Medtronic MiniMed 2007C Implantable Insulin Pump User Manual Dmp9196021 011 c

Medtronic MiniMed, Inc. Implantable Insulin Pump Dmp9196021 011 c

physician part3

117CHAPTER 9 System Alarms and Messages The 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 alarm system will “beep” when certainconditions occur. The beeps are designed to be audible through the skinand 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, 4double tones each minute for 10 minutes and repeat the pattern. Uponhearing the alarm, the patient must communicate with the PPC, to deter-mine the alarm condition. The alarm can be cleared by pressing SEL thenACT. The following descriptions explain the alarm conditions the systemmay encounter.The PPC has three types of alarms: audible, vibrate and visual alarms.The chapter will describe for each alarm condition, which screen messageappears 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 secondsevery minute for 30 minutes. 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.Dmp9196021-011_c.book Page 117 Wednesday, April 3, 2002 5:06 PM
System Alarms and Messages118Alarm Type 2:If the PPC is set to “vibrate”, the vibrator will be turned on for 3 secondsevery 30 minutes while the condition exists. If the PPC is set to “audible”, the PPC will beep 3 times every 30 minuteswhile the condition exists.Some alarms can be cleared by pressing SEL then ACT.Pump alarmsAlarm feedbackThe Alarm Feedback function allows the user to verify the Pump andPump 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”, thePump will beep on each of the first five Pump strokes:• Following a change in the delivery regimen, for example whencompleting a meal Bolus and then changing to a Basal Rate, or atthe start of a bolus.• After the Alarm Feedback function is programmed “YES.”Alarm Feedback will stay on until programmed back to “NO.”Pump low batteryThe Implantable Insulin Pump battery is designed to last approximatelyten years during conditions of normal use (see Chapter 11, TechnicalSpecifications). Battery life may vary somewhat depending upon a user’sinsulin 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. Dmp9196021-011_c.book Page 118 Wednesday, April 3, 2002 5:06 PM
Pump alarms 119The Pump Low Battery alarm can be cleared and the Pump will continueto operate normally. However, users should be instructed to report thealarm immediately to their physician. A Pump replacement or resumptionof conventional insulin therapy should then be scheduled. Depleted pump batteryWhen there is no longer sufficient battery energy to power the Pump, thePump Low Battery Alarm will cease and insulin delivery will stop. Alter-nate insulin therapy must be initiated.System errorThe Implantable Insulin Pump has a sophisticated self-monitoring systemthat periodically checks for circuit faults. If a fault should occur in thePump electronics, insulin delivery will stop. Conventional insulin therapymust be initiated immediately. Using the PPC Supervisor Mode, the phy-sician should use the “DOWNLOAD SOFTWARE” feature to reprogramthe Pump from software in the PPC memory. Notify MiniMed immedi-ately.PPC Display Type of Alarm Pump AlarmPUMP LOW BATTERY1 In 24 hours if no PPC communicationPPC Display Type of Alarm Pump AlarmPUMP STOPPED1 or 2 or 3 or 4 or 5 or 61 In 5 minutes if no PPC communicationDmp9196021-011_c.book Page 119 Wednesday, April 3, 2002 5:06 PM
System Alarms and Messages120Pump self test failIf during a “SELF TEST” the Pump presents a malfunction, the insulindelivery will stop. Clear the message by pressing SEL then ACT. NotifyMiniMed immediately. PPC alarmsThe PPC offers a choice of two alarms, audible and vibrate. In addition, ascreen message appears indicating the type of alarm condition thatoccurred. PPC low batteryIf 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 batteryshould 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 PumpCommunicator).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 Alarm Mo d e to “LOW VOLUME” i n order to extend battery life.PPC Display Type of AlarmPUMP SELF TEST FAIL1PPC Display Type of AlarmPPCLOW BATTERY1!WARNINGDmp9196021-011_c.book Page 120 Wednesday, April 3, 2002 5:06 PM
