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

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Document ID	240463
Application ID	OUjvUEX5yErHPBq+foRecA==
Document Description	physician part1
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	214.56kB (2682000 bits)
Date Submitted	2002-05-02 00:00:00
Date Available	2002-05-02 00:00:00
Creation Date	2002-04-04 08:09:14
Producing Software	Acrobat Distiller 4.05 for Windows
Document Lastmod	2002-04-04 08:16:23
Document Title	Dmp9196021-011_c.book
Document Creator	FrameMaker 6.0

Dmp9196021-011_c.book Page 1 Thursday, April 4, 2002 8:15 AM
Table of Contents
CHAPTER 1
Description 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
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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
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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Download software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Stop Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Supervisor password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Exit supervisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Personal Pump communicator messages . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Clinical history codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Clinical history pump codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
CHAPTER 4
Pump Implantation . . . . . . . . . . . . . . . . . . . . . .
77
Preprogramming and pre-testing the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Registration card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
Emptying and filling the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Remove shipping fluid from the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Rinse the Pump with insulin (IN1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Fill the Pump with insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Measure stroke volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
Prepare the Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Performing the surgical procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
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Pre-operative evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
Formation of the pump pocket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
Catheter placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
Post-operative management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
Post-operative hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
Post-operative x-rays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
CHAPTER 5
Pump Refill Procedure . . . . . . . . . . . . . . . . . . .
97
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Prepare for pump refill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
Perform the refill procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Fill out the refill form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Label syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Prepare the refill syringe for emptying the Pump . . . . . . . . . . . . . . . . . . . . . .100
Prepare the refill syringe for filling the Pump . . . . . . . . . . . . . . . . . . . . . . . . .101
Empty the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Refill the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
Calculate extracted and refill amounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
Calculate refill accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
CHAPTER 6
Explanting the Pump System . . . . . . . . . . . . .
107
Explant considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107
Returning devices/components to MiniMed . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107
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CHAPTER 7
Warnings And Precautions . . . . . . . . . . . . . . .
109
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Electrotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Diagnostic ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
Ultrasound therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
Diagnostic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
Therapeutic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
Elevated anti-insulin antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111
Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113
Emergencies and the use of conventional insulin supplies . . . . . . . . . . . . . . .113
PPC reliability requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113
Maximum dosages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114
Electrical and magnetic fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114
CHAPTER 8
Adverse Reactions . . . . . . . . . . . . . . . . . . . . . .
115
Adverse reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
CHAPTER 9
System Alarms and Messages . . . . . . . . . . . .
117
Pump alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118
Alarm feedback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118
Pump low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118
Depleted pump battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
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System error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
Pump self test fail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
PPC alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
PPC low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
PPC depleted battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121
PPC needs servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122
Low reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122
Empty reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122
Telemetry communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123
Communication error during download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123
Initialize alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124
PPC not initialized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Battery replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Initialize to factory defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Pump stopped . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Pump suspended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Hourly maximum exceeded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Pump alarm table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
CHAPTER 10 Troubleshooting Pump System Under-delivery
131
Diagnostic procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131
Under-delivery caused by backflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131
Under-delivery caused by catheter occlusion . . . . . . . . . . . . . . . . . . . . . . . . .132
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CHAPTER 11
MiniMed 2007C Implantable Insulin
Pump System . . . . . . . . . . . . . . . . . . . . . . . . . .
133
Implantable Insulin Pump MMT-2007C . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133
Personal pump communicator (PPC) model MMT-3150 . . . . . . . . . . . . . . . .134
Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135
APPENDIX A Label Information . . . . . . . . . . . . . . . . . . . . . . 137
Symbol dictionary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137
Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138
Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140
APPENDIX B Implant Worksheet . . . . . . . . . . . . . . . . . . . . . 141
Implant worksheet form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .141
APPENDIX C Refill Form . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Pump refill data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143
APPENDIX D Precautions and General Procedures . . . . . . . 145
Special note and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145
General procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .146
Locating the pump fill port and the side port . . . . . . . . . . . . . . . . . . . . . . . . . .147
Accessing the pump inlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .148
Venting the Minimed refill syringe (optional) . . . . . . . . . . . . . . . . . . . . . . . . .149
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APPENDIX E Pump Rinse Procedure . . . . . . . . . . . . . . . . . . .151
Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151
Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .153
Prepare syringes for emptying the Pump . . . . . . . . . . . . . . . . . . . . . . . . . .153
Prepare syringes for filling the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .153
Program minimal basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .153
Remove insulin from the Pump and fill with NaOH . . . . . . . . . . . . . . . . .154
Equilibrate and pull NaOH through system . . . . . . . . . . . . . . . . . . . . . . . .156
Remove NaOH and fill with rinse buffer . . . . . . . . . . . . . . . . . . . . . . . . . .157
Equilibrate and pull rinse buffer through system . . . . . . . . . . . . . . . . . . . .159
Remove rinse buffer and fill with insulin . . . . . . . . . . . . . . . . . . . . . . . . .159
Equilibrate and pull insulin through system . . . . . . . . . . . . . . . . . . . . . . .161
Remove guide needles and record fill amount . . . . . . . . . . . . . . . . . . . . . .162
Program new basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162
APPENDIX F Side Port Catheter Flush Procedure . . . . . . . . .163
Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .163
Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .164
Record patient’s blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165
Prepare syringes for emptying the Pump . . . . . . . . . . . . . . . . . . . . . . . . . .165
Prepare syringes for filling the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .165
Prepare syringe for flushing the Side Port Catheter . . . . . . . . . . . . . . . . .166
Flushing the Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167
Program minimal basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167
Remove insulin and fill with rinse buffer . . . . . . . . . . . . . . . . . . . . . . . . .167
Equilibrate and pull rinse buffer through system . . . . . . . . . . . . . . . . . . . .169
Flush side port catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .170
Remove rinse buffer and fill with insulin . . . . . . . . . . . . . . . . . . . . . . . . .170
Equilibrate and pull insulin through system . . . . . . . . . . . . . . . . . . . . . . .172
Remove guide needles and record refill amount . . . . . . . . . . . . . . . . . . . .173
Program new basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174
Remove rinse buffer from catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174
Dmp9196021-011_c.book Page 9 Thursday, April 4, 2002 8:15 AM
APPENDIX G Stroke Volume Measurement . . . . . . . . . . . . . .175
Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .175
Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176
Record patient’s blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176
Measuring stroke volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177
Record patient’s blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .179
APPENDIX H Pressure Measurement Using The Side Port
Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .181
Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182
Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183
Record patient’s blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .184
Prepare syringes for emptying the pump . . . . . . . . . . . . . . . . . . . . . . . . . .184
Prepare syringes for filling the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .184
Prepare syringe for priming the test setup . . . . . . . . . . . . . . . . . . . . . . . . .184
Measuring pressure in the side port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185
Program minimal basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185
Remove insulin and fill with rinse buffer . . . . . . . . . . . . . . . . . . . . . . . . .185
Equilibrate and pull rinse buffer through system . . . . . . . . . . . . . . . . . . . .186
Perform pressure test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187
Remove rinse buffer and fill with insulin . . . . . . . . . . . . . . . . . . . . . . . . .191
Equilibrate and pull insulin through system . . . . . . . . . . . . . . . . . . . . . . .192
Remove guide needles and record refill amount . . . . . . . . . . . . . . . . . . . .194
Dmp9196021-011_c.book Page 10 Thursday, April 4, 2002 8:15 AM
10
Dmp9196021-011_c.book Page 11 Thursday, April 4, 2002 8:15 AM
11
CHAPTER 1
Description of the Medtronic
MiniMed 2007C Implantable
Insulin Pump System
Introduction
The Medtronic MiniMed 2007C Implantable Insulin Pump System brings
together sophisticated new technologies to provide continuous intraperitoneal insulin therapy for patients with Insulin Dependent Diabetes Mellitus (IDDM). The development of the Medtronic MiniMed 2007C
Implantable Insulin Pump System is the result of years of cooperative
research and development between MiniMed and:
The Johns Hopkins University, Applied Physics Laboratory.
U.S. National Aeronautics and Space Administration, Goddard Space
Flight Center. U.S. National Institutes of Health.
This manual is intended for use by the physician, surgeon, nurse specialist
and all other members of the healthcare team who care for patients with
the Medtronic MiniMed 2007C Implantable Insulin Pump System.
The Medtronic MiniMed 2007C Implantable Insulin Pump System uses
only special insulin formulations. The only insulin available today for use
in the Pump is HOE 21 PH U-400, manufactured by Aventis.
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12
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System
The system consists of three major components:
•
Implantable Insulin Pump
•
Side Port Catheter
•
Personal Pump Communicator (PPC)
Each of these components, as well as system safety features, are discussed
in detail in the following sections.
Figure 1: Personal Pump Communicator (PPC) and Implantable
Insulin Pump
Dmp9196021-011_c.book Page 13 Thursday, April 4, 2002 8:15 AM
Implantable Insulin Pump
Implantable Insulin Pump
The Implantable Insulin Pump (Pump) is a round disc, 8.1 cm (3.2 inches)
in diameter, 2.0 cm (0.8 inches) thick. The Pump weighs 131 grams (4.6
ounces) when empty. The outside case of the Pump is made of titanium.
Titanium is a biocompatible metal used in many types of implantable
medical devices. A tangential Side Port Catheter is attached to the Pump
prior to implant, using a locking connector (see Figure 2).
Figure 2: The Implantable Insulin Pump
The Implantable Insulin Pump is an advanced insulin infusion device with
sophisticated microelectronics. It delivers a special insulin medication,
using a pulsatile solenoid pumping mechanism that is hermetically sealed
inside the biocompatible titanium case. Insulin delivery rates and profiles
are programmed using an external device, the Personal Pump Communicator (PPC). Specific information on the Implantable Insulin Pump features is outlined in the following sections.
