Technical Specs Part 3

ManualsBrandsMedtronic MiniMed ManualsElectronicsImplantable Insulin Pump

Table Of Contents

117

CHAPTER 9 System 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

Summary of content (28 pages)

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Dmp9196021-011_c.book Page 117 Wednesday, April 3, 2002 5:06 PM 117 CHAPTER 9 System Alarms and Messages The Medtronic MiniMed 2007C Implantable Insulin Pump System is equipped with various alarms and messages that ensure the correct function 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.
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Dmp9196021-011_c.book Page 118 Wednesday, April 3, 2002 5:06 PM 118 System Alarms and Messages 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.
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Dmp9196021-011_c.book Page 119 Wednesday, April 3, 2002 5:06 PM Pump alarms PPC Display Type of Alarm Pump Alarm PUMP LOW BATTERY 1 In 24 hours if no PPC communication 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.
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Dmp9196021-011_c.book Page 120 Wednesday, April 3, 2002 5:06 PM 120 System Alarms and Messages 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 Display Type of Alarm PUMP SELF TEST FAIL 1 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.
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Dmp9196021-011_c.book Page 121 Wednesday, April 3, 2002 5:06 PM Pump alarms 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.
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Dmp9196021-011_c.book Page 122 Wednesday, April 3, 2002 5:06 PM 122 System Alarms and Messages PPC needs servicing When the PPC internal battery (lithium) energy becomes low, the following message will be displayed: PPC Display Type of Alarm PPC NEEDS SERVICING 1 Clear this message by pressing SEL and ACT. Users should be instructed to report this alarm to their physician as soon as possible and have their PPC replaced. If the PPC loses all power, it may also lose information stored in memory.
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Dmp9196021-011_c.book Page 123 Wednesday, April 3, 2002 5:06 PM Pump alarms Clear this message by pressing SEL and ACT, and then continue programming. Users should be instructed to report this alarm to their physician as soon as possible and schedule an appointment for a Pump refill. It is important not to allow the Pump to deplete its insulin supply as this may result in catheter blockage.
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Dmp9196021-011_c.book Page 124 Wednesday, April 3, 2002 5:06 PM 124 System Alarms and Messages Initialize alarm Attempting to initialize a PPC to a Pump that is not compatible with it, results in one of the following messages. The physician should press SEL and ACT to clear the alarm, then verify the personal ID of the Pump is correct.
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Dmp9196021-011_c.book Page 125 Wednesday, April 3, 2002 5:06 PM Pump alarms PPC not initialized If the PPC is not initialized to a Pump, the following message is displayed: PPC Display PPC NOT INITIALIZED Type of Alarm 1 When successfully completing a PPC initialization, the following message is displayed: PPC Display Type of Alarm PUMP INITIALIZED 1 Battery replacement If the PPC main battery (AA 1.
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Dmp9196021-011_c.book Page 127 Wednesday, April 3, 2002 5:06 PM Pump alarms Auto off If the “AUTO OFF” time interval elapses in the Pump, and the PPC recognizes this condition, the following message is displayed: PPC Display Type of Alarm AUTO OFF PUMP PUMP SUSPENDED 1 Press SEL and ACT, and then place the PPC near the Pump and allow the communication to complete. The PPC then communicates with the Pump to reset the “AUTO OFF” duration.
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Dmp9196021-011_c.book Page 131 Wednesday, April 3, 2002 5:06 PM 131 CHAPTER 10 Troubleshooting Pump System Under-delivery Potential under-delivery of insulin by the Medtronic MiniMed 2007C Implantable Insulin Pump System may result in an increase in daily programmed insulin usage, difficulty maintaining euglycemia, occasional hyperglycemia, and problems calculating refill accuracy.
