OH22007CImplantable Insulin Pump

MiniMed ® Implantable Pump System REF MMT-2007C Implantable Pump Unit ** NOTE ** Please refer to the physician and patient manual for instructions for use and detailed information regarding the Medtronic MiniMed Implantable Pump System. INTRODUCTION The Medtronic MiniMed Implantable Pump System is a sophisticated combination of technologies developed to address the requirements of continuous intraperitoneal insulin delivery for patients with Insulin Dependent Diabetes Mellitus (IDDM). The system is comprised of: Implantable Pump, Side Port Catheter, Personal Pump Communicator, and accessory syringe, needle, template, and pipette. The pump and catheter are designed for implantation. The Personal Pump Communicator is designed to provide the patient a variety of insulin delivery options. The accessory items are specifically designed to facilitate refill of the implanted pump and pump functions. INDICATIONS FOR USE The Medtronic MiniMed Implantable Pump System is indicated for intraperitoneal administration of exogenous insulin in patients with diabetes mellitus who are able to actively participate in their treatment program. CONTRAINDICATIONS The MiniMed Implantable Pump System is contraindicated in patients who: • Are unwilling or unable to monitor their blood/glucose level at least four times per day. • Are unwilling or unable to make programming modifications to the pump based on glucose level readings. • Are unable or unwilling to administer insulin by other means if necessary. • Are unable or unwilling to comply with the guidance and advice of the treating physician and other healthcare providers. • Reside at or travel (other than by commercial aircraft) at elevations above 8000 feet. • Have other medical or mental conditions which may place the patient at risk. • Are unwilling or unable to return for routine insulin refill (approx. 2-3 months) according to dosage. • Present current or history of sensitivity to titanium alloy or silicone materials used in the manufacture of system implanted components. PRECAUTIONS Patients should always maintain conventional insulin supplies in the event of pump and or Personal Pump Communicator (PPC) failure. Delivery of insulin can become impaired due to pump failure or catheter occlusion. In the event of impaired insulin delivery, replacement of the pump or catheter may be required. Physicians should review Physicians Manual for full description of Pump replacement procedure and catheter clearing procedures. The Medtronic MiniMed Pump and Catheter Implants should NOT be used if damaged prior to or during implantation procedures. The pump should not be placed in contact with other metal implants. WARNINGS ** NOTE ** The MMT-2007C pump can only be used with the MMT 4021A-4028A Side Port Catheters Physicians should be completely familiar with the function of the pump, catheter, and personal pump communicator prior to use of this device. Patients should be provided a complete copy of the Patient Manual and have demonstrated the ability to program the Personal Pump Communicator (PPC), recognize and respond to safety alarms, and care of the device prior to discharge. The Medtronic MiniMed Implantable Pump System should not be exposed to therapeutic ultrasound. Exposure to ultrasound therapy may cause damage to the pump that may not be apparent. Only special-U400 insulins may be used in the Medtronic MiniMed Implantable Pump System. Use of other insulin types may cause damage to the pump mechanism resulting in impaired insulin delivery or pump failure. Any unauthorized changes or modifications made to any component of the system may prevent effective use of that and other components. POSSIBLE ADVERSE EFFECTS The Medtronic MiniMed Implantable Pump System has undergone an extensive clinical evaluation. Evaluation of the system spanned a period of ten years and involved over 600 subjects in the United States and Europe. Though over delivery of insulin did not occur during the ten year evaluation period, there is a potential for such occurrence. The following are specific adverse effects which should be understood by the physician and explained to the patient. These do not include all adverse effects which can occur with surgery in general or with the use of this devise, but are important considerations particularly in the treatment of people with diabetes. The general surgical risks as well as operative site cosmetic risks should be explained to the patient prior to surgery. Abdominal Pain Foreign Body Reaction Abnormal Healing Skin Disorder Infection Urinary Disorder Necrosis Psychiatric Decompensation Retinal Disorder Skin Erosion Abnormal Liver Function Kidney Disorder Ileus Pocket Lymph Edema Inflammation at Refill Site Pump Failure Hyperglycemia Catheter Occlusion/ Hypoglycemia Encapsulation Ketoacidosis Battery depletion PPC Failure STERILE DEVICE The Medtronic MiniMed Implantable Pump is EO sterilized and packaged sterile in tamper evident package. Do not use if package has been opened or damaged. PRESCRIPTION DEVICE Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. FCC Notice This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference and (2) This device must accept any interference received, including interference that may cause undesirable operation. CAUTION: Any changes or modifications not expressly approved by Medtronic MiniMed could void your ability to operate the equipment. Medtronic MiniMed ® 2007C Implantable Pump System Limited Warranty The Medtronic MiniMed 2007 Implantable Pump and Personal Pump Communicator are components of the Medtronic MiniMed Implantable Pump System designed for the long-term, intraperitoneal infusion of insulin in the intensive treatment of insulin dependent diabetes mellitus (IDDM) with the use of a peritoneal catheter, also a component of the system. Pumps include an exhaustib…

