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

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Document ID	240461
Application ID	OUjvUEX5yErHPBq+foRecA==
Document Description	Patient Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	72.39kB (904920 bits)
Date Submitted	2002-05-02 00:00:00
Date Available	2002-05-02 00:00:00
Creation Date	2002-03-27 16:10:08
Producing Software	Acrobat Distiller 4.05 for Windows
Document Lastmod	2002-03-27 16:17:53
Document Title	MiniMed 2007 Implantable Pump Patient Manual
Document Creator	FrameMaker 6.0
Document Author:	ChristieS

Medtronic
MiniMed 2007C
Implantable
Insulin Pump
System
Patient Manual
These product(s) are covered by one or more of the following U.S.
Patents:
4,373,527
4,395,259
4,525,165
4,568,250
4,569,641
4,573,994
4,619,653
4,636,150
4,731,051
4,776,842
5,167,633
5,176,644
5,197,322
5,217,442
5,257,971
5,460,618
5,466,218
5,514,103
5,527,307
5,559,828
5,797,733
5,915,929
Patents also exist in a number of foreign countries and other U.S.,
international, and foreign patent applications are pending.
D9196020-011 2/01
i
Table of Contents
CHAPTER 1
The Medtronic MiniMed 2007C Implantable Insulin
Pump System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
MiniMed help line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Description of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Implantable insulin pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Medication reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Pumping mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Microelectronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Tone transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Side port catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Personal pump communicator (PPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Special insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
CHAPTER 2
Safety Features . . . . . . . . . . . . . . . . . . . . . . . . .
11
Pump safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Safe telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
ii
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Negative pressure reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
PPC safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Programming sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Maximum dosage limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Alarms and messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
CHAPTER 3
Implanting the MiniMed 2007C Pump System . . .13
Hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Pre-operative procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Implantation procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Post-operative procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Pump refills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Insulin used with the implantable pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Pump refill procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
CHAPTER 4
Programming Your Pump . . . . . . . . . . . . . . . . .
17
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
PPC screen icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
PPC buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Main programming screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Programming a bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Set an immediate bolus (variable bolus option is“off”) . . . . . . . . . . . . . . . . . . .21
Set an immediate bolus (variable bolus option is “on”) . . . . . . . . . . . . . . . . . .22
Set a square wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
iii
Set a dual wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Review the bolus history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Suspend mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Program basal rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Set one basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Set multiple basal rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Set a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Stop a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Personal events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Preset events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Additional events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Pump setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Time and date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Basal delivery patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Initialize PPC to pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Pump setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Exit setup menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Pump setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Turn on the audio bolus feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Use audio bolus in the main menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Turn on the variable bolus feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Set a maximum bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
iv
Set a maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Set time format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Personal event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Pump setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Exit setup menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
CHAPTER 5
Alarms and Messages . . . . . . . . . . . . . . . . . . . . . 47
The pump alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
The PPC alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Alarm type 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Alarm type 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Pump alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Alarm feedback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Pump low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Depleted pump battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
System error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Pump self test fail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
PPC alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
PPC low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
PPC depleted battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
PPC needs servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Low reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
Empty reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
Communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Battery replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
v
Pump suspended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Hourly maximum exceeded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Personal Pump Communicator messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
CHAPTER 6
Warnings and Precautions . . . . . . . . . . . . . . . . . .59
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Electrotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Diagnostic ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Ultrasound therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Diagnostic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Therapeutic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Magnetic resonance imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Pump and catheter under-delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Pump electronic or alarm malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Reservoir level warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Blood glucose monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Conventional insulin supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Physician’s instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
PPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Maximum dosages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Battery change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Proper PPC positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
vi
Physical activities to avoid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Emergency plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Adverse reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Hyperglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Pump pocket infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Pump pocket seroma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
CHAPTER 7
Important Self-Care . . . . . . . . . . . . . . . . . . . . . . .69
Blood glucose monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Meal plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Daily activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Travel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
MiniMed information card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
CHAPTER 8
PPC Care and Maintenance . . . . . . . . . . . . . . . . .73
Installing/replacing the main battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Physical protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Cleaning the outer surface of your PPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
CHAPTER 9
Technical Specifications . . . . . . . . . . . . . . . . . . . .77
Medtronic MiniMed 2007C Implantable Insulin Pump System . . . . . . . . . . . . . . .77
Implantable Insulin Pump (MMT-2007C) . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Personal Pump Communicator (MMT-3132) . . . . . . . . . . . . . . . . . . . . . . . . . .79
Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
1
CHAPTER 1
The Medtronic MiniMed
2007C Implantable
Insulin Pump System
Introduction
This manual is a reference guide for both you and your support network
of family and friends. It is important that other people in your support network know how to use the Medtronic MiniMed 2007C Implantable Insulin Pump System, so they can be of assistance if the need arises.
Throughout the manual you will see note comments which provide
important information about the Medtronic MiniMed 2007C System. If
you have a question not covered in the manual, please talk with your doctor. Your doctor knows the most about your medical condition and can
give you the best answers to your questions about your diabetes treatment.
NOTE: Before you can use the Medtronic MiniMed 2007C
System, you will be trained. This training will
teach you about implantable insulin pump therapy, and how to operate the Medtronic MiniMed
2007C System. This manual can be used to help,
but not replace, your training.
2
The Medtronic MiniMed 2007C Implantable Insulin Pump System
Medtronic MiniMed help line
Medtronic MiniMed provides a 24-hour help line for assistance. Clinical
Services personnel are trained to answer questions you may have about
the Medtronic MiniMed 2007C System.
When Calling From:
Primary Number
Alternate Number
Outside the United States
1-818-576-5040
1-818-362-5958
Within the United States
1-800-826-2099
1-818-362-5958
Description of the system
The Medtronic MiniMed 2007C Implantable Insulin Pump System is an
"open-loop" system, which means you must test your blood glucose in
accordance with the method and frequency recommended by your physician. Based on the results of your blood glucose testing, you can program
the Pump with desired reates of delivery by using the Personal Pump
Communicator (PPC).
The system consists of four components:
•
Implantable Insulin Pump
•
Side Port Catheter
•
Personal Pump Communicator (PPC)
•
Special Insulin
The Medtronic MiniMed 2007C Implantable Insulin Pump System
Implantable insulin pump
The Implantable Insulin Pump (Pump) is a round disc, 8.1 cm (3.2 inches)
in diameter and 2.0 cm (0.8 inches) thick. The Pump weighs 131 grams
(4.6 ounces) when empty. The outside case of the Pump is made of titanium. Titanium is a biocompatible metal used in many types of implantable medical devices. The Pump contains an insulin fill port, located at
the center of the disc. The fill port is used for rinsing and filling the Pump
with insulin, and for diagnostic procedures.
Figure 1: The Implantable Insulin Pump
4
The Medtronic MiniMed 2007C Implantable Insulin Pump System
The Pump has six major components: the medication reservoir, the pumping mechanism, the antenna, the microelectronics, the battery, and the
tone transducer. The following figure shows the interior of the Pump
Figure 2: Interior of the Implantable Insulin Pump
Medication reservoir
The medication reservoir holds the insulin and is refilled with a special
syringe through the Pump fill port.
Pumping mechanism
The pumping mechanism takes insulin from the medication reservoir and
delivers it through a catheter into your body. The pumping mechanism
delivers the same amount of insulin every time it pumps. The amount of
insulin delivered in each “stroke” of the pump mechanism is called the
stroke volume.
The Medtronic MiniMed 2007C Implantable Insulin Pump System
Antenna
The pump antenna receives the radio signals from the PPC and delivers
the PPC’s programmed message to the microelectronics of the Pump.
Microelectronics
The microelectronics are designed to control the pumping mechanism so
that you receive the amount of insulin you have programmed the Pump to
deliver. You tell the microelectronics what to do by using your PPC. The
microelectronics also store pump specifications and programming history
information in its memory.
Battery
The battery supplies power to the pumping mechanism and microelectronics. It is a lithium carbon mono-fluoride battery specially designed for
the Implantable Insulin Pump.
Tone transducer
The tone transducer is a Pump safety feature. It emits audible beeps to
confirm your Pump is operating properly. It also alerts you when your
Pump needs attention.
6
The Medtronic MiniMed 2007C Implantable Insulin Pump System
Side port catheter
The Side Port Catheter (catheter) is a soft plastic tube, made of polyethylene-lined silicone rubber. The Catheter delivers insulin from the Pump
into your peritoneal cavity. Intraperitoneal insulin is rapidly absorbed by
your body and is used to regulate your blood sugar. Your doctor can use
the Catheter’s radio-opaque stripe to help locate it on an X-ray.
The Catheter has a subcutaneous part and an intraperitoneal part as shown
in the following figure.
Subcutaneous Part
Intraperitoneal Part
Figure 3: Side Port Catheter
The Medtronic MiniMed 2007C Implantable Insulin Pump System
Personal pump communicator (PPC)
The Personal Pump Communicator (PPC) is a hand-held device which
allows you to send commands to your Pump and receive Pump information using RF telemetry (radio waves). The PPC is 8.9 cm (3.5 inches)
long, 7.0 cm (2.8 inches) wide and 2.0 (0.8 inches) thick and weighs 115
grams (4.06 ounces). The PPC uses one AA 1.5 volt alkaline battery as
the main power source, and a lithium back-up battery which saves the
PPC memory when the main battery is depleted or being changed. The
PPC has an easy-to-read screen. Programming information is entered
using a four button keyboard. The four buttons and their functions are
described in Chapter 4. See Figure 4.
