Insulet 019 UST500 PDM User Manual

Insulet Corporation UST500 PDM

Contents

Users manual

Contacts and Important InformationoNameAddressTelephone and FaxEmail AddressNameAddressTelephone and FaxEmail AddressNameAddressTelephone Number(s)Policy NumberNameAddressTelephone and FaxEmail Addressmylife OmniPod System Start Date: ______________________PDM Model: ENT500 Serial Number:  _____________________Distributor:Customer Care: DoctorNurse/EducatorHealth InsurancePharmacyXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXUse the spaces below to record important health and product information.
© 2012–2013 Insulet Corporation. All rights reserved.mylife OmniPod is a registered trademark of Insulet Corporation.U.S. Patent No. 6,740,059.OneTouch® Verio™ is a registered trademark of Johnson & Johnson. Third-party trademarks used herein are the trademarks of their respective owners.15858-AW Rev A
iiiContentsIntroduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiiAbout This User Guide  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  viiiSymbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   viiiConventions and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  ixImportant Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  ixIndication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ixContraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xYour Role: Safely Using the mylife OmniPod System. . . . . . . . . . . . .  xi1  Your New mylife OmniPod Insulin Management System. . . .   1Insulin Delivery with the mylife OmniPod System. . . . . . . . . . . . . . .   1How Does the mylife OmniPod System Work?  . . . . . . . . . . . . . . . . . .   2No tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   2Suggested bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   2Carb presets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   2Automated cannula insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   2A fully integrated design with blood glucose monitoring . . . .   3Record keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   3Personalizing your System  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   3The Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   4The Personal Diabetes Manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   4Buttons that program and control the mylife OmniPodSystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   5Primary screens  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   6Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   8Automatic priming, safety checks, and insertion  . . . . . . . . . . . . .   8Occlusion detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   8Table 1:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Alerts and alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   82  Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Set Up the Personal Diabetes Manager (PDM). . . . . . . . . . . . . . . . . . .   9Turn on the PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   9The mylife OmniPod Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  10Enter your PDM ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  10Select the ID screen color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  10Set date and time  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  11Enter basal settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  11Enter blood glucose sound setting and BG goal. . . . . . . . . . . . .  11Enter minimum BG allowed for use in bolus calculation. . . . .  12Enter insulin-to-carbohydrate ratio. . . . . . . . . . . . . . . . . . . . . . . . . .  13Enter correction factor  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  13Set reverse correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  13Set low reservoir advisory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  14Set Pod expiration notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  14
Contentsiv3  Understanding and Adjusting Basal Rates . . . . . . . . . . . . . . . .   16What Is a Basal Rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  16Personalized Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  16Create a basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  17Enable an existing basal program  . . . . . . . . . . . . . . . . . . . . . . . . . . .  19Temporary 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  37Enable an existing bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  38Change, rename, or delete a bolus preset  . . . . . . . . . . . . . . . . . . .  39Cancel an active bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  39Carb Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  40Create a carb preset  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  40Change or edit a carb preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  41Delete a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  425  Using the Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   43The Pod Change Process  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  43Gather equipment and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  44Fill a new Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  46Select the infusion site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  49Prepare the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  50Apply the new Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  51Insert cannula and begin insulin delivery  . . . . . . . . . . . . . . . . . . .  53Check Pod Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  55Suspend Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  56Resume Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  57Avoid Infusion Site Infections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  58Get the Most From Your Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  58Avoid extreme temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  58Water and your Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  58Safe storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  596  Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . .   60The ID Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  60
ContentsvThe Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  60The System Setup Menu  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  62Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  63Reset the time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  63Reset the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  64Change Bolus and Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  64Bolus calcs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  64Ratios/factors/targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  66Temp basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  67Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  67Bolus increment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  67Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  67Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  67Alerts and Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  68Set alerts and reminders  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  69Change Blood Glucose Meter Settings . . . . . . . . . . . . . . . . . . . . . . . . .  71Change BG goal limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  72Manage the blood glucose tags list  . . . . . . . . . . . . . . . . . . . . . . . . .  72Change BG sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  72Customize the Personal Diabetes Manager  . . . . . . . . . . . . . . . . . . . .  73Set PDM options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  73Set ID screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  73Set PDM lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  74Set the Screen time-out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  74Set Diagnostic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  75Diagnostic options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  75Set a Reminder to Vibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  76Get the Most from Your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  77Keep it handy  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  77Communicating with the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  77Water and your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  77Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  77Electrical interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  787  Checking Your Blood Glucose  . . . . . . . . . . . . . . . . . . . . . . . . . . . .   79The Built-in OneTouch® Verio™ Blood Glucose Meter . . . . . . . . . . .  79The OneTouch® Verio™ Blood Glucose Test Strips. . . . . . . . . . . . . . .  80Important test strip information. . . . . . . . . . . . . . . . . . . . . . . . . . . . .  80The OneTouch® Verio™ Control Solution. . . . . . . . . . . . . . . . . . . . . . . .  81When to perform a control solution test. . . . . . . . . . . . . . . . . . . . .  81Check that the meter and test strips are working. . . . . . . . . . . .  81Control solution expiration date. . . . . . . . . . . . . . . . . . . . . . . . . . . . .  81Ensure accurate control solution results . . . . . . . . . . . . . . . . . . . . .  82Performing a Control Solution Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  82Performing a Blood Glucose Reading . . . . . . . . . . . . . . . . . . . . . . . . . .  85Prepare the lancing device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  86Insert the blood glucose test strip . . . . . . . . . . . . . . . . . . . . . . . . . . .  87Fill the blood glucose test strip with blood . . . . . . . . . . . . . . . . . .  88Remove the lancet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  90Blood Glucose Results and the Suggested BolusCalculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  91Entering Blood Glucose Readings Manually. . . . . . . . . . . . . . . . . . . .  92Editing Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  93Low and High Blood Glucose Readings . . . . . . . . . . . . . . . . . . . . . . . .  94Low readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  94
ContentsviHigh readings  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  94Important Health-Related Information . . . . . . . . . . . . . . . . . . . . . . . . .  958  Understanding Your Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   96Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  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 mylife 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  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Keep supplies accessible  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Avoid lows, highs, and DKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109General precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Hypoglycemia (Low Blood Glucose) . . . . . . . . . . . . . . . . . . . . . . . . 109Symptoms of hypoglycemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110To avoid hypoglycemia (low blood glucose) . . . . . . . . . . . . . . . . 110To treat hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . . 111How much is 15 grams of carbohydrate? . . . . . . . . . . . . . . . . . . . 112Hyperglycemia (high blood glucose) . . . . . . . . . . . . . . . . . . . . . . . 114Diabetic ketoacidosis (DKA)  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Handling Special Situations  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119Sick days. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119Exercising, playing sports, or working hard . . . . . . . . . . . . . . . . . 120X-rays, MRIs, and CT scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120Surgery or hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12110  Alerts and Alarms  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  122Safety Checks  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122Blood Glucose Meter Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126Hazard Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126Manual Shut-off of a Hazard Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13411  Communication Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  136The Communication Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136Failure During Pod Activation or Operation  . . . . . . . . . . . . . . . . . . . 136Failure During Pod Deactivation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138Failure During Request for Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139Failure During Bolus Cancellation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142Pod Care and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
ContentsviiCleaning  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142Personal Diabetes Manager Care and Maintenance . . . . . . . . . . .  142Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  142Cleaning and disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  143Replacing batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  144If the PDM becomes submerged in water. . . . . . . . . . . . . .   145If you drop the PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  146Storage and Supplies  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146Suggested Bolus Calculator Examples and Guidelines . . . . . . . .  147Meal bolus calculation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  147Insulin-on-board (IOB) calculation. . . . . . . . . . . . . . . . . . . . . . . . . .  147Examples of suggested bolus calculations  . . . . . . . . . . . . . . . . .  148Calculator guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149mylife OmniPod System Options and Settings . . . . . . . . . . . . . . . .  151Pod Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  152Accuracy Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  153Flow rate error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  153Personal Diabetes Manager Specifications . . . . . . . . . . . . . . . . . . . .  154Blood Glucose Meter Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . .  154mylife OmniPod System Label Symbols . . . . . . . . . . . . . . . . . . . . . . . 155Personal Diabetes Manager Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  156Medical Device Directive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  157mylife OmniPod System Notice Concerning Interference . . . . . 157Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  157Glossary  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  162Index  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  168
viiin About This User GuideSymbols Symbol Term MeaningWarning Describes potential serious adverse reactions, or indicates conditions that could cause death or serious injury.Caution Caution: Consult accompany in docu-ments. 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 mylife OmniPod® Insulin Man-agement System.This User Guide is intended for use only with PDM model ENT500. To learn which version of the PDM you have, turn it over. On the back of the PDM, look for “ENT500.” If you see it, this is the correct User Guide. If you do not see “ENT500” on the back of the PDM, please call Customer Care.This User Guide is periodically updated. Visit the Cus-tomer Care section of mylife-omniPod.com to see the most recent version and to find other helpful information.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 mylife OmniPod® Insulin Management System is intended for subcutaneous (below the skin) delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glu-cose 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.This device is for prescription use only.
IntroductionxOneTouch® Verio™ test strips are used with the built-in One-Touch® Verio™ meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. OneTouch® Verio™ Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.ContraindicationsInsulin 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 OneTouch® Verio™ Blood Glucose Monitoring System for:• Testing on newborns• Testing arterial blood• Diagnosing of or screening for diabetes mellitus The mylife OmniPod System is designed to use rapid-acting U-100 insulin. The following U-100 rapid-acting insulin analogs have been tested and found to be safe for use in the Pod: NovoRapid®, Humalog®, or Apidra®. NovoRapid® is compatible with the mylife OmniPod System for use up to 72 hours (3 days). Before using different insulins with the mylife OmniPod System, check the insulin drug label to make sure it can be used with a pump. Refer to the insulin labeling and follow your healthcare provider’s directions for how often to replace the Pod.Not recommended for individuals with hearing loss. Always verify ability to hear Pod/PDM alerts and alarms.The Pod and PDM may be affected by strong 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.
Introductionxin Your Role: Safely Using the mylife 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 (IC) Ratio: 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 Factor: How much one unit of insulin will lower blood glucose. For example, if your correction 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.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.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.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.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 mylife OmniPod System is more user-friendly than most electronic devices you use every day. In fact, technology is what makes the mylife 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 mylife OmniPod System, especially during the first few weeks and months. When you have questions about diabetes management after starting on the mylife OmniPod System, do not hesitate to talk with your healthcare provider. For nonmedical emergencies or for technical questions about your mylife OmniPod System setup or operation, you can call Customer Care 24 hours a day, 7 days a week.Customer Care:Your healthcare provider will give you all the tools and training you need to be successful with the mylife OmniPod Insulin Man-agement 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 mylife OmniPod System.Being actively involved means:• Frequently monitoring blood glucose levels• Learning how to operate your mylife OmniPod System and practicing proper techniques• Visiting your healthcare providerXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXDo NOT attempt to use the mylife OmniPod® Insulin Management System before you receive training from your healthcare provider. Inadequate training could put your health and safety at risk.
1CHAPTER 1Your New mylife OmniPod Insulin Management Systemn Insulin Delivery with the mylife OmniPod SystemThe mylife OmniPod® Insulin Management System is an innova-tive continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy. The System’s innovative design and features allows you to live your life—and manage your diabetes—with unprece-dented 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 mylife OmniPod System also has many practical, everyday benefits, including convenience, free-dom, 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 mylife OmniPod System, insulin delivery can be changed with the press of a button to adapt to snacks or unex-pected changes in daily routine. The mylife 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 mylife OmniPod Insulin Management System21n How Does the mylife 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• Includes a OneTouch® Verio™ 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 mylife 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.Carb presetsTo make carbohydrate counting easier, the mylife OmniPod Sys-tem includes “carb presets.” You can enter your favorite foods, snacks, or entire meals as “carb presets.” Presets contain the grams of carbohydrate in the food item or meal. Next time you eat this same food, you don’t have to count the carbs; just select your carb preset and the System does the calculating for you. The System stores up to 36 carb presets.Automated cannula insertionWith the mylife OmniPod System, you don’t have to insert the infusion set manually or carry around a separate inserter. You sim-ply press a button on the PDM and the Pod’s automated insertion system safely and consistently inserts the cannula beneath the skin, virtually pain free. It then begins delivering insulin according to your programmed basal rate.