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2007C IMPLANTABLE INSULIN PUMP SYSTEM

Medtronic MiniMed 2007C Implantable Insulin Pump System Patient 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 2/01 4,373,5274,395,2594,525,165 4,568,2504,569,6414,573,994 4,619,6534,636,1504,731,051 4,776,8425,167,6335,176,644 5,197,3225,217,4425,257,971 5,460,6185,466,2185,514,103 5,527,3075,559,8285,797,733 5,915,929 i Table of Contents CHAPTER 1The Medtronic MiniMed 2007C Implantable Insulin PumpSystem ............................ 1 Introduction........................................................1 MiniMedhelpline ...................................................2 Descriptionofthesystem .............................................2 Implantableinsulinpump.......................................... 3 Medicationreservoir ...........................................4 Pumpingmechanism ...........................................4 Antenna .....................................................4 Microelectronics ..............................................5 Battery ......................................................5 Tonetransducer ...............................................5 Sideportcatheter .................................................6 Personalpumpcommunicator(PPC)..................................7 Specialinsulin ...................................................9 CHAPTER 2 SafetyFeatures......................... 11 Pumpsafetyfeatures ................................................11 Safetelemetry ..................................................11 ii Alarms ........................................................11 Negativepressurereservoir ........................................11 PPCsafetyfeatures .................................................12 Programming sequence...........................................12 Maximumdosagelimits...........................................12 Alarmsandmessages .............................................12 CHAPTER 3 Implanting the MiniMed 2007C Pump System . . .13 Hospitalization .....................................................13 Pre-operativeprocedures ..........................................13 Implantationprocedures ..........................................14 Post-operativeprocedures .........................................14 Follow-up ...................................................15 Pump refills.......................................................16 Insulinusedwiththeimplantablepump ..............................16 Pumprefillprocedure ............................................16 CHAPTER 4 ProgrammingYourPump................. 17 Introduction.......................................................17 PPCscreenicons ...................................................18 PPCbuttons .......................................................19 Main programming screen............................................20 Programming a bolus.............................................20 Setanimmediatebolus(variablebolusoptionis“off”) ...................21 Setanimmediatebolus(variablebolusoptionis“on”) ..................22 Setasquarewavebolus ...........................................23 iii Setadualwavebolus.............................................25 Reviewthebolushistory ..........................................27 Suspendmode ..................................................27 Programbasalrates ..............................................28 Setonebasalrate .............................................28 Set multiple basal rates........................................29 Setatemporarybasalrate ......................................30 Stopatemporarybasalrate .....................................31 Personalevents .................................................32 Presetevents ................................................32 Additional events.............................................32 History ...........................................................33 Pumpsetup........................................................35 Timeanddate...................................................35 Autooff ..........................................................36 Alarms ........................................................37 SelfTest .......................................................38 Basaldeliverypatterns ............................................39 Initialize PPC to pump............................................40 PumpsetupII ...................................................40 Exitsetupmenu .................................................40 PumpsetupII ......................................................41 Turnontheaudiobolusfeature .....................................41 Useaudiobolusinthemainmenu...................................42 Turnonthevariablebolusfeature ...................................42 Setamaximumbolus.............................................43 iv Setamaximumbasalrate .........................................44 Set time format..................................................44 Personalevent ..................................................45 Pumpsetup..................................................45 Exitsetupmenu ..............................................45 CHAPTER 5 AlarmsandMessages ..................... 47 Thepumpalarms ...................................................47 ThePPCalarms ....................................................48 Alarmtype1 ...................................................48 Alarmtype2 ...................................................48 Pumpalarms ......................................................49 Alarmfeedback .................................................49 Pumplowbattery ................................................49 Depletedpumpbattery ............................................50 Systemerror ....................................................50 Pumpselftestf…

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2007C IMPLANTABLE INSULIN PUMP SYSTEM

