Medtronic MiniMed Implantable Insulin Pump : User Manual : Page 33

Medtronic MiniMed 2007C Implantable Insulin Pump System

Patient Manual

These product(s) are covered by one or more of the following U.S. Patents:

Patents also exist in a number of foreign countries and other U.S., international, and foreign pa...

D9196020-011 2/01

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

Personal pump communicator (PPC) 7

Special insulin 9

CHAPTER 2 Safety Features 11

Pump safety features 11

Safe telemetry 11

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

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

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

Set a maximum basal rate 44

CHAPTER 5 Alarms and Messages 47

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

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

Physical activities to avoid 65

Pump pocket infection 67

Pump pocket seroma 67

CHAPTER 7 Important Self-Care 69

Blood glucose monitoring 69

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

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 ...

Throughout the manual you will see note comments which provide important information about the Me...

NOTE: Before you can use the Medtronic MiniMed 2007C System, you will be trained. This training w...

Medtronic MiniMed help line

Medtronic MiniMed provides a 24-hour help line for assistance. Clinical Services personnel are tr...

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...

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 (...

Figure 1: The Implantable Insulin Pump

The Pump has six major components: the medication reservoir, the pumping mechanism, the antenna, ...

.

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 Pum...

Pumping mechanism

The pumping mechanism takes insulin from the medication reservoir and delivers it through a cathe...

Antenna

The pump antenna receives the radio signals from the PPC and delivers the PPC’s programmed messag...

Microelectronics

The microelectronics are designed to control the pumping mechanism so that you receive the amount...

Battery

The battery supplies power to the pumping mechanism and microelectronics. It is a lithium carbon ...

Tone transducer

The tone transducer is a Pump safety feature. It emits audible beeps to confirm your Pump is oper...

Side port catheter

The Side Port Catheter (catheter) is a soft plastic tube, made of polyethylene-lined silicone rub...

The Catheter has a subcutaneous part and an intraperitoneal part as shown in the following figure.

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 y...

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 c...

• 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 inc...

• 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. D...

Special insulin

The Medtronic MiniMed 2007C Implantable Insulin Pump System uses a special insulin, purified and ...

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 e...

Alarms

The most important safety feature of your Pump is its self-checking circuitry. If your Pump is no...

Negative pressure reservoir

The Pump reservoir has a negative pressure (vacuum) which will draw in fluids. In the event of a ...

PPC safety features
- Programming sequence

In order to send a command to your Pump, your PPC must be properly positioned nearby and a series...

Maximum dosage limits

Your doctor will program maximum dose limits into your PPC. The programmed maximum basal rate and...

Alarms and messages

Your PPC prompts you with many easy-to-read messages on its screen. Also, the PPC emits beeps to ...

CHAPTER 3 Implanting the MiniMed 2007C Pump System

Hospitalization

You will be admitted to the hospital to have your Medtronic MiniMed 2007C Implantable Insulin Pum...

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 s...

The Pump will be implanted in your abdominal area. Your doctor will discuss the exact location of...

The Pump may be implanted using either local or general anesthesia. This decision will be made by...

Implantation procedures

The Surgeon will make an incision through your skin and create a “pocket” in which to place the P...

Post-operative procedures

The length of your hospital stay will be determined by your doctor. Your stay will depend upon ho...

Before your admission to the hospital, your doctor or a nurse will teach you how to use your PPC ...

• 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 pu...

• Ask your doctor to complete and return your Device Registration Card to MiniMed. This card cont...

• 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 unders...

Follow-up

Before you leave the hospital, your doctor will schedule an appointment for your first follow-up ...

NOTE: ALWAYS keep your PPC with you. During office visits, a member of the healthcare team will c...

Your post-implant recovery will be similar to recovery from other surgical procedures. You will n...

Pump refills
- Insulin used with the implantable pump

Aventis, located in Frankfurt, Germany, is the manufacturer of the insulin used in your Implantab...

Pump refill procedure

It is important that the time between your Pump refills should not exceed 90 days. Refilling your...

Your doctor or a nurse may now numb the disinfected skin area with a local anesthetic. A short ne...

CHAPTER 4 Programming Your Pump

Introduction

You will program your Implantable Insulin Pump with your PPC. The PPC transmits information by RF...

