User Manual
Table Of Contents
- 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 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
- 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
- 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
- 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
- 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
- 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
- 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
- CHAPTER 1 The Medtronic MiniMed 2007C Implantable Insulin Pump System
- 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 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
- 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
- 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
- The medication reservoir holds the insulin and is refilled with a special syringe through the Pum...
- The pumping mechanism takes insulin from the medication reservoir and delivers it through a cathe...
- The pump antenna receives the radio signals from the PPC and delivers the PPC’s programmed messag...
- The microelectronics are designed to control the pumping mechanism so that you receive the amount...
- The battery supplies power to the pumping mechanism and microelectronics. It is a lithium carbon ...
- The tone transducer is a Pump safety feature. It emits audible beeps to confirm your Pump is oper...
- 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
- 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...
- The Medtronic MiniMed 2007C Implantable Insulin Pump System uses a special insulin, purified and ...
- CHAPTER 2 Safety Features
- Your Pump will respond only to telemetry commands from your PPC. Your Pump will not change when e...
- The most important safety feature of your Pump is its self-checking circuitry. If your Pump is no...
- The Pump reservoir has a negative pressure (vacuum) which will draw in fluids. In the event of a ...
- In order to send a command to your Pump, your PPC must be properly positioned nearby and a series...
- Your doctor will program maximum dose limits into your PPC. The programmed maximum basal rate and...
- 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
- 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
- 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...
- The Surgeon will make an incision through your skin and create a “pocket” in which to place the P...
- 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...
- 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...
- Aventis, located in Frankfurt, Germany, is the manufacturer of the insulin used in your Implantab...
- 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
- 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...
- 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 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...
- 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.
- The Main programming screen is used to program features you will use every day, such as a Meal Bo...
- 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...
- 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...
- 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 ...
- 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...
- 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...
- 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 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.
- Your Basal Rate provides you with approximately 50 percent of your daily insulin needs. A Basal R...
- 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...
- 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...
- 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....
- 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...
- This feature appears in the Main menu if it has been activated to "ON" in the Pump Setup II menu....
- You can enter the following preset codes for these popular events:
- • 1 = meal
- • 2 = snack
- • 3 = sick
- • 4 = exercise.
- 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.
- 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.
- This screen permits access to other Pump “SETUP” features. These features are normally programmed...
- 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” 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.
- 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...
- 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....
- 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...
- This screen initializes your PPC to your Pump. Your doctor will normally perform this programming...
- “SETUP II” is another programming menu. “SETUP II” features are used less often than the features...
- From the “SETUP” screen, press SEL until the “EXIT SETUP MENU” screen is displayed. Press ACT. Th...
- 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.
- 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.
- 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...
- 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...
- 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 ...
- 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 ...
- 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 ...
- 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...
- This screen allows you to return to the Setup mode by pressing ACT. If you press SEL the screen w...
- 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 Implantable Insulin Pump has an alarm system which beeps when an error condition occurs. The ...
- 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:
- 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...
- 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 ...
- 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...
- The Implantable Insulin Pump battery is designed to last approximately seven years during conditi...
- PPC Display
- Type of Alarm
- Pump Alarm
- PUMP LOW BATTERY
- 1
- In 24 hours if no PPC communication
- You can clear this condition and your Pump will continue to operate normally. However, you should...
- When there is no longer sufficient battery energy to power the Pump, the Pump Low Battery Alarm w...
- The Implantable Insulin Pump has a sophisticated self-monitoring system that continuously checks ...
- PPC Display
- Type of Alarm
- Pump Alarm
- PUMP STOPPED
- 1 or 2 or 3 or 4 or 5 or 6
- 1
- In 5 minutes if no PPC communication
- During a “SELF TEST,” the Pump finds a malfunction. The Pump will stop delivering insulin. Clear ...
- PPC Display
- Type of Alarm
- PUMP
- SELF TEST FAIL
- 1
- The PPC offers a choice of two alarms, audible and vibrate. In addition, a screen message appears...
- 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...
- PPC Display
- Type of Alarm
- PPC
- LOW BATTERY
- 1
- 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...
- When the PPC main battery (AA 1.5 volt alkaline) no longer has sufficient energy to program the P...
- PPC Display
- Type of Alarm
- PPC
- DEPLETED BATTERY
- 1
- This message can only be cleared by replacing the PPC battery. For instructions on changing the b...
- When the PPC back-up battery (lithium) energy becomes low, the following message will be displayed:
- PPC Display
- Type of Alarm
- PPC
- NEEDS SERVICING
- 1
- You can clear this message by pressing SEL and ACT, and then continue programming. You should rep...
- When the Pump calculates that less than 800 units (2 ml) of insulin remains in its reservoir, the...
- PPC Display
- Type of Alarm
- Pump Alarm
- LOW
- RESERVOIR
- 1
- In 24 hours if no PPC communication
- You can clear this message by pressing SEL and ACT, and then continue programming. You should not...