Pump alarms 121NOTE: If while programming the PPC, the screen goesblank, the PPC beeps six times and then the“CHECK PUMP STATUS” message appears, thebattery needs to be replaced. (See Chapter 3 forinstructions, Install/Replace the Main Battery).PPC depleted batteryWhen the PPC main battery (AA 1.5 volt alkaline) no longer has suffi-cient power 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 3, Personal PumpCommunicator).PPC Display Type of AlarmPPCDEPLETED BATTERY1Dmp9196021-011_c.book Page 121 Wednesday, April 3, 2002 5:06 PM
System Alarms and Messages122PPC needs servicingWhen the PPC internal battery (lithium) energy becomes low, the follow-ing message will be displayed:Clear this message by pressing SEL and ACT. Users should be instructedto report this alarm to their physician as soon as possible and have theirPPC replaced. If the PPC loses all power, it may also lose informationstored in memory.Low reservoirWhen the Pump calculates that less than 800 units (2 ml) of insulinremains in its reservoir, the following display will appear:Clear this message by pressing SEL and ACT. Users should be instructedto report this alarm to their physician as soon as possible and schedule anappointment for a Pump refill.Empty reservoirWhen the Pump calculates that less that 400 units (1ml) of insulin remainsin its reservoir, the following display will appear :PPC Display Type of AlarmPPCNEEDS SERVICING1PPC Display Type of Alarm Pump AlarmLOWRESERVOIR1 In 24 hours if no PPC communicationPPC Display Type of Alarm Pump AlarmEMPTYRESERVOIR1 In 24 hours if no PPC communicationDmp9196021-011_c.book Page 122 Wednesday, April 3, 2002 5:06 PM
Pump alarms 123Clear this message by pressing SEL and ACT, and then continue pro-gramming. Users should be instructed to report this alarm to their physi-cian as soon as possible and schedule an appointment for a Pump refill. Itis important not to allow the Pump to deplete its insulin supply as thismay result in catheter blockage.Telemetry communication errorIf programming is interrupted after partial transmission of a command,the PPC will display the following message on the display screen:Reposition the PPC near the Pump, and then press SEL and ACT. ThePPC will attempt to resume communication with the Pump.PPC Display Type of AlarmTELEMETRY COMM ERROR31Dmp9196021-011_c.book Page 123 Wednesday, April 3, 2002 5:06 PM
System Alarms and Messages124Initialize alarmAttempting to initialize a PPC to a Pump that is not compatible with it,results in one of the following messages. The physician should press SELand ACT to clear the alarm, then verify the personal ID of the Pump iscorrect.Attempting to initialize a PPC to a Pump that contains invalid stroke vol-ume or insulin concentration information, results in one of the followingmessages to be displayed. Contact MiniMed for instructions.Responding “NO” to the “INITIALIZE PPC TO PUMP” screen eightconsecutive times, results in the following message to be displayed. Stepaway from any other Pump in the area and perform the request again.PPC Display Type of AlarmPUMP ERROR0 or 11PPC Display Type of AlarmPUMP ERROR40 or 411PPC Display Type of AlarmTELEMETRY ERROR201Dmp9196021-011_c.book Page 124 Wednesday, April 3, 2002 5:06 PM
Pump alarms 125PPC not initializedIf the PPC is not initialized to a Pump, the following message is dis-played:When successfully completing a PPC initialization, the following mes-sage is displayed:Battery replacementIf 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:The user should reposition the PPC near the Pump, and then press SELand ACT. The PPC will communicate with the Pump.NOTE: If while programming the PPC, the screen goesblank, the PPC beeps six times and then the“CHECK PUMP STATUS” message appears, thebattery needs to be replaced. (See Chapter 3 forinstructions, Install/Replace the Main Battery.)PPC Display Type of AlarmPPCNOT INITIALIZED1PPC Display Type of AlarmPUMP INITIALIZED 1PPC Display Type of AlarmCHECKPUMP STATUS1Dmp9196021-011_c.book Page 125 Wednesday, April 3, 2002 5:06 PM