• Deliver an immediate, square wave or dual wave insulin bolus to compensate for meals. Boluses c...

• 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...

Your PPC has been specifically pre-programmed for use with your Pump. Do not use another PPC to p...

Remember, you must measure your blood sugar at least four times each day, according to the method...

PPC screen icons

Your PPC has an easy-to-read dot matrix liquid crystal display (LCD). The main PPC screen display...

Icon

Description

The bell icon is displayed when the PPC receives a RF telemetry message from the Pump. The icon m...

The reservoir icon is composed of 4 segments that indicate how full the Pump reservoir is, based ...

The PPC shows a “spinning” icon while insulin delivery is in progress. When the Pump delivers a b...

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,...

s UP ARROW

Allows you to make changes to the screen settings by scrolling to higher values. You must then pr...

t DOWN ARROW

Allows you to make changes to the screen settings by scrolling to lower values. You must then pre...

Communicating PPC

1. When commands are programmed the PPC will talk to the Pump. When this occurs the following scr...

2. The word COMMUNICATING will blink to indicate a communication is taking place.

Main programming screen

The Main programming screen is used to program features you will use every day, such as a Meal Bo...

Programming a bolus

Using the PPC, you can program the Pump to deliver a bolus of insulin whenever you need it. The P...

• Immediate Bolus (programmed by reading the PPC screen or listening to beeps, using the Audio Bo...

• Square Wave Bolus

• Dual Wave Bolus

NOTE: To program a Square Wave or Dual Wave Bolus, you must turn on the Variable Bolus programmin...

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 ...

2. Press ACT and “SET BOLUS” appears, and the dashes or previous bolus under “IMM” start flashing.

3. Use the s and t buttons to enter an immediate bolus amount.

4. Press ACT and the screen shows “CONFIRM IMM.” If the number you entered for the immediate bolu...

5. Place the PPC near the Pump to complete the programming. The PPC will beep once and display 0....

6. If the Alarm Feedback feature is “ON,” the Pump will beep during each of the first five stroke...

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 valu...

2. Press ACT and “SET BOLUS TYPE” appears. Use the s and t buttons to choose “NORMAL.”

3. Press ACT and “IMM” appears with the dashes underneath flashing.

4. Use the s and t buttons to enter an immediate bolus amount

5. Press ACT and the screen shows “CONFIRM IMM.”

6. If the number was not correct, wait for the screen to return to Time/Date and then repeat this...

7. If the number you entered for the immediate bolus is correct, press ACT to confirm it. Place t...

8. The PPC will beep once and display the amount of insulin delivered. If the Alarm Feedback feat...

9. The PPC will beep when the bolus delivery is complete. Three segments of the insulin delivery ...

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...

To access Square Wave Bolus you must first turn the Variable Bolus feature "ON" in the SET UP II ...

1. From the Time/Date screen press SEL until the “BOLUS” screen is displayed. The last bolus valu...

2. Press ACT and “SET BOLUS TYPE” appears.

3. Use the s and t buttons to choose “SQUARE”.

4. Press ACT and the dashes underneath “EXT” will appear flashing.

5. Use the s and t buttons enter an extended bolus amount.

6. Press ACT and dashes will appear under the bolus amount you just entered.

7. Use the s and t buttons to enter a time duration that you would like the Square Wave Bolus to ...

8. Press ACT and the screen shows “CONFIRM EXT” asking you to confirm the extended bolus and time...

9. If the numbers you entered are correct, press ACT to confirm them. These values will now be pr...

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 Feedba...

12. The PPC will beep when the bolus delivery is complete. Three segments of the insulin delivery...

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 Wav...

1. From the Time/Date screen press SEL until the “BOLUS” screen is displayed. The last bolus valu...

2. Press ACT and “SET BOLUS TYPE” appears.

3. Use the s and t buttons to choose “DUAL”.

4. Press ACT and “IMM” appears with the dashes underneath flashing.

5. Use the s and t buttons enter an immediate bolus amount

6. Press ACT and the dashes underneath “EXT” will appear flashing.

7. Use the s and t buttons enter an extended bolus amount.

8. Press ACT and dashes will appear under the extended bolus amount you just entered.

9. Use the s and t buttons to enter a time duration that you would like the extended bolus to last.

10. Press ACT and the screen shows “CONFIRM” asking you to confirm the immediate bolus, extended ...

11. If the numbers you entered are correct, press ACT to confirm them. These values will now be p...

12. Place the PPC near the Pump to complete the programming. The PPC will beep once and display t...

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 segments of the insulin delivery...

