Insulet 017 OmniPod User Manual OmniPod UST400

Insulet Corporation OmniPod OmniPod UST400

Usr Manual

Contacts and Important InformationoNameAddressTelephone and FaxEmail AddressNameAddressTelephone and FaxEmail AddressNameAddressTelephone Number(s)Policy NumberNameAddressTelephone and FaxEmail AddressOmniPod System Start Date: ____________________________PDM Model: UST400 Serial Number: ____________________Emergency Services:Dial 911 (USA only; not available in all communities)Insulet Corporation9 Oak Park Drive, Bedford, MA 01370Customer Care (24 hours/7 days): 800-591-3455When calling from outside the United States: 781-457-5098Customer Care Fax: 877-467-8538Web site: MyOmniPod.comDoctorNurse/EducatorHealth InsurancePharmacyUse the spaces below to record important health and product information.
© 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
iiiContentsIntroduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiiAbout This User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiiSymbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiiConventions and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ixImportant Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xIndication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xContraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xYour Role: Safely Using the OmniPod System . . . . . . . . . . . . . . . . . . . xi1 Your New OmniPod Insulin Management System . . . . . . . . . . 1Insulin Delivery with the OmniPod System. . . . . . . . . . . . . . . . . . . . . . 1How Does the OmniPod System Work? . . . . . . . . . . . . . . . . . . . . . . . . . 2No tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Automated cannula insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2A fully-integrated design with blood glucose monitoring . . . . 2Suggested bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Reference food library and carb presets . . . . . . . . . . . . . . . . . . . . . . 3Record keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Personalizing your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3The Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4The Personal Diabetes Manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Buttons that program and control the OmniPod System . . . . . 5Primary screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Automatic priming, safety checks, and insertion . . . . . . . . . . . . . . 8Rapid occlusion detection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Alerts and alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9The OmniPod Starter Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Set Up the Personal Diabetes Manager (PDM) . . . . . . . . . . . . . . . . . . . 9Turn on the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10The Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Enter your PDM ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Select the ID screen color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Set date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Enter basal settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Enter blood glucose sound setting and BG goal. . . . . . . . . . . . . 12Set the suggested bolus calculator. . . . . . . . . . . . . . . . . . . . . . . . . . 12Enter target blood glucose value. . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Enter minimum BG allowed for use in bolus calculation. . . . . 13Enter insulin-to-carbohydrate ratio. . . . . . . . . . . . . . . . . . . . . . . . . . 13Enter correction factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Set reverse correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ContentsivEnter the duration of insulin action . . . . . . . . . . . . . . . . . . . . . . . . . . 14Select bolus increment and enter maximum bolus. . . . . . . . . . 14Set extended bolus doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Set low reservoir advisory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Set expiration notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 Understanding and Adjusting Basal Rates . . . . . . . . . . . . . . . . 16What Is a Basal Rate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Personalized Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Create a basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Enable an existing basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Change, rename, copy, or delete a basal program . . . . . . . . . . . 20Temporary Basal Rates and Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22What is a temporary basal rate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Enable a one-time temporary basal rate. . . . . . . . . . . . . . . . . . . . . 23Cancel a one-time temporary basal rate . . . . . . . . . . . . . . . . . . . . . 24Create a temporary basal preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Enable an existing temporary basal preset . . . . . . . . . . . . . . . . . . 25Cancel an active temporary basal preset . . . . . . . . . . . . . . . . . . . . 26Change, rename, or delete a temporary basal preset . . . . . . . . 26Maximum Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27What is the maximum basal rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Change the maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274 Understanding and Delivering Bolus Doses. . . . . . . . . . . . . . . 28What Is a Bolus? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Bolus Dose Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Suggested Bolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29How a suggested bolus is calculated . . . . . . . . . . . . . . . . . . . . . . . . 30Deliver a Normal Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Deliver a bolus when suggested bolus calculator is On. . . . . . 31Deliver a bolus manually (suggested bolus calc is Off). . . . . . . 33Deliver an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Deliver an extended bolus instead of a normal bolus. . . . . . . . . . . 34Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Replace an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Bolus Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Create a bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Enable an existing bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Change, rename, or delete a bolus preset . . . . . . . . . . . . . . . . . . . 39Cancel an active bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Carb Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Create a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Change or edit a carb preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Delete a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Reference Food Library. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Access the reference food library . . . . . . . . . . . . . . . . . . . . . . . . . . . . 425 Using the Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43The Pod Change Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Gather equipment and supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Deactivate the current Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Fill a new Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Select the infusion site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Apply the new Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Insert cannula and begin insulin delivery. . . . . . . . . . . . . . . . . . . . 52Check Pod Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
ContentsvSuspend Insulin Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Resume Insulin Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Avoid Infusion Site Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Get the Most From Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Water and your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Safe storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 576 Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . 58The ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Insulin gauge and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59PDM settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59The System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Reset the time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Reset the date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Change Bolus and Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Bolus calcs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Ratios/factors/targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Temp basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Bolus increment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Alerts and Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Set alerts and reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Change Blood Glucose Meter Settings . . . . . . . . . . . . . . . . . . . . . . . . . 69Change BG goal limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Manage the blood glucose tags list . . . . . . . . . . . . . . . . . . . . . . . . . 69Change BG sound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Customize the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . 70Set PDM options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71Set Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Diagnostic options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73Set a Reminder to Vibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Get the Most from Your PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Keep it handy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Communicating with the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Water and your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Electrical interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 757 Checking Your Blood Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76The Built-in FreeStyle® Blood Glucose Meter . . . . . . . . . . . . . . . . . . . 76The FreeStyle® Blood Glucose Test Strips. . . . . . . . . . . . . . . . . . . . . . . 77Important test strip information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77The FreeStyle® Control Solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78When to perform a control solution test. . . . . . . . . . . . . . . . . . . . . 78Check that the meter and test strips are working. . . . . . . . . . . . 78Control solution expiration date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Ensure accurate control solution results. . . . . . . . . . . . . . . . . . . . . 78Out-of-range control solution results. . . . . . . . . . . . . . . . . . . . . . . . 79Performing a Control Solution Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80Performing a blood glucose reading . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Prepare the lancing device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
ContentsviInsert the blood glucose test strip . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Set the blood glucose test strip code . . . . . . . . . . . . . . . . . . . . . . . . 86Lance your finger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Lance your forearm, upper arm, or hand. . . . . . . . . . . . . . . . . . . . . 88Fill the blood glucose test strip with blood . . . . . . . . . . . . . . . . . . 89Wait for the reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90Remove the lancet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Blood Glucose Results and the Suggested BolusCalculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Entering Blood Glucose Readings Manually . . . . . . . . . . . . . . . . . . . . 92Editing Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Low and High Blood Glucose Readings. . . . . . . . . . . . . . . . . . . . . . . . . 94Low readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94High readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94Important Health-Related Information . . . . . . . . . . . . . . . . . . . . . . . . . 958 Understanding Your Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Special symbols in record screens . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Insulin Delivery Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97View insulin delivery records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97Blood Glucose Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99View single-day trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99View multiple-day trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Alarm Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Carbohydrate Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101All Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102User Information/Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1029 Living with Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Your Role: Safely Using the OmniPod System. . . . . . . . . . . . . . . . . . 104Daily Diabetes Management Activities . . . . . . . . . . . . . . . . . . . . . . . . 105Check your blood glucose frequently. . . . . . . . . . . . . . . . . . . . . . . 105Inspect the infusion site daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Prepare for Emergencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Water and Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Traveling and Vacationing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Plan for changing time zones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Take enough supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Minimize airport security delays. . . . . . . . . . . . . . . . . . . . . . . . . . . . 108Travel preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108Screening procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108Keep supplies accessible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Avoid Lows, Highs, and DKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109General precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . . . . . . . . . . 109Hyperglycemia (high blood glucose) . . . . . . . . . . . . . . . . . . . . . . . 114Diabetic ketoacidosis (DKA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Handling Special Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119Sick days. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119Exercising, playing sports, or working hard . . . . . . . . . . . . . . . . . 119X-rays, MRIs, and CT scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120Surgery or hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12010 Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121Blood Glucose Meter Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
ContentsviiAlarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124Advisory Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124Hazard Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124Manual Shut-off of a Hazard Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13011 Communication Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131The Communication Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131Failure During Pod Activation or Operation . . . . . . . . . . . . . . . . . . . 131Failure During Pod Deactivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133Failure During Request for Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134Failure During Bolus Cancellation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137Pod Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137Personal Diabetes Manager Care and Maintenance. . . . . . . . . . . 137Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137Cleaning and disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138Replacing batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138If the PDM becomes submerged in water . . . . . . . . . . . . . . . . . . 139If you drop the PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Storage and Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Suggested Bolus Calculator Examples and Guidelines . . . . . . . . 141Meal bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141Insulin-on-board (IOB) calculation. . . . . . . . . . . . . . . . . . . . . . . . . . 141Examples of suggested bolus calculations . . . . . . . . . . . . . . . . . 142Calculator guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143OmniPod System Options and Settings . . . . . . . . . . . . . . . . . . . . . . . 145Pod Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146Accuracy Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147Flow rate from startup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147Flow rate error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147Personal Diabetes Manager Specifications . . . . . . . . . . . . . . . . . . . . 148Blood Glucose Meter Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . 148OmniPod System Label Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149Personal Diabetes Manager Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149OmniPod System Notice Concerning Interference . . . . . . . . . . . . 150Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Customer Bill of Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155Mission Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155Scope of Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155Supply Shipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155Inquiries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155CHAP Accredited. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155Customer’s Bill of Rights and Responsibilities. . . . . . . . . . . . . . . 156Limited Warranty for the Personal Diabetes Manager . . . . . . . . . 157HIPAA Privacy Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158Uses and Disclosures of Medical Information. . . . . . . . . . . . . . . 158Your Rights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161Our Duties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163What To Do If You Have a Problem or Question . . . . . . . . . . . . 163Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
viii■ About This User GuideSymbolsSymbol Term MeaningWarning 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 Manage-ment 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 Cus-tomer Care section of MyOmniPod.com to see the most recent version and to find other helpful infor-mation.Screen displays shown in this User Guide are for illustra-tive purposes only and should not be considered suggestions for user settings. Consult with your health-care provider to determine the appropriate settings for you.Introduction
IntroductionixConventions and TermsImportant InformationIndicationThe OmniPod® Insulin Management System is intended for sub-cutaneous (below the skin) delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requir-ing insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro).Convention/Term MeaningBold 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 MeaningIcon An image on the PDM screen that indi-cates a menu option or item of informa-tion. A table of screen icons appears in the Appendices.Soft keys A row of three unlabeled buttons on the PDM whose label or function appears on the screen directly above the button. The label changes depending on the task you are performing.US Federal law restricts this device to sale by or on the order of a physician.
IntroductionxContraindicationsInsulin 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 instructionsDo not use the integrated FreeStyle® Blood Glucose Monitoring System for:• Testing on newborns• Testing arterial blood• Diagnosing of or screening for diabetes mellitusThe OmniPod System is designed to use rapid-act-ing U-100 insulin. The following U-100 rapid-acting insulin analogs have been tested and found to be safe for use in the Pod: Novolog®/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 label-ing 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 radi-ation 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 treat-ment 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 mul-tiple patients.Parts of the device are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
Introductionxi■ Your Role: Safely Using the OmniPod SystemWork with your healthcare provider to establish diabetes man-agement guidelines and settings that best fit your needs. These may include:Insulin-to-Carbohydrate Ratio (IC): Number of grams of carbo-hydrate covered by one unit of insulin. For example, if your insulin-to-carbohydrate ratio is 1:15, then you need to deliver one unit of insulin to cover every fifteen grams of carbohydrate you eat.Correction or Sensitivity Factor: How much one unit of insulin will lower blood glucose. For example, if your sensitivity factor is 50, one unit of insulin will lower your blood glucose by 50 mg/dL.Target Blood Glucose Value: The blood glucose level you want to achieve. For example, you may want to keep your blood glu-cose close to 100 mg/dL.Duration of Insulin Action: The length of time that insulin remains active and available in your body after a correction or meal bolus.Please read all the instructions provided in this User Guide and practice the blood glucose testing proce-dures before using the System. Monitor your blood glucose with the guidance of your healthcare pro-vider. Undetected hyperglycemia or hypoglycemia can result without proper monitoring.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.
IntroductionxiiYour individual needs influence the initial settings you and your healthcare provider will enter into the Personal Diabetes Man-ager (PDM) during setup (see Chapter 2, Getting Started).Your healthcare provider must help you enter these initial set-tings. Soon you will enter and change your own settings with confidence and ease. The OmniPod System is more user-friendly than most electronic devices you use every day. In fact, technol-ogy is what makes the OmniPod System so easy to use.Your healthcare provider is a valuable resource. You will rely on him or her for a lot of critical information about your OmniPod System, especially during the first few weeks and months. When you have questions about diabetes management after starting on the OmniPod System, do not hesitate to talk with your health-care provider. For nonmedical emergencies or for technical questions about your OmniPod System setup or operation, you can call Customer Care 24 hours a day, 7 days a week.Customer Care (24 hours/7 days): 800-591-3455When calling from outside the United States: 781-457-5098Customer Care Fax: 877-467-8538Web site: MyOmniPod.comYour healthcare provider will give you all the tools and training you need to be successful with the OmniPod Insulin Manage-ment System. However, in the end, your success depends on YOU. You must become actively involved in your own diabetes management to enjoy the outstanding control, freedom, and flexibility that is possible with the OmniPod System.Being actively involved means:• Frequently monitoring blood glucose levels• Learning how to operate your OmniPod System and practic-ing proper techniques• Visiting your healthcare providerDo NOT attempt to use the OmniPod® Insulin Man-agement System before you receive training from your healthcare provider. Inadequate training could put your health and safety at risk.
1CHAPTER 1Your New OmniPod Insulin Management System■ Insulin Delivery with the OmniPod SystemThe OmniPod® Insulin Management System is an innovative continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy in a way no conventional insulin pump can. The System’s innova-tive design and features allows you to live your life—and manage your diabetes—with unprecedented freedom, comfort, convenience, and ease.The long-term health benefits of better blood glucose control are well known. Maintaining near-normal blood glucose levels can help you live a longer, healthier life with fewer diabetes-related complications. The OmniPod System also has many prac-tical, everyday benefits, including convenience, freedom, flexibility, and ease of use.Continuous insulin delivery most closely mimics the insulin release of a healthy pancreas. Since the landmark 10-year Diabetes Control and Complications Trial (DCCT), the long-term health benefits of maintaining near-normal blood glucose levels have been widely recognized.Continuous insulin delivery at preset rates eliminates the need for injections and the interruptions that come with them. In addi-tion, with the OmniPod System, insulin delivery can be changed with the press of a button to adapt to snacks or unexpected changes in daily routine. The OmniPod System is a great option for people with diabetes who require insulin.The OmniPod System works much like the pancreas of a person without diabetes by delivering insulin in two ways:• A small, constant, background supply of insulin (called a basal rate) is delivered automatically at a programmed rate, all day and night.• An extra dose of insulin (called a bolus) can be delivered when you need it to match the carbohydrates in a meal or snack or to correct a high blood glucose.
