should give you an alarm. Choose from 10 to 50 units
in 5-unit increments, then press Next.
Set expiration notification
1. Choose the number of hours before a Pod expires when the
PDM should give you a notification, then press Next. The
values are in 1-hour increments and range from 1 to 24 hours.
(The default is 4 hours.)
The PDM asks whether you want to activate a Pod.
• Press 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.
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.
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.
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
In addition to normal daily changes, insulin needs can vary with
different routines or days of the week. For example, regular
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.
Figure 3-1
Figure 3-2
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
3 Understanding and Adjusting Basal Rates
b. Press the middle Soft Key (labeled with the right arrow) to
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.)
Figure 3-3
d. Press Next.
18
Figure 3-4
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.
Understanding and Adjusting Basal Rates
Basal rates outside the changed segment do not
change.
Figure 3-5
Figure 3-6
e. Repeat steps a–d for each new segment and rate you
want, then press Done.
Press and hold the Power button to turn the screen
back on. In some cases, if it has been less than 5
minutes since the screen timed out, pressing the
Power button returns you to the same screen you
were using. If it has been longer than 5 minutes, the
PDM brings you to the Status screen.
7. Review the graph of the new basal program (Figure 3-5).
8. To see the program as a list, press List (Figure 3-6). To see the
graph again, press Graph.
The total daily basal that will be delivered is shown at the
bottom of each “Basal programs” graph and list.
9. To add the program to the PDM’s memory, press Save.
Repeat steps 1 through 9 (above) for each basal program (up to 7
programs) you want to create.
Enable an existing basal program
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings; then press Select.
2. Choose Basal programs, then press Select.
19
3 Understanding and Adjusting Basal Rates
3. Choose the program you want from the list (Figure 3-7), then
press Enable.
A diamond icon (♦) appears next to the program that
is active. You cannot select the active program to
enable it, because it is already running.
Figure 3-7
4. Press Enable again to start the selected basal program. If a
Pod is active, the PDM beeps to indicate that the chosen
basal program is running.
As a safety feature, you cannot enable a new basal
program while a temporary basal program is in process (see “Temporary Basal Rates and Presets” later in
this chapter); you must first cancel the active temporary basal program.
Change, rename, copy, or delete a basal program
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings; then press Select.
2. Choose Basal programs, then press Select.
3. Choose a program from the list, then press Select.
To view the segments of the basal program
1. Choose View, then press Select (Figure 3-8).
20
Understanding and Adjusting Basal Rates
Figure 3-8
Figure 3-9
3. Enter a start time for the segment you want to change, then
press Next.
4. Enter an end time for this segment, then press Next.
5. Enter a basal rate for the new segment, then press Enter.
6. To save the newly entered segment into the basal program,
press Save (Figure 3-10). If you want to make additional edits,
repeat steps 2–5.
Figure 3-10
To edit or add a segment or rate in the basal program
1. Choose Edit, then press Select.
As a safety feature, you must suspend insulin delivery
before editing an active basal program (see Chapter
5, Using the Pod). Remember to resume delivery after
the edits are made.
2. Choose the segment to change, then press Edit (Figure 3-9).
Or, choose [add new], then press New.
7. To see the program as a list, press List. To see the graph again,
press Graph.
21
3 Understanding and Adjusting Basal Rates
To rename a basal program
1. After choosing a program from the list, choose Rename, then
press Select.
2. Press the Up/Down Controller buttons to enter the characters that spell out the new name you want. Press the middle
soft key (labeled with the right arrow) to move the underscore to the next character, then press Save.
To delete a basal program
1. After choosing a program from the list, choose Delete and
then press Select.
2. Press Delete to permanently delete the program.
To copy a basal program
1. After choosing a program from the list, choose Copy, then
press Select.
2. Press the Up/Down Controller buttons to enter the characters that spell out the name you want for the copied file. Press
the middle soft key (labeled with the right arrow) to move the
underscore to the next character, then press Next.
3. To use the same basal program for the entire 24-hour period,
press Save.
To edit or add segments to the newly copied basal program, follow the steps under “To edit or add a segment or rate in the basal
program” earlier in this chapter.
■ Temporary Basal Rates and Presets
Instead of suspending, changing, and then resuming
the active basal program, try this: Copy the active
program, rename it, make the changes, save it, then
enable it.
22
As a safety feature, you cannot delete the active basal
program.
What is a temporary basal rate?
A temporary basal rate lets you adjust your basal rate for a predetermined period of time.
On occasion, you may need to change the active basal rate for
only a short time. For example, if you are going cross-country
skiing for several hours, you may want to lower the basal rate
during and after you exercise. This is called a “one-time temporary basal rate.”
Some temporary changes are easy to predict and respond to.
They happen routinely and you may know from experience how
they affect your insulin needs. For example, you might take the
same exercise class twice a week for a few weeks or months, or
Understanding and Adjusting Basal Rates
join a summer soccer league. For women, a monthly hormonal
change that affects blood glucose is an example of predictable
change. To easily handle predictable, short-term changes, you
can “preset” a temporary basal rate, so it is ready whenever you
need it. The PDM can remember up to 7 temporary basal presets.
You can set a temporary basal rate for a duration of 30 minutes to
12 hours. Once the time limit is reached, the PDM automatically
returns to the active basal program.
When using units per hour, the OmniPod System allows you to
set temporary basal rates from 0.0 U/hr, up to your max basal
rate. When using percent rate, you can set temporary basal rates
from -100% to +95% of your active rate, as long as the temporary
rate is less than or equal to your max basal rate.
See the sections below on creating, enabling, cancelling, and
changing temporary basal presets.
Enable a one-time temporary basal rate
1. On the Home screen, use the Up/Down Controller buttons
to choose Temp basal, then press Select.
2. If you have created temp basal presets, choose [enter manually] from the list, then press Select.
If you have not created any temp basal presets, the PDM skips
this step.
3. Enter the temporary basal rate in either units per hour (Figure
3-11) or percent change (Figure 3-12), depending on how
you choose to show the rates, then press Enter.
Figure 3-11
Figure 3-12
During initial setup, you and your healthcare provider
either turned Off temporary basal rates, or chose to
show the rates as % or U/hr. To change this setting, see
Chapter 6, Using the Personal Diabetes Manager.
4. Enter the duration for the temporary rate, then press Enter.
5. Press Confirm to start the temporary basal rate shown on the
screen. The Pod beeps to indicate that the temporary basal
rate is running.
23
3 Understanding and Adjusting Basal Rates
Cancel a one-time temporary basal rate
1. On the Home screen, use the Up/Down Controller buttons
to choose Suspend/cancel, then press Select.
2. Choose Cancel temp basal (Figure 3-13), then press Select.
Figure 3-13
3. Press Confirm to cancel the temporary basal shown on the
screen.
Create a temporary basal preset
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose Presets, then press Select.
3. Choose Temp basal presets, then press Select.
4. Choose [add new], then press New.
5. To use the OmniPod System’s default naming system, simply
press Next. The default naming system automatically assigns
program names in numerical order, such as temp basal 1,
temp basal 2, temp basal 3.
Or, 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.
b. Press the middle Soft Key to move the underscore to the
next character.
c. Enter each character one at a time. For example, if you
take an aerobics class two nights a week, you might enter
A, e, r, o, b, i, c, s (Figure 3-14 on the next page). (A blank
character or space is the first and last option in the scrolling menu.)
Capitals and lowercase letters are considered the
same.
24
Understanding and Adjusting Basal Rates
Figure 3-14
Enable an existing temporary basal preset
1. On the Home screen, use the Up/Down Controller buttons
to choose Temp basal, then press Select.
2. Choose the temporary basal preset you want to use from the
list (Figure 3-15), then press Select.
Figure 3-15
d. Press Next.
6. Enter the new temporary basal rate (or percent change), then
press Next.
7. Enter the duration of the temporary basal rate, from 0.5 hours
to 12 hours, then press Next.
8. Review the temporary basal name, rate, and duration, then
press Save to accept it.
Figure 3-16
3. If you want, change the duration for the temporary rate, in
half-hour increments, then press Enter (Figure 3-16).
4. Press Confirm to begin the temporary basal rate shown on
the screen. The Pod beeps to indicate that the chosen temporary basal preset is running.
25
3 Understanding and Adjusting Basal Rates
Cancel an active temporary basal preset
1. On the Home screen, use the Up/Down Controller buttons
to choose Suspend/cancel;, then press Select.
2. Choose Cancel temp basal, then press Select.
3. Press Confirm to cancel the actively running temporary
basal preset.
To change a temporary basal preset
1. Choose Edit, then press Select (Figure 3-17).
Figure 3-17
If you suspend insulin delivery while a temp basal is
running, the temp basal will be cancelled when you
suspend.
Change, rename, or delete a temporary basal preset
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose Presets, then press Select.
3. Choose Temp basal presets, then press Select.
4. Choose a temporary preset from the list, then press Edit.
You cannot edit, change, or delete a temporary basal
preset that is actively running.
26
2. Enter a new rate (or new percent change), for the preset,
then press Next.
3. Enter a new duration for the preset, then press Save.
4. Press Done.
Understanding and Adjusting Basal Rates
To rename a temporary basal preset
1. Choose Rename, then press Select.
2. Press the Up/Down Controller buttons to enter the characters that spell out the name you want, then press Save.
3. Press Done.
To delete a temporary basal preset
1. Choose Delete, then press Select.
2. Press Delete to permanently delete the preset.
■ Maximum Basal Rate
What is the maximum basal rate?
The maximum basal rate is a safety feature that limits the basal
rate (U/hr) that the Pod can deliver. Once you enter it into the
PDM memory, the maximum applies to both regular basal programs and temporary basal rates.
You and your healthcare provider will enter an initial maximum
basal rate into your PDM during the setup process (see Chapter
2, Getting Started). You can change it later as you fine-tune your
System settings or when your needs change.
Change the maximum basal rate
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose System setup, then press Select.
3. Choose Bolus/basal/calcs, then press Select.
4. Choose Max basal, then press Select.
5. Enter a new maximum basal rate, then press Enter.
27
CHAPTER 4
Understanding and Delivering Bolus Doses
■ What Is a Bolus?
A bolus is an extra dose of insulin, delivered when needed to:
• Match the carbohydrates (sugar content) in a meal or snack—
also known as a meal bolus
• Lower blood glucose when it gets too high—also known as a
correction bolus
This extra dose is in addition to the basal rate delivered throughout the day and night (see Chapter 3, Understanding and
Adjusting Basal Rates).
The size of a bolus dose depends on the current factors at the
time you deliver the bolus:
• Your blood glucose level
• Your insulin-to-carbohydrate ratio
• Your correction factor
• Your target blood glucose and correct above threshold
• The amount of insulin on board (IOB) (active insulin) from previous meal and correction boluses
28
•
Your correction threshold, the BG level above which you
would like to take insulin to reduce an elevated blood
glucose
• Your activity level
• The type and amount of food you eat
With the OmniPod System, it is easy to adapt to any situation.
With just a few button presses, you can adjust to unexpected or
changing insulin needs.
During setup, you entered bolus dose settings in the PDM (see
Chapter 2, Getting Started). You can adjust these settings as you
fine-tune your System or when your needs change (see Chapter
6, Using the Personal Diabetes Manager).
Check with your healthcare provider before adjusting these settings.
Understanding and Delivering Bolus Doses
■ Bolus Dose Options
■ Suggested Bolus Calculator
So that you can fully enjoy freedom and flexibility in your life, the
OmniPod System offers the following bolus dose options:
Suggested bolus calculator: When you want the System to
calculate your suggested bolus, based on your personal settings,
your current blood glucose, the amount of insulin still active in
your body from previous boluses, and the grams of carbohydrate (“carbs” for short) you are about to eat.
Normal bolus: When you need a dose of insulin right away to
cover a meal or snack you are about to eat or to reduce a high
blood glucose level
Extended bolus: When you are eating high-fat or high-protein
foods (which take longer to digest and are slower to affect blood
glucose), or when you are eating for an extended period (for
example, at a party or during a holiday meal).
The suggested bolus calculator lets the OmniPod System recommend your bolus based on your personal settings. To review or
adjust these settings—including turning the suggested bolus
calculator On or Off—see Chapter 6, Using the Personal Diabetes Manager.
If the suggested bolus calculator is turned On, the System
automatically calculates a bolus dose. If the suggested bolus
calculator is turned Off, you must enter a bolus amount
manually.
The bolus features in the OmniPod System are designed
for flexibility and convenience. You can easily transition
from a normal to an extended bolus with just a few
button presses.
The suggested bolus calculator will display a suggested bolus dose based on the settings you have
programmed into the PDM. Check with your healthcare provider before using this feature or adjusting
these settings.
If a suggested bolus exceeds the max bolus you
have set, the suggested bolus screen displays
“Exceeds max bolus.” (Figure 4-1 on next page) If you
select Extend or Enter, the following confirmation is
displayed “WARNING: Exceeds max bolus of nn.nn U.
Accept this bolus and temporarily override your
limit?" (Figure 4-2 on next page). Consult your
healthcare provider before changing the setting.
29
4 Understanding and Delivering Bolus Doses
Figure 4-1
Figure 4-2
How a suggested bolus is calculated
The suggested bolus calculator estimates the suggested amount
for each bolus portion based on your personal settings and
inputs.
The settings used to calculate a suggested bolus are:
• Target BG
• Insulin-to-carbohydrate (IC) ratio
• Correction factor (CF)
• Duration of insulin action
30
The inputs used to calculate a suggested bolus are:
• current BG
• carbs entered
• insulin on board (IOB)
A suggested bolus can have a correction bolus only, a meal bolus
only, or both.
Correction bolus: The correction bolus, as the name suggests,
“corrects” for a blood glucose (BG) level above your target BG
level.
Meal bolus: The meal bolus provides insulin for the carbohydrates you enter into the System.
Insulin on board (IOB): Insulin on Board (IOB) the amount of
insulin still working in your body from previous meal and correction boluses. The amount of time the insulin remains “on board”
or “active” depends on what you set for your duration of insulin
action.
The OmniPod System can only subtract insulin on board
(IOB) from a suggested bolus when the current BG is
known.
For formulas for each element of the suggested bolus calculation, detailed examples, and additional guidelines of how the
suggested bolus calculator works, see the Appendix.
Understanding and Delivering Bolus Doses
■ Deliver a Normal Bolus
Deliver a bolus when suggested bolus calculator is On
1. After you check your blood glucose, the PDM displays the
results (Figure 4-3; see the end of Chapter 7, Checking Your
Blood Glucose). Press Next.
Figure 4-3
A blood glucose value is current for up to 10 minutes
after it is tested. So you can wait up to 10 minutes,
restart the bolus process, and not have to retest your
blood glucose in order to include it in the suggested
bolus calculator.
When your blood glucose result reads “HIGH” or
“LOW,” the suggested bolus calculator will be
disabled.
If you use a separate blood glucose meter—not the
Personal Diabetes Manager (PDM)—you will need to
enter your blood glucose manually. On the Home
screen, choose Bolus, then press Select. Use the Up/
Down Controller buttons to enter your current BG
value, then press Yes if you want this value to be used
by the suggested bolus calculator.
You can also enter a BG manually by choosing the
More actions menu, then choosing Add BG Reading. See the end of Chapter 7, Checking Your Blood
Glucose.
31
4 Understanding and Delivering Bolus Doses
2. If you are not going to eat now, press No (Figure 4-4). The
Suggested Bolus screen appears (Figure 4-5). Press Enter to
accept the suggested bolus.
Or, if you wish, press the Up/Down Controller buttons to
increase or decrease the suggested bolus. Then press Enter
to accept the bolus.
Figure 4-4
Figure 4-5
In the Suggested Bolus screen (Figure 4-5), “adjusted
for Insulin on Board (IOB)” appears only when Insulin
on Board (IOB) is a factor in the calculation.
32
To view detailed information about the calculations used for this suggested bolus, press the User
Info/Support button and scroll through the information screens. Press Close to return to the
Suggested Bolus screen.
3. If you are going to eat now:
a. Press Yes (Figure 4-5), enter the number of carbohydrates
you are about to eat, then press Enter.
If you’ve previously entered a carb preset, then either:
• Use the Up/Down Controller buttons to choose
[enter manually], then press Select. Enter the number of carbohydrates that you are going to eat, then
press Enter.
• Use the Up/Down Controller buttons to choose
favorites, snacks, or meals. From there, select a carb
preset you have previously entered (see “Carb Presets”
later in this chapter), then press Select.
b. Press Enter to accept the suggested bolus (Figure 4-6 on
the following page).
Or press the User Info/Support Soft Key (?) button to view
calculation information used for this suggested bolus.
Press Close to return to the Suggested Bolus screen,
then press Enter.
Understanding and Delivering Bolus Doses
Figure 4-6
If the reverse correction feature is turned On and if
your blood glucose level is below your target, the
System subtracts a correction amount from the meal
portion of the bolus.
If the reverse correction setting is turned Off, the
System does not subtract anything for a blood glucose level below your target.
4. If you have set the blood glucose reminder option to On and
you want to add a reminder:
a. Press Yes.
b. Enter the time for the reminder, then press OK.
5. Press Confirm to begin the bolus delivery.
Deliver a bolus manually (suggested bolus calc is Off)
1. On the Home screen, use the Up/Down Controller buttons
to choose Bolus, then press Select.
2. Enter the number of units you want to deliver, then press
Enter.
3. If the blood glucose reminders feature is turned On, you can
now set a blood glucose reminder.
4. Press Confirm to begin the bolus delivery.
As a safety feature, the OmniPod System only allows
you to give a bolus at or below the maximum bolus
dose you have set. See Chapter 6, Using the Personal
Diabetes Manager, for information on resetting your
maximum bolus dose. If suggested bolus calc is On,
you can enter a temporary manual override to make
an adjustment above your max bolus limit (Figure 4-1
and Figure 4-2). Consult your healthcare provider
before changing this setting.
33
4 Understanding and Delivering Bolus Doses
■ Deliver an Extended Bolus
The extended bolus feature lets the OmniPod System deliver
some (or no) insulin now and the remainder over a period of
time you choose.
Deliver an extended bolus instead of a normal bolus
1. After you get your suggested bolus, press Extend instead of
Enter (see Figure 4-7).
If you have set the Extended bolus option to Off,
the PDM will not display the Extend Soft Key. For
information on turning this feature On and Off see
Chapter 6, Using the Personal Diabetes Manager.
2. Enter the units of insulin or percentage of the bolus that you
want to take immediately (Figure 4-8), then press Enter.
Figure 4-8
Figure 4-7
To learn how to set extended boluses in percentages
or units, see Chapter 6, Using the Personal Diabetes
Manager.
34
Understanding and Delivering Bolus Doses
3. Enter the time (up to 8 hours, in 30-minute increments) over
which to deliver the remainder of the bolus, then press Enter
(Figure 4-9). In Figure 4-10 you can see a detailed view of the
extended bolus.
Figure 4-9
Figure 4-10
4. If the blood glucose reminders feature is turned On, you
can now set a blood glucose reminder.
5. Press Confirm to begin the bolus delivery.
As a safety feature, the correction bolus is always
delivered first and cannot be extended. Only the
meal bolus can be extended. For example:
Total bolus = 5 units
Correction bolus
1 unit
Meal bolus
4 units
Deliver now = 2 units
correction bolus
1 unit
meal bolus
1 unit
Extend = 3 units
meal portion
3 units
As a safety feature, you cannot deliver two extended
boluses at the same time. You can, however, cancel
the first extended bolus and replace it with another
(see “Replace an Extended Bolus” on page 36). You
can deliver a normal bolus while an extended bolus is
being delivered.
35
4 Understanding and Delivering Bolus Doses
■ Cancel Active Boluses
The OmniPod System is extremely flexible, so you can use it to
respond to your changing insulin needs. It is easy to cancel an
active bolus (one that is currently being delivered), even after
insulin delivery has started.
1. To check the Pod status, refer to Page 54 for detailed instructions. The ID screen must be confirmed before you can check
Pod status. An on-screen message appears for as long as a
normal bolus is being delivered (Figure 4-11).
Figure 4-11
Figure 4-12
If the bolus has already been completely delivered,
the “Delivering bolus” message and Cancel do not
appear, but the Status screen does appear.
2. Press Cancel.
The Pod beeps to confirm the bolus is cancelled. An on-screen
message tells you how much insulin was delivered before
you cancelled the bolus (Figure 4-12).
3. Press OK to return to the Status screen.
If your suggested bolus contains both a correction
bolus and a meal bolus, the correction bolus is always
delivered first.
■ Replace an Extended Bolus
You can replace one extended bolus with another. The System
tells you how much of the first bolus has not yet been delivered.
1. After you see your suggested bolus, press Extend instead of
Enter (see Figure 4-7 on Page 34).
36
Understanding and Delivering Bolus Doses
2. Press Yes to cancel the active extended bolus (Figure 4-13).
Or press Back to return to the Suggested Meal Bolus screen.
Figure 4-13
Figure 4-15
Figure 4-14
■ Bolus Presets
3. Press Confirm (Figure 4-14).
4. The screen displays the amount of the old extended bolus
that has yet to be delivered (Figure 4-15). Press Next to return
to the Suggested Meal Bolus screen.
You can add what remained of the old extended
bolus to the new one.
Bolus presets are bolus amounts that you program for frequent
use. For example, if you often take the same bolus at lunchtime,
you can create a bolus preset for that amount and name it
“Lunch.”
Bolus presets are available only when the suggested
bolus calculator feature is turned Off. (If the suggested
bolus calculator is turned On, you can still use carb presets. See “Carb Presets” on Page 39.)
37
4 Understanding and Delivering Bolus Doses
Create a bolus preset
1. On the Home screen use the Up/Down Controller buttons
to choose Settings; then press Select.
2. Choose Presets, then press Select.
3. Choose Bolus presets, then press Select.
4. Choose [add new], then press New.
5. To use the OmniPod System’s default naming system, simply
press Next. The default naming system automatically assigns
program names in numerical order, such as bolus 1, bolus 2,
bolus 3.
Or, to give a different name to the program:
a. Press the Up/Down Controller buttons to enter the characters that spell the name you want. An up and down
arrow symbol on the screen indicates which character
you are changing.
b. Press the middle Soft Key (labeled with the right arrow) to
move the underscore to the next character.
c. Enter each character one at a time. For example, if you
frequently take the same bolus at lunchtime, you might
enter L, u, n, c, h (Figure 4-16).
d. Press Next.
6. Enter the new bolus preset amount, up to the maximum
bolus you entered during setup; then press Next.
38
Figure 4-16
Figure 4-17
7. Review the bolus preset name and amount, then press Save
to accept it.
Enable an existing bolus preset
1. On the Home screen, use the Up/Down Controller buttons
to choose Bolus; then press Select.
2. Choose the bolus preset you want to use from the list (Figure
4-17), then press Select.
3. Press Enter to confirm the bolus preset amount, or, if necessary, use the Up/Down Controller buttons to adjust the
bolus amount.
Understanding and Delivering Bolus Doses
4. Press Confirm to deliver the bolus shown on the screen.
Change, rename, or delete a bolus preset
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose Presets, then press Select.
3. Choose Bolus presets, then press Select.
4. Choose a preset from the list, then press Edit.
Change a bolus preset
1. Choose Edit, then press Select.
2. Enter a new insulin amount for the bolus, then press Save.
Rename a bolus preset
1. Choose Rename, then press Select.
2. Press the Up/Down Controller buttons to enter the characters that spell out the name you want,then press Next.
Delete a bolus preset
1. Choose Delete, and then press Select.
2. Press Delete to permanently delete the preset.
Cancel an active bolus preset
1. Press and hold the Power button to turn on the PDM (To
check the Pod status, refer to Page 54 for detailed instructions. The ID screen must be confirmed before you can check
Pod status.), if it is not already on. An on-screen message
appears as long as a bolus is being delivered.
2. Press Cancel.
The Pod beeps to confirm the bolus is cancelled. An on-screen
message tells you how much insulin was delivered before
you cancelled the bolus.
3. Press OK to return to the Status screen.
For more details, see “Cancel Active Boluses” earlier in this
chapter.
■ Carb Presets
Carb presets are favorite food items, snacks, or meals that you eat
frequently. After you enter these items, you can quickly select
one when entering carb amounts during the suggested bolus
calculator process.
Create a carb preset
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings;,then press Select.
2. Choose Presets, then press Select.
3. Choose Carb presets, then press Select.
4. Choose the category for this carb preset: (Favorites, Snacks,
or Meals), then press Select.
5. Choose [add new], then press New.
39
4 Understanding and Delivering Bolus Doses
6. To use the OmniPod System’s default naming system, simply
press Next. The default naming system automatically assigns
program names in numerical order, such as carb preset 1,
carb preset 2, carb preset 3.
Or, to give a different name to the program:
a. Press the Up/Down Controller buttons to enter the characters that spell the name you want. An up and down
arrow symbol on the screen indicates the character you
are changing.
b. Press the middle Soft Key (the right arrow) to move the
underscore to the next character.
c. Enter each character one at a time. For example, if you
frequently eat a breakfast consisting of plain low-fat
yogurt with blueberries, sweetener, and cinnamon, you
might enter
B, l, u, e, [space], Y, o, g, u, r, t (Figure 4-18).
d. Press Next.
7. Enter the grams of carbohydrate in the meal, then press Next.
8. If you want, enter the grams of fiber, fat, and protein in the
meal, and the total calories. Press Next after each entry.
These additional units are not required. If you prefer not
to enter them, simply press Next repeatedly to skip
through the screens.
40
Figure 4-18
If you do include grams of fiber in step 8 to the left, the
suggested bolus calculator uses carbs minus fiber. Alternatively, in step 7, you can enter the total grams of carbs
minus the fiber yourself. Your healthcare provider can
best advise you on how to make this entry.
9. Press Save to add the preset to the category.
Change or edit a carb preset
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose Presets, then press Select.
Understanding and Delivering Bolus Doses
3. Choose Carb presets, then press Select.
4. Choose the category of the preset you want to change, then
press Select (Figure 4-19).
Figure 4-19
Figure 4-20
3. To rename the carb preset, press the Up/Down Controller
buttons to enter the characters that spell out the name you
want, then press Next.
To “erase” characters, press either Up or Down until you reach
the end of the characters, which gives you the option to
choose a blank space.
4. Enter the grams of carbohydrate in the meal, then press Next.
5. If you want, enter the grams of fiber, fat, and protein in the
meal, and the total calories. Press Next after each entry.
These additional units are not required. If you prefer
not to enter them, simply press Next repeatedly to
skip through the screens.
6. Press Save to update the preset.
To change the category for a carb preset
1. Choose the carb preset you want to move to another category, then press Tag (Figure 4-20).
2. Choose a new category, then press Select.
To edit a carb preset
1. Choose the carb preset you want to change, then press Edit.
2. Press Edit again on the next screen.
Delete a carb preset
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose Presets, then press Select.
3. Choose Carb presets, then press Select.
4. Choose the category of the preset you want to change, then
press Select.
5. Choose the carb preset you want to delete, then press Edit.
6. Press Delete.
7. Press Delete again to permanently delete the preset.
41
4 Understanding and Delivering Bolus Doses
■ Reference Food Library
Figure 4-21a
Figure 4-21b
The Food Library is for reference only. (Food references contained in the library cannot be populated
and used for calculations.)
The OmniPod System includes a reference library of over 1,000
common food items. The library shows each item’s grams or carbohydrate, fat, protein, and fiber values , and calories for a single
portion. You can use this information to determine the carbs for
a meal or snack you are going to eat. You can also use it to help
you create carb presets for your favorite meals.
The items in the food library are derived from the USDA database, USDA National Nutrient Database for Standard Reference.
Access the reference food library
1. On the Home screen, use the Up/Down Controller buttons
to choose More actions, then press Select.