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 valu...

2. Press the t button once to display the previous bolus and the time and date it was delivered. ...

Suspend mode

Suspend Mode allows you to cancel bolus programming. In suspend mode the pump will still deliver ...

1. From the Time/Date screen press SEL until the “SUSPEND PUMP” screen is shown.

2. Press ACT.

3. Place the PPC near the Pump to complete the programming. When communication is finished the Pu...

4. All four segments of the insulin delivery icon will be displayed.

5. To restart the Pump, press SEL and ACT.

Program basal rates

Your Basal Rate provides you with approximately 50 percent of your daily insulin needs. A Basal R...

Set one basal rate

1. From the Time/Date screen press SEL until the “BASAL RATE” screen is displayed. Basal Delivery...

2. Press ACT and “1” appears to the right of “A” indicating that you will now program first Basal...

3. Use the s and t 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...

5. Use the s and t buttons to change time to dashes.

6. To enter one Basal Rate, press ACT 2 times.

NOTE: In 24 hr. display mode, “00:00” indicates a start time of MIDNIGHT. In 12hr. display mode, ...

7. Place the PPC near the Pump to complete the programming. The screen will display PPC communica...

8. The screen will calculate and briefly display the total daily Basal insulin from the Basal Rat...

Set multiple basal rates

1. From the Time/Date screen press SEL until the “BASAL RATE” screen is displayed. Basal Delivery...

2. Press ACT and “1” appears to the right of “A” indicating you will now program Basal Rate “1” i...

3. Use the s and t 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...

5. Use the s and t buttons to enter a new start time.

NOTE: In 24 hr. display mode, “00:00” indicates a start time of MIDNIGHT. In 12hr. display mode, ...

6. Press ACT and “SET RATE” and “2” appears, indicating you will now program Basal Rate “2” in Ba...

7. Use the s and t 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 pre...

9. Place the PPC near the Pump to complete the programming.

10. The screen will calculate and briefly display the total daily Basal insulin from the Basal Ra...

NOTE: To set multiple basal profiles in the other patterns (A, B, C), select the pattern in Setup...

Set a temporary basal rate

A Temporary Basal Rate is often used when a brief change in basal delivery is required, for examp...

1. From the Time/Date screen press SEL until the “TEMP BASAL” screen is displayed.

2. Press ACT and “SET DURATION” appears with the start time flashing.

3. Use the s and t buttons to enter a Temporary Basal Rate.

4. Press ACT and “SET AMOUNT” appears with the Temporary Basal Rate flashing.

5. Use the s and t buttons to enter a new start time for the Temporary Basal Rate, then press ACT...

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....

Stop a temporary basal rate

1. From for the Time/Date screen press SEL until the “TEMP BASAL” screen is displayed.

2. Press ACT and “SET DURATION” will appear with the time flashing.

3. Press the t button until the time is set to dashes, then press ACT.

4. Place the PPC near the Pump to complete the programming.

5. When the communication is finished, “SET AMOUNT” will appear with the dashes flashing. Allow t...

Personal events

This feature appears in the Main menu if it has been activated to "ON" in the Pump Setup II menu....

Preset events

You can enter the following preset codes for these popular events:

Additional events

Codes A, B and C can be used to record other events. Be sure to document the events listed for A,...

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.

3. Use the s and t buttons to select the event you want to enter: MEAL, SNACK, SICK, EXERCISE, A,...

4. Press ACT and the time will appear flashing.

5. Use the s and t buttons to enter the time that the event occurred.

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 remaini...

1. From the Time/Date screen, press SEL until the “HISTORY” screen is displayed.

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 ...

4. The screen will automatically change to “MED REMAINING.” The amount of insulin in the Pump res...

5. Press SEL and the screen will change to “INSULIN TOTAL.” The amount of Basal Rate and Bolus in...

6. Press the t button to review insulin delivery rates for other days.

7. Press SEL and the “CLINICAL HISTORY PPC” screen is shown. Ask your doctor what the numbers mean.

8. Press the t button to review other days.

9. Press SEL to find the “CLINICAL HISTORY PUMP” screen. Ask your doctor what the numbers mean. P...

10. Press SEL and the screen will change to the “EST PUMP BATT” display. This screen indicates th...

11. Press SEL and the screen will read “EXIT HISTORY.” Press ACT to return to the Time/Date screen.

Pump setup

This screen permits access to other Pump “SETUP” features. These features are normally programmed...

