Paradigm Infusion Pump - Medtronic Diabetes

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Paradigm Infusion PumpModel MMT-511User Guide

2005, Medtronic MiniMed. All rights reserved.This product is covered by U.S. Patent Nos. 6,551,276 and 6,554,798. Other U.S.and/or foreign patents may be pending.Bolus Wizard is a registered trademark of Medtronic MiniMed.Dual Wave is a trademark of Medtronic MiniMed.Easy Bolus is a trademark of Medtronic MiniMed.Square Wave is a trademark of Medtronic MiniMed.BD Logic is a trademark of Becton, Dickinson and CompanyEnergizer is a registered trademark of Eveready Battery Company.Glucagon Emergency Kit is a registered trademark of Eli Lilly and Company.Paradigm is a registered trademark of Medtronic MiniMed.Paradigm Link is a trademark of Medtronic MiniMed.The Link is a trademark of Becton, Dickinson and Company (Canada only)Quick-serter is a registered trademark of Medtronic MiniMed.Quick-set is a registered trademark of Medtronic MiniMed.Silhouette is a registered trademark of Medtronic MiniMed.Sof-set is a registered trademark of Medtronic MiniMedU.S., international, and foreign patent applications are pending.D9195890-015 040705

Important Safety Information Regarding YourParadigm Insulin Infusion Pump (includes all models)Avoid Immersing Your Pump In WaterAlthough it is unlikely that water damage will occur if your pump is splashedor briefly dunked, you should avoid immersing your Paradigm infusion pumpin water. To swim or participate in other water activities, always disconnectfrom your Paradigm pump and reconnect after water play.If you inadvertently submerge your pump in water, dry the pump quicklyusing a soft, clean towel and verify that it is working properly by selecting“self test” from the pump’s Utilities Menu. If you believe that water hasentered your pump or you observe any other possible pump malfunction,please check your blood glucose, treat high blood glucose (if necessary) withan injection and contact our 24-Hour Help Line at 1-800-MINIMED(1-800-646-4633) for further assistance. Symptoms of high blood glucoseinclude fatigue, excessive thirst and nausea. You should always contact yourhealthcare professional if you experience excessively high or low bloodglucose levels, or if you have any questions about your care.Electrostatic DischargeAlthough your Paradigm pump is designed to be unaffected by typical levelsof electrostatic discharge (ESD), very high levels of ESD can result in a resetof the pump’s software with an associated pump error alarm. In most cases,exposure to high levels of ESD will trigger the pump’s E-13 alarm although,under certain circumstances, high level ESD exposure can cause E-44, BolusStopped or Max Delivery alarms. High levels of ESD are more likely insituations where the relative humidity is very low, such as inside a heatedbuilding during the winter in areas where it is cold outside.If your pump experiences an E-13 or other error alarm, press the “ESC” and“ACT” buttons to clear the alarm. If you are unable to clear the alarm bypressing “ESC” and “ACT”, you may need to remove and replace the pump’sbattery to clear the alarm. After clearing the alarm, you should always verifythat your pump is set to the correct date and time and that all other settings(basal rate, max basal and bolus limits, etc.) are programmed to the desiredvalues, since the software reset could erase your previously programmedsettings. Please see the Alarms and Alerts section of this User Guide formore details regarding what to do if your pump displays an error alarm orother alert message.Please contact our 24-Hour Help Line at 1-800-MINIMED (1-800-646-4633)to report any error alarms or other problems that occur with your pump.

Table of Contents Chapter 1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . 1For your records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Availability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Emergency kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3Pump and user guide conventions . . . . . . . . . . . . . . . . 4Your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Installing the battery the first time. . . . . . . . . . . . . . . . 6Home screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Modes of operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Normal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Special . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Attention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9Pump buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Main menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Bolus menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Suspend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Basal menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Prime menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Utilities menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Initial pump settings . . . . . . . . . . . . . . . . . . . . . . . . . . 15Basal rate information . . . . . . . . . . . . . . . . . . . . . . . .16Meal boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16Correction bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . .16i

Blood glucose targets . . . . . . . . . . . . . . . . . . . . . . . . 16Chapter 2Getting Started . . . . . . . . . . . . . . . . . . . . . . . . 17Reservoir and infusion sets . . . . . . . . . . . . . . . . . . . . . 17Preparing your pump for use . . . . . . . . . . . . . . . . . . . 18Setting the time and date . . . . . . . . . . . . . . . . . . . . . 18Installing the reservoir . . . . . . . . . . . . . . . . . . . . . . . 21Removing the reservoir . . . . . . . . . . . . . . . . . . . . . . . 22Rewinding the pump . . . . . . . . . . . . . . . . . . . . . . . . . 22Verifying insulin type . . . . . . . . . . . . . . . . . . . . . . . . 23Changing insulin type . . . . . . . . . . . . . . . . . . . . . . . . 24Manual Prime . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Priming with fixed prime . . . . . . . . . . . . . . . . . . . . . 30Reviewing the prime history . . . . . . . . . . . . . . . . . . . 32How to wear the pump . . . . . . . . . . . . . . . . . . . . . . . . 33Chapter 3Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Checking pump status. . . . . . . . . . . . . . . . . . . . . . . . . 35Chapter 4Bolus Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Delivering a normal bolus. . . . . . . . . . . . . . . . . . . . . . 39Dual/Square bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Square wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Delivering a square wave bolus . . . . . . . . . . . . . . . 42Normal bolus during a square wave bolus . . . . . . 44Dual wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Delivering a dual wave bolus . . . . . . . . . . . . . . . . . 46Delivering an express bolus . . . . . . . . . . . . . . . . . . . . 49When square/dual wave bolus option is off . . . . . . . 49When square/dual wave bolus option is on . . . . . . . 50Maximum bolus limit (max bolus) . . . . . . . . . . . . . . . 50Setting the maximum bolus limit . . . . . . . . . . . . . . 50ii

