Medtronic MiniMed 3160 Personal Pump Communicator User Manual MiniMed 2007 Implantable Pump Patient Manual

Medtronic MiniMed, Inc. Personal Pump Communicator MiniMed 2007 Implantable Pump Patient Manual

Contents

Users Manual 3

Medtronic MiniMed 2007D Implantable Insulin Pump SystemPatient Manual
© 2003, Medtronic MiniMed. All rights reserved.Medtronic MiniMed™ is a trademark of Medtronic MiniMedDual Wave™ is a trademark of Medtronic MiniMedSquare Wave™ is a trademark of Medtronic MiniMedSteri-strip® is a registered mark from 3MAventis® is a registered mark from Aventis PharmaceuticalGenapol® is a registered mark from Aventis PharmaceuticalLuer Lok® is a registered mark from BD and Co.This device is protected under one or more of the following U.S. Patents:U.S., international, and foreign patent applications are pending.4,731,051 5,217,442 5,527,307 6,427,0884,776,842 5,257,971 5,559,828 6,537,2685,167,633 5,460,618 5,797,733 6,562,0015,176,644 5,466,218 5,915,929 6,564,1055,197,322 5,514,103 6,283,943 6,571,1286025070-011 7/04 REF MMT-31600976
iTable of contentsCHAPTER 1 The Medtronic MiniMed 2007D Implantable Insulin Pump System . . . . . . . . . . . . . . . . . . . . 1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Medtronic MiniMed help line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Description of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Medication reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Pumping mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Microelectronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Tone transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Personal Pump Communicator (PPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Special insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6CHAPTER 2 Safety features . . . . . . . . . . . . . . . . . . . . . . . . . 7Pump safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Safe telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Negative pressure reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7PPC safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Programming sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Maximum dosage limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Table of contentsiiAlarms and messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8CHAPTER 3 Implanting the Medtronic MiniMed 2007D Pump System . . . . . . . . . . . . . . . . . . . . . 9Hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Pre-operative procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Implantation procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Post-operative procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Pump refills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Insulin used with the Implantable Pump . . . . . . . . . . . . . . . . . . . . . . . . . 11Pump refill procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11CHAPTER 4 Programming your Pump . . . . . . . . . . . . . . . . 13Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13PPC screen icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14PPC buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Communicating PPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Main programming screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Programming a bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Set an immediate bolus (Variable Bolus option is “off”) . . . . . . . . . . . . . 17Set an immediate bolus (Variable Bolus option is “on”) . . . . . . . . . . . . . 18Set a Square Wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Set a Dual Wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Review the bolus history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Suspend mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Program basal rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Set one basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Set multiple basal rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Set a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Table of contents iiiStop a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Personal events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Preset events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Additional events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Pump setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Time and date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Basal delivery patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Initialize PPC to pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Pump Setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Exit Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Pump Setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Turn on the audio bolus feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Use audio bolus in the Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . 36Turn on the Variable Bolus feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Set a maximum bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Set a maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Set time format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Personal event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Pump setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Exit Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39CHAPTER 5 Alarms and messages . . . . . . . . . . . . . . . . . . 41The pump alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41The PPC alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Alarm type 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Alarm type 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Table of contentsivPump alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Alarm feedback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Pump low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Depleted pump battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43System error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Pump self test fail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44PPC alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45PPC low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Low reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Empty reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Battery replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Pump suspended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Hourly maximum exceeded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Personal Pump Communicator messages . . . . . . . . . . . . . . . . . . . . . . . . . . . 49CHAPTER 6 Warnings and precautions . . . . . . . . . . . . . . . 51Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Electrotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Diagnostic ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Ultrasound therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Diagnostic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Therapeutic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Magnetic resonance imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Pump and catheter under-delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Pump electronic or alarm malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Reservoir level warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Table of contents vBlood glucose monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Conventional insulin supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Physician’s instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54PPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Maximum dosages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Battery change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Proper PPC positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Physical activities to avoid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Emergency plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Adverse reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Hyperglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Pump pocket infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Pump pocket seroma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57CHAPTER 7 Important Self-Care . . . . . . . . . . . . . . . . . . . . . 59Blood glucose monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Meal plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Daily activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Travel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Medtronic MiniMed information card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61CHAPTER 8 PPC Care and Maintenance . . . . . . . . . . . . . . 63Installing/replacing the main battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63CHAPTER 9 Technical specifications . . . . . . . . . . . . . . . . . 67Implantable Insulin Pump (MMT-2007D) . . . . . . . . . . . . . . . . . . . . . . . 67Personal Pump Communicator (MMT-3160) . . . . . . . . . . . . . . . . . . . . . 68Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69FCC compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
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Table of contents viiList of figuresFigure 1: The Implantable Insulin Pump ................................................................2Figure 2: Interior of the Implantable Insulin Pump ................................................3Figure 3: Side Port Catheter ....................................................................................4Figure 4: Personal Pump Communicator (PPC) .....................................................5
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1CHAPTER 1 The Medtronic MiniMed 2007D Implantable Insulin Pump SystemIntroductionThis manual is a reference guide for both you and your support network offamily and friends. It is important that other people in your support networkknow how to use the Medtronic MiniMed 2007D Implantable Insulin PumpSystem, so they can be of assistance if the need arises.Throughout the manual you will see note comments which provide importantinformation about the Medtronic MiniMed 2007D System. If you have aquestion not covered in the manual, please talk with your doctor. Your doctorknows the most about your medical condition and can give you the bestanswers to your questions about your diabetes treatment. NOTE: Before you can use the Medtronic MiniMed 2007DSystem, you will be trained. This training will teachyou about implantable insulin pump therapy, and howto operate the Medtronic MiniMed 2007D System. Thismanual can be used to help, but not replace, yourtraining.Medtronic MiniMed help lineMedtronic MiniMed provides a 24-hour help line for assistance. ClinicalServices personnel are trained to answer questions you may have about theMedtronic MiniMed 2007D System.When calling from: Primary number Alternate numberOutside the United States 1-818-576-5040 1-818-362-5958Within the United States 1-800-826-2099 1-818-362-5958
Table of contents2Description of the systemThe Medtronic MiniMed 2007D Implantable Insulin Pump System (see Figure 1)is an "open-loop" system, which means you must test your blood glucose inaccordance with the method and frequency recommended by your physician.Based on the results of your blood glucose testing, you can program the Pumpwith desired rates of delivery by using the Personal Pump Communicator (PPC). The system consists of four components:• Implantable Insulin Pump• Side Port Catheter• Personal Pump Communicator (PPC)• Special InsulinImplantable Insulin PumpThe Implantable Insulin Pump (Pump) is a round disc, 8.1 cm (3.2 inches) indiameter and 2.0 cm (0.8 inches) thick. The Pump weighs 131 grams (4.6 ounces)when empty. The outside case of the Pump is made of titanium. Titanium is abiocompatible metal used in many types of implantable medical devices. ThePump contains an insulin fill port, located at the center of the disc. The fill port isused for rinsing and filling the Pump with insulin, and for diagnostic procedures.Figure 1: The Implantable Insulin Pump
Table of contents 3The Pump has six major components: the medication reservoir, the pumpingmechanism, the antenna, the microelectronics, the battery, and the tonetransducer. Figure 2 shows the interior of the Pump.Figure 2: Interior of the Implantable Insulin PumpMedication reservoirThe medication reservoir holds the insulin and is refilled with a specialsyringe through the Pump fill port.Pumping mechanismThe pumping mechanism takes insulin from the medication reservoir anddelivers it through a catheter into your body. The pumping mechanismdelivers the same amount of insulin every time it pumps. The amount ofinsulin delivered in each “stroke” of the pump mechanism is called the strokevolume.Antenna The Pump antenna receives the radio signals from the PPC and delivers thePPC’s programmed message to the microelectronics of the Pump.Microelectronics The microelectronics are designed to control the pumping mechanism so thatyou receive the amount of insulin you have programmed the Pump to deliver.You tell the microelectronics what to do by using your PPC. The
Table of contents4microelectronics also store pump specifications and programming historyinformation in its memory.Battery The battery supplies power to the pumping mechanism and microelectronics. It isa lithium carbon mono-fluoride battery specially designed for the ImplantableInsulin Pump. Tone transducer The tone transducer is a Pump safety feature. It emits audible beeps to confirmyour Pump is operating properly. It also alerts you when your Pump needsattention.Side Port CatheterThe Side Port Catheter (catheter) is a soft plastic tube, made of polyethylene-lined silicone rubber. The Catheter delivers insulin from the Pump into yourperitoneal cavity. Intraperitoneal insulin is rapidly absorbed by your body and isused to regulate your blood sugar. Your doctor can use the Catheter’s radio-opaque stripe to help locate it on an X-ray.The Catheter has a subcutaneous part and an intraperitoneal part as shown inFigure 3.Figure 3: Side Port CatheterIntraperitoneal PartSubcutaneous Part
Table of contents 5Personal Pump Communicator (PPC)The Personal Pump Communicator (PPC) is a hand-held device which allowsyou to send commands to your Pump and receive Pump information using(RF telemetry) radio waves. The PPC is 8.9 cm (3.5 inches) long, 7.0 cm (2.8inches) wide and 2.0 (0.8 inches) thick and weighs 115 grams (4.06 ounces).The PPC uses one AA (1.5) volt alkaline battery as the main power source.The PPC has an easy-to-read screen. Programming information is enteredusing a four button keyboard. The four buttons and their functions aredescribed in Chapter 4. See Figure 4.Figure 4: Personal Pump Communicator (PPC)To send a command to the Pump, place the PPC near the Pump. With yourPPC you can:• Deliver an immediate, square wave or dual wave insulin bolus tocompensate for meals. Boluses can be programmed by reading thescreen or listening to beeps (audio bolus)• Deliver one or many basal rates in a daily pattern• Preprogram three different daily basal patterns• Deliver a temporary basal rate
Table of contents6• Suspend the Pump• Record Personal Events• Program an Automatic OffYour PPC also stores important information in its memory (120 days of data).This information includes:• Current time and date• Time, date and amount of the last meal bolus• Current basal rate• Daily insulin totals (basal and bolus)• Clinical history • Insulin amount remaining in the Pump• Maximum bolus allowed• Maximum basal rate allowed• Insulin concentration usedNOTE: The PPC issued to you by your doctor can only be usedwith your Implantable Insulin Pump. Do not attempt touse any other PPC to program your Pump, unlessspecifically instructed to do so by your doctor. Special insulinThe Medtronic MiniMed 2007D Implantable Insulin Pump System uses a specialinsulin, purified and concentrated exclusively for implantable pump use. Theinsulin is HOE 21 PH U-400, manufactured by Aventis. Only Aventis HOE 21PH U-400 may be used in the Medtronic MiniMed 2007D Implantable InsulinPump System.