Your New OmniPod Insulin Management System21■ 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 meterWith 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 tubingThere 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 calculationCalculating 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 presetsTo 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 System31You can also enter your own favorite foods, snacks, or entire meals as “carb presets.” Presets contain the grams of carbohy-drate in the food item or meal. Next time you eat this same food, you don’t have to count the carbs; just select your carb preset and the System does the calculating for you. The System stores up to 36 carb presets.Automated cannula insertionWith the OmniPod System, you don’t have to insert the infusion set manually or carry around a separate inserter. You simply press a button on the PDM and the Pod’s automated insertion system safely and consistently inserts the cannula beneath the skin, vir-tually pain free. It then begins delivering insulin according to your programmed basal rate.A fully-integrated design with blood glucose monitoringWith 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 keepingAnother convenient part of the OmniPod System is record keep-ing. Paper charts are useful, but sometimes they can be inconvenient to carry or use. The data storage system in the Personal Diabetes Manager (PDM) displays up to 90 days’ worth of information. This includes blood glucose readings, basal rates and bolus doses, carbohydrates, and alarms.Personalizing your System You can personalize your OmniPod System in other ways, too: • Enter and name basal programs• Name and save temporary basal presets• Add your own customized reminders• Enter your name, phone number, doctor’s name and number, and other emergency information
Your New OmniPod Insulin Management System41■ The PodThe Pod (Figure 1-1) is applied to your skin with an adhesive backing, similar to an adhesive bandage.■ The Personal Diabetes ManagerAll Pod operations are programmed and controlled through the palm-sized Personal Diabetes Manager (PDM; Figure 1-2).TopBottomNeedle capViewing windowFill portFigure 1-1Adhesive backingHousing ventFigure 1-2Up/Down ControllerUser Info/SupportSoft Key LabelSoft KeysHome/PowerUSB PortTest Strip PortLCD Screen
Your New OmniPod Insulin Management System51Buttons that program and control the OmniPod SystemButton ActionHome/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 physi-cal button you press. Select, Save, and Back are just three examples of the soft key labels on your PDM.Button ActionUser Info/Support Pressing opens a User Info/Support screen that displays additional information about the cur-rent screen you are viewing. The User Info/Sup-port icon appears when additional information can be viewed. It may be displayed at the top of the screen, to the right of an event detail (such as a suggested bolus), or to the right of a record item (such as a BG history record). (See “Personal Diabetes Manager Icons” in the Appendix).In addition, pressing and holding this button for 2 seconds enables a “bright mode” on the PDM screen.
Your New OmniPod Insulin Management System61Primary screensMessages on the screen either:• Let you identify your PDM• Tell you how the System is operating• List menu choices• Explain how to perform certain tasksThe System’s primary screens are the ID screen (Figure 1-3), the Status screen (Figure 1-4), and the Home screen (Figure 1-6 on the next page). ID screenThe System displays an ID screen to make the PDM easy to iden-tify when you first turn it on. You can personalize the ID screen by adding your name and choosing its color. (See Chapter 6, Using the Personal Diabetes Manager, for details on customizing your PDM.) You must acknowledge the ID screen before you can use the PDM. It is important that you always identify the PDM as yours before you use it.Status screenLists 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 expireFigure 1-3Figure 1-4
Your New OmniPod Insulin Management System71Status support screenFrom the Status screen, press the User Info/Support button to see details about the current insulin on board (IOB) in your body (Figure 1-5). See page 30, for additional information describing insulin on board (IOB).Home screenLists 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 read-ings that are less than 2 hours old.•Temp basal menu to deliver temporary basal rates (This submenu does not appear if temp basal is turned Off in Settings.)•My records menu to review insulin delivery, blood glucose history, alarm history, carb history, and personal user informa-tion•Settings menu to edit, enter, and name basal programs, temp basal, carbohydrate and bolus presets, and to custom-ize System settings•Suspend menu to suspend, cancel, or resume insulin delivery programsIf a Pod has not yet been activated (during Pod changes), the screen displays “No active Pod. Would you like to acti-vate a Pod now?” (See Chapter 5, Using the Pod, for details on activating a Pod.)Figure 1-5Figure 1-6You can go to the Status screen at any time by pressing Status from the Home screen.
Your New OmniPod Insulin Management System81■ Safety FeaturesThe OmniPod System’s state-of-the-art design includes the latest safety technology. Its built-in safety features include:Automatic priming, safety checks, and insertionEvery 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). Micro-processor 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 commu-nication between them—it informs you with beeps and on-screen messages.Rapid occlusion detectionAn 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 alarmsFor your safety, the OmniPod System provides a range of alerts and alarms to tell you that your attention is needed, or to warn you of hazardous situations.See Chapter 6, Using the Personal Diabetes Manager, for a description of notifications and how to set them. See Chapter 10, Alerts and Alarms, for a list of safety alarms built into the Omni-Pod System and how to respond to them.Confirm on ID screen - alerts/alarms do not show on PDM until after ID screen is confirmed.
9CHAPTER 2Getting Started■ The OmniPod Starter KitYour initial shipment contains everything you need to begin using the OmniPod System.If you are a first-time OmniPod System user, you need to meet with your healthcare provider for training and System setup before using it. To get a head start on learning about your new OmniPod System, review this User Guide and complete the Pre-Training section of OmniPod’s online Interactive Training Pro-gram, 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 com-plete the Warranty card and promptly mail it to us. Returning the card allows us to contact you with important product updates or Warranty information.■ 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.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.
Getting Started102Turn on the PDM1. Open the battery compartment on the back of the PDM by pushing the compartment latch and lifting upward (Figure 2-1). No special tools are necessary.2. Insert two (2) new AAA alkaline batteries into the compart-ment.3. Replace the battery door.4. Turn the PDM face up. The PDM has begun to power on auto-matically.■ The Setup WizardThe 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 pro-vider 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.• Press the Soft Key labeled Next, Select, Done, or Save to con-tinue to the next screen.• Press Back to return to the previous screen.The diagram inside the compartment shows you which direction to insert the batteries (Figure 2-2).Figure 2-1Figure 2-2HardResetDo 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.Initial settings are “---” [blank] for target blood glucose value, insulin-to-carbohydrate ratio, correction factor, and duration of insulin action.
Getting Started112To get started, press Next on the Wizard's Welcome Screen to begin setting up your PDM.Enter your PDM ID1. 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 color1. Use the Up/Down Controller buttons to choose a color, then press Next.Set date and time1. 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 settings1. 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.You can adjust these settings later as your needs change or as you fine-tune your OmniPod System.Your ID and the chosen color will be displayed on an identification (ID) screen that you must acknowledge every time you turn on the PDM. Always be sure you properly identify your PDM before using it.
Getting Started1226. 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 tem-porary basals, see Chapter 3, Understanding and Adjusting Basal Rates.Enter blood glucose sound setting and BG goal1. To set the sound for the blood glucose meter, choose On or Off, then press Next.2. Use the Up/Down Controller buttons to enter the lower limit for your blood glucose (BG) goal, then press Next.3. Enter the upper limit for your BG goal, then press Next.4. Press Save to accept the BG goal.Set the suggested bolus calculator1. To set the suggested bolus calculator feature, choose On or Off, then press Next.Enter target blood glucose value1. 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.3. To save the target BG value, press Done. To change these set-tings, select the segment you wish to change and press Edit.You can define up to 8 target BG time segments. To enter additional segments, choose [add new], then:a. Press New. You can add up to 7 basal programs and set 24 segments per program.The lower and upper BG limits are only used when viewing BG History (see Chapter 8, Understanding Your Records).Check with your healthcare provider before adjust-ing these settings.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.”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.
Getting Started132b. 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 “cor-rect above” value or “correction threshold” (the BG value above which you want the PDM to suggest a correction bolus), then press Next.e. When you have finished entering segments, press Done.4. To see the segments as a list, press List. To return to the graphic view, press Graph.5. Press Save to accept the target BG profile you have set.Enter minimum BG allowed for use in bolus calculation1. Use the Up/Down Controller buttons to enter a minimum blood glucose value, below which the System will not calcu-late 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 ratio1. Use the Up/Down Controller buttons to enter your insulin-to-carbohydrate ratio, then press Next. (Insulin-to-carbohy-drate ratio is the number of carbs covered by 1 unit of insulin.)2. To save the ratio, press Done. To change the ratio, select the segment you wish to change and press Edit.You can define up to 8 insulin-to-carbohydrate time seg-ments. 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 factor1. 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:
Getting Started142a. 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 correction1. To set reverse correction, use the Up/Down Controller buttons to choose On or Off, then press Next.Enter the duration of insulin action1. Use the Up/Down Controller buttons to enter the duration of insulin action (how long insulin lasts in your body), then press Next.Select bolus increment and enter maximum bolus1. 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 insu-lin—then press Next.2. Choose the maximum bolus you can give at one time, then press Next.Set extended bolus doses1. To set the units for an extended bolus dose, choose % for per-cent of the total bolus, or choose Units for units of insulin. To turn off the extended bolus feature, choose 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 sug-gested meal bolus dose due to a low BG. Follow your healthcare provider’s recommendation to set reverse correction On or Off.The duration-of-insulin-action setting is used to calculate the amount of insulin on board (IOB) from a previous correction bolus or meal bolus when you use the suggested bolus calculator.The maximum bolus default is 10 units. Check with your healthcare provider before adjusting these set-tings.
Getting Started152Set low reservoir advisory1. 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 notification1. 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 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.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.
16■ 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 mim-ics a healthy pancreas by delivering insulin at the rate that you’ve programmed into the Personal Diabetes Manager (PDM).■ Personalized Basal ProgramsInsulin needs vary throughout the day. Therefore, most people set their basal rates to deliver slightly more or less insulin at 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:Approximately 50% of a person’s total daily insulin dose typically comes from basal insulin delivery; the remain-ing 50% typically comes from bolus doses (see Chapter 4, Understanding and Delivering Bolus Doses).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.CHAPTER 3Understanding and Adjusting Basal Rates
Understanding and Adjusting Basal Rates173In 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 programThe 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.1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.2. Choose Basal programs (Figure 3-1), then press Select. 3. Choose [add new] (Figure 3-2), then press New.4. To use the default naming system, simply press Next. The default naming system automatically assigns program names in numerical order, such as basal 1, basal 2, basal 3.If you want to give a different name to the program:a. Press the Up/Down Controller buttons to scroll through the list of characters. An up-and-down arrow symbol on the screen indicates the character you are changing.Check with your healthcare provider before adjust-ing these settings.Figure 3-1Figure 3-2
Understanding and Adjusting Basal Rates183b. 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 sched-ule, 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 scroll-ing menu.) d. Press Next.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.Figure 3-3Figure 3-4As 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.
Understanding and Adjusting Basal Rates193e. Repeat steps a–d for each new segment and rate you want, then press Done.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 program1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select.2. Choose Basal programs, then press Select.Basal rates outside the changed segment do not change.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.Figure 3-5Figure 3-6
Understanding and Adjusting Basal Rates2033. Choose the program you want from the list (Figure 3-7), then press Enable. 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.Change, rename, copy, or delete a basal program1. 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 program1. Choose View, then press Select (Figure 3-8).Figure 3-7A diamond icon (♦) appears next to the program that is active. You cannot select the active program to enable it, because it is already running.As a safety feature, you cannot enable a new basal program while a temporary basal program is in pro-cess (see “Temporary Basal Rates and Presets” later in this chapter); you must first cancel the active tempo-rary basal program.
Understanding and Adjusting Basal Rates213To edit or add a segment or rate in the basal program1. Choose Edit, then press Select.2. Choose the segment to change, then press Edit (Figure 3-9).Or, choose [add new], then press New.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 2–5.7. To see the program as a list, press List. To see the graph again, press Graph.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.Figure 3-8Figure 3-9Figure 3-10
Understanding and Adjusting Basal Rates223To rename a basal program1. After choosing a program from the list, choose Rename, then press Select.2. Press the Up/Down Controller buttons to enter the charac-ters that spell out the new name you want. Press the middle soft key (labeled with the right arrow) to move the under-score to the next character, then press Save.To copy a basal program1. After choosing a program from the list, choose Copy, then press Select.2. Press the Up/Down Controller buttons to enter the charac-ters 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, fol-low the steps under “To edit or add a segment or rate in the basal program” earlier in this chapter.To delete a basal program1. After choosing a program from the list, choose Delete and then press Select.2. Press Delete to permanently delete the program.■ Temporary Basal Rates and PresetsWhat is a temporary basal rate?A temporary basal rate lets you adjust your basal rate for a pre-determined 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 tempo-rary 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, orInstead 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.As a safety feature, you cannot delete the active basal program.
Understanding and Adjusting Basal Rates233join 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 rate1. 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 manu-ally] 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.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.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.Figure 3-11Figure 3-12
Understanding and Adjusting Basal Rates243Cancel a one-time temporary basal rate1. 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.3. Press Confirm to cancel the temporary basal shown on the screen.Create a temporary basal preset1. 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 scroll-ing menu.)Figure 3-13Capitals and lowercase letters are considered the same.
Understanding and Adjusting Basal Rates253d. 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.Enable an existing temporary basal preset1. 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.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 tempo-rary basal preset is running.Figure 3-14Figure 3-15Figure 3-16
Understanding and Adjusting Basal Rates263Cancel an active temporary basal preset1. 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.Change, rename, or delete a temporary basal preset1. 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.To change a temporary basal preset1. Choose Edit, then press Select (Figure 3-17).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.If you suspend insulin delivery while a temp basal is running, the temp basal will be cancelled when you suspend.You cannot edit, change, or delete a temporary basal preset that is actively running.Figure 3-17
Understanding and Adjusting Basal Rates273To rename a temporary basal preset1. Choose Rename, then press Select.2. Press the Up/Down Controller buttons to enter the charac-ters that spell out the name you want, then press Save.3. Press Done.To delete a temporary basal preset1. Choose Delete, then press Select.2. Press Delete to permanently delete the preset.■ Maximum Basal RateWhat 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 pro-grams 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 rate1. 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.
28■ 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 bolusThis extra dose is in addition to the basal rate delivered through-out 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 pre-vious meal and correction boluses• 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 eatWith 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 adjust-ing these settings.CHAPTER 4Understanding and Delivering Bolus Doses
Understanding and Delivering Bolus Doses294■ Bolus Dose OptionsSo 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 carbohy-drate (“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 levelExtended 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).■ Suggested Bolus CalculatorThe suggested bolus calculator lets the OmniPod System recom-mend 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 Diabe-tes 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 sug-gested bolus dose based on the settings you have programmed into the PDM. Check with your health-care 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.
Understanding and Delivering Bolus Doses304How a suggested bolus is calculatedThe 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 actionThe 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 carbohy-drates 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 correc-tion boluses. The amount of time the insulin remains “on board” or “active” depends on what you set for your duration of insulin action.For formulas for each element of the suggested bolus calcula-tion, detailed examples, and additional guidelines of how the suggested bolus calculator works, see the Appendix.Figure 4-1Figure 4-2The OmniPod System can only subtract insulin on board (IOB) from a suggested bolus when the current BG is known.
