Medtronic MiniMed 2007C Implantable Insulin Pump User Manual MiniMed 2007 Implantable Pump Patient Manual

Medtronic MiniMed, Inc. Implantable Insulin Pump MiniMed 2007 Implantable Pump Patient Manual

Patient Manual

MedtronicMiniMed 2007C Implantable Insulin Pump SystemPatient Manual
These product(s) are covered by one or more of the following U.S.Patents:Patents also exist in a number of foreign countries and other U.S.,international, and foreign patent applications are pending.D9196020-011 2/014,373,527 4,395,259 4,525,1654,568,250 4,569,641 4,573,9944,619,653 4,636,150 4,731,0514,776,842 5,167,633 5,176,6445,197,322 5,217,442 5,257,9715,460,618 5,466,218 5,514,1035,527,307 5,559,828 5,797,7335,915,929
Table of ContentsCHAPTER 1 The Medtronic MiniMed 2007C Implantable InsulinPumpSystem ............................ 1Introduction ........................................................1MiniMedhelpline ...................................................2Descriptionofthesystem .............................................2Implantableinsulinpump.......................................... 3Medicationreservoir ...........................................4Pumpingmechanism ...........................................4Antenna .....................................................4Microelectronics ..............................................5Battery ......................................................5Tonetransducer ...............................................5Sideportcatheter .................................................6Personalpumpcommunicator(PPC)..................................7Specialinsulin ...................................................9CHAPTER 2 SafetyFeatures......................... 11Pumpsafetyfeatures ................................................11Safetelemetry ..................................................11
Alarms ........................................................11Negativepressurereservoir ........................................11PPCsafetyfeatures .................................................12Programming sequence ...........................................12Maximumdosagelimits...........................................12Alarmsandmessages.............................................12CHAPTER 3 Implanting the MiniMed 2007C Pump System. . .13Hospitalization .....................................................13Pre-operativeprocedures ..........................................13Implantationprocedures ..........................................14Post-operativeprocedures .........................................14Follow-up...................................................15Pump refills .......................................................16Insulinusedwiththeimplantablepump ..............................16Pumprefillprocedure ............................................16CHAPTER 4 ProgrammingYourPump................. 17Introduction .......................................................17PPCscreenicons ...................................................18PPCbuttons .......................................................19Main programming screen ............................................20Programming a bolus .............................................20Setanimmediatebolus(variablebolusoptionis“off”)...................21Setanimmediatebolus(variablebolusoptionis“on”) ..................22Setasquarewavebolus...........................................23
Setadualwavebolus.............................................25Reviewthebolushistory ..........................................27Suspendmode ..................................................27Programbasalrates ..............................................28Setonebasalrate .............................................28Set multiple basal rates ........................................29Setatemporarybasalrate ......................................30Stopatemporarybasalrate .....................................31Personalevents .................................................32Presetevents ................................................32Additional events .............................................32History ...........................................................33Pumpsetup........................................................35Timeanddate...................................................35Autooff ..........................................................36Alarms ........................................................37SelfTest .......................................................38Basaldeliverypatterns............................................39Initialize PPC to pump ............................................40PumpsetupII...................................................40Exitsetupmenu .................................................40PumpsetupII......................................................41Turnontheaudiobolusfeature .....................................41Useaudiobolusinthemainmenu...................................42Turnonthevariablebolusfeature ...................................42Setamaximumbolus.............................................43
Setamaximumbasalrate .........................................44Set time format ..................................................44Personalevent ..................................................45Pumpsetup..................................................45Exitsetupmenu ..............................................45CHAPTER 5 AlarmsandMessages..................... 47Thepumpalarms ...................................................47ThePPCalarms ....................................................48Alarmtype1 ...................................................48Alarmtype2 ...................................................48Pumpalarms ......................................................49Alarmfeedback .................................................49Pumplowbattery ................................................49Depletedpumpbattery............................................50Systemerror....................................................50Pumpselftestfail ...............................................50PPCalarms........................................................51PPClowbattery .................................................51PPCdepletedbattery ..........................................52PPCneedsservicing..............................................52Lowreservoir...................................................53Emptyreservoir .................................................53Communicationerror.............................................54Batteryreplacement ..............................................54
Pumpsuspended ................................................54Autooff .......................................................56Hourlymaximumexceeded........................................56PersonalPumpCommunicatormessages ................................57CHAPTER 6 WarningsandPrecautions ..................59Warnings .........................................................59Electrotherapy ..................................................59Diagnostic ultrasound ............................................59Ultrasound therapy ...............................................60Diagnostic radiation ..............................................60Therapeuticradiation .............................................60Magneticresonanceimaging .......................................60Pump and catheter under-delivery ...................................60Pumpelectronicoralarmmalfunction................................61Reservoirlevelwarnings ..........................................61Environmentalconditions .........................................61Precautions........................................................63Bloodglucosemonitoring .........................................63Conventional insulin supplies ......................................63Physician’sinstructions ...........................................63PPC ..........................................................64Maximumdosages ...............................................64Batterychange ..................................................64ProperPPCpositioning ...........................................64
Physicalactivitiestoavoid ........................................65Emergencyplan ....................................................65Adversereactions...................................................66Hyperglycemia..................................................66Hypoglycemia ..................................................66Pumppocketinfection ............................................67Pumppocketseroma .............................................67CHAPTER 7 ImportantSelf-Care.......................69Bloodglucosemonitoring ............................................69Mealplan .........................................................70Daily activities .....................................................70Exercise ..........................................................70Travel ............................................................71MiniMedinformationcard............................................71CHAPTER 8 PPCCareandMaintenance.................73Installing/replacingthemainbattery ....................................73Physicalprotection..................................................75Cleaning the outer surface of your PPC ..................................76CHAPTER 9 TechnicalSpecifications....................77Medtronic MiniMed 2007C Implantable Insulin Pump System ...............77Implantable Insulin Pump (MMT-2007C) ............................77Personal Pump Communicator (MMT-3132) ..........................79SidePortCatheter ...............................................80
CHAPTER 1This manual is a reference guide for both you and your support networkof family and friends. It is important that other people in your support net-work know how to use the Medtronic MiniMed 2007C Implantable Insu-lin Pump System, so they can be of assistance if the need arises.Throughout the manual you will see note comments which provideimportant information about the Medtronic MiniMed 2007C System. Ifyou have a question not covered in the manual, please talk with your doc-tor. Your doctor knows the most about your medical condition and cangive you the best answers to your questions about your diabetes treat-ment.NOTE: Before you can use the Medtronic MiniMed 2007CSystem, you will be trained. This training willteach you about implantable insulin pump ther-apy, and how to operate the Medtronic MiniMed2007CSystem.Thismanualcanbeusedtohelp,but not replace, your training.
The Medtronic MiniMed 2007C Implantable Insulin Pump SystemMedtronic MiniMed provides a 24-hour help line for assistance. ClinicalServices personnel are trained to answer questions you may have aboutthe Medtronic MiniMed 2007C System.The Medtronic MiniMed 2007C Implantable Insulin Pump System is an"open-loop" system, which means you must test your blood glucose inaccordance with the method and frequency recommended by your physi-cian. Based on the results of your blood glucose testing, you can programthe Pump with desired reates of delivery by using the Personal PumpCommunicator (PPC).The system consists of four components:•Implantable Insulin Pump•Side Port Catheter•Personal Pump Communicator (PPC)•Special InsulinWhen 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
The Medtronic MiniMed 2007C Implantable Insulin Pump SystemThe Implantable Insulin Pump (Pump) is a round disc, 8.1 cm (3.2 inches)in diameter 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 tita-nium. Titanium is a biocompatible metal used in many types of implant-able medical devices. The Pump contains an insulin fill port, located atthe center of the disc. The fill port is used for rinsing and filling the Pumpwith insulin, and for diagnostic procedures.Figure 1: The Implantable Insulin Pump
The Medtronic MiniMed 2007C Implantable Insulin Pump SystemThe Pump has six major components: the medication reservoir, the pump-ing mechanism, the antenna, the microelectronics, the battery, and thetone transducer. The following figure shows the interior of the Pump.Figure 2: Interior of the Implantable Insulin PumpThe medication reservoir holds the insulin and is refilled with a specialsyringe through the Pump fill port.The 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 thestroke volume.
The Medtronic MiniMed 2007C Implantable Insulin Pump SystemThe pump antenna receives the radio signals from the PPC and deliversthe PPC’s programmed message to the microelectronics of the Pump.The microelectronics are designed to control the pumping mechanism sothat you receive the amount of insulin you have programmed the Pump todeliver. You tell the microelectronics what to do by using your PPC. Themicroelectronics also store pump specifications and programming historyinformation in its memory.The battery supplies power to the pumping mechanism and microelec-tronics. It is a lithium carbon mono-fluoride battery specially designed forthe Implantable Insulin Pump.The tone transducer is a Pump safety feature. It emits audible beeps toconfirm your Pump is operating properly. It also alerts you when yourPump needs attention.