7CHAPTER 2 Safety featuresPump safety featuresSafe telemetryYour Pump will respond only to telemetry commands from your PPC. YourPump will not change when exposed to electromagnetic fields, such as micro-wave ovens, garage door openers, airport security systems, television or videoremote controls. AlarmsThe most important safety feature of your Pump is its self-checking circuitry.If your Pump is not working properly, it will signal you with an alarm mes-sage on the PPC screen and then automatically turn itself off. This featureensures that your Pump will always deliver insulin in a controlled, predictablemanner.Negative pressure reservoirThe Pump reservoir has a negative pressure (vacuum) which will draw in flu-ids. In the event of a Pump malfunction, this vacuum assures your insulin willstay in the reservoir. There are multiple safety features to assure that yourbody fluids won’t enter the Pump. Only the pumping mechanism can over-come this negative pressure and deliver insulin to your body.
Table of contents8PPC safety featuresProgramming sequenceIn order to send a command to your Pump, your PPC must be properly posi-tioned nearby and a series of programming steps must be followed.Maximum dosage limitsYour doctor will program maximum dose limits into your PPC. The pro-grammed maximum basal rate and bolus amount will protect you from aninsulin overdose, in the event of a programming mistake.Alarms and messagesYour PPC prompts you with many easy-to-read messages on the screen. Also,the PPC emits beeps to notify you of certain conditions, such as battery status,programming errors, and a low or empty pump reservoir. These messages andalarms are discussed further in Chapter 5, entitled, “Alarms and Messages.”
9CHAPTER 3 Implanting the Medtronic MiniMed 2007D Pump SystemHospitalizationYou will be admitted to the hospital to have your Medtronic MiniMed 2007DImplantable Insulin Pump surgically implanted and stabilized. Your PumpSystem will also be programmed and tested prior to your leaving the hospital.Your hospitalization will consist of three types of procedures:• Pre-Operative Procedures• Implantation Procedures• Post-Operative ProceduresPre-operative proceduresYou will have blood drawn, be given diagnostic procedures, and possiblyother tests before your scheduled surgery date. You should ask your doctorwhat tests will be required before your Pump is implanted. You may also meetwith an Anesthesiologist or Surgeon prior to the surgery.The Pump will be implanted in your abdominal area. Your doctor will discussthe exact location of implantation with you. The choice of a Pump site maydepend upon the catheter location and the size and shape of your body orwhether or not you have had any previous abdominal surgery, such as anappendectomy.The Pump may be implanted using either local or general anesthesia. Thisdecision will be made by you, your doctor, the Surgeon, and the Anesthesiolo-gist. If local anesthesia is chosen, you will be awake during the implantationbut the pump site will be numbed. Under general anesthesia, you will be keptasleep during the procedure by the anesthesiologist.
Table of contents10Implantation proceduresThe Surgeon will make an incision through your skin and create a “pocket” inwhich to place the Pump. The Pump is then inserted under the fatty tissue justbeneath your skin. The Surgeon will then secure the Pump in your tissue toprevent movement. A very small opening will be made in your abdominalmuscle wall through which the Surgeon will thread the Side Port Catheter intoyour peritoneal cavity. After the Catheter is positioned and the Pump issecured, the Surgeon will use sutures to close the incision in your skin. Ban-dages are used to protect the incision until it heals. Some Surgeons may wantyou to wear a binder over the implant site for a short time to minimize post-operative swelling.Post-operative proceduresThe length of your hospital stay will be determined by your doctor. Your staywill depend upon how quickly you recover, and how quickly you learn to usethe Medtronic MiniMed 2007D Implantable Insulin Pump System.Before your admission to the hospital, your doctor or a nurse will teach youhow to use your PPC to program the Pump. Before leaving the hospital, youmust become proficient in understanding and using your PPC to program thePump. You should:• Fully understand how to use your PPC.• Demonstrate appropriate responses to warning messages and alarmsfrom your PPC.• Be able to identify signs and symptoms your doctor wants you to report.• Have completed a Patient Emergency Information Card, which indicatesyou have an implantable pump and provides emergency phone numbers.• Ask your doctor to complete and return your Device Registration Cardto Medtronic MiniMed. This card contains the Pump and Catheter serialnumbers, which are needed for device tracking byMedtronic MiniMed.• Schedule an appointment with your doctor for your first follow-up visit.• Read Chapter 5, “Alarms and Messages,” and ask your doctor to explainanything you don’t understand.
Table of contents 11Follow-upBefore you leave the hospital, your doctor will schedule an appointment foryour first follow-up office visit. Your healthcare team will also keep in closecontact with you during the first few weeks following implantation. Frequentadjustments in your insulin delivery are often required for several weeks fol-lowing implantation.NOTE: ALWAYS keep your PPC with you. During office visits,a member of the healthcare team will check the statusof your Pump. Only YOUR PPC can be used to checkYOUR Pump.Your post-implant recovery will be similar to recovery from other surgicalprocedures. You will need to obtain adequate rest, eat a nutritious diet, andavoid individuals who are suffering from infections or viruses. Recoverytimes vary among individuals, but most people recover fully in a few weeks.Your physician will ask you to call if you are not feeling well, particularly ifyou have an elevated temperature or if you notice any redness or drainagearound your incision site.Pump refillsInsulin used with the Implantable PumpAventis, located in Frankfurt, Germany, is the manufacturer of the insulinused in your Implantable Insulin Pump. This insulin, HOE 21 PH U-400, isspecifically designed for implanted pumps. No other insulin should be put inyour Pump.Pump refill procedureIt is important that the time between your Pump refills should not exceed 90days. Refilling your Pump is a sterile procedure. Your doctor or a nurse willfirst disinfect your skin directly over the Pump. All equipment that will touchyour skin during the refill procedure is sterile to minimize the risk of infec-tion.Your doctor or a nurse may now numb the disinfected skin area with a localanesthetic. A short needle will then be inserted through your skin to locate thefill port of the Pump. Then a longer needle will be inserted into the Pump fill
Table of contents12port through the inside of the shorter needle. The doctor or nurse will thenempty unused insulin from the Pump and refill it with new Aventis, HOE 21PH U-400 insulin.
13CHAPTER 4 Programming your PumpIntroductionYou will program your Implantable Insulin Pump with your PPC. The PPCtransmits information by (RF telemetry) radio waves to your Pump. With yourPPC you can:• Deliver an immediate, square wave or dual wave insulin bolus tocompensate for meals. Boluses can be programmed by reading thescreen or listening to beeps (audio bolus)• Deliver one or many basal rates in a daily pattern• Preprogram three different daily basal rate patterns• Deliver a temporary basal rate• Suspend the Pump• Program an Automatic Off• Adjust the tone frequency of the PPC and the audible alarms of thePump.NOTE: Your PPC has been designed for easy use (See Chapter4 for a list of the PPC commands). You must follow aspecific sequence of steps and hold the PPC near thePump to deliver a command. Therefore, you cannotunintentionally program your Pump.Your PPC has been specifically pre-programmed for use with your Pump. Donot use another PPC to program your Pump. You must keep your PPC withyou at all times because it is the only way to program your Pump.Remember, you must measure your blood sugar at least four times each day,according to the method recommended by your doctor. You must then use the
Table of contents14results of your blood sugar tests to determine the appropriate dose of insulinto be delivered by your Pump.PPC screen iconsYour PPC has an easy-to-read dot matrix liquid crystal display (LCD). Themain PPC screen displays the time (12hr. or 24hr. format), month, day, and avariety of icons. The type and purpose of these icons are as follows:Icon DescriptionThe bell icon is displayed when the PPC receives a RF telemetry message from the Pump. The icon may indicate the Pump or PPC has detected a failure, or the Pump is in a “SUSPEND” mode or “STOPPED.” The reservoir icon is composed of 4 segments that indicate how full the Pump reservoir is, based on the history of the Pump delivery.The PPC shows a “spinning” icon while insulin delivery is in progress. When the Pump delivers a bolus amount, the pattern will show three delivery segments. When the Pump delivers a basal rate, the pattern will show one delivery segment. When the Pump is not delivering, all four segments will be displayed.