Time and date

The time and date settings must be correct. The PPC uses the time and date to calculate your tota...

1. From the Time/Date display, press SEL until the “SETUP PUMP” screen is displayed.

2. Press ACT two times. The hour digits will begin flashing. Use the s and t buttons to select th...

3. Press ACT again, and the minute digits will begin flashing. Use the s and t buttons to select ...

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 com...

Auto off

“AUTO OFF” sets an alarm on your PPC, to remind you if you have not programmed your Pump recently...

1. From the “SETUP PUMP” screen, press ACT then SEL.

2. The screen will display “AUTO OFF” with flashing dashes. Press ACT.

3. Use the s and t buttons to select the number of hours before an Auto Off alarm occurs.

4. Press ACT. In this example, a time duration of 10 hours was selected. The PPC will alarm if yo...

5. Place the PPC near the Pump. The PPC will beep once when the communication is completed.

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...

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 inst...

1. Press ACT to enter the “ALARMS” menu.

2. Press the s and t buttons to select the type of alarm you want, then press ACT.

3. The screen will now display “SET PPC FEEDBACK.” This setting should always be “ON”. Press ACT.

4. Place the PPC near the Pump. When the communication is completed, the PPC will change to “SELF...

Self Test

Your doctor may ask you to run a diagnostic test of your Pump System. “SELF TEST” will send messa...

NOTE: Notify your doctor if any of these Self Test events do not occur. If the PPC displays a Min...

1. From the “SETUP PUMP” screen, press SEL until the “SELF TEST” screen is displayed.

2. Press ACT.

3. Place the PPC near the Pump and complete the communication process.

4. Verify the following events occur:

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.

5. If your PPC and Pump “pass” the Self Test, the display will change to “PPC PASSED/PUMP PASSED....

Basal delivery patterns

The PPC allows you to program three different basal delivery patterns (A, B, C). Pattern A is pre...

Basal patterns can be used to follow your normal daily routines. For example, separate patterns c...

1. From the “SETUP PUMP” screen, press SEL until the “DELIVERY PATTERN A” screen is displayed. Pr...

2. Press SEL again until the “DELIVERY PATTERN” screen appears. Press ACT and the screen will cha...

3. Press the s and t buttons to select pattern A, B or C.

4. Press ACT. Place the PPC near the Pump and allow the communication to complete.

NOTE: The PPC will automatically return to the Time/ Date screen. Press SEL until the “BASAL RATE...

Initialize PPC to pump

This screen initializes your PPC to your Pump. Your doctor will normally perform this programming...

Pump setup II

“SETUP II” is another programming menu. “SETUP II” features are used less often than the features...

Exit setup menu

From the “SETUP” screen, press SEL until the “EXIT SETUP MENU” screen is displayed. Press ACT. Th...

Pump setup II

The “SETUP II” screen allows you to program additional features into your PPC. Your doctor will n...

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 ...

1. From the “SETUP II” screen, press ACT. The “AUDIO BOLUS” screen appears.

2. Press ACT, and the screen changes to “SET AUDIO BOLUS” with “ON” flashing.

3. Use the s and t buttons to choose “ON” to turn on the Audio Bolus feature. Choose “OFF” to tur...

NOTE: If “OFF” is chosen, pressing the s and t buttons will have no effect.

4. If “ON” was chosen, the “SET STEP AUDIO BOLUS” screen appears, with a bolus amount of 0.4U fla...

5. Use the s and t 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 s button will not work.

From the Time/Date screen press s button. The PPC will beep one or two times, depending upon the ...

1. Count the number of beeps to determine how much insulin you want to program.

2. Press ACT, and the beeps repeat to confirm the bolus amount you have entered.

3. Press ACT twice, and the PPC will program the Pump. The PPC will beep once when the communicat...

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.