Understanding and Delivering Bolus Doses314■ Deliver a Normal BolusDeliver a bolus when suggested bolus calculator is On1. 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 4-3A 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 Read-ing. See the end of Chapter 7, Checking Your Blood Glucose.
Understanding and Delivering Bolus Doses3242. 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.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 num-ber 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.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.Figure 4-4Figure 4-5To view detailed information about the calcula-tions used for this suggested bolus, press the User Info/Support button and scroll through the infor-mation screens. Press Close to return to the Suggested Bolus screen.
Understanding and Delivering Bolus Doses3344. 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.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 glu-cose level below your target.Figure 4-6As 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.
Understanding and Delivering Bolus Doses344■ Deliver an Extended BolusThe 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 bolus1. After you get your suggested bolus, press Extend instead of Enter (see Figure 4-7).2. Enter the units of insulin or percentage of the bolus that you want to take immediately (Figure 4-8), then press Enter. Figure 4-7If 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.To learn how to set extended boluses in percentages or units, see Chapter 6, Using the Personal Diabetes Manager.Figure 4-8
Understanding and Delivering Bolus Doses3543. 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. 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.Figure 4-9Figure 4-10As 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 unitsCorrection bolus 1 unitMeal bolus 4 unitsDeliver now = 2 unitscorrection bolus 1 unitmeal bolus 1 unitExtend = 3 units meal portion 3 unitsAs 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.
Understanding and Delivering Bolus Doses364■ Cancel Active BolusesThe 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 instruc-tions. 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). 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.■ Replace an Extended BolusYou 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).Figure 4-11Figure 4-12If the bolus has already been completely delivered, the “Delivering bolus” message and Cancel do not appear, but the Status screen does appear.If your suggested bolus contains both a correction bolus and a meal bolus, the correction bolus is always delivered first.
Understanding and Delivering Bolus Doses3742. Press Yes to cancel the active extended bolus (Figure 4-13).Or press Back to return to the Suggested Meal Bolus screen. 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. ■ Bolus PresetsBolus 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.”You can add what remained of the old extended bolus to the new one.Figure 4-13Figure 4-14Bolus 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 pre-sets. See “Carb Presets” on Page 39.)Figure 4-15
Understanding and Delivering Bolus Doses384Create a bolus preset1. 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 char-acters 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. 7. Review the bolus preset name and amount, then press Save to accept it. Enable an existing bolus preset1. 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 neces-sary, use the Up/Down Controller buttons to adjust the bolus amount.Figure 4-16Figure 4-17
Understanding and Delivering Bolus Doses3944. Press Confirm to deliver the bolus shown on the screen.Change, rename, or delete a bolus preset1. 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 preset1. Choose Edit, then press Select.2. Enter a new insulin amount for the bolus, then press Save.Rename a bolus preset1. Choose Rename, then press Select.2. Press the Up/Down Controller buttons to enter the charac-ters that spell out the name you want,then press Next.Delete a bolus preset1. Choose Delete, and then press Select.2. Press Delete to permanently delete the preset.Cancel an active bolus preset1. Press and hold the Power button to turn on the PDM (To check the Pod status, refer to Page 54 for detailed instruc-tions. 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 PresetsCarb 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 preset1. 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.
Understanding and Delivering Bolus Doses4046. 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 char-acters 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. 9. Press Save to add the preset to the category.Change or edit a carb preset1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press Select.2. Choose Presets, then press Select.These additional units are not required. If you prefer not to enter them, simply press Next repeatedly to skip through the screens.If you do include grams of fiber in step 8 to the left, the suggested bolus calculator uses carbs minus fiber. Alter-natively, 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.Figure 4-18
Understanding and Delivering Bolus Doses4143. Choose Carb presets, then press Select.4. Choose the category of the preset you want to change, then press Select (Figure 4-19).To change the category for a carb preset1. Choose the carb preset you want to move to another cate-gory, then press Tag (Figure 4-20).2. Choose a new category, then press Select.To edit a carb preset1. Choose the carb preset you want to change, then press Edit.2. Press Edit again on the next screen.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.6. Press Save to update the preset.Delete a carb preset1. 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.Figure 4-19Figure 4-20These additional units are not required. If you prefer not to enter them, simply press Next repeatedly to skip through the screens.
Understanding and Delivering Bolus Doses424■ Reference Food LibraryThe OmniPod System includes a reference library of over 1,000 common food items. The library shows each item’s grams or car-bohydrate, 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 data-base, USDA National Nutrient Database for Standard Reference.Access the reference food library1. 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.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 calories5. Press OK to return to the list of main food categories.The Food Library is for reference only. (Food refer-ences contained in the library cannot be populated and used for calculations.)Figure 4-21aFigure 4-21b
43CHAPTER 5Using the Pod■ The Pod Change ProcessReplace 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 fol-low 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 Chap-ter 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 dam-aged 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 dis-lodged.• 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, put-ting 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 ketoacido-sis (DKA). DKA can cause symptoms such as breathing difficul-
Using the Pod445ties, shock, coma, or death. If insulin delivery is interrupted for any reason, you may need to replace the missing insulin usu-ally with an injection of rapid-acting insulin. Ask your health-care provider for instructions on handling interrupted insulin delivery.Gather equipment and suppliesGather the following before you begin:• A vial of rapid-acting U-100 insulin (See the warning on pagex of the Introduction for a list of insulins approved for use in the OmniPod System.)• An unopened Pod• AN alcohol prep swabDeactivate the current Pod1. 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.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.NEVER use insulin that is cloudy; it may be old or inac-tive. Failure to use rapid-acting U-100 insulin, or using insulin that is expired or inactive, may lead to hyper-glycemia or diabetic ketoacidosis (DKA).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 Sys-tem with inadequate training or improper setup could put your health and safety at risk.Figure 5-1Figure 5-2
Using the Pod4555. After you press Confirm, you will see the message inFigure 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).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.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 Pod1. 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.Removing the Pod slowly will help to avoid possible skin irritation.Figure 5-3Figure 5-4Check the infusion site for signs of infection. See “Avoid Infusion Site Infections” later in this chapter.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 tem-perature before filling it with insulin.
Using the Pod4654. 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.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 bub-bles. Fill at least to the MIN (minimum) fill line (Figure 5-5). Refer to the Care Giver Guide as an additional reference.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).Use care after removing the needle cap and exposing the fill needle.Only use room temperature insulin when filling the Pod.The Pod requires a minimum of 85 units of insulin to begin operation.The Pod can deliver up to 200 units of insulin. Make sure there is no air in the syringe before attempting to fill a Pod with insulin.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.Figure 5-5Figure 5-6Fillport
Using the Pod4759. 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.10. Remove the needle from the insulin fill port. The port is self-sealing; 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.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.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 automati-cally primes the Pod (Figure 5-8). Once complete, the PDM beeps, letting you know that the priming and safety checks were successful.To ensure proper fill, do not insert the fill syringe at an angle into the fill port.Do not use any other type of needle or filling device besides the syringe provided with each Pod.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.Do not insert the fill syringe into the fill port more than once.NEVER inject air into the fill port. Doing so may result in unintended or interrupted insulin deliv-ery.The fill syringe is intended for single use only and should be used only with the OmniPod System.As a safety feature, the communication distance be-tween 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.
Using the Pod485 Select the infusion siteBefore 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 poten-tial 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).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.Figure 5-7Figure 5-8Avoid 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.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 Pod495Figure 5-9: Adult/YouthFrontBackFigure 5-10: ToddlerFrontBack
Using the Pod505You can reduce the risk of infection at the infusion site by follow-ing 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.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 PodPrepare 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.2. How to verify Pod is ReadyPod is:• Clean and dry• Adhesive pad is intact and undamaged• Pod is intact and in its original conditionTo help avoid condensation from occurring in the viewing window, make sure both your Pod and your insulin are at room temperature.Antibacterial soap may irritate skin, especially at the infusion site. Ask your healthcare provider how to treat any skin irritation.Verify cannula is not extending beyond adhesive backing once needle cap is removed. Figure 5-11Figure 5-12
Using the Pod515• 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.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.5. After you securely apply the Pod, press Next (Figure 5-14).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.For the Pod to work best, apply it:a. Crosswise or at a slight angle on your abdo-men, hip, upper back, or buttocks (in Figure 5-13)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 siteThe 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.The adhesive is designed for one-time use. Once removed, a Pod cannot be reapplied.Figure 5-13a.b.Figure 5-14FF
Using the Pod525Insert cannula and begin insulin delivery1. To insert the soft cannula, press Start (Figure 5-15).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).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.Figure 5-15Figure 5-16You will hear a click when the cannula inserts.Figure 5-20\ Figure 5-17Figure 5-21 Figure 5-18
Using the Pod535Once 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.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.Or press Back to return to the previous screen.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. Ver-ify 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.To help avoid condensation from occurring in the viewing window, make sure both your Pod and your insulin are at room temperature.Condensation may occur in the viewing window, from sweating and perspiration.Figure 5-19
Using the Pod545■ Check Pod StatusTo 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 but-ton, 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.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.■ Suspend Insulin DeliverySometimes 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.1. On the Home screen, use the Up/Down Controller buttons to choose Suspend; then press Select.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.Once a Pod is activated and communicates with the PDM, it can only receive commands from that PDM, not from any other.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 can-celled when you suspend insulin delivery.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 Pod5552. 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.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 sus-pended (Figure 5-21).The Pod beeps every 15 minutes until the end of the suspen-sion period. The Status screen shows INSULIN SUSPENDED until you resume insulin delivery (see “Resume Insulin Deliv-ery” on the next page).At the end of the suspend time, a Pod Advisory alarm occurs (Figure 5-22).4. To resume your programmed basal rate, press OK.Figure 5-23 Figure 5-20Figure 5-21The 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).Figure 5-25\ Figure 5-22
Using the Pod565■ Resume Insulin Delivery1. On the Home screen, use the Up/Down Controller buttons to choose Resume (Figure 5-23), then press Select.2. Press Confirm to restart the basal program for that time seg-ment.■ Avoid Infusion Site Infections• Always wash your hands and use the aseptic technique to pre-pare 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 can-nula 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 infec-tion, 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 PodAvoid extreme temperaturesThe 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.Figure 5-23
Using the Pod575Water and your PodThe Pod is waterproof up to a depth of 25 feet for up to 60 min-utes (IPX8). After exposure to water, rinse off the Pod with clean water and gently dry it with a towel.Safe storageStore 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.Do NOT expose a Pod to direct sunlight for long peri-ods 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 manufac-turer’s instructions for use.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.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.
58CHAPTER 6Using the Personal Diabetes Manager■ The ID ScreenWhen 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. ■ The Status ScreenWhen a Pod is active and the PDM is turned on, the PDM estab-lishes 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 expi-ration. The information obtained is then displayed in the status screen, which shows the System’s current operating status.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 deliveredIt is important that you always identify the PDM as yours before you use it.Figure 6-1Figure 6-2
Using the Personal Diabetes Manager596• Amount of insulin on board (IOB), if suggested bolus calcula-tor isin 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 expireInsulin gauge and displayOne 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.”PDM settingsYou 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 health-care provider before making any changes.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.)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.
Using the Personal Diabetes Manager606■ The System Setup MenuThe 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• DiagnosticsYou 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 TimeOccasionally, 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 sus-pended (see Chapter 5, Using the Pod).1. Suspend insulin delivery.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.Figure 6-3If 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.
Using the Personal Diabetes Manager616Reset the time1. 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).3. Press Confirm to accept the new time (Figure 6-5).Reset the date1. Press the Up/Down Controller buttons to choose the cur-rent 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.■ Change Bolus and Basal SettingsYou 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 set-tings 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.Figure 6-4Figure 6-5If you suspended insulin delivery to change the time or date, remember to resume insulin deliv-ery. If you changed the time or date during the Pod change process, remember to activate a new Pod.
Using the Personal Diabetes Manager6264. Choose one of the options (Figure 6-6a and Figure 6-6b), then press Select. Each option is described below.Bolus calcsWhen 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.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 seg-ments and add segments, up to a total of 8.a. To edit an existing IC ratio time segment, choose the seg-ment, 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.Figure 6-6aFigure 6-6b
Using the Personal Diabetes Manager6364. 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 Control-ler buttons to choose a new start time, end time, and cor-rection 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 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/targetsWhen 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.Figure 6-7Figure 6-8aFigure 6-8b
Using the Personal Diabetes Manager6461. 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 carbohy-drate 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 seg-ment, then press Edit. Use the Up/Down Controller but-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 Control-ler buttons to choose a new start time, end time, and cor-rection 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.When the suggested bolus calculator is turned Off, the Ratios/factors/targets option does not appear in the Bolus/basal/calcs menu.
Using the Personal Diabetes Manager656Temp basalChoose %, U/hr , or Off to set the mode for temporary basal rates and presets, then press Select.ExtendedChoose %, Units, or Off to set the mode for extended boluses, then press Select.Bolus incrementChoose 0.05, 0.10, 0.50, or 1.00 units for bolus increments, then press Select.Max bolusUse the Up/Down Controller buttons to enter the maximum bolus dose you can take, then press Enter.Max basal rateUse the Up/Down Controller buttons to enter the maximum basal rate you can choose, then press Enter.■ Alerts and RemindersIn addition to automatic safety alarms (see Chapter 10, Alerts and Alarms), the OmniPod System offers a number of personal set-tings 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 72-hour 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 cer-tain 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.Some settings have preset defaults, but all settings are changeable. See the Appendix for a list of Sys-tem 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 Deliver-ing Bolus Doses.
Using the Personal Diabetes Manager666Auto-off: Alerts you if the PDM does not receive a Pod status within a predefined period of time. Obtain Pod status by press-ing 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. This alert can be especially reassuring if you are prone to hypo-glycemia unawareness. Ask your healthcare provider about using this alert and where to set it.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 processChoose 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 completedChoose On or Off. The default setting is On.The Low reservoir alert will escalate to an Empty res-ervoir hazard alarm when insulin is depleted. Be sure to respond to the alert when it occurs.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.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.
Using the Personal Diabetes Manager676Custom 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 reminders1. 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.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 remindera. 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 remindera. 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.Figure 6-9
Using the Personal Diabetes Manager686To delete a Bolus remindera. 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, sim-ply 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.)d. Press Next.• Enter the time of day for the reminder, in 30-minute incre-ments, then press Next.• Choose Daily, One time only, or Off, then press Select.Custom reminders will repeat every 15 minutes until acknowledged.Figure 6-10
Using the Personal Diabetes Manager696■ Change Blood Glucose Meter SettingsYou can adjust blood glucose (BG) meter settings:• BG goal lower and upper limits (for BG history)• Manage BG tags list• BG sound—On or Off1. 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 limitsTo change the BG goal limits, press Edit, change either or both values, then press Save.Manage the blood glucose tags listYou 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 6-11Figure 6-12aFigure 6-12b
Using the Personal Diabetes Manager7061. 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; orb. 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 soundTo change BG sound, choose On or Off, then press Select.■ 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 lon-ger 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 Manager716Backlight 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.Set PDM options1. 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 screenTo 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.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.As a safety feature, an ID must be entered to enable the PDM to be identified.Figure 6-13Figure 6-14
Using the Personal Diabetes Manager726To 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 lockChoose On or Off, then press Select.Set the Screen time-outChoose 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-outChoose 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.■ Set Diagnostic FunctionsThe Diagnostics screen allows you to instantly confirm how the System is working or to completely update settings entered dur-ing 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.Reset PDM (soft reset): Restores all settings in the PDM to the factory defaults.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.The lowest setting will drain the battery the least.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.Resetting the PDM deletes all basal programs, temp basal presets, carb presets, bolus presets, and all sug-gested 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.