The Medtronic MiniMed 2007C Implantable Insulin Pump SystemThe Side Port Catheter (catheter) is a soft plastic tube, made of polyethyl-ene-lined silicone rubber. The Catheter delivers insulin from the Pumpinto your peritoneal cavity. Intraperitoneal insulin is rapidly absorbed byyour body and is used to regulate your blood sugar. Your doctor can usethe Catheter’s radio-opaque stripe to help locate it on an X-ray.The Catheter has a subcutaneous part and an intraperitoneal part as shownin the following figure.Figure 3: Side Port CatheterIntraperitoneal PartSubcutaneous Part
The Medtronic MiniMed 2007C Implantable Insulin Pump SystemThe Personal Pump Communicator (PPC) is a hand-held device whichallows you to send commands to your Pump and receive Pump informa-tion using RF telemetry (radio waves). The PPC is 8.9 cm (3.5 inches)long, 7.0 cm (2.8 inches) wide and 2.0 (0.8 inches) thick and weighs 115grams (4.06 ounces). The PPC uses one AA 1.5 volt alkaline battery asthe main power source, and a lithium back-up battery which saves thePPC memory when the main battery is depleted or being changed. ThePPC 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)
The Medtronic MiniMed 2007C Implantable Insulin Pump SystemTo 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 readingthe screen 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•Suspend the Pump•Record Personal Events•Program an Automatic OffYour PPC also stores important information in its memory (120 days ofdata). 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 be usedonly with your Implantable Insulin Pump. Do notattempt to use any other PPC to program yourPump,unlessspecificallyinstructedtodosobyyour doctor.
The Medtronic MiniMed 2007C Implantable Insulin Pump SystemThe Medtronic MiniMed 2007C Implantable Insulin Pump System uses aspecial insulin, purified and concentrated exclusively for implantablepump use. The insulin is HOE 21 PH U-400, manufactured by Aventis.Only Aventis HOE 21 PH U-400 may be used in the Medtronic MiniMed2007C Implantable Insulin Pump System.
The Medtronic MiniMed 2007C Implantable Insulin Pump System
CHAPTER 2Your Pump will respond only to telemetry commands from your PPC.Your Pump will not change when exposed to electromagnetic fields, suchas microwave ovens, garage door openers, airport security systems, andtelevision or video remote controls.The most important safety feature of your Pump is its self-checking cir-cuitry. If your Pump is not working properly, it will signal you with analarm message on the PPC screen and then automatically turn itself off.This feature ensures that your Pump will always deliver insulin in a con-trolled, predictable manner.The Pump reservoir has a negative pressure (vacuum) which will draw influids. In the event of a Pump malfunction, this vacuum assures your insu-lin will stay in the reservoir. Don’t worry, there are multiple safety fea-tures to assure that your body fluids won’t enter the Pump. Only thepumping mechanism can overcome this negative pressure and deliverinsulin to your body.
Safety FeaturesIn order to send a command to your Pump, your PPC must be properlypositioned nearby and a series of programming steps must be followed.Your 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.Your PPC prompts you with many easy-to-read messages on its screen.Also, the PPC emits beeps to notify you of certain conditions, such as bat-tery status, programming errors, and a low or empty pump reservoir.These messages and alarms are discussed further in Chapter 5, entitled,“Alarms and Messages.”
CHAPTER 3You will be admitted to the hospital to have your Medtronic MiniMed2007C Implantable Insulin Pump System surgically implanted and stabi-lized in your tissue. Your Pump System will also be programmed andtested prior to your leaving the hospital.Your hospitalization will consist of three types of procedures:•Pre-Operative Procedures•Implantation Procedures•Post-Operative ProceduresYou will have blood drawn, be given diagnostic procedures, and possiblyother tests before your scheduled surgery date. You should ask your doc-tor what tests will be required before your Pump is implanted. You mayalso meet with an Anesthesiologist or Surgeon prior to the surgery.The Pump will be implanted in your abdominal area. Your doctor will dis-cuss the exact location of implantation with you. The choice of a Pumpsite may depend upon the catheter location, how your body is shaped, andwhether or not you have had any previous abdominal surgery, such as anappendectomy.
Implanting the MiniMed 2007C Pump SystemThe Pump may be implanted using either local or general anesthesia. Thisdecision will be made by you, your doctor, the Surgeon, and the Anesthe-siologist. If local anesthesia is chosen, you will be awake during theimplantation but the pump site will be numbed. Under general anesthesia,you will be kept asleep during the procedure by the anesthesiologist.The Surgeon will make an incision through your skin and create a“pocket”in which to place the Pump. The Pump is then inserted under thefatty tissue just beneath your skin. The Surgeon will then secure the Pumpin your tissue to prevent movement. A very small opening will be made inyour abdominal muscle wall through which the Surgeon will thread theSide Port Catheter into your peritoneal cavity. After the Catheter is posi-tioned and the Pump is secured, the Surgeon will use sutures to close theincision in your skin. Bandages are used to protect the incision until itheals. Some Surgeons may want you to wear a binder over the implantsite for a short time to minimize post-operative swelling.The length of your hospital stay will be determined by your doctor. Yourstay will depend upon how quickly you heal, and how quickly you learnto use the Medtronic MiniMed 2007C Implantable Insulin Pump System.Before your admission to the hospital, your doctor or a nurse will teachyou how to use your PPC to program the Pump. Before leaving the hospi-tal, you must become proficient in understanding and using your PPC toprogram the Pump. You should:•Fully understand how to use your PPC.•Demonstrate appropriate responses to warning messages andalarms from your PPC.•Be able to identify signs and symptoms your doctor wants you toreport.•Have completed a Patient Emergency Information Card, whichindicates you have an implantable pump and provides emergencyphone numbers.
Implanting the MiniMed 2007C Pump System•Ask your doctor to complete and return your Device RegistrationCard to MiniMed. This card contains the Pump and Catheterserial numbers, which are needed for device tracking byMiniMed.•Schedule an appointment with your doctor for your first follow-up visit.•Read Chapter 5, “Alarms and Messages,” and ask your doctor toexplain anything you don’t understand.Before you leave the hospital, your doctor will schedule an appointmentfor your first follow-up office visit. Your healthcare team will also keep inclose contact with you during the first few weeks following implantation.Frequent adjustments in your insulin delivery are often required for sev-eral weeks following implantation.NOTE: ALWAYS keep your PPC with you. During officevisits, a member of the healthcare team will checkthe status of your Pump. Only YOUR PPC can beused to check YOUR Pump.Your post-implant recovery will be similar to recovery from other surgicalprocedures. You will need to obtain adequate rest, eat a nutritious diet,and avoid individuals who are suffering from infections or viruses.Recovery times vary among individuals, but most people recover fully ina few weeks. Your physician will ask you to call if you are not feelingwell, particularly if you have an elevated temperature or if you notice anyredness or drainage around your incision site.
Implanting the MiniMed 2007C Pump SystemAventis, located in Frankfurt, Germany, is the manufacturer of the insulinused in your Implantable Insulin Pump. This insulin, HOE 21 PH U-400,is specifically designed for implanted pumps. No other insulin should beput in your Pump.It is important that the time between your Pump refills should not exceed90 days. Refilling your Pump is a sterile procedure. Your doctor or a nursewill first disinfect your skin directly over the Pump. All equipment thatwill touch your skin during the refill procedure is sterile to minimize therisk of infection.Your doctor or a nurse may now numb the disinfected skin area with alocal anesthetic. A short needle will then be inserted through your skin tolocate the fill port of the Pump. Then a longer needle will be inserted intothe Pump fill port through the inside of the shorter needle. The doctor ornurse will then empty unused insulin from the Pump and refill it with newAventis, HOE 21 PH U-400 insulin.
CHAPTER 4 Programming Your PumpYou will program your Implantable Insulin Pump with your PPC. ThePPC transmits information by RF telemetry (radio waves) to your Pump.With your PPC you can:•Deliver an immediate, square wave or dual wave insulin bolus tocompensate for meals. Boluses can be programmed by readingthe screen 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 ofthe Pump.NOTE: Your PPC has been designed for easy use (Seechapter 5 for a list of the PPC commands). Youmust follow a specific sequence of steps and holdthe PPC near the Pump to deliver a command.Therefore, you cannot unintentionally programyour Pump.
Programming Your PumpYour PPC has been specifically pre-programmed for use with your Pump.Do not use another PPC to program your Pump. You must keep your PPCwith you at all times because it is the only way to program your Pump.Remember, you must measure your blood sugar at least four times eachday, according to the method recommended by your doctor. You mustthen use the results of your blood sugar tests to determine the appropriatedose of insulin to be delivered by your Pump.Your PPC has an easy-to-read dot matrix liquid crystal display (LCD).The main PPC screen displays the time (12hr. or 24hr. format), month,day, and a variety of icons. The type and purpose of these icons are as fol-lows:Icon DescriptionThe bell icon is displayed when the PPC receives a RF telemetry messagefrom the Pump. The icon may indicate the Pump or PPC has detected a fail-ure, or the Pump is in a “SUSPEND”mode or “STOPPED.”The reservoir icon is composed of 4 segments that indicate how full thePump 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 deliv-ery segments. When the Pump delivers a basal rate, the pattern will showone delivery segment. When the Pump is not delivering, all four segmentswill be displayed.