13
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14
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System
The Pump has six major components. These components are outlined
below:
•
medication reservoir
•
pumping mechanism
•
microelectronics
•
antenna
•
battery
•
tone transducer
Other components of the Pump include the inlet valve, fill port, septum,
Freon gas and 20µm filter. Figure 3 shows the interior components of the
Pump.
Figure 3: Interior of the Implantable Insulin Pump
Dmp9196021-011_c.book Page 15 Thursday, April 4, 2002 8:15 AM
Implantable Insulin Pump
The Medication Reservoir stores approximately 15 ml or 6,000 units of
a special U-400 insulin. Depending on an individual’s insulin requirements, the medication reservoir is refilled once in approximately every
two to three months. The medication reservoir is maintained at a negative
pressure (vacuum) at all times to allow for safe and reliable filling. This
vacuum prevents any risk of insulin leakage in the event of a breach in the
Pump case or reservoir. The reservoir is refilled with a special needle
(MiniMed Refill Needle MMT-4102). The fill port has a 20 micron filter
to prevent particulate material from entering the Pump and a redundant
septum and valve configuration to prevent entry of body fluids.
The Pumping Mechanism is a solenoid-operated, hermetically-welded
pulsatile system. The pumping mechanism is designed to seal automatically to prevent leakage both into and out of the reservoir under physiologic temperatures and pressures. The mechanism is designed to provide
an insulin delivery accuracy of +10% from its labeled stroke volume.
Individual Pumps are calibrated to one of seventeen different stroke volumes, ranging from 0.42 µL to 0.58 µL per stroke, in increments of
0.01 µL.
The Microelectronics act as the brain of the Pump. The microelectronics
contain two microprocessors which monitor and control all pump-stroke
activity. All commands delivered from the PPC via RF telemetry to the
Pump are then acknowledged back at the PPC. The Pump has a large
memory which stores Pump specifications and programming history.
The Antenna receives radiowaves from the PPC and delivers PPC programming commands to the Pump microelectronics.
The Battery is a custom-made lithium carbon mono-fluoride power cell,
which supplies energy to the pumping mechanism and microelectronics.
It is similar to batteries used in pacemakers and is designed to provide 6 to
10 years of service, depending on the infusion rate (refer to pump specifications).
The Tone Transducer emits beeps to indicate certain alarm conditions.
These beeps are designed to be audible through the skin and can be set
with the PPC to one of two volumes. The Pump can also be programmed
to emit beeps that signal a programmed change in the medication delivery
rate.
15
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16
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System
Radio-Opaque Identification the Implantable Insulin Pump features
radio-opaque identification. In the event of an emergency, the name
of the manufacturer and the Pump model number can be identified
with an x-ray.
Insulin medication
Only Aventis HOE 21 PH U-400 insulin can be used with the Medtronic
MiniMed 2007C Implantable Insulin Pump System.
HOE 21 PH U-400 is a highly purified, semi-synthetic human insulin
with 0.2% phenol as a preserving agent, glycerol as an isotonic component, TRIS as a buffer, plus zinc and Genapol® as stabilizing agents.
HOE 21 PH U-400 is equivalent in mode of action to normal (soluble)
insulin. A special U-400 insulin concentration has been developed for use
in the Implantable Insulin Pump and is supplied in 10mL vials (400U/
mL) from Aventis.
Side Port Catheter
The Side Port Catheter (Catheter) transports insulin from the Pump into
an individual’s peritoneum where it is absorbed. The Catheter is made of
polyethylene-lined silicone rubber, which is biocompatible with subcutaneous and intraperitoneal tissues and supports the stability of the special
insulin. The Catheter is designed with two perpendicular sections: a
proximal subcutaneous section which attaches tangentially to the Pump
with a locking connector, and a distal section which is placed in the peritoneum (see Figure 4). To enable post-implant localization, a radioopaque
stripe runs the length of the Catheter.
Dmp9196021-011_c.book Page 17 Thursday, April 4, 2002 8:15 AM
Implantable Insulin Pump
Figure 4: The Intraperitoneal Catheter and Side Port
The Catheter side port is intended to provide access to the Catheter and
Pump outlet, in order to perform the non-surgical interventions and diagnostic procedures described in Appendices E, F and G. The side port
allows for the introduction of a needle and small syringe to clear Catheter
obstructions using pressures up to 100 psi. It also allows for the introduction of a needle to verify Pump stroke volume and permit non-surgical
diagnoses of Catheter blockages by direct pressure measurement.
17
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18
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System
Personal Pump Communicator (PPC)
The Personal Pump Communicator (PPC) is the hand-held component of
the MiniMed 2007C Implantable Pump System (see Figure 5).
The PPC allows the physician and patient to communicate with the Pump
by transmitting radio frequency messages when the PPC is held within 3”
of the Pump. Additionally, the PPC stores important programming information in its memory.
Figure 5: Personal Pump Communicator (PPC)
Dmp9196021-011_c.book Page 19 Thursday, April 4, 2002 8:15 AM
Implantable Insulin Pump
The PPC has been designed so the physician and patient can:
•
Program basal infusion rates (48 basal rates, 3 different patterns)
•
Deliver or suspend an immediate, square wave, or dual wave
bolus of insulin
•
Deliver or cancel a temporary basal rate
•
Review the delivery history
•
Enter personal events (meal, snack, exercise)
Independent of the programming function, the PPC is able to receive and
record certain programming data from the Pump. The recorded information is accessible and can be displayed on the screen.
19
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20
Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System
Dmp9196021-011_c.book Page 21 Thursday, April 4, 2002 8:15 AM
21
CHAPTER 2
Indications and
Contraindications
Indications for use
The Medtronic MiniMed 2007C Implantable Insulin Pump System is
indicated for intraperitoneal administration of exogenous insulin in
patients with diabetes mellitus.
Only Aventis HOE 21 PH U-400 insulin is indicated for use in the
Medtronic MiniMed 2007C Implantable Insulin Pump System.
Contraindications for use
The Medtronic MiniMed 2007C Implantable Insulin 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 their treating physician and other healthcare providers.
Dmp9196021-011_c.book Page 22 Thursday, April 4, 2002 8:15 AM
22
Indications and Contraindications
•
reside at or travel (other than by pressurized commercial aircraft)
at elevations above 8,000 feet.
•
have other medical or mental conditions which may place the
patient at risk.
•
are unwilling or unable to return for routine insulin refills according to their dosage requirements (approximately once every 2-3
months).
•
present or have a history of sensitivity to titanium alloy,
polysulfone or silicone materials used in the implanted components of the system.
Possible adverse effects
The MiniMed 2001 Implantable Insulin Pump System has undergone an
extensive clinical evaluation. The model 2007C is essentially identical to
the model 2001 Pump except for the use of updated electronics and battery. Evaluation of components used in the MiniMed 2001 System
spanned a period of ten years and involved approximately 650 patients
from both the U.S. and Europe. Although clinically relevant over-delivery
of insulin did not occur during the ten year evaluation period, there is a
potential for such an 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 device, but are important considerations, particularly in the treatment
of diabetic patients. The general surgical risks, as well as operative site
cosmetic risks, should be explained to the patient prior to surgery.
Dmp9196021-011_c.book Page 23 Thursday, April 4, 2002 8:15 AM
Possible adverse effects
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/Encapsulation
Hypoglycemia
Battery Depletion
Ketoacidosis
PPC Failure
23
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24
Indications and Contraindications
Dmp9196021-011_c.book Page 25 Thursday, April 4, 2002 8:15 AM
25
CHAPTER 3
Personal Pump Communicator
(PPC)
Introduction
The Personal Pump Communicator (PPC) has a comprehensive set of programming features to control the Implantable Insulin Pump in the treatment of IDDM. The PPC cannot be used by the patient until it has been
initialized by the healthcare professional. This chapter of the manual is
divided in two parts:
The first part (Part 1) will describe the PPC/PUMP system initialization
process that will be performed the day prior to implant.
The second part (Part 2) will describe how to use the additional features
that the healthcare professional or patients can activate.
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26
Personal Pump Communicator (PPC)
PPC Icons
After initialization, the PPC Main Screen displays the time (12hr. or 24hr.
format), month, day and a variety of icons. The type and purpose of these
icons are as follows:
Bell Icon:
Displayed when the PPC receives a telemetry message from the Pump
indicating that the Pump has detected an alarm condition, when a PPC
error is detected and when the Pump is Suspended or Stopped.
Reservoir Level Indicator Icon:
The reservoir icon is composed of 4 segments that indicate how full
the Pump reservoir is, based on the history of Pump delivery.
Insulin Delivery Icon:
The PPC simulates spinning the delivery icon when insulin delivery is
in progress by displaying alternating patterns, the pattern changes
every 4 seconds. When the Pump is delivering a bolus, the pattern will
show three delivery segments. When the Pump is delivering a basal
rate, the pattern will show one delivery segment. When the Pump is
not delivering, all four segments will be displayed.
Certain features of the PPC such as programming and dosing limits can be
set only by the healthcare professional in a password-protected mode
called the Supervisor Mode. Information pertaining to initializing the
PPC and entering the PPC Supervisor Mode is not included in the Patient
User Manual.
Dmp9196021-011_c.book Page 27 Thursday, April 4, 2002 8:15 AM
Introduction
PPC buttons
Select:SEL
Activate:
The SEL button steps through each of the displays and
menus.
ACT
Activate:
The ACT button activates programming changes in the
Pump, new information to be entered into the PPC memory, and alarms to be turned off. As a safety check, ACT
must be pressed to complete any programming changes.
A single beep is heard after activating a change.
Up and Down
Arrows:
The ▲ or ▼ arrows allow changes in the screen settings. Pressing ▲ once will find the next highest setting, and pressing ▼ once will find the next lowest
setting. Holding down either button will rapidly scroll
through the list of preset values. Desired values can then
be programmed by pressing ACT.