Table of contents 15PPC buttonsPPC programming information is entered using four buttons:Communicating PPC1. When commands are programmed the PPCwill talk to the Pump. When this occurs thefollowing screen will be displayed.2. The word COMMUNICATING will blink toindicate a communication is taking place.Buttons Description SEL Means SELECT. The SEL button allows you to step through and view each of the option screens.ACT Means ACTIVATE. The ACT button activates programming changes you wish to make. As a safety check, you must press ACT to complete any programming changes. You will always hear a single beep after you have successfully activated a change.UP ARROWAllows you to make changes to the screen settings by scrolling to higher values. You must then press the ACT button for a change to be activated. This button has a Sound Icon. When the “AUDIO BOLUS” feature is turned on, the  button allows you to program an Audio Bolus.DOWN ARROWAllows you to make changes to the screen settings by scrolling to lower values. You must then press the ACT button for a change to be activated. This button has a Light Icon which turns on the backlight. With the display illuminated, you can program your Pump in dark areas. The backlight remains on for 4 seconds after each  press.PPCCOMMUNICATING
Table of contents16Main programming screenThe Main programming screen is used to program features you will use everyday, such as a Meal Bolus or Basal Rate, or putting your Pump in the Suspendmode.Programming a bolusUsing the PPC, you can program the Pump to deliver a bolus of insulin when-ever you need it. The Pump System has several special features which allowyou to customize the programming and delivery of a bolus:• Immediate Bolus (programmed by reading the PPC screen or listening tobeeps, using the Audio Bolus)• Square Wave Bolus• Dual Wave BolusNOTE: To program a Square Wave or Dual Wave Bolus, youmust turn on the Variable Bolus programming option(program “ON” in the “SETUP II” menu). Otherwise,only an Immediate Bolus can be given. The VariableBolus option is programmed by your doctor.
Table of contents 17Set an immediate bolus (Variable Bolus option is “off”)1. From the Time/Date screen, press SEL untilthe “BOLUS” screen is displayed. The Timeand Date will be flashing, and the last bolus isdisplayed.2. Press ACT and “SET BOLUS” appears, andthe dashes or previous bolus under “IMM”start flashing.3. Use the  and  buttons to enter animmediate bolus amount.4. Press ACT and the screen shows “CONFIRMIMM.” If the number you entered for theimmediate bolus is correct, press ACT toconfirm it. This value will now beprogrammed into the Pump. If the numberwas not correct, wait for the screen to returnto Time/Date and then repeat this procedureto enter the correct value.5. Place the PPC near the Pump to complete theprogramming. The PPC will beep once anddisplay 0.0 units.6. If the Alarm Feedback feature is “ON,” thePump will beep during each of the first fivestrokes. The PPC will beep when the bolusdelivery is complete. Three segments of theinsulin delivery icon will be displayed andwill spin slowly during the bolus delivery. Bypressing SEL you can see the amount of insulin being delivered.08:23 Jan 02BOLUS PROGIMM EXT10 U _ _ U_ _SET BOLUSIMM_ _ UCONFIRM IMM 2.6UPPCCOMMUNICATING08:23 JAN 04BOLUS 0.0U
Table of contents18Set an immediate bolus (Variable Bolus option is “on”)1. From the Time/Date screen press SEL untilthe “BOLUS” screen is displayed. The lastbolus value programmed and the Time andDate will be flashing.2. Press ACT and “SET BOLUS TYPE”appears. Use the  and  buttons to choose“NORMAL.”3. Press ACT and “IMM” appears with thedashes underneath flashing.4. Use the  and  buttons to enter animmediate bolus amount5. Press ACT and the screen shows “CONFIRMIMM.”6. If the number was not correct, wait for thescreen to return to Time/Date and then repeatthis procedure to enter the correct value.7. If the number you entered for the immediatebolus is correct, press ACT to confirm it.Place the PPC near the Pump to complete theprogramming.8. The PPC will beep once and display theamount of insulin delivered. If the AlarmFeedback feature is “ON,” the Pump willbeep during each of the first five strokes. 9. The PPC will beep when the bolus delivery iscomplete. Three segments of the insulindelivery icon will be displayed and spinning slowly during the bolusdelivery. By pressing SEL you can see the amount of insulin beingdelivered.08:23 Jan 04BOLUS_ _IMM EXT_ _U _ _USETNORMALBOLUS TYPESET BOLUSIMM_ _UCONFIRMIMM2.6UPPCCOMMUNICATING08:23 JAN 04BOLUS 0.0U
Table of contents 19Set a Square Wave bolus A Square Wave Bolus is delivered evenly over a time period you set, from 30minutes to 4 hours. A Square Wave Bolus is useful during long meals, high fatmeals, or if you have gastroparesis. During a Square Wave Bolus, your BasalRate insulin continues to be delivered.To access Square Wave Bolus you must first turn the Variable Bolus feature"ON" in the SET UP II menu.1. From the Time/Date screen press SEL untilthe “BOLUS” screen is displayed. The lastbolus value programmed and the Time andDate will be flashing.2. Press ACT and “SET BOLUS TYPE”appears.3. Use the  and  buttons to choose“SQUARE”.4. Press ACT and the dashes underneath “EXT”will appear flashing.5. Use the  and  buttons to enter an extendedbolus amount.6. Press ACT and dashes will appear under thebolus amount you just entered.08:23 Jan 04BOLUS PROGIMM EXT10U _ _U_ _SETSQUAREBOLUS TYPESET BOLUSIMM EXT_ _U _ _USET BOLUSIMM EXT4.0U_ _USET BOLUSIMM EXT--4.0U_ _U
Table of contents207. Use the  and  buttons to enter a timeduration that you would like the Square WaveBolus to last.8. Press ACT and the screen shows “CONFIRM EXT” asking you to confirmthe extended bolus and time duration.9. If the numbers you entered are correct, pressACT to confirm them. These values willnow be programmed into the Pump. If eithernumber is not correct, wait for the screen toreturn to Time/Date and then repeat thisprocedure to enter the correct values.10. Place the PPC near the Pump to completethe programming.11. The PPC will beep once and display theamount of insulin being delivered. If theAlarm Feedback feature is “ON,” the Pumpwill beep during each of the first five strokes. 12. The PPC will beep when the bolus delivery iscomplete. Three segments of the insulindelivery icon will be displayed and will spinslowly during the bolus delivery. By pressingSEL you can see the amount of insulin beingdelivered.SET BOLUSIMM EXT 02:004.0U_ _UCONFIRM IMM EXT 02:00 4.0U_ _UPPCCOMMUNICATING08:23 JAN 04BOLUS 0.0U
Table of contents 21Set a Dual Wave bolusVariable Bolus Option Must be “ON.”The Dual Wave Bolus allows you to deliver an Immediate Bolus immediatelyfollowed by a Square Wave Bolus.1. From the Time/Date screen press SEL untilthe “BOLUS” screen is displayed. The lastbolus value programmed will be shown andthe Time and Date will be flashing.2. Press ACT and “SET BOLUS TYPE”appears.3. Use the  and  buttons to choose “DUAL”.4. Press ACT and “IMM” appears with thedashes underneath flashing.5. Use the  and  buttons enter an immediatebolus amount.6. Press ACT and the dashes underneath “EXT”will appear flashing.7. Use the  and  buttons enter an extendedbolus amount.8. Press ACT and dashes will appear under theextended bolus amount you just entered.9. Use the  and  buttons to enter a timeduration that you would like the extendedbolus to last.08:23 Jan 04BOLUSIMM EXTPROG_ _U_ _U_ _SET DUALBOLUS TYPESET BOLUSIMM2.0USET BOLUSIMM EXT 2.0U 2.0USET BOLUS IMM EXT2.0U 2.0U SET BOLUS IMM EXT 2.0U 2.0U02:00
Table of contents2210. Press ACT and the screen shows “CONFIRM” asking you to confirm theimmediate bolus, extended bolus, and timeduration.11. If the numbers you entered are correct, pressACT to confirm them. These values willnow be programmed into the Pump. If anynumber is not correct, wait for the screen toreturn to Time/Date and then repeat thisprocedure to enter the correct values.12. Place the PPC near the Pump to complete theprogramming. The PPC will beep once anddisplay the amount of insulin being delivered.13. If the Alarm Feedback feature is “ON,” thePump will beep during each of the first fivestrokes. 14. The PPC will beep when the bolus delivery is complete. Three segmentsof the insulin delivery icon will be displayed and spinning slowly duringthe bolus delivery. By pressing SEL you can see the amount of insulinbeing delivered.Review the bolus historyYou can review the bolus type, bolus amount, time and day of your last 512insulin boluses.1. From the Time/Date screen press SEL untilthe “BOLUS” screen is displayed. The lastbolus value programmed and the time anddate will be flashing.2. Press the  button once to display theprevious bolus and the time and date it wasdelivered. Each additional  press willdisplay the next previous bolus delivery.CONFIRM IMM EXT 02:00 2.0U 2.0UPPCCOMMUNICATING08:23 JAN 04BOLUS 0.0U08:23 Jan 04BOLUS_ _IMM EXTPROG_ _U_ _U