Figure 4: Personal Pump Communicator (PPC)
8
The Medtronic MiniMed 2007C Implantable Insulin Pump System
To send a command to the Pump, place the PPC near the Pump. With your
PPC you can:
•
Deliver an immediate, square wave or dual wave insulin bolus to
compensate for meals. Boluses can be programmed by reading
the screen or listening to beeps (audio bolus)
•
Deliver one or many basal rates in a daily pattern
•
Preprogram three different daily basal patterns
•
Deliver a temporary basal rate
•
Suspend the Pump
•
Record Personal Events
•
Program an Automatic Off
Your PPC also stores important information in its memory (120 days of
data). This information includes:
•
Current time and date
•
Time, date and amount of the last meal bolus
•
Current basal rate
•
Daily insulin totals (basal and bolus)
•
Clinical history
•
Insulin amount remaining in the Pump
•
Maximum bolus allowed
•
Maximum basal rate allowed
•
Insulin concentration used
NOTE: The PPC issued to you by your doctor can be used
only with your Implantable Insulin Pump. Do not
attempt to use any other PPC to program your
Pump, unless specifically instructed to do so by
your doctor.
The Medtronic MiniMed 2007C Implantable Insulin Pump System
Special insulin
The Medtronic MiniMed 2007C Implantable Insulin Pump System uses a
special insulin, purified and concentrated exclusively for implantable
pump use. The insulin is HOE 21 PH U-400, manufactured by Aventis.
Only Aventis HOE 21 PH U-400 may be used in the Medtronic MiniMed
2007C Implantable Insulin Pump System.
10
The Medtronic MiniMed 2007C Implantable Insulin Pump System
11
CHAPTER 2
Safety Features
Pump safety features
Safe telemetry
Your Pump will respond only to telemetry commands from your PPC.
Your Pump will not change when exposed to electromagnetic fields, such
as microwave ovens, garage door openers, airport security systems, and
television or video remote controls.
Alarms
The most important safety feature of your Pump is its self-checking circuitry. If your Pump is not working properly, it will signal you with an
alarm message on the PPC screen and then automatically turn itself off.
This feature ensures that your Pump will always deliver insulin in a controlled, predictable manner.
Negative pressure reservoir
The Pump reservoir has a negative pressure (vacuum) which will draw in
fluids. In the event of a Pump malfunction, this vacuum assures your insulin will stay in the reservoir. Don’t worry, there are multiple safety features to assure that your body fluids won’t enter the Pump. Only the
pumping mechanism can overcome this negative pressure and deliver
insulin to your body.
12
Safety Features
PPC safety features
Programming sequence
In order to send a command to your Pump, your PPC must be properly
positioned nearby and a series of programming steps must be followed.
Maximum dosage limits
Your doctor will program maximum dose limits into your PPC. The programmed maximum basal rate and bolus amount will protect you from an
insulin overdose, in the event of a programming mistake.
Alarms and messages
Your PPC prompts you with many easy-to-read messages on its screen.
Also, the PPC emits beeps to notify you of certain conditions, such as battery status, programming errors, and a low or empty pump reservoir.
These messages and alarms are discussed further in Chapter 5, entitled,
“Alarms and Messages.”
13
CHAPTER 3
Implanting the
MiniMed 2007C Pump
System
Hospitalization
You will be admitted to the hospital to have your Medtronic MiniMed
2007C Implantable Insulin Pump System surgically implanted and stabilized in your tissue. Your Pump System will also be programmed and
tested prior to your leaving the hospital.
Your hospitalization will consist of three types of procedures:
•
Pre-Operative Procedures
•
Implantation Procedures
•
Post-Operative Procedures
Pre-operative procedures
You will have blood drawn, be given diagnostic procedures, and possibly
other tests before your scheduled surgery date. You should ask your doctor what tests will be required before your Pump is implanted. You may
also meet with an Anesthesiologist or Surgeon prior to the surgery.
The Pump will be implanted in your abdominal area. Your doctor will discuss the exact location of implantation with you. The choice of a Pump
site may depend upon the catheter location, how your body is shaped, and
whether or not you have had any previous abdominal surgery, such as an
appendectomy.
14
Implanting the MiniMed 2007C Pump System
The Pump may be implanted using either local or general anesthesia. This
decision will be made by you, your doctor, the Surgeon, and the Anesthesiologist. If local anesthesia is chosen, you will be awake during the
implantation but the pump site will be numbed. Under general anesthesia,
you will be kept asleep during the procedure by the anesthesiologist.
Implantation procedures
The Surgeon will make an incision through your skin and create a
“pocket” in which to place the Pump. The Pump is then inserted under the
fatty tissue just beneath your skin. The Surgeon will then secure the Pump
in your tissue to prevent movement. A very small opening will be made in
your abdominal muscle wall through which the Surgeon will thread the
Side Port Catheter into your peritoneal cavity. After the Catheter is positioned and the Pump is secured, the Surgeon will use sutures to close the
incision in your skin. Bandages are used to protect the incision until it
heals. Some Surgeons may want you to wear a binder over the implant
site for a short time to minimize post-operative swelling.
Post-operative procedures
The length of your hospital stay will be determined by your doctor. Your
stay will depend upon how quickly you heal, and how quickly you learn
to use the Medtronic MiniMed 2007C Implantable Insulin Pump System.
Before your admission to the hospital, your doctor or a nurse will teach
you how to use your PPC to program the Pump. Before leaving the hospital, you must become proficient in understanding and using your PPC to
program the Pump. You should:
•
Fully understand how to use your PPC.
•
Demonstrate appropriate responses to warning messages and
alarms from your PPC.
•
Be able to identify signs and symptoms your doctor wants you to
report.
•
Have completed a Patient Emergency Information Card, which
indicates you have an implantable pump and provides emergency
phone numbers.
Implanting the MiniMed 2007C Pump System
•
Ask your doctor to complete and return your Device Registration
Card to MiniMed. This card contains the Pump and Catheter
serial numbers, which are needed for device tracking by
MiniMed.
•
Schedule an appointment with your doctor for your first followup visit.
•
Read Chapter 5, “Alarms and Messages,” and ask your doctor to
explain anything you don’t understand.
Follow-up
Before you leave the hospital, your doctor will schedule an appointment
for your first follow-up office visit. Your healthcare team will also keep in
close contact with you during the first few weeks following implantation.
Frequent adjustments in your insulin delivery are often required for several weeks following implantation.
NOTE: ALWAYS keep your PPC with you. During office
visits, a member of the healthcare team will check
the status of your Pump. Only YOUR PPC can be
used to check YOUR Pump.
Your post-implant recovery will be similar to recovery from other surgical
procedures. You will need to obtain adequate rest, eat a nutritious diet,
and avoid individuals who are suffering from infections or viruses.
Recovery times vary among individuals, but most people recover fully in
a few weeks. Your physician will ask you to call if you are not feeling
well, particularly if you have an elevated temperature or if you notice any
redness or drainage around your incision site.
15
16
Implanting the MiniMed 2007C Pump System
Pump refills
Insulin used with the implantable pump
Aventis, located in Frankfurt, Germany, is the manufacturer of the insulin
used in your Implantable Insulin Pump. This insulin, HOE 21 PH U-400,
is specifically designed for implanted pumps. No other insulin should be
put in your Pump.
Pump refill procedure
It is important that the time between your Pump refills should not exceed
90 days. Refilling your Pump is a sterile procedure. Your doctor or a nurse
will first disinfect your skin directly over the Pump. All equipment that
will touch your skin during the refill procedure is sterile to minimize the
risk of infection.
Your doctor or a nurse may now numb the disinfected skin area with a
local anesthetic. A short needle will then be inserted through your skin to
locate the fill port of the Pump. Then a longer needle will be inserted into
the Pump fill port through the inside of the shorter needle. The doctor or
nurse will then empty unused insulin from the Pump and refill it with new
Aventis, HOE 21 PH U-400 insulin.
17
CHAPTER 4
Programming Your
Pump
Introduction
You will program your Implantable Insulin Pump with your PPC. The
PPC transmits information by RF telemetry (radio waves) to your Pump.
With your PPC you can:
•
Deliver an immediate, square wave or dual wave insulin bolus to
compensate for meals. Boluses can be programmed by reading
the screen or listening to beeps (audio bolus)
•
Deliver one or many basal rates in a daily pattern
•
Preprogram three different daily basal rate patterns
•
Deliver a temporary basal rate
•
Suspend the Pump
•
Program an Automatic Off
•
Adjust the tone frequency of the PPC and the audible alarms of
the Pump.
NOTE: Your PPC has been designed for easy use (See
chapter 5 for a list of the PPC commands). You
must follow a specific sequence of steps and hold
the PPC near the Pump to deliver a command.
Therefore, you cannot unintentionally program
your Pump.
18
Programming Your Pump
Your PPC has been specifically pre-programmed for use with your Pump.
Do not use another PPC to program your Pump. You must keep your PPC
with you at all times because it is the only way to program your Pump.
Remember, you must measure your blood sugar at least four times each
day, according to the method recommended by your doctor. You must
then use the results of your blood sugar tests to determine the appropriate
dose of insulin to be delivered by your Pump.
PPC screen icons
Your PPC has an easy-to-read dot matrix liquid crystal display (LCD).
The main PPC screen displays the time (12hr. or 24hr. format), month,
day, and a variety of icons. The type and purpose of these icons are as follows:
Icon
Description
The bell icon is displayed when the PPC receives a RF telemetry message
from the Pump. The icon may indicate the Pump or PPC has detected a failure, or the Pump is in a “SUSPEND” mode or “STOPPED.”
The reservoir icon is composed of 4 segments that indicate how full the
Pump reservoir is, based on the history of the Pump delivery.
The PPC shows a “spinning” icon while insulin delivery is in progress.
When the Pump delivers a bolus amount, the pattern will show three delivery segments. When the Pump delivers a basal rate, the pattern will show
one delivery segment. When the Pump is not delivering, all four segments
will be displayed.
Programming Your Pump
PPC buttons
PPC programming information is entered using four buttons:
Buttons
Description
SEL
Means SELECT. The SEL button allows you to step through and view
each of the option screens.