2. Choose Food library, then press Select.
The screen displays a list of main food categories (Figure 4-21a
and Figure 4-21b).
3. To choose directly from the food categories, choose a main
category, then press Select. Choose a subcategory, then
press Select. Choose a food item from the subcategory, then
press View.
42
4. To choose from an alphabetical list of foods, press Index.
Enter the first letter of the food item, then press Select.
Choose a food item from the alphabetical list, then press
View.
The screen displays the food item’s:
• Name
• Serving size
• Grams of carbohydrate, fiber, fat, and protein
• Total calories
5. Press OK to return to the list of main food categories.
CHAPTER 5
Using the Pod
■ The Pod Change Process
Replace the Pod at least once every 48–72 hours or up to 200
units of insulin (2–3 days). Refer to the insulin labeling and follow your healthcare provider’s directions for how often to replace
your Pod. If you like, you can set the Personal Diabetes Manager
(PDM) to notify you when it is time to replace the Pod (see Chapter 6, Using the Personal Diabetes Manager).
•
•
WARNINGS!
•
•
•
Do NOT apply or use a Pod if the sterile packaging is open or
damaged, or if the pad has been dropped after removal from
the package as this may increase the risk of infection. Pods
are sterile unless packaging has been opened or damaged.
Do NOT apply or use a Pod if it is damaged in any way. A damaged Pod may not work properly.
To minimize the possibility of site infection, do NOT apply a
Pod without first using aseptic technique. This means to:
• wash your hands
•
•
• clean the insulin vial with an alcohol prep swab
• clean the infusion site with soap and water
• keep sterile materials away from any possible germs
Do NOT use a Pod if you are sensitive to or have allergies to
acrylic adhesives, or have fragile or easily damaged skin.
Check often to make sure the Pod and soft cannula are
securely attached and in place. A loose or dislodged cannula
may interrupt insulin delivery. Verify there is no wetness or
scent of insulin, where as may indicate the cannula has dislodged.
Do NOT apply a new Pod until you have deactivated and
removed the old Pod. A Pod that has not been deactivated
properly may continue to deliver insulin as programmed, putting you at risk of over infusion and possible hypoglycemia.
Because insulin Pods use only rapid-acting insulin, users are
at increased risk for developing hyperglycemia (high blood
glucose) if insulin delivery is interrupted. If it is untreated,
severe hyperglycemia can quickly lead to diabetic ketoacidosis (DKA). DKA can cause symptoms such as breathing difficul-
43
5 Using the Pod
ties, shock, coma, or death. If insulin delivery is interrupted for
any reason, you may need to replace the missing insulin usually with an injection of rapid-acting insulin. Ask your healthcare provider for instructions on handling interrupted insulin
delivery.
Gather equipment and supplies
Gather the following before you begin:
• A vial of rapid-acting U-100 insulin (See the warning on
page x of the Introduction for a list of insulins approved for
use in the OmniPod System.)
Deactivate the current Pod
1. On the Home screen, use the Up/Down Controller buttons
to choose More actions, then press Select.
2. Choose Change Pod (Figure 5-1), then press Select.
3. Press Confirm (Figure 5-2) to deactivate the current Pod.
Figure 5-1
Figure 5-2
NEVER use insulin that is cloudy; it may be old or inactive. Failure to use rapid-acting U-100 insulin, or using
insulin that is expired or inactive, may lead to hyperglycemia or diabetic ketoacidosis (DKA).
•
•
An unopened Pod
AN alcohol prep swab
If you are a first-time OmniPod System user, your
healthcare provider will guide you through the steps
for initializing and applying your first Pod. Do NOT
attempt to apply or use a Pod until you have been
trained by your healthcare provider. Use of the System with inadequate training or improper setup
could put your health and safety at risk.
44
4. If an extended bolus or temporary basal or both are actively
running, you will see the message in Figure 5-3 on the next
page. Press Confirm to accept the cancellation.
Or press Back to return to the More actions menu.
Using the Pod
5. After you press Confirm, you will see the message in
Figure 5-4 on the next page.
To remove the old Pod:
a. Gently lift the edges of the adhesive tape from your skin
and remove the entire Pod (Figure 5-3).
Removing the Pod slowly will help to avoid
possible skin irritation.
b. Use soap and water to remove any adhesive that remains
on the skin or, if necessary, use an adhesive remover.
c. Discard the used Pod according to local waste disposal
regulations.
Figure 5-3
Figure 5-4
Check the infusion site for signs of infection.
See “Avoid Infusion Site Infections” later in this
chapter.
6. After removing the old Pod, press Next (Figure 5-4).
7. Press Yes to fill and activate a new Pod (Figure 5-4).
Fill a new Pod
Before filling a Pod, ensure that no other Pods are
being activated within 24 inches of your PDM.
Before filling a Pod with insulin, ensure that the Pod
is above 50° Fahrenheit (10° Celsius). If the Pod has
been exposed to temperatures below 50° F (10° C),
then allow the Pod to be brought back to room temperature before filling it with insulin.
1. Use an alcohol prep swab to clean the top of the insulin vial,
then discard the prep swab.
2. Securely twist the fill needle onto the syringe (Figure 5-5, on
the next page).
3. Pull outward to remove the protective cap from the needle
(Figure 5-6, on the next page). Save the cap; you will need it
later.
45
5 Using the Pod
Use care after removing the needle cap and
exposing the fill needle.
Figure 5-5
Figure 5-6
Only use room temperature insulin when filling
the Pod.
4. Determine the amount of insulin you need to insert into the
Pod. For example, if you will use this Pod for 48 hours, you
need enough insulin to last you 48 hours. Your healthcare
provider will help you determine the correct amount.
The Pod requires a minimum of 85 units of insulin to
begin operation.
The Pod can deliver up to 200 units of insulin.
5. Draw air into the syringe up to the amount of insulin you
want.
6. Insert the needle into the insulin vial and inject the air. This
makes it easier to withdraw insulin from the vial.
7. Turn the vial and syringe upside down. Withdraw insulin from
the vial into the syringe, expelling any and all air or air bubbles. Fill at least to the MIN (minimum) fill line (Figure 5-5).
Refer to the Care Giver Guide as an additional reference.
46
Fill
port
Make sure there is no air in the syringe before
attempting to fill a Pod with insulin.
8. Remove the needle from the vial and insert it straight down
into the insulin fill port on the underside of the Pod
(Figure 5-6).
Be sure to only insert the fill syringe into the fill
port. Attempting to inject insulin into any other
location on the Pod may result in damage to the
Pod or loss of insulin.
Using the Pod
To ensure proper fill, do not insert the fill syringe
at an angle into the fill port.
Do not insert the fill syringe into the fill port more
than once.
Do not use any other type of needle or filling
device besides the syringe provided with each
Pod.
NEVER inject air into the fill port. Doing so may
result in unintended or interrupted insulin delivery.
9. Depress the syringe plunger to completely empty the insulin
into the Pod. The Pod will beep, indicating that the System is
ready to proceed to the next step.
NEVER use a Pod if you hear a crackling noise or
feel resistance when you depress the plunger.
These conditions can result in interrupted insulin
delivery of insulin.
10. Remove the needle from the insulin fill port. The port is selfsealing; insulin will not leak after the needle is removed.
11. Place the protective cap back on the needle and remove the
needle from the syringe.
The fill syringe is intended for single use only and
should be used only with the OmniPod System.
12. After you fill the Pod, it will beep twice. After hearing the
beeps, PDM and pod should be adjacent and touching,
either in or out of tray to ensure proper communication
during priming (Figure 5-7, on the next page). Press Next.
As a safety feature, the communication distance between the Pod and PDM is reduced during activation.
Once a Pod is primed and communicates with the
PDM, the full communication range is restored and
the Pod can receive commands only from that PDM.
13. The Pod will only beep if you have filled it with at least 85 units
of insulin. If you have filled the Pod with more than 85 units
and still do not hear the 2 beeps, call Customer Care.
14. The System performs a series of safety checks and automatically primes the Pod (Figure 5-8). Once complete, the PDM
beeps, letting you know that the priming and safety checks
were successful.
47
5 Using the Pod
Figure 5-7
Figure 5-8
Select the infusion site
Before applying a new Pod, you must first select an appropriate
infusion site. Due to ease of access and viewing, the abdomen is
often used. Your healthcare provider may suggest other potential sites that, like the abdomen, typically have a layer of fatty
tissue, such as the hip, back of upper arm, upper thigh, or lower
back (Figure 5-9 and Figure 5-10, on the next page).
Avoid sites where belts, waistbands, or tight clothing
may rub against, disturb, or dislodge the Pod. Also
avoid sites where the Pod will be affected by folds of
skin.
After filling the Pod with insulin, you should complete
the Pod change process within 60 minutes. As a
reminder that the Pod has been filled, it will beep
every 5 minutes to indicate that time is passing. If you
do not set up the Pod within 60 minutes, you must
deactivate and discard it.
Once a Pod is activated and communicates with the
PDM, it can only receive commands from that PDM,
not from any other.
48
Change the site each time you apply a new Pod. A
new infusion site should be at least 1" away from the
last site. (Using the same location repeatedly may
reduce insulin absorption.)
Do NOT apply the Pod within 2" of your navel or over
a mole or scar, where insulin absorption may be
reduced.
Using the Pod
Figure 5-9: Adult/Youth
Figure 5-10: Toddler
Front
Back
Front
Back
49
5 Using the Pod
To help avoid condensation from occurring in the
viewing window, make sure both your Pod and your
insulin are at room temperature.
Figure 5-11
Figure 5-12
You can reduce the risk of infection at the infusion site by following aseptic technique and disinfecting the infusion site. Before
applying a new Pod, always:
1. Wash hands with soap and water.
2. Use soap to wash the infusion site.
Antibacterial soap may irritate skin, especially at the
infusion site. Ask your healthcare provider how to
treat any skin irritation.
3. Dry the site with a clean towel.
4. Use an alcohol prep swab to disinfect the infusion site. Start at
the center of the site and gently rub outward in a circular
motion.
5. Let the site air-dry thoroughly. Do not blow on the site to dry
it.
Apply the new Pod
Prepare the Pod for applying to your infusion site:
1. To remove the needle cap on the underside of the Pod, place
your thumb on the bottom (flat edge) of the needle cap and
pull it upwards (Figure 5-11). The needle cap will snap off.
50
2. How to verify Pod is Ready
Pod is:
• Clean and dry
• Adhesive pad is intact and undamaged
• Pod is intact and in its original condition
Verify cannula is not extending
beyond adhesive backing once
needle cap is removed.
Using the Pod
•
If Pod is accidentally dropped discard - sterility may be
compromised.
If you are unsure the Pod is ready to be applied to the site,
press “Discard” and do not use (Figure 5-14). Select a new
Pod.
Do not remove the needle cap until you are
instructed to do so by the PDM. When you remove
the needle cap, a drop of insulin may be visible at the
end of the cannula or in the well.
3. Using the pull tabs, remove and discard the white paper
backing from the adhesive tape (Figure 5-12).
4. Apply the Pod to the prepared infusion site. Press firmly to
secure it to your skin.
For the Pod to work best, apply it:
a. Crosswise or at a slight angle on your abdomen, hip, upper back, or buttocks (in Figure 513)
b. Up and down or at a slight angle on your
upper arm or thigh (in Figure 5-13)
c. At least one inch away from the last site
FF
The Pod’s adhesive keeps it securely in place for up to
3 days. However, if necessary, several products are
available to enhance adhesion. Ask your healthcare
provider about these products. Avoid getting body
lotion, creams, or oils near the infusion site; these
products may loosen the adhesive.
5. After you securely apply the Pod, press Next (Figure 5-14).
Figure 5-13
Figure 5-14
a.
b.
The adhesive is designed for one-time use. Once
removed, a Pod cannot be reapplied.
51
5 Using the Pod
The Pod automatically inserts the soft cannula below your
skin. It takes a few seconds to complete the insertion process.
Once the cannula is inserted, the Pod delivers a prime bolus to
fill the cannula with insulin (Figure 5-18).
Insert cannula and begin insulin delivery
1. To insert the soft cannula, press Start (Figure 5-15).
Figure 5-15
Figure 5-16
Figure 5-20\
If you are applying a Pod in a place that does not have
a lot of fatty tissue or is very lean, pinch the skin
around the Pod (Figure 5-17) after you press Start
and hold it until the cannula inserts. Occlusions may
result in lean areas if you do not use this technique.
The soft cannula is tinted light blue to improve visibility
at the insertion site.
52
Figure 5-17
Figure 5-21 Figure 5-18
You will hear a click when the cannula inserts.
Using the Pod
Check the infusion site after insertion to ensure
that the cannula was properly inserted. It is also a
good idea to check your blood glucose about 1.5
to 2 hours after each Pod change and to check
the infusion site periodically. If the cannula is not
properly inserted, hyperglycemia may result. Verify there is no wetness or scent of insulin, where
as may indicate the cannula has dislodged.
If you observe blood in the cannula, check your
blood glucose more frequently to ensure insulin
delivery has not been affected. If you experience
unexpected elevated blood glucose levels,
change your Pod.
Condensation may occur in the viewing window,
from sweating and perspiration.
2. Press Yes if you can see that the cannula is properly inserted.
The PDM returns to the Status screen.
Press No if you see a problem with the cannula. The PDM
instructs you to deactivate the new Pod (Figure 5-19). Press
Discard to restart the process with a new Pod.
Figure 5-19
Once the soft cannula is inserted, the PDM indicates that the
Pod is active (Figure 5-18, on the previous page).
Figure 5-18, on the previous page also displays a reminder to
check the infusion site and cannula. Make sure the Pod is
securely attached to your skin. You can see the cannula
through the small viewing window on the Pod.
To help avoid condensation from occurring in the
viewing window, make sure both your Pod and your
insulin are at room temperature.
Or press Back to return to the previous screen.
53
5 Using the Pod
NEVER inject insulin (or anything else) into the
fill port while the Pod is on your body. Doing so may
result in unintended or interrupted insulin delivery.
■ Check Pod Status
To check Pod status, if the PDM is turned Off, press and hold the
Power button to display the ID screen, then press Confirm to
display the Status screen. If the PDM is On, press Back until you
reach the Status screen. (If you press and hold the Power button, you will turn off the PDM instead.) Or, from the Home
screen, press Status.
The PDM automatically checks the status of the Pod. The PDM
then displays the current reservoir volume, PDM battery level,
last blood glucose, last bolus dose, active basal program, and any
alarm conditions. See Chapter 6, Using the Personal Diabetes
Manager, for details of what you see on the Status screen.
Once a Pod is activated and communicates with the
PDM, it can only receive commands from that PDM,
not from any other.
If the Pod goes into hazard alarm condition and the PDM is
unable to communicate with it to turn off the alarm, you can turn
it off manually. See the end of Chapter 10, Alerts and Alarms, for
instructions.
54
■ Suspend Insulin Delivery
Sometimes you may need to briefly stop insulin delivery (for
example, when editing an active basal program or changing the
time or date). The OmniPod System lets you suspend all insulin
delivery for up to 2 hours. While in suspension, the Pod beeps
once every 15 minutes, reminding you that insulin delivery is
suspended.
At any time during a suspension period, press Resume
to resume the basal program that was running when you
suspended insulin delivery.
Extended boluses and temporary basal rates will be cancelled when you suspend insulin delivery.
1. On the Home screen, use the Up/Down Controller buttons
to choose Suspend; then press Select.
If a temporary basal or extended bolus is in process, the
menu item will read Suspend/cancel instead, and
options for cancelling these programs also appear in the
menu. If these options appear, choose Suspend insulin
delivery.
Using the Pod
2. Enter how long you want to stop all insulin delivery, from 30
minutes to 2 hours, in 30-minute increments (Figure 5-20),
then press Enter.
Figure 5-23
Figure 5-20
Figure 5-21
At the end of the suspend time, a Pod Advisory alarm occurs
(Figure 5-22).
Figure 5-25\ Figure 5-22
3. Press Confirm to confirm that you want to halt all insulin
delivery (basal and bolus). The PDM beeps and an on-screen
message lets you know that insulin delivery is indeed suspended (Figure 5-21).
The Pod beeps every 15 minutes until the end of the suspension period. The Status screen shows INSULIN SUSPENDED
until you resume insulin delivery (see “Resume Insulin Delivery” on the next page).
4. To resume your programmed basal rate, press OK.
The Advisory alarm repeats every 15 minutes until you
press OK.
Insulin delivery will not resume until you press OK. If
you do not press OK to resume insulin delivery, you
could develop hyperglycemia (high blood glucose).
55
5 Using the Pod
■ Resume Insulin Delivery
■ Avoid Infusion Site Infections
1. On the Home screen, use the Up/Down Controller buttons
to choose Resume (Figure 5-23), then press Select.
•
•
Figure 5-23
•
•
•
Always wash your hands and use the aseptic technique to prepare the infusion site before applying a Pod.
Do not apply a Pod to any area of the skin with an active
infection. If you are unsure whether to use a specific site, ask
your healthcare provider.
At least once a day, use the Pod’s viewing window to check
the site for signs of infection and to confirm that the soft cannula is securely in place.
Be aware of the signs of infection, including pain, swelling,
redness, discharge, or heat at the site. If you suspect an infection, immediately remove the Pod and apply a new one in a
different location. Then call your healthcare provider.
Change the Pod as instructed by your healthcare provider.
■ Get the Most From Your Pod
2. Press Confirm to restart the basal program for that time segment.
56
Avoid extreme temperatures
The Pod’s operating temperature is between 40° F and 104° F
(between 4.4° C and 40° C). Under normal circumstances, your
body temperature will keep the Pod well within this range.
Using the Pod
Do NOT expose a Pod to direct sunlight for long periods of time. It is recommended that you remove your
Pod prior to using hot tubs, whirlpools, or saunas.
These conditions could expose the Pod to extreme
temperatures and may also affect the insulin inside
the Pod.
Remember to check your blood glucose levels frequently
before and after removing the Pod. Check with your
healthcare provider for guidelines on removing the Pod
for extended periods.
Insulin degrades at high temperatures and will
freeze near 32° F (0° C). Check the insulin manufacturer’s instructions for use.
Water and your Pod
The Pod is waterproof up to a depth of 25 feet for up to 60 minutes (IPX8). After exposure to water, rinse off the Pod with clean
water and gently dry it with a towel.
Do not expose your Pod to water at depths greater
than 25 feet or for more than 60 minutes. Check
often to make sure the Pod and soft cannula are
securely attached and in place. If the cannula is not
properly inserted, hyperglycemia may result. Verify
there is no wetness or scent of insulin, where as may
indicate the cannula has dislodged.
The PDM is not waterproof. Do not place it in or near
water.
Safe storage
Store unopened Pods in a cool, dry place. Extreme heat or cold
can damage Pods and cause them to malfunction. If Pods are
exposed to extreme temperatures, allow them to return to room
temperature before use.
Pods are sterile unless their packaging is opened or
damaged. Do NOT apply or use a Pod if its sterile
packaging is opened or damaged, or if the Pod has
been dropped after removal from the package as
this may increase the risk of infection or serious
injury.
57
CHAPTER 6
Using the Personal Diabetes Manager
■ The ID Screen
Figure 6-1
Figure 6-2
When you first turn on the PDM, it displays the identification (ID)
screen (Figure 6-1), which allows you to identify that the PDM is
yours. You can personalize the ID screen by adding your name
and choosing its color. 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.
■ The Status Screen
When a Pod is active and the PDM is turned on, the PDM establishes communication with the Pod to obtain a status check.
During the status check, the PDM collects information from the
Pod about bolus deliveries, active basal programs, and Pod expiration. The information obtained is then displayed in the status
screen, which shows the System’s current operating status.
58
The Status screen (Figure 6-2) displays:
• Time, date, and result of last blood glucose checked or
entered manually
• Time, date, and total amount of last bolus delivered
Using the Personal Diabetes Manager
•
•
•
•
•
Amount of insulin on board (IOB), if suggested bolus calculator 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
If a Pod has not yet been activated (as in 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.)
Insulin gauge and display
One of the important icons on the Status screen is the insulin
gauge at the top of the screen. It indicates how much insulin is
left in the Pod’s reservoir. As the reservoir empties, the icon
changes to indicate the amount of insulin remaining.
Next to the insulin gauge, the PDM displays the number of units
remaining in the Pod. As long as more than 50 units remain, the
gauge displays “50+ U.” Once the reservoir volume drops to 50
units, the gauge counts down unit by unit. When the volume
falls below 5 units, the display changes to “LOW.”
Regularly checking the insulin gauge enables you
to plan Pod changes easily. For example, if you
know you will need approximately 20 units during
your work day and the insulin gauge shows only 17
units remaining, you can either take a new Pod with
you or change it before you leave for the day.
PDM settings
You can adjust the PDM settings to meet your individual needs.
1. From the Status screen, press Home.
2. Use the Up/Down Controller buttons to choose Settings,
then press Select.
3. Choose System setup, then press Select.
4. Choose an option from the System setup list, then press
Select (Figure 6-3 on the next page). Check with your healthcare provider before making any changes.
59
6 Using the Personal Diabetes Manager
Figure 6-3
You and your healthcare provider entered initial System settings
using the Setup Wizard (see Chapter 2, Getting Started). After
setup, you can use the System setup menu to customize or
change those settings, as described in this chapter.
■ Reset the Date or Time
Occasionally, you need to change date and time settings (for
example, to adjust for daylight savings time or after resetting the
PDM). As a safety feature, you can change date and time settings
only when the Pod is deactivated or when insulin delivery is suspended (see Chapter 5, Using the Pod).
1. Suspend insulin delivery.
■ The System Setup Menu
The System setup menu lets you personalize the settings that
control the OmniPod System. These include:
• Date and time
• Bolus doses, basal rates, and bolus calculator settings
• Alerts and reminders
• Blood glucose meter settings and tags
• PDM options
• Diagnostics
60
If you are changing the Pod, you can reset the date or
time without suspending by changing the date or
time before activating the new Pod.
2. On the Home screen, use the Up/Down Controller buttons
to choose Settings; then press Select.
3. Choose System setup, then press Select.
4. Choose Date/time, then press Select.
5. Choose either Date or Time, then press Edit.
Using the Personal Diabetes Manager
Reset the time
1. To enter the current time, press the Up/Down Controller
buttons. Press and hold the button to increase or decrease
the time faster.
2. Press 12/24 hr to choose either a 12-hour or 24-hour clock,
then press Enter (Figure 6-4).
Figure 6-4
Figure 6-5
Reset the date
1. Press the Up/Down Controller buttons to choose the current year, then press Next.
2. Choose the current month, then press Next.
3. Choose the current day, then press Next.
4. Choose the date format to be displayed by the PDM, then
press Select.
5. Press Confirm to accept the new date and format.
If you suspended insulin delivery to change the
time or date, remember to resume insulin delivery. If you changed the time or date during the
Pod change process, remember to activate a new
Pod.
■ Change Bolus and Basal Settings
3. Press Confirm to accept the new time (Figure 6-5).
You and your healthcare provider entered initial bolus and basal
System settings using the Setup Wizard. Using the System setup
menu, you can edit all the OmniPod System bolus and basal settings as your needs change. Check with your healthcare provider
before making any changes.
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose System setup, then press Select.
3. Choose Bolus/basal/calcs, then press Select.
61
6 Using the Personal Diabetes Manager
4. Choose one of the options (Figure 6-6a and Figure 6-6b), then
press Select. Each option is described below.
Figure 6-6a
Figure 6-6b
Bolus calcs
When the suggested bolus calculator is turned Off and you want
to turn it On, press On and follow these steps:
1. Target BG and correct-above value—You can edit existing
time segments and add segments, up to a total of 8.
62
a. To edit an existing target BG time segment, choose the
segment, then press Edit. Use the Up/Down Controller
buttons to choose a new start time, end time, target BG
value, and correct-above value (correction threshold). Press
Next after each entry.
b. To add a segment, choose [add new], then press New.
Use the Up/Down Controller buttons to choose a start
time, end time, target BG value, and correct-above value
(correction threshold). Press Next after each entry.
c. When you have completed all the time segments you
want, press Done, then Save.
2. Min BG for calcs (minimum blood glucose value allowed for
calculating boluses)—Use the Up/Down Controller buttons
to enter a new minimum BG, then press Next.
3. Insulin-to-carb (IC) ratio—You can edit existing time segments and add segments, up to a total of 8.
a. To edit an existing IC ratio time segment, choose the segment, then press Edit (Figure 6-7 on next page). Use the
Up/Down Controller buttons to choose a new start time,
end time, and IC ratio. Press Next after each entry.
b. To add a segment, choose [add new], then press New.
Use the Up/Down Controller buttons to choose a start
time, end time, and IC ratio. Press Next after each entry.
c. When you have completed all time segments, press
Done, then Save.
Using the Personal Diabetes Manager
Figure 6-7
5. Reverse correction—Choose On or Off, then press Next.
6. Insulin action (duration)—Use the Up/Down Controller
buttons to choose a duration of insulin action, then press
Done.
7. Press OK.
Ratios/factors/targets
When the suggested bolus calculator is turned On, you can view
and change all the settings using the Ratios/factors/targets
menu option. Choose Review all settings, then press Select
(Figure 6-8a ) or choose one setting from the menu, then press
Select (Figure 6-8b). The steps are the same whether you choose
all settings or individual ones.
4. Correction factor—You can edit existing time segments and
add segments, up to a total of 8.
a. To edit an existing correction factor time segment, choose
the segment, then press Edit. Use the Up/Down Controller buttons to choose a new start time, end time, and correction factor. Press Next after each entry.
b. To add a segment, choose [add new], then press New.
Use the Up/Down Controller buttons to choose a start
time, end time, and correction factor. Press Next after
each entry.
c. When you have completed all time segments, press
Done, then Save.
Figure 6-8a
Figure 6-8b
63
6 Using the Personal Diabetes Manager
When the suggested bolus calculator is turned Off, the
Ratios/factors/targets option does not appear in the
Bolus/basal/calcs menu.
1. Target BG and correct-above value—You can edit existing
segments and add segments, up to a total of 8.
a. To edit an existing target BG time segment, choose the
segment, then press Edit. Use the Up/Down Controller
buttons to choose a new start time, end time, target BG
value, and correct-above value (correction threshold).
Press Next after each entry.
b. To add a segment, choose [add new], then press New.
Use the Up/Down Controller buttons to choose a start
time, end time, target BG value, and correct-above value
(correction threshold). Press Next after each entry.
c. When you have completed all the time segments you
want, press Done, then Save.
2. Min BG for calcs (minimum blood glucose value allowed for
calculating boluses)—Use the Up/Down Controller buttons
to enter a new minimum BG, then press Enter.
3. Insulin-to-carb (IC) ratio—Number of grams of carbohydrate covered by one unit of insulin. You can edit existing
time segments and add segments, up to a total of 8.
a. To edit an existing IC ratio time segment, choose the segment, then press Edit. Use the Up/Down Controller but-
64
tons to choose a new start time, end time, and IC ratio.
Press Next after each entry.
b. To add a segment, choose [add new], then press New.
Use the Up/Down Controller buttons to choose a start
time, end time, and IC ratio. Press Next after each entry.
c. When you have completed all time segments, press
Done, then Save.
4. Correction factor—You can edit existing time segments and
add segments, up to a total of 8.
a. To edit an existing correction factor time segment, choose
the segment, then press Edit. Use the Up/Down Controller buttons to choose a new start time, end time, and correction factor. Press Next after each entry.
b. To add a segment, choose [add new], then press New.
Use the Up/Down Controller buttons to choose a start
time, end time, and correction factor. Press Next after
each entry.
c. When you have completed all time segments, press
Done, then Save.
5. Reverse correction—Choose On or Off, then press Select.
6. Insulin action (duration) or Insulin on Board (IOB)—Use
the Up/Down Controller buttons to choose a duration of
insulin action, then press Enter.