Programming Your PumpPPC programming information is entered using four buttons:1. When commands are programmed thePPC will talk to the Pump. When thisoccurs the following screen will dis-played.2. The word COMMUNICATING will blinkto indicate a communication is taking place.Buttons DescriptionSEL Means SELECT. The SEL button allows you to step through and vieweach of the option screens.ACT Means ACTIVATE. The ACT button activates programming changesyou wish to make. As a safety check, you must press ACT to completeany programming changes. You will always hear a single beep after youhave successfully activated a change.▲▲▲▲UPARROWAllows you to make changes to the screen settings by scrolling to highervalues. You must then press the ACT button for a change to be activated.This button has a Sound Icon. When the “AUDIO BOLUS”feature isturned on, the ▲▲▲▲button allows you to program an Audio Bolus.▼▼▼▼DOWNARROWAllows you to make changes to the screen settings by scrolling to lowervalues. 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 dis-play illuminated, you can program your Pump in dark areas. The back-light remains on for 4 seconds after each ▼▼▼▼press.PPCCOMMUNICATING
Programming Your PumpThe Main programming screen is used to program features you will useevery day, such as a Meal Bolus or Basal Rate, or putting your Pump inthe Suspend mode.Using the PPC, you can program the Pump to deliver a bolus of insulinwhenever you need it. The Pump System has several special featureswhich allow you to customize the programming and delivery of a bolus:•Immediate Bolus (programmed by reading the PPC screen or lis-tening to beeps, using the Audio Bolus).•Square Wave Bolus•Dual Wave BolusNOTE: To program a Square Wave or Dual Wave Bolus,you must turn on the Variable Bolus programmingoption (program “ON”in the “SETUP II”menu).Otherwise, only an Immediate Bolus can be given.The Variable Bolus option is programmed by yourdoctor.
Programming Your Pump1. From the Time/Date screen, press SELuntil the “BOLUS”screen is displayed.The Time and Date will be flashing, andthe last bolus is displayed.2. Press ACT and “SET BOLUS”appears,and the 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 “CON-FIRM IMM.”If the number you enteredfor the immediate bolus is correct, pressACT to confirm it. This value will nowbe programmed into the Pump. If thenumber was not correct, wait for thescreen to return to Time/Date and then repeat this procedure to enterthe correct value.5. Place the PPC near the Pump to completethe programming. The PPC will beeponce and display 0.0 units.6. If the Alarm Feedback feature is “ON,”the Pump will beep during each of thefirst five strokes. The PPC will beepwhen the bolus delivery is complete.Three segments of the insulin deliveryicon will be displayed and will spinslowly during the bolus delivery. By pressing SEL you can see theamount of insulin being delivered.BOLUSPROG --IMM EXT10 U-- USET BOLUSIMM-- UCONFIRMIMM2.6UPPCCOMMUNICATINGBOLUS 0.0U
Programming Your Pump1. From the Time/Date screen press SELuntil the “BOLUS”screen is displayed.The last bolus value programmed and theTime and Date will be flashing.2. Press ACT and “SET BOLUS TYPE”appears. Use the ▲▲▲▲and ▼▼▼▼buttons tochoose “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 “CON-FIRM IMM.”6. If the number was not correct, wait for thescreen to return to Time/Date and thenrepeat this procedure to enter the correctvalue.7. If the number you entered for the immedi-ate bolus is correct, press ACT to con-firm it. Place the PPC near the Pump tocomplete the programming.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 deliv-ery is complete. Three segments of the insulin delivery icon will bedisplayed and spinning slowly during the bolus delivery. By pressingSEL you can see the amount of insulin being delivered.BOLUS--IMM EXT-- U-- USETNORMALBOLUS TYPESET BOLUSIMM-- UCONFIRMIMM2.6UPPCCOMMUNICATINGBOLUS 0.0U
Programming Your PumpA Square Wave Bolus is delivered evenly over a time period you set, from30 minutes to 4 hours. A Square Wave Bolus is useful during long meals,high fat meals, or if you have gastroparesis. During a Square Wave Bolus,your Basal Rate insulin continues to be delivered.To access Square Wave Bolus you must first turn the Variable Bolus fea-ture "ON" in the SET UP II menu.1. From the Time/Date screen press SELuntil the “BOLUS”screen is displayed.The last bolus value programmed and theTime and Date 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 enter anextended bolus amount.6. Press ACT and dashes will appear underthe bolus amount you just entered.BOLUSPROG --IMM EXT10 U-- USETSQUAREBOLUS TYPESET BOLUSIMM EXT-- U-- USET BOLUSIMM EXT-- U4.0USET BOLUSIMM EXT-- U4.0U--
Programming Your Pump7. Use the ▲▲▲▲and ▼▼▼▼buttons to enter a timeduration that you would like the SquareWave Bolus 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,press ACT to confirm them. These valueswill now be programmed into the Pump. If either number is not cor-rect, wait for the screen to return 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,”thePump will beep during each of the firstfive strokes.12. The PPC will beep when the bolus delivery is complete. Three seg-ments of the insulin delivery icon will be displayed and will spinslowly during the bolus delivery. By pressing SEL you can see theamount of insulin being delivered.SET BOLUSIMM EXT-- U4.0U02:00CONFIRMIMM EXT-- U4.0U02:00PPCCOMMUNICATINGBOLUS 0.0U
Programming Your PumpVariable Bolus Option Must be “ON.”The Dual Wave Bolus allows you to deliver an Immediate Bolus immedi-ately followed by a Square Wave Bolus.1. From the Time/Date screen press SELuntil the “BOLUS”screen is displayed.The last bolus value programmed will beshown and the Time and Date will beflashing.2. Press ACT and “SET BOLUS TYPE”appears.3. Use the ▲▲▲▲and ▼▼▼▼buttons to choose“DUAL”.4. Press ACT and “IMM”appears with the dashes underneath flashing.5. Use the ▲▲▲▲and ▼▼▼▼buttons enter an imme-diate bolus amount6. Press ACT and the dashes underneath“EXT”will appear flashing.7. Use the ▲▲▲▲and ▼▼▼▼buttons enter anextended bolus amount.8. Press ACT and dashes will appear underthe extended bolus amount you justentered.BOLUS--IMM EXT-- U-- UPROGSETDUALBOLUS TYPESET BOLUSIMM2.0USET BOLUSIMM EXT2.0U2.0USET BOLUSIMM EXT2.0U2.0U--
Programming Your Pump9. Use the ▲▲▲▲and ▼▼▼▼buttons to enter a timeduration that you would like the extendedbolus to last.10. Press ACT and the screen shows“CONFIRM”asking you to confirm theimmediate bolus, extended bolus, andtime duration.11. If the numbers you entered are correct,press ACT to confirm them. These valueswill now be programmed into the Pump.If any number is not correct, wait for thescreen to return to Time/Date and thenrepeat this procedure to enter the correctvalues.12. Place the PPC near the Pump to completethe programming. The PPC will beeponce and display the amount of insulinbeing delivered.13. If the Alarm Feedback feature is “ON,”the Pump will beep during each of the first five strokes.14. The PPC will beep when the bolus delivery is complete. Three seg-ments of the insulin delivery icon will be displayed and spinningslowly during the bolus delivery. By pressing SEL you can see theamount of insulin being delivered.SET BOLUSIMM EXT2.0U2.0U02:00CONFIRMIMM EXT2.0U2.0U02:00PPCCOMMUNICATINGBOLUS 0.0U
Programming Your PumpYou can review the bolus type, bolus amount, time and day of your last512 insulin boluses.1. From the Time/Date screen press SELuntil the “BOLUS”screen is displayed.The last bolus value programmed and thetime and date will be flashing.2. Press the ▼▼▼▼button once to display theprevious bolus and the time and date it was delivered. Each additional▼▼▼▼press will display the next previous bolus delivery.Suspend Mode allows you to cancel bolus programming. In suspendmode the pump will still deliver a basal rate of approximately 0.2u/hr.1. From the Time/Date screen press SELuntil the “SUSPEND PUMP”screen isshown.2. Press ACT.3. Place the PPC near the Pump to completethe programming. When communicationis finished the Pump will beep 3 times.4. All four segments of the insulin deliveryicon will be displayed.5. To restart the Pump, press SEL and ACT.BOLUS--IMM EXT5.6U-- UPROGSUSPEND PUMPPPCCOMMUNICATINGPUMP SUSPENDED