ACT
Means ACTIVATE. The ACT button activates programming changes
you wish to make. As a safety check, you must press ACT to complete
any programming changes. You will always hear a single beep after you
have successfully activated a change.
▲
UP
ARROW
Allows you to make changes to the screen settings by scrolling to higher
values. You must then press the ACT button for a change to be activated.
This button has a Sound Icon. When the “AUDIO BOLUS” feature is
turned on, the ▲ button allows you to program an Audio Bolus.
▼
DOWN
ARROW
Allows you to make changes to the screen settings by scrolling to lower
values. You must then press the ACT button for a change to be activated.
This button has a Light Icon which turns on the backlight. With the display illuminated, you can program your Pump in dark areas. The backlight remains on for 4 seconds after each ▼ press.
Communicating PPC
1. When commands are programmed the
PPC will talk to the Pump. When this
occurs the following screen will displayed.
2. The word COMMUNICATING will blink
to indicate a communication is taking place.
PPC
COMMUNICATING
19
20
Programming Your Pump
Main programming screen
The Main programming screen is used to program features you will use
every day, such as a Meal Bolus or Basal Rate, or putting your Pump in
the Suspend mode.
Programming a bolus
Using the PPC, you can program the Pump to deliver a bolus of insulin
whenever you need it. The Pump System has several special features
which allow you to customize the programming and delivery of a bolus:
•
Immediate Bolus (programmed by reading the PPC screen or listening to beeps, using the Audio Bolus).
•
Square Wave Bolus
•
Dual Wave Bolus
NOTE: To program a Square Wave or Dual Wave Bolus,
you must turn on the Variable Bolus programming
option (program “ON” in the “SETUP II” menu).
Otherwise, only an Immediate Bolus can be given.
The Variable Bolus option is programmed by your
doctor.
Programming Your Pump
Set an immediate bolus (variable bolus option is“off”)
1. From the Time/Date screen, press SEL
until the “BOLUS” screen is displayed.
The Time and Date will be flashing, and
the last bolus is displayed.
08:23
Jan 02
BOLUS
IMM
EXT
10
--
PROG
--
2. Press ACT and “SET BOLUS” appears,
and the dashes or previous bolus under
“IMM” start flashing.
SET BOLUS
IMM
--
3. Use the ▲ and ▼ buttons to enter an
immediate bolus amount.
4. Press ACT and the screen shows “CON-
FIRM IMM.” If the number you entered
CONFIRM
IMM
for the immediate bolus is correct, press
2.6U
ACT to confirm it. This value will now
be programmed into the Pump. If the
number was not correct, wait for the
screen to return to Time/Date and then repeat this procedure to enter
the correct value.
5. Place the PPC near the Pump to complete
the programming. The PPC will beep
once and display 0.0 units.
6. If the Alarm Feedback feature is “ON,”
PPC
COMMUNICATING
08:23
JAN 04
the Pump will beep during each of the
first five strokes. The PPC will beep
0.0 U
BOLUS
when the bolus delivery is complete.
Three segments of the insulin delivery
icon will be displayed and will spin
slowly during the bolus delivery. By pressing SEL you can see the
amount of insulin being delivered.
21
22
Programming Your Pump
Set an immediate bolus (variable bolus option is “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.
08:23
Jan 04
BOLUS
IMM
--
EXT
--
--
2. Press ACT and “SET BOLUS TYPE”
appears. Use the ▲ and ▼ buttons to
choose “NORMAL.”
SET
BOLUS TYPE
NORMAL
3. Press ACT and “IMM” appears with the
dashes underneath flashing.
4. Use the ▲ and ▼ buttons to enter an
SET BOLUS
IMM
--
immediate bolus amount
5. Press ACT and the screen shows “CON-
FIRM IMM.”
6. If the number was not correct, wait for the
CONFIRM
IMM
2.6U
screen to return to Time/Date and then
repeat this procedure to enter the correct
value.
7. If the number you entered for the immedi-
ate bolus is correct, press ACT to confirm it. Place the PPC near the Pump to
complete the programming.
8. The PPC will beep once and display the
amount of insulin delivered. If the Alarm
Feedback feature is “ON,” the Pump will
beep during each of the first five strokes.
PPC
COMMUNICATING
08:23
BOLUS
JAN 04
0.0 U
9. The PPC will beep when the bolus deliv-
ery is complete. Three segments of the insulin delivery icon will be
displayed and spinning slowly during the bolus delivery. By pressing
SEL you can see the amount of insulin being delivered.
Programming Your Pump
Set a square wave bolus
A Square Wave Bolus is delivered evenly over a time period you set, from
30 minutes to 4 hours. A Square Wave Bolus is useful during long meals,
high fat meals, or if you have gastroparesis. During a Square Wave Bolus,
your Basal Rate insulin continues to be delivered.
To access Square Wave Bolus you must first turn the Variable Bolus feature "ON" in the SET UP II menu.
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.
08:23
Jan 04
BOLUS
IMM
10
EXT
--
PROG
--
2. Press ACT and “SET BOLUS TYPE”
appears.
3. Use the ▲ and ▼ buttons to choose
“SQUARE”.
SET
BOLUS TYPE
SQUARE
4. Press ACT and the dashes underneath
“EXT” will appear flashing.
SET BOLUS
IMM
EXT
--
--
5. Use the ▲ and ▼ buttons enter an
extended bolus amount.
SET BOLUS
IMM
EXT
--
4.0U
6. Press ACT and dashes will appear under
the bolus amount you just entered.
SET BOLUS
IMM
--
EXT
4.0
--
23
24
Programming Your Pump
7. Use the ▲ and ▼ buttons to enter a time
duration that you would like the Square
Wave Bolus to last.
SET BOLUS
IMM
EXT
--
4.0
02:00
8. Press ACT and the screen shows
“CONFIRM EXT” asking you to confirm
the extended bolus and time duration.
CONFIRM
IMM
--
EXT
4.0
02:00
9. If the numbers you entered are correct,
press ACT to confirm them. These values
will now be programmed into the Pump. If either number is not correct, wait for the screen to return to Time/Date and then repeat this
procedure to enter the correct values.
10. Place the PPC near the Pump to complete
the programming.
11. The PPC will beep once and display the
amount of insulin being delivered. If the
Alarm Feedback feature is “ON,” the
Pump will beep during each of the first
five strokes.
PPC
COMMUNICATING
08:23
BOLUS
JAN 04
0.0 U
12. The PPC will beep when the bolus delivery is complete. Three seg-
ments of the insulin delivery icon will be displayed and will spin
slowly during the bolus delivery. By pressing SEL you can see the
amount of insulin being delivered.
Programming Your Pump
Set a dual wave bolus
Variable Bolus Option Must be “ON.”
The Dual Wave Bolus allows you to deliver an Immediate Bolus immediately followed by a Square Wave Bolus.
1. From the Time/Date screen press SEL
until the “BOLUS” screen is displayed.
The last bolus value programmed will be
shown and the Time and Date will be
flashing.
08:23
Jan 04
BOLUS
IMM
EXT
--
PROG
--
--
2. Press ACT and “SET BOLUS TYPE”
appears.
3. Use the ▲ and ▼ buttons to choose
SET
BOLUS TYPE
DUAL
“DUAL”.
4. Press ACT and “IMM” appears with the dashes underneath flashing.
5. Use the ▲ and ▼ buttons enter an imme-
diate bolus amount
6. Press ACT and the dashes underneath
SET BOLUS
IMM
2.0U
“EXT” will appear flashing.
7. Use the ▲ and ▼ buttons enter an
extended bolus amount.
SET BOLUS
IMM
EXT
2.0U
2.0U
8. Press ACT and dashes will appear under
the extended bolus amount you just
entered.
SET BOLUS
IMM
2.0
EXT
2.0U
--
25
26
Programming Your Pump
9. Use the ▲ and ▼ buttons to enter a time
duration that you would like the extended
bolus to last.
SET BOLUS
IMM
2.0 U
EXT
2.0
02:00
10. Press ACT and the screen shows
“CONFIRM” asking you to confirm the
immediate bolus, extended bolus, and
time duration.
CONFIRM
IMM
2.0
EXT
2.0
02:00
11. If the numbers you entered are correct,
press ACT to confirm them. These values
will now be programmed into the Pump.
If any number is not correct, wait for the
screen to return to Time/Date and then
repeat this procedure to enter the correct
values.
12. Place the PPC near the Pump to complete
the programming. The PPC will beep
once and display the amount of insulin
being delivered.
PPC
COMMUNICATING
08:23
BOLUS
JAN 04
0.0 U
13. If the Alarm Feedback feature is “ON,”
the Pump will beep during each of the first five strokes.
14. The PPC will beep when the bolus delivery is complete. Three seg-
ments of the insulin delivery icon will be displayed and spinning
slowly during the bolus delivery. By pressing SEL you can see the
amount of insulin being delivered.
Programming Your Pump
Review the bolus history
You can review the bolus type, bolus amount, time and day of your last
512 insulin boluses.
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.
08:23
BOLUS
IMM
5.6U
PROG
Jan 04
EXT
--
--
2. Press the ▼ button once to display the
previous bolus and the time and date it was delivered. Each additional
▼ press will display the next previous bolus delivery.
Suspend mode
Suspend Mode allows you to cancel bolus programming. In suspend
mode the pump will still deliver a basal rate of approximately 0.2u/hr.
1. From the Time/Date screen press SEL
until the “SUSPEND PUMP” screen is
shown.
SUSPEND PUMP
2. Press ACT.
3. Place the PPC near the Pump to complete
the programming. When communication
is finished the Pump will beep 3 times.
4. All four segments of the insulin delivery
icon will be displayed.