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Dmp9196021-011_c.book Page 132 Wednesday, April 3, 2002 5:06 PM 132 Troubleshooting Pump System Under-delivery Backflow conditions are characterized by increases in daily programmed insulin usage, difficulty in maintaining euglycemia, increasingly negative refill accuracy and sometimes hyperglycemia. Conform a backflow condition by performing the Stroke Volume Measurement Procedure.
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Dmp9196021-011_c.book Page 133 Wednesday, April 3, 2002 5:06 PM 133 CHAPTER 11 Medtronic MiniMed 2007C Implantable Insulin Pump System Implantable Insulin Pump MMT-2007C Diameter Thickness Reservoir Volume 8.1 cm (3.2 inches) 2.0 cm (0.8 inches) 13 ml to 15 ml Weight - Empty 131 gm (4.6 ounces) Insulin - Concentration Aventis HOE 21 PH U-400 Stroke Volume 0.42 to 0.58 ml per stroke 0.17 to 0.23 units per stroke Basal Rate 0.2 to 35.
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Dmp9196021-011_c.book Page 134 Wednesday, April 3, 2002 5:06 PM 134 Medtronic MiniMed 2007C Implantable Insulin Pump System Audio Alarms Low Battery Nearly Depleted Battery System Error Safety Features Negative Pressure Reservoir with Passive Filling Pump Shutdown and Alarm with System Error (unique code sequences) Materials in contact with tissue Titanium, Silicone Rubber Personal pump communicator (PPC) model MMT-3150 Height Length Width 8.9 cm (3.5 inches) 7.0 cm (2.8 inches) 2.0 cm (0.
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Dmp9196021-011_c.book Page 135 Wednesday, April 3, 2002 5:06 PM 135 Storage Temperature 0ºC to 30ºC ( 32ºF to 86ºF) Messages Auto Off in 5 min / Auto Off Pump Suspended Check Pump Status Communication Error Download Complete Empty Reservoir Hourly Maximum Exceeded Low Reservoir PPC Not initialized PPC Needs Servicing PPC Low Battery PPC Depleted Battery Pump Self Test Fail Pump Reset Pump Stopped Pump Version Error Telemetry Communication Error Side Port Catheter MMT- 4027A Length Proximal: 11.8 ± 1.
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Dmp9196021-011_c.book Page 136 Wednesday, April 3, 2002 5:06 PM Medtronic MiniMed 2007C Implantable Insulin Pump System 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 undesired operation. Operation of this device is authorized by the FCC under the FCC ID OH22007C (Implantable Pump) and OH23150 (PPC).
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Dmp9196021-011_c.book Page 138 Wednesday, April 3, 2002 5:06 PM 138 IEC Icon indicating equipment providing a particular degree of protection against electric shock (Type B) 0459 0168 CE Marking/Notified Body Authorization Packaging The icon on each label indicates the contents of the package. The number with the icon is the quantity.
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Dmp9196021-011_c.book Page 140 Wednesday, April 3, 2002 5:06 PM 140 Other Information Manufactured by:Medtronic MiniMed Distributed in the United States by:Medtronic MiniMed Inc. Distributed in Europe by:Medtronic MiniMed S.A.
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Dmp9196021-011_c.book Page 141 Wednesday, April 3, 2002 5:06 PM 141 APPENDIX B Implant Worksheet Implant worksheet form Please refer to “Implant Worksheet” attached.
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Dmp9196021-011_c.book Page 143 Wednesday, April 3, 2002 5:06 PM 143 APPENDIX C Refill Form Pump refill data Please refer to “Refill Data Form” attached.
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Dmp9196021-011_c.book Page 144 Wednesday, April 3, 2002 5:06 PM Date:__________________ 144 Before the refill: _________________U/384.6=_________ g (F)* Patient name:_______________________ Patient code:________ MiniMed Refill Worksheet Insulin remaining from PPC:__________________________ (F) Center:_____________________ Physician name:____________ Estimated refill period:___________________ Days g (4) Average daily insulin use:____________________________ U/d Usable units of insulin (Gx384.