Using the Personal Diabetes Manager736Diagnostic options1. 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.To check alarms1. 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.To reset the PDM1. 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. Be sure to check the alarm function at every Pod change.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.Figure 6-15Figure 6-16
Using the Personal Diabetes Manager746■ Set a Reminder to VibrateFor certain reminders, you can choose vibration instead of beeps or vibration followed by beeps, instead of only beeps. If you acti-vate it, the PDM will vibrate for:• Blood Glucose reminders• Missed Bolus reminders• Custom reminders• “No active Pod” remindersTo change the type of notification1. Use the Up/Down Controller buttons to choose Set-tings,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.■ Get the Most from Your PDMKeep it handyWireless 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 PodWhen you use the PDM to communicate with the Pod, hold the PDM within 24'' (61 cm) of the Pod.Water and your PDMThe PDM cannot be set to vibrate for hazard or advisory alarms.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 Manager756Avoid extreme temperaturesExtreme operating temperatures can affect PDM batteries and interfere with System operation. Avoid using the PDM in temper-atures below 40°F (4.4°C) or above 104°F (40°C).Electrical interferenceThe PDM is designed to withstand normal radio interference and electromagnetic fields. However, as with all wireless communica-tion technology, certain operating conditions can interrupt communication. For example, electric appliances such as micro-wave ovens and electric machinery located in manufacturing environments may cause interference. In most cases, interrup-tions are easy to resolve (see Chapter 11, Communication Failures).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.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.Only connect a USB cable to your PDM when down-loading data to a computer. Other PDM functions are disabled while a USB cable is connected, and the PDM cannot communicate with the Pod.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.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.
76CHAPTER 7Checking Your Blood Glucose■ The Built-in FreeStyle® Blood Glucose MeterWith 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 impor-tant 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 soKeep 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 pro-duce inaccurate results.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 Glucose777■ The FreeStyle® Blood Glucose Test StripsImportant 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, imme-diately close the vial cap tightly.• With clean, dry hands, you can gently touch the test strip any-where 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.■ The FreeStyle® Control SolutionThe FreeStyle® control solution (Figure 7-1) is a red liquid that contains a fixed amount of glu-cose 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 bloodThree 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): 800-591-3455. When calling from outside the United States: 781-457-5098.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.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.Figure 7-1
Checking Your Blood Glucose787When to perform a control solution testYou should perform a control solution test:• When you suspect that your meter or test strips are not work-ing 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 soCheck that the meter and test strips are workingA 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 dateFreeStyle® 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 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.• 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).• The control solution test results should fall within the range printed on the test strip vial label.Use only FreeStyle® control solution with the System. Other brands of control solution may pro-duce inaccurate results with this System.Do not use control solution past the expiration date or you may get inaccurate results.Results from FreeStyle® control solution tests do not reflect your blood glucose level.
Checking Your Blood Glucose797If control solution results are out of this range, REPEAT THE TEST.Out-of-range control solution resultsOut-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 Test1. Grasp the bottom of the test strip with the printed side facing up (Figure 7-2). 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. The control solution range is a target range for control solution only. It is not a target range for your blood glucose.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).Figure 7-2Top, to insert into meterFreeStyle® test stripBottom edges, for blood sample
Checking Your Blood Glucose8073. 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.4. Wait for the PDM to display “Apply a blood sample to the strip” on the screen (Figure 7-5 on the following page). 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 7-3Figure 7-4From some PDM screens, you cannot access the Free-style® 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 dis-played. In these cases, if you insert a test strip, the PDM beeps to alert you.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.)
Checking Your Blood Glucose8175. 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.The “Checking” screen appears while the sample is process-ing (Figure 7-7). The strip port light turns off when the sample is accepted.If BG sound is set to On, the PDM beeps twice. The result appears on the screen.Figure 7-5Figure 7-6Do not apply control solution to both edges of the test strip.Figure 7-7Figure 7-8
Checking Your Blood Glucose8276. 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.c. Press OK.7. If you do not want to mark the test as a control solution test, press Next instead of Tag.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): 800-591-3455. When calling from outside the United States: 781-457-50989. 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.■ Performing a Blood Glucose ReadingFigure 7-9 on the following page shows the parts of the Free-Style® lancing device.You can select a maximum of 2 tags.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.Be sure to discard used test strips. (You can only use test strips once.)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 Glucose837Prepare the lancing device1. Snap off the cap on the lancing device at an angle (Figure 7-10). 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).Release buttonDepth indicator windowDepth settings dialGray cap, for testing on the fingersCocking handleFigure 7-9Clear cap, for testing sites other than the fingerFigure 7-10Figure 7-11
Checking Your Blood Glucose8474. Replace the cap until it snaps or clicks into place (Figure 7-13). Be careful not to touch the exposed needle on the lancet.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 win-dow (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.Use the clear cap to lance at the following test sites: forearm, upper arm and hand. Use the gray cap for finger tests only.Figure 7-12Figure 7-13Figure 7-14Figure 7-15
Checking Your Blood Glucose8576. Pull out the dark gray cocking handle until it clicks (Figure 7-15 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.Insert the blood glucose test strip1. 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.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 (Fig-ure 7-16 and Figure 7-17).From some PDM screens, you cannot access the Free-Style® 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 dis-played. In these cases, if you insert a test strip, the PDM beeps to alert you.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 but-ton to turn on the PDM. Refer to page 54 to check Pod status and to Confirm ID. Figure 7-16TopBottomFigure 7-17
Checking Your Blood Glucose867Set the blood glucose test strip codeAfter 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.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).Lance your finger1. 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).Figure 7-18Figure 7-19If 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 (Fig-ure 7-4). They must always match or your results will be inaccurate.
Checking Your Blood Glucose8774. Press the release button.5. Gently squeeze your finger, if needed, until a blood drop the size of a pinhead forms.Lance your forearm, upper arm, or hand1. 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 get-ting warm.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).Figure 7-20Figure 7-21Figure 7-22Figure 7-23
Checking Your Blood Glucose8875. 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.Fill the blood glucose test strip with blood1. Make sure that the strip is in the PDM and the PDM is pow-ered 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 sta-tus and to Confirm ID. 2. Bring the strip to the blood sample at a slight angle (Figure 7-26).If you do not apply the sample within 10 seconds, the strip port light turns off. To turn it on again, press Light.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).Figure 7-24Figure 7-25Figure 7-26
Checking Your Blood Glucose897Use 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).Wait for the reading1. 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.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 assis-tance to the user, the meter and lancing device should be decontaminated prior to use by the sec-ond person (see Page 138).Figure 7-27Edge of test stripFigure 7-28Do 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
Checking Your Blood Glucose9072. 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.5. Remove the test strip. If the strip-port light was turned on, it now turns off.Figure 7-29Figure 7-30If the suggested bolus calculator feature is turned Off, the Bolus soft key appears instead of Next.
Checking Your Blood Glucose917Remove the lancetWhen 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.■ Blood Glucose Results and the Suggested BolusCalculatorIf 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 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 calcula-tor is turned On or Off. (See “Blood Glucose Records” in Chapter 8, Understanding Your Records.)See “Cleaning and disinfecting” in the Appendix for instructions on how to clean or disinfect your PDM.Figure 7-31Figure 7-32If 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).
Checking Your Blood Glucose927■ Entering Blood Glucose Readings ManuallyYou 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 read-ing from your separate meter.4. Press Tag to assign a tag to the reading. Press OK when fin-ished. (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.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 suspendedFigure 7-33To enter a “LOW” reading, press the Up/Down Controller buttons down until you reach the mini-mum 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.
Checking Your Blood Glucose937■ Editing TagsWithin 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.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 7-34Figure 7-35Figure 7-36
Checking Your Blood Glucose947To 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 ReadingsWARNINGS! “LOW” or “HIGH” blood glucose readings can indicate a poten-tially serious condition requiring immediate medical attention. If left untreated, this situation can quickly lead to diabetic keto-acidosis (DKA), shock, coma, or death.Low readingsIf 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 symptomsIf you get a “LOW Treat your low BG!” reading and feel symptoms such as weakness, sweating, nervousness, headache, or confu-sion, follow your healthcare provider’s recommendation to treat hypoglycemia.Low reading without symptomsIf you get a “LOW Treat your low BG!” reading, but have no symp-toms of low blood glucose, then retest with a new test strip on 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 health-care provider's recommendation to treat hypoglycemia.High readingsIf your reading is above 500 mg/dL, the PDM displays “HIGH Check for ketones!” This indicates severe hyperglycemia (high blood glucose).High reading with symptomsIf you get a “HIGH Check for ketones!” reading and feel symp-toms such as fatigue, thirst, excess urination, or blurry vision, follow your healthcare provider’s recommendation to treat hyperglycemia.High reading without symptomsIf 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 Glucose957■ Important Health-Related InformationFor additional information, consult your test strip product infor-mation sheet.WARNINGS! • Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehy-dration, consult your healthcare provider immediately.• Test results below 70 mg/dL mean low blood glucose (hypo-glycemia).• Test results greater than 250 mg/dL mean high blood glu-cose (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 fore-arm and other alternate sites. Vigorous rubbing of the alter-nate 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 Blood-borne 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.
96CHAPTER 8Understanding Your Records■ Record KeepingRecord keeping is an important part of successful diabetes man-agement. 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 infor-mation. Once the memory is full, new information begins to replace the oldest information.Special symbols in record screensIn the record screens, you may encounter several special symbols: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.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 Records978■ Insulin Delivery RecordsThe 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 dateView insulin delivery records1. 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 deliv-ered 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 dia-mond icon (♦).✔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.This insulin delivery item spans midnight. The date given is the start date.Figure 8-1Figure 8-2
Understanding Your Records988For 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.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 deacti-vation, 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 pro-grammed at the same time. Extended boluses are shown with time and duration. If an extended bolus is active, a dia-mond icon (♦) appears next to it. If a bolus was cancelled, only the amount delivered before cancellation is shown.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.Figure 8-3Figure 8-4The amount shown after cancellation may be in 0.05 unit increments, even though you may have pro-grammed the bolus increment to be in 0.10 units.
Understanding Your Records998■ Blood Glucose RecordsThe 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 trends1. 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.3. Press List to see a list of the current day’s readings (Figure 8-6).LOW and HIGH readings are included in the number of BG readings (n), but not in calculations or averages.Figure 8-5Figure 8-6
Understanding Your Records1008In 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 infor-mation, 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).4. Press Close to return to the List view.5. Press Graph to see a graph of the data (Figure 8-9).View multiple-day trends1. 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 8-7Figure 8-8Figure 8-9Figure 8-10
Understanding Your Records10185. 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.6. Press Back to return to the single-day trends.■ Alarm RecordsThe 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 RecordsThe 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).Figure 8-11Figure 8-12
Understanding Your Records10283. 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 RecordsThe 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.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/SupportYou or your healthcare provider may have entered personal contact information during your start-up visit. To view this infor-mation, 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 can-not change this information.Figure 8-13Figure 8-14
Understanding Your Records1038Add or change user information1. 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.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 Deliver-ing Bolus Doses.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.”Figure 8-15Figure 8-16
104CHAPTER 9Living with Diabetes■ Your Role: Safely Using the OmniPod SystemBefore 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.• Being aware of the signs of hypoglycemia (low blood glu-cose), hyperglycemia (high blood glucose), and diabetic keto-acidosis (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 Man-agement System according to instructions, you may be putting your health and safety at risk. Talk with your healthcare provider if you have questions or con-cerns about using the OmniPod System.
Living with Diabetes1059■ Daily Diabetes Management ActivitiesTo ensure proper OmniPod System operation and your contin-ued good health:• Check your blood glucose frequently• Inspect the infusion site dailyCheck your blood glucose frequentlyWhen you routinely check your blood glucose level, you can iden-tify 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 providerInspect the infusion site dailyAt 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.
Living with Diabetes1069■ Prepare for Emergencies■ Water and Your PodThe 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.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 alka-line)• A vial of rapid-acting U-100 insulin (See the warn-ing 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 pro-vider for airline security (see “Minimize airport security delays” later in this chapter)• 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.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 can-nula are securely applied and in place. If the cannula is not properly inserted, hyperglycemia may result.The Personal Diabetes Manager (PDM) is not water-proof. Do NOT place it in or near water.
Living with Diabetes1079■ Traveling and VacationingPlan for changing time zonesIf 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 health-care provider can help with these adjustments.Take enough suppliesKeeping your emergency kit (refer to Page 106; Prepare for Emer-gencies) 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 peri-ods of time, be sure to take extra Pod supplies. Call 800-591-3455 (from outside the United States: 781-457-5098) to order additional supplies for your trip.
Living with Diabetes1089Minimize airport security delaysWith changing airport security checks and screening proce-dures, 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 flightTo 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 equip-ment • Prescriptions for all medications and supplies with origi-nal prescription labelsScreening ProceduresThe TSA offers the option of requesting a visual inspection of your medical supplies rather than putting them through the X-ray. This must be requested before the screening process begins. Your medical supplies should be ready in a separate bag when 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 sub-mitted for X-ray screening.1If 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 insu-lin pump cannot be removed because it is inserted with a catheter (needle) under the skin.2Visit 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 Diabetes1099Keep supplies accessibleOn 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 air-port security delays”)• Prescriptions for insulin and supplies• Snacks, in case food is not available• Bottled water (especially on planes) to prevent dehydrationThe name and phone number of a physician at your final destination, in case of emergency.Avoid Lows, Highs and DKAYou 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), hyper-glycemia (high blood glucose) and diabetic ketoacidosis (DKA). The easiest and most reliable way to avoid these conditions is to check your blood glucose often.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.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 glu-cose level is low, check your BG level to confirm.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 Chap-ter 6, Using the Personal Diabetes Manager, for how to set the reminder.
Living with Diabetes1109Symptoms of hypoglycemiaNever 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• AnxietyTo avoid hypoglycemia (low blood glucose)• Work with your healthcare provider to establish individual-ized blood glucose targets and guidelines.• Keep a fast-acting carbohydrate with you at all times to respond quickly to low blood glucose. Examples of fast-acting 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.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 symp-toms of hypoglycemia.Periodically check the expiration date of your glucagon kit to make sure it has not expired.Always carry medical identification (emergency wallet card) and wear an emergency medical neck-lace 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 Diabetes1119Again, 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.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).2. Check blood glucose again after 15 minutes.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 tablets4 ounces (118 milliliters) of apple or orange juice6 Lifesavers™ or similar hard candy1/2 can of regular (non-diet) soda2 tablespoons (30 milliliters) of table sugar, honey or corn syrupEven 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.Do NOT use chocolate or candy bars to treat low blood glucose. Their fat content slows down glucose absorption.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 proce-dure with family and friends.