Using the Personal Diabetes Manager
Temp basal
Choose %, U/hr , or Off to set the mode for temporary basal
rates and presets, then press Select.
Extended
Choose %, Units, or Off to set the mode for extended boluses,
then press Select.
Bolus increment
Choose 0.05, 0.10, 0.50, or 1.00 units for bolus increments, then
press Select.
Max bolus
Use the Up/Down Controller buttons to enter the maximum
bolus dose you can take, then press Enter.
Max basal rate
Use the Up/Down Controller buttons to enter the maximum
basal rate you can choose, then press Enter.
Some settings have preset defaults, but all settings
are changeable. See the Appendix for a list of System specifications, including preset default settings.
For additional details on bolus and basal settings,
see Chapter 3, Understanding and Adjusting Basal
Rates, and Chapter 4, Understanding and Delivering Bolus Doses.
■ Alerts and Reminders
In addition to automatic safety alarms (see Chapter 10, Alerts and
Alarms), the OmniPod System offers a number of personal settings to help you manage your diabetes. These features are
optional. You can turn them on or off at any time, except for the
alerts. Those you can set at levels that you find convenient to
remind you to change your Pod.
Notifications you can use are:
BG (blood glucose) reminder: Reminds you to check your blood
glucose. Choose from On or Off. The default setting is Off. When
the reminder is on, the PDM asks you each time you enter a bolus
dose whether you want to set a BG reminder, and you can then
choose a time interval, in 30-minute increments.
Pod expiration: Reminds you when the Pod is nearing the 72hour expiration time. Choose a period from 1 to 24 hours before
expiration, in 1-hour increments. The default setting is 4 hours.
You will hear 2 sets of beeps every minute for 3 minutes. The
notification will repeat every 15 minutes until you press OK to
acknowledge it.
Low reservoir: Alerts you when insulin in the Pod reaches a certain level, so you can plan ahead to change the Pod. Choose a
level from 10 to 50 units, in 5-unit increments. The default setting
is 10 units.
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6 Using the Personal Diabetes Manager
The Low reservoir alert will escalate to an Empty reservoir hazard alarm when insulin is depleted. Be sure
to respond to the alert when it occurs.
Auto-off: Alerts you if the PDM does not receive a Pod status
within a predefined period of time. Obtain Pod status by pressing and holding the PDM’s Power button. Choose a time period
from 1 to 24 hours, in 1-hour increments, or choose Off. The
default setting is Off. Refer to page 54 to check Pod status and to
Confirm ID.
The Auto-off alert will escalate to a hazard alarm if
ignored and will result in the deactivation of your
active Pod. Be sure to respond to the alert when it
occurs.
Turning the PDM on by inserting a blood glucose
test strip does not send a Pod status to the PDM.
This alert can be especially reassuring if you are prone to hypoglycemia unawareness. Ask your healthcare provider about
using this alert and where to set it.
If you use the Auto-off feature, always turn on the
PDM with the Power button before using the system.
This allows the PDM to obtain a Pod status. Refer to
page 54 to check Pod status and to Confirm ID.
66
Bolus reminders: Notifies you if you have not delivered a meal
bolus, manually or using the suggested bolus calculator,
between the times you specify. Choose On or Off and choose up
to 6 time segments.
Program reminders: Pod beeps when a program is in process
(see Chapter 3, Understanding and Adjusting Basal Rates; and
Chapter 4, Understanding and Delivering Bolus Doses, for
details). These include:
• Temporary basal in process
• Extended bolus in process
Choose On or Off. The default setting is On.
Confidence reminders: The Pod or PDM beeps in response to
your instructions, so you become familiar with the operation of
the OmniPod System and feel confident that you are getting the
insulin you need. These notifications include:
• Bolus delivery started
• Bolus delivery completed
• Extended bolus started
• Extended bolus completed
• Temporary basal rate started
• Temporary basal completed
Choose On or Off. The default setting is On.
Using the Personal Diabetes Manager
Custom reminders: Displays text reminders that you enter, at
times that you select. You can choose to receive a notification
Daily, One time only, or Off. You can change or delete these
notifications at any time.
Set alerts and reminders
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose System setup, then press Select.
3. Choose Alerts/reminders, then press Select.
4. Choose the option you want to set (Figure 6-9), then press
Select.
Figure 6-9
5. For all except Bolus reminders and Custom reminders,
choose the desired option or set the desired value, then press
Select or Enter.
6. For Bolus reminders
• Use the Up/Down Controller buttons to choose On or
Off, then press Select.
• If you chose On, you are taken to a new screen where you
can add, edit or delete reminders:
To add a Bolus reminder
a. Use the Up/Down Controller buttons to choose [add
new], then press New.
b. Choose a start time, then press Next.
c. Choose an end time, then press Save.
To edit a Bolus reminder
a. Choose the bolus reminder you wish to edit, then
press Edit.
b. Choose Edit, then press Select.
c. Enter a new start time, then press Next.
d. Enter a new end time, then press Save.
67
6 Using the Personal Diabetes Manager
To delete a Bolus reminder
a. Choose the bolus reminder you wish to delete, then
press Edit.
b. Choose Delete then press Select.
c. Press Delete to remove the bolus reminder.
7. For Custom reminders
• Use the Up/Down Controller buttons to choose [add
new], then press New.
• To use the OmniPod System’s default naming system, simply press Next. The default naming system automatically
assigns names in numerical order, such as alert 1, alert 2,
alert 3.
If you want to give a different name to the reminder:
a. 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.
b. Press the middle Soft Key (the right arrow) to move the
underscore to the next character.
c. Enter each character one at a time. For example, for a
reminder to pick up a prescription, you might enter
R, x (Figure 6-10 ). (A blank character or space is the first
and last option in the scrolling menu.)
68
Figure 6-10
•
•
d. Press Next.
Enter the time of day for the reminder, in 30-minute increments, then press Next.
Choose Daily, One time only, or Off, then press Select.
Custom reminders will repeat every 15 minutes until
acknowledged.
Using the Personal Diabetes Manager
■ Change Blood Glucose Meter Settings
You can adjust blood glucose (BG) meter settings:
• BG goal lower and upper limits (for BG history)
• Manage BG tags list
• BG sound—On or Off
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose System setup, then press Select.
3. Choose BG meter, then press Select.
4. Choose the setting you want to change (Figure 6-11), then
press Select.
Change BG goal limits
To change the BG goal limits, press Edit, change either or both
values, then press Save.
Manage the blood glucose tags list
You can create up to 15 custom blood glucose tags and hide any
of the standard tags you do not plan to use. Standard BG tags are
shown first on the screen (Figure 6-12a), followed by custom
tags, and then [add new] (Figure 6-12b). For more information
about tagging BG readings, see Chapter 7, Checking Your Blood
Glucose.
Figure 6-12a
Figure 6-12b
Figure 6-11
69
6 Using the Personal Diabetes Manager
1. To hide or show a standard BG tag, choose the tag, and press
Show (if it is marked as hidden) or Hide.
Tags you choose to show will be check marked; hidden ones
will not be.
2. To add a custom tag, choose [add new] at the end of the list
of custom tags, then press New.
In the Edit name screen, either:
a. Press Save to save the new tag with the default name,
custom tag1, custom tag2, and so on; or
b. Use the Up/Down Controller buttons to choose letters
and numbers for a name, followed by the middle Soft Key
(the right arrow) to move forward one space. Then press
Save.
3. To delete a custom tag, choose the tag, press Delete, then
press Delete again. Or press Cancel to leave the tag
unchanged.
Change BG sound
To change BG sound, choose On or Off, then press Select.
70
■ Customize the Personal Diabetes Manager
Additional options let you customize how the PDM operates:
ID screen: Identify your PDM by adding your name and choosing
a color. The options you set will be shown on the ID screen every
time you turn on the PDM.
PDM lock: “Locks” the buttons on the PDM. The default setting is
Off. This safety feature can help avoid accidentally changing
basal rates or giving boluses.
Screen time-out: The screen turns off after a time interval that
you set, which occurs if you have not pressed any buttons on the
PDM. This setting preserves battery power by turning off the
screen when you are not using it. Set it at the lowest setting to
maximize battery life.
Press and hold the Power button to turn the screen back
on. In some cases, if it has been less than 5 minutes since
the screen timed out, pressing the Power button returns
you to the same screen you were using. If it has been longer than 5 minutes, the PDM brings you to the Status
screen. To check the Pod status, refer to Page 54 for
detailed instructions. The ID screen must be confirmed
before you can check Pod status.
Using the Personal Diabetes Manager
Backlight time-out: The backlight is on by default while you are
using the PDM. The time-out setting dims the backlight and
causes the screen to dim when you have not used it within the
time interval that you set. Set at the lowest setting to maximize
battery life.
Figure 6-13
Figure 6-14
For extra brightness on the PDM screen, press and
hold the User Info/Support button (?) for 2 seconds.
This enables a “bright mode.” The screen will remain
in this mode until the PDM times out or you turn it off.
To preserve battery life, use this feature only when
necessary.
Set PDM options
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose System setup, then press Select.
3. Choose PDM options (Figure 6-13), then press Select.
4. Choose one of the options (Figure 6-14), then press Select.
Set ID screen
To change the ID:
1. Choose ID, then press Select.
2. 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.
3. Press the middle Soft Key (labeled with the right arrow) to
move the underscore to the next character.
4. 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.)
5. Press Save.
As a safety feature, an ID must be entered to enable
the PDM to be identified.
71
6 Using the Personal Diabetes Manager
To change the ID screen color:
1. Choose Screen color, then press Select.
2. Use the Up/Down Controller buttons to choose a color, then
press Select.
Set PDM lock
Choose On or Off, then press Select.
If you choose On, other PDM options and most
other soft keys are locked and will not respond to
button presses. To use them, you must first set PDM
lock to Off.
Set the Screen time-out
Choose a time interval, then press Select.
When the screen times out and goes black, turn it on again by
pressing the Home/Power button.
Set the Backlight time-out
Choose a time interval, then press Select.
When the screen dims, turn it on again by pressing any button.
The PDM will ignore the usual command and re-light the screen.
The lowest setting will drain the battery the least.
■ Set Diagnostic Functions
The Diagnostics screen allows you to instantly confirm how the
System is working or to completely update settings entered during setup (see Chapter 2, Getting Started). Options include:
Check alarms: Confirms that all alarms work properly when
needed. When you select this function, the PDM beeps and
vibrates, then the Pod beeps.
If the PDM fails to beep, immediately call Customer
Care. If a Pod is active and fails to beep, change the
Pod immediately (see Chapter 5, Using the Pod).
Continuing to use the System in these situations
may put your health and safety at risk.
Reset PDM (soft reset): Restores all settings in the PDM to the
factory defaults.
Resetting the PDM deletes all basal programs, temp
basal presets, carb presets, bolus presets, and all suggested bolus settings. Before you use this feature
and delete these settings, be sure you have a written
record of the information you need. History records
will not be deleted.
As a safety feature, you cannot reset the PDM when a
Pod is active. You must first deactivate the Pod.
72
Using the Personal Diabetes Manager
Diagnostic options
1. On the Home screen, use the Up/Down Controller buttons
to choose Settings, then press Select.
2. Choose System setup, then press Select.
3. Choose Diagnostics, then press Select.
Figure 6-15
Figure 6-16
To check alarms
1. Choose Check alarms, then press Select.
2. Press OK. The PDM beeps three times and vibrates three
times. If a Pod is active, it then beeps three times.
Be sure to check the alarm function at every Pod
change.
To reset the PDM
1. Choose Reset PDM, then press Select.
2. If the Pod is deactivated, the PDM asks for confirmation and
reminds you that you will lose all user settings (Figure 6-15).
Press Confirm to reset the PDM.
If the Pod is still active, you will be unable to reset the PDM
(Figure 6-16). Press OK to return to the Diagnostics menu.
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 your PDM, having these settings
handy will make setup very easy.
73
6 Using the Personal Diabetes Manager
■ Set a Reminder to Vibrate
For certain reminders, you can choose vibration instead of beeps
or vibration followed by beeps, instead of only beeps. If you activate it, the PDM will vibrate for:
• Blood Glucose reminders
• Missed Bolus reminders
• Custom reminders
• “No active Pod” reminders
The PDM cannot be set to vibrate for hazard or advisory
alarms.
To change the type of notification
1. Use the Up/Down Controller buttons to choose Settings,then press Select.
2. Choose Vibration, then press Select.
3. Choose Vibrate, Vibrate then beep, or Off (beep only), then
press Select. (Vibrate then beep means the PDM will repeat
the reminder twice using vibration. After that, it uses beeps.)
Or press Back to return to the Settings menu.
74
■ Get the Most from Your PDM
Keep it handy
Wireless communication technology means you don’t have to
keep the PDM right next to the Pod for the Pod to work. Once
you set your basal program, the Pod continues to deliver your
basal program 24 hours a day, regardless of the location of the
PDM. However, you still need the PDM to deliver a bolus, change
the basal rate, and so on. You can store the PDM conveniently
inside an article of clothing (like a shirt pocket) or put it discreetly
into a drawer, briefcase, or purse.
Communicating with the Pod
When you use the PDM to communicate with the Pod, hold the
PDM within 24'' (61 cm) of the Pod.
Water and your PDM
Do NOT use IV Prep wipes, alcohol swabs, soap,
detergent, or solvents to clean the screen or any
other part of the PDM. The PDM is NOT waterproof.
Do NOT immerse it or place it in or near water.
Using the Personal Diabetes Manager
Avoid extreme temperatures
Extreme operating temperatures can affect PDM batteries and
interfere with System operation. Avoid using the PDM in temperatures below 40°F (4.4°C) or above 104°F (40°C).
Only connect a USB cable to your PDM when downloading data to a computer. Other PDM functions are
disabled while a USB cable is connected, and the
PDM cannot communicate with the Pod.
Do not store or leave the PDM where it may be
exposed to extreme temperatures, such as inside a
car. Extreme heat or cold can cause the device to
malfunction.
The PDM is compatible only with Windows®-based
operating systems. Do not connect a USB cable to
your PDM or attempt to download your data to a
non-Windows®-based computer operating system,
as the PDM may alarm and require a reset.
Never attempt to test your blood glucose while your
PDM is connected via USB cable to a computer.
Doing so could result in electrical shock.
When you connect a USB cable to the PDM, only use
a cable that is less than or equal to 9 feet (2.7 meters)
in length.
Electrical interference
The PDM is designed to withstand normal radio interference and
electromagnetic fields. However, as with all wireless communication technology, certain operating conditions can interrupt
communication. For example, electric appliances such as microwave ovens and electric machinery located in manufacturing
environments may cause interference. In most cases, interruptions are easy to resolve (see Chapter 11, Communication
Failures).
75
CHAPTER 7
Checking Your Blood Glucose
■ The Built-in FreeStyle® Blood Glucose Meter
With the FreeStyle® blood glucose meter, checking your blood
glucose requires a very small sample size, 0.3 microliter of blood.
Refer to your FreeStyle test strip instructions for use for important test strip information.You may want to test for low blood
glucose:
• When you feel symptoms such as weakness, sweating,
nervousness, headache, or confusion
• When you have delayed a meal after taking insulin
• When your healthcare provider advises you to do so
Keep the system and the FreeStyle® accessories away
from young children, as they contain small parts that
may be dangerous if swallowed.
Only use FreeStyle® test strips and FreeStyle® control
solution with the System. Using other brands of test
strips and control solutions with the System can produce inaccurate results.
76
Never attempt to test your blood glucose while your
PDM is connected via USB cable to a computer.
Doing so could result in electrical shock.
This Device is intended for self-testing by the user.
Please read all the instructions provided in this User
Guide and practice the testing procedures before
using the system and FreeStyle® accessories. Follow
the guidance of a healthcare professional for proper
blood glucose monitoring.
Checking Your Blood Glucose
■ The FreeStyle® Blood Glucose Test Strips
Complete information on the FreeStyle® test strips
(such as interferences and performance) can be
found in the test strip package insert. Please read all
instructions provided on the test strip package insert
before using the OmniPod System and FreeStyle
accessories.
Important test strip information
• Store the blood glucose test strip package in a cool, dry place
between 40° and 86° F (4.4° and 30° C).
• Use test strips only when the system is within its operating
temperature range, between 40° and 104° F (4.4° and 40° C).
• Keep test strips away from direct sunlight and heat.
• Store test strips in their original vial only; never transfer them
to another vial or any other container.
• Never store individual test strips outside the vial.
• After removing a blood glucose test strip from the vial, immediately close the vial cap tightly.
• With clean, dry hands, you can gently touch the test strip anywhere when removing it from the vial or inserting it into the
test strip port.
• Do not bend, cut, or alter blood glucose tests strips in any
way.
Do not use strips beyond the expiration date printed
on the package, as this may cause inaccurate results.
For detailed storage and usage information, refer to the
package insert in the box containing the test strip vial.
The cap or vial contains drying agents that may be
harmful if inhaled or swallowed and may cause skin
or eye irritation.
■ The FreeStyle® Control Solution
The FreeStyle® control solution (Figure 7-1) is a
red liquid that contains a fixed amount of glucose and has two important uses:
• To ensure that your meter and test strips
are working together properly
• To practice testing without having to use
your own blood
Three levels of control solution are available:
Low, Normal, and High. For information on
how to obtain control solution, Call Insulet’s
Customer Care (24 hours/7 days): 800-5913455. When calling from outside the United
States: 781-457-5098.
Figure 7-1
77
7 Checking Your Blood Glucose
When to perform a control solution test
You should perform a control solution test:
• When you suspect that your meter or test strips are not working properly
• When you think your test results are not accurate or if your
test results are not consistent with how you feel
• When you drop or damage your PDM or expose it to liquids
• When your healthcare provider advises you to do so
Check that the meter and test strips are working
A control solution test follows the same procedure as a blood
glucose reading, except that you use a sample of control solution
instead of a drop of blood. (See “Performing a Blood Glucose
Reading” later in this chapter.)
When you perform a control solution test, if the reading is within
the control solution acceptable range, the meter is working
properly.
Control solution expiration date
FreeStyle® control solution is good for 3 months after opening
the bottle, or until the expiration date printed on the label,
whichever comes first. Count forward 3 months from the date
you open a new bottle of control solution. This is your discard
date. Write this date on the side of the control solution bottle. For
example, if you open the control solution on January 15, count
78
forward 3 months to April 15. This is the discard date to record
on the bottle, as well as the date to discard it and begin using a
new bottle.
Ensure accurate control solution results
• Replace the cap on the control solution bottle immediately
after using it.
Use only FreeStyle® control solution with the
System. Other brands of control solution may produce inaccurate results with this System.
Do not use control solution past the expiration
date or you may get inaccurate results.
•
•
Do not add water or any liquid to control solution.
Control solution tests are specified to be accurate only when
performed between 59° and 104° F (15° and 40° C).
Results from FreeStyle® control solution tests do
not reflect your blood glucose level.
•
The control solution test results should fall within the range
printed on the test strip vial label.
Checking Your Blood Glucose
The control solution range is a target range for control
solution only. It is not a target range for your blood
glucose.
If control solution results are out of this range, REPEAT THE
TEST.Out-of-range control solution results
Out-of-range test results may be caused by:
• Expired or bad control solution
• Expired or bad test strip
• Error in performing test
• Code on test strip vial does not match code set in the PDM
• Malfunction of the System
• Control solution test done outside 59° to 104° F (15° to 40° C)
If your control solution test results continue to fall outside the
range printed on the test strip vial:
1. The System may not be working properly.
2. Do not use the System to test your blood glucose.
3. Call Insulet's Customer Care (24 hours/7 days): 800-591-3455.
When calling from outside the United States: 781-457-5098.
■ Performing a Control Solution Test
1. Grasp the bottom of the test strip with the printed side facing
up (Figure 7-2).
Figure 7-2
Top, to insert into meter
FreeStyle® test strip
Bottom edges, for blood sample
2. Insert the top of the test strip into the test strip port (Figure 7-3)
until it stops. This turns on the PDM and displays the code
number on the screen. Refer to page 54 to check Pod status
and to Confirm ID.
Always verify and be prepared to adjust the code
on the PDM to match the code number on the
test strip vial (Figure 7-4).
79
7 Checking Your Blood Glucose
If you need to adjust the code number after the PDM
has moved to the next screen, just press the Up/Down
Controller buttons. The code screen reappears and you
can adjust the number.
The code number remains on the PDM screen for your
reference until you have completed the control test.
Figure 7-3
Figure 7-4
From some PDM screens, you cannot access the Freestyle® blood glucose meter. For example, you cannot
use the meter while you are activating a Pod or when
an alert, alarm or communication error screen is displayed. In these cases, if you insert a test strip, the
PDM beeps to alert you.
3. To help you see the test strip port in reduced lighting, when
you insert a test strip into the PDM, you can turn on the port
light. Press the middle Soft Key labeled Light. To turn the light
off, press Light again.
The code number on the screen should match
the code number on the side of your test strip
vial (Figure 7-4 on previous page). They must
always match or your results will be inaccurate.
(See “Set the blood glucose test strip code” later
in this chapter.)
4. Wait for the PDM to display “Apply a blood sample to the
strip” on the screen (Figure 7-5 on the following page).
80
Checking Your Blood Glucose
Figure 7-5
Figure 7-6
The “Checking” screen appears while the sample is processing (Figure 7-7). The strip port light turns off when the sample
is accepted.
Figure 7-7
5. Gently touch only ONE EDGE of the test strip to the control
solution. Specifically, apply the control solution to the test
strip edge next to one of the dark-colored half-circles (Figure
7-6). If BG sound is set to On, the PDM beeps when the test
strip is full.
If you do not apply the sample within 10 seconds, the strip
port light turns off. To turn it on again, press Light.
Figure 7-8
Do not apply control solution to both edges of the
test strip.
If BG sound is set to On, the PDM beeps twice. The result
appears on the screen.
81
7 Checking Your Blood Glucose
6. To mark the result as a control solution result rather than a
blood glucose test:
a. Press Tag.
b. Use the Up/Down Controller buttons to select Control
(Figure 7-8), then press Select. You can select a second tag
for the test result in the same way.
You can select a maximum of 2 tags.
c. Press OK.
7. If you do not want to mark the test as a control solution test,
press Next instead of Tag.
If the suggested bolus calculator feature is turned Off,
the Bolus soft key appears instead of Next.
If you mark a test as a control solution test by mistake,
you can unmark it: Press Tag, select Control, then
press Clear.
8. Compare the control solution test result to the range printed
on the test strip vial label. If the result does not fall within the
range, repeat the test. If the result still does not fall within
the range, call Insulet’s Customer Care (24 hours/7 days):
82
800-591-3455. When calling from outside the United States:
781-457-5098
9. Remove the test strip. If the strip port light was turned on, it
now turns off.
If you remove the test strip before this step, you will still see
the available soft keys.
Be sure to discard used test strips. (You can only use
test strips once.)
■ Performing a Blood Glucose Reading
Figure 7-9 on the following page shows the parts of the FreeStyle® lancing device.
To ensure accurate results, wash your hands and the
test site (for example, your upper arm) with soap and
water. Do not leave any cream or lotion on the test
site. Thoroughly dry your hands and the test site.
Checking Your Blood Glucose
Prepare the lancing device
1. Snap off the cap on the lancing device at an angle
(Figure 7-10).
Figure 7-9
Cocking handle
Figure 7-10
Figure 7-11
Depth settings dial
Depth indicator window
Release button
Clear cap, for testing sites
other than the finger
Gray cap, for testing on the
fingers
2. Insert a new FreeStyle® lancet firmly into the white lancet
holder cup (Figure 7-11). Pushing the device into the cup may
cock the device, which is fine.
3. Hold the lancet firmly in place with one hand. With your other
hand, twist off the rounded top (Figure 7-12 on the following
page).
83
7 Checking Your Blood Glucose
4. Replace the cap until it snaps or clicks into place (Figure 7-13).
Be careful not to touch the exposed needle on the lancet.
Figure 7-12
Figure 7-13
5. The lancing device offers four different depth settings. Level 1
is the shallowest depth; level 4 is the deepest. Move the dial
to the desired setting as shown in the depth indicator window (Figure 7-14). To lance your finger, we recommend that
you start at Level 1. To lance your arm, we recommend that
you start at level 2.
Figure 7-14
Use the clear cap to lance at the following test sites:
forearm, upper arm and hand. Use the gray cap for
finger tests only.
84
Figure 7-15
Checking Your Blood Glucose
6. Pull out the dark gray cocking handle until it clicks (Figure 715 on the previous page). (You may have already cocked the
handle in step 2. This is okay.)
You are now ready to perform a blood glucose test.
Figure 7-16
Figure 7-17
Top
Insert the blood glucose test strip
1. Insert a new blood glucose test strip into the test strip port
until it stops. The test strip port is at the bottom of the PDM.
From some PDM screens, you cannot access the FreeStyle® blood glucose meter. For example, you cannot
use the meter while you are activating a Pod or when
an alert, alarm or communication error screen is displayed. In these cases, if you insert a test strip, the
PDM beeps to alert you.
2. To help you see the test strip port in reduced lighting, press
the middle soft key labeled Light. To turn the light off, press
Light again.
3. Insert only the top end of the strip into the test strip port (Figure 7-16 and Figure 7-17).
Bottom
If you do not start the test within 2 minutes, the PDM
powers off. To restart the PDM, take out the unused strip
and reinsert it, or simply press and hold the Power button to turn on the PDM. Refer to page 54 to check Pod
status and to Confirm ID.
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7 Checking Your Blood Glucose
Set the blood glucose test strip code
After you insert the strip, the PDM displays a code number
(Figure 7-18). This number must match the code on the side of
the vial.
Figure 7-18
Figure 7-19
If you need to adjust the code number after the PDM
has moved to the next screen, just press the Up/Down
Controller buttons. The code screen reappears and you
can adjust the number.
The code number remains on the PDM screen for your
reference until you have completed the BG test.
The code number on the screen should match the
code number on the side of your test strip vial (Figure 7-4). They must always match or your results will
be inaccurate.
To change the code number, press the Up/Down Controller
buttons until the number matches the number on your vial. The
numbers are between 1 and 50.
If you do not adjust the code number within 2 seconds, the next
screen appears automatically (Figure 7-19).
86
Lance your finger
1. To stimulate blood flow, keep your hand warm or lower your
hand to waist level and gently massage your finger.
2. Set the depth setting on the lancing device (Figure 7-20 on
the following page).
3. Lightly touch the lancing device (with the gray cap) against
the side of your fingertip (Figure 7-21 on the following page).
Checking Your Blood Glucose
4. Press the release button.
5. Gently squeeze your finger, if needed, until a blood drop the
size of a pinhead forms.
Figure 7-20
Lance your forearm, upper arm, or hand
1. To bring fresh blood to the surface of the test site, rub the site
vigorously for a few seconds (Figure 7-22) until you feel it getting warm.
Figure 7-21
Figure 7-22
Figure 7-23
2. Set the depth setting on the lancing device (Figure 7-23).
3. Hold the lancing device (with the clear cap) against the top of
your test site.
4. Press the release button. Do not lift up; continue to hold the
button and gradually increase pressure against the site for
several seconds (Figure 7-24 ,on the next page).
87
7 Checking Your Blood Glucose
Figure 7-24
Fill the blood glucose test strip with blood
1. Make sure that the strip is in the PDM and the PDM is powered on. If the PDM has powered off, take out the strip and
reinsert it (Figure 7-25), or simply press and hold the Power
button to turn on the PDM. Refer to page 54 to check Pod status and to Confirm ID.
Figure 7-25
Figure 7-26
5. While holding the lancing device on your test site, look
through the clear cap. The blood sample should be about the
size of a pinhead.
6. Lift the lancing device straight up; be careful not to smear the
blood sample on your test site.
Avoid lancing areas with obvious veins or moles
to avoid excess bleeding. Also avoid lancing
areas where tendons or bones stick out (for
example, hand bones).
