Installation Instructions Part 1

ManualsBrandsMedtronic MiniMed ManualsElectronicsPersonal Pump Communicator

Table Of Contents

Table of Contents

CHAPTER 1 Description of the Medtronic MiniMed 2007C

Implantable Insulin Pump System . . . . . . . . . . 11

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Implantable Insulin Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Insulin medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Personal Pump Communicator (PPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

CHAPTER 2 Indications and Contraindications . . . . . . . . . . 21

Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Contraindications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Possible adverse effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

CHAPTER 3

Personal Pump Communicator (PPC) . . . . . . . 25

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

PPC Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

PPC buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

Communicating with the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Dmp9196021-011_c.book Page 1 Thursday, April 4, 2002 8:15 AM

Summary of content (84 pages)

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Dmp9196021-011_c.book Page 1 Thursday, April 4, 2002 8:15 AM 1 Table of Contents CHAPTER 1 Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System . . . . . . . . . . 11 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Implantable Insulin Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Insulin medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Dmp9196021-011_c.book Page 2 Thursday, April 4, 2002 8:15 AM 2 Install/Replace the main battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29 Part 1: PPC/Pump system initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 Initialize the PPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32 Set the time and date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Dmp9196021-011_c.book Page 3 Thursday, April 4, 2002 8:15 AM 3 Setup II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 Audio bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 Activating the audio bolus feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 Set an audio bolus from the main menu bolus screen . . . . . . . . . . . . . . . . .
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Dmp9196021-011_c.book Page 4 Thursday, April 4, 2002 8:15 AM 4 Pre-operative evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93 Formation of the pump pocket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93 Catheter placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95 Post-operative management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95 Post-operative hospitalization .
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Dmp9196021-011_c.book Page 5 Thursday, April 4, 2002 8:15 AM 5 CHAPTER 7 Warnings And Precautions . . . . . . . . . . . . . . . 109 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109 Electrotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109 Diagnostic ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110 Ultrasound therapy . . .
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Dmp9196021-011_c.book Page 6 Thursday, April 4, 2002 8:15 AM 6 System error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119 Pump self test fail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120 PPC alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120 PPC low battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Dmp9196021-011_c.book Page 7 Thursday, April 4, 2002 8:15 AM 7 CHAPTER 11 MiniMed 2007C Implantable Insulin Pump System . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Implantable Insulin Pump MMT-2007C . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133 Personal pump communicator (PPC) model MMT-3150 . . . . . . . . . . . . . . . .134 Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135 APPENDIX A Label Information . . . .
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Dmp9196021-011_c.book Page 8 Thursday, April 4, 2002 8:15 AM 8 APPENDIX E Pump Rinse Procedure . . . . . . . . . . . . . . . . . . .151 Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151 Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .153 Prepare syringes for emptying the Pump . . . . . . . . . . . . . . . . . . . . . . . . . .153 Prepare syringes for filling the Pump . . . . . . . . . . . . . .
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Dmp9196021-011_c.book Page 9 Thursday, April 4, 2002 8:15 AM 9 APPENDIX G Stroke Volume Measurement . . . . . . . . . . . . . .175 Supplies and solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .175 Preparing for the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176 Record patient’s blood glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .176 Measuring stroke volume . . . . . . . . . . . . . . . . . . . .
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Dmp9196021-011_c.book Page 11 Thursday, April 4, 2002 8:15 AM 11 CHAPTER 1 Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System Introduction The Medtronic MiniMed 2007C Implantable Insulin Pump System brings together sophisticated new technologies to provide continuous intraperitoneal insulin therapy for patients with Insulin Dependent Diabetes Mellitus (IDDM).
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Dmp9196021-011_c.book Page 12 Thursday, April 4, 2002 8:15 AM 12 Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System The system consists of three major components: • Implantable Insulin Pump • Side Port Catheter • Personal Pump Communicator (PPC) Each of these components, as well as system safety features, are discussed in detail in the following sections.
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Dmp9196021-011_c.book Page 13 Thursday, April 4, 2002 8:15 AM Implantable Insulin Pump Implantable Insulin Pump The Implantable Insulin Pump (Pump) is a round disc, 8.1 cm (3.2 inches) in diameter, 2.0 cm (0.8 inches) thick. The Pump weighs 131 grams (4.6 ounces) when empty. The outside case of the Pump is made of titanium. Titanium is a biocompatible metal used in many types of implantable medical devices.
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Dmp9196021-011_c.book Page 14 Thursday, April 4, 2002 8:15 AM 14 Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System The Pump has six major components. These components are outlined below: • medication reservoir • pumping mechanism • microelectronics • antenna • battery • tone transducer Other components of the Pump include the inlet valve, fill port, septum, Freon gas and 20µm filter. Figure 3 shows the interior components of the Pump.
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Dmp9196021-011_c.book Page 15 Thursday, April 4, 2002 8:15 AM Implantable Insulin Pump The Medication Reservoir stores approximately 15 ml or 6,000 units of a special U-400 insulin. Depending on an individual’s insulin requirements, the medication reservoir is refilled once in approximately every two to three months. The medication reservoir is maintained at a negative pressure (vacuum) at all times to allow for safe and reliable filling.