2. Press ACT and the screen changes to “SET VARIABLE BOLUS.” The word “ON” is flashing.

3. Use the s and t buttons to select “ON” or “OFF.”

4. Place the PPC near the Pump and complete the communication. If “ON” was chosen, the Variable B...

Set a maximum bolus

Your doctor will decide if you should use this feature. Setting a maximum bolus amount will prote...

1. From the “SETUP II” menu, press SEL until the “MAX BOLUS” screen is displayed.

2. Press ACT and the screen will change to “SET MAX BOLUS,” with the dashes flashing.

3. Use the s and t buttons to enter a maximum bolus amount (0.0U to 25.0U), then press ACT.

4. Place the PPC near the Pump and complete the communication. The PPC screen will automatically ...

Set a maximum basal rate

Your doctor will decide if you should use this feature. Setting a maximum basal rate will protect...

5. After setting a maximum bolus, the “MAX BASAL” screen appears with the maximum basal rate flas...

6. Use the s and t buttons to enter a maximum basal rate (0.2U/h to 35.0U/h), then press ACT.

7. Place the PPC near the pump and complete the communication. The PPC screen will automatically ...

Set time format

1. From the “SETUP II” screen, press SEL until the “SET TIME FORMAT” screen is displayed.

2. Use the s and t buttons to select either a 12 hour (12:00am) or 24 hour (00.00) time format, t...

3. Place the PPC near the pump and complete the communication. The PPC screen will change to the ...

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.

2. Press ACT and the SET PERSONAL EVENTS screen is displayed and "OFF" is blinking.

3. Use the s and t 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 "PU...

Pump setup

This screen allows you to return to the Setup mode by pressing ACT. If you press SEL the screen w...

Exit setup menu

This screen allows you to return to the Main Menu, Time/Date screen by pressing ACT.

CHAPTER 5 Alarms and Messages

The Medtronic MiniMed 2007C Implantable Insulin Pump System is equipped with various alarms and m...

The pump alarms

The Implantable Insulin Pump has an alarm system which beeps when an error condition occurs. The ...

The PPC alarms

The PPC has three types of alarms, audible or vibrate alarms and visual alarms. This chapter will...

Some alarms can be cleared by pressing SEL then ACT. The difference between these alarms will be ...

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 t...

If the PPC is set to “audible”, the PPC will beep 6 times every minute for 30 minutes. If the ala...

Alarm type 2

If the PPC is set to “vibrate”, the vibrator will be turned on for 3 seconds every minute while t...

If the PPC is set to “audible”, the PPC 6 will beep 3 times every 30 minutes while the condition ...

Pump alarms
- Alarm feedback

The Alarm Feedback function allows you to verify the Pump and the Pump beeper is operating normal...

• Following a change in the delivery regimen, for example when completing a meal Bolus and then c...

• After the Alarm Feedback function is programmed “YES.” Alarm Feedback will stay on until progra...

Pump low battery

The Implantable Insulin Pump battery is designed to last approximately seven years during conditi...

In 24 hours if no PPC communication

You can clear this condition and your Pump will continue to operate normally. However, you should...

Depleted pump battery

When there is no longer sufficient battery energy to power the Pump, the Pump Low Battery Alarm w...

System error

The Implantable Insulin Pump has a sophisticated self-monitoring system that continuously checks ...

1 or 2 or 3 or 4 or 5 or 6

1

In 5 minutes if no PPC communication

Pump self test fail

During a “SELF TEST,” the Pump finds a malfunction. The Pump will stop delivering insulin. Clear ...

PPC alarms

The PPC offers a choice of two alarms, audible and vibrate. In addition, a screen message appears...

PPC low battery

NOTE: If “VIBRATE” is selected, the PPC battery should last about six weeks. If the PPC determine...

If the PPC main battery (AA 1.5 volt alkaline) energy is low, the following alarm display will ap...

You can clear this message by pressing SEL and then ACT, and then continue programming. There sho...

NOTE: If while programming the Pump, the PPC goes blank, the PPC beeps six times and then the "CH...

PPC depleted battery

When the PPC main battery (AA 1.5 volt alkaline) no longer has sufficient energy to program the P...

This message can only be cleared by replacing the PPC battery. For instructions on changing the b...

PPC needs servicing

When the PPC back-up battery (lithium) energy becomes low, the following message will be displayed:

You can clear this message by pressing SEL and ACT, and then continue programming. You should rep...