Living with Diabetes1129Possible causes of hypoglycemia (low blood glucose)Possible cause of low Suggested actionIncorrect basal programConfirm that correct basal program is active.Confirm that PDM time is set cor-rectly.Consult your healthcare provider about adjusting your basal pro-grams or using a temporary (temp) basal rate.Incorrect bolus timingTake 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.Bolus too largePossible cause of low Suggested actionIncorrect target blood glucose levelsConsult healthcare provider about refining these settings as needed.Incorrect correction factor (sensitivity factor)Incorrect insulin-to-carb ratio (IC)Prone to severe hypo-glycemia Consult healthcare provider about hypoglycemia unawareness and about raising target blood glucose levels.Hypoglycemia unawarenessUnplanned physical activityIf 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 Diabetes1139Hyperglycemia (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 deliv-ery from the Pod) occurs, your blood glucose can rise rapidly.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 soresPossible cause of low Suggested actionProlonged or intense exerciseAdjust insulin delivery as instructed by your healthcare provider.Check blood glucose before, during and after activity and treat as necessary.Consult your healthcare provider about adjusting your basal pro-grams or using a temporary (temp) basal rate.Low carbohydrate intake prior to activityConsume 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.Effects of exercise can last several hours—even a full day—after activity ends.An occlusion may result from a blockage, Pod mal-function 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.Hyperglycemia symptoms can be confusing. Always check your blood glucose before you treat for hyperglycemia.
Living with Diabetes1149To 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 addi-tion, 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 providerTo 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 pre-scribed by your healthcare provider.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 ketoaci-dosis (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.8. Investigate possible cause for hyperglycemia to avoid similar problems in the future (see “Possible causes of hyperglyce-mia (high blood glucose)”.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.
Living with Diabetes1159Possible causes of hyperglycemia (high blood glucose)Possible cause of high Suggested actionExpired insulin Deactivate and remove used Pod. Apply a new Pod filled from a new vial of insulin.Insulin exposed to extreme temperaturesInfusion site in or near a scar or moleDeactivate 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 loca-tion 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 fric-tion may dislodge the cannula.Possible cause of high Suggested actionEmpty Pod Deactivate and remove used Pod.Apply a new Pod in a different location.Incorrect basal programConfirm that correct basal program is active.Confirm that PDM time is set correctly.Consult your healthcare provider about adjusting your basal pro-grams or using a temporary (temp) basal rate.Incorrect bolus timingCheck carb intake.Take bolus with food.Check blood glucose before giving meal bolus; if necessary, adjust bolus.Consult healthcare provider for guidance.Bolus too small
Living with Diabetes1169High-protein or high-fat mealCalculate protein/fat intake and account for it in your bolus timing and bolus type. Consult healthcare provider about using the extended bolus option.Less activity than normalConsult your healthcare provider about adjusting your basal pro-grams or using a temporary (temp) basal rate.Blood glucose value greater than 250 mg/dL (with ketones present) before exerciseDo 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 changePossible cause of high Suggested actionWeight loss or gain Consult your healthcare provider for guidance.Menstrual cyclePregnancyCheck with your healthcare provider for guidance on any of the causes or suggested actions above.Possible cause of high Suggested action
Living with Diabetes1179Diabetic 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 pre-ventable—emergency that can occur if you ignore high blood glucose levels.Symptoms of DKA● Nausea and vomiting● Abdominal pain● Dehydration● Fruity-smelling breath● Dry skin or tongue● Drowsiness● Rapid pulse● Labored breathingThe 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 DKAThe 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 left untreated, DKA can cause breathing difficulties, shock, coma, and eventually death.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.
Living with Diabetes1189■ Handling Special SituationsSick daysAny physical stress can cause your blood glucose to rise, and ill-ness 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 ketoaci-dosis (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.• Follow your healthcare provider’s guidelines for taking addi-tional insulin on sick days.• Drink plenty of non-caffeinated fluids to prevent dehydra-tion.• 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 vomitingExercising, playing sports or working hardCheck your blood glucose levels before, during and after exercis-ing, 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.If you are well enough to eat, drink sugar-free bever-ages. However, if you are too sick to eat solid foods, alternate between sugar-free beverages and those containing sugar.
Living with Diabetes1199For 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 one-time use. Do not attempt to reapply a used Pod.If you will need to remove the Pod for more than 1 hour, ask your healthcare provider to recommend appropriate guidelines.X-rays, MRIs and CT scansSurgery or hospitalizationFor 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 pre-pare for these situations.If possible, avoid wasting Pods by planning removal times that coincide with a scheduled Pod replace-ment.The Pod and PDM may be affected by strong radia-tion 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 treat-ment area. Check with your healthcare provider on Pod removal guidelines.The Pod and PDM can tolerate common electromag-netic and electrostatic fields, including airport security and cellular phones.Always carry medical identification and wear an emergency medical necklace or bracelet such as the Medic Alert tag.
120CHAPTER 10Alerts and Alarms■ Safety ChecksThe 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 Man-ager (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 Sys-tem 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 AlertsThese 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.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 Alarms12110The following table explains what the message could mean and what you should do.Alert error message Possible causes ActionMeter Error 1See user manual for further instructions.• 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 health-care 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.Meter Error 2See user manual for further instructions.• 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 pro-vider 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.
Alerts and Alarms12210Meter Error 3See user manual for further instructions.• 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.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.Meter Error 4See user manual for further instructions.• 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.Meter Error 6See user manual for further instructions.• 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.Alert error message Possible causes Action
Alerts and Alarms12310■ AlarmsThe 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:Advisory AlarmsAdvisory 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 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 AlarmsHazard alarms occur either when the Pod is in a very serious con-dition 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. 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.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 Chap-ter 5, Using the Pod).3. Activate and apply a new Pod (see Chapter 5, Using the Pod).
Alerts and Alarms12410If you ever need to return the PDM for repair or replacement, contact your healthcare provider for instructions on going back to treatment byinjections.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.Alarm Type Source Beep Pattern ActionEnd of insulin suspend.Press OK to resume basal rate delivery.Advisory AlarmPod and PDM2 sets of beeps every minute for 3 minutes.Repeats every 15 minutes until insulin delivery is resumed.Press OK to resume insulin delivery at programmed basal rate.Auto-off alert Advisory AlarmPod and PDM2 sets of beeps every minute for 15 minutes.Escalates to Auto-off hazard alarm if not acknowledged within 15 minutes.Press OK to acknowledge.Insulin delivery will not resume until you press OK. If you do not press OK to resume insulin deli-very, you could develop hyper-glycemia (high blood glucose).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 Alarms12510Auto-off.Remove Pod now.Hazard AlarmPod and PDMContinuous tone. Pod has been deactivated. Insulin deliv-ery has stopped. Press OK to acknowl-edge.Change Pod.Check blood glucose.Low reservoir.Replace Pod soon.(This is based on the vol-ume level you selected.)Advisory AlarmPod and PDM2 sets of beeps every minute for 3 minutes.Repeats every 60 minutes until acknowledged.Escalates to Empty reservoir hazard alarm when empty.Press OK to acknowledge.Empty reservoir.Insulin delivery stopped.Change Pod now.Hazard AlarmPod and PDMContinuous tone. This alarm occurs when the Pod's reservoir is out of insulin. Press OK to acknowledge.Change Pod.Check blood glucose.Alarm Type Source Beep Pattern ActionThe 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.
Alerts and Alarms12610Pod expiration advisory.Change Pod now.Advisory AlarmPod and PDM2 sets of beeps repeat periodically.Repeats every 15 minutes during the last hour of the Pod’s life and is independent of the Expiration noti-fication that you can set. (See Chap-ter 6, Using the Personal Diabetes Manager.)Escalates to Pod expired hazard alarm.Press OK to acknowledge.Change Pod. (See Chapter 5, Using the Pod.)Pod expired.Insulin delivery stopped.Change Pod now.Hazard AlarmPod and PDMContinuous tone. This alarm occurs when the Pod has reached the end of its operating life. Press OK to acknowledge.Change Pod.Check blood glucose.Stuck key detected.Check Home button to resolve.For technical support refer to your User Guide.Advisory AlarmPDM 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.Alarm Type Source Beep Pattern Action
Alerts and Alarms12710Occlusion detected.Insulin delivery stopped.Change Pod now.Hazard AlarmPod and PDMContinuous tone. Press OK to acknowledge.Change Pod.Check blood glucose.Pod Error.Insulin delivery stopped.Change pod now.Hazard AlarmPodor PDMContinuous 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 AlarmPDM 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.Alarm Type Source Beep Pattern Action
Alerts and Alarms12810PDM Error.Memory corruption.Press “Ok” to reset PDM and delete all user set-tings. History records will not be deleted.Hazard AlarmPDM Continuous tone. This alarm occurs after the PDM is reset and a memory corruption error occurs. Press OK to acknowledge.Change Pod.Check blood glucose.System Error.Remove pod now.Call Customer Care: 800-591-3455.Hazard AlarmPodor PDMContinuous 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 AlarmPDM 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.Alarm Type Source Beep Pattern Action
Alerts and Alarms12910■ Manual Shut-off of a Hazard AlarmIf you respond to a hazard alarm but the PDM cannot communi-cate 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 adhe-sive 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 regu-lations.Pod deactivation required.Press “Ok” to deactivate.Hazard AlarmPDM Continuous tone. This alarm occurs after a PDM error occurs that requires the user to reset the date and time. Press OK to acknowl-edge.Change Pod.Check blood glucose.Alarm Type Source Beep Pattern ActionFigure 10-1Manual alarm shut-off portFillport
130CHAPTER 11Communication Failures■ The Communication ProcessWhen you turn on or use the Personal Diabetes Manager (PDM), it establishes communication with the active Pod. Usually, com-munication 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.■ Failure During Pod Activation or OperationWhen 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 dis-plays the “Communication error” screen (Figure 11-1 on the next page).1. Move the PDM closer to the Pod. The PDM will try to commu-nicate with the Pod again. If communication still fails, you will see the message in Figure 11-2 on the next page.
Communication Failures131112. 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 communi-cate, it displays the same screen as in Figure 11-2, then finally the “Communication time-out” screen (Figure 11-3). Press OK to check the Pod status.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.Figure 11-1Figure 11-2Figure 11-3Figure 11-4
Communication Failures132113. 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 pre-vious 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.■ Failure During Pod DeactivationTo 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.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.Figure 11-5Figure 11-6Figure 11-7
Communication Failures133112. Press Discard. The PDM will consider the Pod lost and ask whether you want to activate a new Pod.■ Failure During Request for StatusIf 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).2. Press Skip to skip the communication process and immedi-ately bring up Figure 11-10.If you have an unconfirmed correction bolus when you discard a Pod, then the bolus calculator will be temporar-ily disabled. In this situation, the bolus calculator is dis-abled until the duration-of-insulin-action period passes (Figure 11-8). If you have any questions, call Customer Care.Figure 11-8Figure 11-9Figure 11-10
Communication Failures13411At 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 CancellationWhen you instruct the PDM to cancel a bolus, if the PDM cannot send your instruction to the Pod within a few seconds, it displays the “Communication error” screen (Figure 11-12).1. Move the PDM close to the Pod. The PDM tries to communi-cate 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).If the Pod has expired, you will see the screen in Figure 11-11 instead.Figure 11-11Figure 11-12Figure 11-13
Communication Failures135113. 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.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. Figure 11-14Figure 11-15Figure 11-16
136AppendixThe 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 MaintenanceStorageStore 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.CleaningPods 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.■ Personal Diabetes Manager Care and MaintenanceStorageWhen you are not actively using the Personal Diabetes Manager (PDM) to enter or change programs, you can store it in a conve-nient, nearby location. The storage location should be cool and dry.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 (seeChapter 6, Using the Personal Diabetes Manager).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.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.
Appendix137Cleaning and disinfectingKeep 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.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 hous-ing, use Dispatch® Hospital Cleaner Disinfectant Towels with Bleach (available online through major retailers).4. Following the instructions on the label of the Dispatch® Hos-pital Cleaner Disinfectant Towels with Bleach, wipe the out-side surfaces of your PDM. Treated surfaces must remain wet for a full (2) minutes.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 Con-trol 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 batteriesThe PDM uses two (2) AAA alkaline batteries. You can purchase them at any grocery, hardware or convenience store.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.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. While cleaning, do NOT allow debris or liquid to get into the test strip port, USB port, battery compart-ment, or buttons.AAA alkaline batteries are the preferred battery to power the PDM. Do not use any other type of batter-ies. 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 dam-age to the PDM.
Appendix138The 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.To replace batteries1. 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.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 waterThe PDM is not waterproof. Do not place it in water or leave it near water where it can accidentally fall in. If it becomes sub-merged in water:1. Dry the outside of the PDM with a clean, lint-free cloth.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 lightOnce the batteries are replaced, these functions resume.Figure A-1Figure A-2If 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.The diagram inside the compartment shows you which direction to insert the batteries.
Appendix1392. 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.5. Do not put in fresh batteries or attempt to use the PDM until it has thoroughly air-dried.If you drop the PDMThe 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.■ Storage and SuppliesYou can order all OmniPod System products and supplies by call-ing call our Customer Care.Never use a blow dryer or hot air to dry the Pod or PDM. Extreme heat can damage the electronics.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.Store all OmniPod System products and supplies (including unopened Pods) in a cool, dry place. Prod-ucts or supplies that have been exposed to extreme temperatures may not function properly.It is especially important to store your insulin in a well-controlled environment. Inspect insulin before using it; never use insulin that looks cloudy or discolored. Insulin that is cloudy or discolored may be old, conta-minated or inactive. Check the insulin manufacturer’s instructions for use and expiration date.
Appendix140■ Suggested Bolus Calculator Examples and GuidelinesA 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 bolusTarget BG: 100 mg/dLCurrent BG: 200 mg/dLCorrection factor (CF): 50 200 mg/dL (current) – 100 mg/dL (target) = 100 mg/dL100 mg/dL ÷ 50 (CF) = 2 units correction bolusIf the reverse correction feature is turned On and if your current BG is below your target BG, the suggested bolus calculator sub-tracts a correction amount from the meal bolus.Example of reverse correction bolus:Target BG: 100 mg/dLCurrent BG: 75 mg/dLCorrection 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) Meal bolus calculationCarbs entered ÷ insulin-to-carb (IC) ratioExample of meal bolusCarbs entered: 45 grams of carbInsulin-to-carb ratio: 1545 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 hoursTime since previous correction bolus: 1 hourPrevious correction bolus: 3 units3 hours – 1 hour = 2 hours 2 hours ÷ 3 hours = 2/32/3 ∗ 3 units = 2 units correction IOBIn 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 deliver-ing too much insulin when correcting a high BG.