Your New mylife OmniPod Insulin Management System31A 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 OneTouch® Verio™ blood glucose test strips, but with-out 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 mylife OmniPod System is record keeping. Paper charts are useful, but sometimes they can be inconvenient to carry or use. The data storage system in the Personal Diabetes Manager (PDM) displays up to 90 days’ worth of information. This includes blood glucose readings, basal rates and bolus doses, carbohydrates, and alarms.Personalizing your System You can personalize your mylife 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 mylife OmniPod Insulin Management System41n The PodThe Pod (Figure 1-1) is applied to your skin with an adhesive backing, similar to an adhesive bandage.n 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 mylife OmniPod Insulin Management System51Buttons that program and control the mylife OmniPodSystemButton 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 mylife 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 “The mylife Omni-Pod Setup Wizard” on page 10, 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 expire  Figure 1-3 Figure 1-4
Your New mylife 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 readings that are less than 2 hours old•Temp basal menu to deliver temporary basal rates (This submenu does not appear if temp basal is turned Off in Settings.)•My records menu to review insulin delivery, blood glucose history, alarm history, carb history, and personal user informa-tion•Settings menu to edit, enter, and name basal programs, temp basal, carbohydrate and bolus presets, and to custom-ize System settings•Suspend menu to suspend, cancel, or resume insulin delivery programs If 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 1-5 Figure 1-6You can go to the Status screen at any time by pressing Status from the Home screen.
Your New mylife OmniPod Insulin Management System81n Safety FeaturesThe mylife 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 mylife OmniPod System also performs safety checks on the PDM. If it detects any problems in the PDM or the Pod—or in communication between them—it informs you with beeps and on-screen messages.Occlusion detectionAn occlusion is a blockage or interruption in insulin delivery. Ifthe mylife OmniPod System detects an occlusion, it sounds ahazard alarm and prompts you to deactivate and change your Pod (see Chapter 5, Using the Pod).A hazard alarm sounds when an average of 3 to 5 units of missed insulin occurs. This table depicts occlusion detection for 3 differ-ent situations when using U100 insulin (Table 1). If an occlusion is cleared, a volume of insulin could be released. That volume would not exceed 3.9 U. If an occlusion is detected during an immediate bolus, the Pod will alarm at the conclusion of the bolus. Table 1:Alerts and alarmsFor your safety, the mylife 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 mylife OmniPod System and how to respond to them.At very low flow rates checking your blood glucosefrequently may give you an early indication of anocclusion (refer to Chapter 9, page 107).Confirm on ID screen - alerts/alarms do not show on PDM until after ID screen is confirmed.5.00 U Bolus1.00 U/hr basal0.05 U/hr basal200 seconds2.4 hr48 hrMinimumtime202 seconds3.7 hr74 hrTypicaltime300 seconds5.0 hr80 hrMaximumtime(Pod expiration)
9CHAPTER 2Getting Startedn Set Up the Personal Diabetes Manager (PDM)If you are a first-time mylife 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 mylife OmniPod System, review this User Guide. If you have a basic understanding of the System in advance, you will get more out of your training sessions.    Chapter 6 describes the PDM options in detail. The instructions in this chapter are simplified to help you get started.Turn 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.Do NOT use the mylife OmniPod® Insulin Management System until you have been trained by your health-care 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.Figure 2-1 Figure 2-2B
Getting Started1023. Replace the battery door.4. Turn the PDM face up. The PDM has begun to power on auto-matically.n The mylife OmniPod 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. To 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 that can be changed.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.The diagram inside the compartment shows you which direction to insert the batteries (Figure 2-2 on the previous page).Do not use any other type of batteries than AAA alkaline batteries to power the PDM. Never use old or used batteries; the PDM may not work properly.Initial settings are “---” [blank] for target blood glucose value, insulin-to-carbohydrate ratio, correction factor, and duration of insulin action.
Getting Started112Set 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.6. Choose a temporary basal feature, then press Next. Choose % to show temporary basal rates as a percent increase or decrease of your current basal rate. Choose U/hr to show temporary basal rates in units per hour. Or choose Off to turn off the temporary basal feature. For details about setting 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. 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.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).
Getting Started1224. 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. b. Enter a start time for the target BG segment, then press Enter.c. Enter an end time for the target BG segment, then press Next.d. Enter a target blood glucose value, then press Next.Use the Up/Down Controller buttons to enter the “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 0.1 mmol/L incre-ments and range from 2.8 to 3.9 mmol/L.2. Press Next.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 Started132Enter 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 in grams 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:a. Press New.b. Enter a start time for the segment, then press Next.c. Enter an end time for the segment, then press Next.d. Enter the correction factor, then press Next.e. To save the new correction factor segment, press Done.3. To see the factors as a list, press List. To return to the graphic view, press Graph.4. Press Save to accept the correction factors you have set.Set reverse correction1. To set reverse correction, use the Up/Down Controller buttons to choose On or Off, then press Next.If you enter carbs and reverse corrections are On, the System will subtract insulin from the suggested meal bolus to compensate for a low blood glucose (below the BG target you set). With reverse corrections Off, the System will not subtract insulin from the sug-gested meal bolus dose due to a low BG. Follow your healthcare provider’s recommendation to set reverse correction On or Off.
Getting Started142Enter 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 unit 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.Set 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 Pod 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.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.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.
Getting Started152Your healthcare provider will help you fill and apply your first Pod. The process is easy because on-screen messages walk you through every step. Please refer to Chapter 5, Using the Pod, for detailed instructions.   You may want to adjust the PDM screen time-out and backlight time-out. For more information on how to do this, see Chapter 6, Using the Personal Diabetes Manager.Use the form at the end of this User Guide to write down all your settings from the Setup Wizard. If you ever need to reset or replace your PDM, having these settings handy will make setup very easy.
16CHAPTER 3Understanding and Adjusting Basal Ratesn 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 mylife OmniPod® Insulin Management System, the Pod mimics a healthy pancreas by delivering insulin at the rate that you’ve programmed into the Personal Diabetes Manager (PDM).n 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).00:00–08:00  0.60 U/hr Between 00:00 (midnight) and 08:00, the Pod delivers 0.60 units of insulin per hour.08:00–15:00 0.80 U/hr Between 08:00 and 15:00, the Pod delivers 0.80 units of insulin per hour.15:00–24:00  0.70 U/hr Between 15:00 and 24:00 (midnight), the Pod delivers 0.70 units of insulin per hour.
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 that can be changed.Check with your healthcare provider before adjust-ing these settings.Figure 3-1 Figure 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 08:00 and 15:00):a. Choose an existing basal segment, then press Edit.Or, choose [add new], then press New.b. Enter the start time (for example, 08:00), then press Next. Basal segments are in 30-minute increments.c. Enter the end time (for example, 15:00), then press Next.d. Enter the rate for the new basal segment (for example, 0.80 U/hr), then press Next.Figure 3-3 Figure 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.Basal rates outside the changed segment do not change.
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.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 3-5 Figure 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.A diamond icon (u) appears next to the program that is active. You cannot select the active program to enable it, because it is already running.Figure 3-7As 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 view the segments of the basal program1. Choose View, then press Select (Figure 3-8).To 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 3-8 Figure 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, press Copy to accept this change, 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 programAfter choosing a program from the list, press Delete to accept this change and then press Select.4. Press Delete to permanently delete the program.  n 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 plan for. They happen routinely and you may know from experience how they affect your insulin needs. For example, you might take the same exercise class twice a week for a few weeks or months, or join a summer soccer league. For women, a monthly hormonal change that affects blood glucose is an example of predictableInstead 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 Rates233change. 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 System automati-cally returns to the active basal program. When using units per hour, the mylife 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 “Off” to +95% of your active rate, as long as the tem-porary rate is less than or equal to your max basal rate. Another limit on the temp basal rate when configured in % is that the rate cannot be decreased such that the resultant flow rate will be less than 0.05 U/hr. Example – if flow rate is 0.10 U/hr, you can’t create a temp basal of -60%.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 3-11 Figure 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 mylife 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 which character can be changed.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 3-15 Figure 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. n 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.
28CHAPTER 4Understanding and Delivering Bolus Dosesn 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 mylife OmniPod System, it is easy to adapt to any situa-tion. 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.
Understanding and Delivering Bolus Doses294n Bolus Dose OptionsSo that you can fully enjoy freedom and flexibility in your life, the mylife 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 level.Extended bolus: When you are eating high-fat or high-protein foods (which take longer to digest and are slower to affect blood glucose).  n Suggested Bolus CalculatorThe suggested bolus calculator lets the mylife OmniPod System recommend your bolus based on your personal settings. To review or adjust these settings—including turning the sug-gested bolus calculator On or Off—see Chapter 6, Using the Personal Diabetes Manager.If the suggested bolus calculator is turned On, the System automatically calculates a bolus dose. If the suggested bolus calculator is turned Off, you must enter a bolus amount manually.  When using the extended bolus function the usershould check their blood glucose levels more fre-quently to avoid hypoglycemia or hyperglycemia.The bolus features in the mylife 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 4-1 Figure 4-2The mylife OmniPod System can only subtract insulin on board (IOB) from a suggested bolus when the current BG is known.
Understanding and Delivering Bolus Doses314n 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 4-4), 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 (?) button to view calcula-tion 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 IOB” appears only when Insulin on Board (IOB) is a factor in the calculation.Figure 4-4 Figure 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 Doses334  4. If you have set the blood glucose reminder option to On and you want to add a reminder:a. Press Yes.b. Enter the time for the reminder, then press OK.5. Press Confirm to begin the bolus delivery.Deliver a bolus manually (suggested bolus calc is Off)1. On the Home screen, use the Up/Down Controller buttons to choose Bolus, then press Select.2. Enter the number of units you want to deliver, then press Enter.3. If the blood glucose reminders feature is turned On, you can now set a blood glucose reminder. 4. Press Confirm to begin the bolus delivery.  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 mylife 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 reset-ting your maximum bolus dose. If suggested bolus calc is On, you can enter a temporary manual over-ride to make an adjustment above your max bolus limit (Figure 4-1 and Figure 4-2). Consult your health-care provider before changing this setting.
Understanding and Delivering Bolus Doses344n Deliver an Extended BolusThe extended bolus feature lets the mylife 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 4-9 Figure 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 units    correction bolus 1 unit    meal bolus 4 unitsDeliver now = 2 units  correction bolus 1 unit    meal 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 Doses364n Cancel Active BolusesThe mylife 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. n 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 4-11 Figure 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. n 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 4-13 Figure 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 mylife 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. The up and down arrow symbol on the screen indicates which character can be changed.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 4-16 Figure 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.
Understanding and Delivering Bolus Doses404n 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.6. To use the mylife OmniPod System’s default naming system, simply press Next. The default naming system automatically assigns program names in numerical order, such as carb pre-set 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 that can be changed.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 on the next page).d. Press Next.7. Enter the grams of carbohydrate in the meal, then press Next.8. For American food label enter the fiber. For European food label do not enter the fiber, because it is already counted off the carbohydrate. Press Next.9. If you want, enter the grams of fat and protein in the meal, and the total calories. Press Next after each entry. These additional units are not required. If you prefer not to enter them, simply press Next repeatedly to skip through the screens.
Understanding and Delivering Bolus Doses41410. 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.3. 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.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 4-18Figure 4-19 Figure 4-20
Understanding and Delivering Bolus Doses424To 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. For American food label enter the fiber. For European food label do not enter the fiber, because it is already counted off the carbohydrate. Press Next.6. If you want, enter the grams of fat and protein in the meal, and the total calories. Press Next after each entry.7. 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.These additional units are not required. If you prefer not to enter them, simply press Next repeatedly to skip through the screens.
43CHAPTER 5Using the Podn The Pod Change ProcessReplace the Pod at least once every 72 hours or up to 200 units of insulin (3 days). Refer to the insulin labeling and follow your healthcare provider’s directions for how often to replace your Pod. If you like, you can set the Personal Diabetes Manager (PDM) to notify you when it is time to replace the Pod (see 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 Pod 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, which 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.