▲ or ▼
Sound Icon
the Up Arrow
When the Audio Bolus feature is turned on, pressing ▲
allows programming an Audio Bolus.
Light Icon
the Down
Arrow:
From the main operating screen, pressing ▼ once will
turn on the backlight. The backlight allows the Pump to
be programmed in the dark. The backlight will turn off
automatically after four seconds.
27
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28
Personal Pump Communicator (PPC)
Communicating with the pump
Place the PPC near the Pump when the screen displays, “PPC COMMUNICATING.” The word "COMMUNICATING" will blink as indication of
succesfull communication. If a communication link between the PPC and
Pump is not established, a “TELEMETRY COMM ERROR 3” message
will appear. The PPC will beep six times once every minute until the
screen is acknowledged by pressing SEL and ACT. The screen will then
display “PPC COMMUNICATING” again.
After a communication is established between the PPC and Pump and
program information is successfully transferred to the Pump, the PPC will
beep once and return to the Time/Date screen.
•
Always press the PPC buttons slowly and firmly. Wait until the
screen changes before pressing the button again.
•
A flashing value on the screen means that the value is activated,
and can be changed by pressing the arrow buttons.
•
The PPC cannot be turned off. Once the battery has been
installed, the PPC is on and remains on until the battery is
removed.
•
Certain types of Radio Frequency (RF) generating equipment
could affect PPC communication with the Pump. If you are experiencing communication difficulties, change locations.
•
The time and date settings must be correct to ensure appropriate
calculation of insulin delivery and display of daily totals and
activity history.
Dmp9196021-011_c.book Page 29 Thursday, April 4, 2002 8:15 AM
Introduction
Install/Replace the main battery
The battery used to power the PPC is a 1.5v AA alkaline. The life of the
battery is approximately 8 weeks during normal usage conditions. If the
vibrator mode is selected, the battery life is approximately 6 weeks.
•
Locate the battery door on the back of the PPC.
•
Slide the locking bar to the left.
•
Push the middle part of the PPC box (under the battery door) and
lift by gently pulling up the battery door to unlatch.
•
Remove the old battery, noting the polarity. The screen will be
blank.
•
Position the new battery so the + and - markings on the battery
match the polarity diagram in the battery compartment.
•
Close the battery door.
•
Slide the locking bar to the right.
•
The PPC screen will reappear within 30 seconds:
1. The PPC will beep 6 times, and after a
few seconds, the screen will display
“CHECK PUMP STATUS”.
PPC
4 102 100
PUMP
2. Press SEL then ACT, and place the PPC
near the Pump.
__ __ __
08:26
JAN O2
CHECK
PUMP STATUS
3. Wait a few seconds for the communica-
tion to complete.
PPC
COMMUNICATING
29
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30
Personal Pump Communicator (PPC)
NOTE: When the PPC displays “PPC LOW BATTERY”,
the message can be cleared, and programming
continued. There should be sufficient energy in
the battery to communicate with the Pump a few
more times, but the battery should be changed as
soon as possible.
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.
Dmp9196021-011_c.book Page 31 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization
Part 1: PPC/Pump system initialization
The Implantable Insulin Pump arrives from MiniMed with preset factory
default values. During the initialization process these preset values are
downloaded into the PPC memory. The preset values can then be changed
by the healthcare professional, allowing the system to be personalized for
each patient. The factory default values are as follows:
Bolus Delivery Type
Normal
Off Locked
Maximum status
Off
Maximum Bolus
25 U
Password
YIQ8
Audio Bolus
Off
Personal Events
status
OFF
Audio Feedback
Disabled
Personal ID
000
(32 characters)
Auto Off duration
Off
PPC alarm type
High
Basal Delivery Pattern
Refill Amount
25 g
Maximum Basal Rate
35 U/H
Time Format
12 hours
Insulin Concentration
400 U/ml
Variable Bolus status
Off
31
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32
Personal Pump Communicator (PPC)
Initialize the PPC
When the healthcare professional receives a new PPC it must be “married” to the Pump. Following are the basic steps used to initialize a Pump
System the day prior to implant:
1. The PPC is delivered without a battery in
place. After installing a new battery, the
PPC will beep six times and the screen
will identify the PPC software used (see
Chapter 1, Install/Replace the Main
Battery).
PPC
4 162 100
PUMP
__ __ __
2. The screen now changes to, “PPC NOT
INITIALIZED”, and the PPC will beep six
times once every minute until the initialization process is started. Press SEL and
then ACT, then quickly place the PPC
over the Pump.
PPC
NOT INITIALIZED
3. When a communication link has been
established, the screen will read, “PPC
COMMUNICATING”, and then will
change to the next screen.
PPC
COMMUNICATING
4. “NO” is blinking. Check to make sure the
serial number displayed on the screen
matches the Pump serial number. Press
either ▲ or ▼ once to change “NO” to
“YES” and then press ACT. Place the
PPC over the Pump.
INITIALIZING "NO"
PPC to PUMP
..................................
........................47568
5. The screen again reads “PPC COMMUNI-
CATING”, and the PPC will beep 3 times
at the end of the programming sequence.
During this process, the PPC receives all
of the factory preset values contained in
the Pump memory.
PPC
COMMUNICATING
Dmp9196021-011_c.book Page 33 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization
6. The screen will read “PUMP SUS-
PENDED”. The Pump and PPC are
now “married”.
PUMP SUSPENDED
7. Press SEL, then ACT and place the PPC
near the Pump.
PPC
COMMUNICATING
8. The screen now reads
“PUMP INITIALIZED”.
PUMP INITIALIZED
9. Press SEL and then ACT again, and the
PPC will display the Time/Date screen.
11:16
JAN O2
NOTE: When the alarm type is set to “VIBRATE” the
beeps from the PPC during normal programming
will be low volume.
33
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34
Personal Pump Communicator (PPC)
Set the time and date
The time and date settings must be correct to ensure accurate calculation
of insulin delivery, daily totals, and the proper display of insulin activity
history.
1. Press SEL until the “SETUP PUMP”
08:32
Jan 02
screen is displayed, then press ACT two
SET
2000
TIME-DATE
times. The first two digits of the time
(hours) will be flashing. Use the ▲ and ▼
buttons to select the correct hour, then
press ACT. The last two digits of the time
(minutes) will be flashing. Use the ▲ and ▼ buttons to select the correct minute, then press ACT. Repeat the programming process to
enter information for the year, month and day.
2. After completing the programming pro-
cess, quickly place the PPC near the
PPC
Pump. The PPC will display “PPC
COMMUNICATING
COMMUNICATING” while transferring the time and date information to the
Pump. The PPC will then move to the
next screen, “AUTO-OFF.” Skip the “AUTO-OFF” screen by pressing SEL once to reach the next screen, “ALARMS”.
Dmp9196021-011_c.book Page 35 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization
Set alarms
Alarms alert the user in the event the PPC or Pump recognizes an insulin
delivery problem. The Alarm Feedback screen must always be in the
“ON” position.
1. Press ACT to enter the “ALARMS”
menu.
ALARMS
2. The PPC has three alarm options, two
audible tones (Low/High) and a vibrate
mode. Press the ▲ and ▼ buttons to
select the desired alarm, then press ACT.
SET
PPC
ALARM TYPE
LOW/HIGH/VIBRATE
3. The screen will now display “SET
ALARM FEEDBACK”. This setting
should always be “ON”. Press ACT.
SET
ALARM
FEEDBACK
ON/OFF
4. Place the PPC near the Pump. When the
communication is completed, the PPC
screen will change to “SELF TEST” and
then to the Time/Date screen.
PPC
COMMUNICATING
NOTE: When the alarm type is set
to “vibrate” the beeps from the PPC during normal programming will be low volume.
35
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36
Personal Pump Communicator (PPC)
Set maximum bolus, basal rate and time display format
This programming is performed in the “SETUP II” menus. These screens
allow healthcare professionals to limit the maximum amount of insulin a
patient can deliver, either when taking a bolus or setting a new basal rate.
Access to the “SETUP II” menus is through the “SETUP PUMP” screen.
1. Press SEL until the “SETUP PUMP”
screen is displayed. Press ACT and press
SEL to reach the “SETUP II” screen.
Press ACT and then SEL to reach the
“MAX BOLUS” screen.
MAX BOLUS
--
2. Press ACT and the maximum bolus
amount (units) will start flashing. Press
the ▲ and ▼ buttons to change the maximum allowable bolus (0.0 to 25.0 units)
and then press ACT again.
SET
MAX BOLUS
--- ----- u
3. Place the PPC near the Pump and com-
plete the communication process. The
PPC screen will automatically change to
the “MAX BASAL” screen.
PPC
COMMUNICATING
4. Press ACT and the screen will change to
“SET MAX BASAL RATE”. The maximum basal amount will start flashing.
Press the ▲ and ▼ buttons to change the
maximum allowable basal rate (0.2 to
35.0 units/hour) and then press ACT
again.
SET
MAX BASAL RATE
0.2u/h
5. Place the PPC near the Pump and com-
plete the communication process. The
PPC screen will automatically change to
“TIME FORMAT.”
PPC
COMMUNICATING
Dmp9196021-011_c.book Page 37 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization
6. Press ACT and the screen will change to
“SET TIME FORMAT.” Press the ▲ and
▼ buttons to select either a 12 hour (AM/
PM) or 24 hour (military time) format,
and then press ACT.
SET
TIME FORMAT
12/24 HOUR
7. Place the PPC near the Pump and com-
plete the communication process. The
PPC screen will return to the “PERSONAL EVENTS” screen. Allow the
PPC to time out and return to the Time/
Date screen.
PPC
COMMUNICATING
NOTE: Adding screens to the main menu, such as
“PERSONAL EVENTS” increases the number of
SEL button presses required to reach “SETUP
PUMP.”
37
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38
Personal Pump Communicator (PPC)
Lock maximum bolus/basal, enter personal ID and password, stop
Pump
To access the Supervisor Mode press SEL until the “SETUP PUMP”
screen is displayed. Then press and hold down the ▲ and ▼ buttons
simultaneously until the “ENTER SUPERVISOR PASSWORD” screen
appears.