Table of contents 23Suspend modeSuspend Mode allows you to cancel bolus programming. In suspend mode thepump will still deliver a basal rate of approximately 0.2u/hr.1. From the Time/Date screen press SEL untilthe “SUSPEND PUMP” screen is shown.2. Press ACT.3. Place the PPC near the Pump to complete theprogramming. When communication isfinished the Pump will beep 3 times.4. All four segments of the insulin delivery iconwill be displayed.5. To restart the Pump, press SEL and ACT.Program basal ratesYour Basal Rate provides you with approximately 50 percent of your dailyinsulin needs. A Basal Rate is normally delivered all the time, throughout theday and night. Your PPC allows you to tailor your Basal Rates to meet yourchanging insulin needs throughout the day. If you want to, the PPC candeliver a different Basal Rate every 30 minutes throughout the day. For somepeople, one Basal Rate will work fine. Other people find that multiple BasalRates will help them respond better to their insulin needs. You should discusswith your doctor the number and amount of Basal Rates that are best for you.Set one basal rate1. From the Time/Date screen press SEL untilthe “BASAL RATE” screen is displayed.Basal Delivery Pattern “A” and the currentBasal Rate appear. The word “NOW” alsoappears and is flashing.SUSPEND PUMPPPCCOMMUNICATING08:13 OCT 02PUMP SUSPENDED BASAL RATE : A NOW00:00 0.2U/H
Table of contents242. Press ACT and “1” appears to the right of“A” indicating that you will now program thefirst Basal Rate “1” in Basal Delivery Pattern“A.” The Basal Rate is flashing.3. Use the  and  buttons to enter a new BasalRate.4. Press ACT and the screen displays “SETRATE,” indicating you will now program astart time for Basal Rate “2” The time isflashing.5. Use the  and  buttons to change time to dashes.6. To enter one Basal Rate, press ACT 2 times.NOTE: In 24 hr. display mode, “00:00” indicates a start timeof MIDNIGHT. In 12hr. display mode, the screen willread “12:00am.”7. Place the PPC near the Pump to complete theprogramming. The screen will display PPCcommunicating.8. The screen will calculate and briefly displaythe total daily Basal insulin from the BasalRates you have programmed. BASAL RATE: A 1 SET RATE00:00 0.2U/H BASAL RATE: A 2 SET RATE00:30 _ _U/HPPCCOMMUNICATING24 HOUR TOTAL4.8U
Table of contents 25Set multiple basal rates1. From the Time/Date screen press SEL untilthe “BASAL RATE” screen is displayed.Basal Delivery Pattern “A” and the currentBasal Rate appear. The word “NOW” alsoappears and is flashing.2. Press ACT and “1” appears to the right of“A” indicating you will now program BasalRate “1” in Basal Delivery Pattern “A.” TheBasal Rate is flashing.3. Use the  and  buttons to enter a new BasalRate.4. Press ACT and the screen displays “SETRATE”, indicating you will now program astart time for Basal Rate “2” The time isflashing.5. Use the  and  buttons to enter a new starttime.NOTE: In 24 hr. display mode, “00:00” indicates a start timeof MIDNIGHT. In 12hr. display mode, the screen willread “12:00am.”6. Press ACT and “SET RATE” and “2”appears, indicating you will now programBasal Rate “2” in Basal Delivery Pattern “A.”The Basal Rate is flashing. 7. Use the  and  buttons to enter a BasalRate and start time for Basal Rate #2.8. Continue this procedure until all desired BasalRates and start times are programmed. Thenpress  and ACT.9. Place the PPC near the Pump to complete theprogramming. BASAL RATE: A NOW00:00 0.2U/H BASAL RATE: A 1 SET RATE00:00 0.2U/H BASAL RATE : A 2 SET RATE04:30 _ _U/H BASAL RATE: A 2 SET RATE05:00 _ _U/HPPCCOMMUNICATING
Table of contents2610. The screen will calculate and briefly displaythe total daily Basal insulin from the BasalRates you have programmed.NOTE: To set multiple basal profiles in the other patterns (A,B, C), select the pattern in Setup II menu and followthe above procedure.Set a temporary basal rateA Temporary Basal Rate is often used when a brief change in basal delivery isrequired, for example during exercise.1. From the Time/Date screen press SEL untilthe “TEMP BASAL” screen is displayed.2. Press ACT and “SET DURATION” appearswith the Temporary Basal Rate durationflashing.3. Use the  and  buttons to enter aTemporary Basal Rate duration.4. Press ACT and “SET AMOUNT” appearswith the Temporary Basal Rate flashing.5. Use the  and  buttons to enter theTemporary Basal Rate, then press ACTagain.6. Place the PPC near the Pump to complete theprogramming.NOTE: When your Pump is delivering a Temporary BasalRate, pressing SEL will display “TEMP BASAL.” Thiswill remind you that the Temporary Basal Rate featureis currently active.24 HOUR TOTAL4.8U TEMP BASAL_ _ _ _U/HTEMP BASALSET DURATION00:30 _ _U/HTEMP BASALSET AMOUNT00:30 1.5U/HPPCCOMMUNICATING
Table of contents 27Stop a temporary basal rate 1. From for the Time/Date screen press SELuntil the “TEMP BASAL” screen isdisplayed.2. Press ACT and “SET DURATION” willappear with the time flashing.3. Press the  button until the time is set todashes, then press ACT.4. Place the PPC near the Pump to complete theprogramming.5. When the communication is finished, “SETAMOUNT” will appear with the dashesflashing. Allow the PPC to return to the Time/Date screen or press ACT. The TemporaryBasal Rate is now canceled. Personal events This feature appears in the Main menu if it has been activated to "ON" in thePump Setup II menu. The Personal Event menu allows you to enter important“events” during the day.Preset eventsYou can enter the following preset codes for these popular events:• 1 = meal• 2 = snack•3 = sick• 4 = exerciseAdditional eventsCodes A, B and C can be used to record other events. Be sure to document theevents listed for A, B, and C. NOTE: Events that happened in the past or present can beentered.TEMP BASAL1.5U/H00:30SET DURATIONPPCCOMMUNICATINGTEMP BASALSET AMOUNT_ _ _ _U/H
Table of contents281. From the Time/Date screen, press SEL untilthe “SET PERSONAL EVENTS” screen isdisplayed.2. Press ACT and the screen will change to“SET EVENT” with “MEAL” flashing.3. Use the  and  buttons to select the eventyou want to enter: MEAL, SNACK, SICK,EXERCISE, A, B, C.4. Press ACT and the time will appear flashing.5. Use the  and  buttons to enter the timethat the event occurred.6. Press ACT to enter the event in the PPCmemory.HistoryThe History menu allows you to look at important Pump data, such as theamount of insulin remaining in the Pump reservoir or total insulin deliverysince the last refill. The History menu contains the following options: MedRemaining, Insulin Total Basal Bolus, Clinical Hist PPC, Clinical HistoryPump, Est Pump Battery. To read Pump Data perform the following steps.From the Time/Date screen, press SEL until the“HISTORY” screen is displayed.1. Press ACT and the screen will change to“READ PUMP DATA” with the entire screenflashing.EVENT_ _SETEVENTMEALSET TIME EVENTMEAL08:32AmHISTORYREAD PUMP DATA• • • • • • • • • • • • • • • •• • • • • • • • • • • 10057
Table of contents 292. Press ACT, place the PPC near the Pump.History data will be transferred to the PPC.3. The screen will automatically change to “MEDREMAINING.” The amount of insulin in thePump reservoir is reported in units.4. Press SEL and the screen will change to“INSULIN TOTAL.” The amount of BasalRate and Bolus insulin delivered is reported forthe day indicated.5. Press the  button to review insulin deliveryrates for other days.6. Press SEL and the “CLINICAL HISTORYPPC” screen is shown. Ask your doctor whatthe numbers mean.7. Press the  button to review other days.8. Press SEL to find the “CLINICAL HISTORYPUMP” screen. Ask your doctor what thenumbers mean. Press the  button to reviewother days.9. Press SEL and the screen will change to the“EST PUMP BATT” display. This screenindicates the energy left in the Pump battery.Ask your Physician what the numbers mean.10. Press SEL and the screen will read “EXIT HISTORY.” Press ACT to return to theTime/Date screen.PPCCOMMUNICATINGMED REMAINING7263U Jan 02INSULIN TOTALBASAL BOLUS9U 22U6:26 Jan 02CLINICAL HISTORYPPC116:26 Jan 02CLINICAL HISTORY14PUMP Jan 02EST PUMP BATTERYNO LD LD2.9U 2.7UEXIT HISTORY
Table of contents30Pump setupThis screen permits access to other Pump “SETUP” features. These featuresare normally programmed for you by your doctor or nurse. To reach the“SETUP PUMP” menu, press SEL until the “SETUP PUMP” screen is dis-played, then ACT to access the SETUP screens.Time and dateThe time and date settings must be correct. The PPC uses the time and date tocalculate your total daily insulin and display Pump history.1. From the Time/Date display, press SEL untilthe “SETUP PUMP” screen is displayed.2. Press ACT two times. The hour digits willbegin flashing. Use the  and  buttons toselect the current hour.3. Press ACT again, and the minute digits will begin flashing. Use the  and buttons to select the current minute.4. Repeat this programming process again to select the current year, monthand day.5. At the conclusion of programming press ACT,and then place the PPC near the Pump. Whenthe communication process is complete, thePPC will automatically move to the nextscreen, “AUTO OFF.”08:32 Jan 02SET 2004TIME-DATEPPCCOMMUNICATING
Table of contents 31Auto off“AUTO OFF” sets an alarm on your PPC to remind you if you have not pro-grammed your Pump recently. The “AUTO OFF” alarm can be set between 1and 16 hours. To turn off the "AUTO OFF" program set the time to dashes.1. From the “SETUP PUMP” screen, press ACTthen SEL.2. The screen will display “AUTO OFF” withflashing dashes. Press ACT.3. Use the  and  buttons to select the numberof hours before an Auto Off alarm occurs.4. Press ACT. In this example, a time duration of10 hours was selected. The PPC will alarm ifyou did not program your Pump during thepast 10 hours.5. Place the PPC near the Pump. The PPC willbeep once when the communication iscompleted.AlarmsThere are three PPC Alarm options, two audible tones (Low/High) and avibrate mode.“ALARMS” will alert you if either the PPC or Pump recognizesa problem. The vibrate only alarm provides all programming feedback fromPPC with beeps.1. Press ACT on the ALARMS menu to enterthe “ALARMS” menu.AUTO OFF_ _ HRSAUTO OFF 10 HRSSETPPCCOMMUNICATINGALARMS