88
2. Bring the strip to the blood sample at a slight angle (Figure 726).
If you do not apply the sample within 10 seconds, the strip
port light turns off. To turn it on again, press Light.
Checking Your Blood Glucose
Use only one edge of the blood glucose test strip per test. Do
not apply blood to both edges (Figure 7-27). Only use strips
once. Discard used strips.
The test strip pulls the blood into the strip through the edge
(Figure 7-28).
Figure 7-27
Figure 7-28
Do not:
• Press the strip against the test site
• Scrape the blood onto the strip
• Apply blood to the flat side of the strip
• Apply blood to the strip when it is out of the meter
• Put blood or foreign objects into the test strip port
Wait for the reading
1. Do not pull the test strip away from the sample until you hear
1 beep or see the word “Checking” on the screen (Figure 7-29,
on the next page). This means you applied enough blood
and the meter is reading your glucose.
Edge of
test strip
The lancing device is intended for individual use and
should not be shared. If the device is being operated
by a second person who is providing testing assistance to the user, the meter and lancing device
should be decontaminated prior to use by the second person (see Page 138).
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7 Checking Your Blood Glucose
Figure 7-29
Figure 7-30
2. If after 5 seconds the PDM does not display “Checking,” the
sample may be too small. If needed, add more blood to the
same edge of the strip for up to 60 seconds from the time of
the first application.
The strip port light turns off when the blood sample is
accepted.The reading is complete when you hear 2 beeps (if
BG sound is turned On) and the PDM shows your reading on
the screen (Figure 7-30).
The time the test takes depends on your blood glucose level.
The higher your glucose level, the longer it takes to get a
result.
3. To mark the result as a pre- or post-meal test, to indicate a
level of exercise or to indicate other situations connected to
this blood glucose reading, press Tag. Then:
a. Use the Up/Down Controller buttons to select a tag,
then press Select (Figure 7-31 on the next page).You can
select a second tag for the reading in the same way.
To learn how to manage your list of tags and to add
custom tags, see ”Manage the blood glucose tags list” in
Chapter 6, Using the Personal Diabetes Manager.
b. Press OK to return to the reading screen (Figure 7-30),
then press Next.
4. If you do not want to mark the test, press Next instead of Tag.
If the suggested bolus calculator feature is turned Off,
the Bolus soft key appears instead of Next.
5. Remove the test strip. If the strip-port light was turned on, it
now turns off.
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Checking Your Blood Glucose
Figure 7-31
Figure 7-32
■ Blood Glucose Results and the Suggested Bolus
Calculator
If the suggested bolus calculator feature is turned On when you
check your blood glucose, the PDM will display the result. From
here, press Next to enter carbs (if eating) and have the System
calculate a suggested bolus. (See “Suggested Bolus Calculator” in
Chapter 4, Understanding and Delivering Bolus Doses.)
If you use the suggested bolus calculator within 10
minutes after taking a blood glucose reading, or if you
store a BG reading (for example, one you enter manually)
within the same 10 minutes, that BG value will be used
automatically in the suggested bolus calculator process
(Figure 7-33 on the next page).
Remove the lancet
When you have finished testing, remove the lancet from the
lancing device (Figure 7-32). Discard the used lancet properly in a
puncture-resistant container. Then wash your hands with soap
and water.
See “Cleaning and disinfecting” in the Appendix for
instructions on how to clean or disinfect your PDM.
If the suggested bolus calculator feature is turned Off, the Next
soft key does not appear. Instead:
Press Bolus to open a screen where you can enter a bolus
manually.
Or press Done to return to the Status screen to see the most
recent BG result.
The BG result, either from the PDM or from manual entry, is
stored in the System’s history, whether suggested bolus calculator is turned On or Off. (See “Blood Glucose Records” in Chapter
8, Understanding Your Records.)
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7 Checking Your Blood Glucose
Figure 7-33
■ Entering Blood Glucose Readings Manually
You can enter blood glucose readings manually into the PDM.
This is particularly helpful if you use a separate blood glucose
meter.
1. On the Home screen, use the Up/Down Controller buttons
to choose More actions,then press Select.
2. Choose Add BG reading, then press Select.
3. Use the Up/Down Controller buttons to enter the BG reading from your separate meter.
The Bolus Entry screen does not open if:
• A regular bolus is currently in process
• The meter temperature is out of range
• You have tagged this BG reading as a Control
• The BG reading is less than your “Min BG for calcs”
• Insulin is suspended
92
To enter a “LOW” reading, press the Up/Down
Controller buttons down until you reach the minimum value (20); then press down one more time.
To enter a “HIGH” reading, press up until you reach
the maximum value (500); then press up one more
time.
4. Press Tag to assign a tag to the reading. Press OK when finished. (For an explanation of entering tags, see page 90.)
5. Press Save to save the reading.
Or press Cancel to return to the More actions menu without
saving the reading.
Checking Your Blood Glucose
■ Editing Tags
Within 2 hours of a blood glucose reading, you can remove or
change a tag or add one. However, you cannot alter a Control tag.
1. On the Home screen, use the Up/Down Controller buttons
to choose More actions, then press Select.
2. Choose Assign/Edit BG tags, then press Select.
3. Use the Up/Down Controller buttons to choose a reading,
then press Tag (Figure 7-34). A User Info/Support icon (?) is
shown to the right of any reading to which you have already
assigned one or two tags.
Or press Done to return to the More actions menu.
Figure 7-34
Figure 7-35
4. Use the Up/Down Controller buttons to choose the first tag
you want, then press Select (Figure 7-35). A diamond icon
appears next to selected tags, as in “Pre-meal” in the figure. You
can select up to two tags for each BG reading.
5. To remove a selected tag, highlight it and press Clear. (The
soft key changes from Select to Clear when you highlight
the tag.)
6. Press OK to return to the list of readings.
7. If no BG readings have been entered into the PDM within the
past 2 hours, you will see the screen in Figure 7-36. Press OK
to return to the More actions menu.
Figure 7-36
93
7 Checking Your Blood Glucose
To learn how to manage your list of tags and to add custom tags,
see ”Manage the blood glucose tags list” in Chapter 6, Using the
Personal Diabetes Manager.
■ Low and High Blood Glucose Readings
WARNINGS!
“LOW” or “HIGH” blood glucose readings can indicate a potentially serious condition requiring immediate medical attention.
If left untreated, this situation can quickly lead to diabetic ketoacidosis (DKA), shock, coma, or death.
Low readings
If your reading is below 20 mg/dL, the PDM displays: “LOW Treat
your low BG!” This indicates severe hypoglycemia (low blood
glucose).
Low reading with symptoms
If you get a “LOW Treat your low BG!” reading and feel symptoms
such as weakness, sweating, nervousness, headache, or confusion, follow your healthcare provider’s recommendation to treat
hypoglycemia.
Low reading without symptoms
If you get a “LOW Treat your low BG!” reading, but have no symptoms of low blood glucose, then retest with a new test strip on
94
your fingers. If you still get a “LOW Treat your low BG!” reading,
perform a control solution test to ensure your system is working
properly. If the system is working properly, follow your healthcare provider's recommendation to treat hypoglycemia.
High readings
If your reading is above 500 mg/dL, the PDM displays “HIGH
Check for ketones!” This indicates severe hyperglycemia (high
blood glucose).
High reading with symptoms
If you get a “HIGH Check for ketones!” reading and feel symptoms such as fatigue, thirst, excess urination, or blurry vision,
follow your healthcare provider’s recommendation to treat
hyperglycemia.
High reading without symptoms
If you get a “HIGH Check for ketones!” reading, but have no
symptoms of high blood glucose, then retest with a new test
strip on your fingers. If you still get a “HIGH Check for ketones!”
reading, perform a control solution test to ensure your system is
working properly. If the system is working properly, follow your
healthcare provider's recommendation to treat hyperglycemia.
You can add and edit tags for LOW and HIGH BG readings
just as you would to any other reading. To add tags, see
page 92; to edit tags, see page 93.
Checking Your Blood Glucose
■ Important Health-Related Information
•
For additional information, consult your test strip product information sheet.
WARNINGS!
•
•
•
•
•
Severe dehydration and excessive water loss may cause false
low results. If you believe you are suffering from severe dehydration, consult your healthcare provider immediately.
Test results below 70 mg/dL mean low blood glucose (hypoglycemia).
Test results greater than 250 mg/dL mean high blood glucose (hyperglycemia).
If you get results below 70 mg/dL or above 250 mg/dL, but
do not have symptoms of hypoglycemia or hyperglycemia
(see Chapter 9, Living with Diabetes), repeat the test. If you
have symptoms or continue to get results that fall below 70
mg/dL or above 250 mg/dL, follow the treatment advice of
your healthcare provider.
If you are experiencing symptoms that are not consistent
with your blood glucose reading and you have followed all
instructions described in this User Guide, call your healthcare
provider immediately.
•
•
•
•
•
•
Blood circulation is different between the finger and other
test sites like the forearm, upper arm, and hand. You may see
differences in blood glucose measurements between the
other test sites and your finger after eating, taking insulin
medication, or exercise.
You may see changes in blood glucose in blood samples
from the finger sooner than in blood samples from the forearm and other alternate sites. Vigorous rubbing of the alternate test sites before lancing helps to minimize these
differences.
Do not use during xylose-absorption testing.
The lancing device is for individual use only and must not be
shared. Always use a new, sterile lancet; lancets are for single
use only.
Objects that may be soiled with blood may then transmit
pathogens. See “Cleaning and disinfecting” in the Appendix
for instructions on how to clean or disinfect your PDM.
“FDA Public Health Notification: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
ucm224025.htm.
“CDC Clinical Reminder: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne
Pathogens” (2010) http://www.cdc.gov/injectionsafety/
Fingerstick-DevicesBGM.html.
95
CHAPTER 8
Understanding Your Records
■ Record Keeping
Record keeping is an important part of successful diabetes management. The Personal Diabetes Manager (PDM) helps simplify
this task. It automatically stores records of insulin delivery history,
blood glucose readings, alarms and carbohydrates. The PDM can
store over 5,000 records or approximately 90 days’ worth of information. Once the memory is full, new information begins to
replace the oldest information.
If the PDM batteries run out, data in the memory is at
risk. Do NOT remove the old batteries until you have
new ones on hand. The PDM protects data in the
memory for up to 2 hours after the batteries run out
or are removed.
96
Special symbols in record screens
In the record screens, you may encounter several special symbols:
Records with a question-mark symbol next to them have
additional information available. To see this information, use
the Up/Down Controller buttons to highlight the record,
then press the User Info/Support button to view details
about that record.
The record for this item has been “lost.”
If the PDM can no longer communicate with an
active Pod, then you must activate a new Pod. The
PDM may not be able to communicate with the
active Pod because of signal interference or because
you have discarded the Pod. If you change the Pod
without getting a Status update, any “unconfirmed”
records will be “lost.” If this occurs, the PDM will not
display insulin totals for any day containing “lost”
records.
Understanding Your Records
✔ The record for this item is “unconfirmed.”
When you power on the PDM, it will request a status
update from the active Pod and then update the
insulin history. If the PDM does not receive a status
update from the Pod, the PDM will update history
with “unconfirmed” records. The next time the PDM
receives a status update, it will update these records.
Figure 8-1
Figure 8-2
This insulin delivery item spans midnight. The date given
is the start date.
■ Insulin Delivery Records
The PDM stores:
• Basal rates (including any rate changes and temporary basals)
• Bolus doses (both normal and extended)
• Dates, times and how long insulin delivery was suspended,
and dates and times when it was resumed
• Total daily doses (basal plus boluses) by date
View insulin delivery records
1. On the Home screen, use the Up/Down Controller buttons
to choose My records, then press Select.
2. Choose Insulin delivery, then press Select (Figure 8-1).
The PDM displays a summary of today’s information,
including total boluses delivered, total basal amount delivered and total daily dose delivered (Figure 8-2). Press the
Up/Down Controller buttons to view the summary for
previous days.
Wherever you see the ? symbol, press the User Info/Support
button to see additional information.
3. To review your basal history by day, press Basal.
The display shows the basal deliveries that have occurred for
the current day, most recent first (Figure 8-3 on the next
page). The active basal rate or program is indicated by a diamond icon (♦).
97
8 Understanding Your Records
Figure 8-3
Figure 8-4
For a temporary basal program, the display shows the %
adjustment that have been made to the default basal rate
(active or current). So, in Figure 8-3, “1.10 temp U/hr (+10%)”
means that you delivered a temporary basal of 1.10 units per
hour, which was 10% more than the default basal. (Notice
that two hours later, the basal rate returns to the default.)
Also, the “Pod activated” entry shows what time you applied
a new Pod.
Press the Up/Down Controller buttons for earlier or later
dates.
98
Press Event to use the Up/Down Controller buttons to scroll
through the list of information on the screen. Choose a
record, then press the User Info/Support button to view
details about that record. Record details may include insulin
delivery, that was interrupted due to a Pod alarm, Pod deactivation, or user cancellation. The screen shows the amount of
the bolus or basal that remained undelivered.
4. Press Day to return to dates.
5. To review your bolus history by day, press Bolus.
The display indicates whether the bolus was normal or
extended (marked “e” in Figure 8-4). Normal and extended
boluses are displayed separately even if they were programmed at the same time. Extended boluses are shown
with time and duration. If an extended bolus is active, a diamond icon (♦) appears next to it. If a bolus was cancelled,
only the amount delivered before cancellation is shown.
The amount shown after cancellation may be in 0.05
unit increments, even though you may have programmed the bolus increment to be in 0.10 units.
Press the Up/Down Controller buttons for different dates.
Press Event to use the Up/Down Controller buttons to scroll
through the list of information on the screen. Press Day to
return to dates.
Understanding Your Records
■ Blood Glucose Records
Figure 8-5
Figure 8-6
The PDM stores blood glucose records for the past 90 days. You
can choose to view individual readings, single-day trends with
individual readings, or trends for the previous 7, 14, 30, 60 or 90
days.
View single-day trends
1. On the Home screen, use the Up/Down Controller buttons
to choose My records, then press Select.
2. Choose BG history, then press Select.
The PDM displays the current-day trends first (Figure 8-5),
including:
• Number of days and number of blood glucose
readings (n)
• Average blood glucose (Avg BG)
• Lowest and highest blood glucose (Min/max)
• The BG goal you have set
• Percentage of readings within the BG goal
• Percentage of readings above the BG goal
• Percentage of readings below the BG goal.
LOW and HIGH readings are included in the number
of BG readings (n), but not in calculations or averages.
3. Press List to see a list of the current day’s readings
(Figure 8-6).
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8 Understanding Your Records
In the List view, press Event to select individual readings.
Readings with a question mark icon (?) next to them have
additional information available (Figure 8-7). To see this information, use the Up/Down Controller buttons to choose the
reading. Then press the User Info/Support button to view
details about that reading (Figure 8-8).
Figure 8-7
Figure 8-8
View multiple-day trends
1. On the Home screen, use the Up/Down Controller buttons
to choose My records, then press Select.
2. Choose BG history, then press Select.
3. Press Trends to display blood glucose data for the past 7
days.
4. Continue pressing the middle soft key to view trends for the
previous 14, 30, 60 and 90 days.
The PDM displays the same details for multiple days as for
single days, plus the average number of BG measurements
taken per day (Figure 8-10).
Figure 8-9
4. Press Close to return to the List view.
5. Press Graph to see a graph of the data (Figure 8-9).
100
Figure 8-10
Understanding Your Records
5. For the 7-, 14- and 30-day trends, press Graph to see a graph
of the trends (Figure 8-11). (Graphs are not available for 60- or
90-day trends.) Press Stats to return to the detail view.
Figure 8-11
Figure 8-12
■ Alarm Records
The PDM lists the entire alarm history for the OmniPod System.
The PDM can store over 90 days’ worth of alarm records.
1. On the Home screen, use the Up/Down Controller buttons
to choose My records, then press Select.
2. Choose Alarm history, then press Select.
The PDM displays the date, time and type of each alarm
(Figure 8-12).
3. Press the Up/Down Controller buttons to see additional
screens.
4. Choose an alarm record, then press User Info/Support to
see more information.
■ Carbohydrate Records
6. Press Back to return to the single-day trends.
The PDM displays the records of carbohydrates you have
entered.
1. On the Home screen, use the Up/Down Controller buttons
to choose My records, then press Select.
2. Choose Carb history, then press Select.
The PDM displays the date, time and grams of carbohydrate
you have entered (Figure 8-13 on the following page).
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8 Understanding Your Records
Figure 8-13
Figure 8-14
2. Choose All history, then press Select.
The PDM displays all history for the most recent date (Figure
8-14).
3. Press the Up/Down Controller buttons to see additional
days.
Press Event to use the Up/Down Controller buttons to scroll
through the list of information on the screen. Press Day to
use the Up/Down Controller for dates.
■ User Information/Support
3. Press the Up/Down Controller buttons to see additional
days.
Press Event to use the Up/Down Controller buttons to scroll
through the list of information on the screen. Press Day to
use the Up/Down Controller buttons for dates.
■ All Records
The PDM displays the combined insulin delivery, blood glucose,
alarm and carbohydrate records.
1. On the Home screen, use the Up/Down Controller buttons
to choose My records, then press Select.
102
You or your healthcare provider may have entered personal
contact information during your start-up visit. To view this information, press the User Info/Support button (to the right of the
Power button) while on the Home screen. Or follow the steps
below to view the information. You can add or change the user
information at any time.
You may want to include your name, address, phone, email
address, emergency contact and phone, doctor’s or healthcare
provider’s name and phone, prescription numbers or other
information.
The user information screen also displays product information
for your OmniPod System (make, model, serial number). You cannot change this information.
Understanding Your Records
The User Info/Support icon is also displayed on
the suggested bolus screen. For information about
the support information displayed on these
screens, see Chapter 4, Understanding and Delivering Bolus Doses.
Figure 8-15
Figure 8-16
Add or change user information
The first line of My Info displays the information that was
entered for the ID screen during your PDM setup. For
information on editing this line, see Chapter 6, Using the
Personal Diabetes Manager, “Customize the Personal
Diabetes Manager.”
1. On the Home screen, use the Up/Down Controller buttons
to choose My records, then press Select.
2. Choose My info, then press Select.
3. Choose an existing line or [My info] (Figure 8-15), then press
Edit.
4. 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.
5. Press the middle soft key to move the underscore to the next
character.
6. Enter each character one at a time. For example, if you want
to enter your address, you might enter 5, 6, 5, [space], M, a, i, n,
[space], S, t, [period]. (A blank character or space is the first
and last option in the scrolling menu.)
For your healthcare provider and local phone number, you
might enter J, a, n, e, [space], S, m, i, t, h, [comma], [space], 5, 5,
5, [hyphen], 1, 2, 3, 4 (Figure 8-16).
7. Press Save.
8. Repeat steps 3–7 for each line of personal information you
want to enter or change. Twenty lines are available.
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CHAPTER 9
Living with Diabetes
■ Your Role: Safely Using the OmniPod System
Before deciding on the OmniPod® Insulin Management System,
you and your healthcare provider discussed the advantages and
benefits of the OmniPod System, as well as the responsibilities
that come with insulin pump therapy. Remember: safe use
begins and ends with you. If you have questions or doubts about
being able to safely use the OmniPod System at any time, consult
your healthcare provider immediately.
Most problems are easily avoided by:
• Learning all you can about successful diabetes management.
• Being actively involved in your treatment.
• Checking your blood glucose levels frequently.
• Washing your hands and disinfecting infusion sites to reduce
the possibility of infection.
104
•
•
•
Being aware of the signs of hypoglycemia (low blood glucose), hyperglycemia (high blood glucose), and diabetic ketoacidosis (DKA). (See “Avoid Lows, Highs and DKA” later in this
chapter.)
Keeping a diabetes emergency kit with you at all times. (See
“Prepare for Emergencies” later in this chapter.)
Knowing how to contact your healthcare provider in case of
an emergency.
If you are unable to use the OmniPod Insulin Management System according to instructions, you may
be putting your health and safety at risk. Talk with
your healthcare provider if you have questions or concerns about using the OmniPod System.
Living with Diabetes
■ Daily Diabetes Management Activities
To ensure proper OmniPod System operation and your continued good health:
• Check your blood glucose frequently
• Inspect the infusion site daily
Check your blood glucose frequently
When you routinely check your blood glucose level, you can identify and treat high or low blood glucose before it becomes a
problem (see “Avoid Lows, Highs and DKA” later in this chapter).
Check your blood glucose (BG):
• At least 4 to 6 times a day: when you wake up, before every
meal, and before going to bed
• Whenever you feel nauseated or sick
• Before driving a car
• Whenever your blood glucose has been running unusually
high or low
• If you suspect that your blood glucose is high or low
• Before, during, and after exercise
• As directed by your healthcare provider
Inspect the infusion site daily
At least once a day, use the Pod’s viewing window to inspect the
infusion site. Check the site for signs of infection, such as pain,
swelling, redness, discharge or heat.
If an infusion site shows signs of infection:
1. Immediately remove the Pod and apply a new
one at a different site (see Chapter 5, Using the Pod).
2. Contact your healthcare provider.
Treat the infection according to instructions from
your healthcare provider. (Refer to Chapter 5, Using
the Pod, for how to prepare and care for a site.)
Consider making infusion site checks a part of your
regular daily routine (like showering or brushing your
teeth). That way, it’s easy to remember. Verify there is
no wetness or scent of insulin, where as may indicate
the cannula has dislodged.
If you observe blood in the cannula, check your blood
glucose more frequently to ensure insulin delivery
has not been affected. If you experience unexpected
elevated blood glucose levels, change your Pod.
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9 Living with Diabetes
■ Prepare for Emergencies
Keep an emergency kit with you at all times to
quickly respond to any diabetes emergency. The kit
should include:
• Several new, sealed Pods
• Extra new PDM batteries (at least two AAA alkaline)
• A vial of rapid-acting U-100 insulin (See the warning on page x of the Introduction for insulins
approved for use in the OmniPod System.)
• Syringes for injecting insulin
• Instructions from your healthcare provider about
how much insulin to inject if delivery from the
Pod is interrupted
• Blood glucose test strips
• Ketone test strips
• Lancing device and lancets
• Glucose tablets or another fast-acting source of
carbohydrate
• Alcohol prep swabs
• A copy of the letter from your healthcare provider for airline security (see “Minimize airport
security delays” later in this chapter)
106
•
•
Phone numbers for your healthcare provider
and/or doctor in case of an emergency
Glucagon kit and written instructions for giving
an injection if you are unconscious (see ”Avoid
Lows, Highs and DKA” later in this chapter)
Ask your healthcare provider to help you develop
plans for handling emergency situations, including
what to do if you cannot reach your healthcare
provider.
■ Water and Your Pod
The Pod is waterproof to a depth of 25 feet for up to 60 minutes
(IPX8). After the Pod gets wet, rinse it off with clean water and dry
it with a towel.
Do NOT expose your Pod to water at depths greater
than 25 feet or for longer than 60 minutes. Check the
infusion site often to make sure the Pod and soft cannula are securely applied and in place. If the cannula
is not properly inserted, hyperglycemia may result.
The Personal Diabetes Manager (PDM) is not waterproof. Do NOT place it in or near water.
9
Living with Diabetes
■ Traveling and Vacationing
Plan for changing time zones
If you’re planning a vacation or business trip to a different time
zone, you may need to adjust your basal rate programs. For
changes of just a few hours, basal rate adjustments are minor
and easy to calculate. For long-distance travel, however, figuring
out the correct program can be more challenging. Your healthcare provider can help with these adjustments.
Take enough supplies
Keeping your emergency kit (refer to Page 106; Prepare for Emergencies) with you during trips or vacations
is especially important (see “Prepare for Emergencies” earlier in
this chapter). It may be difficult or impossible to get insulin or
supplies in an unfamiliar place. If traveling by air, be sure to pack
your supplies in your carry-on luggage. When packing for travel,
take more supplies than you think you’ll need. Be sure to include:
• Diabetes emergency kit packed in your carry-on luggage
• Enough Pods for your trip, plus a backup supply
• Extra new PDM batteries
• Additional blood glucose meter
•
•
•
•
•
Insulin syringes or pens in case you need injections
Several vials of insulin or insulin cartridges if you use a pen
Glucagon kit (Make sure any person you are traveling with
knows how to give the injection.)
Alcohol prep swabs
Written prescriptions for all medications and supplies
(Generic medications may be easier to find than brand
names outside the U.S.)
When you travel outside the country or for long periods of time, be sure to take extra Pod supplies. Call
800-591-3455 (from outside the United States: 781457-5098) to order additional supplies for your trip.
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9 Living with Diabetes
Minimize airport security delays
With changing airport security checks and screening procedures, you may have questions on how this impacts
traveling with your diabetes supplies. Below you will find
more information on prepping for travel and what you can
expect when going through security checkpoints.
Travel Preparation
• Review theTSA's website for travel updates
• Pack extra supplies and hypoglycemia treatments
• Carry contact information for your physician
• Arrive at the airport 2-3 hours prior to your flight
To ensure airport security checks run smoothly, be sure you have
the following items easily accessible:
• All diabetes supplies in your carry-on luggage
• A signed letter from your healthcare provider explaining
you need to carry insulin supplies and OmniPod equipment
• Prescriptions for all medications and supplies with original prescription labels
Screening Procedures
The TSA offers the option of requesting a visual inspection of
your medical supplies rather than putting them through the Xray. This must be requested before the screening process begins.
Your medical supplies should be ready in a separate bag when
108
you approach the Security Officer.
In order to prevent contamination or damage to your supplies,
the TSA states that you should be asked at the security
checkpoint to display, handle, and repack your own supplies
during the visual inspection process. Any medication and/or
associated supplies that cannot be cleared visually must be submitted for X-ray screening.1
If you're concerned or uncomfortable about going through the
walk-through metal detector, the TSA states that you should
notify the Security Officer that you're wearing a pump and would
like a full-body pat-down and a visual inspection of your pump
instead. You should also advise the Security Officer that the insulin pump cannot be removed because it is inserted with a
catheter (needle) under the skin.2
Visit the TSA's Contact Center if you have any further questions or
concerns.
If the security detector goes off, tell the security screener that you
have diabetes and wear an insulin Pod (pump).
Pods and PDMs can safely pass through airport X-ray
machines (see the FCC notice in the Appendix).
Living with Diabetes
Keep supplies accessible
On airplanes and trains, keep these items with you, rather than
checking them:
• Personal Diabetes Manager (PDM)
• An emergency kit
• Vials of insulin (cargo area temperatures may affect insulin)
• A copy of your healthcare provider’s letter (see “Minimize airport security delays”)
• Prescriptions for insulin and supplies
• Snacks, in case food is not available
• Bottled water (especially on planes) to prevent dehydration
The name and phone number of a physician at your final
destination, in case of emergency.
General precautions
• Keep careful records and discuss changes and adjustments
with your healthcare provider.
• Tell your healthcare provider if you have extreme highs or
lows, or if highs or lows are occurring more often than usual.
• If you have technical problems with your OmniPod System
and cannot resolve them, do not hesitate to call Customer
Care.
Avoid Lows, Highs and DKA
You can avoid most risks related to using the OmniPod System
by practicing proper techniques and by acting promptly at the
first sign of trouble. You can avoid potential problems by
knowing the signs of hypoglycemia (low blood glucose), hyperglycemia (high blood glucose) and diabetic ketoacidosis (DKA).
The easiest and most reliable way to avoid these conditions is to
check your blood glucose often.
Hypoglycemia unawareness is a condition in which
you do not realize when your blood glucose level is
low. If you are prone to hypoglycemia unawareness,
you may want to use the OmniPod System’s blood
glucose reminder and check your blood glucose
more frequently. See “Alerts and Reminders” in Chapter 6, Using the Personal Diabetes Manager, for how
to set the reminder.