Using the Pod445• 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-ties, 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 page 8 of the Introduction for a list of insulins approved for use in the mylife 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.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 mylife OmniPod System user, your healthcare provider will guide you through the steps for initializing and applying your first Pod. Do NOT attempt to apply or use a Pod until you have been trained by your healthcare provider. Use of the System with inadequate training or improper setup could put your health and safety at risk.Figure 5-1 Figure 5-2
Using the Pod4554. If an extended bolus or temporary basal or both are actively running, you will see a message similar to that shown in Fig-ure 5-3. Press Confirm to accept the cancellation.Or press Back to return to the More actions menu.5. After you press Confirm, you will see the message inFigure 5-4.To remove the old Pod:a. Gently lift the edges of the adhesive tape from your skin and remove the entire Pod (Figure 5-5). 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 or contact Customer Care for more informa-tion about how to dispose of your used Pod.6. After removing the old Pod, press Next.7. Press Yes to fill and activate a new Pod (Figure 5-6)..Removing the Pod slowly will help to avoid possible skin irritation.Figure 5-3 Figure 5-4Check the infusion site for signs of infection. See “Avoid Infusion Site Infections” later in this chapter.Figure 5-5 Figure 5-6
Using the Pod465Fill 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 5-7).3. Pull outward to remove the protective cap from the needle (Figure 5-8). Save the cap; you will need it later.    4. Determine the amount of insulin you need to insert into the Pod. For example, if you will use this Pod for 72 hours, you need enough insulin to last you 72 hours. Your healthcare provider will help you determine the correct amount.  Before filling a Pod, ensure that no other Pods are being activated within 61 cm (24 inches) of your PDM.Before filling a Pod with insulin, ensure that the Pod is above 10° Celsius. If the Pod has been exposed to temperatures below 10° C, then allow the Pod to be brought back to room temperature before filling it with insulin.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.Figure 5-7 Figure 5-8
Using the Pod4755. 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 5-9). 8. Remove the needle from the vial and insert it straight down into the insulin fill port on the underside of the Pod (Figure 5-10).  Any air bubbles present in the fill syringe could be transferred into the reservoir during the fill process.  The pod does not purge air that is introduced into the reservoir by way of customer fill. Failure to expel air bubbles from the fill syringe may result in interrupted insulin delivery.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.To ensure proper fill, do not insert the fill syringe at an angle into the fill port.Figure 5-9 Figure 5-10Fillport
Using the Pod4859. 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 5-11on 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, please call Customer Care.14. The System performs a series of safety checks and automati-cally primes the Pod (Figure 5-12 on next page). Once com-plete, the PDM beeps, letting you know that the priming and safety checks were successful.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 deliv-ery 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 mylife 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 Pod495     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 5-13 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 5-11 Figure 5-12Avoid 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 2.5 cm (1 inch) away from the last site. (Using the same location repeatedly may reduce insulin absorption.)Do NOT apply the Pod within 5 cm (2 inches) of your navel or over a mole, a tattoo, or scar, where insulin absorption may be reduced.
Using the Pod505Prepare the infusion siteYou 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.Figure 5-13: Pod placement optionsFront    BackTo 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.
Using the Pod515Apply 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 5-14). The needle cap will snap off.2. Verify that the Pod is ready to be applied:• Pod is clean and dry.• Adhesive pad is intact and undamaged.• Pod is intact and in its original condition• If Pod is accidentally dropped, discard it; sterility may be compromised.If you are unsure the Pod is ready to be applied to the site, press “Discard” and do not use it (Figure 5-17 on the next page). Select a new Pod. 3. Using the pull tabs, remove and discard the white paper backing from the adhesive tape (Figure 5-14).4. Apply the Pod to the prepared infusion site. Press firmly to secure it to your skin.Figure 5-14 Figure 5-15Verify cannula does not extend beyond adhesive backing once needle cap is removed. 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.FF
Using the Pod5255. Once you securely apply the Pod, press Next (Figure 5-17). For the Pod to work best, apply it:a. Crosswise or at a slight angle on your abdo-men, hip, or buttocks (in Figure 5-16)b. Up and down or at a slight angle on your upper arm or thigh (in Figure 5-16)c. At least 2.5 cm (1 inch) away from the last siteFigure 5-13a.b.Figure 5-16 Figure 5-17The 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.
Using the Pod535Insert cannula and begin insulin delivery1. To insert the soft cannula, press Start (Figure 5-18).The Pod automatically inserts the soft cannula below your skin. It takes a few seconds to complete this process. Once the cannula is inserted, the Pod delivers a prime bolus to fill the cannula with insulin (Figure 5- 20).Once the soft cannula is inserted, the PDM indicates that the Pod is active (Figure 5-21). 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 5-19) 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.Figure 5-18 Figure 5-19You will hear a click when the cannula inserts.Figure 5- 20 Figure 5-21
Using the Pod545Figure 5-21 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.When you see the pink slide insert in this position, it meansthat the cannula is inserted (Figure 5-22). 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 5-23 on the next page). Press Discard to restart the process with a new Pod.Check the infusion site after insertion to ensure that the cannula was properly inserted. Youshould check your blood glucose 1.5 to 2 hoursafter each Pod change and check the infusion siteperiodically. If the cannula is not properly inserted, hyperglycemia may result. Verify there is no wetness or scent of insulin, which may indi-cate 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, due to perspiration.Figure 5-22
Using the Pod555Or press Back to return to the previous screen. n 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 insulin reservoir volume, PDM battery level, last blood glucose value, last bolus dose, active basal pro-gram, 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 on the Pod. See the end of Chapter 10, Alerts and Alarms, for instructions.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.Figure 5-19Figure 5-23Once a Pod is activated and communicates with the PDM, it can only receive commands from that PDM, not from any other.
Using the Pod565n 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 mylife 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 deliv-ery is suspended.    1. On the Home screen, use the Up/Down Controller buttons to choose Suspend; then press Select. 2. Enter how long you want to stop all insulin delivery, from 30 minutes to 2 hours, in 30-minute increments (Figure 5-24), 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 now sus-pended (Figure 5-25).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 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.Figure 5-20Figure 5-24 Figure 5-25
Using the Pod5754. At the end of the suspend time, a Pod Advisory alarm occurs (Figure 5-26).5. To resume your programmed basal rate, press OK.   n Resume Insulin Delivery1. On the Home screen, use the Up/Down Controller buttons to choose Resume (Figure 5-27), then press Select.2. Press Confirm to restart the basal program for that time seg-ment.The Advisory alarm repeats every 15 minutes until you press OK.Insulin delivery will not resume until you press OK. If you do not press OK to resume insulin delivery, you could develop hyperglycemia (high blood glucose).Figure 5-22Figure 5-26Figure 5-23Figure 5-27
Using the Pod585n 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.n Get the Most From Your PodAvoid extreme temperaturesThe Pod’s operating temperature is between 4.4°C and 40°C (between 40°F and 104°F). Under normal circumstances, your body temperature will keep the Pod well within this range.Water and your PodThe Pod is waterproof up to a depth of 7.6 meters (25 feet) for up to 60 minutes (IPX8). After exposure to water, rinse off the Pod with clean water and gently dry it with a towel. Do NOT expose 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 0°C (32°F). Follow the insulin manufac-turer’s instructions for use.
Using the Pod595Safe 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 your Pod to water at depths greater than 7.6 meters 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, which 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 ordamaged. Do NOT apply or use a Pod if its sterilepackaging is opened or damaged, or if the Pod hasbeen dropped after removal from the package asthis may increase the risk of infection or seriousinjury.
60CHAPTER 6Using the Personal Diabetes Managern 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. n 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 6-1 Figure 6-2
Using the Personal Diabetes Manager616• Amount of insulin on board (IOB), if suggested bolus calcula-tor is in use• Name and rate of active basal program or temp basal program • “Ext bolus,” the amount of insulin and the delivery time remaining if an extended bolus is being delivered• “INSULIN SUSPENDED” if insulin delivery has been suspended • Time and date when the Pod will 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 Manager626n The System Setup MenuThe System setup menu lets you personalize the settings that control the mylife 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.Figure 6-3
Using the Personal Diabetes Manager636n 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.Reset 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).If you are changing the Pod, you can reset the date or time without suspending by changing the date or time before activating the new Pod.Figure 6-4 Figure 6-5
Using the Personal Diabetes Manager646Reset 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.n 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 mylife OmniPod System bolus and basal settings as your needs change. Check with your healthcare provider before making any changes.1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press Select.2. Choose System setup, then press Select.3. Choose Bolus/basal/calcs, then press Select.4. 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.If 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.Figure 6-6a Figure 6-6b
Using the Personal Diabetes Manager656a. 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 (smallest 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. 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.Figure 6-7
Using the Personal Diabetes Manager6665. 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.1. Target BG and correct-above value—You can edit existing segments and add segments, up to a total of 8.a. To edit an existing target BG time segment, choose the segment, then press Edit. Use the Up/Down Controller buttons to choose a new start time, end time, target BG value, and correct-above value (correction threshold). Press Next after each entry.b. To add a segment, choose [add new], then press New. Use the Up/Down Controller buttons to choose a start time, end time, target BG value, and correct-above value (correction threshold). Press Next after each entry.c. When you have completed all the time segments you want, press Done, then Save.2. Min BG for calcs (smallest 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 segment, then press Edit. Use the Up/Down Controller Figure 6-8a Figure 6-8bWhen 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 Manager676buttons 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.Temp 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. 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 Manager686n Alerts and RemindersIn addition to automatic safety alarms (see Chapter 10, Alerts and Alarms), the mylife OmniPod System offers a number of personal settings to help you manage your diabetes. These features are optional. You can turn them on or off at any time, except for the alerts. Those you can set at levels that you find convenient to remind you to change your Pod. Notifications you can use are:BG (blood glucose) reminder: Reminds you to check your blood glucose. Choose from On or Off. The default setting is Off. When the reminder is on, the PDM asks you each time you enter a bolus dose whether you want to set a BG reminder, and you can then choose a time interval, in 30-minute increments.Pod expiration: Reminds you when the Pod is nearing the 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.Auto-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 55 to check Pod status and to Confirm ID.      This alert can be especially beneficial if you are prone to hypogly-cemia unawareness. Ask your healthcare provider about using this alert and where to set it.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 Manager696Bolus 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 mylife OmniPod System and feel confident that you are get-ting 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.Custom reminders: Displays text reminders that you enter, at times that you select. You can choose to receive a notification Daily, One time only, or Off. You can change or delete these notifications at any time.Set alerts and 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.Figure 6-9
Using the Personal Diabetes Manager7065. 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.To 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 mylife OmniPod System’s default naming sys-tem, simply press Next. The default naming system automatically assigns names in numerical order, such as alert 1, alert 2, alert 3.If you want to give a different name to the reminder:a. Use the Up/Down Controller buttons to scroll through the list of characters. An up-and-down arrow symbol on the screen indicates the character that can be changed.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 on the next page). (A blank character or space is the first and last option in the scrolling menu.)
Using the Personal Diabetes Manager716d. 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.n 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.Custom reminders will repeat every 15 minutes until acknowledged.Figure 6-10Figure 6-11
Using the Personal Diabetes Manager726Change 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.1. To hide or show a standard BG tag, choose the tag, and press Show (if it is marked as hidden) or Hide.Tags you choose to show will be check marked; hidden ones will not be.2. To add a custom tag, choose [add new] at the end of the list of custom tags, then press New. In the Edit name screen, either:a. Press Save to save the new tag with the default name, custom tag1, custom tag2, and so on; 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.Figure 6-12a Figure 6-12b
Using the Personal Diabetes Manager736n Customize the Personal Diabetes Manager Additional options let you customize how the PDM operates:ID screen: Make your PDM unique 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. The ID screen must be confirmed before you can check Pod status.Backlight time-out: The backlight is on by default while you are using the PDM. The time-out setting dims the backlight and causes the screen to dim when you have not used it within the time interval that you set. Set at the lowest setting to maximize battery life.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 that can be changed.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 55 for detailed instructions. 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.
Using the Personal Diabetes Manager7463. 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.To change the ID screen color:1. Choose Screen color, then press Select.2. Use the Up/Down Controller buttons to choose a color, then press Select.Set PDM 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.As a safety feature, an ID must be entered to enable the PDM to be identified.Figure 6-13 Figure 6-14If 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.