5. To restart the Pump, press SEL and ACT.
PPC
COMMUNICATING
08:13
OCT 02
PUMP SUSPENDED
27
28
Programming Your Pump
Program basal rates
Your Basal Rate provides you with approximately 50 percent of your
daily insulin needs. A Basal Rate is normally delivered all the time,
throughout the day and night. Your PPC can tailor your Basal Rates to
meet your changing insulin needs throughout the day. If you want to, the
PPC can deliver a different Basal Rate every 30 minutes throughout the
day. For some people, one Basal Rate will work fine. Other people find
that multiple Basal Rates will help them respond better to their insulin
needs. You should discuss with your doctor the number and amount of
Basal Rates that are best for you.
Set one basal rate
1. From the Time/Date screen press SEL
until the “BASAL RATE” screen is displayed. Basal Delivery Pattern “A” and
the current Basal Rate appear. The word
“NOW” also appears and is flashing.
BASAL RATE : A NOW
0.2U/H
00:00
2. Press ACT and “1” appears to the right of
“A” indicating that you will now program
first Basal Rate “1” in Basal Delivery
Pattern “A.” The Basal Rate is flashing.
SET RATE
BASAL RATE : A
0.2U/H
00:00
3. Use the ▲ and ▼ buttons to enter a new
Basal Rate.
4. Press ACT and the screen displays “SET
SET RATE
BASAL RATE: A
00:30
TIME,” indicating you will now program
a start time for Basal Rate “2” The time is
flashing.
5. Use the ▲ and ▼ buttons to change time to dashes.
6. To enter one Basal Rate, press ACT 2 times.
--
U/H
Programming Your Pump
NOTE: In 24 hr. display mode, “00:00” indicates a start
time of MIDNIGHT. In 12hr. display mode, the
screen will read “12:00am.”
7. Place the PPC near the Pump to complete
the programming. The screen will display
PPC communicating.
PPC
COMMUNICATING
8. The screen will calculate and briefly dis-
play the total daily Basal insulin from the
Basal Rates you have programmed.
24 HOUR TOTAL
4.8U
Set multiple basal rates
1. From the Time/Date screen press SEL
until the “BASAL RATE” screen is displayed. Basal Delivery Pattern “A” and
the current Basal Rate appear. The word
“NOW” also appears and is flashing.
BASAL RATE : A NOW
0.2U/H
00:00
2. Press ACT and “1” appears to the right of
“A” indicating you will now program
Basal Rate “1” in Basal Delivery Pattern
“A.” The Basal Rate is flashing.
SET RATE
BASAL RATE : A
0.2U/H
00:00
3. Use the ▲ and ▼ buttons to enter a new
Basal Rate.
4. Press ACT and the screen displays “SET
TIME”, indicating you will now program
a start time for Basal Rate “2” The time is
flashing.
5. Use the ▲ and ▼ buttons to enter a new
start time.
SET RATE
BASAL RATE : A
04:30
--
U/H
29
30
Programming Your Pump
NOTE: In 24 hr. display mode, “00:00” indicates a start
time of MIDNIGHT. In 12hr. display mode, the
screen will read “12:00am.”
6. Press ACT and “SET RATE” and “2”
appears, indicating you will now program
Basal Rate “2” in Basal Delivery Pattern
“A.” The Basal Rate is flashing.
SET RATE
BASAL RATE : A
--
05:00
U/H
7. Use the ▲ and ▼ buttons to enter a Basal
Rate and start time for Basal Rate #2.
8. Continue this procedure until all desired
Basal Rates and start times are programmed. Then press ▼ and ACT.
PPC
COMMUNICATING
9. Place the PPC near the Pump to complete
the programming.
10. The screen will calculate and briefly dis-
play the total daily Basal insulin from the
Basal Rates you have programmed.
24 HOUR TOTAL
4.8U
NOTE: To set multiple basal profiles in the other patterns
(A, B, C), select the pattern in Setup II menu and
follow the above procedure.
Set a temporary basal rate
A Temporary Basal Rate is often used when a brief change in basal delivery is required, for example during exercise.
1. From the Time/Date screen press SEL
until the “TEMP BASAL” screen is displayed.
TEMP BASAL
--
--
U/H
Programming Your Pump
2. Press ACT and “SET DURATION”
appears with the start time flashing.
3. Use the ▲ and ▼ buttons to enter a Tem-
SET DURATION
TEMP BASAL
00:30
--
U/H
porary Basal Rate.
4. Press ACT and “SET AMOUNT”
appears with the Temporary Basal Rate
flashing.
SET AMOUNT
TEMP BASAL
00:30
1.5U/H
5. Use the ▲ and ▼ buttons to enter a new
start time for the Temporary Basal Rate,
then press ACT again.
PPC
COMMUNICATING
6. Place the PPC near the Pump to complete
the programming.
NOTE: When your Pump is delivering a Temporary Basal
Rate, pressing SEL will display “TEMP BASAL.”
This will remind you that the Temporary Basal
Rate feature is currently active.
Stop a temporary basal rate
1. From for the Time/Date screen press SEL
until the “TEMP BASAL” screen is displayed.
SET AMOUNT
TEMP BASAL
--
2. Press ACT and “SET DURATION” will
appear with the time flashing.
3. Press the ▼ button until the time is set to
dashes, then press ACT.
4. Place the PPC near the Pump to complete
the programming.
PPC
COMMUNICATING
1.5U/H
31
32
Programming Your Pump
5. When the communication is finished,
“SET AMOUNT” will appear with the
dashes flashing. Allow the PPC to return
to the Time/Date screen or press ACT.
The Temporary Basal Rate is now canceled.
SET AMOUNT
TEMP BASAL
--
--
U/H
Personal events
This feature appears in the Main menu if it has been activated to "ON" in
the Pump Setup II menu. The Personal Event menu allows you to enter
important “events” during the day.
Preset events
You can enter the following preset codes for these popular events:
•
1 = meal
•
2 = snack
•
3 = sick
•
4 = exercise.
Additional events
Codes A, B and C can be used to record other events. Be sure to document
the events listed for A, B, and C.
NOTE: Events that happened in the past or present can be
entered.
1. From the Time/Date screen, press SEL
until the “SET PERSONAL EVENTS”
screen is displayed.
2. Press ACT and the screen will change to
“SET EVENT” with “MEAL” flashing.
EVENT
__
Programming Your Pump
3. Use the ▲ and ▼ buttons to select the
event you want to enter: MEAL,
SNACK, SICK, EXERCISE, A, B, C.
SET
EVENT
MEAL
4. Press ACT and the time will appear flash-
ing.
5. Use the ▲ and ▼ buttons to enter the time
that the event occurred.
08:32
Am
SET TIME
EVENT
MEAL
6. Press ACT to enter the event in the PPC
memory.
History
The History menu allows you to look at important Pump data, such as the
amount of insulin remaining in the Pump reservoir or total insulin delivery since the last refill. The History menu contains the following options:
Med Remaing, Insulin Total Basal Bolus, Clinical Hist PPC, Clinical History Pump, Est Pump Battery. To read Pump Data perform the following
steps.
1. From the Time/Date screen, press SEL
until the “HISTORY” screen is displayed.
READ PUMP DATA
............................................
..................................10057
2. Press ACT and the screen with change to
“READ PUMP DATA” with the entire
screen flashing.
3. Press ACT, and then place the PPC near
the Pump. History data in the Pump will
be transferred to the PPC.
PPC
COMMUNICATING
33
34
Programming Your Pump
4. The screen will automatically change to
“MED REMAINING.” The amount of
insulin in the Pump reservoir is reported
in units.
MED REMAINING
7263
5. Press SEL and the screen will change to
“INSULIN TOTAL.” The amount of
Basal Rate and Bolus insulin delivered is
reported for the day indicated.
6. Press the ▼ button to review insulin
delivery rates for other days.
7. Press SEL and the “CLINICAL HIS-
INSULIN
BASAL
TOTAL
BOLUS
6:26
Jan 02
22
Jan 02
CLINICAL HISTORY
PPC
11
TORY PPC” screen is shown. Ask your
doctor what the numbers mean.
8. Press the ▼ button to review other days.
9. Press SEL to find the “CLINICAL HIS-
TORY PUMP” screen. Ask your doctor
what the numbers mean. Press the ▼ button to review other days.
6:26
14
10. Press SEL and the screen will change to
the “EST PUMP BATT” display. This
screen indicates the energy left in the
Pump battery. Ask your Physician what
the numbers mean.
Jan 02
EST PUMP BATTERY
NO LD
LD
2.9 V
11. Press SEL and the screen will read
“EXIT HISTORY.” Press ACT to return
to the Time/Date screen.
Jan 02
CLINICAL HISTORY
PUMP
EXIT HISTORY
2.7V
Programming Your Pump
Pump setup
This screen permits access to other Pump “SETUP” features. These features are normally programmed for you by your doctor or nurse. To reach
the “SETUP PUMP” menu, press SEL until the “SETUP PUMP” screen
is displayed, then ACT to access the SETUP screens.
Time and date
The time and date settings must be correct. The PPC uses the time and
date to calculate your total daily insulin and display Pump history.
1. From the Time/Date display, press SEL
until the “SETUP PUMP” screen is displayed.
08:32
SET
TIME-DATE
Jan 02
2000
2. Press ACT two times. The hour digits
will begin flashing. Use the ▲ and ▼ buttons to select the current hour.
3. Press ACT again, and the minute digits will begin flashing. Use the ▲
and ▼ buttons to select the current minute.
4. Repeat this programming process again to select the current year,
month and day.
5. At the conclusion of programming press
ACT, and then place the PPC near the
Pump. When the communication process
is complete, the PPC will automatically
move to the next screen, “AUTO OFF.”
PPC
COMMUNICATING
35
36
Programming Your Pump
Auto off
“AUTO OFF” sets an alarm on your PPC, to remind you if you have not
programmed your Pump recently. The “AUTO OFF” alarm can be set
between 1 and 16 hours. To turn off "Auto Off" program set the time to
dashes.
1. From the “SETUP PUMP” screen, press
ACT then SEL.
AUTO OFF
2. The screen will display “AUTO OFF”
--
HRS
with flashing dashes. Press ACT.