WARNING
Patients should not be given the Supervisor
Mode password, to avoid the accidental
programming of a large priming bolus
(99.8 U) or diagnostic insulin rate.
1. The first zero will be flashing. Press the
▲ and ▼ buttons to select the first digit,
then press ACT.The screen advances to
the second zero. Press the ▲ and ▼ buttons to select the second digit, then press
ACT. Repeat for the last two digits. The
factory pre-set password is YIQ8.
ENTER
SUPERVISOR
PASSWORD
0000
2. Entry into the Supervisor Mode is indi-
cated by the screen “PUMP REFILL.”
PUMP
REFILL
3. Press SEL until the “SET MAXIMUMS
SCREEN” is displayed, and then ACT to
reach “SET MAXIMUMS”.
Press the ▲ and ▼ buttons to select
“ON” if the patient is not given access to
this feature, or “OFF” if the patient is permitted access. Press ACT again.
SET
MAXIMUMS OFF/ON
Dmp9196021-011_c.book Page 39 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization
4. Place the PPC near the Pump and com-
plete the communication process. The
PPC screen will automatically advance to
the “PERSONAL ID” screen. Press
ACT.
PPC
COMMUNICATING
5. The first of the 32 possible ID locations is
flashing. Enter the patient ID (alphanumeric) by pressing the ▲ and ▼ buttons and then ACT after each entry. Continue to press ACT, activating each “0”
until the screen changes.
SET PERSONAL ID
..................................
.................20KOLO5
6. Place the PPC near the Pump and com-
plete the communication process.
PPC
COMMUNICATING
7. Press SEL until the “SUPERVISOR
PASSWORD” screen is displayed. Then
press ACT.
SET
SUPERVISOR
PASSWORD
Y1Q8
8. The screen now reads, “SET SUPERVI-
SOR PASSWORD”. Press ACT. Use the
▲ and ▼ buttons to enter a new supervisor password (alphanumeric), pressing
ACT after each entry.
SET
SUPERVISOR
PASSWORD
0000
NOTE: Record the password in the patient’s chart.
39
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40
Personal Pump Communicator (PPC)
Program a basal rate
1. From the Time/Date screen, press SEL
until the “BASAL RATE” screen is displayed. Preset delivery pattern “A”, a
basal rate of 0.2 U/H, and the word
“NOW” is flashing. Press ACT.
08:26
OCT 12
2. A “1” now appears to the right of the “A”
indicating that this programming will
BASAL RATE : A NOW
effect the 1st basal change within the “A”
00:00
0.2u/h
pattern, (there are 3 patterns available
[A,B,C] and 48 basal changes possible
within each pattern). The flashing
0.2 U/H indicates the value can be changed. Use the ▲ and ▼ buttons to change the value and then press ACT.
NOTE: 00:00 indicates a start time of MIDNIGHT in
24hr. display mode. In 12hr. display mode, the
screen indicates the start time as 12:00am.
3. The screen now displays “SET TIME”,
SET RATE
and a time of 00:30 or 12:30 am (24 or 12
BASAL RATE: A
hour respectively) and a “2.”
-U/H
00:30
If one basal is all that will be used, press
ACT two times. If more than one basal
rate is to be programmed, enter a start
time and amount of the new basal rate for that time period, then press
ACT and enter the new basal rate.
The user can enter a new basal rate at 30 minute intervals, up to 48
basal rates.
4. Place the PPC near the Pump and com-
plete the communication process.
PPC
COMMUNICATING
Dmp9196021-011_c.book Page 41 Thursday, April 4, 2002 8:15 AM
Part 1: PPC/Pump system initialization
5. The PPC will briefly display the calcu-
lated total basal dose for 24 hours, based
on the values and times entered in the
Basal Rate programming screen. In this
example, the total basal dose is
4.8 U/day.
24 HOUR TOTAL
4.8U
41
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42
Personal Pump Communicator (PPC)
Part 2: Additional PPC programming features
Main menu
This second part will develop how to program the additional features that
the patient or the healthcare professional can activate.
Program a bolus
A properly initialized PPC is now ready to program a bolus.
The PPC/Pump allows you to set and deliver a bolus of insulin whenever
needed. The PPC has several special features which allow you to customize the programming and delivery of boluses.
•
Normal Bolus and Audio Bolus
•
Square Wave Bolus
•
Dual Wave Bolus
NOTE: To use the Variable bolus programming options,
(e.g. square, dual), this option needs to be programmed “ON” in the SETUP II menu. If it is not
“ON” only the default bolus, “Normal bolus”,
will be available.
Set a normal bolus with the variable bolus feature turned off
1. From the Time/Date screen, press SEL.
The “BOLUS” screen is displayed, with
the time and date flashing.
08:13
BOLUS
IMM
10 U
Jan 02
EXT
--
PROG
2. Press ACT and the “SET BOLUS” screen
appears.The dashes under “IMM” are
flashing. Press the ▲ and ▼ buttons to
enter an immediate bolus amount.
SET BOLUS
IMM
-U
--
Dmp9196021-011_c.book Page 43 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features
3. Press ACT and the “CONFIRM” screen
is displayed, with the screen flashing.
Confirm the bolus amount by pressing
ACT again.
CONFIRM
IMM
2.6U
4. Place the PPC near the Pump and com-
plete the communication process.
PPC
COMMUNICATING
5. When the bolus programming is com-
plete, the PPC will beep once and then
briefly display the amount of insulin currently delivered.
08:13
BOLUS
Jan 02
0.0U
The Pump will beep at each of the first five strokes (if audio feedback is
ON). The PPC beeps and at the end of the bolus. Three segments of the
insulin delivery icon will be displayed and spinning slowly during the
bolus delivery. By pressing SEL you can read the amount of insulin delivered.
43
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44
Personal Pump Communicator (PPC)
Set a normal bolus with the variable bolus feature turned on
1. From the Time/Date screen press SEL
until the “BOLUS” screen is displayed.
The last bolus value programmed and the
Time and Date will be flashing.
08:13
BOLUS
IMM
-- U
Jan 02
EXT
--
2. Press ACT and the “SET BOLUS TYPE”
screen appears. If “NORMAL” is not
flashing, use the ▲ and ▼ buttons to
select “NORMAL.” Press ACT.
SET
BOLUS TYPE
NORMAL
3. The “SET BOLUS” screen appears, with
dashes under “IMM” flashing. Use the ▲
and ▼ buttons to enter an immediate
bolus amount.
SET BOLUS
IMM
--- --- U
4. Press ACT and the “CONFIRM” screen
is displayed, with the screen flashing.
Confirm the bolus amount by pressing
ACT again.
CONFIRM
IMM
2.6u
5. Place the PPC near the Pump and com-
plete the communication process.
PPC
COMMUNICATING
6. When the bolus programming is com-
plete, the PPC will beep once and then
briefly display the amount of insulin currently delivered.
08:23
JAN 04
BOLUS
0.0U
The Pump will beep at each of the first five strokes (if audio feedback is
ON). The PPC beeps at the end of the bolus. Three segments of the insulin
delivery icon will be displayed and spinning slowly during the bolus
delivery. By pressing SEL you can read the amount of insulin delivered.
Dmp9196021-011_c.book Page 45 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features
Set a square wave bolus
A Square Wave Bolus of insulin is delivered evenly over a preset period
of time, from 30 minutes to 4 hours. A Square Wave Bolus may be desirable when eating long meals such as banquets or receptions, high fat
meals, or to compensate for gastroparesis. During a Square Wave Bolus,
the programmed basal rate is also delivered.
To access this feature you must first turn the Variable Bolus feature “ON”
in the “SETUP II” menu.
1. From the Time/Date screen, press SEL.
The “BOLUS” screen is displayed, showing the last bolus programmed with the
time and date flashing.
08:13
BOLUS
IMM
10 U
Jan 02
EXT
--
PROG
--
2. Press ACT and the “SET BOLUS TYPE”
screen appears. Press the ▲ and ▼ buttons to select “SQUARE”. Press ACT.
SET
BOLUS TYPE
SQUARE
3. The “BOLUS” screen appears, with
dashes under “EXT” flashing. Use the ▲
and ▼ buttons to enter an extended bolus
amount. Press ACT.
SET BOLUS
IMM
EXT
--
4.0U
4. Blinking dashes will now appear under
the bolus amount entered.
Use the ▲ and ▼ buttons to enter a time
duration for the Square Wave Bolus, in
one-half hour increments from 30 minutes to four hours.
SET BOLUS
IMM
EXT
--
4.0U
2:00
5. Press ACT and the “CONFIRM BOLUS”
screen is displayed, with the screen flashing. Confirm the Square Wave Bolus by
pressing ACT again.
CONFIRM BOLUS
IMM
EXT
--
4.0U
2:00
45
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46
Personal Pump Communicator (PPC)
6. Place the PPC near the Pump and com-
plete the communication process.
7. When the bolus programming is com-
plete, the PPC will beep once and then
briefly display the amount of insulin currently delivered.
PPC
COMMUNICATING
16:06
JAN 03
BOLUS
0.0U
The Pump will beep at each of the first five strokes (if audio feedback is
ON). The PPC beeps at the end of the bolus. Three segments of the insulin
delivery icon will be displayed and spinning slowly during the bolus
delivery. By pressing SEL you can read the amount of insulin delivered.
Dmp9196021-011_c.book Page 47 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features
Set a dual wave bolus
The Dual Wave Bolus programs a Normal Bolus immediately followed
by a Square Wave Bolus.
To access this feature you must first turn the Variable Bolus feature ON in
the SETUP II menu.
1. From the Time/Date screen, press SEL.
The “BOLUS” screen is displayed, showing the last bolus programmed with the
time and date flashing.