Programming Your PumpYour Basal Rate provides you with approximately 50 percent of yourdaily insulin needs. A Basal Rate is normally delivered all the time,throughout the day and night. Your PPC can tailor your Basal Rates tomeet your changing insulin needs throughout the day. If you want to, thePPC can deliver a different Basal Rate every 30 minutes throughout theday. For some people, one Basal Rate will work fine. Other people findthat multiple Basal Rates will help them respond better to their insulinneeds. You should discuss with your doctor the number and amount ofBasal Rates that are best for you.1. From the Time/Date screen press SELuntil the “BASAL RATE”screen is dis-played. Basal Delivery Pattern “A”andthe current Basal Rate appear. The word“NOW”also appears and is flashing.2. Press ACT and “1”appears to the right of“A”indicating that you will now programfirst Basal Rate “1”in Basal DeliveryPattern “A.”The Basal Rate is flashing.3. Use the ▲▲▲▲and ▼▼▼▼buttons to enter a newBasal Rate.4. Press ACT and the screen displays “SETTIME,”indicating you will now programa start time for Basal Rate “2”Thetimeisflashing.5. Use the ▲▲▲▲and ▼▼▼▼buttons to change time to dashes.6. To enter one Basal Rate, press ACT 2times.BASAL RATE : A NOW0.2U/H00:00BASAL RATE : A 10.2U/H00:00SET RATEBASAL RATE: A 2-- U/H00:30SET RATE
Programming Your PumpNOTE: In24hr.displaymode,“00:00”indicates a starttime of MIDNIGHT. In 12hr. display mode, thescreen will read “12:00am.”7. Place the PPC near the Pump to completethe programming. The screen will displayPPC communicating.8. The screen will calculate and briefly dis-play the total daily Basal insulin from theBasal Rates you have programmed.1. From the Time/Date screen press SELuntil the “BASAL RATE”screen is dis-played. Basal Delivery Pattern “A”andthe current Basal Rate appear. The word“NOW”also appears and is flashing.2. Press ACT and “1”appears to the right of“A”indicating you will now programBasal Rate “1”in Basal Delivery Pattern“A.”The Basal Rate is flashing.3. Use the ▲▲▲▲and ▼▼▼▼buttons to enter a newBasal Rate.4. Press ACT and the screen displays “SETTIME”, indicating you will now programa start time for Basal Rate “2”Thetimeisflashing.5. Use the ▲▲▲▲and ▼▼▼▼buttons to enter a newstart time.PPCCOMMUNICATING24 HOUR TOTAL4.8UBASAL RATE : A NOW0.2U/H00:00BASAL RATE : A 10.2U/H00:00SET RATEBASAL RATE : A 2-- U/H04:30SET RATE
Programming Your PumpNOTE: In24hr.displaymode,“00:00”indicates a starttime of MIDNIGHT. In 12hr. display mode, thescreen will read “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 desiredBasal Rates and start times are pro-grammed. Then press ▼▼▼▼and ACT.9. Place the PPC near the Pump to completethe programming.10. The screen will calculate and briefly dis-play the total daily Basal insulin from theBasal Rates you have programmed.NOTE: To set multiple basal pro-files in the other patterns(A, B, C), select the pattern in Setup II menu andfollow the above procedure.A Temporary Basal Rate is often used when a brief change in basal deliv-ery is required, for example during exercise.1. From the Time/Date screen press SELuntil the “TEMP BASAL”screen is dis-played.BASAL RATE : A 2-- U/H05:00SET RATEPPCCOMMUNICATING24 HOUR TOTAL4.8UTEMP BASAL-- U/H--
Programming Your Pump2. Press ACT and “SET DURATION”appears with the start time flashing.3. Use the ▲▲▲▲and ▼▼▼▼buttons to enter a Tem-porary Basal Rate.4. Press ACT and “SET AMOUNT”appears with the Temporary Basal Rateflashing.5. Use the ▲▲▲▲and ▼▼▼▼buttons to enter a newstart time for the Temporary Basal Rate,then press ACT again.6. Place the PPC near the Pump to completethe programming.NOTE: When your Pump is delivering a Temporary BasalRate, pressing SEL will display “TEMP BASAL.”This will remind you that the Temporary BasalRate feature is currently active.1. From for the Time/Date screen press SELuntil the “TEMP BASAL”screen is dis-played.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 completethe programming.TEMP BASAL -- U/H00:30SET DURATIONTEMP BASAL 1.5U/H00:30SET AMOUNTPPCCOMMUNICATINGTEMP BASAL 1.5U/H--SET AMOUNTPPCCOMMUNICATING
Programming Your Pump5. When the communication is finished,“SET AMOUNT”will appear with thedashes flashing. Allow the PPC to returnto the Time/Date screen or press ACT.The Temporary Basal Rate is now can-celed.This feature appears in the Main menu if it has been activated to "ON" inthe Pump Setup II menu. The Personal Event menu allows you to enterimportant “events”during the day.You can enter the following preset codes for these popular events:•1=meal•2=snack•3=sick•4 = exercise.Codes A, B and C can be used to record other events. Be sure to documentthe events listed for A, B, and C.NOTE: Events that happened in the past or present can beentered.1. From the Time/Date screen, press SELuntil the “SET PERSONAL EVENTS”screen is displayed.2. Press ACT and the screen will change to“SET EVENT”with “MEAL”flashing.TEMP BASAL-- U/H--SET AMOUNTEVENT__
Programming Your Pump3. Use the ▲▲▲▲and ▼▼▼▼buttons to select theevent you want to enter: MEAL,SNACK,SICK,EXERCISE,A,B,C.4. Press ACT and the time will appear flash-ing.5. Use the ▲▲▲▲and ▼▼▼▼buttons to enter the timethat the event occurred.6. Press ACT to enter the event in the PPCmemory.The History menu allows you to look at important Pump data, such as theamount of insulin remaining in the Pump reservoir or total insulin deliv-ery since the last refill. The History menu contains the following options:Med Remaing, Insulin Total Basal Bolus, Clinical Hist PPC, Clinical His-tory Pump, Est Pump Battery. To read Pump Data perform the followingsteps.1. From the Time/Date screen, press SELuntil the “HISTORY”screen is displayed.2. Press ACT and the screen with change to“READ PUMP DATA”with the entirescreen flashing.3. Press ACT, and then place the PPC nearthe Pump. History data in the Pump willbetransferredtothePPC.SETEVENTMEALSET TIMEEVENTMEALREAD PUMP DATA..............................................................................10057PPCCOMMUNICATING
Programming Your Pump4. The screen will automatically change to“MED REMAINING.”The amount ofinsulin in the Pump reservoir is reportedin units.5. Press SEL and the screen will change to“INSULIN TOTAL.”The amount ofBasal Rate and Bolus insulin delivered isreported for the day indicated.6. Press the ▼▼▼▼button to review insulindelivery rates for other days.7. Press SEL and the “CLINICAL HIS-TORY PPC”screen is shown. Ask yourdoctor what the numbers mean.8. Press the ▼▼▼▼button to review other days.9. Press SEL to find the “CLINICAL HIS-TORY PUMP”screen. Ask your doctorwhat the numbers mean. Press the ▼▼▼▼but-tontoreviewotherdays.10. Press SEL and the screen will change tothe “EST PUMP BATT”display. Thisscreen indicates the energy left in thePump battery. Ask your Physician whatthe numbers mean.11. Press SEL and the screen will read“EXIT HISTORY.”Press ACT to returnto the Time/Date screen.MED REMAINING7263 UINSULIN TOTAL9U22 UBASAL BOLUSCLINICAL HISTORY11PPCCLINICAL HISTORY14PUMPEST PUMP BATTERY2.9 V2.7VNO LD LDEXIT HISTORY
Programming Your PumpThis screen permits access to other Pump “SETUP”features. These fea-tures are normally programmed for you by your doctor or nurse. To reachthe “SETUP PUMP”menu, press SEL until the “SETUP PUMP”screenis displayed, then ACT to access the SETUP screens.The time and date settings must be correct. The PPC uses the time anddate to calculate your total daily insulin and display Pump history.1. From the Time/Date display, press SELuntil the “SETUP PUMP”screen is dis-played.2. Press ACT two times. The hour digitswill begin flashing. Use the ▲▲▲▲and ▼▼▼▼but-tons to select 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,month and day.5. At the conclusion of programming pressACT, and then place the PPC near thePump. When the communication processis complete, the PPC will automaticallymove to the next screen, “AUTO OFF.”SET 2000TIME-DATEPPCCOMMUNICATING
Programming Your Pump“AUTO OFF”sets an alarm on your PPC, to remind you if you have notprogrammed your Pump recently. The “AUTO OFF”alarm can be setbetween 1 and 16 hours. To turn off "Auto Off" program set the time todashes.1. From the “SETUP PUMP”screen, pressACT then SEL.2. The screen will display “AUTO OFF”with flashing dashes. Press ACT.3. Use the ▲▲▲▲and ▼▼▼▼buttons to select thenumber of hours before an Auto Offalarm occurs.4. Press ACT. In this example, a time dura-tion of 10 hours was selected. The PPCwill alarm if you did not program your Pump during the past 10hours.5. Place the PPC near the Pump. The PPCwill beep once when the communicationis completed.AUTO OFF-- HRSAUTO OFF10 HRSSETPPCCOMMUNICATING