3. Use the ▲ and ▼ buttons to select the
number of hours before an Auto Off
alarm occurs.
SET
AUTO OFF
10
4. Press ACT. In this example, a time dura-
HRS
tion of 10 hours was selected. The PPC
will alarm if you did not program your Pump during the past 10
hours.
5. Place the PPC near the Pump. The PPC
will beep once when the communication
is completed.
PPC
COMMUNICATING
Programming Your Pump
Alarms
There are three PPC Alarm options, two audible tones (Low/High) and a
vibrate mode.
“ALARMS” will alert you if either the PPC or Pump recognizes a problem. Your doctor or nurse will make sure the “ALARM FEEDBACK”
screen is in the “ON” position.
Vibrate only for alarms, all programming feedback from PPC is done with
beeps.
NOTE: If you want the PPC to vibrate instead of beep, the
PPC battery will only last 6 weeks instead of 8
weeks, under conditions of normal use.
1. Press ACT to enter the “ALARMS”
menu.
ALARMS
2. Press the ▲ and ▼ buttons to select the
type of alarm you want, then press ACT.
SET
PPC
ALARM TYPE
LOW/HIGH/VIBRATE
3. The screen will now display “SET PPC
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
will change to “SELF TEST” and then
timeout to the Time / Day screen.
PPC
COMMUNICATING
37
38
Programming Your Pump
Self Test
Your doctor may ask you to run a diagnostic test of your Pump System.
“SELF TEST” will send messages between your PPC and Pump to check
their operation.
NOTE: Notify your doctor if any of these Self Test events
do not occur.
If the PPC displays a MiniMed logo and software
number, the PPC has re-started but has a low battery. Replace the battery immediately.
1. From the “SETUP PUMP” screen, press
SEL until the “SELF TEST” screen is
displayed.
SELF TEST
2. Press ACT.
3. Place the PPC near the Pump and com-
plete the communication process.
4. Verify the following events occur:
PPC
COMMUNICATING
The Pump will beep four times.
The PPC backlight will turn on.
The PPC will sound a long changing tone.
The PPC will vibrate.
The PPC will beep once.
The PPC screen display all possible icons and numbers.
Programming Your Pump
5. If your PPC and Pump “pass” the Self
Test, the display will change to “PPC
PASSED/PUMP PASSED.” After several
seconds, the screen will change back to
the Time/Date screen.
PPC
PASSED
PUMP
PASSED
Basal delivery patterns
The PPC allows you to program three different basal delivery patterns (A,
B, C). Pattern A is preset at the factory. Patterns B and C can be programmed from the “SETUP PUMP” menus. Each basal rate pattern can
accept up to 48 different basal rates, one for each half-hour of the day.
These are programmed from the "Basal Rate" screen in the Main Programming menu.
Basal patterns can be used to follow your normal daily routines. For
example, separate patterns could be programmed for a typical work day,
weekend day, and travel day.
1. From the “SETUP PUMP” screen, press
SEL until the “DELIVERY PATTERN
A” screen is displayed. Press ACT.
DELIVERY
PATTERN
2. Press SEL again until the “DELIVERY
PATTERN” screen appears. Press ACT
and the screen will change to “SET
DELIVERY PATTERN”.
SET
DELIVERY
PATTERN
A,B,C
3. Press the ▲ and ▼ buttons to select pat-
tern A, B or C.
4. Press ACT. Place the PPC near the Pump
PPC
COMMUNICATING
and allow the communication to complete.
NOTE: The PPC will automatically return to the Time/
Date screen. Press SEL until the “BASAL RATE”
screen is displayed. The pattern you have selected
will appear on this screen.
39
40
Programming Your Pump
Initialize PPC to pump
This screen initializes your PPC to your Pump. Your doctor will normally
perform this programming for you. Contact your doctor, if you need to
have your PPC replaced.
Pump setup II
“SETUP II” is another programming menu. “SETUP II” features are used
less often than the features in “SETUP.” “SETUP II” features are
explained in the next section.
Exit setup menu
From the “SETUP” screen, press SEL until the “EXIT SETUP MENU”
screen is displayed. Press ACT. The PPC will return to the Time/Date
screen.
Programming Your Pump
Pump setup II
The “SETUP II” screen allows you to program additional features into
your PPC. Your doctor will normally program “SETUP II” features for
you.
1. From the “SETUP” screen, press SEL until the “SETUP II” screen is
displayed.
Turn on the audio bolus feature
The “AUDIO BOLUS” feature allows you to deliver a bolus without
looking at the PPC screen. There are two Audio Bolus amounts you can
deliver, 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).
1. From the “SETUP II” screen, press ACT.
The “AUDIO BOLUS” screen appears.
AUDIO BOLUS
2. Press ACT, and the screen changes to
“SET AUDIO BOLUS” with “ON” flashing.
0.4U
ON
3. Use the ▲ and ▼ buttons to choose “ON”
to turn on the Audio Bolus feature.
Choose “OFF” to turn the Audio Bolus
off. Press ACT again.
SET
AUDIO BOLUS
0.4U
ON
NOTE: If “OFF” is chosen, pressing the ▲ and ▼ buttons
will have no effect.
4. If “ON” was chosen, the “SET STEP
AUDIO BOLUS” screen appears, with a
bolus amount of 0.4U flashing.
SET STEP
AUDIO BOLUS
0.4U
ON
41
42
Programming Your Pump
5. Use the ▲ and ▼ buttons to choose a bolus amount of either 0.4U or
0.8U.
6. Press ACT. “AUDIO BOLUS” will now appear on the PPC Main
Menu.
Use audio bolus in the main menu
NOTE: When an audio bolus is being delivered, the ▲
button will not work.
From the Time/Date screen press ▲ button. The PPC will beep one or two
times, depending upon the bolus amount set (0.4U or 0.8U).
1. Count the number of beeps to determine
how much insulin you want to program.
SET BOLUS
IMM
1.2U
2. Press ACT, and the beeps repeat to con-
firm the bolus amount you have entered.
3. Press ACT twice, and the PPC will pro-
PPC
COMMUNICATING
gram the Pump. The PPC will beep once
when the communication is completed.
Turn on the variable bolus feature
If “OFF” is chosen, the Variable Bolus feature will not be available.
1. From the “SETUP II” menu, press SEL
until the “VARIABLE BOLUS” screen is
displayed.
VARIABLE
BOLUS
ON/OFF
Programming Your Pump
2. Press ACT and the screen changes to
“SET VARIABLE BOLUS.” The word
“ON” is flashing.
SET
VARIABLE
BOLUS
ON
3. Use the ▲ and ▼ buttons to select “ON”
or “OFF.”
4. Place the PPC near the Pump and com-
plete the communication. If “ON” was
chosen, the Variable Bolus option will
appear in the Main Menu / Bolus screen.
PPC
COMMUNICATING
Set a maximum bolus
Your doctor will decide if you should use this feature. Setting a maximum
bolus amount will protect you from over-delivering insulin in case you
make a programming mistake.
1. From the “SETUP II” menu, press SEL
until the “MAX BOLUS” screen is displayed.
MAX BOLUS
--
2. Press ACT and the screen will change to
“SET MAX BOLUS,” with the dashes
flashing.
SET
MAX BOLUS
--
3. Use the ▲ and ▼ buttons to enter a maxi-
mum bolus amount (0.0U to 25.0U), then
press ACT.
PPC
COMMUNICATING
4. Place the PPC near the Pump and com-
plete the communication. The PPC screen
will automatically change to the “MAX BASAL RATE” screen and
then times out to the Time/Date screen if no further action is taken.
43
44
Programming Your Pump
Set a maximum basal rate
Your doctor will decide if you should use this feature. Setting a maximum
basal rate will protect you from over-delivering insulin in case you make
a programming mistake.
5. After setting a maximum bolus, the “MAX BASAL” screen appears
with the maximum basal rate flashing.
6. Use the ▲ and ▼ buttons to enter a maxi-
mum basal rate (0.2U/h to 35.0U/h), then
press ACT.
SET
MAX BASAL RATE
0.2U/H
7. Place the PPC near the pump and com-
plete the communication. The PPC screen
will automatically change to the “TIME
FORMAT” screen.
PPC
COMMUNICATING
Set time format
1. From the “SETUP II” screen, press SEL
until the “SET TIME FORMAT” screen
is displayed.
2. Use the ▲ and ▼ buttons to select either
SET
TIME FORMAT
12/24 HOUR
a 12 hour (12:00am) or 24 hour (00.00)
time format, then press ACT.
3. Place the PPC near the pump and com-
plete the communication. The PPC screen
will change to the “PERSONAL
EVENTS” screen.
PPC
COMMUNICATING
Programming Your Pump
Personal event
To activate this feature located in the Main Menu it must be "ON."
1. From the "SET UP II" screen, press SEL
until the "PERSONAL EVENTS" screen
is displayed.
PERSONAL
EVENT
OFF
2. Press ACT and the SET PERSONAL
EVENTS screen is displayed and "OFF" is
blinking.
SET
PERSONAL
EVENT
OFF
3. Use the ▲ and ▼ buttons to select ON or
OFF. Press ACT.
4. Place the PPC near the Pump and complete
the communications. The PPC screen will
change to "PUMP SET UP."
PPC
COMMUNICATING
Pump setup
This screen allows you to return to the Setup mode by pressing ACT. If
you press SEL the screen will change to “EXIT SET UP MENU.”
Exit setup menu
This screen allows you to return to the Main Menu, Time/Date screen by
pressing ACT.
45
46
Programming Your Pump
47
CHAPTER 5
Alarms and
Messages
The Medtronic MiniMed 2007C Implantable Insulin Pump System is
equipped with various alarms and messages that ensure the correct function of the system.