Appendix141Example of meal IOBDuration of insulin action: 3 hoursTime since previous meal bolus: 2 hoursPrevious meal bolus: 4.5 units3 hours – 2 hours = 1 hour 1 hours ÷ 3 hours = 1/31/3 ∗ 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.Examples of suggested bolus calculationsThe examples below use these settings:• Target BG: 100 mg/dL• I/C ratio: 1:15• Correction factor (CF): 50• Duration of insulin action: 3 hrsExample 1Current BG level: 150 mg/dLCarb intake: 0 grams of carbohydrate (carbs)Meal IOB: 1 unitsCorrection insulin on board (IOB): 1 unitsCorrection bolus: 150 mg/dL (current) – 100 mg/dL (target) = 5050 ÷ 50 (CF) = 1 unit Meal bolus: 0 (carbs) ÷ 15 (IC ratio) = 0 unitsSuggested bolus dose = 1 (correction) + 0 (meal) – 2 (IOB) = 0UExample 2Current BG level: 150 mg/dLCarb intake: 45 carbsMeal IOB: 0 unitsCorrection IOB: 0 unitsCorrection bolus: 150 mg/dL (current) – 100 mg/dL (target) = 5050 ÷ 50 (CF) = 1 unitMeal bolus: 45 (carbs) ÷ 15 (IC ratio) = 3 unitsSuggested bolus dose = 1 (correction) + 3 (meal) – 0 (IOB) = 4UMeal insulin on board (IOB) is only used to reduce a correction bolus, and the correction bolus is only reduced until it becomes 0 units.
Appendix142Example 3Current BG level: 100 mg/dLCarb intake: 45 carbsMeal IOB: 1 unitCorrection insulin on board (IOB): 0 unitsCorrection bolus: 100 mg/dL (current) – 100 mg/dL (target) = 00 ÷ 50 (CF) = 0 unitsMeal bolus: 45 (carbs) ÷ 15 (IC ratio) = 3 unitsSuggested bolus dose = 0 (correction) + 3 (meal) – 0 (IOB) = 3UExample 4Current BG level: 150 mg/dLCarb intake: 60 carbsMeal insulin on board (IOB): 0 unitsCorrection IOB: 1 unitCorrection bolus: 150 mg/dL (current) – 100 mg/dL (target) = 5050÷ 50 (CF) = 1 unitMeal bolus: 60 (carbs) ÷ 15 (IC ratio) = 4 unitsSuggested bolus dose = 1 (correction) + 4 (meal) – 1 (IOB) = 4UCalculator guidelinesWhen 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, andChapter 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 cur-rent correction bolus, if any remains, until it is zero. At that point, any remaining correction IOB is subtracted from the current meal bolus.Meal IOB is never subtracted from another meal bolus—only from a correction bolus.
Appendix143• 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 sug-gested 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.
Appendix144■ OmniPod System Options and SettingsTime 12-hour or 24-hour clockDate MM/DD/YYDD/MM/YYMM.DD.YYDD.MM.YYYY.MM.DDYY-MM-DDMaximum basal rate 30 U/hrDefault is 3.00 U/hrBasal programs 7Basal rate segments 24 per programBasal rate increment 0.05 unitsTemp basal presets 7Temp basal %, Units, or Off30 minutes to 12 hours in 30-minute incrementsDefault is OffBlood glucose (BG) goal for BG historyUpper and lower limits; 70 to 200 mg/dL in 1 mg/dL increments Blood glucose reminder On or Off; maximum of 4Reminder time of 1 to 4 hours after every bolus dose in 30-minute incrementsDefault is OffBlood glucose meter sound On or OffDefault is OnSuggested bolus calculator On or OffDefault is OnTarget BG value and correction threshold8 time segments; 70 to 200 mg/dL in 1 mg/dL increments Minimum BG allowed for use by the suggested bolus calculator50 to 70 mg/dL in 1 mg/dL incre-mentsDefault is 70 mg/dLInsulin-to-carb (IC) ratio 8 time segments; 1 to 150 g carb/U in 1g carb/U incrementsCorrection (sensitivity) factor8 time segments; 1 to 300 mg/dL in 1 mg/dL incrementsReverse correction On or OffDefault is OnDuration of insulin action 2 to 6 hours in 30-minute incre-mentsBolus increment 0.05, 0.1, 0.5, or 1.0 unitsDefault is 0.1 unitsMaximum bolus size 30 unitsDefault is 10 unitsExtended bolus %, Units, or Off30 minutes to 8 hours in 30-minute incrementsDefault is Off
Appendix145■ Pod SpecificationsSize: 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 unitsCannula insertion depth: 6.5mmWaterproof rating: IPX8 (25 feet for up to 60 minutes)Insulin concentration: U-100Alarm type: AudibleOperating relative humidity range: 20–85%, noncondensingStorage relative humidity range: 20–85%, noncondensingOperating atmospheric pressure: 696 hPA to 1060 hPAStorage atmospheric pressure: 696 hPA to 1060 hPANon-pyrogenic: Fluid pathway onlyType 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 minuteRange: 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 unitsBolus presets 7Carbohydrate presets 36Suspend 30 minutes to 2 hoursLow reservoir volume indicator10 to 50 units in 5-unit incrementsDefault is 10.0 unitsPod expiration alert 1 to 24 hours in 1-hour incrementsDefault is 4 hoursAuto-off alert 1 to 24 hours or Off in 1-hour incrementsDefault is OffPDM lock On or OffDefault is OffHistory storage 5400 records/90 daysLanguage English
Appendix146■ Accuracy Test ResultsThe following graphs are designed to show flow accuracy of the Pod against given time periods.Flow rate from startupThe 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.Flow rate errorThe 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 oper-ating temperature. The overall mean percentage flow error was 1.40%.
Appendix147■ Personal Diabetes Manager SpecificationsSize: 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) LCDBattery: Powered by 2 AAA alkaline batteriesBattery life: Approximately 3 weeksOperating 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% non-condensingStorage relative humidity range: 10% to 90% non-condensingOperating atmospheric pressure: 696 hPA to 1062 hPAStorage atmospheric pressure: 703 hPA to 1062 hPACommunication 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: AudibleAlert type: Audible and vibratoryWarranty: 4 Year Limited (PDM)■ Blood Glucose Meter SpecificationsAssay method: Coulometric electrochemical sensorCalibration: Plasma equivalentHematocrit: 15% to 65%Measurement units: mg/dLResult range: 20 to 500 mg/dLSample: Whole blood, capillarySample size: 300 nanoliters (0.3 microliter)Test time: Results as fast as 7 seconds
Appendix148■ OmniPod System Label Symbols■ Personal Diabetes Manager IconsSymbol MeaningDo not reuse this device; single-use onlyCaution: Consult accompanying documentsRefer to Instruction ManualSterilized by ethylene oxideManufacture date: (year–month)Lot numberExpiration date (use-by date): (year–month)Reference/reorder numberDevice serial numberType BF medical device (protection from electrical shock)ManufacturerNon-pyrogenic; fluid pathway onlyNot MRI-safeWaterproof to 25 feet for up to 60 minutesKeep drySymbol MeaningStorage temperatureDo not use if package is damagedRx ONLY Prescription home-use IVDIcon Meaning Icon MeaningPower More actionsBolus CommunicationPod change Up/DownDiagnostics/settings Up/Down (on color)Temp basal Status Suspend/cancel Text entry rightMy Records SubmenuAdvisory alarm Home screen
Appendix149■ OmniPod System Notice ConcerningInterferenceThe 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, includ-ing 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 com-pliance 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.(Alternating) Hazard alarm Insulin gaugeAlert Apply blood sample/Blood glucose recordsPDM lock Setup WizardBattery 3/4 full Battery fullBattery 1/4 full Battery half fullBasal program Battery empty“Lost” history recordUser Information/Support“Unconfirmed” history recordTemperature out of range“Delivery Spans Midnight” history recordActive/default program or selected BG tagIcon Meaning Icon Meaning
Appendix150■ Electromagnetic CompatibilityThe 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 sus-ceptible to interference.General NotesMedical 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 Manage-ment System is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.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 elec-trical 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 equip-ment that complies with FCC and CISPR emissions requirements.The OmniPod System communicates with the following characteristics:Frequency: 433 Mhz, FSK modulation, with an effective radi-ated power of 13mWThe OmniPod System greatly exceeds the immunity require-ments of the general standard for electromagnetic compatibility, IEC 60601-1-2.
Appendix151Electromagnetic EmissionsThis 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 environmentRF Emissions (CISPR 11) Group 2 The Pod and the PDM emit low level electromagnetic energy (RF) in order to communicate. Although unlikely, nearby electronic equip-ment may be affected.CISPR B Emissions ClassificationClass B The System is suitable for use in all establishments including domestic establishments.Electromagnetic ImmunityThe System is intended for use in the electromagnetic environment specified below. You should observe these requirements in the use of the System.Immunity againstIEC 60601-1-2test levelCompliance level (of this device) Electromagnetic environmentElectroStatic Discharge, ESD (IEC 61000-4-2)contact discharge:± 6 kVair discharge: ± 8 kV± 8 kV± 15 kVIf floors are covered with synthetic material, try to avoid electro-static discharges.Power Frequency mag-netic fields 50/60 Hz (IEC 61000-4-8)3 A/m 400 A/m Suitable for most environments. Magnetic field strengths in excess of 400 A/m would be unlikely except in close proximity to industrial magnetic devices.
Appendix152Radiated RF (IEC 61000-4-3)80 MHz–2.5 GHz 10 V/m Portable and mobile RF communications equipment should be used no closer to any part of the System than the recom-mended 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 MHzd=0.7 √P 800 MHz to 2.5 GHzwhere P is the maximum output power rating of the transmit-ter 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 compli-ance 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 struc-tures, objects, and people.aField 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.Electromagnetic Immunity (Continued)
Appendix153Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the SystemYou can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communi-cations equipment (transmitters) and the System, as recommended below, according to the maximum output power of the com-munications equipment.Rated maximum output power of transmitter, in wattsSeparation distance according to frequency of transmitter, in meters150 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 √P0.01 0.12 0.035 0.0700.1 0.37 0.11 0.221 1.17 0.35 0.710 3.70 1.11 2.21100 11.7 3.5 7.0For 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 struc-tures, objects, and people.
Appendix154■ Customer Bill of RightsMission StatementInsulet Corporation is dedicated to designing, developing, and distributing products that provide superior treatment options and lifelong health benefits for people with diabetes.Scope of ServicesInsulet 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 virtu-ally pain-free automated cannula insertion.ComplianceThe 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).Supply ShipmentInsulet Corporation contacts customers to schedule quarterly supply shipments approximately two weeks prior to delivery.InquiriesRepresentatives 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 1-800-591-3455 (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 AccreditedInsulet 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.
Appendix155Customer’s Bill of Rights and ResponsibilitiesYou 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 affili-ation.3. Expect confidentiality of all information pertaining to you, your medical care and service. Please review our HIPAA Pri-vacy 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 pay-ment.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 pre-scribed, following instructions provided for use, handling care, safety and cleaning.3. Supply Insulet Corporation with insurance information nec-essary 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.
Appendix156■ Limited Warranty for the Personal Diabetes ManagerLimited Warranty CoverageInsulet Corporation warrants to the original purchaser (“you”) that the Per-sonal 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 ProcedureYou must notify Insulet Corporation of the claimed defect within the war-ranty 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 descrip-tion of the claimed defect. Insulet Corporation's authorization must be obtained prior to returning the PDM. If authorized, the PDM must be prop-erly 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.ConditionsProof 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.ExclusionsThis 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. 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.MiscellaneousREPAIR 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 WAR-RANTY. IN NO EVENT SHALL INSULET CORPORATION, ITS SUPPLIERS, OR ITS DISTRIBUTORS BE LIABLE FOR CONSEQUENTIAL OR INCIDENTAL DAM-AGES 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 conse-quential 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 WarrantyUnless modified in writing and signed by both parties, this Warranty is understood to be the complete and exclusive agreement between the par-ties, 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.
Appendix157■ HIPAA Privacy NoticeTHIS 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 InformationWe 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 UsTreatment, 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.
Appendix158Appointment 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 health-related 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 DisclosuresRequired 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.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,
Appendix159repairs, or replacement, or lookback (including locating and noti-fying individuals who have received products that have been recalled, withdrawn, or are the subject of lookback); or (iv) to con-duct 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.
Appendix160Required 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 RightsThe 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 athttp://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. 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.
Appendix161Your 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 Medi-cal 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 down-load our Request Form athttp://www.myomniPod.com/images/upload/HIPAA_Privacy_Notice_Request_Form.pdfand 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 athttp://www.myomniPod.com/images/upload/HIPAA_Privacy_Notice_Request_Form.pdfand 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.
Appendix162Our DutiesGenerally: 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 HIPAAPrivacy Notice. The current HIPAA Privacy Notice is posted on our Web sites at:Insulet.comMyOmniPod.comYou can also request a hard copy of the HIPAA Privacy Notice at any time by contacting our Privacy Officer.What To Do If You Have a Problem or QuestionIf 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 CorporationAttn: Privacy Officer9 Oak Park DriveBedford, MA 01730or 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.
163GlossaryA1c (see Hemoglobin A1c)Advisory alarmNotification by the PDM that a serious condition exists.Aseptic techniqueA method for maintaining sterilization and preventing contamination.Basal programOne or more basal rates that together cover a 24-hour period from midnight to midnight.Basal rateA 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 goalA range of blood glucose levels that you are trying to achieve dur-ing 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 levelThe amount of glucose, or sugar, in the blood. Blood glucose meterA device used to check blood glucose content.Bolus doseA dose of insulin taken to correct an elevated blood glucose level or to cover carbohydrates in a meal or snack.Bolus presetA bolus dose of insulin, in units, that can be assigned a custom name and preprogrammed into the PDM.
Glossary164CalorieA unit of measurement used to express the energy value of food. Calories come from carbohydrate, protein, fat, and alcohol.CannulaA small, thin tube inserted below the skin, which serves to intro-duce 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 countingA method of meal planning based on counting the number of grams of carbohydrate in a given food.Carb presetA 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.Correction bolusAn 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 thresholdThe blood glucose level above which you would like to take insu-lin to reduce an elevated blood glucose. CSII (continuous subcutaneous insulin infusion)Delivering insulin continuously under the skin (“subcutaneously”) on a programmed schedule.Dawn phenomenonAn early morning rise in blood glucose level caused by the normal release of hormones that block insulin’s effect.
Glossary165Diabetes 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 mellitusA 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 actionThe 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 bolusA feature of the OmniPod System that allows a meal bolus dose to be given over an extended period of time.FatOne 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, mar-garine, salad dressings, red meat, and whole-milk dairy foods.FiberThe 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 LibraryThe 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 data-base, USDA National Nutrient Database for Standard Reference.GlucoseA simple sugar (also known as dextrose) used by the body for energy. Without insulin, the body cannot use glucose for energy.BThe Food Library is for reference only. (Food refer-ences contained in the library cannot be populated and used for calculations.)