Table of contents322. Press the  and  buttons to select the typeof alarm you want, then press ACT.3. The screen will now display “SETALARM FEEDBACK.” This setting shouldalways be “ON”. Press ACT.4. Place the PPC near the Pump. When thecommunication is completed, the PPC willchange to “SELF TEST” and then timeout tothe Time / Day screen.Self testYour doctor may ask you to run a diagnostic test of your Pump System.“SELF TEST” will send messages between your PPC and Pump to checktheir operation.NOTE: Notify your doctor if any of these Self Test events donot occur.If the PPC displays a Medtronic MiniMed logo andsoftware number, the PPC has re-started but has a lowbattery. Replace the battery immediately.1. From the “SETUP PUMP” screen, press SELuntil the “SELF TEST” screen is displayed.2. Press ACT.3. Place the PPC near the Pump and completethe communication process.4. Verify the following events occur:The Pump will beep four times.The PPC backlight will turn on.SETPPCALARM TYPE LOW/HIGH/VIBRATESETALARMFEEDBACK ON/OFFPPCCOMMUNICATINGSELF TESTPPCCOMMUNICATING
Table of contents 33The PPC will sound a long changing tone.The PPC will vibrate.The PPC will beep once.The PPC screen displays all possible icons and numbers.5. If your PPC and Pump “pass” the Self Test,the display will change to “PPC PASSED/PUMP PASSED.” After several seconds, thescreen will change back to the Time/Datescreen.Basal delivery patternsThe PPC allows you to program three different basal delivery patterns (A, B,C). Pattern A is preset at the factory. Patterns B and C can be programmedfrom the “SETUP PUMP” menus. Each basal rate pattern can accept up to 48different basal rates, one for each half-hour of the day. These are programmedfrom the "Basal Rate" screen in the Main Programming menu.Basal patterns can be used to follow your normal daily routines. For example,separate patterns could be programmed for a typical work day, weekend day,and travel day. 1. From the “SETUP PUMP” screen, press SELuntil the “DELIVERY PATTERN A” screenis displayed. Press ACT.2. Press SEL again until the “DELIVERYPATTERN” screen appears. Press ACT andthe screen will change to “SET DELIVERYPATTERN”.3. Press the  and  buttons to selectpattern A, B or C.4. Press ACT. Place the PPC near the Pumpand allow the communication tocomplete.PPC PUMPPASSED PASSED DELIVERY APATTERNDELIVERY A,B,CPATTERNSETPPCCOMMUNICATING
Table of contents34NOTE: The PPC will automatically return to the Time/Datescreen. Press SEL until the “BASAL RATE” screen isdisplayed. The pattern you have selected will appearon this screen.Initialize PPC to pumpThis screen initializes your PPC to your Pump. Your doctor will normally per-form this programming for you. Contact your doctor if you need to have yourPPC replaced.Pump Setup II“SETUP II” is another programming menu. “SETUP II” features are used lessoften than the features in “SETUP.” “SETUP II” features are explained in thenext section. Exit Setup MenuFrom the “SETUP” screen, press SEL until the “EXIT SETUP MENU”screen is displayed. Press ACT. The PPC will return to the Time/Date screen.
Table of contents 35Pump Setup II The “SETUP II” screen allows you to program additional features into yourPPC. Your doctor will normally program “SETUP II” features for you.1. From the “SETUP” screen, press SEL until the “SETUP II” screen isdisplayed. Turn on the audio bolus featureThe “AUDIO BOLUS” feature allows you to deliver a bolus without lookingat the PPC screen. There are two step sizes you can select, 0.4U and 0.8U.With each press of the  button, the PPC will beep one time (0.4U setting) ortwo times (0.8U setting) depending on the delivery amount selected per keypress.1. From the “SETUP II” screen, press ACT. The“AUDIO BOLUS” screen appears.2. Press ACT, and the screen changes to “SETAUDIO BOLUS” with “ON” flashing.3. Use the  and  buttons to choose “ON” toturn on the Audio Bolus feature. Choose“OFF” to turn the Audio Bolus off. PressACT again.NOTE: If “OFF” is chosen, pressing the  and  buttons willhave no effect.4. If “ON” was chosen, the “SET STEP AUDIOBOLUS” screen appears, with a bolus amountof 0.4U flashing.5. Use the  and  buttons to choose a step sizeof either 0.4U or 0.8U.6. Press ACT and program the Pump. “AUDIO BOLUS” will now appearon the PPC Main Menu.AUDIO BOLUSON0.4U SET AUDIO BOLUSON0.4U SET STEP AUDIO BOLUSON0.4U
Table of contents36Use audio bolus in the Main MenuNOTE: When an immediate bolus is being delivered, the button will be disabled.From the Time/Date screen press  button. Each time the  button is pressedthe PPC will beep one or two times, depending upon the step size set (0.4U or0.8U). 1. Count the number of beeps to determine howmuch insulin you want to program. The bolusamount delivered is determined by the stepsize and the number of times the  button ispressed. For example: If the step size isprogrammed to 0.4U and the  button ispressed three times, the total bolus delivered will be 1.2U (3 x 0.4U).2. Press ACT, and the beeps repeat to confirmthe bolus amount you have entered.3. Press ACT twice, and the PPC will programthe Pump. The PPC will beep once when thecommunication is completed.Turn on the Variable Bolus featureIf “OFF” is chosen, the Variable Bolus feature will not be available.1. From the “SETUP II” menu, press SEL untilthe “VARIABLE BOLUS” screen isdisplayed.2. Press ACT and the screen changes to “SETVARIABLE BOLUS.” The word “ON” isflashing.3. Use the  and  buttons to select “ON” or“OFF.”SET BOLUSIMM12UPPCCOMMUNICATINGVARIABLE ON/OFFBOLUSVARIABLE ONBOLUSSET
Table of contents 374. Place the PPC near the Pump and completethe communication. 5. If “ON” was chosen, the Variable Bolusoption will appear in the Main Menu / Bolusscreen.Set a maximum bolusYour doctor will decide if you should use this feature. Setting a maximumbolus amount will minimize the chance of you over-delivering insulin in caseyou make a programming mistake.1. From the “SETUP II” menu, press SEL untilthe “MAX BOLUS” screen is displayed.2. Press ACT and the screen will change to“SET MAX BOLUS,” with the dashesflashing.3. Use the  and  buttons to enter amaximum bolus amount (0.0U to 25.0U),then press ACT.4. Place the PPC near the Pump and completethe communication. The PPC screen willautomatically change to the “MAX BASALRATE” screen and then times out to the Time/Date screen if no further action istaken.PPCCOMMUNICATINGMAX BOLUS_ _ UMAX BOLUS_ _USETPPCCOMMUNICATING
Table of contents38Set a maximum basal rateYour doctor will decide if you should use this feature. Setting a maximumbasal rate will protect you from over-delivering insulin in case you make aprogramming mistake.1. After setting a maximum bolus, the “MAX BASAL” screen appears withthe maximum basal rate flashing. 2. Use the  and  buttons to enter a maximumbasal rate (0.2U/h to 35.0U/h), then pressACT.3. Place the PPC near the pump and completethe communication. The PPC screen willautomatically change to the “TIMEFORMAT” screen.Set time format1. From the “SETUP II” screen, press SEL untilthe “SET TIME FORMAT” screen isdisplayed.2. Use the  and  buttons to select either a 12hour (12:00am) or 24 hour (00.00) timeformat, then press ACT.3. Place the PPC near the pump and completethe communication. The PPC screen willchange to the “PERSONAL EVENTS”screen. MAX BASAL RATESET0.2U/HPPCCOMMUNICATINGSETTIME FORMAT 12/24 HOURPPCCOMMUNICATING
Table of contents 39Personal eventTo activate this feature located in the Main Menu it must be "ON."1. From the "SET UP II" screen, press SELuntil the "PERSONAL EVENTS" screen isdisplayed.2. Press ACT and the "SET PERSONALEVENTS" screen is displayed and "OFF" isblinking. 3. Use the ▲ and ▼ buttons to select "ON" or"OFF." Press ACT.4. Place the PPC near the Pump and completethe communications. The PPC screen willchange to "PUMP SET UP."Pump setupThis screen allows you to return to the Setup mode by pressing ACT. If youpress SEL the screen will change to “EXIT SET UP MENU.”Exit Setup MenuThis screen allows you to return to the Main Menu, Time/Date screen bypressing ACT.EVENTSPERSONAL OFFEVENTSOFFPERSONALSETPPCCOMMUNICATING
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41CHAPTER 5 Alarms and messagesThe Medtronic MiniMed 2007D Implantable Insulin Pump System isequipped with various alarms and messages that ensure the correct function ofthe system.The pump alarmsThe Implantable Insulin Pump has an alarm system which beeps when anerror condition occurs. The beeps are audible through the skin and alert youthat the Pump needs attention. The Pump alarm consists of 4 beeps eachminute for 10 minutes then, 4 double tones each minute for 10 minutes andwill then repeat pattern. Upon hearing the alarm, you need to communicatewith your PPC to determine the alarm condition and call your Physician. Usethe Read Pump Data option to communicate to the Pump. The alarm can becleared by pressing SEL and ACT.