The pump alarms
The Implantable Insulin Pump has an alarm system which beeps when an
error condition occurs. The beeps are audible through the skin and alert
you that the Pump needs attention. The Pump will alarm consists of 4
tones each minute for 10 minutes then, 4 double tones each minute for 10
minutes and repeat pattern. Upon hearing the alarm, you need to communicate with your PPC to determine the alarm condition and call your Physician. Use the Read Pump Data option to communicate to the pump. The
alarm can be cleared by pressing SEL and ACT.
48
Alarms and Messages
The PPC alarms
The PPC has three types of alarms, audible or vibrate alarms and visual
alarms. This chapter will describe, for each alarm condition, which screen
message appears.
Some alarms can be cleared by pressing SEL then ACT. The difference
between these alarms will be explained later in this chapter.
Two audible or vibrate alarm types are used:
Alarm type 1
If the PPC is set to “vibrate”, the vibrator will be turned on for 3 seconds
every minute until the condition is cleared.
If the PPC is set to “audible”, the PPC will beep 6 times every minute for
30 minutes. If the alarm is not cleared in 30 minutes, the PPC will beep 6
alternating tones. The PPC will continue to do so every minute until the
condition is cleared.
Alarm type 2
If the PPC is set to “vibrate”, the vibrator will be turned on for 3 seconds
every minute while the condition exists.
If the PPC is set to “audible”, the PPC 6 will beep 3 times every 30 minutes while the condition exists.
Alarms and Messages
Pump alarms
Alarm feedback
The Alarm Feedback function allows you to verify the Pump and the
Pump beeper is operating normally. When Alarm Feedback is programmed “YES,” the Pump will beep on each of the first five Pump
strokes:
•
Following a change in the delivery regimen, for example when
completing a meal Bolus and then changing to a Basal Rate.
•
After the Alarm Feedback function is programmed “YES.” Alarm
Feedback will stay on until programmed back to “NO.”
Pump low battery
The Implantable Insulin Pump battery is designed to last approximately
seven years during conditions of normal use (see Chapter 9, Technical
Specifications). Battery life may vary somewhat depending upon your
insulin delivery requirements. When battery energy becomes low, a voltage sensor in the Pump will trigger the Pump Low Battery Alarm. A
Pump Low Battery Alarm indicates there is approximately eight weeks of
battery energy remaining.
PPC Display
Type of
Alarm
PUMP LOW BATTERY
Pump Alarm
In 24 hours if no PPC
communication
You can clear this condition and your Pump will continue to operate normally. However, you should notify your doctor as soon as possible. Your
doctor will then schedule a Pump replacement, and may switch you back
to conventional insulin therapy.
49
50
Alarms and Messages
Depleted pump battery
When there is no longer sufficient battery energy to power the Pump, the
Pump Low Battery Alarm will cease. This means that insulin delivery has
stopped. You must switch to another type of insulin therapy.
System error
The Implantable Insulin Pump has a sophisticated self-monitoring system
that continuously checks for circuit faults. If the Pump detects a circuit
error, it will beep and then automatically shut itself off. When this
occurs, you must switch to your alternative insulin therapy established between you and your doctor. Notify your doctor immediately of
the System Error.
PPC Display
Type of Alarm
Pump Alarm
PUMP STOPPED
In 5 minutes if no PPC
communication
1 or 2 or 3 or 4 or 5 or 6
Pump self test fail
During a “SELF TEST,” the Pump finds a malfunction. The Pump will
stop delivering insulin. Clear the message by pressing SEL then ACT.
You must switch to your alternative insulin therapy established
between you and your doctor. Notify your doctor immediately of the
Self Test Error.
PPC Display
Type of Alarm
PUMP
SELF TEST FAIL
Alarms and Messages
PPC alarms
The PPC offers a choice of two alarms, audible and vibrate. In addition, a
screen message appears indicating the type of alarm condition that
occurred.
PPC low battery
NOTE: If “VIBRATE” is selected, the PPC battery should
last about six weeks. If the PPC determines that
the vibrator is causing a low battery condition, it
will automatically change the Alarm Mode to
“LOW VOLUME” in order to extend battery life.
If the PPC main battery (AA 1.5 volt alkaline) energy is low, the following alarm display will appear:
PPC Display
Type of Alarm
PPC
LOW BATTERY
You can clear this message by pressing SEL and then ACT, and then continue programming. There should be sufficient energy in the battery for at
least 24 hours. For instructions on changing the battery, refer to Chapter
8, PPC Care and Maintenance.
NOTE: If while programming the Pump, the PPC goes
blank, the PPC beeps six times and then the
"CHECK PUMP STATUS" message appears, the
PPC (AA 1.5v alkaline) battery needs to be
replaced. For instructions, see "Installing/Replacing the Main Battery" in Chapter 8.
51
52
Alarms and Messages
PPC depleted battery
When the PPC main battery (AA 1.5 volt alkaline) no longer has sufficient energy to program the Pump, the following message will appear on
the display:
PPC Display
Type of Alarm
PPC
DEPLETED BATTERY
This message can only be cleared by replacing the PPC battery. For
instructions on changing the battery, refer to Chapter 8.
PPC needs servicing
When the PPC back-up battery (lithium) energy becomes low, the following message will be displayed:
PPC Display
Type of Alarm
PPC
NEEDS SERVICING
You can clear this message by pressing SEL and ACT, and then continue
programming. You should report this alarm to your doctor as soon as possible to schedule a PPC replacement. Be aware that if the PPC loses all
power, it may lose its memory contents.
Alarms and Messages
Low reservoir
When the Pump calculates that less than 800 units (2 ml) of insulin
remains in its reservoir, the following display will appear:
PPC Display
Type of Alarm
Pump Alarm
LOW
In 24 hours if no PPC communication
RESERVOIR
You can clear this message by pressing SEL and ACT, and then continue
programming. You should notify your doctor of the Low Reservoir message, and schedule a Pump refill appointment as soon as possible.
Empty reservoir
When the Pump calculates that less that 400 units (1 ml) of insulin
remains in its reservoir, the following display will appear:
PPC Display
Type of Alarm
Pump Alarm
EMPTY
In 24 hours if no PPC
communication
RESERVOIR
You can clear this message by pressing SEL and ACT, and then continue
programming. The PPC Medication Remaining function reads calculated
values only, and there may still be some insulin left in the Pump reservoir.
You should be report this alarm to your doctor as soon as possible, and
schedule an appointment for a Pump refill. It is important not to allow the
pump to deplete its insulin supply as this may result in a catheter blockage.
53
54
Alarms and Messages
Communication error
If programming is interrupted after partial transmission of a command,
the PPC will display the following message on the display screen:
PPC Display
Type of Alarm
TELEMETRY COMM ERROR 3
You should reposition the PPC near the pump, press SEL and ACT. The
PPC will attempt to resume communication with the Pump.
Battery replacement
If the PPC main battery (AA 1.5V alkaline) has been replaced or the PPC
recognizes the “PUMP STATUS” needs to be checked, the following
message is displayed:
PPC Display
Type of Alarm
CHECK PUMP STATUS
Place the PPC near the pump, then press SEL and ACT. Allow the communications to complete.
NOTE: If while programming the Pump, the PPC goes
blank, the PPC beeps six times and then the
"CHECK PUMP STATUS" message appears, the
PPC (AA 1.5v alkaline) battery needs to be
replaced. For instructions, see "Installing/Replacing the Main Battery" in Chapter 8.
Alarms and Messages
Pump suspended
If the Pump operation has been suspended, the following message is displayed:
PPC Display
Type of Alarm
PUMP
SUSPENDED
During “SUSPEND PUMP,” the Pump will deliver a basal rate of
0.2 U/h. To restart insulin delivery programming, press SEL and ACT.
Then place the PPC near the Pump and allow the communication to complete.
55
56
Alarms and Messages
Auto off
If the “AUTO OFF” time interval elapses, the following message is displayed:
PPC Display
Type of Alarm
AUTO OFF PUMP
PUMP SUSPENDED
The Pump will initiate the internal alarm sequence of four beeps every
minute for 5 minutes, then double-beep 4 times every minute for 10 minutes, then repeating the pattern. The alarm is cleared by pressing SEL and
ACT, place the PPC near the pump. The PPC will communicate with the
Pump to reset the "Auto Off" duration.
Hourly maximum exceeded
If you attempt to deliver more than 2.5 times the pre-programmed bolus
maximum in one hour, the following message to be displayed:
PPC Display
Type of alarm
HOURLY MAX
EXCEEDED
Press SEL and ACT, place the PPC near the Pump and allow the communication to complete. You may exceed this limit by programming another
bolus within 10 minutes.
Alarms and Messages
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.
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.
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.
PPC NEEDS
SERVICING
The internal PPC backup battery is depleted. 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 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.
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
When the Pump recognizes a system malfunction, it
automatically stops and insulin delivery ceases. Notify
your physician immediately.
1 or 2 or 3 or 4or 5 or 6
57
58
Alarms and Messages
Display Screen Message
Message Meaning or Action Required
PUMP SUSPENDED
The Pump is in suspend mode
TELEMETRY COMM
ERROR 3
The PPC and Pump are not communicating. Reposition
the PPC over the Pump, then press SEL and ACT. If the
error message persists, notify your physician immediately.
59
CHAPTER 6
Warnings and
Precautions
Warnings
Electrotherapy
The Medtronic MiniMed 2007C Implantable Insulin Pump System has
been tested with electrosurgical cutting tools, electrocoagulation, and cardiac defibrillation medical equipment. Typical use of this type of device
has not affected the Pump. However, after such procedures, you should
test the Pump function (e.g., program “SELF TEST”) to determine that
the Pump and PPC are operating properly. If the system is not performing
correctly, contact your doctor.
Diagnostic ultrasound
The Medtronic MiniMed 2007C Implantable Insulin Pump System has
been tested with diagnostic ultrasound procedures. These procedures have
no effect on the Pump. However, after such procedures, you should test
the Pump function (e.g., program a “SELF TEST”) to determine that the
Pump and PPC are operating properly. If the system is not performing
correctly, contact your doctor.