System Alarms and Messages126Initialize to factory defaultsWhen the Pump is reinitialized to its factory default settings, the follow-ing message is displayed:Pump stoppedIf the Pump is intentionally stopped, the following message is displayed:To restart the Pump, press SEL and ACT, and then place the PPC nearthe Pump and allow the communication to complete. The Pump can onlybe stopped in the Supervisor Mode.Pump suspendedIf the Pump operation has been suspended, the following message is dis-played:During “SUSPEND PUMP”, the Pump will deliver a basal rate of 0.2 U/h. To restart insulin delivery programming, press SEL and ACT,then place the PPC near the Pump and allow the communication to com-plete. PPC Display Type of AlarmPUMPRESET1PPC Display Type of AlarmPUMPSTOPPED2PPC Display Type of AlarmPUMPSUSPENDED2Dmp9196021-011_c.book Page 126 Wednesday, April 3, 2002 5:06 PM
Pump alarms 127Auto offIf the “AUTO OFF” time interval elapses in the Pump, and the PPC rec-ognizes this condition, the following message is displayed:Press SEL and ACT, and then place the PPC near the Pump and allow thecommunication to complete. The PPC then communicates with the Pumpto reset the “AUTO OFF” duration. If five more minutes elapse, the Pump will initiate the internal alarmsequence of a beep every 15 seconds for 10 minutes, then double-beepsevery 15 seconds for 10 minutes, then repeating the pattern. The alarm iscleared by pressing SEL and ACT.Hourly maximum exceededAttempting to deliver more than 2.5 times the pre-programmed bolusmaximum in one hour, causes the following message to be displayed:Press SEL and ACT, and then place the PPC near the Pump and allow thecommunication to complete. The patient may exceed the pre-programmedbolus limit by programming another bolus within 10 minutes.PPC Display Type of AlarmAUTO OFF PUMPPUMP SUSPENDED1PPC Display Type of AlarmHOURLY MAXEXCEEDED1Dmp9196021-011_c.book Page 127 Wednesday, April 3, 2002 5:06 PM
System Alarms and Messages128Pump alarm tableAlarm Condition Type of Alarm Pump CommunicationsAUTO OFF 1 YESCHECK PUMPSTATUS1YESEMPTYRESERVOIR1YESHOURLY MAXEXCEEDED1NOLOW RESERVOIR 1 YESPPC DEPLETED BATTERY1NOPPC NEEDS SERVICING1NOPPC LOW BATTERY1NOPPC NOT INITIALIZED1YESPUMP INITIALIZED 1 NOPUMPLOW BATTERY1YESPUMPRESET1NOPUMP SELF TEST FAIL1NOPUMP ERROR0 or 11NOPUMP ERROR40 or 411NOPUMP STOPPED1 or 2 or 3 or 4 or 5 or 61YESDmp9196021-011_c.book Page 128 Wednesday, April 3, 2002 5:06 PM
Pump alarms 129PUMP SUSPENDED 2 YESPUMP STOPPED 2 YESTELEMETRY COMM ERROR1YESTELEMETRY COMM ERROR201NODmp9196021-011_c.book Page 129 Wednesday, April 3, 2002 5:06 PM
System Alarms and Messages130Dmp9196021-011_c.book Page 130 Wednesday, April 3, 2002 5:06 PM
131CHAPTER 10 Troubleshooting Pump System Under-deliveryPotential under-delivery of insulin by the Medtronic MiniMed 2007CImplantable Insulin Pump System may result in an increase in daily pro-grammed insulin usage, difficulty maintaining euglycemia, occasionalhyperglycemia, and problems calculating refill accuracy. This chapterdescribes how to diagnose potential Pump System problems that maycause insulin under-delivery, and offers potential Pump and Catheter solu-tions to correct for under-delivery.Diagnostic proceduresWhen refill procedures reveal the possibility of a Pump System under-delivery problem, diagnostic procedures must be performed to verify ifthere is a problem with either the Pump or Catheter. The Stroke VolumeMeasurement Procedure tests Pump function, while the Pressure Mea-surement Procedure tests Catheter patency. These diagnostic proceduresshould be performed according to the steps outlined in Appendix G andAppendix H, respectively.Under-delivery caused by backflowBackflow results in the inverted flow of insulin through the Pump Sys-tem. Backflow is caused by insulin deposits that compromise valve integ-rity, and allow the negative reservoir pressure (vacuum) to pull insulinback into the reservoir. To compensate for this under-delivery, the usercan program appropriate increases in their basal rates and bolus amounts.Dmp9196021-011_c.book Page 131 Wednesday, April 3, 2002 5:06 PM