Table of contents42The PPC alarmsThe PPC has three types of alarms, audible or vibrate alarms and visualalarms. This chapter will describe, for each alarm condition, which screenmessage appears. Some alarms can be cleared by pressing SEL then ACT. The differencebetween these alarms will be explained later in this chapter. Two audible or vibrate alarm types are used:Alarm type 1 If the PPC is set to “vibrate”, the vibrator will be turned on for 3 secondsevery minute until the condition is cleared. If the PPC is set to “audible”, the PPC will beep 6 times every minute for 30minutes. If the alarm is not cleared in 30 minutes, the PPC will beep 6 alter-nating tones. The PPC will continue to do so every minute until the conditionis cleared.Alarm type 2 If the PPC is set to “vibrate”, the vibrator will be turned on for 3 secondsevery minute while the condition exists. If the PPC is set to “audible”, the PPC will emit 6 beeps, 3 times for every 30minutes while the condition exists.
Table of contents 43Pump alarmsAlarm feedbackThe Alarm Feedback function allows you to verify the Pump and the Pumpbeeper are operating normally. When Alarm Feedback is programmed “YES,”the Pump will beep on each of the first five Pump strokes:• Following a change in the delivery regimen, for example whencompleting a meal Bolus and then changing to a Basal Rate.• After the Alarm Feedback function is programmed “YES.” AlarmFeedback will stay on until programmed back to “NO.” Pump low batteryThe Implantable Insulin Pump battery is designed to last approximately sevenyears during conditions of normal use (see Chapter 9, Technical Specifica-tions). Battery life may vary somewhat depending upon your insulin deliveryrequirements. When battery energy becomes low, a voltage sensor in thePump will trigger the Pump Low Battery Alarm. A Pump Low Battery Alarmindicates there are approximately eight weeks of battery energy remaining.You can clear this condition and your Pump will continue to operate normally.However, you should notify your doctor as soon as possible. Your doctor willthen schedule a Pump replacement, and may switch you back to conventionalinsulin therapy. Depleted pump batteryWhen there is no longer sufficient battery energy to power the Pump, thePump Low Battery Alarm will cease. This means that insulin delivery hasstopped. You must switch to another type of insulin therapy.PPC display Type of alarm Pump alarmPUMP LOW BATTERY 1 In 24 hours if no PPC communication
Table of contents44System errorThe Implantable Insulin Pump has a sophisticated self-monitoring system thatcontinuously checks for circuit faults. If the Pump detects a circuit error, itwill beep and then automatically shut itself off. When this occurs, youmust switch to your alternative insulin therapy established between youand your doctor. Notify your doctor immediately of the System Error.Pump self test failIf during a “SELF TEST,” the Pump finds a malfunction. The Pump will stopdelivering insulin. Clear the message by pressing SEL then ACT. You mustswitch to your alternative insulin therapy established between you andyour doctor. Notify your doctor immediately of the Self Test Error.PPC display Type of alarm Pump alarmPUMP STOPPED1 or 2 or 3 or 4 or 5 or 61 In 5 minutes if no PPC communicationPPC display Type of alarmPUMP SELF TEST FAIL1
Table of contents 45PPC alarmsThe PPC offers a choice of two alarms, audible and vibrate. In addition, ascreen message appears indicating the type of alarm condition that occurred.PPC low batteryIf the PPC main battery (AA 1.5 volt alkaline) energy is low, the followingalarm display will appear:You can clear this message by pressing SEL and then ACT, and then continueprogramming. There should be sufficient energy in the battery for at least 24hours. For instructions on changing the battery, refer to Chapter 8, PPC Careand Maintenance.NOTE: If while programming the Pump the PPC screen goesblank, the PPC beeps six times and then the "CHECKPUMP STATUS" message appears, the PPC (AA 1.5volt alkaline) battery needs to be replaced. Forinstructions, see "Installing/Replacing the MainBattery" in Chapter 8.Low reservoirWhen the Pump calculates that less than 800 units (2 ml) of insulin remains inits reservoir, the following display will appear:You can clear this message by pressing SEL and ACT, and then continue pro-gramming. You should notify your doctor of the Low Reservoir message, andschedule a Pump refill appointment as soon as possible.PPC display Type of alarmPPC LOW BATTERY1PPC display Type of alarm Pump alarmLOWRESERVOIR1 In 24 hours if no PPC communication
Table of contents46Empty reservoirWhen the Pump calculates that less than 400 units (1 ml) of insulin remain inits reservoir, the following display will appear:You can clear this message by pressing SEL and ACT, and then continue pro-gramming. The PPC Medication Remaining function reads calculated valuesonly, and there may still be some insulin left in the Pump reservoir. Youshould report this alarm to your doctor as soon as possible, and schedule anappointment for a Pump refill. It is important not to allow the pump to depleteits insulin supply as this may result in a catheter blockage.Communication errorIf programming is interrupted after partial transmission of a command, thePPC will display the following message on the display screen:You should reposition the PPC near the pump, press SEL and ACT. The PPCwill attempt to resume communication with the Pump. PPC display Type of alarm Pump alarmEMPTYRESERVOIR1 In 24 hours if no PPCcommunicationPPC display Type of alarmCOMM ERROR RE-ATTEMPT 1
Table of contents 47Battery replacementIf the PPC main battery (AA 1.5V alkaline) has been replaced or the PPC rec-ognizes the “PUMP STATUS” needs to be checked, the following message isdisplayed:Place the PPC near the pump, then press SEL and ACT. Allow the communi-cation to complete.NOTE: If while programming the Pump, the PPC goes blank,the PPC beeps six times and then the "CHECK PUMPSTATUS" message appears, the PPC (AA 1.5Valkaline) battery needs to be replaced. Forinstructions, see "Installing/Replacing the MainBattery" in Chapter 8.Pump suspendedIf the Pump operation has been suspended, the following message is dis-played:During “SUSPEND PUMP,” the Pump will deliver a basal rate of 0.2 U/h. To restart insulin delivery programming, press SEL and ACT. Thenplace the PPC near the Pump and allow the communication to complete. PPC display Type of alarmCHECK PUMP STATUS 1PPC display Type of alarmPUMP SUSPENDED2
Table of contents48Auto offIf the “AUTO OFF” time interval elapses, the following message is displayed:The Pump will initiate the internal alarm sequence of four beeps every minutefor 5 minutes, then double-beep 4 times every minute for 10 minutes, thenrepeating the pattern. The alarm is cleared by pressing SEL and ACT, placethe PPC near the Pump. The PPC will communicate with the Pump to resetthe "Auto Off" duration.Hourly maximum exceededIf you attempt to deliver more than 2.5 times the pre-programmed bolus max-imum in one hour, the following message will be displayed:Press SEL and ACT, place the PPC near the Pump and allow the communica-tion to complete. You may exceed this limit by programming another boluswithin 10 minutes.PPC display Type of alarmAUTO OFF PUMPPUMP SUSPENDED1PPC display Type of alarmHOURLY MAXEXCEEDED1
Table of contents 49Personal Pump Communicator messagesDisplay screen message Message meaning or action requiredAUTO OFF PUMPPUMP SUSPENDEDAuto Off time interval has elapsed. Pump operation is suspended.BOLUS 0.0 u A bolus has been programmed and is being delivered.CHECK PUMP STATUSThe PPC battery has been replaced. The PPC needs to check the Pump status.EMPTY RESERVOIR The PPC has recognized the Pump has 400 units (1 ml) or less insulin remaining in its reservoir. Schedule a Pump refill as soon as possible. Allowing the reservoir to completely empty may damage the Pump.HOURLY MAX EXCEEDEDYou attempt to deliver more than 2.5 times the bolus maximum in one hour. To clear the message, press SEL and ACT. You may exceed this limit by programming another bolus within 10 minutes.LOW RESERVOIR The PPC has recognized the Pump has 800 units (2 ml) or less insulin remaining in its reservoir. Schedule a Pump refill as soon as possible. Allowing the reservoir to completely empty may damage the Pump.PPC LOW BATTERY The PPC can be programmed. Replace the PPC AA 1.5 volt alkaline battery.PUMP LOW BATTERYThe Pump battery energy is low but still functioning. Schedule a replacement as soon as possible.PUMP RESET The Pump was reprogrammed to the preset factory values.PUMP SELF TEST FAIL A Pump malfunction was detected during a Self Test. Notify your physician immediately.PUMP STOPPED1 or 2 or 3 or 4 or 5 or 6When the Pump recognizes a system malfunction, it automatically stops and insulin delivery ceases. Notify your physician immediately.PUMP SUSPENDED The Pump is in suspend modeTELEMETRY COMM ERROR 3 The PPC and Pump are not communicating. Reposition the PPC over the Pump, then press SEL and ACT. If the error message persists, notify your physician immediately.