Glossary166Hazard alarmNotification by the PDM that a dangerous condition exists.Healthcare providerA 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.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 unawarenessA condition in which a person does not feel or recognize the symptoms of hypoglycemia.InfusingIntroducing a liquid substance under the skin into the body.Infusion siteA place on the body where an infusion set or Pod is placed and cannula is inserted.InsulinA 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 previ-ous bolus dose. In the OmniPod System, insulin on board (IOB) is considered in two parts: the Insulin on Board (IOB) from a previ-ous 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)
Glossary167Insulin-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 vitroLiterally, “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.KetonesAcidic 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.OcclusionA blockage or interruption in insulin delivery. Prime bolusAn amount of insulin used to fill the cannula, preparing it to begin delivering insulin under your skin.ProteinOne of the three main energy sources in food (the other two are carbohydrate and fat). Protein is necessary for the growth, main-tenance, 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.It is important to rule out ketoacidosis when you experience symptoms that might otherwise indicate the flu.
Glossary168Reverse 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.Sensitivity factor (see correction factor)SharpsAny 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 containerA puncture-proof container used for storage and disposal of used sharps.Soft KeyA 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.SubcutaneousUnder the skin.Suggested bolus calculatorA 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 sug-gested bolus are current BG, carbs entered, and insulin on board. The bolus calculator can be turned Off or On in the PDM.Target blood glucose (BG) levelThe ideal number at which you would like your blood glucose level to be. The OmniPod System uses this number in calculating bolus doses.Temp basalA basal rate that is used to cover predictable, short-term changes in basal insulin need. Temporary rates are often used during exer-cise and for sick-day insulin adjustments.Temporary basal presetAn 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)
170IndexAactivate a new Pod. . . . . . . . . . . . . . . 43–57active insulin . . . . . . .See insulin on boardaddbasal segment or rate . . . . . . . . . 17–21bolus reminder. . . . . . . . . . . . . . . . . . . .68custom reminders. . . . . . . . . . . . . . . . .68user information . . . . . . . . . . . . . . . . 104adhesive . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 50remover. . . . . . . . . . . . . . . . . . . . . . . . . . .45advisory alarms. . . . . . . . . . 124–127, 165airport security . . . . . . . . . . . . . . . . . . . . 109alarms . . . . . . . . . . . . . . . . . . . . . . 8, 124–131acknowledge . . . . . . . . . . . . . . . . . . . 124advisory. . . . . . . . . . . . . . . . . . . . 124–127hazard . . . . . . . . . . . . . . . . . . . . . 124–131history records . . . . . . . . . . . . . . . . . . 102alert escalation . . . . . . . . . . . . . . . . . . . . 124alerts and reminders. . . . . . . . . . . . . 66–69auto-off alert. . . . . . . . . . . . . . . . . . . . . . 66BG reminder . . . . . . . . . . . . . . . . . . . . . . 66bolus reminders. . . . . . . . . . . . . . . . . . . 67confidence reminders. . . . . . . . . . . . . 67custom reminders . . . . . . . . . . . . . . . . 67low reservoir alert. . . . . . . . . . . . . 15, 66missed bolus. . . . . . . . . . . . . . . . . . . . . . 67Pod expiration reminder . . . . . . . . . . 66program reminders . . . . . . . . . . . . . . . 67aseptic technique . . . . . . . . . . 43, 56, 165automated cannula insertion. . . . . .2, 52auto-off alert . . . . . . . . . . . . . . . . . . . . . . . . 66Bbacklight time-out. . . . . . . . . . . . . . . . . . . 71set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73basal history. . . . . . . . . . . . . . . . . . . . . . . . .98basal program . . . . . . . . . . .11, 16–22, 165add segment or rate . . . . . . . . . . . . . . 21copy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17delete. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22edit segment or rate . . . . . . . . . . . . . . 21enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19rename . . . . . . . . . . . . . . . . . . . . . . . . . . . 22basal rate . . . . . . . . . . . . . 1, 11, 16–27, 165maximum. . . . . . . . . . . . . . . . . . . . . . . . . 27temporary . . . . . . . . . . . . . . . . . . . . . . . . 22basal segment. . . . . . . . . . . . . . .11, 16, 165basal settings. . . . . . . . . . . . . . . . . . . . . . . . 11batteries. . . . . . . . . . . . . . . . . . . . .10, 97, 139BG tag . . . . . . . . . . . . . . . . See tag a BG resultblood glucoseBG goal . . . . . . . . . . . . . . . . . . .12, 69, 165BG reminder . . . . . . . . . . . . . . . . . . . . . . 66checking. . . . . . . . . . . . . . . . . . . xi, 77–96code . . . . . . . . . . . . . . . . . . . . . . . . . . 81, 87goal limit. . . . . . . . . . . . . . . . . . . . . . . . . . 69history . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Index171level. . . . . . . . . . . . . . . . . . . . . . . . . . 28, 165monitoring. . . . . . . . . . . . . . . . . . . . . . xi, 2sound . . . . . . . . . . . . . . . . . . . . . . . . . 12, 70test sites. . . . . . . . . . . . . . . . . . . 77, 88–89test strip. . . . . . . . . . . . . . . . . . . . . . . . . . .86blood glucose meter. . . . . .2, 77–96, 165error messages. . . . . . . . . . . . . 121–123readings. . . . . . . . . . . . . . . . . . . . . . . . 3, 91settings . . . . . . . . . . . . . . . . . . . . . . . . . . .69specifications . . . . . . . . . . . . . . . . . . . 149blood glucose readingsenter manually . . . . . . . . . . . . . . . . . . . .93low and high . . . . . . . . . . . . . . . . . . . . . .95bolus . . . . . . . . . . . . . . . . . . . . . . . 1, 3, 28–41cancel. . . . . . . . . . . . . . . . . . . . . . . . . . . . .35dose. . . . . . . . . . . . . . . . . . . . . . . . . .28, 165extended. . . . . . . . . . . . . . . . . . . . . . 29, 33history . . . . . . . . . . . . . . . . . . . . . . . . . . . .99manual delivery. . . . . . . . . . . . . . . . . . .33normal . . . . . . . . . . . . . . . . . . . . . . . . 29, 30presets . . . . . . . . . . . . . . . . . . . 37–39, 165ratios/factors/targets. . . . . . . . . . . . . .64reminders . . . . . . . . . . . . . . . . . . . . . 67, 68settings . . . . . . . . . . . . . . . . . . . . . . . 61–65suggested bolus calculator . . .29–33, 142–145bolus presets . . . . . . . . . . . . . . . 37–39, 165cancel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39change. . . . . . . . . . . . . . . . . . . . . . . . . . . . 39create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39enable . . . . . . . . . . . . . . . . . . . . . . . . . . . .38rename . . . . . . . . . . . . . . . . . . . . . . . . . . .39bolus reminderadd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68bolus reminders . . . . . . . . . . . . . . . . . . . . . 67Bolus/basal/calcs menu . . . . . . . . . . . . . 61bright mode . . . . . . . . . . . . . . . . . . . . . . .5, 71buttonsHome/Power. . . . . . . . . . . . . . . . . . . . . . . 5Up/Down Controller . . . . . . . . . . . . . . . 5User Info/Support. . . . . . . . . . . . . . . . . . 5Ccalorie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166cancelbolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35bolus preset. . . . . . . . . . . . . . . . . . . . . . . 39one-time temporary basal rate. . . . 24temporary basal presets . . . . . . . . . . 26cannula. . . . . . . . . . . . . . . . . . . . . . . . . . 2, 166automated insertion. . . . . . . . . . . .8, 52carb presets . . . . . . . . . . . . . . 3, 39–41, 166change. . . . . . . . . . . . . . . . . . . . . . . . . . . . 40change category. . . . . . . . . . . . . . . . . . 41create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39delete. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41edit . . . . . . . . . . . . . . . . . . . . . . . . . . . 40, 41rename . . . . . . . . . . . . . . . . . . . . . . . . . . . 41carbohydrate . . . . . . . . . . . . . . . . . . . . 1, 166counting . . . . . . . . . . . . . . . . . . . . . . 3, 166history . . . . . . . . . . . . . . . . . . . . . . . . . . .102carbohydrate bolus . . . . . .See meal boluscare and maintenance. . . . . . . . . . . . . .138cellular phones . . . . . . . . . . . . . . . . . . . . .120changebasal programs . . . . . . . . . . . . . . . . . . . 20basal settings . . . . . . . . . . . . . . . . . . . . . 61bolus presets. . . . . . . . . . . . . . . . . . . . . . 39bolus settings. . . . . . . . . . . . . . . . . . . . . 61carb presets. . . . . . . . . . . . . . . . . . . . . . . 40temporary basal presets . . . . . . . . . . 26
Index172user information . . . . . . . . . . . . . . . . 104check alarms. . . . . . . . . . . . . . . . . . . . . . . . .73check blood glucose. . . . . . . . . . . . . 77–96cleaning . . . . . . . . . . . . . . . . . . . . . . .138, 139clock12-hour or 24-hour. . . . . . . . . . . . . . . .61code number, test strip vial . . . . . . 82, 88communicationdistance to Pod . . . . . . . . . . . . . . 75, 149interruption. . . . . . . . . . . . . . . . . . 76, 132communication failure . . . . . . . 132–137bolus cancellation. . . . . . . . . . . . . . . 136Pod activation. . . . . . . . . . . . . . . . . . . 132Pod deactivation . . . . . . . . . . . . . . . . 134Pod operation. . . . . . . . . . . . . . . . . . . 132request for status. . . . . . . . . . . . . . . . 135complications, diabetes-related . 1, 166confidence reminders . . . . . . . . . . . . . . .67contact information . . . . . . . . . . . . . . . 103continuous subcutaneous insulin infusion . . . . . . . . . . . . . . . . . . . . . . . . . 166control solution. . . . . . . . . . . . . . . . . . . . . .79expiration . . . . . . . . . . . . . . . . . . . . . . . . .79results. . . . . . . . . . . . . . . . . . . . . . . . . 79, 83test. . . . . . . . . . . . . . . . . . . . . . . . . . . . 81–84copy basal program . . . . . . . . . . . . . . . . . 22correct-above value . . . . . See correction thresholdcorrection bolus . . . . . . . . . . . 30, 142, 166correction factor. . . . . 13, 28, 63, 65, 166correction IOB . . . . . . . . . . . . . . . . . . . . . .142correction threshold. . . . .28, 62, 64, 166createbasal program . . . . . . . . . . . . . . . . . . . . 17bolus preset. . . . . . . . . . . . . . . . . . . . . . . 37carb presets. . . . . . . . . . . . . . . . . . . . . . . 39temporary basal presets . . . . . . . . . . 24CSII . . . . . .See continuous subcutaneous insulin infusionCT scans . . . . . . . . . . . . . . . . . . . . . . . . . . . .120custom reminders . . . . . . . . . . . . . . . 67, 68customize PDM. . . . . . . . . . . . . . . . . . . . . . 71Ddate and time. . . . . . . . . . . . . . . . . . . . 11, 60dawn phenomenon . . . . . . . . . . . . . . . .166deactivation . . . . . . See Pod deactivatingdeletebasal program . . . . . . . . . . . . . . . . . . . . 22bolus presets. . . . . . . . . . . . . . . . . . . . . . 39bolus reminder . . . . . . . . . . . . . . . . . . . 68carb presets. . . . . . . . . . . . . . . . . . . . . . . 41temporary basal presets . . . . . . . . . . 27depth settings, lancing device. . . . . . . 86diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . .167Diabetes Control and ComplicationsTrial (DCCT) . . . . . . . . . . . . . . . . . . . . . .167diabetes emergency kit . . . . . . . . . . . .107diabetes mellitus . . . . . . . . . . . . . . . . . . . . . xdiabetic ketoacidosis . . . . . . . . . . . See DKAdiagnostic functions. . . . . . . . . . . . . . . . . 73check alarms. . . . . . . . . . . . . . . . . . . . . . 73reset PDM. . . . . . . . . . . . . . . . . . . . . . . . . 73disinfecting wipes . . . . . . . . . . . . . . . . . .139DKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .169avoiding . . . . . . . . . . . . . . . . . . . . . . . . .118symptoms . . . . . . . . . . . . . . . . . . . . . . .118treating . . . . . . . . . . . . . . . . . . . . . . . . . .118duration of insulin action. . . . . xi, 14, 30,142–143, 167Eeditbasal segment or rate. . . . . . . . . . . . . 21
Index173bolus reminder. . . . . . . . . . . . . . . . . . . .68carb presets . . . . . . . . . . . . . . . . . . . . . . .41electrical interference. . . . . . . . . . . . . . . .76electrical safety . . . . . . . . . . . . . . . 152–155electromagnetic compatibility 152–155electromagnetic fields . . . . . . . . . . . . . . .76emergency kit . . . . . . . . . . . .105, 107, 108empty reservoir hazard alarm. . . . . . 126enablebasal program. . . . . . . . . . . . . . . . . . . . .19bolus preset. . . . . . . . . . . . . . . . . . . . . . .38one-time temporary basal rate. . . .23temporary basal presets . . . . . . . . . .25enterID screen color . . . . . . . . . . . . . . . . . . . .11tags . . . . . . . . . . . . . . . . . . . . . . . . . . . 70, 91error messages, BG meter. . . . . 121–123exercise. . . . . . . . . . . . . . . . . . . . . . . .114, 119expirationcontrol solution . . . . . . . . . . . . . . . . . . .79Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66test strips. . . . . . . . . . . . . . . . . . . . . . . . . .78extended bolus. . . . . .14, 29, 33–35, 167Extended option. . . . . . . . . . . . . . . . . . . . .65extreme temperatures. . . . . . . . . . . . . . .75Ffailure . . . . . . . See communication failurefat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167fiber . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40, 167fill syringe. . . . . . . . . . . . . . . . . . . . . . . . 46–48Flow accuracyPod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .148Flow rate error . . . . . . . . . . . . . . . . . . . . . .148food library . . . . . . . . . . . . . . . . . . . . 3, 42, 166glucagon . . . . . . . . . . . . . . . . . . . . . . . . . . .108glucose . . . . . . . . . . . . . . . . . . . . . . . . . . x, 167Hhard work. . . . . . . . . . . . . . . . . . . . . . . . . . .119hazard alarm, manual shut-off. . . . . .131hazard alarms. . . . . . . . . . . . .124–131, 167healthcare provider. . . . . . . . . . . . . . xi, 167hemoglobin A1c (HbA1c). . . . . . . . . . .168HIPAA privacy notice . . . . . . . . . 159–164historyalarms. . . . . . . . . . . . . . . . . . . . . . . . . . . .102all . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98blood glucose. . . . . . . . . . . . . . . . . . . .100bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99carbohydrates . . . . . . . . . . . . . . . . . . .102insulin delivery. . . . . . . . . . . . . . . . 97, 98Home screen . . . . . . . . . . . . . . . . . . . . . . .6–7Home/Power button . . . . . . . . . . . . . . . . . 5hospitalization. . . . . . . . . . . . . . . . . . . . . .120hyperglycemia . . . . . .105, 114–117, 168avoiding . . . . . . . . . . . . . . . . . . . . . . . . .115causes . . . . . . . . . . . . . . . . . . . . . . . . . . .116symptoms . . . . . . . . . . . . . . . . . . . . . . .114treating . . . . . . . . . . . . . . . . . . . . . . . . . .115hypoglycemia . . . 