Easy bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Setting up easy bolus . . . . . . . . . . . . . . . . . . . . . . . .Delivering an easy bolus . . . . . . . . . . . . . . . . . . . . . .Bolus history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52535556Basal menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .What are start and stop times? . . . . . . . . . . . . . . . . .Delivering a basal . . . . . . . . . . . . . . . . . . . . . . . . . . .Maximum basal rate (max basal) . . . . . . . . . . . . . . . . .Setting max basal rate . . . . . . . . . . . . . . . . . . . . . . .Temporary basal rate (temp) . . . . . . . . . . . . . . . . . . . .How does it work? . . . . . . . . . . . . . . . . . . . . . . . . . .Delivering a temporary basal rate . . . . . . . . . . . . . .Verifying temporary basal delivery . . . . . . . . . . . . .Canceling a temporary basal rate . . . . . . . . . . . . . . .Personal basal patterns . . . . . . . . . . . . . . . . . . . . . . . .Turning on personal basal patterns . . . . . . . . . . . . .Delivering personal basal patterns . . . . . . . . . . . . . .Selecting a pattern . . . . . . . . . . . . . . . . . . . . . . . . . .Basal review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Standard basal rates . . . . . . . . . . . . . . . . . . . . . . .60616264646566666768697071737474Chapter 5Basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Chapter 6Suspend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Suspending the pump . . . . . . . . . . . . . . . . . . . . . . . . . 78Resuming pump delivery . . . . . . . . . . . . . . . . . . . . . . . 79iii

Chapter 7Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Setting the alert type. . . . . . . . . . . . . . . . . . . . . . . . . . 82Using Auto-off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84Stop auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Reviewing the alarms . . . . . . . . . . . . . . . . . . . . . . . . . 85Daily totals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Reviewing the daily totals . . . . . . . . . . . . . . . . . . . . . . 87Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Setting up block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Setting the time and date . . . . . . . . . . . . . . . . . . . . . . 90Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Setting the language . . . . . . . . . . . . . . . . . . . . . . . . . . 93RF options (remote control) . . . . . . . . . . . . . . . . . . . . 94Adding an RF ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94Deleting an RF ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Reviewing the RF ID codes . . . . . . . . . . . . . . . . . . . . . 98Clear pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99Clearing pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Selftest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Chapter 8Remote Control . . . . . . . . . . . . . . . . . . . . . . . 107Using your remote control . . . . . . . . . . . . . . . . . . . . 108Remote control buttons . . . . . . . . . . . . . . . . . . . . . 108Waking up your pump . . . . . . . . . . . . . . . . . . . . . . . 109Deliver an easy bolus . . . . . . . . . . . . . . . . . . . . . . . . . 110Suspend/resume the pump . . . . . . . . . . . . . . . . . . . 110Installing a new remote battery . . . . . . . . . . . . . . . . 111Cleaning your remote control . . . . . . . . . . . . . . . . . 112If the remote control is dropped . . . . . . . . . . . . . . . . 112If the remote control falls in water. . . . . . . . . . . . . . 112iv

Chapter 9Troubleshooting & Care . . . . . . . . . . . . . . . . . 113Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . .My pump has a no delivery alarm . . . . . . . . . . . . .What happens if I leave the battery out too long? .What is a check settings alarm? . . . . . . . . . . . . . . .I submerged my pump in water . . . . . . . . . . . . . . .My screen appears distorted . . . . . . . . . . . . . . . . . .Pump maintenance . . . . . . . . . . . . . . . . . . . . . . . . . .Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Installing a new pump battery . . . . . . . . . . . . . .Cleaning your pump. . . . . . . . . . . . . . . . . . . . . . . . . .Storing your pump . . . . . . . . . . . . . . . . . . . . . . . . . . .Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Avoiding extreme temperatures . . . . . . . . . . . . . . .Avoiding dunking the pump in water . . . . . . . . . .Special circumstances . . . . . . . . . . . . . . . . . . . . . . . .If the pump is dropped . . . . . . . . . . . . . . . . . . . . . ndications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . .Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Diabetic ketoacidosis (DKA) . . . . . . . . . . . . . . . . . .Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Skin infections . . . . . . . . . . . . . . . . . . . . . . . . . . . .Reservoir and infusion sets . . . . . . . . . . . . . . . . . .X-rays, MRIs and CT scans . . . . . . . . . . . . . . . . . . .General precautions . . . . . . . . . . . . . . . . . . . . . . . . . .Precautions - hypoglycemia . . . . . . . . . . . . . . . . . . . .Precautions - hyperglycemia . . . . . . . . . . . . . . . . . . .Precautions - infusion sets and sites . . . . . . . . . . . . .123123124124124124125125125127128129Chapter 10User Safety . . . . . . . . . . . . . . . . . . . . . . . . . . 123v