Programming Your PumpThere are three PPC Alarm options, two audible tones (Low/High) and avibrate mode.“ALARMS”will alert you if either the PPC or Pump recognizes a prob-lem. Your doctor or nurse will make sure the “ALARM FEEDBACK”screen is in the “ON”position.Vibrate only for alarms, all programming feedback from PPC is done withbeeps.NOTE: If you want the PPC to vibrate instead of beep, thePPC battery will only last 6 weeks instead of 8weeks, under conditions of normal use.1. Press ACT to enter the “ALARMS”menu.2. Press the ▲▲▲▲and ▼▼▼▼buttons to select thetype of alarm you want, then press ACT.3. The screen will now display “SET PPCFEEDBACK.”This setting shouldalways be “ON”.PressACT.4. Place the PPC near the Pump. When thecommunication is completed, the PPCwill change to “SELF TEST”and thentimeout to the Time / Day screen.ALARMSSETPPCALARM TYPELOW/HIGH/VIBRATESETALARMFEEDBACKON/OFFPPCCOMMUNICATING
Programming Your PumpYour 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 eventsdo not occur.If the PPC displays a MiniMed logo and softwarenumber, the PPC has re-started but has a low bat-tery. Replace the battery immediately.1. From the “SETUP PUMP”screen, pressSEL until the “SELF TEST”screen isdisplayed.2. Press ACT.3. Place the PPC near the Pump and com-plete the communication process.4. Verify the following events occur:The Pump will beep four times.The PPC backlight will turn on.The PPC will sound a long changing tone.The PPC will vibrate.The PPC will beep once.The PPC screen display all possible icons and numbers.SELF TESTPPCCOMMUNICATING
Programming Your Pump5. If your PPC and Pump “pass”the SelfTest, the display will change to “PPCPASSED/PUMP PASSED.”After severalseconds, the screen will change back tothe Time/Date screen.The 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 pro-grammed from the “SETUP PUMP”menus. Each basal rate pattern canaccept up to 48 different basal rates, one for each half-hour of the day.These are programmed from the "Basal Rate" screen in the Main Pro-gramming menu.Basal patterns can be used to follow your normal daily routines. Forexample, separate patterns could be programmed for a typical work day,weekend day, and travel day.1. From the “SETUP PUMP”screen, pressSEL until the “DELIVERY PATTERNA”screen is displayed. Press ACT.2. Press SEL again until the “DELIVERYPATTERN”screen appears. Press ACTand the screen will change to “SETDELIVERY PATTERN”.3. Press the ▲▲▲▲and ▼▼▼▼buttons to select pat-tern A, B or C.4. Press ACT. Place the PPC near the Pumpand allow the communication to com-plete.NOTE: The PPC will automatically return to the Time/Date screen. Press SEL until the “BASAL RATE”screen is displayed. The pattern you have selectedwill appear on this screen.PPC PUMPPASSED PASSEDDELIVERY APATTERNDELIVERY A,B,CPATTERNSETPPCCOMMUNICATING
Programming Your PumpThis screen initializes your PPC to your Pump. Your doctor will normallyperform this programming for you. Contact your doctor, if you need tohave your PPC replaced.“SETUP II”is another programming menu. “SETUP II”features are usedless often than the features in “SETUP.”“SETUP II”features areexplained in the next section.From the “SETUP”screen, press SEL until the “EXIT SETUP MENU”screen is displayed. Press ACT. The PPC will return to the Time/Datescreen.
Programming Your PumpThe “SETUP II”screen allows you to program additional features intoyour PPC. Your doctor will normally program “SETUP II”features foryou.1. From the “SETUP”screen, press SEL until the “SETUP II”screen isdisplayed.The “AUDIO BOLUS”feature allows you to deliver a bolus withoutlooking at the PPC screen. There are two Audio Bolus amounts you candeliver, 0.4U and 0.8U. With each press of the ▲▲▲▲button, the PPC willbeep one time (0.4U setting) or two times (0.8U setting).1. From the “SETUP II”screen, press ACT.The “AUDIO BOLUS”screen appears.2. Press ACT, and the screen changes to“SET AUDIO BOLUS”with “ON”flash-ing.3. Use the ▲▲▲▲and ▼▼▼▼buttons to choose “ON”to turn on the Audio Bolus feature.Choose “OFF”to turn the Audio Bolusoff. Press ACT again.NOTE: If “OFF”is chosen, press-ing the▲and▼buttonswill have no effect.4. If “ON”was chosen, the “SET STEPAUDIO BOLUS”screen appears, with abolus amount of 0.4U flashing.0.4UAUDIO BOLUSONSET0.4UAUDIO BOLUSONSET STEP0.4UAUDIO BOLUSON
Programming Your Pump5. Use the ▲▲▲▲and ▼▼▼▼buttons to choose a bolus amount of either 0.4U or0.8U.6. Press ACT.“AUDIO BOLUS”will now appear on the PPC MainMenu.NOTE: When an audio bolus is being delivered, the▲▲▲▲button will not work.From the Time/Date screen press ▲▲▲▲button. The PPC will beep one or twotimes, depending upon the bolus amount set (0.4U or 0.8U).1. Count the number of beeps to determinehow much insulin you want to program.2. Press ACT, and the beeps repeat to con-firm the bolus amount you have entered.3. Press ACT twice, and the PPC will pro-gram the Pump. The PPC will beep oncewhen the communication is completed.If “OFF”is chosen, the Variable Bolus feature will not be available.1. From the “SETUP II”menu, press SELuntil the “VARIABLE BOLUS”screen isdisplayed.SET BOLUSIMM1.2UPPCCOMMUNICATINGVARIABLE ON/OFFBOLUS
Programming Your Pump2. Press ACT and the screen changes to“SET VARIABLE BOLUS.”The word“ON”is flashing.3. Use the ▲▲▲▲and ▼▼▼▼buttons to select “ON”or “OFF.”4. Place the PPC near the Pump and com-plete the communication. If “ON”waschosen, the Variable Bolus option willappear in the Main Menu / Bolus screen.Your doctor will decide if you should use this feature. Setting a maximumbolus amount will protect you from over-delivering insulin in case youmake a programming mistake.1. From the “SETUP II”menu, press SELuntil the “MAX BOLUS”screen is dis-played.2. Press ACT and the screen will change to“SET MAX BOLUS,”with the dashesflashing.3. Use the ▲ ▲ ▲ ▲ and ▼▼▼▼buttons to enter a maxi-mum bolus amount (0.0U to 25.0U), thenpress ACT.4. Place the PPC near the Pump and com-plete the communication. The PPC screenwill automatically change to the “MAX BASAL RATE”screen andthen times out to the Time/Date screen if no further action is taken.VARIABLE ONBOLUSSETPPCCOMMUNICATINGMAX BOLUS--UMAX BOLUS--USETPPCCOMMUNICATING
Programming Your PumpYour doctor will decide if you should use this feature. Setting a maximumbasal rate will protect you from over-delivering insulin in case you makea programming mistake.5. After setting a maximum bolus, the “MAX BASAL”screen appearswith the maximum basal rate flashing.6. Use the ▲ ▲ ▲ ▲ and ▼▼▼▼buttons to enter a maxi-mum basal rate (0.2U/h to 35.0U/h), thenpress ACT.7. Place the PPC near the pump and com-plete the communication. The PPC screenwill automatically change to the “TIMEFORMAT”screen.1. From the “SETUP II”screen, press SELuntil the “SET TIME FORMAT”screenis displayed.2. Use the ▲ ▲ ▲ ▲ and ▼▼▼▼buttons to select eithera 12 hour (12:00am) or 24 hour (00.00)time format, then press ACT.3. Place the PPC near the pump and com-plete the communication. The PPC screenwill change to the “PERSONALEVENTS”screen.MAX BASAL RATE0.2U/HSETPPCCOMMUNICATINGSETTIME FORMAT12/24 HOURPPCCOMMUNICATING
Programming Your PumpTo activate this feature located in the Main Menu it must be "ON."1. From the "SET UP II" screen, press SELuntil the "PERSONAL EVENTS" screenis displayed.2. Press ACT and the SET PERSONALEVENTS screen is displayed and "OFF" isblinking.3. Use the ▲and ▼buttons to select ON orOFF. Press ACT.4. Place the PPC near the Pump and completethe communications. The PPC screen willchange to "PUMP SET UP."This screen allows you to return to the Setup mode by pressing ACT.Ifyou press SEL the screen will change to “EXIT SET UP MENU.”This screen allows you to return to the Main Menu, Time/Date screen bypressing ACT.EVENTPERSONAL OFFEVENTOFFPERSONALSETPPCCOMMUNICATING
Programming Your Pump
CHAPTER 5 Alarms and MessagesThe Medtronic MiniMed 2007C Implantable Insulin Pump System isequipped with various alarms and messages that ensure the correct func-tion of the system.The Implantable Insulin Pump has an alarm system which beeps when anerror condition occurs. The beeps are audible through the skin and alertyou that the Pump needs attention. The Pump will alarm consists of 4tones each minute for 10 minutes then, 4 double tones each minute for 10minutes and repeat pattern. Upon hearing the alarm, you need to commu-nicate with your PPC to determine the alarm condition and call your Phy-sician. Use the Read Pump Data option to communicate to the pump. Thealarm can be cleared by pressing SEL and ACT.