60
Warnings and Precautions
Ultrasound therapy
The Medtronic MiniMed 2007C Implantable Insulin Pump System should
not be exposed to therapeutic ultrasound procedures, such as lithotripsy.
Exposure to ultrasound therapy may damage the Pump System.
Diagnostic radiation
The Medtronic MiniMed 2007C Implantable Insulin Pump System has
been tested with Computerized Tomography and X-ray. These procedures
have no effect on the Pump. However, after such procedures, you should
test the Pump function (e.g., program a “SELF TEST”) to determine that
the Pump and PPC are operating properly. If the system is not performing
correctly, contact your doctor.
Therapeutic radiation
The Medtronic MiniMed 2007C Implantable Insulin Pump System has
been tested with therapeutic radiation. These procedures have no effect on
the Pump. However, it is recommended not to focus therapeutic levels of
radiation directly over the pump. After such procedures, you should test
the Pump function (e.g., program a “SELF TEST”) to determine that the
Pump and PPC are operating properly. If the system is not performing
correctly, contact your doctor.
Magnetic resonance imaging
You cannot undergo Magnetic Resonance Imaging procedures with the
MiniMed 2007C Implantable Pump System.
Pump and catheter under-delivery
Under-delivery or “backflow” may occur when insulin deposits collect in
the pumping mechanism inside your Pump. These deposits affect the vacuum seal in the pumping mechanism, and can prevent some of the insulin
from being delivered. If the pumping mechanism is unable to seal tightly,
the pump will under-deliver its insulin.
Warnings and Precautions
If your Pump is under-delivering its insulin, you may feel symptoms of
hyperglycemia. If this occurs, you should contact your doctor immediately. Your doctor will instruct you how to manage your blood glucose
levels until the Pump can be corrected.
Another under-delivery condition is caused by body fluids or body tissue
collecting at the tip of the Catheter. To correct a Catheter obstruction,
your doctor may need to flush your Catheter with a sterile solution.
Pump electronic or alarm malfunction
If the Pump’s electronic or alarm systems malfunction, Self Test circuitry
will detect the malfunction and may stop the Pump. Notify your doctor
immediately if this occurs. If your doctor cannot correct the malfunction,
your Pump may need to be replaced and you will need to take alternative
insulin therapy.
Infection, skin erosion, unresolved backflow, or catheter occlusion may
also require that your Pump or Catheter be removed or replaced.
Reservoir level warnings
Have your Pump refilled before the reservoir is empty. Alarms in the PPC
will alert you to low and depleted reservoir levels. For more information
on alarms and messages, see Chapter 7. If the low reservoir alarm sounds
and you do not have a refill appointment scheduled within two weeks, call
your doctor immediately to schedule a refill.
Environmental conditions
NOTE: If you are in doubt about whether a condition or
situation will affect your Pump, contact your doctor for advice.
The Implantable Insulin Pump, like all microelectronic devices, should
not be exposed to extreme electrical or magnetic fields or temperature
extremes which may adversely affect the Pump and its insulin. Do not
allow your Implantable Insulin Pump to be exposed to the following environmental conditions:
61
62
Warnings and Precautions
•
Physical damage to the Pump and the Pump pocket
•
Altitudes greater than 2500 meters or 8,000 feet (skiing, hiking,
sky-diving)
•
Depths greater than 4 meters or 15 feet (scuba diving, etc.)
•
Elevated temperatures (hot tubs, saunas)
Avoid any sharp blows or pressure on the Pump. A direct blow may damage the Pump or injure the Pump pocket. Extreme pressure on the Pump
may cause the sutures and the tissue pocket to be damaged resulting in
Pump migration and a possible dislodging of the Catheter. If you suspect
that your Pump or Pump pocket have been damaged, you should contact
your doctor immediately. You may need to wear a pressure bandage or
reduce your level of physical activity until the Pump pocket heals completely.
You may not reside at or travel to an elevation in excess of 8,000 feet, or
dive below 15 feet. High altitudes and depths will change the Pump’s
insulin flow. This warning does not apply to commercial airline travel.
Airline cabins are adequately pressurized at any altitude for Pump use. It
is still possible to ski, dive or sky-dive with the proper precautions. Consult with your doctor.
Exposure to elevated temperatures in excess of 104°F (i.e. hot tubs, saunas), for longer than one hour, can effect the potency of the insulin and the
function of your Pump System (see “Pump and Catheter Under-delivery”
on the previous page). If you have any questions about an activity you are
planning, you should contact your doctor for advice.
This device may experience communication interruptions when operated
at or near some airport facilities. This will not affect the operation of the
pump, and it will continue delivery of insulin per previously programmed
levels.
Warnings and Precautions
Precautions
Blood glucose monitoring
You must check your blood sugar at least four times daily, using a technique recommended by your doctor. Notify your doctor of any increased
frequency of serious low or high excursions in your blood sugar. High
blood sugar values may indicate under-delivery of insulin. If you experience symptoms of high blood sugar, check the programmed insulin delivery settings in your PPC and contact your doctor immediately.
Conventional insulin supplies
Carry conventional insulin supplies with you at all times, including insulin and a means to inject it, in case your PPC is damaged, lost or inoperative. Periodically review with your doctor your recommended insulin
delivery procedure you should utilize in the event your MiniMed 2007
Implantable Pump System becomes inoperative.
Physician’s instructions
Follow your doctor’s instructions about your insulin delivery. The range
of insulin delivery with your PPC is a basal rate between 0.2 and 35 units
per hour (U/H), and a maximum meal bolus of 25 units (U). Your doctor
may narrow this range by programming maximum limits for your Basal
Rate and Bolus. The alarm “Hourly Maximum Exceeded” will be displayed if you try to program more than 2.5 times the maximum bolus in
one hour.
63
64
Warnings and Precautions
PPC
The PPC is an electronic device, and can be damaged if dropped. Do not
get the PPC wet or take it into very hot or humid environments, such as
steam baths or saunas. If the PPC is damaged, check the displays for
proper operation by performing a “SELF TEST”. If the “SELF TEST”
finds a problem, you will need to replace your PPC. For more information
on the “SELF TEST” procedure, see Chapter 6, Warnings and Precautions.
Maximum dosages
Your doctor may program specific limits for your Basal Rate and Meal
Bolus. These maximum limits provide a regimen specific to your needs.
Battery change
Carry a fresh AA 1.5-volt alkaline battery with you at all times. The estimated PPC main battery life is approximately 8 weeks, although this can
be influenced by how often you program your Pump. If the Low Battery
message appears, change the battery as soon as possible, preferably
immediately. If the Depleted Battery Alarm occurs, the PPC will not function and you will no longer be able to program your Pump.
Proper PPC positioning
Keep the PPC near to the Pump during a programming sequence. Separation of the PPC and Pump may result in a partial transmission of a command. If this occurs, the PPC will alarm and display “TELEMETRY
COM ERROR” on the screen.
Warnings and Precautions
Physical activities to avoid
Physical activities which are not permitted are those involving very highor low altitudes and pressure changes. Such activities include skiing,
(above 8,000 feet), sky diving, and scuba diving. When you must participate in such activities, discuss them with you physician who will provide
treatment requirements, such as the temporary use of another method of
insulin delivery, and will refill your Pump with buffer.
Emergency plan
Be fully informed and thoroughly understand what to do in an emergency.
Carry your emergency card with you at all times. Additionally, it is
important for individuals close to you, such as family, friends, and coworkers, to know what to do if you are unable to treat yourself due to illness or injury.
The following instructions should be used by your family or co-workers
to set the Pump at the lowest basal rate while your doctor is consulted:
1. Press SEL until the PPC displays “SUSPEND PUMP”.
2. Press ACT, the PPC will indicate “PPC COMMUNICATING”.
3. Position the PPC near the Pump.
4. When programming is complete, the PPC will beep and the display
will automatically return to the Time/Day screen. The message
“PUMP SUSPENDED” will be displayed. The Pump will deliver a
basal rate of approximately 0.2 U/h.
In addition to the procedure above, review with family members the
proper procedure for administering glucagon.
It is important to closely monitor blood sugar levels on refill days. During
a refill procedure, a very small amount of insulin may be deposited subcutaneously possibly resulting in hypoglycemia.
65
66
Warnings and Precautions
Adverse reactions
In clinical studies, adverse reactions associated with the Medtronic MiniMed 2007 Implantable Insulin Pump System included hypoglycemia,
diabetic ketoacidosis hyperglycemia skin erosion, infection, abnormal
healing, elevated anti-insulin antibodies, intestinal obstruction, post-operative discomfort and pain, and corrective surgery for Pump and Catheter
malfunctions. Malfunctions in the order of frequency and seriousness
include insulin aggregation resulting in Pump under-delivery, Catheter
occlusion or tissue overgrowth, early Pump battery depletion (e.g., less
than six years after implantation) and electronic Pump failure. Adverse
events associated with the use of Aventis HOE 21 PH U-400 insulin are
described in the package insert accompanying the insulin medication.
Hyperglycemia
Your Implantable Insulin Pump uses a special short-acting insulin, so
your body will not have any reserve of long-acting insulin. Interruption of
insulin delivery (due to Pump malfunction or clogging of the Catheter) or
the sudden onset of stress (emotional upset, infection, etc.) may result in a
rapid rise of blood sugar levels, and possibly the development of diabetic
ketoacidosis (DKA). Check your blood sugar levels, and your urine for
ketones, if you suspect a high glucose level. Supplemental insulin delivered by conventional means may be required. Establish a protocol with
your doctor for rapidly identifying and treating hyperglycemia to avoid
the onset of DKA.
Hypoglycemia
The best method for identifying hypoglycemia is testing your blood sugar
levels. Establish a protocol with your doctor for identifying and treating
symptoms of hypoglycemia to avoid an insulin reaction.