Troubleshooting Pump System Under-delivery132Backflow conditions are characterized by increases in daily programmedinsulin usage, difficulty in maintaining euglycemia, increasingly negativerefill accuracy and sometimes hyperglycemia. Conform a backflow con-dition by performing the Stroke Volume Measurement Procedure. Thenrinse the Pump System with NaOH solution to dissolve insulin deposits,following the Pump Rinse Procedure outlined in Appendix E.Under-delivery caused by catheter occlusionUnder-delivery caused by Catheter occlusion can occur either abruptly orgradually. The insulin usage and clinical symptoms are identical to thoseof Pump under-delivery. Confirm a Catheter occlusion condition by per-forming a Pressure Measurement Procedure. Then perform the followingprocedures to clear the occlusion:• First, flush the Catheter by using the Side Port Catheter FlushProcedure outlined in Appendix F.• If the Flush Procedure is unsuccessful, replace the Catheter.Catheter replacement surgery should be performed in a manner similar tothe initial Pump System implantation. PPC initialization will not be nec-essary. However, after the Catheter replacement, Pump function anddelivery verifications must be performed.Dmp9196021-011_c.book Page 132 Wednesday, April 3, 2002 5:06 PM
133CHAPTER 11 Medtronic MiniMed 2007C Implantable Insulin Pump SystemImplantable Insulin Pump MMT-2007CDiameterThicknessReservoir Volume8.1 cm (3.2 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 ml per stroke0.17 to 0.23 units per strokeBasal Rate 0.2 to 35.0 units per hour (U/h)Basal Patterns 3 patterns of up to 48 basal rates each.Meal Bolus 0.2 to 25.0 unitsBolus Duration Immediate, Square Wave (30 minutes to 4 hours), or both together. Audio Bolus Temporary Basal Rate 0.2 to 35.0 units per hour30 minute increment duration30 minutes up to 24 hours delayDiagnostic Rate 10 to 150 U/hPower Supply Lithium - Carbon Monofluoride Bat-teryBattery life See Figure 1Dmp9196021-011_c.book Page 133 Wednesday, April 3, 2002 5:06 PM
Medtronic MiniMed 2007C Implantable Insulin Pump System134Personal pump communicator (PPC) model MMT-3150Audio Alarms Low BatteryNearly Depleted BatterySystem ErrorSafety Features Negative Pressure Reservoir with Passive FillingPump Shutdown and Alarm with Sys-tem Error (unique code sequences)Materials in contact with tissue Titanium, Silicone Rubber HeightLength Width8.9 cm (3.5 inches)7.0 cm (2.8 inches)2.0 cm (0.8 inches)Weight 115 gm (4.0 ounces)Main Power Source 1.5 Volt Alkaline Battery Type AAMain Battery Life 6-8 weeksBackup Battery Lithium Battery Backup Battery Life 3 years minimum with no AA battery installedOperating Temperature 0ºC to 40ºC (32ºF to 104ºF)Dmp9196021-011_c.book Page 134 Wednesday, April 3, 2002 5:06 PM
135Side Port CatheterStorage Temperature 0ºC to 30ºC ( 32ºF to 86ºF)Messages Auto Off in 5 min / Auto Off Pump SuspendedCheck Pump StatusCommunication ErrorDownload CompleteEmpty ReservoirHourly Maximum Exceeded Low Reservoir PPC Not initializedPPC Needs ServicingPPC Low BatteryPPC Depleted BatteryPump Self Test FailPump ResetPump Stopped Pump Version ErrorTelemetry Communication ErrorMMT- 4027ALength Proximal: 11.8 ± 1.3 cm (4.7 ± 0.5 inches)Distal:17.8 ± 0.7 cm (7.0 ± 0.3 inches)MMT- 4028ALength Proximal:11.8 ± 1.3 cm (4.7 ± 0.5 inches)Distal:10.2 ± 0.4 cm (4.0 ± 0.2 inchesMaterial Polyethylene-lined Silicone RubberSideport Polysulfone, Silicone SeptumDmp9196021-011_c.book Page 135 Wednesday, April 3, 2002 5:06 PM
Medtronic MiniMed 2007C Implantable Insulin Pump System136This 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 OH23150 (PPC).Any changes or modifications to the system not expressly approved byMiniMed could void the user’s authority to operate the system.Figure 15: Average Pump Battery LifeAverage Pump Service Life vs. Daily Insulin Delivery(U-400 Insulin Delivered After 6 Month Shelf Life)78910111213140 102030405060708090100Daily Insulin Delivery (Units)Pump Life (Years)Dmp9196021-011_c.book Page 136 Wednesday, April 3, 2002 5:06 PM
137APPENDIX A Label InformationSymbol dictionaryDo Not Reuse This DevicePlease Read “Important Information”Sterilized by Ethylene OxideManufacture Date (Year-Month)Lot NumberExpiration Date (Use By Date) (Year-Month)REF MMT-XXXX Reference / Record Number (reordernumber)SN Device Serial NumberDmp9196021-011_c.book Page 137 Wednesday, April 3, 2002 5:06 PM