1 Table of Contents CHAPTER 1Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System . . . . . . . . . .11 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Implantable Insulin Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Insulin medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 Personal Pump Communicator (PPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 CHAPTER 2 Indications and Contraindications . . . . . . . . . .21 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Contraindications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Possible adverse effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 CHAPTER 3 Personal Pump Communicator (PPC) . . . . . . .25 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 PPC Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26 PPC buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27 Communicating with the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28 Dmp9196021-011_c.book Page 1 Thursday, April 4, 2002 8:15 AM 2 Install/Replace the main battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29 Part 1: PPC/Pump system initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 Initialize the PPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32 Set the time and date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34 Set alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35 Set maximum bolus, basal rate and time display format . . . . . . . . . . . . . . .36 Lock maximum bolus/basal, enter personal ID and password, stop Pump .38 Program a basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 Part 2: Additional PPC programming features . . . . . . . . . . . . . . . . . . . . . . . . . . . .42 Main menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42 Program a bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42 Set a normal bolus with the variable bolus feature turned off . . . . . . . . . . .42 Set a normal bolus with the variable bolus feature turned on . . . . . . . . . . .44 Set a square wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45 Set a dual wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47 Review bolus history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49 Suspend mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49 Programming a basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 Programming basal delivery pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 Setting basal rate profiles in each delivery pattern . . . . . . . . . . . . . . . . . . .51 Program a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52 Set a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52 Stop a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54 Personal events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54 History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56 Setup Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58 Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58 Self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59 Initialize PPC to Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60 Setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60 Exit setup menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60 Dmp9196021-011_c.book Page 2 Thursday, April 4, 2002 8:15 AM 3 Setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 Audio bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 Activating the audio bolus feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 Set an audio bolus from the main menu bolus screen . . . . . . . . . . . . . . . . .62 Variable bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62 Refill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64 Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65 Diagnostic rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67 Initialize to factory defaults . . . . . . . . . .…

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85 Fill the Pump with insulin 1.Remove another refill syringe (IN2) from a refill kit package. 2.Firmly attach the two-way stopcock to the refill syringe and attach an 18 gauge needle to the stopcock. Label the syringe IN2. 3.Draw 20 mL of INSULIN (two vials) into the IN2 syringe. 4.Remove the 18 gauge needle and expel all air bubbles in the syringe. 5.Close the stopcock. 6.Retract the plunger until it locks into place. This should be no further than 55 mL. Do not go beyond the vent hole. Press the lock into the plunger groove to be sure it is firmly secured. 7.Shake vigorously for a minimum of 30 seconds to degas the INSU- LIN. 8.Point the syringe tip upward and slowly open the stopcock to vent the syringe. 9.Release the locking ring on the refill syringe. 10.Expel the air in the syringe and carefully observe it to ensure no air bubbles remain in the syringe. If air bubbles are noted, repeat steps 5 - 10. 11.Fill the hub of the refill needle with INSULIN and attach it to the stopcock. 12.Prime the needle and close the stopcock. 13.Place a sterile beaker or sterile barrier towel on the scale and tare it (position balance at 0.) 14.Weigh the refill syringe and record the weight on the Implant Work- sheet. Dmp9196021-011_c.book Page 85 Wednesday, April 3, 2002 5:04 PM 86 15.Press the refill syringe into the Pump fill port, open the stopcock and allow the Pump vacuum to draw INSULIN into the reservoir until the fluid level stops moving. Close the stopcock. 16.Remove the IN2 syringe and prepare for aspiration without expelling any fluid. Obtain a vacuum by pulling back on the plunger until it locks. Press the lock into the plunger groove to be sure it is firmly secured. 17.Reenter the Pump fill port with the stopcock closed. 18.Open the stopcock and withdraw 2 mL in order to activate the nega- tive pressure safety feature of the Pump. Close the stopcock and remove the syringe. 19.Weigh the IN2 syringe to calculate the Pump refill amount. Subtract the weight after the fill and 2 mL withdrawal from the weight before the fill and record the difference on the Implant Worksheet. Measure stroke volume 1.Place the PPC in the sterile bag. Enter the Supervisor Mode. The screen displays “PUMP REFILL”. Press ACT until the “SET REFILL AMOUNT” screen appears. When filling the Pump for the first time, set the “EXTRACTED AMOUNT” to zero. Otherwise, enter the amount of insulin extracted. Then use the