Using the Personal Diabetes Manager756n Set Diagnostic FunctionsThe Diagnostics screen allows you to instantly confirm how the System is working or to completely update settings entered during setup (see Chapter 2, Getting Started). Options include:Check alarms: Confirms that all alarms work properly when needed. When you select this function, the PDM beeps and vibrates, then the Pod beeps. This function cannot be executed unless insulin delivery is suspended.  Reset PDM (soft reset): Restores all settings in the PDM to the factory defaults.Diagnostic 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. TThe PDM beeps three times and vibrates three times. If the Pod is active, it beeps three times, then sounds the alarm tone for 5 seconds.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.   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, 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.Be sure to check the alarm function at every Pod change.
Using the Personal Diabetes Manager766n 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 Settings, then press Select.2. Choose Vibration, then press Select.3. Choose Vibrate, Vibrate then beep, or Off (beep only), then press Select. (Vibrate then beep means the PDM will repeat the reminder twice using vibration. After that, it uses beeps.)Or press Back to return to the Settings menu.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 6-15 Figure 6-16The PDM cannot be set to vibrate for hazard or advisory alarms.
Using the Personal Diabetes Manager776n 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 152 cm (60'') of the Pod.Water and your PDMAvoid extreme temperaturesExtreme operating temperatures can damage PDM batteries and interfere with System operation. Avoid using the PDM in temperatures below 4.4°C (40°F) or above 40°C (104°F).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. 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.
Using the Personal Diabetes Manager786Electrical 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).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.When you connect a USB cable to the PDM, only use a cable that is less than or equal to 2.7 meters (9 feet) in length.
79CHAPTER 7Checking Your Blood Glucosen The Built-in OneTouch® Verio™ Blood Glucose MeterWith the OneTouch® Verio™ blood glucose meter, checking your blood glucose requires a very small sample size, 0.4 μL (microli-ter) of blood. Refer to your OneTouch® Verio™ Test Strip Insert for important test strip information.You may want to test for low blood glucose:• When you feel symptoms such as weakness, sweating, nervousness, headache, or confusion• When you have delayed a meal after taking insulin• When your healthcare provider advises you to do soKeep the system and the OneTouch® Verio™ accesso-ries away from young children, as they contain small parts that may be dangerous if swallowed.Only use OneTouch® Verio™ test strips and One-Touch® Verio™ control solution with the System. Using other brands of test strips and control solutions with the System can produce 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 OneTouch® Verio™ accessories. Follow the guidance of a healthcare professional for proper blood glucose monitoring.
Checking Your Blood Glucose807n The OneTouch® Verio™ Blood Glucose Test StripsImportant test strip information• Store the test strip vial in a cool dry place between 41° and 86° F (5° and 30° C). Keep away from direct sunlight and heat. Exposure to temperatures and/or humidity outside the stor-age limits may cause inaccurate readings.• The expiration date is printed on the vial.• The discard date is 6 months after you first open a test strip vial. When you open a new vial, write the discard date on the label.•Do Not use after the expiration or discard date, whichever comes first.• Store your test strips in the vial only. To avoid damage or contamination, Do Not put test strips in any other container.• Open the vial only when taking out a test strip for use.• Close the vial lid tightly right away after removing a test strip. Use each test strip as soon as you take it out of the vial.•Do Not use test strips from a vial that is damaged or left open to air.•Do Not get dirt, food, or liquids on the test strip. You may touch the test strip anywhere on its surface with clean, dry hands.•Do Not bend, cut, or alter test strips in any way.• Test strips are for single use only.•Never reuse a test strip that already has blood or control solution on it.• Operating temperature of the meter and strip is 6°- 44°C.• Apply only OneTouch® Verio™ Control Solution or a blood sample to the test strip.•Do Not put the used test strip back in the vial after taking a test.• Used test strips may be considered biohazardous waste in your area. Be sure to follow your health care professional’s advice or local laws when throwing them away.Complete information on the OneTouch® Verio™ test strips (such as interferences and performance) can be found in the test strip insert. Please read all instruc-tions provided on the test strip insert before using the OmniPod System and OneTouch® Verio™ accessories.Keep the test strip vial away from children. Test strips are a choking hazard. Do Not swallow test strips. The test strip vial may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation. Do Not ingest or swallow any items.
Checking Your Blood Glucose817n The OneTouch® Verio™ Control SolutionThe OneTouch® Verio™ control solution (Fig-ure 7-1) is a liquid that consists of a viscosity-adjusting agent, a preservative, a dye, a buffer and glucose in water and has two important uses:• To check that the meter and test strips are working together properly and that the test is performed correctly• To practice testing without having to use your own bloodTwo levels of control solution are available: Mid (Blue Cap: 102-138 mg/dL) and High (Red Cap: 298-403 mg/dL). 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.When to perform a control solution test• Whenever you open a new vial of test strips• If you suspect that the meter or test strips are not working properly• If you have had repeated unexpected blood glucose results• If you drop or damage the meterCheck 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 dateOneTouch® Verio™ control solution is good for 6 months after opening the bottle, or until the expiration date printed on the label, whichever comes first. Count forward 6 months from the date you open a new bottle of control solution. This is your dis-card 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 6 months to July 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.For detailed storage and usage information, refer to the test strip insert.Figure 7-1
Checking Your Blood Glucose827Ensure 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 43° and 111°F(6° and 44°C).• The control solution test results should fall within the range printed on the test strip vial label.If 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• Malfunction of the System• Control solution test must be performed between 43° and 111°F (6° and 44°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.n Performing a Control Solution Test1. Grasp the bottom of the test strip with the gold side facing up (Figure 7-2).Use only OneTouch® Verio™ control solution with the System. Other brands of control solution may produce inaccurate results with this System.Do not use control solution past the expiration date or you may get inaccurate results.Results from OneTouch® Verio™ control solution tests do not reflect your blood glucose level.The control solution range is a target range for control solution only. It is not a target range for your blood glucose.
Checking Your Blood Glucose8372. Insert a test strip into the test strip port with the gold side of the test strip and silver prongs facing you. (Figure 7-3) until it stops. This turns on the PDM on the screen. Refer to page 57 to check Pod status and to Confirm ID.Figure 7-2Channel to apply sampleOneTouch® Verio™ test stripSilver prongs, insert into test strip portAlways verify that you are using OneTouch® Verio™ test strips with your PDM (Figure 7-4).From some PDM screens, you cannot access the One-Touch® Verio™ blood glucose meter. For example, you cannot use the meter while you are activating a Pod or when an alert, alarm or communication error screen is displayed. In these cases, if you insert a test strip, the PDM beeps to alert you.Figure 7-3 Figure 7-4
Checking Your Blood Glucose8473. 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).5. Remove the vial cap and place it on a flat surface with the top of the cap pointing up. Squeeze the vial to dis-card the first drop. Then, wipe both the tip of the control solution vial and the top of the cap with a clean, damp tissue or cloth. Next, squeeze a drop into the small well on the top of the cap or onto another clean, non-absor-bent surface. 6. Gently touch only ONE SIDE of the test strip to the control solution drop. Specifically, apply the control solution to the test strip side next to the gold metallic channel (Figure 7-6 on the previous page). 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 Countdown Screen appears while the sample is process-ing (Figure 7-7). The strip port light turns off when the sample is accepted.Figure 7-5 Figure 7-6Do not apply control solution to both sides of the test strip.Figure 7-7 Figure 7-8
Checking Your Blood Glucose857If BG sound is set to On, the PDM beeps twice. The PDM automatically marks the result as a control solution test (Fig-ure 7-8 on the previous page).7. 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: 781-457-5098.8. 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.n Performing a Blood Glucose ReadingFigure 7-9 shows the parts of the lancing device.If the words Control solution do not show on the screen, you MUST tag this result as a control solution test. If you do not mark this result as a control solution result it will be included in your BG averages and your averages may change, too. Repeat the test with a new test strip. If the problem persists, con-tact Insulet's Customer Care (24 hours/7days): 800-591-3455. When calling from outside the United States: 781-457-5098. Be sure to discard used test strips. (You can only use test strips once.) Used test strips are considered bio-hazardous material.Release ButtonDepth WheelCocking ControlFigure 7-9Lancing Device CapDepth IndicatorEjection ControlLancing device depicted in Figure 7-9 is representative only. Please follow the instructions included with your specific lancing device.
Checking Your Blood Glucose867Prepare the lancing device1. Remove the cap by turning it counterclockwise and then pulling it straight off of the device. (Figure 7-10).2. Insert a new 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).4. Place the cap back onto the device; turn clockwise to secure the cap (Figure 7-13). Be careful not to touch the exposed needle on the lancet.5. The lancing device has seven puncture depth settings, num-bered 1 through 7. Smaller numbers are for a shallower punc-ture and the larger numbers are for a deeper puncture. (Figure 7-14 on the next page).To ensure accurate results, wash your hands with soap and water. Do not leave any cream or lotion on your hands or fingers. Thoroughly dry your hands.Figure 7-10 Figure 7-11Figure 7-12 Figure 7-13Lancing device depicted in Figures 7-10, 7-11, 7-12 and 7-13 is representativeonly. Please follow the instructions included with your specific lancingdevice.
Checking Your Blood Glucose8776. Pull out the cocking handle until it clicks (Figure 7-15). (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 bottom end of the strip into the test strip port (Figure 7-16 and Figure 7-17).Consult your lancing device instructions to ensure proper usage.Figure 7-14 Figure 7-15 From some PDM screens, you cannot access the One-Touch® Verio™ blood glucose meter. For example, you cannot use the meter while you are activating a Pod or when an alert, alarm or communication error screen is displayed. In these cases, if you insert a test strip, the PDM beeps to alert you.Figure 7-16BottomTopFigure 7-17Lancing device depicted in Figures 7-14 and 7-15 is representative only. Please follow the instructions included with your specific lancing device.
Checking Your Blood Glucose887Fill the blood glucose test strip with blood1. Make sure that the strip is in the PDM and the PDM is pow-ered on. Refer to page 55 to check Pod status and to Confirm ID. 2. Hold the lancing device firmly against the side of your finger. Press the release button. Remove the lancing device from your finger.3. Gently squeeze and/or massage your fingertip until a round drop of blood forms on your fingertip.4. Bring the strip to the blood sample at a slight angle (Figure 7-18).If you do not apply the sample within 10 seconds, the strip port light turns off. To turn it on again, press Light.Use only one edge of the blood glucose test strip per test. Do not apply blood to both sides (Figure 7-19 on the next page). Only use strips once. Discard used strips.If you do not start the test within 2 minutes, the PDM powers off. Refer to page 55 to check Pod status and to Confirm ID. If the blood smears or runs, DO NOT use that sample. Dry the area and gently squeeze another drop of blood, or puncture a new site.Figure 7-18
Checking Your Blood Glucose897The test strip pulls the blood into the strip through the sides (Figure 7-20).1. Do not pull the test strip away from the sample until you hear 1 beep or see the countdown screen on the screen (Figure 7-21 on the next page). This means you applied enough blood and the meter is reading your glucose.Figure 7-19Side of test strip, apply blood hereFigure 7-20The 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 137 for PDM disinfection or refer to lancing device instructions for use for lancing device decontamination instructions). Do not:• Press the strip against the test site• Share a lancing device with anyone.• 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 the countdown screen, the sample may be too small. 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 7-22).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. 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 7-24), 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.Remove the lancet6. When you have finished testing, place the lancet protec-tive cover on a hard surface, then push the rounded top into the cupped side of the cover. Then, remove the lan-cet from the lancing device (Figure 7-23 on the next page). Discard the used lancet properly in a puncture-resistant con-tainer. Then wash your hands with soap and water.If the words Control solution show on the screen, repeat the test with a new test strip. If the problem persists, contact Insulet's Customer Care (24 hours/7days): 800-591-3455. When calling from outside the United States: 781-457-5098. Figure 7-21 Figure 7-22If the suggested bolus calculator feature is turned Off, the Bolus soft key appears instead of Next.
Checking Your Blood Glucose917.n 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 7-23If 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 7-24 on the next page).Lancing device depicted in Figure 7-23 is representative only. Please follow the instructions included with your specific lancing device.
Checking Your Blood Glucose927n 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• The BG reading has been tagged as a Control• The BG reading is less than your “Min BG for calcs”• Insulin is suspendedFigure 7-24To 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 (600); then press up one more time.
Checking Your Blood Glucose937n 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 7-25). 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 7-26 on the next page). 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 7-27. Press OK to return to the More actions menu.Figure 7-25Figure 7-26 Figure 7-27
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.n 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 600 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 90; to edit tags, see page 93.
