Medtronic MMT-3160, MiniMed 2007D, MMT-2007D User Manual
Medtronic
MiniMed 2007D
Implantable
Insulin Pump
System
Patient Manual
© 2003, Medtronic MiniMed. All rights reserved.
Medtronic MiniMed™ is a trademark of Medtronic MiniMed
Dual W a ve™ is a trademark of Medtronic MiniMed
Square W ave™ is a trademark of Medtronic MiniMed
Steri-strip® is a registered mark from 3M
A v e n tis® is a registered mark from Aventis Pharmaceutical
Genapol® is a registered mark from Aventis Pharmaceutical
Luer Lok® is a registered mark from BD and Co.
This device is protected under one or more of the following U.S. Patents:
4,731,051 5,217,442 5,527,307 6,427,088
4,776,842 5,257,971 5,559,828 6,537,268
5,167,633 5,460,618 5,797,733 6,562,001
5,176,644 5,466,218 5,915,929 6,564,105
5,197,322 5,514,103 6,283,943 6,571,128
U.S., international, and foreign patent applications are pending.
6025070-011 7/0 4
0976
REF MMT-3160
Table of contents
CHAPTER 1 The Medtronic MiniMed 2007D Implantable
Insulin Pump System . . . . . . . . . . . . . . . . . . . . 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Medtronic MiniMed help line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Description of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Medication reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Pumping mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
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Antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Microelectronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Tone transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Personal Pump Communicator (PPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Special insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
CHAPTER 2 Safety features . . . . . . . . . . . . . . . . . . . . . . . . . 7
Pump safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Safe telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Negative pressure reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
PPC safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Programming sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Maximum dosage limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
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Alarms and messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
CHAPTER 3 Implanting the Medtronic MiniMed
2007D Pump System . . . . . . . . . . . . . . . . . . . . . 9
Hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Pre-operative procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Implantation procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Post-operative procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Pump refills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Insulin used with the Implantable Pump . . . . . . . . . . . . . . . . . . . . . . . . . 11
Pump refill procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
CHAPTER 4 Programming your Pump . . . . . . . . . . . . . . . . 13
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
PPC screen icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
PPC buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Communicating PPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Main programming screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Programming a bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Set an immediate bolus (Variable Bolus option is “off”) . . . . . . . . . . . . . 17
Set an immediate bolus (Variable Bolus option is “on”) . . . . . . . . . . . . . 18
Set a Square Wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Set a Dual Wave bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Review the bolus history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Suspend mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Program basal rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Set one basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Set multiple basal rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Set a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
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Stop a temporary basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Personal events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Preset events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Additional events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Pump setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Time and date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Basal delivery patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Initialize PPC to pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Pump Setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
iii
Exit Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Pump Setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Turn on the audio bolus feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Use audio bolus in the Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Turn on the Variable Bolus feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Set a maximum bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Set a maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Set time format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Personal event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Pump setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Exit Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
CHAPTER 5 Alarms and messages . . . . . . . . . . . . . . . . . . 41
The pump alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
The PPC alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Alarm type 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Alarm type 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
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Pump alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Alarm feedback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Pump low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Depleted pump battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
System error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Pump self test fail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
PPC alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
PPC low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Low reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Empty reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Battery replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Pump suspended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Hourly maximum exceeded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Personal Pump Communicator messages . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
CHAPTER 6 Warnings and precautions . . . . . . . . . . . . . . . 51
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Electrotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Diagnostic ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Ultrasound therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Diagnostic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Therapeutic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Magnetic resonance imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Pump and catheter under-delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Pump electronic or alarm malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Reservoir level warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
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Blood glucose monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Conventional insulin supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Physician’s instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
PPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Maximum dosages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Battery change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Proper PPC positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Physical activities to avoid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Emergency plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Adverse reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Hyperglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Pump pocket infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
v
Pump pocket seroma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
CHAPTER 7 Important Self-Care . . . . . . . . . . . . . . . . . . . . . 59
Blood glucose monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Meal plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Daily activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Travel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Medtronic MiniMed information card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
CHAPTER 8 PPC Care and Maintenance . . . . . . . . . . . . . . 63
Installing/replacing the main battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
CHAPTER 9 Technical specifications . . . . . . . . . . . . . . . . . 67
Implantable Insulin Pump (MMT-2007D) . . . . . . . . . . . . . . . . . . . . . . . 67
Personal Pump Communicator (MMT-3160) . . . . . . . . . . . . . . . . . . . . . 68
Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
FCC compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
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List of figures
Figure 1: The Implantable Insulin Pump ................................................................2
Figure 2: Interior of the Implantable Insulin Pump ................................................3
Figure 3: Side Port Catheter ....................................................................................4
Figure 4: Personal Pump Communicator (PPC) .....................................................5
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CHAPTER 1 The Medtronic MiniMed
2007D 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 2007D 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 2007D 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.
1
NOTE: Before you can use the Medtronic MiniMed 2007D
System, you will be trained. This training will teach
you about implantable insulin pump therapy, and how
to operate the Medtronic MiniMed 2007D System. This
manual can be used to help, but not replace, your
training.
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 2007D 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
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Description of the system
The Medtronic MiniMed 2007D Implantable Insulin Pump System (see Figure 1)
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 rates 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
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
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The Pump has six major components: the medication reservoir, the pumping
mechanism, the antenna, the microelectronics, the battery, and the tone
transducer. Figure 2 shows the interior of the Pump.
3
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.
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
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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 c onfirm
your Pump is operating properly. It also alerts you when your Pump needs
attention.
Side Port Catheter
The Side Port Catheter (catheter) is a soft plastic tube, made of polyethylenelined 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 radioopaque stripe to help locate it on an X-ray.
The Catheter has a subcutaneous part and an intraperitoneal part as shown in
Figure 3.
Subcutaneous Part
Intraperitoneal Part
Figure 3: Side Port Catheter
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.
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.
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Figure 4: Personal Pump Communicator (PPC)
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
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• 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 only be used
Special insulin
The Medtronic MiniMed 2007D Implantable Insulin Pump System uses a sp ecial
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 2007D Implantable Insulin
Pump System.
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.
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, television or video
remote controls.
Alarms
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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. 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.
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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 the 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.”
CHAPTER 3 Implanting the Medtronic
MiniMed 2007D Pump
System
Hospitalization
You will be admitted to the hospital to have your Medtronic MiniMed 2007D
Implantable Insulin Pump surgically implanted and stabilized. 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
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• 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 and the size and shape of your body or
whether or not you have had any previous abdominal surgery, such as an
appendectomy.
The Pump may be implanted using either local or general anesthesia. This
decision will be made by you, your doctor , the Su r geon, 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.
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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 postoperative swelling.
Post-operative procedures
The length of your hospital stay will be determined by your doctor. Your stay
will depend upon how quickly you recover, and how quickly you learn to use
the Medtronic MiniMed 2007D 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 emergen cy ph on e n umbers.
• Ask your doctor to complete and return your Device Registration Card
to Medtronic MiniMed. This card contains the Pump and Catheter serial
numbers, which are needed for device tracking by
Medtronic MiniMed.
• Schedule an appointment with your doctor for your first follow-up 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,
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.
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a member of the healthcare team will check the status
of your Pump. Only YOUR PPC can be used to check
YOUR Pump.
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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
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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.
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)
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• 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
4 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.
Your PPC has been specifically pre-programmed for use with your Pump. Do
not use another PPC to program your Pump. You must keep yo ur 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
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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.
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