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51CHAPTER 6 Warnings and precautionsWarningsElectrotherapyThe Medtronic MiniMed 2007D Implantable Insulin Pump System has beentested with electrosurgical cutting tools, electrocoagulation, and cardiacdefibrillation medical equipment. Typical use of this type of device has notaffected the Pump. However, after such procedures you should test the Pumpfunction (e.g., program “SELF TEST”) to determine that the Pump and PPCare operating properly. If the system is not performing correctly, contact yourdoctor.Diagnostic ultrasound The Medtronic MiniMed 2007D Implantable Insulin Pump System has beentested with diagnostic ultrasound procedures. These procedures have no effecton the Pump. However, after such procedures you should test the Pump func-tion (e.g., program a “SELF TEST”) to determine that the Pump and PPC areoperating properly. If the system is not performing correctly, contact yourdoctor.Ultrasound therapyThe Medtronic MiniMed 2007D Implantable Insulin Pump System should notbe exposed to therapeutic ultrasound procedures, such as lithotripsy. Exposureto ultrasound therapy may damage the Pump System.Diagnostic radiationThe Medtronic MiniMed 2007D Implantable Insulin Pump System has beentested with Computerized Tomography and X-ray. These procedures have noeffect on the Pump. However, after such procedures you should test the Pumpfunction (e.g., program a “SELF TEST”) to determine that the Pump and PPC
Table of contents52are operating properly. If the system is not performing correctly, contact yourdoctor.Therapeutic radiationThe Medtronic MiniMed 2007D Implantable Insulin Pump System has beentested with therapeutic radiation. These procedures have no effect on thePump. However, it is recommended not to focus therapeutic levels of radia-tion directly over the pump. After such procedures, you should test the Pumpfunction (e.g., program a “SELF TEST”) to determine that the Pump and PPCare operating properly. If the system is not performing correctly, contact yourdoctor.Magnetic resonance imagingYou cannot undergo Magnetic Resonance Imaging procedures with theMedtronic MiniMed 2007D Implantable Pump System.Pump and catheter under-deliveryUnder-delivery or “backflow” may occur when insulin deposits collect in thepumping mechanism inside your Pump. These deposits affect the vacuum sealin the pumping mechanism, and can prevent some of the insulin from beingdelivered. If the pumping mechanism is unable to seal tightly, the pump willunder-deliver its insulin.If your Pump is under-delivering insulin, you may feel symptoms of hypergly-cemia. If this occurs, you should contact your doctor immediately. Your doc-tor will instruct you on how to manage your blood glucose levels until thePump can be corrected.Another under-delivery condition can also be caused by body fluids or bodytissue collecting at the tip of the Catheter. To correct a Catheter obstruction,your doctor may need to flush your Catheter with a sterile solution.Pump electronic or alarm malfunctionIf the Pump’s electronic or alarm systems malfunction, Self Test circuitry willdetect the malfunction and may stop the Pump. Notify your doctor immedi-ately if this occurs. If your doctor cannot correct the malfunction, your Pumpmay need to be replaced and you will need to take alternative insulin therapy.
Table of contents 53Reservoir level warningsHave your Pump refilled before the reservoir is empty. Alarms in the PPC willalert you to low and depleted reservoir levels. For more information on alarmsand messages, see Chapter 5. If the low reservoir alarm sounds and you do nothave a refill appointment scheduled within two weeks, call your doctor imme-diately to schedule a refill. Environmental conditionsNOTE: If you are in doubt about whether a condition orsituation will affect your Pump, contact your doctorfor advice.The Implantable Insulin Pump, like all microelectronic devices, should not beexposed to extreme electrical or magnetic fields or temperature extremeswhich may adversely affect the Pump and its insulin. Do not allow yourImplantable Insulin Pump to be exposed to the following environmental con-ditions:• Physical damage to the Pump and the Pump pocket• Altitudes greater than 2500 meters or 8,000 feet (skiing, hiking, sky-diving)• Depths greater than 4 meters or 15 feet (scuba diving, etc.)• Elevated temperatures (hot tubs, saunas)Avoid any sharp blows or pressure on the Pump. A direct blow may damagethe Pump or injure the Pump pocket. Extreme pressure on the Pump maycause the sutures and the tissue pocket to be damaged resulting in Pumpmigration and a possible dislodging of the Catheter. If you suspect that yourPump or Pump pocket have been damaged, you should contact your doctorimmediately. You may need to wear a pressure bandage or reduce your levelof physical activity until the Pump pocket heals completely.You may not reside at or travel to an elevation in excess of 8,000 feet, or divebelow 15 feet. High altitudes and depths will change the Pump’s insulin flow.This warning does not apply to commercial airline travel. Airline cabins areadequately pressurized at any altitude for Pump use. It is still possible to ski,dive or sky-dive with the proper precautions. Consult your doctor.Exposure to elevated temperatures in excess of 104 degrees Fahrenheit (i.e.hot tubs, saunas) for longer than one hour can effect the potency of the insulin
Table of contents54and the function of your Pump System (see “Pump and Catheter Under-deliv-ery” on the previous pages). If you have any questions about an activity youare planning, you should contact your doctor for advice.This device may experience communication interruptions when operated at ornear some airport facilities. This will not affect the operation of the pump,and it will continue delivery of insulin per previously programmed levels.PrecautionsBlood glucose monitoringYou must check your blood sugar at least four times daily, using a techniquerecommended by your doctor. Notify your doctor of any increased frequencyof serious low or high excursions in your blood sugar. High blood sugar val-ues may indicate under-delivery of insulin. If you experience symptoms ofhigh blood sugar, check the programmed insulin delivery settings in your PPCand contact your doctor immediately.Conventional insulin suppliesCarry conventional insulin supplies with you at all times, including insulinand a means to inject it, in case your PPC is damaged, lost or inoperative.Periodically review with your doctor your recommended insulin delivery pro-cedure you should utilize in the event your MedtronicMiniMed 2007D Implantable Pump System becomes inoperative.Physician’s instructionsFollow your doctor’s instructions about your insulin delivery. The range ofinsulin delivery with your PPC is a basal rate between 0.2 and 35 units perhour (U/H), and a maximum meal bolus of 25 units (U). Your doctor may nar-row this range by programming maximum limits for your Basal Rate andBolus. The alarm “Hourly Maximum Exceeded” will be displayed if you tryto program more than 2.5 times the maximum bolus in one hour.PPCThe PPC is an electronic device and can be damaged if dropped. Do not getthe PPC wet or take it into very hot or humid environments, such as steambaths or saunas. If the PPC is damaged, check the displays for proper opera-tion by performing a “SELF TEST”. If the “SELF TEST” finds a problem,
Table of contents 55you will need to replace your PPC. For more information on the “SELFTEST” procedure, see Chapter 6, Warnings and Precautions.Maximum dosagesYour doctor may program specific limits for your Basal Rate and Meal Bolus.These maximum limits provide a regimen specific to your needs.Battery changeCarry a fresh AA 1.5-volt alkaline battery with you at all times. The estimatedPPC main battery life is approximately 6 weeks, although this can be influ-enced by how often you program your Pump. If the Low Battery messageappears, change the battery as soon as possible, preferably immediately.Proper PPC positioningKeep the PPC near to the Pump during a programming sequence. Separationof the PPC and Pump may result in a partial transmission of a command. Ifthis occurs, the PPC will alarm and display “COMM ERROR RE-ATTEMPT” on the screen.Physical activities to avoidPhysical activities which are not permitted are those involving very HIGH orLOW altitudes and pressure changes. Such activities include skiing, (above8,000 feet), sky diving, and scuba diving. When you must participate in suchactivities, discuss them with your physician who will provide treatmentrequirements, such as the temporary use of another method of insulin delivery,and will refill your Pump with buffer. Emergency planBe fully informed and thoroughly understand what to do in an emergency.Carry your emergency card with you at all times. Additionally, it is importantfor individuals close to you, such as family, friends, and co-workers, to knowwhat to do if you are unable to treat yourself due to illness or injury.The following instructions should be used by your family or friends to set thePump to the lowest basal rate while your doctor is consulted:1. Press SEL until the PPC displays “SUSPEND PUMP”.2. Press ACT, the PPC will indicate “PPC COMMUNICATING”.
Table of contents563. Position the PPC near the Pump.4. When programming is complete, the PPC will beep and the display willautomatically return to the Time/Day screen. The message “PUMPSUSPENDED” will be displayed. The Pump will deliver a basal rate ofapproximately 0.2 U/h.In addition to the procedure above, review with family members the properprocedure for administering glucagon. It is important to closely monitor blood sugar levels on refill days. During arefill procedure, a very small amount of insulin may be deposited subcutane-ously possibly resulting in hypoglycemia.Adverse reactionsIn clinical studies, adverse reactions associated with the Medtronic MiniMed 2007 Implantable Insulin Pump System included hypoglycemia,diabetic ketoacidosis, hyperglycemia, skin erosion, infection, abnormal heal-ing, elevated anti-insulin antibodies, intestinal obstruction, post-operative dis-comfort and pain. Malfunctions in the order of frequency and seriousnessinclude insulin aggregation resulting in Pump under-delivery, Catheter occlu-sion or tissue overgrowth, early Pump battery depletion and electronic Pumpfailure. Adverse events associated with the use of Aventis HOE 21 PH U-400insulin are described in the package insert accompanying the insulin medica-tion.HyperglycemiaYour Implantable Insulin Pump uses a special regular insulin, so your bodywill not have any reserve of long-acting insulin. Interruption of insulin deliv-ery (due to Pump malfunction or clogging of the Catheter) or the sudden onsetof stress (emotional upset, infection, etc.) may result in a rapid rise of bloodsugar levels, and possibly the development of diabetic ketoacidosis (DKA).Check your blood sugar levels, and your urine for ketones, if you suspect ahigh glucose level. Supplemental insulin delivered by conventional meansmay be required. Establish a protocol with your doctor for rapidly identifyingand treating hyperglycemia to avoid the onset of DKA.