Checking Your Blood Glucose957n 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.• 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 Recordsn 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, date and time are at risk. Do NOT remove the old batteries until you have new ones on hand. The PDM protects data in the mem-ory 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 Records978n 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 (u).4The 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 8-1 Figure 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 (u) 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 8-3 Figure 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 Records998n 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 8-5 Figure 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.5. 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 8-7 Figure 8-8Figure 8-9 Figure 8-10
Understanding Your Records1018For 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.n Alarm RecordsThe PDM lists the entire alarm history for the mylife 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.n 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).3. Press the Up/Down Controller buttons to see additional days.Press Event to use the Up/Down Controller buttons to scroll through the list of information on the screen. Press Day to use the Up/Down Controller buttons for dates.Figure 8-11 Figure 8-12
Understanding Your Records1028n 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.n 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 mylife OmniPod System (make, model, serial number). You cannot change this information.Figure 8-13 Figure 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 that can be changed.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 8-15 Figure 8-16
104CHAPTER 9Living with Diabetesn Your Role: Safely Using the mylife OmniPod SystemBefore deciding on the mylife OmniPod® Insulin Management System, you and your healthcare provider discussed the advan-tages and benefits of the mylife OmniPod System, as well as the responsibilities that come with insulin pump therapy. Remem-ber: safe use begins and ends with you. If you have questions or doubts about being able to safely use the mylife OmniPod Sys-tem 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 mylife OmniPod Insulin Management System according to instructions, you may be putting your health and safety at risk. Talk with your healthcare provider if you have questions or concerns about using the mylife OmniPod System.
Living with Diabetes1059n Daily Diabetes Management ActivitiesTo ensure proper mylife OmniPod System operation and your continued 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 infusion sites.)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, which 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 Diabetes1069n Prepare for Emergenciesn Water and Your PodThe Pod is waterproof to a depth of 7.6 meters (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). Do not use rechargeable batteries.• A vial of rapid-acting U-100 insulin (See the warn-ing on page 8 of the Introduction for insulins approved for use in the mylife 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 7.6 meters (25 feet) or for longer than 60 min-utes. Check the infusion site often to make sure the Pod and soft cannula are securely applied and in place. If the cannula is not properly inserted, hyper-glycemia may result.
Living with Diabetes1079n 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 with you during trips or vacations is especially important (see “Prepare for Emergencies” on page 106). 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. Do not use rechargeable 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.)The Personal Diabetes Manager (PDM) is not water-proof. Do NOT place it near water and never immerse it.
Living with Diabetes1089• Alcohol prep swabs• Written prescriptions for all medications and supplies. (Generic medications may be easier to find than brand names outside the country.)Minimize airport security delaysWith changing airport security checks and screening procedures, you may have questions on how this impacts traveling with your diabetes supplies. Below you will find more information on prepping for travel and what you can expect when going through security checkpoints.Travel Preparation• Review the airport websites 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 mylife OmniPod equipment • Prescriptions for all medications and supplies with origi-nal prescription labelsScreening ProceduresThe airport may offer 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, you should be asked at the security checkpoint to display, han-dle, and repack your own supplies during the visual inspection process. Any medication and/or associated supplies that cannot be cleared visually must be submitted for X-ray screening.If you're concerned or uncomfortable about going through the walk-through metal detector, you should notify the Security Offi-cer that you're wearing a pump and would like a full-body pat-down and a visual inspection of your pump instead. You should also advise the Security Officer that the insulin pump cannot be When you travel outside the country or for long peri-ods of time, be sure to take extra Pod supplies. CallCustomer Care to order additional supplies for your trip.
Living with Diabetes1099removed because it is inserted with a catheter (needle) under the skin.Visit the airport websites 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).Keep 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.n Avoid lows, highs, and DKAYou can avoid most risks related to using the mylife 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 mylife OmniPod System and cannot resolve them, do not hesitate to call Cus-tomer 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 it.Pods and PDMs can safely pass through airport X-ray machines (see the “mylife OmniPod System Notice Concerning Interference” in the Appendix).
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. 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 mylife OmniPod System’s blood glucose reminder and check your blood glu-cose more frequently. See “Alerts and Reminders” in Chapter 6, Using the Personal Diabetes Manager, for how to set the reminder.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.
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?”).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 page 115).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.)Even if you cannot check your blood glucose, do NOT wait to treat symptoms of hypoglycemia, especially if you are alone. Waiting to treat symptoms could lead to severe hypoglycemia, which can quickly lead to shock, coma or death.Do NOT use chocolate or candy bars to treat low blood glucose. Their fat content slows down glucose absorption.
Living with Diabetes1129How much is 15 grams of carbohydrate?Examples of fast-acting foods:Three 5-gram glucose tablets, or four 4-gram tablets118 milliliters of apple or orange juice6 pieces of hard candy1/2 can of regular (non-diet) soda30 milliliters of table sugar or honey 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 Diabetes1139Possible causes of hypoglycemia (low blood glucose)Possible cause of low blood glucoseSuggested 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 blood glucoseSuggested actionIncorrect target blood glucose levelsConsult healthcare provider about refining these settings as needed.Incorrect correction 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 Diabetes1149Hyperglycemia (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 sores Possible cause of low blood glucoseSuggested 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 activity Consume carbohydrate before activity, especially if you have not decreased insulin beforehand.Alcohol consumption Check blood glucose before going to bed.Consult healthcare provider for guidance.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 Diabetes1159To 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 strenuous physical activities• 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 Diabetes1169Possible causes of hyperglycemia (high blood glucose)Possible cause of high blood glucoseSuggested actionExpired insulin Deactivate and remove used Pod. Apply a new Pod filled from a new vial of insulin.Insulin exposed to extreme temperatures Infusion 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. Possible cause of high blood glucoseSuggested actionAvoid sites near a waistband, belt, or other areas where fric-tion may dislodge the cannula.
Living with Diabetes1179Possible cause of high blood glucoseSuggested actionEmpty Pod Deactivate and remove used Pod.Apply a new Pod in a different location.Incorrect basal program Confirm that correct basal program is active.Confirm that PDM time is set correctly.Consult your healthcare provider about adjusting your basal pro-grams or using a temporary (temp) basal rate.Incorrect bolus timing Check carb intake.Take bolus with food.Check blood glucose before giving meal bolus; if necessary, adjust bolus.Consult healthcare provider for guidance.Bolus too smallHigh-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 normal Consult 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 strenuous activity Do NOT exercise when ketones are present. (Blood glucose increases with exercise when ketones are present.) Consult healthcare provider for guidance.Infection or illness See “Sick days” later in this chapter.Consult your healthcare provider about sick day guidelines and about medication changes.Medication changePossible cause of high blood glucoseSuggested action
Living with Diabetes1189Diabetic 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.Weight 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 blood glucoseSuggested actionIf left untreated, DKA can cause breathing difficulties, shock, coma, and eventually death.
Living with Diabetes1199To 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. n 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.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 Diabetes1209• Follow your healthcare provider’s guidelines for taking addi-tional insulin on sick days.• Drink plenty of noncaffeinated fluids to prevent dehydration.• 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.For some contact sports, you may want to remove the Pod.Be sure to check your blood glucose levels before removing the Pod and after applying a new one. Pods are designed for 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 scans 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.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.
Living with Diabetes1219Surgery 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. Always carry medical identification and wear an emergency medical necklace or bracelet such as the Medic Alert tag.
122CHAPTER 10Alerts and Alarmsn Safety ChecksThe mylife OmniPod System has a very important safety feature: It can check its own functions automatically and alert you when something needs attention. When you turn on the Personal Dia-betes Manager (PDM), the System automatically performs a series of safety checks. (Refer to Page 54 for detailed instruc-tions. The ID screen must be confirmed before you can check Pod status.) To make you aware of a serious or potentially serious condition, the System sounds an alarm and displays an on-screen message. The message has instructions for taking care of the alarm condition. Alarm conditions are easy to handle. They are not a problem if you attend to them promptly.n 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 Alarms12310The following table explains what the message could mean and what you should do. Alert error message Possible causes ActionBG Meter Error 1.Meter problem.For customer support call 800.591.3455.• There is a problem with the meter.1. DO NOT use the meter. Contact Customer Care.BG Meter Error 2.Meter or strip problem.Retest with a new strip.• Error message could be caused either by a used test strip or a problem with the meter. 1. Repeat the test with a new test strip.2. If the error persists, call Customer Care or repeat the blood test.BG Meter Error 3.Meter was not ready. Retest with a new strip.• The sample was applied before the meter was ready. 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 or perform another blood test.
Alerts and Alarms12410BG Meter Error 4.Strip fill problem.Retest with a new strip. • Not enough blood or control solution was applied or more was added after the meter began to count down.• The test strip may have been damaged or moved during testing.• The sample was improp-erly applied.• There is a problem with the meter.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 or perform another blood test.BG Meter Error 5.Strip problem.Retest with a new strip. • The meter has detected a problem with the test strip, possible cause is test strip damage.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 Alarms12510Temperature too high. Out of operating range.For customer support call 800.591.3455.• Meter is too hot (above 111°F) to work correctly. 1. Move the meter and test strips to a cooler area. Insert a new test strip when the meter and test strips are within the operating range (43–111°F). If you do not get another Temperature too high message, you can proceed with testing.Temperature too low. Out of operating range.For customer support call 800.591.3455.• Meter is too cold (below 43°F)to work correctly.1. Move the meter and test strips to a warmer area. Insert a new test strip when the meter and test strips are within the operating range (43–111°F). If you do not get another Temperature too low message, you can proceed with testing.Alert error message Possible causes Action
Alerts and Alarms12610n AlarmsThe mylife 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 table on page 129.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.Hazard alarms are continuous tones. If the alarm is NOT acknowledged immediately, the Pod periodically gener-ates an intermittent alarm tone and then returns to the continuous tone.
Alerts and Alarms12710       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).If you ever need to return the PDM for repair or replacement, contact your healthcare provider for instructions on going back to treatment byinjections.
Alerts and Alarms12810Use 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 Alarms12910Auto-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 Action The Low reservoir alert will escalate to an Empty reservoir hazard alarm when insulin is depleted. Be sure to respond to the alert when it first occurs.
Alerts and Alarms13010Pod 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 Using the Personal Diabetes Manager in Chapter 6.)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, notify Customer Care.Alarm Type Source Beep Pattern Action
Alerts and Alarms13110Occlusion 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.For customer support, refer to your User Guide.Hazard AlarmPDM Continuous tone. This alarm occurs if an unexpected error is detected in the PDM. Press OK to acknowledge.Remove Pod.Notify Customer Care immediately.Check blood glucose.Alarm Type Source Beep Pattern Action
Alerts and Alarms13210PDM Error.Memory corruption.Press OK to reset PDM and delete all user settings. 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.For customer support, refer to your User Guide.Hazard AlarmPodor PDMContinuous tone. This alarm occurs if an unexpected error is detected in the Pod or PDM. Press OK to acknowledge.Remove Pod.Notify 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 Alarms13310Pod 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 acknowledge.Change Pod.Check blood glucose.Alarm Type Source Beep Pattern Action
Alerts and Alarms13410n 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.4. The Reset Button is located in the PDM’s battery compart-ment (Figure 10-3). The Reset Button allows the user to reset the PDM (i.e. if the screen locks up and goes into an alarm). The users PDM settings are not lost.Figure 10-2Manual alarm shut-off portFillportFigure 10-3ResetButton
Alerts and Alarms13510
136CHAPTER 11Communication Failuresn 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 “mylife Omni-Pod System Notice Concerning Interference” in the Appen-dix.n 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.As a safety feature, the communication distance between the Pod and PDM is reduced during activation. Once a Pod is primed and communicates with the PDM, the full communication range is restored and the Pod can receive commands only from that PDM.
Communication Failures137112. 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 11-1 Figure 11-2 Figure 11-3 Figure 11-4
Communication Failures138113. 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.n 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 11-5 Figure 11-6Figure 11-7
Communication Failures139112. Press Discard. The PDM will consider the Pod lost and ask whether you want to activate a new Pod. n 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).Or: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 11-9 Figure 11-10
Communication Failures14011At either “Pod status not available” screen, press Home to return to the Home screen or press Status to send another status request.n 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 “” on page 140 instead.Figure 11-11Figure 11-12 Figure 11-13
Communication Failures141113. 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, call 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 11-14 Figure 11-15Figure 11-16
142AppendixThe mylife OmniPod® Insulin Management System has no user-serviceable parts. If you require assistance operating or main-taining the System, please call Customer Care.n 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.n 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.