Alarms and MessagesThe 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: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 for30 minutes. If the alarm is not cleared in 30 minutes, the PPC will beep 6alternating tones. The PPC will continue to do so every minute until thecondition is cleared.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 6 will beep 3 times every 30 min-utes while the condition exists.
Alarms and MessagesThe Alarm Feedback function allows you to verify the Pump and thePump beeper is operating normally. When Alarm Feedback is pro-grammed “YES,”thePumpwillbeeponeachofthefirstfivePumpstrokes:•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.”The Implantable Insulin Pump battery is designed to last approximatelyseven years during conditions of normal use (see Chapter 9, TechnicalSpecifications). Battery life may vary somewhat depending upon yourinsulin delivery requirements. When battery energy becomes low, a volt-age sensor in the Pump will trigger the Pump Low Battery Alarm. APump Low Battery Alarm indicates there is approximately eight weeks ofbattery energy remaining.You can clear this condition and your Pump will continue to operate nor-mally. However, you should notify your doctor as soon as possible. Yourdoctor will then schedule a Pump replacement, and may switch you backto conventional insulin therapy.PPC Display Type ofAlarm Pump AlarmPUMP LOW BATTERY 1 In 24 hours if no PPCcommunication
Alarms and MessagesWhen 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.The Implantable Insulin Pump has a sophisticated self-monitoring systemthat continuously checks for circuit faults. If the Pump detects a circuiterror, it will beep and then automatically shut itself off. When thisoccurs, you must switch to your alternative insulin therapy estab-lished between you and your doctor. Notify your doctor immediately ofthe System Error.During a “SELF TEST,”the Pump finds a malfunction. The Pump willstop delivering insulin. Clear the message by pressing SEL then ACT.You must switch to your alternative insulin therapy establishedbetween you and your doctor. Notify your doctor immediately of theSelf Test Error.PPC Display Type of Alarm Pump AlarmPUMP STOPPED1or2or3or4or5or61 In 5 minutes if no PPCcommunicationPPC Display Type of AlarmPUMPSELF TEST FAIL1
Alarms and MessagesThe PPC offers a choice of two alarms, audible and vibrate. In addition, ascreen message appears indicating the type of alarm condition thatoccurred.NOTE: If “VIBRATE”is selected, the PPC battery shouldlast about six weeks. If the PPC determines thatthe vibrator is causing a low battery condition, itwill automatically change the Alarm Mode to“LOW VOLUME”in order to extend battery life.If the PPC main battery (AA 1.5 volt alkaline) energy is low, the follow-ing alarm display will appear:You can clear this message by pressing SEL and then ACT, and then con-tinue programming. There should be sufficient energy in the battery for atleast 24 hours. For instructions on changing the battery, refer to Chapter8, PPC Care and Maintenance.NOTE: If while programming the Pump, the PPC goesblank, the PPC beeps six times and then the"CHECK PUMP STATUS" message appears, thePPC (AA 1.5v alkaline) battery needs to bereplaced. For instructions, see "Installing/Replac-ing the Main Battery" in Chapter 8.PPC Display Type of AlarmPPCLOW BATTERY1
Alarms and MessagesWhen the PPC main battery (AA 1.5 volt alkaline) no longer has suffi-cient energy to program the Pump, the following message will appear onthe display:This message can only be cleared by replacing the PPC battery. Forinstructions on changing the battery, refer to Chapter 8.When the PPC back-up battery (lithium) energy becomes low, the follow-ing message will be displayed:You can clear this message by pressing SEL and ACT, and then continueprogramming. You should report this alarm to your doctor as soon as pos-sible to schedule a PPC replacement. Be aware that if the PPC loses allpower, it may lose its memory contents.PPC Display Type of AlarmPPCDEPLETED BATTERY1PPC Display Type of AlarmPPCNEEDS SERVICING1
Alarms and MessagesWhen the Pump calculates that less than 800 units (2 ml) of insulinremains in its reservoir, the following display will appear:You can clear this message by pressing SEL and ACT, and then continueprogramming. You should notify your doctor of the Low Reservoir mes-sage, and schedule a Pump refill appointment as soon as possible.When the Pump calculates that less that 400 units (1 ml) of insulinremains in its reservoir, the following display will appear:You can clear this message by pressing SEL and ACT, and then continueprogramming. The PPC Medication Remaining function reads calculatedvalues only, and there may still be some insulin left in the Pump reservoir.You should be report this alarm to your doctor as soon as possible, andschedule an appointment for a Pump refill. It is important not to allow thepump to deplete its insulin supply as this may result in a catheter block-age.PPC Display Type of Alarm Pump AlarmLOWRESERVOIR1 In 24 hours if no PPC communicationPPC Display Type of Alarm Pump AlarmEMPTYRESERVOIR1 In 24 hours if no PPCcommunication
Alarms and MessagesIf programming is interrupted after partial transmission of a command,the PPC will display the following message on the display screen:You should reposition the PPC near the pump, press SEL and ACT. ThePPC will attempt to resume communication with the Pump.If the PPC main battery (AA 1.5V alkaline) has been replaced or the PPCrecognizes the “PUMP STATUS”needs to be checked, the followingmessage is displayed:Place the PPC near the pump, then press SEL and ACT. Allow the com-munications to complete.NOTE: If while programming the Pump, the PPC goesblank, the PPC beeps six times and then the"CHECK PUMP STATUS" message appears, thePPC (AA 1.5v alkaline) battery needs to bereplaced. For instructions, see "Installing/Replac-ing the Main Battery" in Chapter 8.PPC Display Type of AlarmTELEMETRY COMM ERROR 3 1PPC Display Type of AlarmCHECK PUMP STATUS 1
Alarms and MessagesIf the Pump operation has been suspended, the following message is dis-played:During “SUSPEND PUMP,”the Pump will deliver a basal rate of0.2 U/h. To restart insulin delivery programming, press SEL and ACT.Then place the PPC near the Pump and allow the communication to com-plete.PPC Display Type of AlarmPUMPSUSPENDED2
Alarms and MessagesIf the “AUTO OFF”time interval elapses, the following message is dis-played:The Pump will initiate the internal alarm sequence of four beeps everyminute for 5 minutes, then double-beep 4 times every minute for 10 min-utes, then repeating the pattern. The alarm is cleared by pressing SEL andACT, place the PPC near the pump. The PPC will communicate with thePump to reset the "Auto Off" duration.If you attempt to deliver more than 2.5 times the pre-programmed bolusmaximum in one hour, the following message to be displayed:Press SEL and ACT, place the PPC near the Pump and allow the commu-nication to complete. You may exceed this limit by programming anotherbolus within 10 minutes.PPC Display Type of AlarmAUTO OFF PUMPPUMP SUSPENDED1PPC Display Type of alarmHOURLY MAXEXCEEDED1
Alarms and MessagesDisplay Screen Message Message Meaning or Action RequiredAUTO OFF PUMP PUMPSUSPENDEDAuto Off time interval has elapsed. Pump operation issuspended.BOLUS 0.0 u A bolus has been programmed and is being delivered.CHECK PUMPSTATUSThe PPC battery has been replaced. The PPC needs tocheck the Pump status.EMPTY RESERVOIR The PPC has recognized the Pump has 400 units (1 ml)or less insulin remaining in its reservoir. Schedule aPump refill as soon as possible. Allowing the reservoirto completely empty may damage the Pump.HOURLY MAXEXCEEDEDYou attempt to deliver more than 2.5 times the bolusmaximum in one hour. To clear the message, press SELand ACT. You may exceed this limit by programminganother 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 aPump refill as soon as possible. Allowing the reservoirto completely empty may damage the Pump.PPC NEEDSSERVICINGThe internal PPC backup battery is depleted. The PPCcan be programmed. Replace the PPC as soon as possi-ble.PPC DEPLETEDBATTERYThe PPC cannot be programmed. Replace the PPC AA1.5 volt alkaline battery.PPC LOW BATTERY The PPC can be programmed. Replace the PPC AA 1.5volt alkaline battery.PUMP LOWBATTERYThe 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 val-ues.PUMP SELF TEST FAIL A Pump malfunction was detected during a Self Test.Notify your physician immediately.PUMP STOPPED1or2or3or4or5or6When the Pump recognizes a system malfunction, itautomatically stops and insulin delivery ceases. Notifyyour physician immediately.