08:13
Jan 02
BOLUS
IMM
EXT
--- --- U ---- ---- U
--- ---
2. Press ACT and the “SET BOLUS TYPE”
screen appears. Press the ▲ and ▼ buttons to select “DUAL.” Press ACT.
SET
BOLUS TYPE
DUAL
3. The “BOLUS” screen appears, with
dashes under “IMM” flashing. Use the ▲
and ▼ buttons to enter the immediate
portion of the Dual Wave Bolus. Press
ACT.
SET BOLUS
IMM
2.0u
4. The “BOLUS” screen now shows dashes
flashing under “EXT.”
Use the ▲ and ▼ buttons to enter the
extended portion of the Dual Wave
Bolus. Press ACT.
SET BOLUS
IMM
EXT
2.0u
2.0u
5. Blinking dashes will now appear under
the bolus amount entered.
Use the ▲ and ▼ buttons to enter a time
duration for the Square Wave Bolus, in
one-half hour increments from 30 minutes to four hours.
SET BOLUS
IMM
2.0u
EXT
2.0u
2:00
47
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48
Personal Pump Communicator (PPC)
6. Press ACT and the “CONFIRM BOLUS”
screen is displayed, with the screen flashing. Confirm the Dual Wave Bolus by
pressing ACT again.
CONFIRM BOLUS
IMM
EXT
2.0u
2.0u
2:00
7. Place the PPC over the pump and com-
plete the communication process.
PPC
COMMUNICATING
8. When the bolus programming is com-
plete, the PPC will beep once and then
briefly display the amount of insulin currently delivered.
16:06
BOLUS
JAN 03
0.0u
The pump will beep at each of the first five strokes (if audio feedback
is ON). The PPC beeps at the end of the bolus. Three segments of the
insulin delivery icon will be displayed and spinning slowly during the
bolus delivery. By pressing SEL, you can visualize the amount of
insulin delivered.
Dmp9196021-011_c.book Page 49 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features
Review bolus history
To review the type, amount, time and day of your last 512 insulin boluses.
1. From the Time/Date screen, press SEL.
The “BOLUS” screen is displayed, showing the last bolus programmed.
Use the ▲ and ▼ buttons to display previous boluses, along with the time and
day each bolus was delivered.
08:23
BOLUS
IMM
---- U
PROG
Jan 02
--- ----- ---
EXT
Suspend mode
The Suspend Pump mode allows the user to cancel a bolus delivery, while
still delivering a basal rate of 0.2 U/hr.
1. From the Time/Date screen, press SEL
until the “SUSPEND PUMP” screen is
displayed. Press ACT. The screen will
display a flashing “SUSPEND PUMP”
message. Press ACT again.
SUSPEND PUMP
2. Place the PPC near the Pump and com-
plete the communication process.
3. When the communication is complete, the
Pump will beep 3 times and the PPC
screen will change to “PUMP SUSPENDED”. All four segments of the
insulin delivery icon are shown. The PPC
will beep every half-hour as long as the
Pump remains suspended.
PPC
COMMUNICATING
08:13
OCT 12
PUMP SUSPENDED
NOTE: To restart the pump, press SEL. The “PUMP
SUSPENDED” screen will begin flashing. Then
press ACT.
49
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50
Personal Pump Communicator (PPC)
Programming a basal rate
Basic basal rate programming was described in earlier in this chapter.
This section describes additional basal rate options.
Programming basal delivery pattern
The PPC allows three basal delivery patterns. One such basal pattern
could be used for a working day, another for a weekend day, etc. Each of
the basal delivery patterns is a set of up to 48 basal rates, one for each
half-hour of the day. Pattern A is the factory pre-set. To access profiles B
or C you must enter the “SETUP I” screens.
1. Press SEL until the “PUMP SETUP”
screen is displayed. Press ACT. Press
SEL again to access the basal rate profile
screen, “DELIVERY PATTERN”.
DELIVERY
PATTERN
2. Press ACT and the screen will change to
“SET DELIVERY PATTERN”. Use the
▲ and ▼ keys select the pattern preferred; A, B, or C. Each pattern can contain up to 48 different basal rates. Press
ACT after choosing a pattern.
SET
DELIVERY
PATTERN
A,B,C
3. Place the PPC near the Pump and allow
the communication to complete.
PPC
COMMUNICATING
NOTE: When the PPC times out, press SEL until the
“BASAL RATE” screen is displayed. The basal
pattern selected in SETUP II will now appear to
the right of “BASAL RATE” A, B, or C.
Dmp9196021-011_c.book Page 51 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features
Setting basal rate profiles in each delivery pattern
Each of the basal delivery patterns is a set of up to 48 basal rates, one for
each half-hour of the day.
1. Press SEL until the “BASAL RATE”
screen is displayed. A basal pattern is
selected (for example Pattern A). Press
ACT.
BASAL RATE : A NOW
0.2U/H
00:00
2. A “SET RATE” and “1” is now displayed
SET RATE
to the right of the “A” indicating this proBASAL RATE : A
st
gramming will set the 1 basal rate
0.2U/H
00:00
within the “A” profile. The “0.2U/H” is
now flashing, indicating the value can be
changed. Use the ▲ and ▼ arrow keys
to program a new value, for example “0.4 U/H”, and then press ACT.
NOTE: 00:00 indicates a start time of MIDNIGHT in 24hr.
display mode. 12:00am indicates a start time of
MIDNIGHT in 12hr. display mode.
3. The screen now displays “SET TIME”,
with a time of “00:30” or “12:30am”
SET TIME
BASAL RATE : A
flashing (24 or 12 hour respectively) and
04:30
0.4u/h
a “2.” This screen allows the second basal
rate to be set. Enter a start time for the 2nd
basal rate within the “A” profile, for
example “04:30.” Press ACT. (Example: a second basal rate of 0.4U/
H starting at 04:30.)
4. This screen changes to “SET RATE”
again, indicating the 2nd basal rate can
now be programmed. Use the ▲ and ▼
arrow buttons to enter a new rate, for
example “0.2U/H”, and then press ACT.
SET TIME
BASAL RATE :
04:30
0.4u/h
51
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52
Personal Pump Communicator (PPC)
5. A “3” now appears on the screen with
“SET TIME.” Follow the same procedure
previously described and program a new
profile. If no additional profiles are
needed change the flashing time to dashes
(by pressing ▼ ) and press ACT.
SET TIME
BASAL RATE :
05:00
0.2u/h
6. The screen will indicate “PPC COMMU-
NICATING.” Place the PPC near the
Pump and complete the communication
process.
PPC
COMMUNICATING
7. The screen will briefly display the calcu-
lated 24 hour basal dose based on the
basal rate programming. In this example
a total of “8.4U” will be delivered.
24 HOUR TOTAL
8.4u
To set multiple basal profiles in the other patterns (A,B,C), select the pattern in SETUP II menu and follow the same
procedure.
Program a temporary basal rate
A Temporary Basal Rate is often used when a brief change in basal delivery is required, for example during exercise.
Set a temporary basal rate
1. From the time and date display press SEL
until the “TEMPORARY
screen is displayed.
BASAL”
TEMP BASAL
--- --- --- --u/h
2. Press ACT and the “SET DURATION”
screen appears. The time duration of the
Temporary Basal Rate is displayed as
flashing dashes. Press the ▲ and ▼ buttons to enter a time duration, in 30 minute
increments from 30 minutes to 24 hours.
SET DURATION
TEMP BASAL
--- --- u/h
00:30
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Part 2: Additional PPC programming features
3. Press ACT and “SET AMOUNT” screen
appears. The amount of the Temporary
Basal Rate is now flashing.
Press the ▲ and ▼ buttons to enter a
delivery amount. Press ACT again.
SET AMOUNT
TEMP BASAL
1.5u/h
00:30
4. Place the PPC near the Pump and com-
plete the communication process.
5. When the communication is complete, the
Pump will beep once. The PPC screen
will briefly show the “TEMP BASAL”
screen before returning to the Time/Date
screen.
PPC
COMMUNICATING
08:13
OCT 02
TEMP BASAL
NOTE: When the Pump is delivering a Temporary Basal
rate, the first screen displayed when SEL is
pressed is “TEMP BASAL.” The PPC will also
beep every 30 minutes to alert the user that a
Temporary Basal rate is currently active.
53
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54
Personal Pump Communicator (PPC)
Stop a temporary basal rate
1. From the Time/Date screen press SEL
until the “TEMP BASAL” screen is displayed. Press ACT and the “SET DURATION” appears, with the time duration
flashing. Press ▼ once until it resets to
dashes. Then press ACT.
SET DURATION
TEMP BASAL
--- --1.5u/h
2. Place the PPC near the Pump and com-
plete the communication process.
PPC
COMMUNICATING
3. When the communication is complete, the
PPC will briefly return to the “TEMP
BASAL” screen with the amount dashes
flashing. Allow the PPC to return to the
Time/Date screen.
SET AMOUNT
TEMP BASAL
--- --- --- --- u/h
Personal events
This feature allows the user to enter event codes into the PPC memory,
and record the time and date of entry. Preset event codes are: 1 = meal, 2
= snack, 3 = sick and 4 = exercise. In addition, other event codes A, B and
C can be entered to record other important events. These other event
codes should be documented prior to their use.
To access the “EVENTS” screen in the main menu, “ON” must be activated in the “SETUP II” menu, “PERSONAL EVENTS” screen.
1. From the Time/Date screen, press SEL
until “SETUP PUMP” is displayed, then
press ACT.
Press SEL until “SETUP II” is displayed,
then press ACT.
Press SEL until “PERSONAL EVENTS”
is screen is displayed.
PERSONAL
EVENTS
OFF
Dmp9196021-011_c.book Page 55 Thursday, April 4, 2002 8:15 AM
Part 2: Additional PPC programming features
2. Press ACT and “ON” or “OFF” begins
flashing.