Appendix143Cleaning and disinfectingCleaning is to keep free from dirt, stains, or impurities; unsoiled.Disinfecting is the process of destroying pathogenic organisms or rendering them inert.Keep your PDM test strip port and USB port free of debris and liquids. Dirt, dust, blood, and control solution can impair the functionality of your PDM or damage it.If the battery compartment becomes soiled, gently shake out the debris or use a dry, lint-free cloth to remove it.You should clean and disinfect your PDM at least once a week. You should also clean your PDM whenever it is visibly soiled. For both cleaning and disinfecting the same process should be fol-lowed. Therefore, if you are intending to complete weekly cleaning and disinfection you should complete the process out-lined to the right. Use the guidelines below to clean or disinfect your PDM:The PDM can be cleaned and disinfected up to twice a week over the course of the life of the device (4 years). 1. Be sure to turn off your PDM before cleaning or disinfecting.2. To clean and disinfect the outside surfaces of the PDM hous-ing, use Dispatch® Hospital Cleaner Disinfectant Towels with Bleach or its formula equivalent (available online through major retailers).3. 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 two (2) minutes.4. Let your PDM air dry completely before checking your BG next. We recommend you perform a control solution test to ensure the System functions properly. See ”Performing a Control Solution Test” in Chapter 7, Checking Your Blood Glu-cose.5. If you see any signs of deterioration of the PDM (i.e. cracking, separation, discolorations), please contact Customer Care.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. It is recommended that the user pre-clean the device prior to each disinfection cycle.While cleaning, do NOT allow debris or liquid to get into the test strip port, USB port, battery compart-ment, or buttons (see Figure A-1 on the next page).
Appendix144.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.The PDM automatically alerts you when its battery power gets low (see Figure A-2). When you see the “Low PDM battery” alert, press OK to turn off the alert. Replace the batteries as soon as you can.AAA alkaline batteries are the required 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. Do no use rechargeable batteries.Figure A-1Test Strip Port (BG)IR PortUSB PortBatteryCompartment(Reverse Side)ButtonsFigure A-2 Figure A-3
Appendix145 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.2. Open the battery compartment; remove the batteries and discard them.3. Use a clean, lint-free cloth to gently absorb any water in the battery compartment.4. Leave the battery compartment door open until the PDM is thoroughly dry.5. Do not put in fresh batteries or attempt to use the PDM until it has thoroughly air-dried.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.If the batteries run out, date and time are 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.Never use a blow dryer or hot air to dry the Pod or PDM. Extreme heat can damage the electronics.
Appendix146If 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.n Storage and SuppliesTo order all mylife OmniPod System products and supplies, call Customer Care.If your PDM is damaged or not working as it should, please call 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, please call Customer Care.Store all mylife OmniPod System products and sup-plies (including unopened Pods) in a cool, dry place. Products or supplies that have been exposed to extreme temperatures may not function properly.It is especially important to store your insulin in a 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.
Appendix147n 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 IC 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.
Appendix148Example of meal insulin-on-board 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• IC 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 unitCorrection IOB: 1 unitCorrection 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 (meal + correction IOB) = 0 UExample 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) = 4 UMeal IOB is used only to reduce a correction bolus, and the correction bolus is only reduced until it becomes 0 units.
Appendix149Example 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) = 3 UExample 4Current BG level: 150 mg/dLCarb intake: 60 carbsMeal 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) = 4 UCalculator guidelinesWhen the suggested bolus calculator is turned On, the mylife OmniPod System applies these guidelines to the suggested bolus doses:• Suggested bolus doses are rounded down to the nearest 0.05 U.• If the total of the suggested bolus calculation (correction bolus plus meal bolus) is less than zero, the suggested bolus dose is 0.00 U.• 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.Meal IOB is never subtracted from another meal bolus – only from a correction bolus.
Appendix150• 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.• The calculated insulin on board is rounded up to the nearest 0.05 U.• A reverse correction only occurs if the meal bolus is greater than 0.00 U.• 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.
Appendix151n mylife OmniPod System Options and Settings Time 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 4 active at any one time. Created at time of bolus entry; reminder can be set for 30 minutes to 4 hours after bolus is started, in 30-minute increments. Default is Off.Blood 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 factor 8 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 incrementsBolus 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
Appendix152n Pod SpecificationsSize: 3.9 cm x 5.2 cm x 1.45 cmWeight (without insulin): 25 grams Operating temperature range: 4.4°C to 40°C Under normal circumstances, your body temperature will keep the Pod well within this range.Startup temperature: above 10°CStorage temperature range: 0°C to 30°CReservoir volume (deliverable): 200 unitsCannula insertion depth: 6.5 mmWaterproof rating: IPX8 (7.6 meters for up to 60 minutes)Insulin concentration: U-100Alarm type: AudibleOperating relative humidity range: 20–85%, non-condensingStorage relative humidity range: 20–85%, non-condensingOperating atmospheric pressure: 696 hPA to 1060 hPAStorage atmospheric pressure: 696 hPA to 1060 hPANon-pyrogenic: Fluid pathway onlyType BF Medical Device: Protection from electrical shockFlow Capability:         Basal: Programmable by the user in 0.05 U 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 > 0.05 U/hr         Bolus: +/- 5% for all set values > 0.05 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
Appendix153n Accuracy Test ResultsThe following graph is designed to show flow accuracy of the Pod against given time periods.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%.
Appendix154n Personal Diabetes Manager SpecificationsSize: 6.21cm x 11.25cm x 2.5cmWeight (with batteries): 125 grams Screen: 3.6cm wide x 4.8cm long; 6.1cm diagonal screen LCDBattery: Powered by (2) AAA alkaline batteriesBattery life: Approximately 3 weeksOperating temperature range: 4.4°C to 40°CStorage temperature range: -29°C to 60°COperating 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 152.40 cm during normal operation.Alarm type: AudibleAlert type: Audible and vibratoryWarranty: 4 Year Limited (PDM)n 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 microliters)Test time: Results in as fast as 7 seconds
Appendix155n mylife OmniPod System Label Symbols Symbol 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 7.6 meters for up to 60 minutesKeep drySymbol MeaningStorage temperatureDo not use if package is damagedAuthorized Representative in the EuropeanCommunityProduct is designed and manufactured in accor-dance with applicable standards/guidelines andmay be sold in the EU (European Union)Do not throw away; contains mercuryQuantity of Pod(s), Needle(s) and Syringe(s) thatare packaged individually or as 10 packs.
Appendix156n Personal Diabetes Manager IconsIcon 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(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 recordBlood Glucose Meter - Temperature out of range“Delivery Spans Midnight” history recordActive/default program or selected BG tagIcon Meaning Icon Meaning
Appendix157n Medical Device DirectiveThis device complies with Medical Device Directive 93/42/EEC.Contact Person: The Complaints OfficerAddress: HealthLink Europe BV, Centaurusweg 123NL-5015 TC TILBURG, The NetherlandsTEL: +31.13.5479300FAX: +31.13.5479302E-mail: complaints@HealthlinkEurope.comInsulet Corporation complies with EU Directive, HIPAA, and rele-vant provisions of PIPEDA.n mylife OmniPod System Notice Concerning InterferenceThe mylife 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 mylife OmniPod Sys-tem does cause harmful interference to radio and television reception, the interference may be corrected by one of the fol-lowing measures:• Move or reposition the mylife OmniPod System.• Increase the distance between the System and the other device that is emitting or receiving interference.Insulet Corporation declares that the mylife OmniPod System is in compliance with the essential requirements and other rele-vant provisions of Directive 1999/5/EC. This ISM device complies with Canadian ICES-003 and IC-RSS-210.n Electromagnetic CompatibilityThe information contained in this section (such as separation distances) is, in general, specifically written with regard to the mylife OmniPod System. The numbers provided will not guaran-tee 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.
Appendix158General 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 the function of medical electrical equipment.Insulet Corporation declares that the mylife OmniPod Insulin Management System is in compliance with the essential require-ments 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 mylife OmniPod System communicates with the following characteristics:Frequency: 433 MHz, FSK modulation, with an effective radi-ated power of 13mWThe mylife OmniPod System greatly exceeds the immunity requirements of the general standard for electromagnetic com-patibility, IEC 60601-1-2.Electromagnetic 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.
Appendix159Electromagnetic Immunity The 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.
Appendix160Radiated 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 150 KHz to 80 MHzd=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.a  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment.Electromagnetic Immunity (Continued)
Appendix161Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the System You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF 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.
162GlossaryA1c (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 during a certain period of the day. For example, you may want one BG goal before meals, a different BG goal two hours after meals, and yet another BG goal for bedtime.Blood glucose (see glucose)Blood glucose 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.
Glossary163CalorieA 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 mylife OmniPod System calculates the correction bolus by taking the difference between your current blood glu-cose level and your target blood glucose level, then dividing the result by your correction factor.Correction 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 insulin 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.
Glossary164Diabetes 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 mylife OmniPod® Insulin Management System.Extended bolusA feature of the mylife 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-grain bread, and bran cereal or granola. Fiber is a type of carbohydrate but does not raise blood glucose levels as other carbohydrates do.GlucoseA simple sugar (also known as dextrose) used by the body for energy. Without insulin, the body cannot use glucose for energy.Hazard 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.
Glossary165Hemoglobin 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 mylife OmniPod System, insulin on board (IOB) is considered in two parts: the Insulin on Board (IOB) from a previous correction bolus and the IOB from a previous meal bolus.The amount of time insulin remains “on board” or “active” depends on each individual’s duration of insulin action. Talk with your healthcare provider to determine your duration of insulin action.The mylife 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)Insulin-to-carbohydrate ratio (IC ratio)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.
Glossary166In 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 mylife 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.Reverse correction (negative correction)Using an individual’s correction 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 mylife OmniPod® Insulin Manage-ment System, which should be turned on or off according to the advice of a healthcare provider.It is important to rule out ketoacidosis when you experience symptoms that might otherwise indicate the flu.