Low reservoir

When the Pump calculates that less than 800 units (2 ml) of insulin remains in its reservoir, the...

In 24 hours if no PPC communication

You can clear this message by pressing SEL and ACT, and then continue programming. You should not...

Empty reservoir

When the Pump calculates that less that 400 units (1 ml) of insulin remains in its reservoir, the...

In 24 hours if no PPC communication

You can clear this message by pressing SEL and ACT, and then continue programming. The PPC Medica...

Communication error

If programming is interrupted after partial transmission of a command, the PPC will display the f...

PPC Display

Type of Alarm

TELEMETRY COMM ERROR 3

1

You should reposition the PPC near the pump, press SEL and ACT. The PPC will attempt to resume co...

Battery replacement

If the PPC main battery (AA 1.5V alkaline) has been replaced or the PPC recognizes the “PUMP STAT...

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 "CH...

Pump suspended

If the Pump operation has been suspended, the following message is displayed:

During “SUSPEND PUMP,” the Pump will deliver a basal rate of 0.2 U/h. To restart insulin delivery...

Auto off

If the “AUTO OFF” time interval elapses, the following message is displayed:

The Pump will initiate the internal alarm sequence of four beeps every minute for 5 minutes, then...

Hourly maximum exceeded

If you attempt to deliver more than 2.5 times the pre-programmed bolus maximum in one hour, the f...

Press SEL and ACT, place the PPC near the Pump and allow the communication to complete. You may e...

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.

BOLUS0.0 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. ...

HOURLY MAX EXCEEDED

You attempt to deliver more than 2.5 times the bolus maximum in one hour. To clear the message, p...

LOW RESERVOIR

The PPC has recognized the Pump has 800 units (2 ml) or less insulin remaining in its reservoir. ...

PPC NEEDS SERVICING

The internal PPC backup battery is depleted. The PPC can be programmed. Replace the PPC as soon a...

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

1 or 2 or 3 or 4or 5 or 6

When the Pump recognizes a system malfunction, it automatically stops and insulin delivery ceases...

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....

CHAPTER 6 Warnings and Precautions

Warnings
- Electrotherapy

The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with electrosurgical ...

Diagnostic ultrasound

The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with diagnostic ultra...

Ultrasound therapy

The Medtronic MiniMed 2007C Implantable Insulin Pump System should not be exposed to therapeutic ...

Diagnostic radiation

The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with Computerized Tom...

Therapeutic radiation

The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with therapeutic radi...

Magnetic resonance imaging

You cannot undergo Magnetic Resonance Imaging procedures with the MiniMed 2007C Implantable Pump ...

Pump and catheter under-delivery

Under-delivery or “backflow” may occur when insulin deposits collect in the pumping mechanism ins...

If your Pump is under-delivering its insulin, you may feel symptoms of hyperglycemia. If this occ...

Another under-delivery condition is caused by body fluids or body tissue collecting at the tip of...

Pump electronic or alarm malfunction

If the Pump’s electronic or alarm systems malfunction, Self Test circuitry will detect the malfun...

Infection, skin erosion, unresolved backflow, or catheter occlusion may also require that your Pu...

Reservoir level warnings

Have your Pump refilled before the reservoir is empty. Alarms in the PPC will alert you to low an...

Environmental conditions

NOTE: If you are in doubt about whether a condition or situation will affect your Pump, contact y...

The Implantable Insulin Pump, like all microelectronic devices, should not be exposed to extreme ...

• 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 Pu...

You may not reside at or travel to an elevation in excess of 8,000 feet, or dive below 15 feet. H...

Exposure to elevated temperatures in excess of 104°F (i.e. hot tubs, saunas), for longer than one...

This device may experience communication interruptions when operated at or near some airport faci...

Precautions
- Blood glucose monitoring

You must check your blood sugar at least four times daily, using a technique recommended by your ...

Conventional insulin supplies

Carry conventional insulin supplies with you at all times, including insulin and a means to injec...

Physician’s instructions

Follow your doctor’s instructions about your insulin delivery. The range of insulin delivery with...

PPC

The PPC is an electronic device, and can be damaged if dropped. Do not get the PPC wet or take it...