PERSONAL ON/OFF
EVENTS
3. Use the ▲ and ▼ buttons to select “ON”,
then press ACT again. The “PERSONAL
EVENTS” screen will now appear on the
main menu. Allow the PPC to return to
the Time/Date screen.
SET
PERSONAL ON/OFF
EVENTS
4. To set an event: From the Time/Date
screen press SEL until the “EVENT”
screen is displayed then press ACT.
The screen changes to “SET EVENT”
with the word “MEAL” flashing.
Use the ▲ and ▼ buttons to select the
desired event.
5. Press ACT and the current time will
appear flashing.
Use the ▲ and ▼ buttons to enter the
time the event occurred.
Press ACT when the proper time is displayed. Then allow the screen return to
Time/Date.
SET
EVENT
MEAL
07:32Am
SET TIME
EVENT
MEAL
NOTE: Only historic or current event times can be
entered.
NOTE: If the Personal Events feature is turned “OFF” in
“SETUP II”, events cannot be entered into the
PPC.
55
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56
Personal Pump Communicator (PPC)
History
Historical Pump data, such as insulin medication remaining, amount of
bolus and basal delivery since the last refill, etc., can be accessed and read
on the PPC.
1. From the Time/Date screen press SEL
until the “HISTORY” screen is displayed. Press ACT and the “READ
PUMP DATA” screen will appear flashing.
Press ACT again.
READ PUMP DATA
000000000000000000000000
000000000000000000010057
2. Place the PPC near the Pump and com-
plete the communication process. The
PPC will acquire data from the Pump.
screen will change to “MED
REMAINING”, indicating the estimated
amount of insulin medication remaining
in the Pump. Record this number if
required.
PPC
COMMUNICATING
3. The
MED REMAINING
2263 u
4. Press SEL and the screen will read
“INSULIN TOTAL.” Delivered amounts
of basal and bolus insulin medication are
displayed for the date flashing on the
screen. Use the ▲ and ▼ buttons to
review other daily totals.
5. Press SEL and the screen will change to
“CLINICAL HISTORY PPC”. Use the
▲ and ▼ buttons to review other PPC
events.
Jan 02
INSULIN TOTAL
BASAL
BOLUS
9u
6:16
22u
Jan 02
CLINICAL HISTORY
PPC
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Part 2: Additional PPC programming features
6. Press SEL and the screen will change to
“CLINICAL HISTORY PUMP”. Use the
▲ and ▼ buttons to review Pump events.
6:26
Jan 02
CLINICAL HISTORY
PUMP
14
7. Press SEL and the screen will change to
Jan 02
“EST PUMP BATT”. This screen indiEST PUMP BATTERY
NO LD
LD
cates the Pump battery status, during no2.9
2.7V
load (battery power is not used) and load
(extended communication sequence) conditions. The Pump is set to alarm for low
battery when the loaded (LD) voltage is at or below 2.5 volts.
8. Press SEL and the screen will read
“EXIT HISTORY.” Press ACT. The PPC
will return to the Time/Date screen.
EXIT HISTORY
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58
Personal Pump Communicator (PPC)
Setup Pump
The “SETUP PUMP” screen permits access to the primary Setup menus
for the Pump. Setup features discussed previously in this chapter are referenced here. Other Setup features not previously discussed are presented
here. Press SEL until the “SETUP PUMP” screen is displayed, then press
ACT to access the SETUP menus.
Auto off
Auto Off is a safety feature, reminding the user to update insulin medication delivery programming in the Pump. An alarm can be set after a
period of programming inactivity, from one to 16 hours. At the onset of
the alarm the Pump will automatically be placed in SUSPEND mode.
1. From the “ SETUP PUMP” screen, press
ACT. Press SEL to reach the “AUTO
OFF” screen, then press ACT. The screen
will display “AUTO OFF” with flashing
dashes/time. Use the ▲ and ▼ buttons to
select the number of hours before an
“AUTO OFF” alarm occurs.
AUTO OFF
--- --- HRS
2. Press ACT. In this example, a time dura-
tion of 10 hours was selected. The PPC
will alarm if the user did not attempt to
program the Pump during the previous 10
hours and be placed in SUSPEND mode.
SET
AUTO OFF
10 HRS
3. Place the PPC near the Pump and com-
plete the communication process.The
PPC will beep once and return to the
Time/Date screen.
PPC
COMMUNICATING
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Setup Pump
Self test
1. Self Test allows the user to perform a
diagnostic test of the Pump and PPC
operating system. Messages are relayed
between the PPC and Pump. From the
“SETUP PUMP” screen, press ACT.
Press SEL until the “SELF TEST” screen
is displayed. Press ACT.
SELF TEST
2. Place the PPC near the Pump and com-
plete the communication process.
PPC
COMMUNICATING
Verify that the following events occur:
•
A series of tones will be heard from the Pump (4 beeps).
•
An alarm tone will be heard from the PPC.
•
The backlight on the PPC will turn on.
•
The PPC screen will briefly activate all possible display icons,
numbers, etc.
•
The PPC will vibrate.
NOTE: If the above test results do not occur or the screen
displays irregular characters, please notify
MiniMed. If the PPC displays the MiniMed logo
and software version, the PPC has restarted due
to a low battery. Replace the battery immediately.
If all electronics “pass” the Self Test, the screen will automatically
change to “PPC PASSED/PUMP PASSED.” After several seconds, the
screen will return to the Time/Date screen.
59
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60
Personal Pump Communicator (PPC)
Initialize PPC to Pump
From the “SETUP PUMP” screen press ACT until “INITIALIZE PPC
TO PUMP” is displayed. This option “marries” the PPC to the Pump, and
it is used to initialize a new PPC. For initialization programming follow
the steps described in, Part 1: PPC/Pump sytem initialization.
Setup II
“SETUP II” permits access to an additional group of Setup menus for the
Pump. From the “SETUP PUMP” screen, press ACT until the “SETUP
II” screen is displayed. Setup II features are presented in the next section.
Exit setup menu
1. From the SETUP “pump” screen, press
SEL until the “EXIT SETUP MENU”
screen is displayed. Press ACT. The PPC
will return to the Time/Date screen.
EXIT SETUP MENU
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Setup II
Setup II
Audio bolus
The Audio Bolus feature allows the user to deliver a bolus without looking at the PPC screen. There are two Audio Bolus increments, 0.4U and
0.8U. With each press of the ▲ button, the PPC will beep one time (0.4U
setting) or two times (0.8U setting), depending on the delivery amount
selected per button press.
Activating the audio bolus feature
1. From the “SETUP II” screen, press ACT.
AUDIO BOLUS
The “AUDIO BOLUS’ screen is shown.
ON
2. Press ACT, and the screen changes to
“SET AUDIO BOLUS” with “OFF/ON”
flashing. Use the ▲ and ▼ buttons to
choose “ON” to activate the Audio Bolus
feature or “OFF” to disable it. Then press
ACT.
0.4u
SET
AUDIO BOLUS
0.4u
ON
3. If “ON” was chosen, the “SET STEP
AUDIO BOLUS” appears with a step
value of 0.4U or 0.8U flashing on the
screen. Use the ▲ and ▼ buttons to
choose between a step rate of 0.4U or
0.8U. Press ACT. The Audio Bolus feature is now activated.
SET STEP
AUDIO BOLUS
0.4u
NOTE: If “OFF” is chosen, pressing the ▲ button will
have no effect.
61
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62
Personal Pump Communicator (PPC)
Set an audio bolus from the main menu bolus screen
1. From the Time/Date screen press the ▲
button. The PPC beeps either one or two
times, depending upon the audio bolus
step amount set. The user counts the
number of beeps to determine how much
insulin was programmed.
SET BOLUS
IMM
0.8U
2. In this example the PPC was programmed
for a 0.8U increment, and the PPC beeps
PPC
two times for the 0.8U bolus.
COMMUNICATING
Press ACT and the audio sequence
repeats to confirm the bolus amount.
Press ACT twice and the Pump will be
programmed. The PPC beeps once when the programming is completed. Place the PPC on the Pump to complete the communication
process.
NOTE: While an audio bolus is being delivered, the ▲
button will not function.
Variable bolus
To access the Variable Bolus feature enter “SETUP II” and press SEL
one time.
The screen will display
BOLUS”. Press ACT.
“VARIABLE
The screen will now display “SET VARIABLE BOLUS” and “ON or OFF” will be
flashing. Use the ▲ and ▼ buttons to select
“ON” or “OFF”, then Press ACT.
VARIABLE
BOLUS
SET
VARIABLE
BOLUS
ON
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Setup II
Place the PPC near the Pump to complete
communication. If “ON” was chosen the
Variable Bolus option is now available in the
Main Menu/Bolus screen.
PPC
COMMUNICATING
NOTE: If “OFF” is chosen, theVariable Bolus option (Square, Dual) will not be
available in the (Main Menu) Bolus screen.
63
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64
Personal Pump Communicator (PPC)
Refill
The refill procedure will be described in Chapter 5 “Pump Refill Procedure.” The following screens are used at the end of this procedure, and
allow you to enter the new refill volume and to calculate the refill accuracy.
The "PUMP REFILL" screen appears when
you access the Supervisor Mode. Press ACT.
PUMP REFILL
The PPC prompts for the residual amount of
insulin removed from the Pump. Use the ▲
and ▼ buttons to enter the weight (grams) of
extracted insulin.
SET
EXTRACTED AMOUNT
---- ---- g
Press ACT and the PPC prompts for the refill
insulin amount. Use the ▲ and ▼ buttons to
enter the weight (grams) of insulin refilled in
the Pump.
SET
REFILL AMOUNT
---- ---- g
Press ACT. Confirm that the insulin concentration defaults to U-400. Press ACT again.
SET
INSULIN
U400
CONCENTRATION
Place the PPC near the Pump to complete the
process.
PPC
COMMUNICATING
The calculated accuracy will be displayed
briefly. Record this value on the refill form.
CALCULATED
ACCURACY
---- ---- %
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Setup II
Priming
WARNING
A priming bolus is not intended as a therapeutic bolus. It should be only used when the
Pump is not implanted.