and    buttons to enter the refill amount from the Implant Worksheet. Program the Pump. 2.Again, enter the Supervisor Mode and program “STOP PUMP”. From the screen “PUMP STOPPED”, press SEL. “PUMP STOPPED” will begin flashing. Press both the



and    buttons at the same time, until the screen changes to the password screen. Reen- ter the password and the screen will change to “PUMP REFILL.” Press SEL to reach the “PRIMING” screen. “NO” will be flashing. Use the



and    buttons to select “YES,” then press ACT. When the word “CONFIRM” is highlighted, press ACT again. Place the PPC near the Pump to complete the communication process. Record the Dmp9196021-011_c.book Page 86 Wednesday, April 3, 2002 5:04 PM 87 time the priming bolus was initiated on the implant worksheet. If you have removed the plastic tubing placed on the Pump outlet, DO NOT TRY TO REPLACE THE TUBING BACK ON THE PUMP OUTLET. You can displace or damage the “O” ring placed around the outlet. To measure the stroke volume, you need to use the procedure described in Appendix G, after the Catheter has been attached. 3.Listen for five beeps and observe that fluid is being pumped from tub- ing attached to the Pump outlet. 4.Attach the 18 gauge needle (from the 3 ml syringe filled with RINSE BUFFER) to the plastic tubing from the Pump outlet. 5.Remove the 3 ml syringe and fill the needle hub. 6.Insert the pipette into the hub. A meniscus of fluid will be present in the pipette. This should be done on a flat surface with the pipette/tub- ing assembly horizontal. (see Figure 8). Figure 8: Testing Pump Stroke Volume with a Pipette 7.Note the exact location of the fluid meniscus in the pipette. 8.Measure the stroke volume by noting the volume displaced by a mini- mum of 10 pulses. Record the total volume delivered and the number of pulses on the Implant Worksheet. Divide the total volume deliv- ered by the total number of pulses used to deliver that volume. The volume per stroke must be between 0.40 and 0.60 μL. Record this value on the Implant Worksheet. ! WARNING Dmp9196021-011_c.book Page 87 Wednesday, April 3, 2002 5:04 PM 88 Prepare the Side Port Catheter The Side Port Catheter (“Catheter”) is attached to the Pump before implantation; however, it must be primed with INSULIN and inspected before being attached to the Pump. Never insert a needle into the connector end of the Catheter for priming or for testing. there may be a precision sealing surface in the connector that will be damaged by the insertion of any needle. 1.Keep the Catheter in its package until the Pump is prepared and stroke volume has been verified. Remove the Catheter from its sterile pack- age and document the serial number on the Implant Worksheet. 2.Using the last insulin syringe (IN2) from the Pump preparation proce- dure, enter the Catheter port cone and push a small volume of insulin out of the connector end of the Catheter. This primes the proximal portion of the Catheter and cleans any debris from the connector out- let. Remove the syringe. 3.Remove the plastic tubing and tubing retainer from the Pump outlet. Remove the tubing retainer, by rotating it one-quarter turn clockwise to disengage it from the connector flange.Then lift and remove the tubing and retainer together from the Pump outlet.Dispose of the tub- ing and retainer. ! WARNING Dmp9196021-011_c.book Page 88 Wednesday, April 3, 2002 5:04 PM 89 Figure 9: Rotate Tubing Retainer Figure 9-2: Pull Tubing Retainer off Pump. Dmp9196021-011_c.book Page 89 Wednesday, April 3, 2002 5:04 PM 90 Figure…