77, 105, 110–114, 168avoiding . . . . . . . . . . . . . . . . . . . . . . . . .111causes . . . . . . . . . . . . . . . . . . . . . . . . . . .113symptoms . . . . . . . . . . . . . . . . . . . 77, 110treating . . . . . . . . . . . . . . . . . . . . . . . . . .111hypoglycemia unawareness. . . .77, 111,168Iicons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150insulin gauge . . . . . . . . . . . . . . . . . . . . . 59ID screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Index174color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72illness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119infection . . . . . . . . . . . . . . . . . . . . . . . . 56, 106infusion set, automated insertion. . . . . 2infusion site. . . . . . . . . . . . 49, 56, 106, 168infusion site, inspection. . . . . . . . . . . . 106insulin . . . . . . 16, 28, 43, 46, 47, 107, 109,141, 168insulin action . . . . See duration of insulin actioninsulin deliveryresume. . . . . . . . . . . . . . . . . . . . . . . . . . . .56suspend. . . . . . . . . . . . . . . . . . . . . . . . . . .54insulin delivery records . . . . . . . . . . 97–99insulin delivery, continuous. . . . . . . . . . . 1insulin gauge icon . . . . . . . . . . . . . . . . . . .59insulin on board (IOB). .28, 30, 142–145, 168insulin reservoir. . . . . . . . . . . . . . . . . . . . . .59insulin, rapid-acting vs. long-acting 118insulin-to-carb (IC) ratio. . . xi, 13, 28, 63,64, 168interruption in communication. . . . . .76IV Prep wipes . . . . . . . . . . . . . . . . . . . 75, 139Kketoacidosis . . . . . . . . . . . . . . . . . . . . . . See DKAketones. . . . . . . . . . . . . . . . . . . . 95, 118, 169Llancet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85lancingfinger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88lancing device . . . . . . . . . . . . . . . . . . . 84–89long-acting insulin. . . . . . . . . . . . . . . . . .118low battery alert. . . . . . . . . . . . . . . . . . . .140low blood glucose . . See hypoglycemialow reservoir advisory . . . . . . . . . . . . . .126low reservoir alert . . . . . . . . . . . . . . . 15, 66lows, highs, and DKA, avoid. . . . . . . . .110Mmanual shut-off of hazard alarm. . . .131maximum basal rate. . . . . . . . . . . . . 27, 65maximum bolus . . . . . . . . . . . . . . . . . 14, 65meal bolus. . . . . . . . . . . . 30, 142–145, 169meal IOB. . . . . . . . . . . . . . . . . . . . . . . . . . . .143Medic Alert tag . . . . . . . . . . . . . . . . . . . . .120medical electrical equipment. 152–155menuBolus/basal/calcs . . . . . . . . . . . . . . . . . 61More actions. . . . . . . . . . . . . . . . . . . .7, 31My records. . . . . . . . . . . . . . . . . . . . . . . . . 7Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Suspend/resume . . . . . . . . . . . . . . . . . . 7System setup . . . . . . . . . . . . . . . . . . . . . 60Temp basal. . . . . . . . . . . . . . . . . . . . . . . . . 7microwave ovens. . . . . . . . . . . . . . . . . . . . 76Min BG for calcs . . . . . . . . . . . . . .13, 62, 64missed bolus reminder . . . . . . . . . . 67–68More actions menu. . . . . . . . . . . . . . . . . . 31MRIs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120multiple daily injections (MDIs). . . . .169multiple-day trends, BG history. . . . .101Nnormal bolus . . . . . . . . . . . . . . . . . . . . 29, 30Oocclusion . . . . . . . . . . . . . . .8, 114, 118, 169occlusion detected hazard alarm . . .128OmniPod label symbols . . . . . . . . . . . .150OmniPod System. . . . . . . . . . . . . . . . . . . . . 2one-time temporary basal rate . . . . . . 23
Index175cancel. . . . . . . . . . . . . . . . . . . . . . . . . . . . .24enable . . . . . . . . . . . . . . . . . . . . . . . . . . . .23operating temperatures . . . 75, 147, 149optionsBolus calcs . . . . . . . . . . . . . . . . . . . . . . . .62Extended. . . . . . . . . . . . . . . . . . . . . . . . . .65Max basal rate. . . . . . . . . . . . . . . . . . . . .65Max bolus . . . . . . . . . . . . . . . . . . . . . . . . .65Ratios/factors/targets . . . . . . . . . . . . .64Temp basal. . . . . . . . . . . . . . . . . . . . . . . .65Options and settings . . . . . . . . . . . . . . 146PPDM . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 58–76backlight time-out . . . . . . . . . . . . . . . .71batteries . . . . . . . . . . . . . . . . . . . . .10, 139BG goal. . . . . . . . . . . . . . . . . . . . . . . . . . . .69blood glucose sound. . . . . . . . . . . . . .70cleaning. . . . . . . . . . . . . . . . . . . . . . . . . 139communication with Pod . . 132–137customize. . . . . . . . . . . . . . . . . . . . .71–73disinfecting wipes. . . . . . . . . . . . . . . 139dropped . . . . . . . . . . . . . . . . . . . . . . . . 141icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150ID screen. . . . . . . . . . . . . . . . . . . . . . . . . . 58PDM lock. . . . . . . . . . . . . . . . . . . . . . 71–72repair or replacement . . . . . . . . . . . .125screen time-out . . . . . . . . . . . . . . . . . . .71settings . . . . . . . . . . . . . . . . . . . . . . . . . . .59setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9specifications . . . . . . . . . . . . . . . . . . . .149Status screen. . . . . . . . . . . . . . . . . . 58–59storage. . . . . . . . . . . . . . . . . . . . . . . . . . .138submerged in water . . . . . . . . . . . . . . 75version. . . . . . . . . . . . . . . . . . . . . . . . . . . .viiiPDM error hazard alarm . . . . . . . . . . . .129PDM lock . . . . . . . . . . . . . . . . . . . . . . . 71, 138set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72PDM options, System setup . . . . . . . . .71personal contact information. . . . . . .103Personal Diabetes Manager . . . See PDMphysical exertion . . . . . . . . . . . . . . . . . . .119playing sports . . . . . . . . . . . . . . . . . . . . . .119Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 43–57applying . . . . . . . . . . . . . . . . . . . . . . . . . . 50change process . . . . . . . . . . . . . . . . . . . 43check status. . . . . . . . . . . . . . . . . . . . . . .54cleaning . . . . . . . . . . . . . . . . . . . . . . . . .138deactivating . . . . . . . . . . . . . . . . . . . . . . 44expiration reminder. . . . . . . . . . . . . . . 66filling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46flow accuracy . . . . . . . . . . . . . . . . . . . .148flow rate error. . . . . . . . . . . . . . . . . . . .148in water . . . . . . . . . . . . . . . . . . . . . . . . . . . 57inserting cannula . . . . . . . . . . . . . . . . . 52priming . . . . . . . . . . . . . . . . . . . . . . . . . . . 48removal. . . . . . . . . . . . . . . . . . 44–45, 119safety checks. . . . . . . . . . . . . . . . . . . . . . 48specifications . . . . . . . . . . . . . . . . . . . .147storage. . . . . . . . . . . . . . . . . . . . . . . 57, 138Pod error hazard alarm . . . . . . . . . . . . .128Pod expiration advisory . . . . . . . . . . . .127Pod expired hazard alarm . . . . . . . . . .127Pod occlusion hazard alarm . . . . . . . .128prescriptions . . . . . . . . . . . . . . . . . . . . . . .109for travel . . . . . . . . . . . . . . . . . . . . . . . . .108prime bolus . . . . . . . . . . . . . . . . . . . . 52, 169priming, automatic . . . . . . . . . . . . . . . . . . . 8program reminders. . . . . . . . . . . . . . . . . . 67protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . .169
Index176Rradio interference. . . . . . . . . . . . . . . . . . . .76rapid-acting insulin . . . . . . . . . . . . . . . . 118Ratios/factors/targets option . . . . 64–65record keeping . . . . . . . . . . . . . . 3, 97–104record screens . . . . . . . . . . . . . . . . . .97–104alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . 102all . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103blood glucose. . . . . . . . . . . . . . . . . . . 100carbohydrates. . . . . . . . . . . . . . . . . . . 102combined records. . . . . . . . . . . . . . . 103insulin delivery. . . . . . . . . . . . . . . . . . . .98personal contact information . . . 103special symbols . . . . . . . . . . . . . . 97, 101User Info/Support. . . . . . . . . . . . . . . 103reference food library. . . . . . . . . . . . . 3, 42remove a Pod. . . . . . . . . . . . . . . 44–45, 119renamebasal program . . . . . . . . . . . . . . . . . . . .22bolus presets. . . . . . . . . . . . . . . . . . . . . .39custom reminders. . . . . . . . . . . . . . . . .68temporary basal presets . . . . . . . . . .27replace batteries. . . . . . . . . . . . . . . . . . . 140resetdate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61PDM . . . . . . . . . . . . . . . . . . . . . . . . . . 73–74time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61resume insulin delivery . . . . . . . . . . . . . . 56reverse correction . . .14, 32, 63, 65, 142,169Ssafety. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 105alerts and alarms. . . . . . . . . . . . . . . . . . . 8automatic priming . . . . . . . . . . . . . . . . . 8automatic safety checks. . . . . . . . . . . . 8electrical . . . . . . . . . . . . . . . . . . . 152–155occlusion detection . . . . . . . . . . . . . . . . 8safety checks . . . . . . . . . . . . . . . . . . . . . . .121screen time-out . . . . . . . . . . . . . . . . . . . . . 71set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72sensitivity factor . . See correction factorsetbacklight time-out . . . . . . . . . . . . . . . . 73ID screen. . . . . . . . . . . . . . . . . . . . . . . . . . 72PDM lock. . . . . . . . . . . . . . . . . . . . . . . . . . 72screen time-out. . . . . . . . . . . . . . . . . . . 72settings, BG meter . . . . . . . . . . . . . . . . . . . 69Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . 10sharps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .170sharps container. . . . . . . . . . . . . . . . . . . .170shock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43shut-off, manual. . . . . . . . . . . . . . . . . . . .131sick days. . . . . . . . . . . . . . . . . . . . . . . . . . . .119soap, solvent . . . . . . . . . . . . . . 75, 138, 139soft keys . . . . . . . . . . . . . . . . . . . . . . .ix, 5, 170soft reset . . . . . . . . . . . . . . . . . . See reset PDMspecial symbols in record screens . . . 97specificationsBG meter. . . . . . . . . . . . . . . . . . . . . . . . .149PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .147sports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119Status screen . . . . . . . . . . . . . . . 6–7, 58–59storage temperatures . . . . . . . . .147, 149stuck key advisory . . . . . . . . . . . . . . . . . .127suggested bolus calculator. . . . . . . 3, 12,29–33, 92, 170examples . . . . . . . . . . . . . . . . . . .142–144guidelines. . . . . . . . . . . . . . . . . . . . . . . .144suppliespacking for travel . . . . . . . . . . . . . . . .108
Index177surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120suspend insulin delivery . . . . . . . . . . . . .54symbolsin history records. . . . . . . . . . . . . . . . . .97on screen . . . . . . . . . . . . . . . . . . . . . . . 150System labels . . . . . . . . . . . . . . . . . . . 150symptomsDKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118hyperglycemia . . . . . . . . . . . . . . . . . . 114hypoglycemia. . . . . . . . . . . . . . . . 77, 110System error hazard alarm. . . . . . . . . 130System options and settings. . . . . . . 146System setup menu . . . . . . . . . . . . . . . . .60Ttag a BG reading result. . . . . . . . . . . . . . .83tagsenter . . . . . . . . . . . . . . . . . . . . . . . . . . 70, 91target BG . . . . . . . . . . . . . . . .28, 62, 64, 170target blood glucose value . . . . . . . . . .12temperaturesextreme. . . . . . . . . . . . . . . . . . . . . . . . . . . 75operating . . . . . . . . . . . . . . . 75, 147, 149storage. . . . . . . . . . . . . . . . . . . . . .147, 149temporary basal . . . . . . . . . . . . . . . . . 12, 65temporary basal presets . . . . 24–27, 170cancel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26change. . . . . . . . . . . . . . . . . . . . . . . . . . . . 26create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27enable . . . . . . . . . . . . . . . . . . . . . . . . . . . .25rename . . . . . . . . . . . . . . . . . . . . . . . . . . .27temporary basal rate . . . . . . . 22–27, 170temporary basal rate, one-time. . . . . . 23test strips . . . . . . . . . . . . . . .2, 77, 78, 80, 86code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87expiration . . . . . . . . . . . . . . . . . . . . . . . . .78text, entering and changing . . . . .17, 22,24, 27, 38, 39time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 60time segment . . . . . . . See basal segmenttime zones. . . . . . . . . . . . . . . . . . . . . . . . . .108travel concerns . . . . . . . . . . . . . . . . . . . . .108UUp/Down Controller buttons . . . . . . . . . 5User Guide symbols . . . . . . . . . . . . . . . . . .viiiUser Info/Supportbutton . . . . . . . . . . . . . . . . . . . . . . . . 5, 103icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5screen. . . . . . . . . . . . . . . . . . . . . . . . . . . .104Vvacation . . . . . . . . . . . . . . . . . . . . . . . . . . . .108Wwarranty. . . . . . . . . . . . . . . . . . . . . . . . . . . .158water . . . . . . . . . . . . . . . . . . . . . . 75, 107, 140wireless communication technology 76XX-rays. . . . . . . . . . . . . . . . . . . . . . . . . .109, 120
My PDM SettingsUse this form to keep track of your important PDM settings. Remember to update your information as you change or add settings.Basal Program 1Name _________________________________12:00 AM to ________________ to ________________ to ________________ to ________________ to ________________ to ________________ to ________Rate___________ U/hr___________ U/hr___________ U/hr___________ U/hr___________ U/hr___________ U/hr___________ U/hrTarget BGTarget 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 ________Target BG_________ _________ _________ _________ _________ _________ _________ _________ Suggest correctionwhen BG is above___________ mg/dL___________ mg/dL___________ mg/dL___________ mg/dL___________ mg/dL___________ mg/dL___________ mg/dL___________ mg/dLBasal Program 2Name _________________________________12:00 AM to ________________ to ________________ to ________________ to ________________ to ________________ to ________________ to ________Rate___________ U/hr___________ U/hr___________ U/hr___________ U/hr___________ U/hr___________ U/hr___________ U/hrInsulin-to-Carbohydrate RatioInsulin-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 ActionTime that insulin will remain “active” in the body from a previous bolus. ___________ hrsCorrection FactorCorrection 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/dLBolus PresetsName________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Units_____________ U_____________ U_____________ U_____________ U_____________ U_____________ U_____________ UTemp Basal PresetsName________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________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 PresetsName________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________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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