Glossary167SharpsAny 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 mylife OmniPod System uses this number in cal-culating 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)
Index168IndexAactivate a new Pod. . . . . . . . . . . . . . . 43–45active insulin . . . . . . .See insulin on boardaddbasal segment or rate . . . . . . . . . 17–21bolus reminder. . . . . . . . . . . . . . . . . . . .70custom reminders. . . . . . . . . . . . . . . . .70user information . . . . . . . . . . . . . . . .  103adhesive. . . . . . . . . . . . . . . . . . . . . . . . . .  4, 51remover. . . . . . . . . . . . . . . . . . . . . . . . . . .45advisory alarms . . . . . . . . . .  126–130, 162airport security  . . . . . . . . . . . . . . . . . . . .  108alarms . . . . . . . . . . . . . . . . . . . . . . 8, 126–134acknowledge  . . . . . . . . . . . . . . . . . . .  127advisory. . . . . . . . . . . . . . . . . . . . 126–130hazard  . . . . . . . . . . . . . . . . . . . . . 126–134history records . . . . . . . . . . . . . . . . . .  101alert escalation  . . . . . . . . . . . . . . . . . . . .  126alerts and reminders. . . . . . . . . . . . . 68–71auto-off alert . . . . . . . . . . . . . . . . . . . . . .68BG reminder  . . . . . . . . . . . . . . . . . . . . . .68bolus reminders. . . . . . . . . . . . . . . . . . .69confidence reminders. . . . . . . . . . . . . 69custom reminders  . . . . . . . . . . . . . . . . 69low reservoir alert . . . . . . . . . . . . . 14, 68missed bolus . . . . . . . . . . . . . . . . . . . . . . 69Pod expiration reminder . . . . . . . . . . 68program reminders . . . . . . . . . . . . . . . 69aseptic technique  . . . . . . . . . . . . . . 58, 162automated cannula insertion. . . . .  2, 53auto-off alert  . . . . . . . . . . . . . . . . . . . . . . . .68Bbacklight time-out. . . . . . . . . . . . . . . . . . .73set  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74basal history . . . . . . . . . . . . . . . . . . . . . . . . .97basal program . . . . . . . . . .  11, 16–22, 162add segment or rate  . . . . . . . . . . . . . .21copy  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22create . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22edit segment or rate  . . . . . . . . . . . . . .21enable  . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19rename  . . . . . . . . . . . . . . . . . . . . . . . . . . .22basal rate . . . . . . . . . . . . . 1, 11, 16–27, 162maximum. . . . . . . . . . . . . . . . . . . . . . . . . 27temporary  . . . . . . . . . . . . . . . . . . . . . . . . 22basal segment. . . . . . . . . . . . . .  11, 16, 162basal settings . . . . . . . . . . . . . . . . . . . . . . . . 11batteries . . . . . . . . . . . . . . . . . . . . . .9, 96, 144blood glucoseBG goal  . . . . . . . . . . . . . . . . . .  11, 72, 162BG reminder . . . . . . . . . . . . . . . . . . . . . . 68checking . . . . . . . . . . . . . . . . . . . .9, 79–95goal limit. . . . . . . . . . . . . . . . . . . . . . . . . . 72history . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99level. . . . . . . . . . . . . . . . . . . . . . . . . . 28, 162monitoring. . . . . . . . . . . . . . . . . . . . . . . 9, 3sound . . . . . . . . . . . . . . . . . . . . . . . . . 11, 72test strip  . . . . . . . . . . . . . . . . . . . . . . . . . . 87blood glucose meter  . . . . .3, 79–95, 162error messages. . . . . . . . . . . . .  122–124readings  . . . . . . . . . . . . . . . . . . . . . . . .3, 89settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 71specifications . . . . . . . . . . . . . . . . . . . .154blood glucose readingsenter manually. . . . . . . . . . . . . . . . . . . . 92low and high. . . . . . . . . . . . . . . . . . . . . . 94bolus . . . . . . . . . . . . . . . . . . . . . . .  1, 3, 28–42
Index169cancel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36dose. . . . . . . . . . . . . . . . . . . . . . . . . . 28, 162extended. . . . . . . . . . . . . . . . . . . . . . 29, 34history  . . . . . . . . . . . . . . . . . . . . . . . . . . . .98manual delivery . . . . . . . . . . . . . . . . . . .33normal . . . . . . . . . . . . . . . . . . . . . . . . 29, 31presets . . . . . . . . . . . . . . . . . . . 37–39, 162ratios/factors/targets. . . . . . . . . . . . . .66reminders . . . . . . . . . . . . . . . . . . . . . 69, 70settings  . . . . . . . . . . . . . . . . . . . . . . . 64–67suggested bolus calculator. . .  29–34, 147–150bolus presets . . . . . . . . . . . . . . . 37–39, 162cancel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39change. . . . . . . . . . . . . . . . . . . . . . . . . . . .39create . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39enable  . . . . . . . . . . . . . . . . . . . . . . . . . . . .38rename. . . . . . . . . . . . . . . . . . . . . . . . . . . .39bolus reminderadd. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70bolus reminders . . . . . . . . . . . . . . . . . . . . .69Bolus/basal/calcs menu. . . . . . . . . . . . . .64bright mode . . . . . . . . . . . . . . . . . . . . . .  5, 73buttonsHome/Power. . . . . . . . . . . . . . . . . . . . . . . 5Up/Down Controller . . . . . . . . . . . . . . . 5User Info/Support . . . . . . . . . . . . . . . . . . 5Ccalorie . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  163cancelbolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36bolus preset. . . . . . . . . . . . . . . . . . . . . . .39one-time temporary basal rate. . . .24temporary basal presets  . . . . . . . . . .26cannula . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 163automated insertion . . . . . . . . . . .  8, 53carb presets  . . . . . . . . . . . . . .2, 40–42, 163change. . . . . . . . . . . . . . . . . . . . . . . . . . . .41change category . . . . . . . . . . . . . . . . . .41create . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42edit  . . . . . . . . . . . . . . . . . . . . . . . . . . . 41, 42rename  . . . . . . . . . . . . . . . . . . . . . . . . . . .42carbohydrate . . . . . . . . . . . . . . . . . . . . 1, 163counting . . . . . . . . . . . . . . . . . . . . . . . .  163history  . . . . . . . . . . . . . . . . . . . . . . . . . .  101carbohydrate bolus . . . . .  See meal boluscare and maintenance . . . . . . . . . . . . .  142cellular phones . . . . . . . . . . . . . . . . . . . .  120changebasal programs  . . . . . . . . . . . . . . . . . . . 20basal settings . . . . . . . . . . . . . . . . . . . . .64bolus presets. . . . . . . . . . . . . . . . . . . . . .39bolus settings . . . . . . . . . . . . . . . . . . . . . 64carb presets . . . . . . . . . . . . . . . . . . . . . . .41temporary basal presets  . . . . . . . . . . 26user information . . . . . . . . . . . . . . . .  103check alarms. . . . . . . . . . . . . . . . . . . . . . . . . 75check blood glucose. . . . . . . . . . . . . 79–95cleaning . . . . . . . . . . . . . . . . . . . . . . .142, 143clock12-hour or 24-hour. . . . . . . . . . . . . . . .63communicationdistance to Pod  . . . . . . . . . . . . . . 77, 154interruption. . . . . . . . . . . . . . . . . . 78, 136communication failure  . . . . . . .  136–141bolus cancellation. . . . . . . . . . . . . . .  140Pod activation. . . . . . . . . . . . . . . . . . .  136Pod deactivation . . . . . . . . . . . . . . . .  138Pod operation. . . . . . . . . . . . . . . . . . .  136
Index170request for status  . . . . . . . . . . . . . . .  139complications, diabetes-related . .1, 163confidence reminders  . . . . . . . . . . . . . . .69contact information . . . . . . . . . . . . . . .  102continuous subcutaneous insulin infusion . . . . . . . . . . . . . . . . . . . . . . . . .  163control solutionexpiration . . . . . . . . . . . . . . . . . . . . . . . . .81results. . . . . . . . . . . . . . . . . . . . . . . . . 82, 85test. . . . . . . . . . . . . . . . . . . . . . . . . . . . 82–85copy basal program  . . . . . . . . . . . . . . . . .22correct-above value   . . . . .See  correction thresholdcorrection bolus . . . . . . . . . . . 30, 147, 163correction factor . . . . . 13, 28, 65, 67, 163correction IOB . . . . . . . . . . . . . . . . . . . . .  147correction threshold . . . . .28, 65, 66, 163createbasal program  . . . . . . . . . . . . . . . . . . . .17bolus preset. . . . . . . . . . . . . . . . . . . . . . .38carb presets . . . . . . . . . . . . . . . . . . . . . . .40temporary basal presets  . . . . . . . . . .24CSII  . . . . .  See  continuous subcutaneous insulin infusionCT scans . . . . . . . . . . . . . . . . . . . . . . . . . . .  120custom reminders . . . . . . . . . . . . . . . 69, 70customize PDM. . . . . . . . . . . . . . . . . . . . . .73Ddate and time. . . . . . . . . . . . . . . . . . . . 11, 63dawn phenomenon . . . . . . . . . . . . . . .  163deactivation   . . . . . .See Pod deactivatingdeletebasal program  . . . . . . . . . . . . . . . . . . . .22bolus presets. . . . . . . . . . . . . . . . . . . . . .39bolus reminder. . . . . . . . . . . . . . . . . . . .70carb presets . . . . . . . . . . . . . . . . . . . . . . .42temporary basal presets  . . . . . . . . . . 27diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . .  164Diabetes Control and Complications Tri-al (DCCT). . . . . . . . . . . . . . . . . . . . . . . .  164diabetes emergency kit. . . . . . . . . . . .  106diabetes mellitus . . . . . . . . . . . . . . . . . . . . . 7diabetic ketoacidosis  . . . . . . . . . . . See DKAdiagnostic functions . . . . . . . . . . . . . . . . . 75check alarms . . . . . . . . . . . . . . . . . . . . . . 75reset PDM. . . . . . . . . . . . . . . . . . . . . . . . . 75disinfecting wipes . . . . . . . . . . . . . . . . .  143DKA  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166avoiding . . . . . . . . . . . . . . . . . . . . . . . . .119symptoms  . . . . . . . . . . . . . . . . . . . . . . .118treating . . . . . . . . . . . . . . . . . . . . . . . . . .119duration of insulin action . . . . .  9, 14, 30, 147–148, 164Eeditbasal segment or rate . . . . . . . . . . . . .21bolus reminder  . . . . . . . . . . . . . . . . . . .70carb presets. . . . . . . . . . . . . . . . . . . . . . . 42electrical interference  . . . . . . . . . . . . . . . 78electrical safety . . . . . . . . . . . . . . .  157–161electromagnetic compatibility 157–161electromagnetic fields. . . . . . . . . . . . . . . 78emergency kit . . . . . . . . . . . .104, 106, 107empty reservoir hazard alarm  . . . . . .129enablebasal program  . . . . . . . . . . . . . . . . . . . . 19bolus preset. . . . . . . . . . . . . . . . . . . . . . . 38one-time temporary basal rate. . . . 23temporary basal presets  . . . . . . . . . . 25
Index171enterID screen color . . . . . . . . . . . . . . . . . . . .10tags . . . . . . . . . . . . . . . . . . . . . . . . . . . 72, 90error messages, BG meter. . . . . 122–124exercise . . . . . . . . . . . . . . . . . . . . . . .  114, 120expirationcontrol solution . . . . . . . . . . . . . . . . . . .81Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68extended bolus . . . . . .14, 29, 34–35, 164Extended option. . . . . . . . . . . . . . . . . . . . .67extreme temperatures. . . . . . . . . . . . . . .77Ffailure  . . . . . . . See communication failurefat  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  164fiber  . . . . . . . . . . . . . . . . . . . . . . . . . . . .41, 164fill syringe. . . . . . . . . . . . . . . . . . . . . . . . 46–48Flow accuracyPod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  153Flow rate error . . . . . . . . . . . . . . . . . . . . .  153Gglucagon . . . . . . . . . . . . . . . . . . . . . . . . . .  107glucose . . . . . . . . . . . . . . . . . . . . . . . . . . 7, 164Hhard work. . . . . . . . . . . . . . . . . . . . . . . . . .  120hazard alarm, manual shut-off . . . . .  134hazard alarms. . . . . . . . . . . .  126–134, 164healthcare provider. . . . . . . . . . . . . . 9, 164hemoglobin A1c (HbA1c). . . . . . . . . .  165historyalarms. . . . . . . . . . . . . . . . . . . . . . . . . . .  101all . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  102basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97blood glucose. . . . . . . . . . . . . . . . . . . . .99bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98carbohydrates. . . . . . . . . . . . . . . . . . .  101insulin delivery . . . . . . . . . . . . . . . . 96, 97Home screen . . . . . . . . . . . . . . . . . . . . . .  6–7Home/Power button  . . . . . . . . . . . . . . . . . 5hospitalization. . . . . . . . . . . . . . . . . . . . .  121hyperglycemia. . . . . .  104, 114–118, 165avoiding  . . . . . . . . . . . . . . . . . . . . . . . .  115causes. . . . . . . . . . . . . . . . . . . . . . . . . . .  116symptoms  . . . . . . . . . . . . . . . . . . . . . .  114treating . . . . . . . . . . . . . . . . . . . . . . . . .  115hypoglycemia . . . . . .  104, 109–114, 165avoiding  . . . . . . . . . . . . . . . . . . . . . . . .  110causes. . . . . . . . . . . . . . . . . . . . . . . . . . .  113symptoms  . . . . . . . . . . . . . . . . . . . 79, 109treating . . . . . . . . . . . . . . . . . . . . . . . . .  111hypoglycemia unawareness . . .110, 165Iicons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  156insulin gauge  . . . . . . . . . . . . . . . . . . . . .61ID screen  . . . . . . . . . . . . . . . . . . . . . . . . . . . .60color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10set  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73illness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  119infection . . . . . . . . . . . . . . . . . . . . . . . . 58, 105infusion set, automated insertion. . . . . 2infusion site. . . . . . . . . . . .  49, 58, 105, 165infusion site, inspection. . . . . . . . . . . .  105insulin . .16, 28, 43, 46, 48, 106, 146, 165insulin action  . . .  See duration of insulin action insulin deliveryresume. . . . . . . . . . . . . . . . . . . . . . . . . . . . 57suspend. . . . . . . . . . . . . . . . . . . . . . . . . . . 56insulin delivery records . . . . . . . . . . 96–98insulin delivery, continuous. . . . . . . . . . . 1