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117 CHAPTER 9System Alarms and Messages The Medtronic MiniMed 2007C Implantable Insulin Pump System is equipped with various alarms and messages that ensure the correct func- tion of the system. The Implantable Insulin Pump alarm system will “beep” when certain conditions occur. The beeps are designed to be audible through the skin and alert the patient that the Pump needs attention. For severe alarm con- ditions the Pump will alarm 4 tones each minute for 10 minutes then, 4 double tones each minute for 10 minutes and repeat the pattern. Upon hearing the alarm, the patient must communicate with the PPC, to deter- mine the alarm condition. The alarm can be cleared by pressing SEL then ACT. The following descriptions explain the alarm conditions the system may encounter. The PPC has three types of alarms: audible, vibrate and visual alarms. The chapter will describe for each alarm condition, which screen message appears and the vibrate or audible alarm associated with it. 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 seconds every minute for 30 minutes. If the PPC is set to “audible”, the PPC will beep 6 times every minute for 30 minutes. If the alarm is not cleared in 30 minutes, the PPC will beep 6 alternating tones. The PPC will continue to do so every minute. Dmp9196021-011_c.book Page 117 Wednesday, April 3, 2002 5:06 PM System Alarms and Messages 118 Alarm Type 2: If the PPC is set to “vibrate”, the vibrator will be turned on for 3 seconds every 30 minutes while the condition exists. If the PPC is set to “audible”, the PPC will beep 3 times every 30 minutes while the condition exists. Some alarms can be cleared by pressing SEL then ACT. Pump alarms Alarm feedback The Alarm Feedback function allows the user to verify the Pump and Pump alarm are operating normally. Physicians can also use Alarm Feed- back to measure the time intervals between Pump strokes to verify accu- rate insulin delivery. 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 when completing a meal Bolus and then changing to a Basal Rate, or at the start of a bolus. •After the Alarm Feedback function is programmed “YES.” Alarm Feedback will stay on until programmed back to “NO.” Pump low battery The Implantable Insulin Pump battery is designed to last approximately ten years during conditions of normal use (see Chapter 11, Technical Specifications). Battery life may vary somewhat depending upon a user’s insulin delivery requirements. When battery energy becomes low, a volt- age sensor in the Pump will trigger the Pump Low Battery Alarm. A Pump Low Battery Alarm indicates there is approximately eight weeks of battery energy remaining. Dmp9196021-011_c.book Page 118 Wednesday, April 3, 2002 5:06 PM Pump alarms 119 The Pump Low Battery alarm can be cleared and the Pump will continue to operate normally. However, users should be instructed to report the alarm immediately to their physician. A Pump replacement or resumption of conventional insulin therapy should then be scheduled. Depleted pump battery When there is no longer sufficient battery energy to power the Pump, the Pump Low Battery Alarm will cease and insulin delivery will stop. Alter- nate insulin therapy must be initiated. System error The Implantable Insulin Pump has a sophisticated self-monitoring system that periodically checks for circuit faults. If a fault should occur in the Pump electronics, insulin delivery will stop. Conventional insulin therapy must be initiated immediately. Using the PPC Supervisor Mode, the phy- sician should use the “DOWNLOAD SOFTWARE” feature to reprogram the Pump from software in the PPC memory. Notify MiniMed immedi- ately. PPC DisplayType of AlarmPump Alarm PUMP LOW BATTERY 1In 24 hours if no PPC communication PPC DisplayType of AlarmPump Alarm PUMP STOPPED 1 or 2 or 3 or 4 or 5 or 6 1In 5 minutes if no PPC communication Dmp9196021-011_c.book Page 119 Wednesday, April 3, 2002 5:06 PM System Alarms and Messages 120 Pump self test fail If during a “SELF TEST” the Pump presents a malfunction, the insulin delivery will stop. Clear the message by pressing SEL then ACT. Notify MiniMed immediately. PPC alarms The PPC offers a choice of two alarms, audible and vibrate. In addition, a screen message appears indicating the type of alarm condition that occurred. PPC low battery If the PPC main battery (AA 1.5 volt alkaline) energy is low, the follow- ing alarm display appears each time a new function is programmed: Clear this message by pressing SEL and then ACT. While the battery should have sufficient energy for a few additional programming com- mands, the battery should be changed as soon as possible. For instruc- tions on changing the battery, (see Chapter 3, Personal Pump Communicator). If “VIBRATOR” is selected, the PPC bat- tery should last about six weeks during nor- mal use conditions. If the PPC determines that the vibrator is causing a low battery condition, it will automatically change the A l a r m M o d e t o “ L O W V O L U M E ” i n order to extend battery life. PPC DisplayType of Alarm PUMP SELF TEST FAIL 1 PPC DisplayType of Alarm PPC LOW BATTERY 1 ! WARNING Dmp9196021-011_c.book Page 120 Wednesday, April 3, 2002 5:06 PM Pump alarms 121 NOTE: If while programming the PPC, the screen goes blank, the PPC beeps six times and then the “CHECK PUMP STATUS” message appears, the battery needs to be replaced. (See Chapter 3 for instructions, Install/Replace the Main Battery). PPC depleted battery When the PPC main battery (AA 1.5 volt alkaline) no longer has suffi- cient power to program the Pump, the following message will appear on the display: This message can only be cleared by replacing the PPC battery. For instructions on changing the battery, (refer to Chapter 3, Pe…

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