Alarms and MessagesPUMP SUSPENDED The Pump is in suspend modeTELEMETRY COMMERROR 3The PPC and Pump are not communicating. Repositionthe PPC over the Pump, then press SEL and ACT. If theerror message persists, notify your physician immedi-ately.Display Screen Message Message Meaning or Action Required
CHAPTER 6 Warnings and PrecautionsThe Medtronic MiniMed 2007C Implantable Insulin Pump System hasbeen tested with electrosurgical cutting tools, electrocoagulation, and car-diac defibrillation medical equipment. Typical use of this type of devicehas not affected the Pump. However, after such procedures, you shouldtest the Pump function (e.g., program “SELF TEST”) to determine thatthe Pump and PPC are operating properly. If the system is not performingcorrectly, contact your doctor.The Medtronic MiniMed 2007C Implantable Insulin Pump System hasbeen tested with diagnostic ultrasound procedures. These procedures haveno effect on the Pump. However, after such procedures, you should testthe Pump function (e.g., program a “SELF TEST”) to determine that thePump and PPC are operating properly. If the system is not performingcorrectly, contact your doctor.
Warnings and PrecautionsThe Medtronic MiniMed 2007C Implantable Insulin Pump System shouldnot be exposed to therapeutic ultrasound procedures, such as lithotripsy.Exposure to ultrasound therapy may damage the Pump System.The Medtronic MiniMed 2007C Implantable Insulin Pump System hasbeen tested with Computerized Tomography and X-ray. These procedureshave no effect on the Pump. However, after such procedures, you shouldtest the Pump function (e.g., program a “SELF TEST”) to determine thatthe Pump and PPC are operating properly. If the system is not performingcorrectly, contact your doctor.The Medtronic MiniMed 2007C Implantable Insulin Pump System hasbeen tested with therapeutic radiation. These procedures have no effect onthe Pump. However, it is recommended not to focus therapeutic levels ofradiation directly over the pump. After such procedures, you should testthe Pump function (e.g., program a “SELF TEST”) to determine that thePump and PPC are operating properly. If the system is not performingcorrectly, contact your doctor.You cannot undergo Magnetic Resonance Imaging procedures with theMiniMed 2007C Implantable Pump System.Under-delivery or “backflow”may occur when insulin deposits collect inthe pumping mechanism inside your Pump. These deposits affect the vac-uum seal in the pumping mechanism, and can prevent some of the insulinfrom being delivered. If the pumping mechanism is unable to seal tightly,the pump will under-deliver its insulin.
Warnings and PrecautionsIf your Pump is under-delivering its insulin, you may feel symptoms ofhyperglycemia. If this occurs, you should contact your doctor immedi-ately. Your doctor will instruct you how to manage your blood glucoselevels until the Pump can be corrected.Another under-delivery condition is caused by body fluids or body tissuecollecting at the tip of the Catheter. To correct a Catheter obstruction,your doctor may need to flush your Catheter with a sterile solution.If the Pump’s electronic or alarm systems malfunction, Self Test circuitrywill detect the malfunction and may stop the Pump. Notify your doctorimmediately if this occurs. If your doctor cannot correct the malfunction,your Pump may need to be replaced and you will need to take alternativeinsulin therapy.Infection, skin erosion, unresolved backflow, or catheter occlusion mayalso require that your Pump or Catheter be removed or replaced.Have your Pump refilled before the reservoir is empty. Alarms in the PPCwill alert you to low and depleted reservoir levels. For more informationon alarms and messages, see Chapter 7. If the low reservoir alarm soundsand you do not have a refill appointment scheduled within two weeks, callyour doctor immediately to schedule a refill.NOTE: If you are in doubt about whether a condition orsituation will affect your Pump, contact your doc-tor for advice.The Implantable Insulin Pump, like all microelectronic devices, shouldnot be exposed to extreme electrical or magnetic fields or temperatureextremes which may adversely affect the Pump and its insulin. Do notallow your Implantable Insulin Pump to be exposed to the following envi-ronmental conditions:
Warnings and Precautions•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 dam-age the Pump or injure the Pump pocket. Extreme pressure on the Pumpmay cause the sutures and the tissue pocket to be damaged resulting inPump migration and a possible dislodging of the Catheter. If you suspectthat your Pump or Pump pocket have been damaged, you should contactyour doctor immediately. You may need to wear a pressure bandage orreduce your level of physical activity until the Pump pocket heals com-pletely.You may not reside at or travel to an elevation in excess of 8,000 feet, ordive below 15 feet. High altitudes and depths will change the Pump’sinsulin flow. This warning does not apply to commercial airline travel.Airline cabins are adequately pressurized at any altitude for Pump use. Itis still possible to ski, dive or sky-dive with the proper precautions. Con-sult with your doctor.Exposure to elevated temperatures in excess of 104°F (i.e. hot tubs, sau-nas), for longer than one hour, can effect the potency of the insulin and thefunction of your Pump System (see “Pump and Catheter Under-delivery”on the previous page). If you have any questions about an activity you areplanning, you should contact your doctor for advice.This device may experience communication interruptions when operatedat or near some airport facilities. This will not affect the operation of thepump, and it will continue delivery of insulin per previously programmedlevels.
Warnings and PrecautionsYou must check your blood sugar at least four times daily, using a tech-nique recommended by your doctor. Notify your doctor of any increasedfrequency of serious low or high excursions in your blood sugar. Highblood sugar values may indicate under-delivery of insulin. If you experi-ence symptoms of high blood sugar, check the programmed insulin deliv-ery settings in your PPC and contact your doctor immediately.Carry conventional insulin supplies with you at all times, including insu-lin and a means to inject it, in case your PPC is damaged, lost or inopera-tive. Periodically review with your doctor your recommended insulindelivery procedure you should utilize in the event your MiniMed 2007Implantable Pump System becomes inoperative.Follow your doctor’s instructions about your insulin delivery. The rangeof insulin delivery with your PPC is a basal rate between 0.2 and 35 unitsper hour (U/H), and a maximum meal bolus of 25 units (U). Your doctormay narrow this range by programming maximum limits for your BasalRate and Bolus. The alarm “Hourly Maximum Exceeded”will be dis-played if you try to program more than 2.5 times the maximum bolus inone hour.
Warnings and PrecautionsThe PPC is an electronic device, and can be damaged if dropped. Do notget the PPC wet or take it into very hot or humid environments, such assteam baths or saunas. If the PPC is damaged, check the displays forproper operation by performing a “SELF TEST”.Ifthe“SELF TEST”finds a problem, you will need to replace your PPC. For more informationon the “SELF TEST”procedure, see Chapter 6, Warnings and Precau-tions.Your doctor may program specific limits for your Basal Rate and MealBolus. These maximum limits provide a regimen specific to your needs.Carry a fresh AA 1.5-volt alkaline battery with you at all times. The esti-mated PPC main battery life is approximately 8 weeks, although this canbe influenced by how often you program your Pump. If the Low Batterymessage appears, change the battery as soon as possible, preferablyimmediately. If the Depleted Battery Alarm occurs, the PPC will not func-tion and you will no longer be able to program your Pump.Keep the PPC near to the Pump during a programming sequence. Separa-tion of the PPC and Pump may result in a partial transmission of a com-mand. If this occurs, the PPC will alarm and display “TELEMETRYCOM ERROR”on the screen.
Warnings and PrecautionsPhysical activities which are not permitted are those involving very hig-hor low altitudes and pressure changes. Such activities include skiing,(above 8,000 feet), sky diving, and scuba diving. When you must partici-pate in such activities, discuss them with you physician who will providetreatment requirements, such as the temporary use of another method ofinsulin delivery, and will refill your Pump with buffer.Be fully informed and thoroughly understand what to do in an emergency.Carry your emergency card with you at all times. Additionally, it isimportant for individuals close to you, such as family, friends, and co-workers, to know what to do if you are unable to treat yourself due to ill-ness or injury.The following instructions should be used by your family or co-workersto set the Pump at 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”.3. Position the PPC near the Pump.4. When programming is complete, the PPC will beep and the displaywill automatically return to the Time/Day screen. The message“PUMP SUSPENDED”will be displayed. The Pump will deliver abasal rate of approximately 0.2 U/h.In addition to the procedure above, review with family members theproper procedure for administering glucagon.It is important to closely monitor blood sugar levels on refill days. Duringa refill procedure, a very small amount of insulin may be deposited subcu-taneously possibly resulting in hypoglycemia.
Warnings and PrecautionsIn clinical studies, adverse reactions associated with the Medtronic Min-iMed 2007 Implantable Insulin Pump System included hypoglycemia,diabetic ketoacidosis hyperglycemia skin erosion, infection, abnormalhealing, elevated anti-insulin antibodies, intestinal obstruction, post-oper-ative discomfort and pain, and corrective surgery for Pump and Cathetermalfunctions. Malfunctions in the order of frequency and seriousnessinclude insulin aggregation resulting in Pump under-delivery, Catheterocclusion or tissue overgrowth, early Pump battery depletion (e.g., lessthan six years after implantation) and electronic Pump failure. Adverseevents associated with the use of Aventis HOE 21 PH U-400 insulin aredescribed in the package insert accompanying the insulin medication.Your Implantable Insulin Pump uses a special short-acting insulin, soyour body will not have any reserve of long-acting insulin. Interruption ofinsulin delivery (due to Pump malfunction or clogging of the Catheter) orthe sudden onset of stress (emotional upset, infection, etc.) may result in arapid rise of blood sugar levels, and possibly the development of diabeticketoacidosis (DKA). Check your blood sugar levels, and your urine forketones, if you suspect a high glucose level. Supplemental insulin deliv-ered by conventional means may be required. Establish a protocol withyour doctor for rapidly identifying and treating hyperglycemia to avoidthe onset of DKA.The best method for identifying hypoglycemia is testing your blood sugarlevels. Establish a protocol with your doctor for identifying and treatingsymptoms of hypoglycemia to avoid an insulin reaction.