- When the Pump calculates that less that 400 units (1 ml) of insulin remains in its reservoir, the...
- PPC Display
- Type of Alarm
- Pump Alarm
- EMPTY
- RESERVOIR
- 1
- In 24 hours if no PPC communication
- You can clear this message by pressing SEL and ACT, and then continue programming. The PPC Medica...
- 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...
- If the PPC main battery (AA 1.5V alkaline) has been replaced or the PPC recognizes the “PUMP STAT...
- PPC Display
- Type of Alarm
- CHECK PUMP STATUS
- 1
- 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...
- If the Pump operation has been suspended, the following message is displayed:
- PPC Display
- Type of Alarm
- PUMP
- SUSPENDED
- 2
- During “SUSPEND PUMP,” the Pump will deliver a basal rate of 0.2 U/h. To restart insulin delivery...
- If the “AUTO OFF” time interval elapses, the following message is displayed:
- PPC Display
- Type of Alarm
- AUTO OFF PUMP
- PUMP SUSPENDED
- 1
- The Pump will initiate the internal alarm sequence of four beeps every minute for 5 minutes, then...
- If you attempt to deliver more than 2.5 times the pre-programmed bolus maximum in one hour, the f...
- PPC Display
- Type of alarm
- HOURLY MAX EXCEEDED
- 1
- Press SEL and ACT, place the PPC near the Pump and allow the communication to complete. You may e...
- 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
- The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with electrosurgical ...
- The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with diagnostic ultra...
- The Medtronic MiniMed 2007C Implantable Insulin Pump System should not be exposed to therapeutic ...
- The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with Computerized Tom...
- The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with therapeutic radi...
- You cannot undergo Magnetic Resonance Imaging procedures with the MiniMed 2007C Implantable Pump ...
- 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...
- 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...
- Have your Pump refilled before the reservoir is empty. Alarms in the PPC will alert you to low an...
- 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...
- You must check your blood sugar at least four times daily, using a technique recommended by your ...
- Carry conventional insulin supplies with you at all times, including insulin and a means to injec...
- Follow your doctor’s instructions about your insulin delivery. The range of insulin delivery with...
- The PPC is an electronic device, and can be damaged if dropped. Do not get the PPC wet or take it...
- Your doctor may program specific limits for your Basal Rate and Meal Bolus. These maximum limits ...
- Carry a fresh AA 1.5-volt alkaline battery with you at all times. The estimated PPC main battery ...
- Keep the PPC near to the Pump during a programming sequence. Separation of the PPC and Pump may r...
- Physical activities which are not permitted are those involving very highor low altitudes and pre...
- 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, ...
- In clinical studies, adverse reactions associated with the Medtronic MiniMed 2007 Implantable Ins...
- Your Implantable Insulin Pump uses a special short-acting insulin, so your body will not have any...
- The best method for identifying hypoglycemia is testing your blood sugar levels. Establish a prot...
- Pump pocket infection, although rare, occur around the Pump implantation site. If you notice pain...
- 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...
- 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...
- 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 ...
- There are no restrictions on your normal work, school, social, or sexual activities unless you ha...
- You may participate in most physical activities with your MiniMed 2007 Implantable Pump Insulin S...
- You may travel with your Medtronic MiniMed 2007C Implantable Insulin Pump System. All extended tr...
- Your doctor will give you a Patient Emergency Information Card when you receive your Pump System....
- CHAPTER 8 PPC Care and Maintenance
- 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...
- • 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...
- • 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
- 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 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
- 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
- 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)
- 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
- MMT- 4027A
- Length
- Proximal:
- Distal:
- 11.8 ± 1.3 cm (4.7 ± 0.5 inches)
- 17.8 ± 0.7 cm (7.0 ± 0.3 inches)
- MMT- 4024A
- Length
- Proximal:
- Distal:
- 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’...
ii
Alarms ........................................................11
Negativepressurereservoir ........................................11
PPCsafetyfeatures .................................................12
Programming sequence ...........................................12
Maximumdosagelimits...........................................12
Alarmsandmessages.............................................12
CHAPTER 3 Implanting the MiniMed 2007C Pump System. . .13
Hospitalization.....................................................13
Pre-operativeprocedures ..........................................13
Implantationprocedures ..........................................14
Post-operativeprocedures .........................................14
Follow-up...................................................15
Pump refills .......................................................16
Insulinusedwiththeimplantablepump ..............................16
Pumprefillprocedure ............................................16
CHAPTER 4
ProgrammingYourPump................. 17
Introduction .......................................................17
PPCscreenicons ...................................................18
PPCbuttons .......................................................19
Main programming screen ............................................20
Programming a bolus .............................................20
Setanimmediatebolus(variablebolusoptionis“off”)...................21
Setanimmediatebolus(variablebolusoptionis“on”) ..................22
Setasquarewavebolus...........................................23