Index172insulin gauge icon . . . . . . . . . . . . . . . . . . .61insulin on board (IOB). .28, 30, 147–150, 165insulin reservoir. . . . . . . . . . . . . . . . . . . . . .61insulin, rapid-acting vs. long-acting .  118insulin-to-carb (IC) ratio9, 13, 28, 65, 66, 165interruption in communication. . . . . .78IV Prep wipes . . . . . . . . . . . . . . . . . . . 77, 143Kketoacidosis . . . . . . . . . . . . . . . . . . . . . . See DKAketones . . . . . . . . . . . . . . . . . . . . 94, 118, 166Llancing device . . . . . . . . . . . . . . . . . . . 85–87long-acting insulin. . . . . . . . . . . . . . . . .  118low battery alert . . . . . . . . . . . . . . . . . . .  144low blood glucose  . . See hypoglycemialow reservoir advisory  . . . . . . . . . . . . .  129low reservoir alert  . . . . . . . . . . . . . . . 14, 68lows, highs, and DKA, avoid. . . . . . . .  109Mmanual shut-off of hazard alarm. . .  134maximum basal rate. . . . . . . . . . . . . 27, 67maximum bolus . . . . . . . . . . . . . . . . . 14, 67meal bolus. . . . . . . . . . . . 30, 147–150, 166meal IOB. . . . . . . . . . . . . . . . . . . . . . . . . . .  148Medic Alert tag . . . . . . . . . . . . . . . . . . . .  121medical electrical equipment.  157–161menuBolus/basal/calcs. . . . . . . . . . . . . . . . . . 64More actions . . . . . . . . . . . . . . . . . . .  7, 31My records . . . . . . . . . . . . . . . . . . . . . . . . . 7Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Suspend/resume. . . . . . . . . . . . . . . . . . . 7System setup  . . . . . . . . . . . . . . . . . . . . .62Temp basal. . . . . . . . . . . . . . . . . . . . . . . . . 7microwave ovens . . . . . . . . . . . . . . . . . . . .78Min BG for calcs. . . . . . . . . . . . . . .12, 65, 66missed bolus reminder . . . . . . . . . . 69–70More actions menu . . . . . . . . . . . . . . . . . .31MRIs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  120multiple daily injections (MDIs) . . . .  166multiple-day trends, BG history. . . .  100Nnormal bolus . . . . . . . . . . . . . . . . . . . . 29, 31Oocclusion . . . . . . . . . . . . . . . . .114, 118, 166occlusion detected hazard alarm . . .131OmniPod label symbols . . . . . . . . . . . .155OmniPod System . . . . . . . . . . . . . . . . . . . . . 2one-time temporary basal rate . . . . . . 23cancel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24enable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23operating temperatures . . . 77, 152, 154optionsBolus calcs . . . . . . . . . . . . . . . . . . . . . . . . 64Extended  . . . . . . . . . . . . . . . . . . . . . . . . . 67Max basal rate  . . . . . . . . . . . . . . . . . . . .67Max bolus. . . . . . . . . . . . . . . . . . . . . . . . . 67Ratios/factors/targets . . . . . . . . . . . . . 66Temp basal. . . . . . . . . . . . . . . . . . . . . . . . 67Options and settings . . . . . . . . . . . . . . .151PPDM . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 60–78backlight time-out . . . . . . . . . . . . . . . . 73batteries . . . . . . . . . . . . . . . . . . . . . . 9, 144BG goal  . . . . . . . . . . . . . . . . . . . . . . . . . . . 72blood glucose sound  . . . . . . . . . . . . . 72
Index173cleaning. . . . . . . . . . . . . . . . . . . . . . . . .  143communication with Pod . . 136–141customize . . . . . . . . . . . . . . . . . . . . . 73–74disinfecting wipes. . . . . . . . . . . . . . .  143dropped  . . . . . . . . . . . . . . . . . . . . . . . .  146icons . . . . . . . . . . . . . . . . . . . . . . . . . . . .  156ID screen . . . . . . . . . . . . . . . . . . . . . . . . . .60PDM lock. . . . . . . . . . . . . . . . . . . . . . 73–74repair or replacement . . . . . . . . . . .  127screen time-out . . . . . . . . . . . . . . . . . . .73settings  . . . . . . . . . . . . . . . . . . . . . . . . . . .61specifications  . . . . . . . . . . . . . . . . . . .  154Status screen. . . . . . . . . . . . . . . . . .60–61storage. . . . . . . . . . . . . . . . . . . . . . . . . .  142submerged in water. . . . . . . . . . . . . . .77version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6PDM error hazard alarm  . . . . . . . . . . .  132PDM lock  . . . . . . . . . . . . . . . . . . . . . . .73, 142set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74PDM options, System setup. . . . . . . . . .73personal contact information. . . . . .  102Personal Diabetes Manager  . . .See PDMphysical exertion. . . . . . . . . . . . . . . . . . .  120playing sports  . . . . . . . . . . . . . . . . . . . . .  120Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . .4, 43–45applying . . . . . . . . . . . . . . . . . . . . . . . . . .51change process . . . . . . . . . . . . . . . . . . .43check status. . . . . . . . . . . . . . . . . . . . . . .55cleaning. . . . . . . . . . . . . . . . . . . . . . . . .  142deactivating  . . . . . . . . . . . . . . . . . . . . . .44expiration reminder. . . . . . . . . . . . . . .68filling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46flow accuracy . . . . . . . . . . . . . . . . . . .  153flow rate error . . . . . . . . . . . . . . . . . . .  153inserting cannula  . . . . . . . . . . . . . . . . .53priming . . . . . . . . . . . . . . . . . . . . . . . . . . .48removal . . . . . . . . . . . . . . . . . . 44–45, 120safety checks. . . . . . . . . . . . . . . . . . . . . .48specifications  . . . . . . . . . . . . . . . . . . .  152storage. . . . . . . . . . . . . . . . . . . . . . . . . .  142Pod error hazard alarm . . . . . . . . . . . .  131Pod expiration advisory. . . . . . . . . . . .  130Pod expired hazard alarm. . . . . . . . . .  130Pod occlusion hazard alarm  . . . . . . .  131prescriptions. . . . . . . . . . . . . . . . . . . . . . .  109for travel  . . . . . . . . . . . . . . . . . . . . . . . .  108prime bolus. . . . . . . . . . . . . . . . . . . . . 53, 166priming, automatic . . . . . . . . . . . . . . . . . . . 8program reminders. . . . . . . . . . . . . . . . . . 69protein  . . . . . . . . . . . . . . . . . . . . . . . . . . . .  166Rradio interference  . . . . . . . . . . . . . . . . . . .78rapid-acting insulin . . . . . . . . . . . . . . . .  118Ratios/factors/targets option . . . . 66–67record keeping . . . . . . . . . . . . . . 3, 96–103record screens . . . . . . . . . . . . . . . . . .96–103alarms. . . . . . . . . . . . . . . . . . . . . . . . . . .  101all . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  102blood glucose. . . . . . . . . . . . . . . . . . . . . 99carbohydrates  . . . . . . . . . . . . . . . . . .  101combined records  . . . . . . . . . . . . . .  102insulin delivery. . . . . . . . . . . . . . . . . . . .97personal contact information . . .  102special symbols . . . . . . . . . . . . . . 96, 100User Info/Support. . . . . . . . . . . . . . .  102remove a Pod. . . . . . . . . . . . . . . 44–45, 120renamebasal program  . . . . . . . . . . . . . . . . . . . .22bolus presets. . . . . . . . . . . . . . . . . . . . . .39custom reminders  . . . . . . . . . . . . . . . . 70temporary basal presets  . . . . . . . . . . 27
Index174replace batteries . . . . . . . . . . . . . . . . . . .  145resetdate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64PDM  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63resume insulin delivery . . . . . . . . . . . . . .57reverse correction  . . . . . . .  13, 33, 66, 67, 147, 166Ssafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 104alerts and alarms. . . . . . . . . . . . . . . . . . . 8automatic priming . . . . . . . . . . . . . . . . . 8automatic safety checks. . . . . . . . . . . . 8electrical . . . . . . . . . . . . . . . . . . . 157–161safety checks  . . . . . . . . . . . . . . . . . . . . . .  122screen time-out. . . . . . . . . . . . . . . . . . . . . .73set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74setbacklight time-out . . . . . . . . . . . . . . . .74ID screen . . . . . . . . . . . . . . . . . . . . . . . . . .73PDM lock. . . . . . . . . . . . . . . . . . . . . . . . . .74screen time-out . . . . . . . . . . . . . . . . . . .74settings, BG meter . . . . . . . . . . . . . . . . . . .71Setup Wizard  . . . . . . . . . . . . . . . . . . . . . . . .10sharps . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  167sharps container. . . . . . . . . . . . . . . . . . .  167shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44shut-off, manual . . . . . . . . . . . . . . . . . . .  134sick days . . . . . . . . . . . . . . . . . . . . . . . . . . .  119soap, solvent. . . . . . . . . . . . . . . 77, 142, 143soft keys . . . . . . . . . . . . . . . . . . . . . . . 7, 5, 167soft reset . . . . . . . . . . . . . . . . . . . See reset PDMspecial symbols in record screens. . . .96specificationsBG meter. . . . . . . . . . . . . . . . . . . . . . . .  154PDM  . . . . . . . . . . . . . . . . . . . . . . . . . . . .  154Pod  . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  152sports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  120Status screen . . . . . . . . . . . . . . . 6–7, 60–61storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59storage temperatures. . . . . . . . . .152, 154stuck key advisory . . . . . . . . . . . . . . . . .  130suggested bolus calculator . . . . . . . 2, 12, 29–33, 91, 167examples  . . . . . . . . . . . . . . . . . . 147–149guidelines. . . . . . . . . . . . . . . . . . . . . . .  149suppliespacking for travel . . . . . . . . . . . . . . . .107surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121suspend insulin delivery . . . . . . . . . . . . . 56symbolsin history records. . . . . . . . . . . . . . . . . . 96on screen . . . . . . . . . . . . . . . . . . . . . . . .156System labels  . . . . . . . . . . . . . . . . . . . .155symptomsDKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118hyperglycemia . . . . . . . . . . . . . . . . . . .114hypoglycemia. . . . . . . . . . . . . . . . 79, 109System options and settings. . . . . . . .151System setup menu  . . . . . . . . . . . . . . . . . 62Ttagsenter . . . . . . . . . . . . . . . . . . . . . . . . . . 72, 90target BG . . . . . . . . . . . . . . . . . . .  28, 64, 167target blood glucose value . . . . . . . . . . 12temperaturesextreme. . . . . . . . . . . . . . . . . . . . . . . . . . . 77operating . . . . . . . . . . . . . . . 77, 152, 154storage. . . . . . . . . . . . . . . . . . . . . .152, 154temporary basal . . . . . . . . . . . . . . . . . 11, 67
Index175temporary basal presets . . . . 24–27, 167cancel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26change. . . . . . . . . . . . . . . . . . . . . . . . . . . .26create . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24delete . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27enable  . . . . . . . . . . . . . . . . . . . . . . . . . . . .25rename. . . . . . . . . . . . . . . . . . . . . . . . . . . .27temporary basal rate. . . . . . . . 22–27, 167temporary basal rate, one-time . . . . . .23test strips . . . . . . . . . . . . . . .3, 79, 80, 82, 87text, entering and changing . . . . .17, 22, 24, 27, 38, 39, 40time  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 63time segment   . . . . . . . See basal segmenttime zones. . . . . . . . . . . . . . . . . . . . . . . . .  107travel concerns . . . . . . . . . . . . . . . . . . . .  107UUp/Down Controller buttons . . . . . . . . . 5User Guide symbols. . . . . . . . . . . . . . . . . . . . 6User Info/Supportbutton . . . . . . . . . . . . . . . . . . . . . . . . 5, 102icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5screen. . . . . . . . . . . . . . . . . . . . . . . . . . .  103Vvacation . . . . . . . . . . . . . . . . . . . . . . . . . . .  107Wwater . . . . . . . . . . . . . . . . . .  58, 77, 106, 145wireless communication technology . . 78XX-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 _________________________________00:00 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.00:00 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 _________________________________00:00 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.00:00 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.00:00 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
My Notes_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

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