The Priming Bolus is used during the preparation of the Pump for implantation. This feature “Primes” the Pump piston chamber, outlet port and
Catheter. The Pump will pulse approximately 500 times during this function. To access this feature, the Pump must be in “PUMP STOPPED”
mode.
1. From the “PUMP STOPPED” screen,
press SEL. The screen will begin flashing.
2. Press the ▲ and ▼ buttons at the same
time until the “ENTER SUPERVISOR
PASSWORD” screen appears.
08:13
Oct 12
PUMP STOPPED
ENTER
SUPERVISOR
PASSWORD
YIQ8
3. Re-enter the supervisor password, press-
ing ACT after each letter or number is
PRIMING
entered. The factory preset password is:
YIQ8. If the password has been changed,
enter the new password. When the Supervisor Password is successfully entered,
the screen will change to “PUMP REFILL”. Press SEL until the
“PRIMING” screen appears.
4. Press ACT and “NO” appears flashing.
Press the ▲ and ▼ buttons to change to
“YES”, then press ACT.
PRIMING
99.8u
NO
65
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66
Personal Pump Communicator (PPC)
5. The word “CONFIRM” now appears.
Press ACT to activate the factory preset
priming bolus of 99.8U.
CONFIRM
PRIMING
YES
99.8u
6. Place the PPC over the Pump and com-
plete the communication process.
PPC
COMMUNICATING
7. The progress of the Priming Bolus can be
verified by pressing SEL. The Priming
Bolus takes approximately 10 minutes to
complete.
08:13
OCT 12
PRIMING
0.0u
NOTE: The PPC will alarm every minute during the Priming Bolus. The Priming Bolus can be terminated
at any time by using the “SUSPEND PUMP” feature.
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Setup II
Diagnostic rate
WARNING
A diagnostic rate is intended for use only when
the Pump is filled with buffer.
The Diagnostic Rate feature is used to help “diagnose” Pump delivery
problems. Fill the Pump with rinse buffer before using this feature. To
access this feature, the Pump must be in the “PUMP STOPPED” mode.
1. From the “PUMP STOPPED” screen,
press SEL. The screen will begin flashing.
08:13
OCT 12
PUMP STOPPED
2. Press the ▲ and ▼ buttons at the same
time until the “ENTER SUPERVISOR
PASSWORD” screen appears. Re-enter
the supervisor password, pressing ACT
after each letter or number is entered.
The factory preset password is: YIQ8.
SET
SUPERVISOR
PASSWORD
0000
3. When the Supervisor Password is suc-
cessfully entered, the screen will change
to “PUMP REFILL”. Press SEL until the
“DIAGNOSTIC RATE” screen appears.
DIAGNOSTIC
RATE
--- --- u/h
4. Press ACT and the word “SET” appears
flashing. Use the ▲ and ▼ buttons to
enter a Diagnostic Rate (units/hour).
SET
DIAGNOSTIC
RATE
10 u/h
5. Press ACT and the word “SET” changes
to “DELIVER”. “NO” also appears
flashing. Use the ▲ and ▼ buttons
change “NO” to “YES”, then press ACT.
DELIVER
DIAGNOSTIC
RATE
10 u/h
67
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68
Personal Pump Communicator (PPC)
6. The entire screen will be flashing. Press
ACT again to confirm the Diagnostic
Delivery Rate.
CONFIRM
DIAGNOSTIC
RATE
10 u/h
7. Place the PPC near the Pump and com-
plete the communication process.
PPC
COMMUNICATING
8. The
words “DIAGNOSTIC RATE”
appear briefly on the screen.The PPC
then returns to the Time/Date screen.
08:13
OCT 12
DIAGNOSTIC RATE
NOTE: Press SEL and the PPC will indicate “DIAGNOSTIC RATE.”
NOTE: Diagnostic Rate Delivery can be terminated at any
time by using the “SUSPEND PUMP” feature.
Dmp9196021-011_c.book Page 69 Thursday, April 4, 2002 8:15 AM
Setup II
Initialize to factory defaults
This feature resets all programmed parameters in the Pump to preset factory default values. To access this feature, the Pump must be in the
“PUMP STOPPED” mode.
1. From the “PUMP STOPPED” screen,
press SEL. The screen will begin flashing.
2. Press the ▲ and ▼ buttons at the same
time until the “ENTER SUPERVISOR
PASSWORD” screen appears. Reenter
the Supervisor Password, pressing ACT
after each letter or number is entered.
The factory preset password is: YIQ8.
3. When the Supervisor Password is suc-
cessfully entered, the screen will change
to “PUMP REFILL”. Press SEL until the
“INITIALIZE
TO
FACTORY
DEFAULTS” screen appears.
4. Press ACT and the word “CONFIRM”
will appear. Press ACT again to activate.
08:13
oct 12
PUMP STOPPED
ENTER
SUPERVISOR
PASSWORD
0000
INITIALIZE
TO FACTORY
DEFAULTS
INITIALIZE
TO FACTORY
DEFAULTS
CONFIRM
5. Place the PPC over the Pump and com-
plete the communication process.
PPC
COMMUNICATING
6. The PPC will now read “PUMP SUS-
PENDED.” Press SEL then ACT.
08:13
OCT 02
PUMP SUSPENDED
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70
Personal Pump Communicator (PPC)
7. Place the PPC over the Pump and com-
plete the communication process.
PPC
COMMUNICATING
8. The PPC now displays the “PUMP
RESET” screen, and beeps six times
every minute until the Pump is restarted.
Press SEL then ACT. The PPC returns
to the Time/Date screen. The Pump may
now be reprogrammed.
08:13
OCT 02
PUMP
RESET
Download software
This feature has been disabled at the factory.
1. From the “PUMP REFILL” screen in the
Supervisor menu, press SEL until the
“DOWNLOAD SOFTWARE” screen
appears.
DOWNLOAD
SOFTWARE
Stop Pump
This screen allows the Physician to stop the operation of the Pump.
From the “PUMP REFILL” screen in the
Supervisor Menu, press SEL until the “STOP
PUMP” screen appears.
Press ACT and the word “CONFIRM”
appears highlighted with the entire screen
flashing. Press ACT again to confirm.
STOP PUMP
CONFIRM
STOP PUMP
Dmp9196021-011_c.book Page 71 Thursday, April 4, 2002 8:15 AM
Setup II
Place the PPC near the Pump and allow the
communication to complete.
PPC
COMMUNICATING
The PPC will beep four times to confirm the
“STOP PUMP” command. To restart the
Pump, press SEL and “PUMP STOPPED”
will start to flash. Press ACT. Place the PPC
near the Pump. When the communication is
complete, the PPC returns to the Time/Date
screen.
08:13
OCT 02
PUMP STOPPED
Supervisor password
If the password is lost, access the Supervisor Menu as follows :
•
Program the time to midnight (12:00 am or 00:00) and the date to
January 01.
•
Enter the password 0000 within one minute. If the password is
not entered within one minute the time will be reset to midnight
again.
•
Record the new password in the patient’s chart.
71
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72
Personal Pump Communicator (PPC)
Exit supervisor
To exit the Supervisor Programming Menu, press SEL until the “EXIT
SUPERVISOR” screen appears, then press ACT.
Personal Pump communicator messages
Display Screen Message
Message Meaning or Action Required
AUTO OFF PUMP PUMP
SUSPENDED
Auto Off time interval has elapsed. Pump operation is
suspended.
BOLUS
0.0 u
A bolus has been programmed and is being delivered.
CHECK PUMP
STATUS
The PPC battery has been replaced. The PPC needs to
check the Pump status.
LOW RESERVOIR
The PPC has recognized the Pump has 800 units (2 ml)
or less insulin remaining in its reservoir. Schedule a
Pump refill as soon as possible. Allowing the reservoir
to completely empty may damage the Pump.
EMPTY RESERVOIR
The PPC has recognized the Pump has 400 units (1 ml)
or less insulin remaining in its reservoir. Schedule a
Pump refill as soon as possible. Allowing the reservoir
to completely empty may damage the Pump.
HOURLY MAX
EXCEEDED
You attempt to deliver more than 2.5 times the bolus
maximum in one hour. To clear the message, press
SEL and ACT. You may exceed this limit by programming another bolus within 10 minutes.
PPC NEEDS
SERVICING
The internal PPC backup battery is depleted. The PPC
can be programmed. Replace the PPC as soon as possible.
PPC LOW BATTERY
The internal PPC backup battery is low. The PPC can
be programmed. Replace the PPC as soon as possible.
PPC DEPLETED
BATTERY
The PPC cannot be programmed. Replace the PPC AA
1.5 volt alkaline battery.
PPC NOT INITIALIZED
The PPC has not been initialized to a Pump.
PPC LOW BATTERY
The PPC can be programmed. Replace the PPC AA 1.5
volt alkaline battery.
PUMP LOW
BATTERY
The Pump battery energy is low but still functioning.
Schedule a replacement as soon as possible.
Dmp9196021-011_c.book Page 73 Thursday, April 4, 2002 8:15 AM
Setup II
Display Screen Message
Message Meaning or Action Required
PUMP INITIALIZED
The PPC has been “married” to a Pump . Press SEL
and ACT.
PRIMING
A Priming Bolus has been programmed and is being
delivered.
XX U
PUMP RESET
The Pump was reprogrammed to the preset factory values.
PUMP SELF TEST FAIL
A Pump malfunction was detected during a Self Test.
Notify your physician immediately.
PUMP STOPPED
The Pump is in stop mode.
PUMP STOPPED
1 or 2 or 3 or 4or 5 or 6
When the Pump recognizes a system malfunction, it
automatically stops and insulin delivery ceases. Notify
your physician immediately.
PUMP SUSPENDED
The Pump is in suspend mode
PUMP ERROR
User attempts to initialize the PPC to a Pump that is not
compatible with it. Clear by pressing SEL and ACT.