Adverse reactions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 130Hyperglycemia and diabetic ketoacidosis (DKA) . . 130Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131Site infection/abscesses . . . . . . . . . . . . . . . . . . . . . . 131Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132Insulin pump and remote control . . . . . . . . . . . . . 132Chapter 11Alarms and Alerts . . . . . . . . . . . . . . . . . . . . . 135Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135E (Error) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136Off no power . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137Empty reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . 137No reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137No delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138Motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138Batt out limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138Max delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139Button error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139Check settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 139Bolus stopped . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Failed batt test . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141Low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141Low reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141Message in Alarm History . . . . . . . . . . . . . . . . . . . . 142vi

Chapter 12Pump Specifications . . . . . . . . . . . . . . . . . . . . 143Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Alarms and error messages . . . . . . . . . . . . . . . . . .Backlight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Insulin delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . .Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Delivery accuracy . . . . . . . . . . . . . . . . . . . . . . . . . .Displacement accuracy . . . . . . . . . . . . . . . . . . . . . .Drive motor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Dual wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . .Easy bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Infusion pressure . . . . . . . . . . . . . . . . . . . . . . . . . .Insulin concentration/type . . . . . . . . . . . . . . . . . . .Normal bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Occlusion detection . . . . . . . . . . . . . . . . . . . . . . . .Personal basal delivery patterns . . . . . . . . . . . . . . .Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Prime function . . . . . . . . . . . . . . . . . . . . . . . . . . . .Program safety checks . . . . . . . . . . . . . . . . . . . . . .Pump size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pump weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Remote control . . . . . . . . . . . . . . . . . . . . . . . . . . . .Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Square wave bolus . . . . . . . . . . . . . . . . . . . . . . . . .Temporary basal rate . . . . . . . . . . . . . . . . . . . . . . .Time and date display . . . . . . . . . . . . . . . . . . . . . . .Water tight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Factory default settings . . . . . . . . . . . . . . . . . . . . . . .Icon table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47147147147147147148148148148149150Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153vii

viii

Chapter 1Introduction Whether you are beginning pump therapy for the first time, orupgrading from a previous model, we are pleased that you havechosen Medtronic MiniMed as your partner to help you gain better control of your diabetes. We believe that the combination ofstate-of-the-art technology and the simple, menu-driven programming of the Paradigm pump will provide many benefits.This User Guide is designed to help you use your pump; however,working with your healthcare professional is strongly recommended for your safety and to simplify your familiarity with thepump and pump therapy.For your recordsThe pump serial number is located on the back of your pump.Please enter the serial number, purchase date, and pump startdate in the table below.Serial NumberPurchase DatePump start date:1

AssistanceMedtronic MiniMed provides a 24-hour help line for assistance inthe United States. The help line is staffed with technicians who aretrained in the set-up and operation of the Paradigm pump and areable to answer pump-related questions. When calling the help-line,please have your pump and serial number available. The help-linetelephone number is also on the back of your pump.24-hour Product Help-lineif calling from inside the United States800.646.4633(800-MiniMed)if calling from outside of the UnitedStates818.576.5555Web sitewww.minimed.comAvailabilityThe Paradigm insulin pump and its components are availablethrough Medtronic MiniMed and from authorized distributors.2Chapter 1

Emergency kitKeep an emergency kit with you at all times to make sure that youalways have necessary supplies. This kit should include: Fast-acting glucose tablets Blood glucose monitoring supplies Urine ketone monitoring supplies Short acting insulin and insulin syringe with directions fromyour healthcare professional regarding how much insulin totake An extra Paradigm infusion set and Paradigm reservoir Dressing and adhesive Extra AAA Alkaline and A23 batteries (Energizerrecommended) Paradigm Quick Reference Card Glucagon Emergency KitInform a family member, co-worker, and/or friend where thisemergency kit is kept.Please refer to Chapter 10, User Safety for more information onpump safety.Introduction3

Pump and user guide conventionsThe following terms and icons are used to describe the pump inthis User Guide.“Pr

An extra Paradigm infusion set and Paradigm reservoir Dressing and adhesive Extra AAA Alkaline and A23 batteries (Energizer recommended) Paradigm Quick Reference Card Glucagon Emergency Kit Inform a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to Chapter 10, User Safety for more information on

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