Hypoglycemia (low blood glucose)
Hypoglycemia can occur even when a Pod is working properly.
Never ignore the signs of low blood glucose (no matter how
mild). If left untreated, severe hypoglycemia can cause seizures
or lead to unconsciousness. If you suspect that your blood glucose level is low, check your BG level to confirm.
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9 Living with Diabetes
Symptoms of hypoglycemia
Never ignore these symptoms:
• Shakiness
• Fatigue
• Unexplained sweating
• Cold, clammy skin
• Weakness
• Blurred vision or a headache
• Sudden hunger
• Rapid heart rate
• Confusion
• Tingling in the lips or tongue
• Anxiety
•
•
•
•
Work with your healthcare provider to establish individualized blood glucose targets and guidelines.
Keep a fast-acting carbohydrate with you at all times to
respond quickly to low blood glucose. Examples of fastacting carbs are glucose tablets, hard candies or juice.
Teach your friends, family members and colleagues to
recognize the signs of hypoglycemia, so they can help if you
develop hypoglycemia unawareness or a severe adverse
reaction.
Keep a glucagon injection kit with your emergency supplies.
Teach friends and family members how to give a glucagon
injection in case you have severe hypoglycemia and become
unconscious.
Periodically check the expiration date of your glucagon
kit to make sure it has not expired.
To avoid hypoglycemia (low blood glucose)
Make sure your blood glucose is at least 100 mg/dL
before driving or working with dangerous machinery
or equipment. Hypoglycemia may cause you to lose
control of a car or dangerous equipment. Also, when
you focus intently on a task, you may miss the symptoms of hypoglycemia.
110
Always carry medical identification (emergency
wallet card) and wear an emergency medical necklace or bracelet such as the Medic Alert tag. (See the
end of the Appendix for address, telephone and
website information for obtaining these items.)
Living with Diabetes
Again, frequent blood glucose checks are the key to avoiding
potential problems. Detecting low blood glucose early lets you
treat it before it becomes a problem.
Check with your healthcare provider for guidance in any and all
areas listed above.
To treat hypoglycemia (low blood glucose)
Any time your blood glucose is low, treat immediately. Check it
every 15 minutes while you are treating, to make sure you don’t
overtreat the condition and cause blood glucose levels to rise
too high.
Even if you cannot check your blood glucose, do NOT
wait to treat symptoms of hypoglycemia, especially
if you are alone. Waiting to treat symptoms could
lead to severe hypoglycemia, which can quickly lead
to shock, coma or death.
1. If blood glucose is below 70 mg/dL, eat or drink 15 grams of
fast-acting carbohydrate, such as glucose tablets, juice, or
hard candy (see “How much is 15 grams of carbohydrate?”
below).
Do NOT use chocolate or candy bars to treat low
blood glucose. Their fat content slows down glucose
absorption.
3. If blood glucose remains low, eat another 15 grams of
carbohydrate. Contact your healthcare provider as needed
for guidance.
4. Repeat steps 2 and 3 until blood glucose is within the BG goal.
5. Investigate possible cause for hypoglycemia to avoid similar
problems in the future (see “Possible causes of hypoglycemia
(low blood glucose)” on the next page).
6. How much is 15 grams of carbohydrate?
Examples of fast-acting foods:
Three 5-gram glucose tablets, or four 4-gram tablets
4 ounces (118 milliliters) of apple or orange juice
6 Lifesavers™ or similar hard candy
1/2 can of regular (non-diet) soda
2 tablespoons (30 milliliters) of table sugar, honey or corn syrup
Teach people you trust (like family members and
close friends) how to give a glucagon injection. You
will need to rely on them to give it to you if you have
severe hypoglycemia and become unconscious.
Include a copy of the glucagon instructions in your
emergency kit and periodically review the procedure with family and friends.
2. Check blood glucose again after 15 minutes.
111
9 Living with Diabetes
Possible causes of hypoglycemia (low blood glucose)
Possible cause of low
Incorrect basal
program
Incorrect bolus
timing
Bolus too large
112
Suggested action
Possible cause of low
Confirm that correct basal program
is active.
Confirm that PDM time is set correctly.
Consult your healthcare provider
about adjusting your basal programs or using a temporary (temp)
basal rate.
Incorrect target
blood glucose levels
Take bolus with food.
Check blood glucose before giving
meal bolus; if necessary, adjust
bolus.
Check bolus size and timing.
Do NOT overcorrect for post-meal
glucose levels.
Check carb intake.
Consult healthcare provider for
guidance.
Prone to severe hypoglycemia
Suggested action
Consult healthcare provider about
refining these settings as needed.
Incorrect correction
factor (sensitivity
factor)
Incorrect insulin-tocarb ratio (IC)
Hypoglycemia
unawareness
Unplanned physical
activity
Consult healthcare provider about
hypoglycemia unawareness and
about raising target blood glucose
levels.
If blood glucose is below 100 mg/dL,
eat a snack before activity.
Consult your healthcare provider
about using a temporary (temp)
basal rate.
Living with Diabetes
Possible cause of low
Suggested action
Prolonged or intense
exercise
Adjust insulin delivery as instructed
by your healthcare provider.
Check blood glucose before, during
and after activity and treat as
necessary.
Effects of exercise can last
several hours—even a full
day—after activity ends.
Consult your healthcare provider
about adjusting your basal programs or using a temporary (temp)
basal rate.
Low carbohydrate
intake prior to
activity
Consume carbohydrate before
activity, especially if you have not
decreased insulin beforehand.
Alcohol consumption
Check blood glucose before going
to bed.
Consult healthcare provider for
guidance.
Hyperglycemia (high blood glucose)
Insulin Pods use rapid-acting insulin, so you have no long-acting
insulin in your body. If an occlusion (interruption of insulin delivery from the Pod) occurs, your blood glucose can rise rapidly.
An occlusion may result from a blockage, Pod malfunction or from using old or inactive insulin. If
insulin delivery is interrupted by an occlusion, check
your blood glucose level and follow the treatment
guidelines established by your healthcare provider.
Hyperglycemia could result if appropriate actions
are not taken.
Symptoms of hyperglycemia (high blood glucose)
• Fatigue
• Frequent urination, especially during the night
• Unusual thirst or hunger
• Unexplained weight loss
• Blurred vision
• Slow healing of cuts or sores
Hyperglycemia symptoms can be confusing.
Always check your blood glucose before you
treat for hyperglycemia.
113
9 Living with Diabetes
To avoid hyperglycemia (high blood glucose)
Check your blood glucose at least 4–6 times a day (when you
wake up, before each meal, and before going to bed). In addition, always check it:
• If you feel nauseated or sick
• Before driving a car
• Whenever your blood glucose has been running unusually
high or low
• If you suspect that your blood glucose is high or low
• Before, during and after exercise
• As directed by your healthcare provider
To treat hyperglycemia (high blood glucose)
Always check your blood glucose levels frequently while treating
hyperglycemia. You don’t want to over-treat the condition and
cause your BG level to drop too far.
1. Check your blood glucose level. The result will help you to
find out how much insulin is needed to return your blood
glucose to the BG goal.
2. If your blood glucose is 250 mg/dL or above, check for
ketones. If ketones are present, follow your healthcare
provider’s guidelines.
3. If ketones are not present, take a correction bolus as prescribed by your healthcare provider.
114
4. Check blood glucose again after 2 hours.
5. If blood glucose levels have not decreased, take a second
bolus by injection, using a sterile syringe. Ask your healthcare
provider whether to inject the same amount of insulin as in
step 3.
6. If you feel nauseated at any point, check for ketones and call
your healthcare provider immediately (see “Diabetic ketoacidosis (DKA)” later in this chapter).
7. If blood glucose remains high after another 2 hours (a total of
4 hours), replace the Pod. Use a new vial of insulin to fill the
new Pod. Then:
• Contact your healthcare provider for guidance.
• Drink eight ounces of water every 30 minutes until blood
glucose is within BG goal.
If you need emergency attention, ask a friend or
family member to take you to the emergency
room or call an ambulance. Do NOT drive yourself.
8. Investigate possible cause for hyperglycemia to avoid similar
problems in the future (see “Possible causes of hyperglycemia (high blood glucose)”.
Living with Diabetes
Possible causes of hyperglycemia (high blood glucose)
Possible cause of high
Suggested action
Possible cause of high
Suggested action
Expired insulin
Deactivate and remove used Pod.
Apply a new Pod filled from a new
vial of insulin.
Empty Pod
Deactivate and remove used Pod.
Apply a new Pod in a different
location.
Incorrect basal
program
Confirm that correct basal program
is active.
Confirm that PDM time is set
correctly.
Consult your healthcare provider
about adjusting your basal programs or using a temporary (temp)
basal rate.
Incorrect bolus
timing
Check carb intake.
Take bolus with food.
Check blood glucose before giving
meal bolus; if necessary, adjust
bolus.
Consult healthcare provider for
guidance.
Insulin exposed
to extreme
temperatures
Infusion site in or
near a scar or mole
Deactivate and remove used Pod.
Apply a new Pod in a different
location.
Infected infusion site
Deactivate and remove used Pod.
Apply a new Pod in a different location and consult your healthcare
provider.
Dislodged cannula
Deactivate and remove used Pod.
Apply a new Pod in a different
location.
Avoid sites near a waistband,
belt, or other areas where friction may dislodge the cannula.
Bolus too small
115
9 Living with Diabetes
Possible cause of high
Suggested action
Possible cause of high
Suggested action
High-protein or
high-fat meal
Calculate protein/fat intake and
account for it in your bolus timing
and bolus type.
Consult healthcare provider about
using the extended bolus option.
Weight loss or gain
Consult your healthcare provider
for guidance.
Less activity than
normal
Consult your healthcare provider
about adjusting your basal programs or using a temporary (temp)
basal rate.
Blood glucose value
greater than
250 mg/dL (with
ketones present)
before exercise
Do NOT exercise when ketones are
present. (Blood glucose increases
with exercise when ketones are
present.)
Consult healthcare provider for
guidance.
Infection or illness
See “Sick days” later in this chapter.
Consult your healthcare provider
about sick day guidelines and
about medication changes.
Medication change
116
Menstrual cycle
Pregnancy
Check with your healthcare provider for guidance on any
of the causes or suggested actions above.
Living with Diabetes
Diabetic ketoacidosis (DKA)
Insulin Pods use rapid-acting insulin, so you have no long-acting
insulin in your body. If insulin delivery from the Pod is interrupted
(an occlusion), your blood glucose can rise rapidly and lead to
diabetic ketoacidosis (DKA). DKA is a serious—but totally preventable—emergency that can occur if you ignore high blood
glucose levels.
If left untreated, DKA can cause breathing difficulties,
shock, coma, and eventually death.
Symptoms of DKA
● Nausea and vomiting
● Abdominal pain
● Dehydration
● Fruity-smelling breath
● Dry skin or tongue
● Drowsiness
● Rapid pulse
● Labored breathing
The symptoms of DKA are much like those of the flu. Before
assuming you have the flu, check your blood glucose and check
for ketones to rule out DKA.
To avoid DKA
The easiest and most reliable way to avoid DKA is by checking
your blood glucose at least 4–6 times a day. Routine checks
allow you to identify and treat high blood glucose before DKA
develops.
To treat DKA
• Once you have begun treatment for high blood glucose,
check for ketones. Check for ketones any time your blood
glucose is 250 mg/dL or above.
• If ketones are negative or trace, continue treating for high
blood glucose.
• If ketones are present, and you are feeling nauseated or ill,
immediately call your healthcare provider for guidance.
• If ketones are positive, but you are not feeling nauseated or ill,
replace the Pod, using a new vial of insulin.
• Check blood glucose again after 2 hours. If blood glucose
level has not declined, immediately call your healthcare
provider for guidance.
If you need emergency attention, ask a friend or
family member to take you to the emergency
room or call an ambulance. Do NOT drive yourself.
117
9 Living with Diabetes
■ Handling Special Situations
•
Sick days
Any physical stress can cause your blood glucose to rise, and illness is a physical stress. Your healthcare provider can help you
make a plan for sick days. The following are only general
guidelines.
When you are ill, check your blood glucose more often (at least
once every 2 hours) to avoid DKA. The symptoms of DKA are
much like those of the flu. Before assuming you have the flu,
check your blood glucose to rule out DKA (see ”Diabetic ketoacidosis (DKA)” earlier in this chapter).
•
To handle sick days
• Treat the underlying illness to promote faster recovery.
• Eat as normally as you can.
• Adjust bolus doses, if necessary, to match changes in meals
and snacks.
• Always continue your basal insulin, even if you are unable to
eat. Contact your healthcare provider for suggested basal
rate adjustments during sick days.
• Check your blood glucose every 2 hours and keep careful
records of results.
• Check for ketones when blood glucose is 250 mg/dL or
higher.
118
Follow your healthcare provider’s guidelines for taking additional insulin on sick days.
Drink plenty of non-caffeinated fluids to prevent dehydration.
If you are well enough to eat, drink sugar-free beverages. However, if you are too sick to eat solid foods,
alternate between sugar-free beverages and those
containing sugar.
•
Call your healthcare provider immediately if you have:
• Persistent nausea
• Vomiting for more than 2 hours
• High blood glucose or ketones that stay high even
though you take extra insulin
• Low blood glucose with nausea and vomiting
Exercising, playing sports or working hard
Check your blood glucose levels before, during and after exercising, playing sports, or doing unusually hard physical labor.
The Pod’s adhesive keeps it securely in place for up to 3 days.
However, if necessary, several products are available to enhance
adhesion. Ask your healthcare provider about these products.
Avoid getting body lotion, creams, or oils near the infusion site;
these products may loosen the adhesive.
Living with Diabetes
For some contact sports, you may want to remove the Pod.
Be sure to check your blood glucose levels before removing the
Pod and after applying a new one. Pods are designed for onetime use. Do not attempt to reapply a used Pod.
If possible, avoid wasting Pods by planning removal
times that coincide with a scheduled Pod replacement.
If you will need to remove the Pod for more than 1 hour, ask your
healthcare provider to recommend appropriate guidelines.
Surgery or hospitalization
For scheduled surgeries or hospitalization, you should tell the
doctor/surgeon or hospital staff about your insulin Pod. It may
be necessary to remove it for certain procedures or treatments.
Remember to replace the basal insulin that was missed while the
Pod was removed. Your healthcare provider can help you prepare for these situations.
Always carry medical identification and wear an
emergency medical necklace or bracelet such as
the Medic Alert tag.
X-rays, MRIs and CT scans
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 on
Pod removal guidelines.
The Pod and PDM can tolerate common electromagnetic and electrostatic fields, including airport security
and cellular phones.
119
CHAPTER 10
Alerts and Alarms
■ Safety Checks
The OmniPod System has a very important safety feature: It can
check its own functions and let you know when something
needs attention. When you turn on the Personal Diabetes Manager (PDM), the System automatically performs a series of safety
checks. (Refer to Page 54 for detailed instructions. The ID screen
must be confirmed before you can check Pod status.) To make
you aware of a serious or potentially serious condition, the System sounds an alarm and displays an on-screen message. The
message has instructions for taking care of the alarm condition.
Alarm conditions are easy to handle. They are not a problem if
you attend to them promptly.
■ Blood Glucose Meter Alerts
These alerts let you know about an error in the blood glucose
meter, test strip, sample, or results. The PDM beeps and displays
an error message number, as in Figure 10-1.
120
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.
Figure 10-1
Alerts and Alarms
10
The following table explains what the message could mean and
what you should do.
Alert error message
Meter Error 1
See user manual for
further instructions.
Meter Error 2
See user manual for
further instructions.
Possible causes
Action
•
•
•
•
Blood sample is too small.
Problem with the test strip.
Problem with the meter.
Very low blood glucose: less
than 20 mg/dL.
1. If you have symptoms, such as weakness, sweating, nervousness,
headache or confusion, follow the recommendations of your healthcare provider for treating hypoglycemia.
2. Conduct a control solution test using a new test strip. If the results of
the control solution test are within the range printed on the side of
the test strip vial, retest using blood and a new test strip.
3. If the control solution test does not work, or the error persists, call
Customer Care.
•
•
•
Problem with the test strip.
Problem with the meter.
Very high blood glucose:
above 500 mg/dL.
HIGH control solution
applied when temperature
is too cold. (This applies
only to control solution
labeled HIGH.)
1. If you have symptoms, such as thirst, fatigue, excess urination or
blurry vision, follow the recommendations of your healthcare provider for treating hyperglycemia.
2. Conduct a control solution test using a new test strip. If the results of
the control solution test are within the range printed on the side of
the test strip vial, retest using blood and a new test strip.
3. If the control solution test does not work or the error persists, call
Customer Care.
•
121
10 Alerts and Alarms
Alert error message
Meter Error 3
Possible causes
•
1. Be sure you see the Blood Drop and Test Strip symbols on the display
screen before you apply blood or control solution.
2. Conduct a control solution test using a new test strip. If the results of
the control solution test are within the range printed on the side of
the test strip vial, retest using blood and a new test strip.
3. If the control solution test does not work or the error persists, call
Customer Care.
•
•
Incorrect test procedure.
For example, putting blood
on the test strip before
inserting the test strip into
the meter or applying
blood before the Blood
Drop and Test Strip symbols
display.
Problem with the test strip.
Problem with the meter.
•
•
Problem with the test strip.
Problem with the meter.
1. Conduct a control solution test using a new test strip. If the results of
the control solution test are within the range printed on the side of
the test strip vial, retest using blood and a new test strip.
2. If the control solution test does not work or the error persists, call
Customer Care.
•
Blood sample was applied
while the code number was
being changed.
1. Retest using a new test strip. Do not press any buttons or Soft Keys
while applying blood or control solution to the test strip.
2. If the error persists, call Customer Care.
See user manual for
further instructions.
Meter Error 4
See user manual for
further instructions.
Meter Error 6
See user manual for
further instructions.
122
Action
Alerts and Alarms
■ Alarms
The OmniPod System provides alarms to make you aware of
serious or potentially serious conditions. When a condition
occurs that requires your attention an Advisory Alarm or a
Hazard Alarm will sound. Advisory alarms beep intermittently
and inform you about a condition that requires your attention.
Hazard alarms are continuous tones and occur when either the
Pod or PDM is in a serious condition. During an alarm the PDM
will display an on-screen message with instructions for taking
care of the alarm condition. Be sure to respond to all alarms
when they occur.
Details on how to handle an Advisory or a Hazard Alarm are
below:
Many alarms (such as Auto-off) will escalate and
result in deactivation of the active Pod if ignored. Be
sure to respond to all alarms when they occur.
Advisory Alarms
Advisory alarms tell you about a condition that requires your
attention. Each advisory alarm beeps intermittently. When you
hear an advisory alarm, first turn on the PDM to display the
Status screen. The PDM communicates with the Pod, if
necessary, and the screen displays a message describing the
alarm and how to resolve it. All advisory alarms are time sensitive
and require a response. Some advisory alarms escalate to hazard
10
alarms if you do not respond within a certain time period (as
noted in the following table).
Some advisory alarms are controlled by levels you set in the
Settings screen. One example is the level at which the Low
reservoir volume alarm sounds.
Hazard Alarms
Hazard alarms occur either when the Pod is in a very serious condition or something is wrong with the PDM. Hazard alarms are
continuous tones and each has an on-screen message. Follow
the instructions in the message to fix the alarm situation. For
details, see the following table.
When a hazard alarm occurs in the Pod, all insulin
delivery stops. Failing to address the situation could
result in hyperglycemia. If you had a temp basal or
extended bolus running when the hazard occurred,
the PDM will remind you of this.
Due to the serious nature of hazard alarms, you must
act promptly to resolve them.
1. Acknowledge the alarm condition by pressing
OK, which silences the alarm.
2. Deactivate and remove the active Pod (see Chapter 5, Using the Pod).
3. Activate and apply a new Pod (see Chapter 5,
Using the Pod).
123
10 Alerts and Alarms
If you ever need to return the PDM for repair or
replacement, contact your healthcare provider
for instructions on going back to treatment by
injections.
Alarm
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 your PDM, having these settings
handy will make setup very easy.
Type
Source
Beep Pattern
Action
End of insulin suspend.
Press OK to resume basal
rate delivery.
Advisory
Alarm
Pod
and
PDM
2 sets of beeps every minute for 3
minutes.
Press OK to resume insulin delivery at
programmed basal rate.
Auto-off alert
Advisory
Alarm
Pod
and
PDM
2 sets of beeps every minute for 15
minutes.
124
Repeats every 15 minutes until
insulin delivery is resumed.
Escalates to Auto-off hazard alarm
if not acknowledged within 15
minutes.
Insulin delivery will not resume
until you press OK. If you do not
press OK to resume insulin delivery, you could develop hyperglycemia (high blood glucose).
Press OK to acknowledge.
The Auto-off alert will escalate to
a hazard alarm if ignored and
will result in the deactivation of
your active Pod. Be sure to
respond to the alert when it
occurs.
Alerts and Alarms
Alarm
Auto-off.
Remove Pod now.
10
Type
Source
Beep Pattern
Action
Hazard
Alarm
Pod
and
PDM
Continuous tone.
Pod has been deactivated. Insulin delivery has stopped. Press OK to acknowledge.
Change Pod.
Check blood glucose.
Low reservoir.
Replace Pod soon.
(This is based on the volume level you selected.)
Advisory
Alarm
Pod
and
PDM
2 sets of beeps every minute for 3
minutes.
Repeats every 60 minutes until
acknowledged.
Escalates to Empty reservoir
hazard alarm when empty.
Empty reservoir.
Insulin delivery stopped.
Change Pod now.
Hazard
Alarm
Pod
and
PDM
Continuous tone.
Press OK to acknowledge.
The Low reservoir alert will
escalate to an Empty reservoir
hazard alarm when insulin is
depleted. Be sure to respond to
the alert when it first occurs.
This alarm occurs when the Pod's
reservoir is out of insulin. Press OK to
acknowledge.
Change Pod.
Check blood glucose.
125
10 Alerts and Alarms
Alarm
Pod expiration advisory.
Change Pod now.
Type
Source
Beep Pattern
Action
Advisory
Alarm
Pod
and
PDM
2 sets of beeps repeat periodically.
Press OK to acknowledge.
Repeats every 15 minutes during
the last hour of the Pod’s life and is
independent of the Expiration notification that you can set. (See Chapter 6, Using the Personal Diabetes
Manager.)
Change Pod. (See Chapter 5, Using the
Pod.)
Escalates to Pod expired hazard
alarm.
Pod expired.
Insulin delivery stopped.
Change Pod now.
Hazard
Alarm
Pod
and
PDM
Continuous tone.
This alarm occurs when the Pod has
reached the end of its operating life.
Press OK to acknowledge.
Change Pod.
Check blood glucose.
Advisory
Stuck key detected.
Alarm
Check Home button to
resolve.
For technical support refer
to your User Guide.
126
PDM
2 sets of beeps every 5 minutes.
Check the key described on the screen.
(In this example, the stuck key is the
Home button.) Press the key to unstick
it.
If this does not work, call Customer
Care.
Alerts and Alarms
Alarm
Type
Source
Beep Pattern
Action
Occlusion detected.
Insulin delivery stopped.
Change Pod now.
Hazard
Alarm
Pod
and
PDM
Continuous tone.
Press OK to acknowledge.
Pod Error.
Insulin delivery stopped.
Change pod now.
Hazard
Alarm
10
Change Pod.
Check blood glucose.
Pod
or
PDM
Continuous tone.
This alarm occurs when the Pod detects
an unexpected error. Press OK to
acknowledge.
Change Pod.
Check blood glucose.
PDM Error.
Remove Pod now.
Call Customer Care:
800-591-3455.
Hazard
Alarm
PDM
Continuous tone.
This alarm occurs if an unexpected error
is detected in the PDM. Press OK to
acknowledge.
Remove Pod.
Call Customer Care immediately.
Check blood glucose.
127
10 Alerts and Alarms
Alarm
Type
Source
Beep Pattern
Action
PDM Error.
Memory corruption.
Press “Ok” to reset PDM
and delete all user settings. History records will
not be deleted.
Hazard
Alarm
PDM
Continuous tone.
This alarm occurs after the PDM is reset
and a memory corruption error occurs.
Press OK to acknowledge.
System Error.
Remove pod now.
Call Customer Care:
800-591-3455.
Hazard
Alarm
Change Pod.
Check blood glucose.
Pod
or
PDM
Continuous tone.
This alarm occurs if an unexpected error
is detected in the Pod or PDM. Press OK
to acknowledge.
Remove Pod.
Call Customer Care immediately.
Check blood glucose.
PDM Error.
Press OK to reset clock.
Hazard
Alarm
PDM
Continuous tone.
This alarm occurs after the PDM is reset,
indicating that the time and date must
be reset. Press OK to acknowledge.
Reset clock.
Check blood glucose.
128
Alerts and Alarms
Alarm
Type
Pod deactivation required. Hazard
Alarm
Press “Ok” to deactivate.
10
Source
Beep Pattern
Action
PDM
Continuous tone.
This alarm occurs after a PDM error
occurs that requires the user to reset the
date and time. Press OK to acknowledge.
Change Pod.
Check blood glucose.
■ Manual Shut-off of a Hazard Alarm
If you respond to a hazard alarm but the PDM cannot communicate with the Pod to acknowledge or shut off the alarm, you can
shut off the alarm manually.
1. Remove the Pod from your body if you have not already
done so.
2. Press the end of a paper clip or similar item straight down into
the manual alarm shut-off port (Figure 10-2) on the bottom
of the Pod. The port can be found by peeling back the adhesive pad from the bottom of the Pod at the square end. The
alarm shut-off port is to the right of the fill port.
3. Press the paper clip straight down into the manual alarm shut
off port until the alarm stops and can no longer be heard.
Then discard the Pod according to local waste disposal regulations.
Figure 10-1
Manual
alarm shutoff port
Fill
port
129
CHAPTER 11
Communication Failures
■ The Communication Process
■ Failure During Pod Activation or Operation
When you turn on or use the Personal Diabetes Manager (PDM),
it establishes communication with the active Pod. Usually, communication occurs quickly. Occasionally, communication takes
longer and the PDM displays the communication icon during
that time in the upper left-hand corner of the current screen.
However, if communication does not work, the PDM will walk
you through the necessary steps to re-establish communication.
Communication can fail if the PDM is:
• Too far from the Pod—The PDM and Pod should be side by
side while priming during activation.
• Interrupted by outside interference—See the “OmniPod
System Notice Concerning Interference” in the Appendix.
When you send an instruction from the PDM—such as Start to
begin bolus delivery or Enable to begin using a different basal
program—the Pod usually responds quickly. However, if the
PDM cannot send your instruction within a few seconds, it displays the “Communication error” screen (Figure 11-1 on the next
page).
1. Move the PDM closer to the Pod. The PDM will try to communicate with the Pod again. If communication still fails, you will
see the message in Figure 11-2 on the next page.
130
Communication Failures
Figure 11-1
Figure 11-2
2. Move across the room or to a different room. Then press
Retry.
a. If you press Retry within 2 minutes, the PDM tries to
communicate with the Pod again. If it cannot communicate, it displays the same screen as in Figure 11-2, then
finally the “Communication time-out” screen (Figure 113). Press OK to check the Pod status.
Figure 11-3
11
Figure 11-4
b. If the status check fails, you will see the screen in Figure
11-4. Press OK to try checking Pod status again or press
Discard to begin the deactivation process.
131
11 Communication Failures
3. If at any point in this process the PDM can communicate
again with the Pod, you will see either:
a. Figure 11-5, indicating that your original instruction or
command was successfully sent to the Pod. When you
press OK, or within 5 seconds, the System displays the next
screen in the command sequence you were entering.
b. Figure 11-6, indicating that your last command was not
sent to the Pod. Press OK.
If you were activating a Pod, the System returns to the previous screen where you can continue activation. If you
were issuing any other command, the System returns to
the Status screen, where you can reissue the command.