Maximum dosages

Your doctor may program specific limits for your Basal Rate and Meal Bolus. These maximum limits ...

Battery change

Carry a fresh AA 1.5-volt alkaline battery with you at all times. The estimated PPC main battery ...

Proper PPC positioning

Keep the PPC near to the Pump during a programming sequence. Separation of the PPC and Pump may r...

Physical activities to avoid

Physical activities which are not permitted are those involving very highor low altitudes and pre...

Emergency plan

Be fully informed and thoroughly understand what to do in an emergency. Carry your emergency card...

The following instructions should be used by your family or co-workers to set the Pump at the low...

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 t...

In addition to the procedure above, review with family members the proper procedure for administe...

It is important to closely monitor blood sugar levels on refill days. During a refill procedure, ...

Adverse reactions

In clinical studies, adverse reactions associated with the Medtronic MiniMed 2007 Implantable Ins...

Hyperglycemia

Your Implantable Insulin Pump uses a special short-acting insulin, so your body will not have any...

Hypoglycemia

The best method for identifying hypoglycemia is testing your blood sugar levels. Establish a prot...

Pump pocket infection

Pump pocket infection, although rare, occur around the Pump implantation site. If you notice pain...

Pump pocket seroma

A Pump pocket seroma is generally characterized by swelling around the area of implantation. It m...

CHAPTER 7 Important Self-Care

Having a Medtronic MiniMed 2007 Implantable Insulin Pump System is only one aspect of an overall ...

This manual presents general information regarding blood glucose monitoring, meal planning, exerc...

A support person such as a family member or friend should also read this manual and pay particula...

Blood glucose monitoring

NOTE: Remember much of the success of implantable pump therapy depends on accurate and frequent b...

Your Pump System does not monitor your blood glucose levels. You must continue to self-monitor yo...

If you begin to have a problem with glycemic control, it is very important to record your blood g...

Meal plan

You will always receive some basal insulin from your Implantable Insulin Pump. When you program a...

As with any insulin therapy, it is recommended that you keep some form of fast-acting sugar with ...

Daily activities

There are no restrictions on your normal work, school, social, or sexual activities unless you ha...

Exercise

You may participate in most physical activities with your MiniMed 2007 Implantable Pump Insulin S...

Travel

You may travel with your Medtronic MiniMed 2007C Implantable Insulin Pump System. All extended tr...

MiniMed information card

Your doctor will give you a Patient Emergency Information Card when you receive your Pump System....

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 b...

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...

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 ...

6. Close the battery door.

7. Slide the locking bar to the right.

8. The PPC screen reappears after 30 seconds:

9. The PPC will beep six times and display “PPC/PUMP.”

10. After a few seconds, the screen will change to “CHECK PUMP STATUS.”

11. Press SEL and ACT, then place the PPC over the Pump.

12. Allow the communication to complete.

NOTE: When the PPC displays “PPC LOW BATTERY,” you can clear the message and continue programming...

Physical protection

• Protect the PPC from direct contact with water and moisture. Never take the PPC into a sauna or...

• Protect the PPC from temperatures greater than 40° C (104° F). Do not leave the PPC in direct s...

• 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 compo...

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 u...

• 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.

CHAPTER 9 Technical Specifications

Medtronic MiniMed 2007C Implantable Insulin Pump System
- Implantable Insulin Pump (MMT-2007C)

Component

Performance Specification

Insulin - Concentration

Aventis HOE 21 PH U-400

Stroke Volume

0.42 to 0.58 ml per stroke

0.17 to 0.23 units per stroke

Basal Rate

0.2 to 35.0 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

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

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

Personal Pump Communicator (MMT-3150)

Component

Performance Specification

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)

Storage Temperature

-0ºC to 30ºC ( 32ºF to 86ºF)

Messages

Auto Off in 5 min / Auto Off Pump Suspended

Hourly Maximum Exceeded

Telemetry Communications Error

Side Port Catheter

11.8 ± 1.3 cm (4.7 ± 0.5 inches)

17.8 ± 0.7 cm (7.0 ± 0.3 inches)

11.8 ± 1.3 cm (4.7 ± 0.5 inches)

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 con...

Operation of this device is authorized by the FCC under the FCC ID OH22007C (Implantable Pump) an...

Any changes or modifications to the system not expressly approved by MiniMed could void the user’...