138PackagingThe icon on each label indicates the contents of the package. The number with the icon is the quantity.MiniMed 2007C Implantable Insulin PumpMiniMed 3150 Personal Pump CommunicatorIEC Icon indicating equipment provid-ing a particular degree of protectionagainst electric shock (Type B)CE Marking/Notified Body Authoriza-tion0459 0168Dmp9196021-011_c.book Page 138 Wednesday, April 3, 2002 5:06 PM
139MiniMed 4024A and 4027A Side Port CatheterMiniMed 4105 Refill Kit MiniMed 4102 Refill NeedlesDmp9196021-011_c.book Page 139 Wednesday, April 3, 2002 5:06 PM
140Other InformationManufactured by:Medtronic MiniMedDistributed in the United States by:Medtronic MiniMed Inc.Distributed in Europe by:Medtronic MiniMed S.A. - Paris, FranceCE Marking:Notified Body:GMED - FranceNotified Body Authorizations:0459, 0168Year of Initial CE Authorization:2000Dmp9196021-011_c.book Page 140 Wednesday, April 3, 2002 5:06 PM
141APPENDIX B Implant WorksheetImplant worksheet formPlease refer to “Implant Worksheet” attached.Dmp9196021-011_c.book Page 141 Wednesday, April 3, 2002 5:06 PM
142 Date:__________ Center:_________ Patient Code:____________Patient name:__________________________________________Pump Label:Catheter Label:PPC Label:Insulin Lot Number:_________Communicator-settings:Patient Communicator ID:________ Supervisor Code:_________Max meal bolus:________U Max basal rate:____________U/hMaximums (locked/unlocked):______ Alarm feedback "ON":__Basal rate programmed with PPC:________U/hWeight of full "IN 2" syringe before filling the reservoir:_____________________g (1)Weight of full "IN 2" syringe after filling the reservoir and remov-ing 2ml from the pump:__________________ g (2)Total amount placed in the reservoir (1-2):_________________ gVerification of alarm feedback: yes / noTime delivery started, priming bolus:_____________Calculated stroke volume:a) number of strokes delivered:________________b) total volume delivered:_________________c) calculated stroke volume (b/a):__________Ve r i f ic a t i o n of the delivery from the catheter tip: yes / noDate:_____________ Surgeon name:_____________________Anesthesia:____________________ Pocket depth:_________cmCatheter fixation:________________ Pump fixation:__________Catheter type:_______________ Pump type:_______________Pump orientation:Complications:MiniMed Implant WorksheetDmp9196021-011_c.book Page 142 Wednesday, April 3, 2002 5:06 PM
143APPENDIX C Refill FormPump refill dataPlease refer to “Refill Data Form” attached.Dmp9196021-011_c.book Page 143 Wednesday, April 3, 2002 5:06 PM
144Before the refill: _________________U/384.6=_________ g (F)*Insulin remaining from PPC:__________________________ (F)Data:Weight of primed "RB" syringe:_____________ g (A)Weight of "RB" syringe after insulin withdrawn:______________________ g (B)Weight of filled "IN" syringe:_____________ g (C)Weight of "IN" after pump filled and 2mlwithdrawn:______________________________ g (D)Amount withdrawn Refill Amount (B)_______________ g (C)_________________ g- (A)______________ g - (D)________________ g=________________ g (E) = _________________ g*Corrected for density of insulinDate:__________________Patient name:_______________________ Patient code:________Center:_____________________ Physician name:____________Insulin "IN" _______Rinse Buffer "RB" ________Previous refill amount:_____________________________ g (1)Residual amount withdrawn (E):_____________________ g (2)Actual amount used (line 1 - line 2):___________________ g (3)Theoretical amount used:__________________________ g (4)(line 1 - remaining dose from PPC (F)Difference between actual and theoreticalamount used (line 4 - line 3):_________________________ g (5)Percentage difference: Refill accuracy (line 5 / line 4, then x 100):________ %Usable units of insulin (Gx384.6): ______________________ UAverage daily insulin use:____________________________ U/dEstimated refill period:___________________ DaysSchedule next refill visit:_______________ D / M / YMiniMed Refill WorksheetDmp9196021-011_c.book Page 144 Wednesday, April 3, 2002 5:06 PM

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