Figure 11-5
■ Failure During Pod Deactivation
To review the deactivation process, see “Deactivate the current
Pod” in Chapter 5, Using the Pod.
If you press Confirm to deactivate the active Pod and the PDM
cannot send your instruction to the Pod, you will see the screen
in Figure 11-7.
Figure 11-7
Figure 11-6
Either:
1. Press Retry to try deactivating the Pod again. If the PDM still
cannot send the instruction, you will see Figure 11-7 again.
Follow step 2.
132
Communication Failures
2. Press Discard. The PDM will consider the Pod lost and ask
whether you want to activate a new Pod.
If you have an unconfirmed correction bolus when you
discard a Pod, then the bolus calculator will be temporarily disabled. In this situation, the bolus calculator is disabled until the duration-of-insulin-action period passes
(Figure 11-8). If you have any questions, call Customer
Care.
11
■ Failure During Request for Status
If you turn on the PDM or press Status and the PDM cannot
communicate with the Pod, it displays a communication icon
(Figure 11-9). Below the icon is a soft key labeled Skip.
Either:
1. Wait until you see the “Pod status not available” screen
(Figure 11-10).
Figure 11-9
Figure 11-10
Figure 11-8
2. Press Skip to skip the communication process and immediately bring up Figure 11-10.
133
11 Communication Failures
If the Pod has expired, you will see the screen in
Figure 11-11 instead.
the “Communication error” screen (Figure 11-12).
Figure 11-12
Figure 11-13
Figure 11-11
At either “Pod status not available” screen, press Home to return
to the Home screen or press Status to send another status
request.
■ Failure During Bolus Cancellation
When you instruct the PDM to cancel a bolus, if the PDM cannot
send your instruction to the Pod within a few seconds, it displays
134
1. Move the PDM close to the Pod. The PDM tries to communicate with the Pod again.
2. If the PDM still cannot communicate with the Pod, you will
see the “Bolus status unknown” message (Figure 11-13).
Communication Failures
If your PDM is damaged or not working as
expected. contact Customer Care for assistance.
Be sure to check your blood glucose frequently.
Remove your Pod and contact your healthcare
provider for treatment guidelines to follow after
you remove it.
3. Move across the room or to a different room. Then either:
a. Press Discard to begin the deactivation process.
b. Press Retry to repeat the attempts to communicate with
the Pod. The PDM tries to communicate with the Pod
again. If it cannot communicate, it displays the same
screen as in Figure 11-13, then finally a second “Bolus
status unknown” screen (Figure 11-14). Press OK to check
the Pod status or press Discard to begin the deactivation
process.
4. If at any point in this process the PDM can communicate
again with the Pod, you will see Figure 11-15. The message
indicates that your original instruction to cancel the bolus
was successful.
a. Press OK. The PDM displays the screen in Figure 11-16,
showing how much insulin was delivered before the
bolus was canceled.
b. Press OK again to return to the Status screen.
Figure 11-14
11
Figure 11-15
Figure 11-16
135
Appendix
The OmniPod® Insulin Management System has no user-serviceable parts. If you require assistance operating or maintaining
the System, please call our Customer Care.
■ Pod Care and Maintenance
■ Personal Diabetes Manager Care and
Maintenance
Storage
Store unopened Pods in a cool, dry place. Extreme heat or cold
can damage Pods and cause them to malfunction. If Pods are
exposed to extreme temperatures, inspect them carefully before
use. Pods are sterile unless packaging is opened or damaged. Do
not apply or use a Pod if its sterile packaging is opened or
damaged.
Cleaning
Pods are waterproof. If you need to clean a Pod, you can gently
wash it with a clean, damp cloth. Or you can use mild soap and
water. However, do not use strong detergents or solvents. They
can damage the Pod’s casing or irritate the infusion site.
Hold the Pod securely and take care while cleaning
it, so the cannula doesn’t kink and the Pod doesn’t
become detached from your skin.
136
Storage
When you are not actively using the Personal Diabetes Manager
(PDM) to enter or change programs, you can store it in a convenient, nearby location. The storage location should be cool and
dry.
Do not store or leave the PDM where it may be
exposed to extreme temperatures, such as inside a
car. Extreme heat or cold can cause the device to
malfunction.
If the PDM is not safe from children or others who may press the
buttons by accident, consider using the optional PDM lock
safety feature to prevent accidental program changes (see
Chapter 6, Using the Personal Diabetes Manager).
Appendix
Cleaning and disinfecting
Keep your PDM test strip port and USB port free of debris and
liquids. Dirt, dust, blood, and control solution can impair the
functionality of your PDM or damage it.
If the battery compartment becomes soiled, gently shake out
the debris or use a dry, lint-free cloth to remove it.
Do NOT use IV Prep™ wipes, alcohol wipes, soap,
detergent, or solvents. Never put any liquid into the
battery compartment. The PDM is NOT waterproof.
Do NOT immerse it or place it in or near water.
Use the guidelines below to clean or disinfect your PDM:
1. Clean your PDM if it is visibly dirty. Disinfect your PDM at least
once per week.
2. Be sure to turn off your PDM before cleaning or disinfecting.
3. To clean and disinfect the outside surfaces of the PDM housing, use Dispatch® Hospital Cleaner Disinfectant Towels with
Bleach (available online through major retailers).
4. Following the instructions on the label of the Dispatch® Hospital Cleaner Disinfectant Towels with Bleach, wipe the outside surfaces of your PDM. Treated surfaces must remain wet
for a full (2) minutes.
While cleaning, do NOT allow debris or liquid to get
into the test strip port, USB port, battery compartment, or buttons.
5. Let your PDM air dry completely before checking your BG
next. We recommend you perform a control solution test to
ensure the System functions properly. See”Performing a Control Solution Test” in Chapter 7, Checking Your Blood Glucose.
6. When finished, thoroughly wash your hands with soap and
water.
7. If you require assistance, contact call our Customer Care.
Replacing batteries
The PDM uses two (2) AAA alkaline batteries. You can purchase
them at any grocery, hardware or convenience store.
AAA alkaline batteries are the preferred battery to
power the PDM. Do not use any other type of batteries. Never use old or used batteries; the PDM may
not work properly. Using any kind of batteries other
than alkaline may reduce battery life and cause damage to the PDM.
On average, a pair of batteries powers the PDM for 3 weeks. The
battery life indicator on the PDM shows the battery power level.
See ”Personal Diabetes Manager Icons” later in this Appendix for
the various battery power levels and their respective icons.
137
Appendix
The PDM automatically alerts you when its battery power gets
low (see Figure A-1). When you see the “Low PDM battery” alert,
press OK to turn off the alert. Replace the batteries as soon as
you can.
Figure A-1
If the batteries run out, data in the memory is at risk.
DO NOT remove the old batteries until you have
new ones at hand. The PDM protects data in the
memory for up to 2 hours after the batteries run out
or are removed.
Figure A-2
To replace batteries
1. Open the battery compartment on the back of the PDM by
pushing the compartment latch inward and then upward
(Figure A-2). No special tools are necessary.
2. Insert 2 new AAA alkaline batteries into the compartment.
The diagram inside the compartment shows you
which direction to insert the batteries.
When your PDM alerts you that battery power is getting
low, the PDM will maximize remaining battery life by:
• Turning off your vibration alert (if set)
• Disabling bright mode
• Disabling the test strip port light
Once the batteries are replaced, these functions resume.
138
3. Replace the battery door.
4. Turn the PDM face up. The PDM powers on automatically.
The PDM is now ready to use. Dispose of the old batteries in
accordance with local waste disposal regulations.
If the PDM becomes submerged in water
The PDM is not waterproof. Do not place it in water or leave it
near water where it can accidentally fall in. If it becomes submerged in water:
1. Dry the outside of the PDM with a clean, lint-free cloth.
Appendix
2. Open the battery compartment; remove the batteries and
discard them.
3. Use a clean, lint-free cloth to gently absorb any water in the
battery compartment.
4. Leave the battery compartment door open until the PDM is
thoroughly dry.
Never use a blow dryer or hot air to dry the Pod or
PDM. Extreme heat can damage the electronics.
5. Do not put in fresh batteries or attempt to use the PDM until
it has thoroughly air-dried.
If you drop the PDM
The PDM is built to withstand reasonable amounts of abuse, but
shock or a severe impact can damage it. If you drop the PDM or if
it is otherwise subjected to severe impact:
1. Inspect the outside of the PDM for visible signs of damage.
2. Press and hold the Power button to see whether the PDM
turns on and whether the LCD screen is damaged.
3. Inspect the inside of the battery compartment for visible
signs of damage.
4. Do NOT use the PDM if it appears damaged or is not working
as it should.
If you are unable to use your PDM to check your BG, have a back
up meter on hand to check your BG.
If your PDM is damaged or not working as it
should, call our Customer Care for assistance. Be
sure to check your blood glucose frequently.
Remove your Pod and contact your healthcare
provider for treatment guidelines to follow after
you remove it.
If you require assistance, call our Customer Care.
■ Storage and Supplies
Store all OmniPod System products and supplies
(including unopened Pods) in a cool, dry place. Products or supplies that have been exposed to extreme
temperatures may not function properly.
It is especially important to store your insulin in a wellcontrolled environment. Inspect insulin before using
it; never use insulin that looks cloudy or discolored.
Insulin that is cloudy or discolored may be old, contaminated or inactive. Check the insulin manufacturer’s
instructions for use and expiration date.
You can order all OmniPod System products and supplies by calling call our Customer Care.
139
Appendix
■ Suggested Bolus Calculator Examples and
Guidelines
A suggested bolus is equal to the sum of a correction bolus and
meal bolus, then adjusted for insulin on board, if applicable.
Examples of each of these elements are shown below.
Example of correction bolus
Target BG: 100 mg/dL
Current BG: 200 mg/dL
Correction factor (CF): 50
200 mg/dL (current) – 100 mg/dL (target) = 100 mg/dL
100 mg/dL ÷ 50 (CF) = 2 units correction bolus
If the reverse correction feature is turned On and if your current
BG is below your target BG, the suggested bolus calculator subtracts a correction amount from the meal bolus.
Example of reverse correction bolus:
Target BG: 100 mg/dL
Current BG: 75 mg/dL
Correction factor (CF): 50
75 mg/dL (current) – 100 mg/dL (target) = –25 mg/dL
–25 mg/dL ÷ 50 CF = –0.5 units reverse correction bolus
(reduces meal bolus)
140
Meal bolus calculation
Carbs entered ÷ insulin-to-carb (IC) ratio
Example of meal bolus
Carbs entered: 45 grams of carb
Insulin-to-carb ratio: 15
45 carbs ÷ 15 I/C ratio = 3 units meal bolus
Insulin-on-board (IOB) calculation
(Duration of insulin action – time since your previous bolus) ÷
(duration of insulin action) ∗ (previous bolus)
IOB from a previous correction bolus is called “correction IOB,”
and IOB from a previous meal bolus is called “meal IOB.”
Example of correction insulin-on-board (IOB)
Duration of insulin action: 3 hours
Time since previous correction bolus: 1 hour
Previous correction bolus: 3 units
3 hours – 1 hour = 2 hours
2 hours ÷ 3 hours = 2/3
2/3 ∗ 3 units = 2 units correction IOB
In other words, one hour after your previous correction bolus,
you have received only 1 unit of insulin from it; 2 units of insulin
are still working to correct your BG. This feature prevents delivering too much insulin when correcting a high BG.
Appendix
Example of meal IOB
Duration of insulin action: 3 hours
Time since previous meal bolus: 2 hours
Previous meal bolus: 4.5 units
3 hours – 2 hours = 1 hour
1 hours ÷ 3 hours = 1/3
1/3 ∗ 4.5 units = 1.5 units meal insulin on board (IOB)
In other words, two hours after your previous meal bolus, you
have received 3 units of insulin from it; 1.5 units of insulin are still
working to cover your meal.
Meal insulin on board (IOB) is only used to reduce a
correction bolus, and the correction bolus is only
reduced until it becomes 0 units.
Examples of suggested bolus calculations
The examples below use these settings:
• Target BG: 100 mg/dL
• I/C ratio: 1:15
• Correction factor (CF): 50
• Duration of insulin action: 3 hrs
Example 1
Current BG level: 150 mg/dL
Carb intake: 0 grams of carbohydrate (carbs)
Meal IOB: 1 units
Correction insulin on board (IOB): 1 units
Correction bolus: 150 mg/dL (current) – 100 mg/dL (target) = 50
50 ÷ 50 (CF) = 1 unit
Meal bolus: 0 (carbs) ÷ 15 (IC ratio) = 0 units
Suggested bolus dose = 1 (correction) + 0 (meal) – 2 (IOB) = 0U
Example 2
Current BG level: 150 mg/dL
Carb intake: 45 carbs
Meal IOB: 0 units
Correction IOB: 0 units
Correction bolus: 150 mg/dL (current) – 100 mg/dL (target) = 50
50 ÷ 50 (CF) = 1 unit
Meal bolus: 45 (carbs) ÷ 15 (IC ratio) = 3 units
Suggested bolus dose = 1 (correction) + 3 (meal) – 0 (IOB) = 4U
141
Appendix
Example 3
Current BG level: 100 mg/dL
Carb intake: 45 carbs
Meal IOB: 1 unit
Correction insulin on board (IOB): 0 units
Correction bolus: 100 mg/dL (current) – 100 mg/dL (target) = 0
0 ÷ 50 (CF) = 0 units
Meal bolus: 45 (carbs) ÷ 15 (IC ratio) = 3 units
Suggested bolus dose = 0 (correction) + 3 (meal) – 0 (IOB) = 3U
Meal IOB is never subtracted from another meal
bolus—only from a correction bolus.
Example 4
Current BG level: 150 mg/dL
Carb intake: 60 carbs
Meal insulin on board (IOB): 0 units
Correction IOB: 1 unit
Correction bolus: 150 mg/dL (current) – 100 mg/dL (target) = 50
50÷ 50 (CF) = 1 unit
Meal bolus: 60 (carbs) ÷ 15 (IC ratio) = 4 units
Suggested bolus dose = 1 (correction) + 4 (meal) – 1 (IOB) = 4U
142
Calculator guidelines
When the suggested bolus calculator is turned On, the OmniPod
System applies these guidelines to the suggested bolus doses:
• Suggested bolus doses are rounded down to the nearest
0.05U.
• If the total of the suggested bolus calculation (correction
bolus plus meal bolus) is less than zero, the suggested bolus
dose is 0.00U.
• The System will not suggest a bolus dose if your current
blood glucose (BG) reading is below the minimum BG you
have set for bolus calculation (see Chapter 2, Getting Started,
and Chapter 6, Using the Personal Diabetes Manager).
• The System suggests a correction bolus only when your BG
reading is above the correction threshold or correct-above
value you have set (see Chapter 2, Getting Started, and
Chapter 6, Using the Personal Diabetes Manager).
• Meal IOB, which is insulin on board from a previous meal
bolus, is subtracted first from the current correction bolus, if
any, until it is zero. However, any remaining meal IOB is never
subtracted from the current meal bolus.
• Correction IOB, which is insulin on board (active insulin) from
a previous correction bolus, is then subtracted from the current correction bolus, if any remains, until it is zero. At that
point, any remaining correction IOB is subtracted from the
current meal bolus.
Appendix
•
•
•
The calculated insulin on board is rounded up to the nearest
0.05U.
A reverse correction only occurs if the meal bolus is greater
than 0.00U.
If your blood glucose value is below the target blood glucose
value and you have set reverse correction to On, the suggested correction bolus is subtracted from the suggested
meal bolus. If you have set reverse correction to Off, the
System will not subtract insulin from the suggested meal
bolus dose.
If you manually increase or decrease the suggested bolus, the
following rules apply:
• If you increase a suggested bolus, the increase is applied to
the meal bolus unless there is no meal bolus, in which case it
is applied to the correction bolus.
• If you decrease a suggested bolus, the decrease is applied to
the meal bolus until it reaches zero; then it is applied to the
correction bolus. If there is no meal bolus, the decrease is
applied to the correction bolus.
143
Appendix
■ OmniPod System Options and Settings
12-hour or 24-hour clock
MM/DD/YY
DD/MM/YY
MM.DD.YY
DD.MM.YY
YY.MM.DD
YY-MM-DD
Maximum basal rate
30 U/hr
Default is 3.00 U/hr
Basal programs
Basal rate segments
24 per program
Basal rate increment
0.05 units
Temp basal presets
Temp basal
%, Units, or Off
30 minutes to 12 hours in 30minute increments
Default is Off
Blood glucose (BG) goal for Upper and lower limits; 70 to 200
BG history
mg/dL in 1 mg/dL increments
Blood glucose reminder
On or Off; maximum of 4
Reminder time of 1 to 4 hours
after every bolus dose in 30minute increments
Default is Off
Time
Date
144
Blood glucose meter sound On or Off
Default is On
Suggested bolus calculator On or Off
Default is On
Target BG value and
8 time segments; 70 to 200 mg/dL
correction threshold
in 1 mg/dL increments
Minimum BG allowed for
50 to 70 mg/dL in 1 mg/dL increuse by the suggested bolus ments
calculator
Default is 70 mg/dL
Insulin-to-carb (IC) ratio
8 time segments; 1 to 150 g
carb/U in 1g carb/U increments
Correction (sensitivity)
8 time segments; 1 to 300 mg/dL
factor
in 1 mg/dL increments
Reverse correction
On or Off
Default is On
Duration of insulin action 2 to 6 hours in 30-minute increments
Bolus increment
0.05, 0.1, 0.5, or 1.0 units
Default is 0.1 units
Maximum bolus size
30 units
Default is 10 units
Extended bolus
%, Units, or Off
30 minutes to 8 hours in 30minute increments
Default is Off
Appendix
Bolus presets
Carbohydrate presets
Suspend
Low reservoir volume
indicator
Pod expiration alert
Auto-off alert
PDM lock
History storage
Language
36
30 minutes to 2 hours
10 to 50 units in 5-unit increments
Default is 10.0 units
1 to 24 hours in 1-hour increments
Default is 4 hours
1 to 24 hours or Off in 1-hour
increments
Default is Off
On or Off
Default is Off
5400 records/90 days
English
■ Pod Specifications
Size: 1.53" wide x 2.05" long x 0.57" high
(3.88cm x 5.2cm x 1.44cm)
Weight (with full reservoir): 30 grams (1.05 oz)
Operating temperature range: 40° F to 104° F (4.4° C to 40° C)
Under normal circumstances, your body temperature will keep
the Pod well within this range.
Startup temperature: above 50° F (10° C)
Storage temperature range: 32° F to 86° F (0° C to 30° C)
Reservoir volume (deliverable): 200 units
Cannula insertion depth: 6.5mm
Waterproof rating: IPX8 (25 feet for up to 60 minutes)
Insulin concentration: U-100
Alarm type: Audible
Operating relative humidity range: 20–85%, noncondensing
Storage relative humidity range: 20–85%, noncondensing
Operating atmospheric pressure: 696 hPA to 1060 hPA
Storage atmospheric pressure: 696 hPA to 1060 hPA
Non-pyrogenic: Fluid pathway only
Type BF: Medical device (protection from electrical shock)
Flow Capability:
Basal: Programmable by the user in 0.05U pulses
up to 30.0 U per hour
Bolus:
Rate: 1.5 units per minute
Range: 0.05 to 30.0 units
Delivery accuracy (tested per IEC 60601-2-24):
Basal: +/- 5% at rates > 0.1 U/hr
Bolus: +/- 5% for all set values > 0.1 units
145
Appendix
■ Accuracy Test Results
The following graphs are designed to show flow accuracy of the
Pod against given time periods.
Flow rate from startup
The following graph shows changes in the flow rate over the
stabilization period. The measurements were made using a Pod
with a basal rate of 0.05 U/h at high operating temperature.
146
Flow rate error
The following trumpet curve shows the accuracy of the delivery
rate in relation to the observation period. The measurements
were made using a Pod with a basal rate of 0.05 U/h at high operating temperature. The overall mean percentage flow error was
1.40%.
Appendix
■ Personal Diabetes Manager Specifications
■ Blood Glucose Meter Specifications
Size: 2.5" wide x 4.5" long x 1.0" high (6.4cm x 11.4cm x 2.5cm)
Weight (with batteries): 135 grams (4.76 oz)
Screen: 1.4" wide x 1.9" long (3.6cm x 4.8cm); 2.4" diagonal
(6.1cm) LCD
Battery: Powered by 2 AAA alkaline batteries
Battery life: Approximately 3 weeks
Operating temperature range: 40° F to 104° F (4.4° C to 40° C)
Storage temperature range: -20.2° F to 140° F (-29° C to 60° C)
Operating relative humidity range: 10% to 90% noncondensing
Storage relative humidity range: 10% to 90% non-condensing
Operating atmospheric pressure: 696 hPA to 1062 hPA
Storage atmospheric pressure: 703 hPA to 1062 hPA
Communication distance: At start up the PDM and pod should
be adjacent and touching, either in or out of tray to ensure
proper communication during priming. At least 60" (152.40 cm)
during normal operation.
Alarm type: Audible
Alert type: Audible and vibratory
Warranty: 4 Year Limited (PDM)
Assay method: Coulometric electrochemical sensor
Calibration: Plasma equivalent
Hematocrit: 15% to 65%
Measurement units: mg/dL
Result range: 20 to 500 mg/dL
Sample: Whole blood, capillary
Sample size: 300 nanoliters (0.3 microliter)
Test time: Results as fast as 7 seconds
147
Appendix
■ OmniPod System Label Symbols
Symbol
Meaning
Meaning
Do not reuse this device; single-use only
Storage temperature
Caution: Consult accompanying documents
Do not use if package is damaged
Refer to Instruction Manual
Sterilized by ethylene oxide
Manufacture date: (year–month)
Lot number
Rx ONLY
Prescription home-use IVD
■ Personal Diabetes Manager Icons
Icon
Meaning
Icon
Meaning
Power
More actions
Reference/reorder number
Bolus
Communication
Device serial number
Type BF medical device
(protection from electrical shock)
Pod change
Up/Down
Diagnostics/
settings
Up/Down (on color)
Manufacturer
Temp basal
Status
Non-pyrogenic; fluid pathway only
Suspend/cancel
Text entry right
Not MRI-safe
My Records
Submenu
Waterproof to 25 feet for up to 60 minutes
Advisory alarm
Home screen
Expiration date (use-by date): (year–month)
Keep dry
148
Symbol
Appendix
Icon
Meaning
(Alternating)
Hazard alarm
Icon
Meaning
Insulin gauge
Alert
Apply blood sample/
Blood glucose records
PDM lock
Setup Wizard
Battery 3/4 full
Battery full
Battery 1/4 full
Battery half full
Basal program
Battery empty
“Lost” history
record
“Unconfirmed”
history record
“Delivery Spans
Midnight”
history record
User Information/
Support
Temperature out of
range
Active/default
program or selected
BG tag
■ OmniPod System Notice
ConcerningInterference
The OmniPod Insulin Management System (both the Pod and
the Personal Diabetes Manager or PDM) complies with Part 15
of the FCC Rules. Operation is subject to the following two
conditions:
1. These devices may not cause harmful interference.
2. These devices must accept any interference received, including interference that may cause undesirable operation.
Changes or modifications not expressly approved by Insulet
could void the user’s authority to operate the equipment.
Both the Pod and the PDM generate, use, and can radiate radio
frequency energy, and may cause harmful interference to radio
communications. There are no guarantees that interference will
not occur in a particular installation. If the OmniPod System does
cause harmful interference to radio and television reception, the
interference may be corrected by one of the following measures:
• Move or relocate the OmniPod System.
• Increase the distance between the OmniPod System and the
other device that is emitting or receiving interference.
Insulet Corporation declares that the OmniPod System is in compliance with the essential requirements and other relevant
provisions of Directive 1999/5/EC. This ISM device complies with
Canadian ICES-003 and IC-RSS-210.
149
Appendix
■ Electromagnetic Compatibility
The information contained in this section (such as separation
distances) is, in general, specifically written with regard to the
OmniPod System. The numbers provided will not guarantee
faultless operation but should provide reasonable assurance of
such. This information may not be applicable to other medical
electrical equipment; older equipment may be particularly susceptible to interference.
General Notes
Medical electrical equipment requires special precautions
regarding electromagnetic compatibility (EMC) and needs to be
installed and put into service according to the EMC information
provided in this document and the instructions for use.
Portable and mobile RF communications equipment can affect
medical electrical equipment.
Insulet Corporation declares that the OmniPod Insulin Management System is in compliance with the essential requirements
and other relevant provisions of Directive 1999/5/EC.
150
Cables and accessories not specified within the instructions for
use are not authorized. Using other cables and/or accessories
may adversely impact safety, performance, and electromagnetic
compatibility (increased emission and decreased immunity).
Care should be taken if the System is used adjacent to other electrical equipment; if adjacent use is inevitable, such as in work
environments, the System should be observed to verify normal
operation in this setting.
The System communicates by low level RF energy. As with all RF
receivers, the potential for disturbance exists, even with equipment that complies with FCC and CISPR emissions requirements.
The OmniPod System communicates with the following
characteristics:
Frequency: 433 Mhz, FSK modulation, with an effective radiated power of 13mW
The OmniPod System greatly exceeds the immunity requirements of the general standard for electromagnetic compatibility,
IEC 60601-1-2.
Appendix
Electromagnetic Emissions
This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure
that is used in such an environment.
Emissions
Compliance according to
Electromagnetic environment
RF Emissions (CISPR 11)
Group 2
The Pod and the PDM emit low level electromagnetic energy (RF) in
order to communicate. Although unlikely, nearby electronic equipment may be affected.
CISPR B
Class B
The System is suitable for use in all establishments including domestic
Emissions Classification
establishments.
Electromagnetic Immunity
The System is intended for use in the electromagnetic environment specified below. You should observe these requirements in the
use of the System.
IEC 60601-1-2
Compliance level
Immunity against
test level
(of this device)
Electromagnetic environment
ElectroStatic Discharge, contact discharge: ± 8 kV
If floors are covered with synthetic material, try to avoid electroESD (IEC 61000-4-2)
± 6 kV
± 15 kV
static discharges.
air discharge: ± 8 kV
Power Frequency mag- 3 A/m
400 A/m
Suitable for most environments. Magnetic field strengths in
netic fields 50/60 Hz
excess of 400 A/m would be unlikely except in close proximity
(IEC 61000-4-8)
to industrial magnetic devices.
151
Appendix
Radiated RF
(IEC 61000-4-3)
80 MHz–2.5 GHz
Electromagnetic Immunity (Continued)
10 V/m
Portable and mobile RF communications equipment should
be used no closer to any part of the System than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter as below.
Recommended separation distance:
d=1.17 √P
d=0.35/ √P 80 MHz to 800 MHz
d=0.7 √P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and
d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,a should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflections from structures, objects, and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment.
152
Appendix
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment
and the System
You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System, as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power Separation distance according to frequency of transmitter, in meters
of transmitter, in watts
150 kHz to 80 MHz, d = 1.17 √P 80 MHz to 800 MHz, d = 0.35 √P 800 MHz to 2.5 GHz, d = 0.7 √P
0.01
0.12
0.035
0.070
0.1
0.37
0.11
0.22
1.17
0.35
0.7
10
3.70
1.11
2.21
100
11.7
3.5
7.0
For transmitters rated at a maximum output power not listed above, the recommended separation distances in meters (m) can be estimated
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
153
Appendix
■ Customer Bill of Rights
Mission Statement
Insulet Corporation is dedicated to designing, developing, and
distributing products that provide superior treatment options
and lifelong health benefits for people with diabetes.