Warnings and PrecautionsPump pocket infection, although rare, occur around the Pump implanta-tion site. If you notice pain, redness, or swelling in the area of your Pump,contact your doctor immediately. Pump pocket infections may require theremoval of your Pump.A Pump pocket seroma is generally characterized by swelling around thearea of implantation. It may occur after surgery or if a blow is received tothe Pump site. If you notice swelling around your Pump, contact yourdoctor immediately.
Warnings and Precautions
CHAPTER 7 Important Self-CareHaving a Medtronic MiniMed 2007 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 glu-cose levels.This manual presents general information regarding blood glucose moni-toring, meal planning, exercise and other issues concerning your implant-able Pump. You will be instructed more specifically on these self-careissues by your doctor, nurse, and dietitian. Be sure to discuss all questionswith them as they 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, “DevelopEmergency Plan”in Chapter 6. Your support person should also be ableto program the PPC to stop insulin delivery as described in Chapter 6.NOTE: Remember much of the success of implantablepump therapy depends on accurate and frequentblood glucose monitoring.Your Pump System does not monitor your blood glucose levels. You mustcontinue to self-monitor your blood glucose at least four times daily, andthen use this glucose information to program your Pump System. Blood
Important Self-Careglucose monitoring is the only way to determine if you are receiving thecorrect amount of insulin. You should test your blood glucose accordingto the method recommended by your doctor.If you begin to have a problem with glycemic control, it is very importantto record your blood glucose measurements. A careful record may helpdetermine if the problem is related to your Pump or another cause.You will always receive some basal insulin from your Implantable InsulinPump. When you program a meal bolus, this will be in addition to yourbasal rate.As with any insulin therapy, it is recommended that you keep some formof fast-acting sugar with you at all times to treat hypoglycemia. If youhave any questions concerning your meal plan and insulin therapy, dis-cuss them with your healthcare team as they are your best source of infor-mation.There are no restrictions on your normal work, school, social, or sexualactivities unless you have a medical condition which does not allow suchactivities. Because your Pump is implanted, you may bathe and showerwithout any interruption in insulin therapy. However, your PPC is notwaterproof and should be protected from getting damp or wet.You may participate in most physical activities with your MiniMed 2007Implantable Pump Insulin System. Rough contact sports are not recom-mended as Pump pocket injury may occur. Exercise may reduce yourinsulin requirements, therefore, you must check your blood glucose fre-quently during periods of exercise. In addition, it may be necessary toreduce your basal rate during the exercise.
Important Self-CareYou may travel with your Medtronic MiniMed 2007C Implantable InsulinPump System. All extended trips should be discussed with your doctor. Itis safe to travel in a pressurized aircraft, which includes all commercialairlines. Security systems at airports will not affect your Pump, but youmay be asked to show your Patient Emergency Information Card whichexplains the Pump and PPC. Remember to always carry conventionalinsulin supplies with you when you travel (insulin and syringes or anexternal Pump) in case of a medical emergency.Your doctor will give you a Patient Emergency Information Card whenyou receive your Pump System. It provides information about your Pump,as well as important phone numbers in case of a medical emergency.CarryYourInformationCardWithYouAtAllTimes.It is also rec-ommended that you wear a bracelet or necklace indicating that you wearan implantable insulin Pump.
Important Self-Care
CHAPTER 8 PPC Care and MaintenancePPC Battery life is estimated to be approximately 8 weeks. Only AA 1.5volt alkaline or lithium batteries are recommended for use with the PPC.To replace the PPC Main 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 liftby gently pulling up the battery door to unlatch.4. Remove the old battery, noting the polarity. The PPC screen will beblank.5. Position the new battery so the + and - markings on the battery matchthe polarity 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:
PPC Care and Maintenance9. The PPC will beep six times and display“PPC/PUMP.”10. After a few seconds, the screen willchange to “CHECK PUMP STATUS.”11. Press SEL and ACT,thenplacethePPCover the Pump.12. Allow the communication to complete.PPC 0 209PUMP 0 211CHECKPUMP STATUSPPCCOMMUNICATING
PPC Care and MaintenanceNOTE: When the PPC displays “PPC LOW BATTERY,”you can clear the message and continue program-ming. There should be sufficient energy in the bat-tery to communicate with the Pump for a minimumIf while programming the Pump, the PPC goesblank, the PPC beeps six times and then the"CHECK PUMP STATUS" message appears, thePPC (AA 1.5v alkaline) battery needs to bereplaced. For instructions, see "Installing/Replac-ing the Main Battery" in Chapter 8.•Protect the PPC from direct contact with water and moisture.Never take the PPC into a sauna or steam bath. If the PPC comesin contact with moisture where the battery compartment is wet,remove the battery and dry compartment thoroughly. Replace thebattery and perform a “SELF TEST.”•Protect the PPC from temperatures greater than 40°C (104°F).Do not leave the PPC in direct sunlight.•Protect the PPC from cold temperatures less below freezing(0°C or 32°F).•Do not drop the PPC. Protect the PPC from sharp blows. Eithercould damage the electrical components of the PPC and affect itsability to program your implantable Pump.
PPC Care and Maintenance•If necessary, use a slightly damp cloth and mild soap to clean theoutside of the PPC. Do not use a wet cloth or dip the PPC in anyliquid. Moisture may 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, espe-cially the keyboard panel.
CHAPTER 9 Technical Specifications Component Performance SpecificationDiameter ThicknessReservoir Volume 8.1 cm (2.3 inches)2.0 cm (0.8 inches) 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 µlperstroke0.17 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 each.Meal Bolus 0.2 to 25.0 unitsBolus Duration Immediate, Square Wave (30 minutes to 4 hours), or bothtogether. Audio Bolus
Technical SpecificationsTemporary Basal Rate 0.2 to 35.0 units per hour30 minute increment duration30 minutes up to 24 hours delayDiagnostic Rate 10 to 150 U/hPower Supply Lithium - Carbon Monofluoride BatteryBattery life See graph below.Audio Alarms Low BatteryNearly Depleted BatterySystem ErrorSafety Features Negative Pressure Reservoir with Passive FillingPump Shutdown and Alarm with System Error (unique codesequences)Materials Titanium Housing, Polyethylene-lined Silicone RubberCatheterComponent Performance Specification
Technical SpecificationsComponent Performance SpecificationHeight 8.9 cm (3.5 inches)Length 7.0 cm (2.8 inches)Width 2.0 cm (0.8 inches)Weight 115 gm (4.0 ounces)Main Power Source 1.5 Volt Alkaline Battery Type AAMain Battery Life Approximately 8 weeks, depending upon usageBackup Battery Lithium Battery (MMT-4207)Backup Battery Life 3 years minimum with no AA battery installedOperating Temperature 0ºCto40ºC(32ºF to 104ºF)Average Pump Service Life vs. DailyInsulin Delivery(U-400 Insulin Delivered After 6 Month Shelf Life)678910111213140 10 20 30 40 50 60 70 80 90 100 110 120 130 140Daily Insulin Delivery (Units)Pump Life (Years)
Technical SpecificationsStorage Temperature -0ºCto30ºC(32ºFto86ºF)Messages AutoOffin5min/AutoOffPumpSuspendedCheck Pump StatusCommunication ErrorDownload CompleteEmpty ReservoirHourly Maximum ExceededLow ReservoirPPC Not initializedPPC Needs ServicingPPC Low BatteryPPC Depleted BatteryPump Self Test FailPump ResetPump StoppedPump Version ErrorTelemetry Communications ErrorComponent Performance Specification
Technical SpecificationsThis device complies with part 15 of the FCC Rules. Operation is subjectto the following two conditions: (1) This device may not cause harmfulinterference, and (2) this device must accept any interference received,including interference that may cause undesired operation.Operation of this device is authorized by the FCC under the FCC IDOH22007C (Implantable Pump) and 0H23150 (PPC).Any changes or modifications to the system not expressly approved byMiniMed could void the user’s authority to operate the system.MMT- 4027ALengthProximal:Distal:11.8±1.3cm (4.7±0.5inches)17.8 ± 0.7 cm (7.0 ± 0.3 inches)MMT- 4024ALengthProximal:Distal:11.8±1.3cm (4.7±0.5inches)10.2 ± 0.4 cm (4.0 ± 0.2 inchesMaterial Polyethylene-lined Silicone RubberSideport Polysulfone, Silicone Septum
Technical Specifications

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