Warnings and Precautions
Pump pocket infection
Pump pocket infection, although rare, occur around the Pump implantation site. If you notice pain, redness, or swelling in the area of your Pump,
contact your doctor immediately. Pump pocket infections may require the
removal of your Pump.
Pump pocket seroma
A Pump pocket seroma is generally characterized by swelling around the
area of implantation. It may occur after surgery or if a blow is received to
the Pump site. If you notice swelling around your Pump, contact your
doctor immediately.
67
68
Warnings and Precautions
69
CHAPTER 7
Important Self-Care
Having a Medtronic MiniMed 2007 Implantable Insulin Pump System is
only one aspect of an overall management program to treat your diabetes.
There are many other requirements for achieving near normal blood glucose levels.
This manual presents general information regarding blood glucose monitoring, meal planning, exercise and other issues concerning your implantable Pump. You will be instructed more specifically on these self-care
issues by your doctor, nurse, and dietitian. Be sure to discuss all questions
with them as they are your best source of information.
A support person such as a family member or friend should also read this
manual and pay particular attention to the section entitled, “Develop
Emergency Plan” in Chapter 6. Your support person should also be able
to program the PPC to stop insulin delivery as described in Chapter 6.
Blood glucose monitoring
NOTE: Remember much of the success of implantable
pump therapy depends on accurate and frequent
blood glucose monitoring.
Your Pump System does not monitor your blood glucose levels. You must
continue to self-monitor your blood glucose at least four times daily, and
then use this glucose information to program your Pump System. Blood
70
Important Self-Care
glucose monitoring is the only way to determine if you are receiving the
correct amount of insulin. You should test your blood glucose according
to the method recommended by your doctor.
If you begin to have a problem with glycemic control, it is very important
to record your blood glucose measurements. A careful record may help
determine if the problem is related to your Pump or another cause.
Meal plan
You will always receive some basal insulin from your Implantable Insulin
Pump. When you program a meal bolus, this will be in addition to your
basal rate.
As with any insulin therapy, it is recommended that you keep some form
of fast-acting sugar with you at all times to treat hypoglycemia. If you
have any questions concerning your meal plan and insulin therapy, discuss them with your healthcare team as they are your best source of information.
Daily activities
There are no restrictions on your normal work, school, social, or sexual
activities unless you have a medical condition which does not allow such
activities. Because your Pump is implanted, you may bathe and shower
without any interruption in insulin therapy. However, your PPC is not
waterproof and should be protected from getting damp or wet.
Exercise
You may participate in most physical activities with your MiniMed 2007
Implantable Pump Insulin System. Rough contact sports are not recommended as Pump pocket injury may occur. Exercise may reduce your
insulin requirements, therefore, you must check your blood glucose frequently during periods of exercise. In addition, it may be necessary to
reduce your basal rate during the exercise.
Important Self-Care
Travel
You may travel with your Medtronic MiniMed 2007C Implantable Insulin
Pump System. All extended trips should be discussed with your doctor. It
is safe to travel in a pressurized aircraft, which includes all commercial
airlines. Security systems at airports will not affect your Pump, but you
may be asked to show your Patient Emergency Information Card which
explains the Pump and PPC. Remember to always carry conventional
insulin supplies with you when you travel (insulin and syringes or an
external Pump) in case of a medical emergency.
MiniMed information card
Your doctor will give you a Patient Emergency Information Card when
you receive your Pump System. It provides information about your Pump,
as well as important phone numbers in case of a medical emergency.
Carry Your Information Card With You At All Times. It is also recommended that you wear a bracelet or necklace indicating that you wear
an implantable insulin Pump.
71
72
Important Self-Care
73
CHAPTER 8
PPC Care and
Maintenance
Installing/replacing the main battery
PPC Battery life is estimated to be approximately 8 weeks. Only AA 1.5
volt alkaline or lithium batteries are recommended for use with the PPC.
To replace the PPC Main Battery:
1. Locate the battery door on the back of the PPC.
2. Slide the locking bar to the left.
3. Push the middle part of the PPC box (under the battery door) and lift
by gently pulling up the battery door to unlatch.
4. Remove the old battery, noting the polarity. The PPC screen will be
blank.
5. Position the new battery so the + and - markings on the battery match
the polarity diagram in the battery compartment.
6. Close the battery door.
7. Slide the locking bar to the right.
8. The PPC screen reappears after 30 seconds:
74
PPC Care and Maintenance
9. The PPC will beep six times and display
“PPC/PUMP.”
10. After a few seconds, the screen will
PPC
PUMP
0 209
0 211
change to “CHECK PUMP STATUS.”
11. Press SEL and ACT, then place the PPC
over the Pump.
08:26
JAN O2
CHECK
PUMP STATUS
12. Allow the communication to complete.
PPC
COMMUNICATING
PPC Care and Maintenance
NOTE: When the PPC displays “PPC LOW BATTERY,”
you can clear the message and continue programming. There should be sufficient energy in the battery to communicate with the Pump for a minimum
If while programming the Pump, the PPC goes
blank, the PPC beeps six times and then the
"CHECK PUMP STATUS" message appears, the
PPC (AA 1.5v alkaline) battery needs to be
replaced. For instructions, see "Installing/Replacing the Main Battery" in Chapter 8.
Physical protection
•
Protect the PPC from direct contact with water and moisture.
Never take the PPC into a sauna or steam bath. If the PPC comes
in contact with moisture where the battery compartment is wet,
remove the battery and dry compartment thoroughly. Replace the
battery and perform a “SELF TEST.”
•
Protect the PPC from temperatures greater than 40° C (104° F).
Do not leave the PPC in direct sunlight.
•
Protect the PPC from cold temperatures less below freezing
(0°C or 32°F).
•
Do not drop the PPC. Protect the PPC from sharp blows. Either
could damage the electrical components of the PPC and affect its
ability to program your implantable Pump.
75
76
PPC Care and Maintenance
Cleaning the outer surface of your PPC
•
If necessary, use a slightly damp cloth and mild soap to clean the
outside of the PPC. Do not use a wet cloth or dip the PPC in any
liquid. Moisture may harm the PPC’s electrical components.
•
Never use organic solvents or harsh detergents to clean the PPC.
•
Always completely dry the PPC after cleaning.
•
Never spray any cleaning solutions directly onto the PPC, especially the keyboard panel.
77
CHAPTER 9
Technical
Specifications
Medtronic MiniMed 2007C Implantable Insulin
Pump System
Implantable Insulin Pump (MMT-2007C)
Component
Performance Specification
Diameter
Thickness
Reservoir Volume
8.1 cm (2.3 inches)
2.0 cm (0.8 inches)
13 ml to 15 ml
Weight - Empty
131 gm (4.6 ounces)
Insulin - Concentration
Aventis HOE 21 PH U-400
Stroke Volume
0.42 to 0.58 µl per stroke
0.17 to 0.23 units per stroke
Basal Rate
0.2 to 35.0 units per hour (U/h)
Basal Patterns
3 Patterns of up to 48 basal rates each.
Meal Bolus
0.2 to 25.0 units
Bolus Duration
Immediate, Square Wave (30 minutes to 4 hours), or both
together. Audio Bolus
78
Technical Specifications
Component
Performance Specification
Temporary Basal Rate
0.2 to 35.0 units per hour
30 minute increment duration
30 minutes up to 24 hours delay
Diagnostic Rate
10 to 150 U/h
Power Supply
Lithium - Carbon Monofluoride Battery
Battery life
See graph below.
Audio Alarms
Low Battery
Nearly Depleted Battery
System Error
Safety Features
Negative Pressure Reservoir with Passive Filling
Pump Shutdown and Alarm with System Error (unique code
sequences)
Materials
Titanium Housing, Polyethylene-lined Silicone Rubber
Catheter
Technical Specifications
Average Pump Service Life vs. Daily
Insulin Delivery
Pump Life (Years)
(U-400 Insulin Delivered After 6 Month Shelf Life)
14
13
12
11
10
10 20 30 40 50 60 70 80 90 100 110 120 130 140
Daily Insulin Delivery (Units)
Personal Pump Communicator (MMT-3150)
Component
Performance Specification
Height
8.9 cm (3.5 inches)
Length
7.0 cm (2.8 inches)
Width
2.0 cm (0.8 inches)
Weight
115 gm (4.0 ounces)
Main Power Source
1.5 Volt Alkaline Battery Type AA
Main Battery Life
Approximately 8 weeks, depending upon usage
Backup Battery
Lithium Battery (MMT-4207)
Backup Battery Life
3 years minimum with no AA battery installed
Operating Temperature
0ºC to 40ºC (32ºF to 104ºF)
79
80
Technical Specifications
Component
Performance Specification
Storage Temperature
-0ºC to 30ºC ( 32ºF to 86ºF)
Messages
Auto Off in 5 min / Auto Off Pump Suspended
Check Pump Status
Communication Error
Download Complete
Empty Reservoir
Hourly Maximum Exceeded
Low Reservoir
PPC Not initialized
PPC Needs Servicing
PPC Low Battery
PPC Depleted Battery
Pump Self Test Fail
Pump Reset
Pump Stopped
Pump Version Error
Telemetry Communications Error
Technical Specifications
Side Port Catheter
MMT- 4027A
Length
Proximal:
11.8 ± 1.3 cm (4.7 ± 0.5 inches)
Distal:
17.8 ± 0.7 cm (7.0 ± 0.3 inches)
MMT- 4024A
Length
Proximal:
11.8 ± 1.3 cm (4.7 ± 0.5 inches)
Distal:
10.2 ± 0.4 cm (4.0 ± 0.2 inches
Material
Polyethylene-lined Silicone Rubber
Sideport
Polysulfone, Silicone Septum
This device complies with part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Operation of this device is authorized by the FCC under the FCC ID
OH22007C (Implantable Pump) and 0H23150 (PPC).
Any changes or modifications to the system not expressly approved by
MiniMed could void the user’s authority to operate the system.
81
82
Technical Specifications

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