Scope of Services
Insulet Corporation’s scope of services is limited to providing the
OmniPod Insulin Management System. The System consists of
the handheld, wireless Personal Diabetes Manager (PDM), which
programs the Pod with insulin delivery instructions, and the
compact, lightweight Pod, which is worn discreetly beneath
clothing and delivers insulin based on instructions from the
PDM. The PDM contains a fully integrated blood glucose meter
and is very similar in materials, construction, and appearance to a
personal digital assistant. The Pod features no tubing and virtually pain-free automated cannula insertion.
Compliance
The OmniPod Insulin Management System is manufactured and
distributed by Insulet Corporation. The company is committed
to complying with all federal and state regulations. If you have
any questions or concerns regarding any of our activities, please
contact us at 1-800-591-3455 (from outside the United States,
781-457-5098).
154
Supply Shipment
Insulet Corporation contacts customers to schedule quarterly
supply shipments approximately two weeks prior to delivery.
Inquiries
Representatives are available to answer product-related inquiries
24 hours per day at our toll free number, 1-800-591-3455 (from
outside the United States, 781-457-5098). For all other questions,
concerns, or complaints, please contact us between the hours of
8:30am and 6:00pm Eastern Time, Monday through Friday, at 1800-591-3455 (from outside the United States, 781-457-5098).
We will respond immediately whenever possible; some issues
may take up to 14 days to resolve.
CHAP Accredited
Insulet Corporation has been accredited by the Community
Health Accreditation Program (CHAP) since 2007. To learn more
about CHAP or to communicate concerns that you have been
unable to resolve directly with the company, please visit
www.chapinc.org or call CHAP at 800-656-9656.
Appendix
Customer’s Bill of Rights and Responsibilities
You have the right to:
1. Receive considerate and respectful service.
2. Receive service without regard to race, creed, national origin,
sex, age, disability, sexual orientation, illness, or religious affiliation.
3. Expect confidentiality of all information pertaining to you,
your medical care and service. Please review our HIPAA Privacy Notice later in this section.
4. Receive a timely response to your request for service.
5. Receive continued service.
6. Select the medical equipment supplier of your choice.
7. Make informed decisions regarding your care planning.
8. Understand what services will be provided to you.
9. Obtain an explanation of charges, including policy for payment.
10. Agree to or refuse any part of the plan of service or plan of
care.
11. Voice complaints without fear of termination of service or
other reprisals.
12. Have your communication needs met.
You have the responsibility to:
1. Ask questions about any part of the plan of service or plan of
care that you do not understand.
2. Use the equipment for the purpose for which it was prescribed, following instructions provided for use, handling
care, safety and cleaning.
3. Supply Insulet Corporation with insurance information necessary to obtain payment for services.
4. Be accountable for charges not covered by your insurance.
You are responsible for settlement in full of your account.
5. Notify us immediately of:
a. Equipment failure, damage or need of supplies.
b. Any change in your prescription or physician.
c. Any change or loss in insurance coverage.
d. Any change of address or telephone number, whether
permanent or temporary.
155
Appendix
■ Limited Warranty for the Personal Diabetes
Manager
Limited Warranty Coverage
Insulet Corporation warrants to the original purchaser (“you”) that the Personal Diabetes Manager (the “PDM”) will be free from defects in materials
and workmanship, under normal use and conditions, for a period of four (4)
years from the date of purchase. If Insulet Corporation determines that the
PDM is defective during the warranty period, Insulet Corporation will either
repair or replace, at its option, the PDM at no charge to you, subject to the
conditions and exclusions stated herein. This Warranty applies only to new
devices and, in the event the PDM is repaired or replaced, the warranty
period shall not be extended.
Warranty Claim Procedure
You must notify Insulet Corporation of the claimed defect within the warranty period by writing or calling: Insulet Corporation, 9 Oak Park Drive,
Bedford, Massachusetts 01730; Telephone: 800-591-3455 (from outside the
United States: 781-457-5098) and Fax: 877-467-8538. The claim must
include the date of purchase, model number, serial number, and a description of the claimed defect. Insulet Corporation's authorization must be
obtained prior to returning the PDM. If authorized, the PDM must be properly packaged and returned to Insulet Corporation. Insulet Corporation will
pay all freight and transportation charges, where applicable, incurred in
shipping a PDM to be repaired or replaced under this Warranty.
Conditions
Proof of Purchase in the form of a bill of sale or receipted invoice showing
that the PDM is within the warranty period must be presented to obtain
warranty service.
Exclusions
This Warranty covers only the original purchaser and cannot be transferred
with sale, rental or other transfer of the PDM to any other person or entity.
156
THIS WARRANTY DOES NOT APPLY IF THE PDM HAS BEEN:
• changed or modified by any person or entity other than Insulet
Corporation;
• serviced or repaired by any person or entity other than Insulet
Corporation;
• damaged by an act of God, misuse, abuse, negligence, accident, wear
and tear, unreasonable use, or by other causes unrelated to defective
materials or workmanship.
Miscellaneous
REPAIR OR REPLACEMENT AS PROVIDED UNDER THIS WARRANTY IS YOUR
EXCLUSIVE REMEDY. ANY APPLICABLE IMPLIED WARRANTIES, INCLUDING
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE, ARE LIMITED IN DURATION TO THE DURATION OF THIS WARRANTY. IN NO EVENT SHALL INSULET CORPORATION, ITS SUPPLIERS, OR ITS
DISTRIBUTORS BE LIABLE FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY ON THE
PDM. Some states do not allow limitation on how long an implied warranty
lasts, and some states do not allow the exclusion or limitation of consequential or incidental damages, so the above limitations or exclusions may
not apply to you.
This Warranty gives you specific legal rights, and you may also have other
rights which vary from state to state. This Warranty is valid only in the
United States.
No Other Warranty
Unless modified in writing and signed by both parties, this Warranty is
understood to be the complete and exclusive agreement between the parties, superseding all prior agreements, oral or written, and all other
communications between the parties relating to the subject matter of this
agreement. No employee of Insulet Corporation or any other party is
authorized to make any warranty in addition to those made in this
Warranty.
Appendix
■ HIPAA Privacy Notice
THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION IS USED
AND DISCLOSED AND HOW YOU CAN GET ACCESS TO IT. PLEASE
REVIEW IT CAREFULLY.
This notice of privacy practices (the “HIPAA Privacy Notice”)
describes how we may use and disclose your Medical
Information to carry out treatment, payment, or health care
operations and for other purposes that are permitted or required
by law, including by the Health Insurance Portability and
Accountability Act (“HIPAA”) and all regulations issued
thereunder. It also describes your rights to access and control
your Medical Information. As used herein, “Medical Information”
is information about you, including demographic information,
that may identify you and that relates to your past, present, or
future physical or mental health or condition and related health
care services.
Uses and Disclosures of Medical Information
We will only use and disclose your Medical Information as
permitted by law. Except for disclosures outlined in this HIPAA
Privacy Notice and/or permitted by law, we will obtain your
written authorization before using your Medical Information or
disclosing it to any outside persons or organizations. You may
revoke any written authorization you have provided to us at any
time, except to the extent that we have made any uses or
disclosures of your Medical Information in reliance on such
authorization. To revoke a previously issued authorization, please
send your request in writing, along with a copy of the
authorization being revoked, to our Privacy Officer. If a copy of
the applicable authorization is not available, please provide a
detailed description and date of the same to our Privacy Officer.
There are some situations in which we may use or disclose your
Medical Information without your prior written authorization, as
described further below.
Uses and Disclosures of Your Medical Information Related
to the Treatment and Services Provided by Us
Treatment, Payment, and Health Care Operations: We may use
your Medical Information for treatment, to obtain payment for
treatment, for administrative purposes, and to evaluate the
quality of care that you receive without your authorization. We
may use or disclose Medical Information about you without your
authorization for several other reasons.
Example of Treatment: In connection with treatment, we may
use your Medical Information to provide you with one of our
medical devices.
Example of Payment: We may use your Medical Information to
generate a health insurance claim and to collect payment on
invoices for services and/or medical devices provided.
Example of Health Care Operations: We may use your Medical
Information in order to process and fulfill your orders and to
provide you with customer service.
157
Appendix
Appointment Reminder and Other Communications: We may
use or disclose your Medical Information without your prior
written authorization to provide you or others with, among
other things: (i) appointment reminders; (ii) product/supply
reorder notifications; and/or (iii) information about treatment
alternatives or other health-related products and services that
we provide.
Family, Friends, and Emergencies: If you require emergency
treatment and we are unable to obtain your consent, we may
disclose your Medical Information to a family member or relative
who is involved in your care.
Marketing: We may use or disclose your Medical Information to
provide you with marketing communications about the healthrelated products and services that we provide, and about
products, services, treatment, or healthcare providers that may
be of interest to you.
Additional Categories of Uses and Disclosures
Required by Law: We may use or disclose your Medical
Information to the extent that applicable law requires the use or
disclosure of such Medical Information. Where the use and/or
disclosure of Medical Information is by law, the use or disclosure
will be made in compliance with the law and will be limited to
the relevant requirements of the law. You will be notified, as
required by law, of any such uses or disclosures.
158
Public Health: We may disclose your Medical Information for
public health activities and purposes to a public health authority
that is permitted by law to collect or receive the information.
The disclosure will be made for the purpose of controlling
disease, injury, or disability. We may also disclose your Medical
Information, if directed by the public health authority, to a
foreign government agency that is collaborating with the public
health authority.
Communicable Diseases: We may disclose your Medical
Information, if authorized by law, to a person who may have
been exposed to a communicable disease or may otherwise be
at risk of contracting or spreading the disease or condition.
Health Oversight: We may disclose Medical Information to a
health oversight agency for activities authorized by law, such as
audits, investigations, and inspections. Oversight agencies
seeking this information include government agencies that
oversee the healthcare system, government benefit programs,
other government regulatory programs, and civil rights laws.
Food and Drug Administration: We may disclose your Medical
Information to a person or company as directed or required by
the Food and Drug Administration: (i) to report adverse events
(or similar activities with respect to food or dietary supplements),
product defects or problems (including problems with the use or
labeling of a product), or biological product deviations; (ii) to
track FDA-regulated products; (iii) to enable product recalls,
Appendix
repairs, or replacement, or lookback (including locating and notifying individuals who have received products that have been
recalled, withdrawn, or are the subject of lookback); or (iv) to conduct post-marketing surveillance.
Legal Proceedings: We may disclose your Medical Information in
the course of any judicial or administrative proceeding, in
response to an order of a court or administrative tribunal (to the
extent such disclosure is expressly authorized), in certain
conditions in response to a subpoena, discovery request, or
other lawful process.
Law Enforcement: We may disclose Medical Information, as long
as applicable legal requirements are met, for law enforcement
purposes. These law enforcement purposes include: (i) legal
processes otherwise required by law; (ii) limited information
requests for identification and location purposes; (iii) pertaining
to victims of a crime; (iv) suspicion that death has occurred as a
result of criminal conduct; (v) in the event that a crime occurs on
the premises of the practice; and (vi) medical emergency in
which it is likely that a crime has occurred.
Research: We may disclose your Medical Information to
researchers when their research has been approved by an
institutional review board that has reviewed the research
proposal and established protocols to ensure the privacy of your
Medical Information.
Criminal Activity: Consistent with applicable federal and state
laws, we may disclose your Medical Information if we believe the
use or disclosure is necessary to prevent or lessen a serious and
imminent threat to the health or safety of a person or the public.
We may also disclose Medical Information if it is necessary for law
enforcement authorities to identify or apprehend an individual.
Military Activity and National Security: When the appropriate
conditions apply, we may use or disclose Medical Information of
individuals who are Armed Forces personnel: (i) for activities
deemed necessary by appropriate military command
authorities; (ii) for the purpose of a determination by the
Department of Veterans Affairs of your eligibility for benefits; or
(iii) to foreign military authority if you are a member of that
foreign military service. We may also disclose your Medical
Information to authorized federal officials for conducting
national security and intelligence activities.
Workers’ Compensation: We may disclose your Medical
Information as authorized to comply with workers'
compensation laws and other similar, legally established
programs.
Inmates: We may use or disclose your Medical Information if you
are an inmate of a correctional facility and your physician created
or received your Medical Information in the course of providing
care to you.
159
Appendix
Required Uses and Disclosures: Under the law, we must make
disclosures to you when required by the Secretary of the
Department of Health and Human Services to investigate or
determine our compliance with the requirements of HIPAA.
Nonidentifiable Information: We may use or disclose your
Medical Information if we have removed from it any information
that is personally identifiable to you.
Your Rights
The following is a statement of your rights with respect to your
Medical Information and a brief description of how you may
exercise these rights.
You Have the Right to Inspect and Copy Your Medical
Information: This means you may inspect and obtain a copy of
Medical Information about you, provided, however, that
applicable law may limit your ability to inspect or copy certain
types of records. In certain circumstances, if we deny your
request to review Medical Information, you may have a right to
have this decision reviewed. If you would like to make a request
to review your Medical Information, please download our
Request Form at
http://www.myomniPod.com/images/upload/
HIPAA_Privacy_Notice_Request_Form.pdf
and follow the directions included on that form.
160
We will respond to your request in a reasonable amount of time.
If your request is honored, we may charge a nominal fee for
photocopying expenses. Please contact our Privacy Officer if you
have questions about access to your Medical Information.
You May Have the Right to Amend Your Medical Information:
If you believe that the Medical Information we have about you is
incorrect or incomplete, you may ask us to make an amendment
to your Medical Information. You may request an amendment as
long as the Medical Information is still maintained in our records.
If you would like to make a request to review your Medical
Information, please download our Request Form at
http://www.myomniPod.com/images/upload/
HIPAA_Privacy_Notice_Request_Form.pdf
and follow the directions included on that form.
We will respond to your request in a reasonable amount of time.
Please contact our Privacy Officer if you have questions about
requesting an amendment to your Medical Information
You Have the Right to Request a Restriction of Your Medical
Information: You may ask us not to use or disclose any part of
your Medical Information for the purposes of treatment,
payment, or healthcare operations. You may also request that
any part of your Medical Information not be disclosed to family
members or friends who may be involved in your care or for
notification purposes as described in this HIPAA Privacy Notice.
Appendix
Your request must state the specific restriction requested and to
whom you want the restriction to apply. We are not required to
agree to a restriction that you may request, but if we do agree to
the requested restriction, we may not use or disclose your Medical Information in violation of that restriction unless it is needed
to provide emergency treatment. If you would like to request a
restriction of the use of your Medical Information, please download our Request Form at
http://www.myomniPod.com/images/upload/
HIPAA_Privacy_Notice_Request_Form.pdf
and follow the directions included on that form.
We will respond to your request in a reasonable amount of time.
Please contact our Privacy Officer if you have questions about
requesting a restriction of the use of your Medical Information.
You Have the Right to Request to Receive Confidential
Communications from Us by Alternative Means or at an
Alternative Location: We will accommodate reasonable requests
to receive confidential communications from us by alternate
means or at an alternative location. We may also limit this
accommodation by asking you for information as to how
payment will be handled or specification of an alternative
address or other method of contact. We will not request an
explanation from you as to the basis for the request. Please make
this request in writing to our Privacy Officer.
You Have the Right to Receive an Accounting of Certain
Disclosures We Have Made, if any, of Your Medical Information:
This right applies to disclosures for purposes other than
treatment, payment, or healthcare operations as described in
this HIPAA Privacy Notice. It excludes disclosures we may have
made to you, for a facility directory, to family members or friends
involved in your care, or for notification purposes. You have the
right to receive specific information regarding these disclosures
that occurred after April 14, 2003, or as otherwise provided for
under applicable law. You may request a shorter time frame. The
right to receive this information is subject to certain exceptions,
restrictions, and limitations. If you would like to request an
accounting of certain disclosure of your Medical Information,
please download our Request Form at
http://www.myomniPod.com/images/upload/
HIPAA_Privacy_Notice_Request_Form.pdf
and follow the directions included on that form.
We will respond to your request in a reasonable amount of time.
Please contact our Privacy Officer if you have questions about
requesting an accounting of the disclosures of your Medical
Information.
161
Appendix
Our Duties
Generally: We are required by law to maintain the privacy and
security of your Medical Information and to provide you with
notice of our privacy practices with respect to Medical
Information.
Revisions and Modifications: We may change our HIPAA Privacy
Notice at any time. Before we make a significant change in our
policies, we will change this HIPAA Privacy Notice and post our
new notice (the “Revised HIPAA Privacy Notice”). We are required
to abide by the terms of this HIPAA Privacy Notice until a Revised
HIPAA Privacy Notice becomes effective. The Revised HIPAA
Privacy Notice will be effective for all Medical Information that
we maintain as of the effective date of the Revised HIPAA Privacy
Notice even if we collected or received the Medical Information
prior to the effective date of the Revised HIPAA
Privacy Notice. The current HIPAA Privacy Notice is posted on our
Web sites at:
Insulet.com
MyOmniPod.com
You can also request a hard copy of the HIPAA Privacy Notice at
any time by contacting our Privacy Officer.
162
What To Do If You Have a Problem or Question
If you have any questions relating to this HIPAA Privacy Notice or
if you have a problem or complaint, please contact us by writing
to:
Insulet Corporation
Attn: Privacy Officer
9 Oak Park Drive
Bedford, MA 01730
or by e-mailing us at privacy@insulet.com.
Furthermore, if you believe that Insulet has violated your privacy
rights with respect to your Medical Information, you have the
right to file a complaint in writing with our Privacy Officer or with
the Secretary of Health and Human Services at 200 Independence
Avenue, S.W. Washington, D.C. 20201, or by calling 202-619-0257.
Glossary
A1c (see Hemoglobin A1c)
Advisory alarm
Notification by the PDM that a serious condition exists.
Aseptic technique
A method for maintaining sterilization and preventing
contamination.
Basal program
One or more basal rates that together cover a 24-hour period
from midnight to midnight.
Basal rate
A small base or background amount of insulin that is delivered, at
a preset rate, continuously for a specified period of time. Basal
rates are measured in units per hour (U/hr).
Basal segment (time segment)
The time period during which a specific basal rate is delivered.
BG goal
A range of blood glucose levels that you are trying to achieve during a certain period of the day. For example, you may want one
BG goal before meals, a different BG goal two hours after meals,
and yet another BG goal for bedtime.
Blood glucose (see glucose)
Blood glucose level
The amount of glucose, or sugar, in the blood.
Blood glucose meter
A device used to check blood glucose content.
Bolus dose
A dose of insulin taken to correct an elevated blood glucose level
or to cover carbohydrates in a meal or snack.
Bolus preset
A bolus dose of insulin, in units, that can be assigned a custom
name and preprogrammed into the PDM.
163
Glossary
Calorie
A unit of measurement used to express the energy value of food.
Calories come from carbohydrate, protein, fat, and alcohol.
Cannula
A small, thin tube inserted below the skin, which serves to introduce a liquid medication into the body.
Carbohydrate (carb)
One of the three main nutrients found in food. (The other two
are protein and fat.) Foods that contain carbohydrates include
starches, sugars, vegetables, fruits, and dairy products.
Carbohydrate counting
A method of meal planning based on counting the number of
grams of carbohydrate in a given food.
Carb preset
A favorite food item, snack, or entire meal that can be assigned a
custom name and preprogrammed into the PDM. You set the
carbohydrate value (and, optionally, the fat, protein, fiber, and
total calories) for each carb preset.
Complications (of diabetes)
Harmful effects of diabetes such as damage to the eyes, kidney,
heart, blood vessels, nervous system, teeth and gums, feet, and
skin.
164
Correction bolus
An amount of insulin taken to compensate for high blood glucose
levels. The OmniPod System calculates the correction bolus by
taking the difference between your current blood glucose level
and your target blood glucose value, then dividing the result by
your correction factor.
Correction factor (also known as sensitivity factor)
A value that indicates how much one unit of insulin will lower
your blood glucose. For example, if your correction factor is 50,
one unit of insulin will lower your blood glucose by 50 mg/dL.
Correction threshold
The blood glucose level above which you would like to take insulin to reduce an elevated blood glucose.
CSII (continuous subcutaneous insulin infusion)
Delivering insulin continuously under the skin (“subcutaneously”)
on a programmed schedule.
Dawn phenomenon
An early morning rise in blood glucose level caused by the normal
release of hormones that block insulin’s effect.
Glossary
Diabetes Control and Complications Trial (DCCT)
A study by the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), conducted from 1983 to 1993 in
people with type 1 diabetes, which showed that good blood
glucose control significantly helped prevent or delay diabetes
complications.
Diabetes, diabetes mellitus
A condition characterized by hyperglycemia (high blood glucose)
resulting from the body’s inability to use blood glucose for energy.
In type 1 diabetes, the pancreas no longer makes insulin and
therefore blood glucose cannot enter the cells to be used for
energy. In type 2 diabetes, either the pancreas does not make
enough insulin or the body is unable to use insulin correctly.
Diabetic ketoacidosis (see Ketoacidosis)
Duration of insulin action
The length of time that certain types of insulin remain active and
available in your body after a bolus. This duration can vary greatly
depending on the type of insulin you take. Only use rapid-acting
insulin with the OmniPod® Insulin Management System.
Extended bolus
A feature of the OmniPod System that allows a meal bolus dose to
be given over an extended period of time.
Fat
One of the three main energy sources in food. (The other two are
carbohydrate and protein.) Fat is a concentrated source of energy,
providing 9 calories per gram. Foods high in fat include oils, margarine, salad dressings, red meat, and whole-milk dairy foods.
Fiber
The indigestible part of plant foods. Foods that are high in fiber
include broccoli, beans, raspberries, squash, whole-rain bread,
and bran cereal. Fiber is a type of carbohydrate but does not raise
blood glucose levels as other carbohydrates do.
Food Library
BThe Food Library is for reference only. (Food references contained in the library cannot be populated
and used for calculations.)
The OmniPod System includes a reference library of over 1,000
common food items. The library shows each item’s carbohydrate,
fat, protein, fiber, and calories for a single portion.
The items in the food library are derived from the USDA database, USDA National Nutrient Database for Standard Reference.
Glucose
A simple sugar (also known as dextrose) used by the body for
energy. Without insulin, the body cannot use glucose for energy.
165
Glossary
Hazard alarm
Notification by the PDM that a dangerous condition exists.
Infusing
Introducing a liquid substance under the skin into the body.
Healthcare provider
A professional who practices medicine or teaches people how to
manage their health. All healthcare providers are a resource for
valuable diabetes management information.
Hemoglobin A1c (HbA1c)
A test that measures a person’s average blood glucose level over
the past 2 to 3 months. Also called glycosylated hemoglobin, the
test shows the amount of glucose that sticks to the red blood cell,
which is proportional to the amount of glucose in the blood.
Infusion site
A place on the body where an infusion set or Pod is placed and
cannula is inserted.
Hyperglycemia (high blood glucose)
A higher-than-normal level of glucose in the blood; generally 180
mg/dL or higher.
Hypoglycemia (low blood glucose)
A lower-than-normal level of glucose in the blood; generally 70
mg/dL or lower.
Hypoglycemia unawareness
A condition in which a person does not feel or recognize the
symptoms of hypoglycemia.
166
Insulin
A hormone that helps the body use glucose for energy. The beta
cells of a healthy pancreas make insulin.
Insulin on board (IOB) (active insulin)
The amount of insulin that is still “active” in the body from a previous bolus dose. In the OmniPod System, insulin on board (IOB) is
considered in two parts: the Insulin on Board (IOB) from a previous correction bolus and the IOB from a previous meal bolus.
The amount of time insulin remains “on board” or “active”
depends on each individual’s duration of insulin action. Talk with
your healthcare provider to determine your duration of insulin
action.
The OmniPod System continually calculates the Insulin on Board
(IOB) to help prevent “stacking” of bolus doses, which is a major
cause of hypoglycemia.
Insulin reaction (see hypoglycemia)
Glossary
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.
In vitro
Literally, “in glass.” Refers to a biological function taking place in a
laboratory dish rather than in a living organism.
Ketoacidosis (diabetic ketoacidosis or DKA)
A very serious condition in which extremely high blood glucose
levels and a severe lack of insulin cause the body to break down
fat for energy. The breakdown of fat releases ketones into the
blood and urine. DKA can take hours or days to develop, with
symptoms that include stomach pain, nausea, vomiting, fruity
breath odor, and rapid breathing.
It is important to rule out ketoacidosis when you
experience symptoms that might otherwise indicate
the flu.
Ketones
Acidic by-products that result from the breakdown of fat for
energy. The presence of ketones indicates that the body is using
stored fat and muscle (instead of glucose) for energy.
Meal bolus (also known as carbohydrate bolus)
An amount of insulin administered before a meal or snack to
ensure that blood glucose levels stay within the desired BG goal
after a meal. The OmniPod System calculates a meal bolus by
dividing the grams of carbohydrates you are about to eat by your
insulin-to-carbohydrate ratio.
Multiple daily injections (MDIs)
Introducing insulin into the body with a syringe several times a
day.
Occlusion
A blockage or interruption in insulin delivery.
Prime bolus
An amount of insulin used to fill the cannula, preparing it to
begin delivering insulin under your skin.
Protein
One of the three main energy sources in food (the other two are
carbohydrate and fat). Protein is necessary for the growth, maintenance, and repair of body cells and tissues. Protein contains 4
calories per gram. Foods high in protein include meat, poultry,
fish, legumes and dairy products.
167
Glossary
Reverse correction (negative correction)
Using an individual’s correction factor (sensitivity factor), the
reverse correction is a calculation that reduces a portion of a
meal bolus dose when the patient’s blood glucose level is below
their blood glucose target. This feature is an option in the
OmniPod® Insulin Management System, which should be
turned on or off according to the advice of a healthcare provider.
Suggested bolus calculator
A feature that calculates bolus doses with user-specific settings
and inputs. The settings used to calculate a suggested bolus are
target BG, insulin-to-carbohydrate (IC) ratio, correction factor (CF)
and duration of insulin action. The inputs used to calculate a suggested bolus are current BG, carbs entered, and insulin on board.
The bolus calculator can be turned Off or On in the PDM.
Sensitivity factor (see correction factor)
Target blood glucose (BG) level
The ideal number at which you would like your blood glucose
level to be. The OmniPod System uses this number in calculating
bolus doses.
Sharps
Any medical item that may cause punctures or cuts to those
handling them. Sharps include needles, syringes, scalpel blades,
disposable razors, and broken medical glassware. Dispose of
used sharps according to local waste disposal regulations.
Sharps container
A puncture-proof container used for storage and disposal of
used sharps.
Soft Key
A button 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.
Subcutaneous
Under the skin.
168
Temp basal
A basal rate that is used to cover predictable, short-term changes
in basal insulin need. Temporary rates are often used during exercise and for sick-day insulin adjustments.
Temporary basal preset
An adjustment in a basal rate, in either % or U/hr, that can be
assigned a custom name and preprogrammed into the PDM.