Table of contents 57HypoglycemiaThe best method for identifying hypoglycemia is testing your blood sugar lev-els. Establish a protocol with your doctor for identifying and treating symp-toms of hypoglycemia to avoid an insulin reaction.Pump pocket infectionPump pocket infection, although rare, occurs around the Pump implantationsite. If you notice pain, redness, or swelling in the area of your Pump, contactyour doctor immediately. Pump pocket infections may require the removal ofyour Pump.Pump pocket seromaA Pump pocket seroma is generally characterized by swelling around the areaof implantation. It may occur after surgery or if a blow is received to thePump site. If you notice swelling around your Pump, contact your doctorimmediately.
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59CHAPTER 7 Important Self-CareHaving a Medtronic MiniMed 2007D Implantable Insulin Pump System isonly one aspect of an overall management program to treat your diabetes.There are many other requirements for achieving near normal blood glucoselevels.This manual presents general information regarding blood glucose monitor-ing, meal planning, exercise and other issues concerning your implantablePump. You will be instructed more specifically on these self-care issues byyour doctor, nurse, and dietitian. Be sure to discuss all questions with them asthey are your best source of information.A support person such as a family member or friend should also read thismanual and pay particular attention to the section entitled, “Emergency Plan”in Chapter 6. Your support person should also be able to program the PPC tostop insulin delivery as described in Chapter 6. Blood glucose monitoringNOTE: Remember much of the success of implantable pumptherapy depends on accurate and frequent bloodglucose monitoring. Your Pump System does not monitor your blood glucose levels. You mustcontinue to self-monitor your blood glucose at least four times daily, and thenuse this glucose information to program your Pump System. Blood glucosemonitoring is the only way to determine if you are receiving the correctamount of insulin. You should test your blood glucose according to themethod recommended by your doctor. If you begin to have a problem with glycemic control, it is very important torecord your blood glucose measurements. A careful record may help deter-mine if the problem is related to your Pump or another cause.
Table of contents60Meal planYou will always receive some basal insulin from your Implantable InsulinPump. When you program a meal bolus, this will be in addition to your basalrate. As with any insulin therapy, it is recommended that you keep some form offast-acting sugar with you at all times to treat hypoglycemia. If you have anyquestions concerning your meal plan and insulin therapy, discuss them withyour healthcare team as they are your best source of information.Daily activitiesThere are no restrictions on your normal work, school, social, or sexual activ-ities unless you have a medical condition which does not allow such activities.Because your Pump is implanted, you may bathe and shower without anyinterruption in insulin therapy. However, your PPC is not waterproof andshould be protected from getting damp or wet.ExerciseYou may participate in most physical activities with your Medtronic MiniMed 2007D Implantable Pump Insulin System. Rough contact sports arenot recommended as Pump pocket injury may occur. Exercise may reduceyour insulin requirements, therefore, you must check your blood glucose fre-quently during periods of exercise. In addition, it may be necessary to reduceyour basal rate during the exercise.TravelYou may travel with your Medtronic MiniMed 2007D Implantable InsulinPump System. All extended trips should be discussed with your doctor. It issafe to travel in a pressurized aircraft, which includes all commercial airlines.Security systems at airports will not affect your Pump, but you may be askedto show your Patient Emergency Information Card which explains the Pumpand PPC. Remember to always carry conventional insulin supplies with youwhen you travel (insulin and syringes or an external Pump) in case of a medi-cal emergency.
Table of contents 61Medtronic MiniMed information cardYour doctor will give you a Patient Emergency Information Card when youreceive your Pump System. It provides information about your Pump, as wellas important phone numbers in case of a medical emergency. Carry YourInformation Card With You At All Times. It is also recommended that youwear a bracelet or necklace indicating that you have an implantable insulinPump.
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63CHAPTER 8 PPC Care and MaintenanceInstalling/replacing the main batteryPPC Battery life is estimated to be approximately 4 weeks. Only AA 1.5 voltalkaline battery is recommended for use with the PPC. To replace the PPCMain Battery: 1. Locate the battery door on the back of the PPC.2. Slide the locking bar to the left.3. Push the middle part of the PPC box (under the battery door) and lift bygently pulling up the battery door to unlatch.4. Remove the old battery, noting the polarity. The PPC screen will be blank.5. Position the new battery so the + and - markings on the battery match thepolarity diagram in the battery compartment.6. Close the battery door.7. Slide the locking bar to the right.8. The PPC screen reappears after 30 seconds.9. The PPC will beep six times and display “PPC/PUMP.”10. After a few seconds, the screen will change to“CHECK PUMP STATUS.”11. Press SEL and ACT, then place the PPC overthe Pump.PPC 8 102 100PUMP 3 100 34808:26 JAN O2CHECKPUMP STATUS
Table of contents6412. Allow the communication to complete.NOTE: When the PPC displays “PPC LOW BATTERY,” youcan clear the message and continue programming.There should be sufficient energy in the battery tocommunicate with the Pump. If while programming thePPC goes blank, the PPC beeps six times and then the"CHECK PUMP STATUS" message appears, the PPC(AA 1.5v alkaline) battery needs to be replaced. Forinstructions, see "Installing/Replacing the MainBattery" in this Chapter.Physical protection• Protect the PPC from direct contact with water and moisture. Never takethe PPC into a sauna or steam bath. If the PPC comes in contact withmoisture where the battery compartment is wet, remove the battery anddry compartment thoroughly. Replace the battery and perform a “SELFTEST.”• Protect the PPC from temperatures greater than 40°C (104°F). Do notleave the PPC in direct sunlight.• Protect the PPC from cold temperatures less than below freezing 0°C(32°F).• Do not drop the PPC. Protect the PPC from sharp blows. Either coulddamage the electrical components of the PPC and affect its ability toprogram your implantable Pump.PPCCOMMUNICATING
Table of contents 65Cleaning the outer surface of your PPC• If necessary, use a slightly damp cloth and mild soap to clean the outsideof the PPC. Do not use a wet cloth or dip the PPC in any liquid. Moisturemay harm the PPC’s electrical components.• Never use organic solvents or harsh detergents to clean the PPC.• Always completely dry the PPC after cleaning.• Never spray any cleaning solutions directly onto the PPC, especially thekeyboard panel.
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67CHAPTER 9 Technical specificationsImplantable Insulin Pump (MMT-2007D) Component Performance SpecificationDiameter 8.1 cm (3.2 inches)Thickness 2.0 cm (0.8 inches)Reservoir Volume 13 ml to 15 mlWeight - Empty 131 gm (4.6 ounces)Insulin - Concentration Aventis HOE 21 PH U-400Stroke Volume 0.42 to 0.58 µl per stroke0.17 to 0.23 units per strokeBasal Rate 0.2 to 35.0 units per hour (U/h)Basal Patterns 3 Patterns of up to 48 basal rates eachMeal Bolus 0.2 to 25.0 unitsBolus Duration Immediate, Square Wave (30 minutes to 4 hours), or both together. Audio Bolus Temporary Basal Rate 0.2 to 35.0 units per hour30 minute increment duration30 minutes up to 24 hours durationDiagnostic Rate 10 to 150 U/hPower Supply Lithium - Carbon Monofluoride BatteryAudio Alarms Low BatterySystem ErrorSafety Features Negative Pressure Reservoir with Passive FillingPump Shutdown and Alarm with System Error (unique code sequences)Materials Titanium Housing, Polyethylene-lined Silicone Rubber Catheter
Table of contents68Personal Pump Communicator (MMT-3160)Component Performance SpecificationHeight 2.0 cm (0.8 inches)Length 8.9cm (3.5 inches)Width 7.0 cm (2.8 inches)Weight 115 gm (4.0 ounces)Main Power Source 1.5 Volt Alkaline Battery Type AAMain Battery Life Approximately 4 weeks, depending upon usageOperating Temperature 0ºC to 40ºC (32ºF to 104ºF)Storage Temperature -0ºC to 30ºC (32ºF to 86ºF)Messages Auto Off Pump SuspendedCheck Pump StatusCommunication ErrorEmpty ReservoirHourly Maximum ExceededLow Reservoir PPC Not initializedPPC Low BatteryPump Self Test FailPump ResetPump StoppedPump Version ErrorTelemetry Communications Error
Table of contents 69Side Port Catheter Operation is subject to the following two conditions: (1) This device may notcause harmful interference, and (2) this device must accept any interferencereceived, including interference that may cause undesired operation.Any changes or modifications to the system not expressly approved byMedtronic MiniMed could void the user’s authority to operate the system.FCC complianceThis device complies with Part 15 of the FCC Rules. Operation is subject tothe following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interferencethat may cause undesired operation.MMT- 4027Length Proximal: Distal:11.8 ± 1.3 cm (4.7 ± 0.5 inches)17.8 ± 0.7 cm (7.0 ± 0.3 inches)MMT- 4024Length Proximal: Distal:11.8 ± 1.3 cm (4.7 ± 0.5 inches)10.2 ± 0.4 cm (4.0 ± 0.2 inchesMaterial Polyethylene-lined Silicone RubberSideport Polysulfone, Silicone Septum
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