Verify the personal ID of the Pump responding corresponds to the personal ID entered into the PPC.
0 or 1
PUMP ERROR
The Pump has invalid data. The PPC will not initialize
to Pump.
40 or 41
TELEMETRY
ERROR
COMM
TELEMETRY COMM
ERROR
20
The PPC and Pump are not communicating. Reposition the PPC over the Pump, then press SEL and ACT.
If the error message persists, contact MiniMed.
If the response is “NO” to the “INITIALIZE PPC TO
PUMP” until this screen appears. Move the PPC away
from any other Pump and perform the request again.
73
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74
Personal Pump Communicator (PPC)
Clinical history codes
In the “HISTORY” menu, the user can access clinical history from the
PPC and the Pump. Each number code corresponds to a particular event.
The following table lists each of the number codes with their corresponding events.
Clinical history PPC/Pump codes
Clinical Event
Code
Clinical Event
Code
Version Error
Time Out
No Response
Retry Packet
No Synchronization
Bad CRC
Invalid transmission
RX Overflow
Invalid Op code
TX Underflow
10
Bolus Total Error
13
Unknown IRQ Vector
12
Bad Duplicates
15
NMI Occurred
14
Stop Pump Alarm
17
Suspend Alarm
16
Prime Pump Alarm
19
Diagnostic Rate Alarm
18
Max Clock Stealer
21
Exclusion List Full
20
Non Initialized PPC
23
Min Clock Stealer
22
Pump Initialized
25
Pump Self Test Error
24
Pump Reset to Defaults
26
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Setup II
Clinical Event
Code
Clinical Event
Code
Download Failure
27
Hourly Maximum
28
Refill Divide Error
29
Refill Invalid Calculation
30
Divide by 0
31
EEPROM Error
32
Bad EEPROM
33
Main Battery Low
34
Main Battery Depleted
35
Back-up Battery Low
36
Temporary Basal Rate
37
Check Pump Status
38
Download Complete
39
Invalid Concentration
40
Invalid Stroke Volume
41
Battery Removed
42
IP Communication Error
Charge Time Too Long
Post-Fire Voltage Reading
too High
Over-Delivery Error
Under-Delivery Error
Dead Battery
Auto Off Interval Exceeded
Low Reservoir
Empty Reservoir
Low Battery
10
Normal Delivery Mode
11
Stop Delivery Mode
12
Suspend Delivery Mode
13
Diagnostic Rate delivery
mode
14
Priming Bolus Delivery
Mode
15
Insulin Concentration
Change
16
75
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76
Personal Pump Communicator (PPC)
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77
CHAPTER 4
Pump Implantation
Preprogramming and pre-testing the pump
Every Implantable Insulin Pump is fully tested before shipment and is
accompanied by a package insert indicating the measured stroke volume
and Pump type. Prior to shipping, each Pump is filled with sterile rinse
buffer to assure sterility.
Programming of the Pump may be performed a day before Pump implantation. The Implantable Insulin Pump may be programmed through the
outer tray of the sterile package. First, the PPC needs to be “married” to
the Pump, then the Pump function is verified by performing the initialization procedure described in Chapter 3, PPC/Pump System Initialization.
Registration card
To ensure proper patient identification and device serial number tracking,
the Registration Card that accompanies each Pump must be completed
and promptly returned to MiniMed.
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78
Pump Implantation
Supplies and solutions
Before preparing the Pump, be sure to read Appendix D, Precautions and
General Procedures. Assemble the necessary materials prior to starting
the procedure:
Supplies
•
One (1) 100 µL sterile pipette (available non sterile from
MiniMed) MMT-4104
•
One (1) sterile scalpel blade
•
One (1) scale (0.01g resolution)
•
One (1) sterile beaker (or sterile barrier towel) for weighing
•
One (1) sterile bag for PPC
•
One (1) Pump System: PPC, Pump and Side Port Catheter
•
Sterile markers and Steri-Strips®
•
Three (3) refill Kits - MMT-4105:
•
•
•
1 kit to remove shipping fluid from Pump
1 kit to fill the Pump with U-400 INSULIN (to rinse the
pump)
• 1 kit to fill the Pump with U-400 INSULIN (final insulin
fill)
One (1) 3 mL syringe (fluid barrier)
•
Three (3) MiniMed refill needles, MMT-4102
•
Three (3) 18 gauge needles
•
One (1) Implant Worksheet
•
One (1) Back-up Pump System: PPC, Pump and Side Port Catheter
Solutions
•
One (1) bottle of sterile water, room temperature
•
One (1) vial 10 mL rinse buffer (RB)
•
Four (4) vials 10 mL Aventis HOE 21 PH U-400 INSULIN
Dmp9196021-011_c.book Page 79 Thursday, April 4, 2002 8:15 AM
Preprogramming and pre-testing the pump
Emptying and filling the Pump
To prepare the Pump for implantation, the Pump must be emptied and
then filled twice and tested with insulin. These procedures are performed
in the operating room prior to implanting the patient. As this is a surgery,
all supplies and required equipment should be prepared in accordance
with the institution’s approved sterile procedures.
WARNING
When you remove the Pump from the
sterile box, do not remove the plastic
tubing placed at the Pump outlet. Trim
the distal part with a scalpel blade. This
tubing will be used for the “Stroke
Volume Measurement” procedure.
DO NOT TRY TO REPLACE THE TUBING
BACK ON THE PUMP OUTLET, or you can displace or damage the “O” ring placed around the outlet.
A sterile field is established in the operating room to prepare the RINSE
BUFFER (RB) syringe and remove the shipping fluid from the pump.
Document the Pump, Catheter and PPC serial numbers on the Implant
Worksheet.
79
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80
Pump Implantation
Remove shipping fluid from the Pump
1. Using aseptic technique, open the Pump sterile package. Do not
remove the plastic tubing from the Pump outlet. Trim the distal part
of the tubing with the scalpel blade.
2. Remove the refill syringe from the refill kit package.
3. Firmly attach the two-way stopcock to the refill syringe and attach an
18 gauge needle to the stopcock.
4. Draw approximately 4 mL of RINSE BUFFER into the refill syringe.
5. Fill the hub of the refill needle with RINSE BUFFER and firmly
attach it to the stopcock, prime the needle and close the stopcock.
Figure 6: Filling the Hub of the Refill Needle
Dmp9196021-011_c.book Page 81 Thursday, April 4, 2002 8:15 AM
Preprogramming and pre-testing the pump
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. Fill one 3 mL syringe with RINSE BUFFER (RB) and attach a needle.
8. Fill the Pump fill port using the 3 mL syringe. Any time a refill nee-
dle is to be inserted into the Pump fill port, a fluid barrier must be
present to prevent air from entering the Pump reservoir.
9. With the stopcock still closed, insert the RB syringe into the Pump fill
port. Press down with at least one-half pound of force to open the
inlet valve. As the needle passes through the septum and seats in the
valve, you can feel approximately 0.5mm of movement as the valve is
opened.
10. Open the stopcock and allow the syringe vacuum to empty the Pump
of shipping fluid. Allow 30 seconds after the fluid level appears to
have stopped rising in the refill syringe, to assure the Pump is completely emptied. Close the stopcock and remove the syringe.
81
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82
Pump Implantation
Rinse the Pump with insulin (IN1)
11. Remove the second refill syringe from the refill kit package.
12. Firmly attach the two-way stopcock to the refill syringe and attach an
18 gauge needle to the stopcock. Use the sterile marker to label the
syringe, “IN1”.
13. Draw 20 mL of INSULIN (two vials) into the refill syringe.
14. Remove the 18 gauge needle and expel all air bubbles in the syringe.
15. Close the stopcock.
16. 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.
17. Shake vigorously for a minimum of 30 seconds to degas the
INSULIN.
18. Point the syringe tip upward and slowly open the stopcock to vent the
syringe.
19. Release the locking ring on the refill syringe.
20. Expel air in the syringe and carefully observe to ensure no air bubbles
remain in the syringe. If air bubbles are noted, repeat steps 15 - 20.
21. Fill the hub of the refill needle with INSULIN and attach it to the
stopcock.
22. Prime the needle and close the stopcock.
23. Refill the fill port with the 3 mL RINSE BUFFER syringe, as needed,
to maintain the fluid barrier.
24. Use the “IN1” syringe containing the degassed INSULIN to fill the
Pump.
Dmp9196021-011_c.book Page 83 Thursday, April 4, 2002 8:15 AM
Preprogramming and pre-testing the pump
OPTIONAL
25. Use this step only if the plunger is not moving forward while filling
the reservoir.
26. With the refill needle pointing down, vent the syringe head space by
pulling back firmly on the plunger until the second sealing ring on the
black rubber cap passes beyond the vent hole (see Figure 7).
Figure 7: Venting the Syringe Head Space
83
Dmp9196021-011_c.book Page 84 Thursday, April 4, 2002 8:15 AM
84
Pump Implantation
27. With the stopcock closed, press the refill needle into the Pump fill
port.
28. Open the stopcock. Maintain downward pressure on the barrel of the
syringe to ensure the inlet valve of the Pump remains open.
WARNING
Never push on the refill syringe plunger to
fill the Pump. When the refill needle is
properly seated in the fill port of the
Pump, the vacuum in the reservoir will
draw the insulin from the syringe.
29. Allow the Pump vacuum to draw the INSULIN into the reservoir.
When the INSULIN stops moving, the Pump is filled. Close the stopcock and remove the syringe.
30. Prepare the IN1 syringe for aspiration. Remove any air from the
syringe, prime the needle, close the stopcock and 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. A fluid barrier of at
least 2 mL should remain in the syringe.
31. Press the refill needle back into the Pump fill port with the stopcock
closed.
32. Open the stopcock and empty the Pump. Allow 30 seconds after the
INSULIN level appears to have stopped rising in the refill syringe to
assure the Pump is completely emptied.
33. Close the stopcock and remove the syringe.

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