Time segment (see basal segment)
Index
activate a new Pod. . . . . . . . . . . . . . . 43–57
active insulin . . . . . . .See insulin on board
add
basal segment or rate . . . . . . . . . 17–21
bolus reminder. . . . . . . . . . . . . . . . . . . . 68
custom reminders. . . . . . . . . . . . . . . . . 68
user information . . . . . . . . . . . . . . . . 104
adhesive . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 50
remover. . . . . . . . . . . . . . . . . . . . . . . . . . . 45
advisory alarms . . . . . . . . . . 124–127, 165
airport security . . . . . . . . . . . . . . . . . . . . 109
alarms . . . . . . . . . . . . . . . . . . . . . . 8, 124–131
acknowledge . . . . . . . . . . . . . . . . . . . 124
advisory. . . . . . . . . . . . . . . . . . . . 124–127
hazard . . . . . . . . . . . . . . . . . . . . . 124–131
history records . . . . . . . . . . . . . . . . . . 102
alert escalation . . . . . . . . . . . . . . . . . . . . 124
alerts and reminders. . . . . . . . . . . . . 66–69
170
auto-off alert. . . . . . . . . . . . . . . . . . . . . . 66
BG reminder . . . . . . . . . . . . . . . . . . . . . . 66
bolus reminders. . . . . . . . . . . . . . . . . . . 67
confidence reminders. . . . . . . . . . . . . 67
custom reminders . . . . . . . . . . . . . . . . 67
low reservoir alert. . . . . . . . . . . . . 15, 66
missed bolus. . . . . . . . . . . . . . . . . . . . . . 67
Pod expiration reminder . . . . . . . . . . 66
program reminders . . . . . . . . . . . . . . . 67
aseptic technique . . . . . . . . . . 43, 56, 165
automated cannula insertion. . . . . .2, 52
auto-off alert . . . . . . . . . . . . . . . . . . . . . . . . 66
backlight time-out. . . . . . . . . . . . . . . . . . . 71
set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
basal history . . . . . . . . . . . . . . . . . . . . . . . . . 98
basal program . . . . . . . . . . .11, 16–22, 165
add segment or rate . . . . . . . . . . . . . . 21
copy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
delete. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
edit segment or rate . . . . . . . . . . . . . . 21
enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
rename . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
basal rate . . . . . . . . . . . . . 1, 11, 16–27, 165
maximum. . . . . . . . . . . . . . . . . . . . . . . . . 27
temporary . . . . . . . . . . . . . . . . . . . . . . . . 22
basal segment. . . . . . . . . . . . . . .11, 16, 165
basal settings. . . . . . . . . . . . . . . . . . . . . . . . 11
batteries. . . . . . . . . . . . . . . . . . . . .10, 97, 139
BG tag . . . . . . . . . . . . . . . . See tag a BG result
blood glucose
BG goal . . . . . . . . . . . . . . . . . . .12, 69, 165
BG reminder . . . . . . . . . . . . . . . . . . . . . . 66
checking. . . . . . . . . . . . . . . . . . . xi, 77–96
code . . . . . . . . . . . . . . . . . . . . . . . . . . 81, 87
goal limit. . . . . . . . . . . . . . . . . . . . . . . . . . 69
history . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Index
level. . . . . . . . . . . . . . . . . . . . . . . . . . 28, 165
monitoring. . . . . . . . . . . . . . . . . . . . . . xi, 2
sound . . . . . . . . . . . . . . . . . . . . . . . . . 12, 70
test sites. . . . . . . . . . . . . . . . . . . 77, 88–89
test strip. . . . . . . . . . . . . . . . . . . . . . . . . . .86
blood glucose meter. . . . . .2, 77–96, 165
error messages. . . . . . . . . . . . . 121–123
readings. . . . . . . . . . . . . . . . . . . . . . . . 3, 91
settings . . . . . . . . . . . . . . . . . . . . . . . . . . .69
specifications . . . . . . . . . . . . . . . . . . . 149
blood glucose readings
enter manually . . . . . . . . . . . . . . . . . . . .93
low and high . . . . . . . . . . . . . . . . . . . . . .95
bolus . . . . . . . . . . . . . . . . . . . . . . . 1, 3, 28–41
cancel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
dose. . . . . . . . . . . . . . . . . . . . . . . . . . 28, 165
extended. . . . . . . . . . . . . . . . . . . . . . 29, 33
history . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
manual delivery. . . . . . . . . . . . . . . . . . .33
normal . . . . . . . . . . . . . . . . . . . . . . . . 29, 30
presets . . . . . . . . . . . . . . . . . . . 37–39, 165
ratios/factors/targets. . . . . . . . . . . . . .64
reminders . . . . . . . . . . . . . . . . . . . . . 67, 68
settings . . . . . . . . . . . . . . . . . . . . . . . 61–65
suggested bolus calculator . . .29–33,
142–145
bolus presets . . . . . . . . . . . . . . . 37–39, 165
cancel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
change. . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
rename . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
bolus reminder
add . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
bolus reminders . . . . . . . . . . . . . . . . . . . . . 67
Bolus/basal/calcs menu . . . . . . . . . . . . . 61
bright mode . . . . . . . . . . . . . . . . . . . . . . .5, 71
buttons
Home/Power. . . . . . . . . . . . . . . . . . . . . . . 5
Up/Down Controller . . . . . . . . . . . . . . . 5
User Info/Support. . . . . . . . . . . . . . . . . . 5
calorie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166
cancel
bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
bolus preset. . . . . . . . . . . . . . . . . . . . . . . 39
one-time temporary basal rate. . . . 24
temporary basal presets . . . . . . . . . . 26
cannula. . . . . . . . . . . . . . . . . . . . . . . . . . 2, 166
automated insertion . . . . . . . . . . . .8, 52
carb presets . . . . . . . . . . . . . . 3, 39–41, 166
change. . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
change category. . . . . . . . . . . . . . . . . . 41
create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
delete. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
edit . . . . . . . . . . . . . . . . . . . . . . . . . . . 40, 41
rename . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
carbohydrate . . . . . . . . . . . . . . . . . . . . 1, 166
counting . . . . . . . . . . . . . . . . . . . . . . 3, 166
history . . . . . . . . . . . . . . . . . . . . . . . . . . .102
carbohydrate bolus . . . . . .See meal bolus
care and maintenance. . . . . . . . . . . . . .138
cellular phones . . . . . . . . . . . . . . . . . . . . .120
change
basal programs . . . . . . . . . . . . . . . . . . . 20
basal settings . . . . . . . . . . . . . . . . . . . . . 61
bolus presets. . . . . . . . . . . . . . . . . . . . . . 39
bolus settings. . . . . . . . . . . . . . . . . . . . . 61
carb presets. . . . . . . . . . . . . . . . . . . . . . . 40
temporary basal presets . . . . . . . . . . 26
171
Index
user information . . . . . . . . . . . . . . . . 104
check alarms. . . . . . . . . . . . . . . . . . . . . . . . . 73
check blood glucose. . . . . . . . . . . . . 77–96
cleaning . . . . . . . . . . . . . . . . . . . . . . .138, 139
clock
12-hour or 24-hour. . . . . . . . . . . . . . . . 61
code number, test strip vial . . . . . . 82, 88
communication
distance to Pod . . . . . . . . . . . . . . 75, 149
interruption . . . . . . . . . . . . . . . . . . 76, 132
communication failure . . . . . . . 132–137
bolus cancellation. . . . . . . . . . . . . . . 136
Pod activation. . . . . . . . . . . . . . . . . . . 132
Pod deactivation . . . . . . . . . . . . . . . . 134
Pod operation. . . . . . . . . . . . . . . . . . . 132
request for status. . . . . . . . . . . . . . . . 135
complications, diabetes-related . 1, 166
confidence reminders . . . . . . . . . . . . . . . 67
contact information . . . . . . . . . . . . . . . 103
continuous subcutaneous insulin
infusion . . . . . . . . . . . . . . . . . . . . . . . . . 166
control solution. . . . . . . . . . . . . . . . . . . . . .79
expiration . . . . . . . . . . . . . . . . . . . . . . . . . 79
results. . . . . . . . . . . . . . . . . . . . . . . . . 79, 83
172
test. . . . . . . . . . . . . . . . . . . . . . . . . . . . 81–84
copy basal program . . . . . . . . . . . . . . . . . 22
correct-above value . . . . . See correction
threshold
correction bolus . . . . . . . . . . . 30, 142, 166
correction factor. . . . . 13, 28, 63, 65, 166
correction IOB . . . . . . . . . . . . . . . . . . . . . .142
correction threshold. . . . . 28, 62, 64, 166
create
basal program . . . . . . . . . . . . . . . . . . . . 17
bolus preset. . . . . . . . . . . . . . . . . . . . . . . 37
carb presets. . . . . . . . . . . . . . . . . . . . . . . 39
temporary basal presets . . . . . . . . . . 24
CSII . . . . . .See continuous subcutaneous
insulin infusion
CT scans . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
custom reminders . . . . . . . . . . . . . . . 67, 68
customize PDM. . . . . . . . . . . . . . . . . . . . . . 71
date and time. . . . . . . . . . . . . . . . . . . . 11, 60
dawn phenomenon . . . . . . . . . . . . . . . .166
deactivation . . . . . . See Pod deactivating
delete
basal program . . . . . . . . . . . . . . . . . . . . 22
bolus presets. . . . . . . . . . . . . . . . . . . . . . 39
bolus reminder . . . . . . . . . . . . . . . . . . . 68
carb presets. . . . . . . . . . . . . . . . . . . . . . . 41
temporary basal presets . . . . . . . . . . 27
depth settings, lancing device. . . . . . . 86
diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . .167
Diabetes Control and Complications
Trial (DCCT) . . . . . . . . . . . . . . . . . . . . . .167
diabetes emergency kit . . . . . . . . . . . .107
diabetes mellitus . . . . . . . . . . . . . . . . . . . . . x
diabetic ketoacidosis . . . . . . . . . . . See DKA
diagnostic functions. . . . . . . . . . . . . . . . . 73
check alarms. . . . . . . . . . . . . . . . . . . . . . 73
reset PDM. . . . . . . . . . . . . . . . . . . . . . . . . 73
disinfecting wipes . . . . . . . . . . . . . . . . . .139
DKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .169
avoiding . . . . . . . . . . . . . . . . . . . . . . . . .118
symptoms . . . . . . . . . . . . . . . . . . . . . . .118
treating . . . . . . . . . . . . . . . . . . . . . . . . . .118
duration of insulin action. . . . . xi, 14, 30,
142–143, 167
edit
basal segment or rate. . . . . . . . . . . . . 21
Index
bolus reminder. . . . . . . . . . . . . . . . . . . .68
carb presets . . . . . . . . . . . . . . . . . . . . . . .41
electrical interference. . . . . . . . . . . . . . . .76
electrical safety . . . . . . . . . . . . . . . 152–155
electromagnetic compatibility 152–155
electromagnetic fields . . . . . . . . . . . . . . .76
emergency kit . . . . . . . . . . . .105, 107, 108
empty reservoir hazard alarm. . . . . . 126
enable
basal program. . . . . . . . . . . . . . . . . . . . .19
bolus preset. . . . . . . . . . . . . . . . . . . . . . .38
one-time temporary basal rate. . . .23
temporary basal presets . . . . . . . . . .25
enter
ID screen color . . . . . . . . . . . . . . . . . . . .11
tags . . . . . . . . . . . . . . . . . . . . . . . . . . . 70, 91
error messages, BG meter. . . . . 121–123
exercise . . . . . . . . . . . . . . . . . . . . . . . .114, 119
expiration
control solution . . . . . . . . . . . . . . . . . . .79
Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
test strips. . . . . . . . . . . . . . . . . . . . . . . . . .78
extended bolus. . . . . .14, 29, 33–35, 167
Extended option. . . . . . . . . . . . . . . . . . . . .65
extreme temperatures. . . . . . . . . . . . . . . 75
failure . . . . . . . See communication failure
fat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167
fiber . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40, 167
fill syringe. . . . . . . . . . . . . . . . . . . . . . . . 46–48
Flow accuracy
Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .148
Flow rate error . . . . . . . . . . . . . . . . . . . . . .148
food library . . . . . . . . . . . . . . . . . . . . 3, 42, 166
glucagon . . . . . . . . . . . . . . . . . . . . . . . . . . .108
glucose . . . . . . . . . . . . . . . . . . . . . . . . . . x, 167
hard work. . . . . . . . . . . . . . . . . . . . . . . . . . .119
hazard alarm, manual shut-off. . . . . .131
hazard alarms. . . . . . . . . . . . .124–131, 167
healthcare provider. . . . . . . . . . . . . . xi, 167
hemoglobin A1c (HbA1c). . . . . . . . . . .168
HIPAA privacy notice . . . . . . . . . 159–164
history
alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . .102
all . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
blood glucose. . . . . . . . . . . . . . . . . . . .100
bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
carbohydrates . . . . . . . . . . . . . . . . . . .102
insulin delivery. . . . . . . . . . . . . . . . 97, 98
Home screen . . . . . . . . . . . . . . . . . . . . . . .6–7
Home/Power button . . . . . . . . . . . . . . . . . 5
hospitalization. . . . . . . . . . . . . . . . . . . . . .120
hyperglycemia . . . . . .105, 114–117, 168
avoiding . . . . . . . . . . . . . . . . . . . . . . . . .115
causes . . . . . . . . . . . . . . . . . . . . . . . . . . .116
symptoms . . . . . . . . . . . . . . . . . . . . . . .114
treating . . . . . . . . . . . . . . . . . . . . . . . . . .115
hypoglycemia . . . 77, 105, 110–114, 168
avoiding . . . . . . . . . . . . . . . . . . . . . . . . .111
causes . . . . . . . . . . . . . . . . . . . . . . . . . . .113
symptoms . . . . . . . . . . . . . . . . . . . 77, 110
treating . . . . . . . . . . . . . . . . . . . . . . . . . .111
hypoglycemia unawareness. . . .77, 111,
168
icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150
insulin gauge . . . . . . . . . . . . . . . . . . . . . 59
ID screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
173
Index
color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
illness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
infection . . . . . . . . . . . . . . . . . . . . . . . . 56, 106
infusion set, automated insertion. . . . . 2
infusion site. . . . . . . . . . . . 49, 56, 106, 168
infusion site, inspection. . . . . . . . . . . . 106
insulin . . . . . . 16, 28, 43, 46, 47, 107, 109,
141, 168
insulin action . . . . See duration of insulin
action
insulin delivery
resume. . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
suspend. . . . . . . . . . . . . . . . . . . . . . . . . . . 54
insulin delivery records . . . . . . . . . . 97–99
insulin delivery, continuous. . . . . . . . . . . 1
insulin gauge icon . . . . . . . . . . . . . . . . . . . 59
insulin on board (IOB). .28, 30, 142–145,
168
insulin reservoir. . . . . . . . . . . . . . . . . . . . . .59
insulin, rapid-acting vs. long-acting 118
insulin-to-carb (IC) ratio. . . xi, 13, 28, 63,
64, 168
interruption in communication. . . . . . 76
174
IV Prep wipes . . . . . . . . . . . . . . . . . . . 75, 139
ketoacidosis . . . . . . . . . . . . . . . . . . . . . . See DKA
ketones. . . . . . . . . . . . . . . . . . . . 95, 118, 169
lancet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
lancing
finger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
lancing device . . . . . . . . . . . . . . . . . . . 84–89
long-acting insulin. . . . . . . . . . . . . . . . . .118
low battery alert . . . . . . . . . . . . . . . . . . . .140
low blood glucose . . See hypoglycemia
low reservoir advisory . . . . . . . . . . . . . .126
low reservoir alert . . . . . . . . . . . . . . . 15, 66
lows, highs, and DKA, avoid. . . . . . . . .110
manual shut-off of hazard alarm. . . .131
maximum basal rate. . . . . . . . . . . . . 27, 65
maximum bolus . . . . . . . . . . . . . . . . . 14, 65
meal bolus. . . . . . . . . . . . 30, 142–145, 169
meal IOB. . . . . . . . . . . . . . . . . . . . . . . . . . . .143
Medic Alert tag . . . . . . . . . . . . . . . . . . . . .120
medical electrical equipment. 152–155
menu
Bolus/basal/calcs . . . . . . . . . . . . . . . . . 61
More actions. . . . . . . . . . . . . . . . . . . .7, 31
My records. . . . . . . . . . . . . . . . . . . . . . . . . 7
Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Suspend/resume . . . . . . . . . . . . . . . . . . 7
System setup . . . . . . . . . . . . . . . . . . . . . 60
Temp basal. . . . . . . . . . . . . . . . . . . . . . . . . 7
microwave ovens. . . . . . . . . . . . . . . . . . . . 76
Min BG for calcs . . . . . . . . . . . . . . 13, 62, 64
missed bolus reminder . . . . . . . . . . 67–68
More actions menu. . . . . . . . . . . . . . . . . . 31
MRIs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
multiple daily injections (MDIs). . . . .169
multiple-day trends, BG history. . . . .101
normal bolus . . . . . . . . . . . . . . . . . . . . 29, 30
occlusion . . . . . . . . . . . . . . .8, 114, 118, 169
occlusion detected hazard alarm . . .128
OmniPod label symbols . . . . . . . . . . . .150
OmniPod System . . . . . . . . . . . . . . . . . . . . . 2
one-time temporary basal rate . . . . . . 23
Index
cancel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
enable . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
operating temperatures . . . 75, 147, 149
options
Bolus calcs . . . . . . . . . . . . . . . . . . . . . . . .62
Extended. . . . . . . . . . . . . . . . . . . . . . . . . .65
Max basal rate. . . . . . . . . . . . . . . . . . . . .65
Max bolus . . . . . . . . . . . . . . . . . . . . . . . . .65
Ratios/factors/targets . . . . . . . . . . . . .64
Temp basal. . . . . . . . . . . . . . . . . . . . . . . .65
Options and settings . . . . . . . . . . . . . . 146
PDM . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 58–76
backlight time-out . . . . . . . . . . . . . . . .71
batteries . . . . . . . . . . . . . . . . . . . . . 10, 139
BG goal. . . . . . . . . . . . . . . . . . . . . . . . . . . .69
blood glucose sound. . . . . . . . . . . . . .70
cleaning. . . . . . . . . . . . . . . . . . . . . . . . . 139
communication with Pod . . 132–137
customize . . . . . . . . . . . . . . . . . . . . . 71–73
disinfecting wipes. . . . . . . . . . . . . . . 139
dropped . . . . . . . . . . . . . . . . . . . . . . . . 141
icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
ID screen . . . . . . . . . . . . . . . . . . . . . . . . . . 58
PDM lock. . . . . . . . . . . . . . . . . . . . . . 71–72
repair or replacement . . . . . . . . . . . .125
screen time-out . . . . . . . . . . . . . . . . . . . 71
settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
specifications . . . . . . . . . . . . . . . . . . . .149
Status screen. . . . . . . . . . . . . . . . . . 58–59
storage. . . . . . . . . . . . . . . . . . . . . . . . . . .138
submerged in water . . . . . . . . . . . . . . 75
version . . . . . . . . . . . . . . . . . . . . . . . . . . . .viii
PDM error hazard alarm . . . . . . . . . . . .129
PDM lock . . . . . . . . . . . . . . . . . . . . . . . 71, 138
set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
PDM options, System setup . . . . . . . . . 71
personal contact information. . . . . . .103
Personal Diabetes Manager . . . See PDM
physical exertion . . . . . . . . . . . . . . . . . . .119
playing sports . . . . . . . . . . . . . . . . . . . . . .119
Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 43–57
applying . . . . . . . . . . . . . . . . . . . . . . . . . . 50
change process . . . . . . . . . . . . . . . . . . . 43
check status. . . . . . . . . . . . . . . . . . . . . . . 54
cleaning . . . . . . . . . . . . . . . . . . . . . . . . .138
deactivating . . . . . . . . . . . . . . . . . . . . . . 44
expiration reminder. . . . . . . . . . . . . . . 66
filling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
flow accuracy . . . . . . . . . . . . . . . . . . . .148
flow rate error. . . . . . . . . . . . . . . . . . . .148
in water . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
inserting cannula . . . . . . . . . . . . . . . . . 52
priming . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
removal. . . . . . . . . . . . . . . . . . 44–45, 119
safety checks. . . . . . . . . . . . . . . . . . . . . . 48
specifications . . . . . . . . . . . . . . . . . . . .147
storage. . . . . . . . . . . . . . . . . . . . . . . 57, 138
Pod error hazard alarm . . . . . . . . . . . . .128
Pod expiration advisory . . . . . . . . . . . .127
Pod expired hazard alarm . . . . . . . . . .127
Pod occlusion hazard alarm . . . . . . . .128
prescriptions . . . . . . . . . . . . . . . . . . . . . . .109
for travel . . . . . . . . . . . . . . . . . . . . . . . . .108
prime bolus . . . . . . . . . . . . . . . . . . . . 52, 169
priming, automatic . . . . . . . . . . . . . . . . . . . 8
program reminders. . . . . . . . . . . . . . . . . . 67
protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . .169
175
Index
radio interference. . . . . . . . . . . . . . . . . . . . 76
rapid-acting insulin . . . . . . . . . . . . . . . . 118
Ratios/factors/targets option . . . . 64–65
record keeping . . . . . . . . . . . . . . 3, 97–104
record screens . . . . . . . . . . . . . . . . . .97–104
alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . 102
all . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
blood glucose. . . . . . . . . . . . . . . . . . . 100
carbohydrates. . . . . . . . . . . . . . . . . . . 102
combined records. . . . . . . . . . . . . . . 103
insulin delivery. . . . . . . . . . . . . . . . . . . . 98
personal contact information . . . 103
special symbols . . . . . . . . . . . . . . 97, 101
User Info/Support. . . . . . . . . . . . . . . 103
reference food library. . . . . . . . . . . . . 3, 42
remove a Pod. . . . . . . . . . . . . . . 44–45, 119
rename
basal program . . . . . . . . . . . . . . . . . . . . 22
bolus presets. . . . . . . . . . . . . . . . . . . . . .39
custom reminders. . . . . . . . . . . . . . . . . 68
temporary basal presets . . . . . . . . . . 27
replace batteries. . . . . . . . . . . . . . . . . . . 140
reset
176
date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
PDM . . . . . . . . . . . . . . . . . . . . . . . . . . 73–74
time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
resume insulin delivery . . . . . . . . . . . . . . 56
reverse correction . . .14, 32, 63, 65, 142,
169
safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 105
alerts and alarms. . . . . . . . . . . . . . . . . . . 8
automatic priming . . . . . . . . . . . . . . . . . 8
automatic safety checks. . . . . . . . . . . . 8
electrical . . . . . . . . . . . . . . . . . . . 152–155
occlusion detection . . . . . . . . . . . . . . . . 8
safety checks . . . . . . . . . . . . . . . . . . . . . . .121
screen time-out . . . . . . . . . . . . . . . . . . . . . 71
set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
sensitivity factor . . See correction factor
set
backlight time-out . . . . . . . . . . . . . . . . 73
ID screen . . . . . . . . . . . . . . . . . . . . . . . . . . 72
PDM lock. . . . . . . . . . . . . . . . . . . . . . . . . . 72
screen time-out . . . . . . . . . . . . . . . . . . . 72
settings, BG meter . . . . . . . . . . . . . . . . . . . 69
Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . 10
sharps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .170
sharps container. . . . . . . . . . . . . . . . . . . .170
shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
shut-off, manual . . . . . . . . . . . . . . . . . . . .131
sick days. . . . . . . . . . . . . . . . . . . . . . . . . . . .119
soap, solvent . . . . . . . . . . . . . . 75, 138, 139
soft keys . . . . . . . . . . . . . . . . . . . . . . .ix, 5, 170
soft reset . . . . . . . . . . . . . . . . . . See reset PDM
special symbols in record screens . . . 97
specifications
BG meter. . . . . . . . . . . . . . . . . . . . . . . . .149
PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149
Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .147
sports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
Status screen . . . . . . . . . . . . . . . 6–7, 58–59
storage temperatures . . . . . . . . . 147, 149
stuck key advisory . . . . . . . . . . . . . . . . . .127
suggested bolus calculator . . . . . . . 3, 12,
29–33, 92, 170
examples . . . . . . . . . . . . . . . . . . .142–144
guidelines. . . . . . . . . . . . . . . . . . . . . . . .144
supplies
packing for travel . . . . . . . . . . . . . . . .108
Index
surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
suspend insulin delivery . . . . . . . . . . . . .54
symbols
in history records. . . . . . . . . . . . . . . . . .97
on screen . . . . . . . . . . . . . . . . . . . . . . . 150
System labels . . . . . . . . . . . . . . . . . . . 150
symptoms
DKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
hyperglycemia . . . . . . . . . . . . . . . . . . 114
hypoglycemia. . . . . . . . . . . . . . . . 77, 110
System error hazard alarm . . . . . . . . . 130
System options and settings. . . . . . . 146
System setup menu . . . . . . . . . . . . . . . . .60
tag a BG reading result. . . . . . . . . . . . . . .83
tags
enter . . . . . . . . . . . . . . . . . . . . . . . . . . 70, 91
target BG . . . . . . . . . . . . . . . .28, 62, 64, 170
target blood glucose value . . . . . . . . . .12
temperatures
extreme. . . . . . . . . . . . . . . . . . . . . . . . . . . 75
operating . . . . . . . . . . . . . . . 75, 147, 149
storage. . . . . . . . . . . . . . . . . . . . . .147, 149
temporary basal . . . . . . . . . . . . . . . . . 12, 65
temporary basal presets . . . . 24–27, 170
cancel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
change. . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
rename . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
temporary basal rate . . . . . . . 22–27, 170
temporary basal rate, one-time. . . . . . 23
test strips . . . . . . . . . . . . . . .2, 77, 78, 80, 86
code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
expiration . . . . . . . . . . . . . . . . . . . . . . . . . 78
text, entering and changing . . . . . 17, 22,
24, 27, 38, 39
time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 60
time segment . . . . . . . See basal segment
time zones. . . . . . . . . . . . . . . . . . . . . . . . . .108
travel concerns . . . . . . . . . . . . . . . . . . . . .108
Up/Down Controller buttons . . . . . . . . . 5
User Guide symbols . . . . . . . . . . . . . . . . . .viii
User Info/Support
button . . . . . . . . . . . . . . . . . . . . . . . . 5, 103
icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
screen. . . . . . . . . . . . . . . . . . . . . . . . . . . .104
vacation . . . . . . . . . . . . . . . . . . . . . . . . . . . .108
warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . .158
water . . . . . . . . . . . . . . . . . . . . . . 75, 107, 140
wireless communication technology 76
X-rays. . . . . . . . . . . . . . . . . . . . . . . . . . 109, 120
177
My PDM Settings
Use this form to keep track of your important PDM settings. Remember to update your information as you change or add settings.
Basal Program 1
Basal Program 2
Name _________________________________
12:00 AM to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
Rate
___________ U/hr
___________ U/hr
___________ U/hr
___________ U/hr
___________ U/hr
___________ U/hr
___________ U/hr
Target BG
Target BG (“correct to” values) for
each time segment defined, starting
at midnight. These values are used
by the suggested bolus calculator.
12:00 AM to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
Name _________________________________
12:00 AM to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
Rate
___________ U/hr
___________ U/hr
___________ U/hr
___________ U/hr
___________ U/hr
___________ U/hr
___________ U/hr
Insulin-to-Carbohydrate Ratio
Target BG
Suggest correction
when BG is above
_________
_________
_________
_________
_________
_________
_________
_________
___________ mg/dL
___________ mg/dL
___________ mg/dL
___________ mg/dL
___________ mg/dL
___________ mg/dL
___________ mg/dL
___________ mg/dL
Insulin-to-carbohydrate ratio for each time
segment defined, starting at midnight.
12:00 AM to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
1 unit of insulin
covers
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb
My PDM Settings
Duration of Insulin Action
Time that insulin will remain “active” in the body
from a previous bolus.
Temp Basal Presets
Name
___________ hrs
Correction Factor
Correction factor for each time segment defined,
starting at midnight.
12:00 AM to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
________ to ________
1 unit of insulin
decreases BG by
__________ mg/dL
__________ mg/dL
__________ mg/dL
__________ mg/dL
__________ mg/dL
__________ mg/dL
__________ mg/dL
__________ mg/dL
Bolus Presets
Name
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
Units
_____________ U
_____________ U
_____________ U
_____________ U
_____________ U
_____________ U
_____________ U
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
Rate (circle
measurement)
________ U/hr or %
________ U/hr or %
________ U/hr or %
________ U/hr or %
________ U/hr or %
________ U/hr or %
________ U/hr or %
Carb Presets
Name
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
________________________________________
Grams of
carbohydrate
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb
__________ g carb

---

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Modify Date                     : 2011:05:10 12:23:32-04:00
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Metadata Date                   : 2011:05:10 12:23:32-04:00
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Format                          : application/pdf
Title                           : OmniPod UST400.book
Creator                         : c_sullivan
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