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Dmp9196021-011_c.book Page 16 Thursday, April 4, 2002 8:15 AM 16 Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System Radio-Opaque Identification the Implantable Insulin Pump features radio-opaque identification. In the event of an emergency, the name of the manufacturer and the Pump model number can be identified with an x-ray. Insulin medication Only Aventis HOE 21 PH U-400 insulin can be used with the Medtronic MiniMed 2007C Implantable Insulin Pump System.
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Dmp9196021-011_c.book Page 17 Thursday, April 4, 2002 8:15 AM Implantable Insulin Pump Figure 4: The Intraperitoneal Catheter and Side Port The Catheter side port is intended to provide access to the Catheter and Pump outlet, in order to perform the non-surgical interventions and diagnostic procedures described in Appendices E, F and G. The side port allows for the introduction of a needle and small syringe to clear Catheter obstructions using pressures up to 100 psi.
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Dmp9196021-011_c.book Page 18 Thursday, April 4, 2002 8:15 AM 18 Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System Personal Pump Communicator (PPC) The Personal Pump Communicator (PPC) is the hand-held component of the MiniMed 2007C Implantable Pump System (see Figure 5). The PPC allows the physician and patient to communicate with the Pump by transmitting radio frequency messages when the PPC is held within 3” of the Pump.
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Dmp9196021-011_c.book Page 21 Thursday, April 4, 2002 8:15 AM 21 CHAPTER 2 Indications and Contraindications Indications for use The Medtronic MiniMed 2007C Implantable Insulin Pump System is indicated for intraperitoneal administration of exogenous insulin in patients with diabetes mellitus. Only Aventis HOE 21 PH U-400 insulin is indicated for use in the Medtronic MiniMed 2007C Implantable Insulin Pump System.
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Dmp9196021-011_c.book Page 22 Thursday, April 4, 2002 8:15 AM 22 Indications and Contraindications • reside at or travel (other than by pressurized commercial aircraft) at elevations above 8,000 feet. • have other medical or mental conditions which may place the patient at risk. • are unwilling or unable to return for routine insulin refills according to their dosage requirements (approximately once every 2-3 months).
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Dmp9196021-011_c.book Page 25 Thursday, April 4, 2002 8:15 AM 25 CHAPTER 3 Personal Pump Communicator (PPC) Introduction The Personal Pump Communicator (PPC) has a comprehensive set of programming features to control the Implantable Insulin Pump in the treatment of IDDM. The PPC cannot be used by the patient until it has been initialized by the healthcare professional.
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Dmp9196021-011_c.book Page 26 Thursday, April 4, 2002 8:15 AM 26 Personal Pump Communicator (PPC) PPC Icons After initialization, the PPC Main Screen displays the time (12hr. or 24hr. format), month, day and a variety of icons. The type and purpose of these icons are as follows: Bell Icon: Displayed when the PPC receives a telemetry message from the Pump indicating that the Pump has detected an alarm condition, when a PPC error is detected and when the Pump is Suspended or Stopped.
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Dmp9196021-011_c.book Page 27 Thursday, April 4, 2002 8:15 AM Introduction PPC buttons Select:SEL Activate: The SEL button steps through each of the displays and menus. ACT Activate: The ACT button activates programming changes in the Pump, new information to be entered into the PPC memory, and alarms to be turned off. As a safety check, ACT must be pressed to complete any programming changes. A single beep is heard after activating a change.
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Dmp9196021-011_c.book Page 28 Thursday, April 4, 2002 8:15 AM 28 Personal Pump Communicator (PPC) Communicating with the pump Place the PPC near the Pump when the screen displays, “PPC COMMUNICATING.” The word "COMMUNICATING" will blink as indication of succesfull communication. If a communication link between the PPC and Pump is not established, a “TELEMETRY COMM ERROR 3” message will appear. The PPC will beep six times once every minute until the screen is acknowledged by pressing SEL and ACT.
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Dmp9196021-011_c.book Page 29 Thursday, April 4, 2002 8:15 AM Introduction Install/Replace the main battery The battery used to power the PPC is a 1.5v AA alkaline. The life of the battery is approximately 8 weeks during normal usage conditions. If the vibrator mode is selected, the battery life is approximately 6 weeks. • Locate the battery door on the back of the PPC. • Slide the locking bar to the left.
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Dmp9196021-011_c.book Page 30 Thursday, April 4, 2002 8:15 AM 30 Personal Pump Communicator (PPC) NOTE: When the PPC displays “PPC LOW BATTERY”, the message can be cleared, and programming continued. There should be sufficient energy in the battery to communicate with the Pump a few more times, but the battery should be changed as soon as possible.
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Dmp9196021-011_c.book Page 31 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization Part 1: PPC/Pump system initialization The Implantable Insulin Pump arrives from MiniMed with preset factory default values. During the initialization process these preset values are downloaded into the PPC memory. The preset values can then be changed by the healthcare professional, allowing the system to be personalized for each patient.
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Dmp9196021-011_c.book Page 32 Thursday, April 4, 2002 8:15 AM 32 Personal Pump Communicator (PPC) Initialize the PPC When the healthcare professional receives a new PPC it must be “married” to the Pump. Following are the basic steps used to initialize a Pump System the day prior to implant: 1. The PPC is delivered without a battery in place. After installing a new battery, the PPC will beep six times and the screen will identify the PPC software used (see Chapter 1, Install/Replace the Main Battery).
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Dmp9196021-011_c.book Page 33 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization 6. The screen will read “PUMP SUS- PENDED”. The Pump and PPC are now “married”. PUMP SUSPENDED 7. Press SEL, then ACT and place the PPC near the Pump. PPC COMMUNICATING 8. The screen now reads “PUMP INITIALIZED”. PUMP INITIALIZED 9. Press SEL and then ACT again, and the PPC will display the Time/Date screen.
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Dmp9196021-011_c.book Page 34 Thursday, April 4, 2002 8:15 AM 34 Personal Pump Communicator (PPC) Set the time and date The time and date settings must be correct to ensure accurate calculation of insulin delivery, daily totals, and the proper display of insulin activity history. 1. Press SEL until the “SETUP PUMP” 08:32 Jan 02 screen is displayed, then press ACT two SET 2000 TIME-DATE times. The first two digits of the time (hours) will be flashing.
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Dmp9196021-011_c.book Page 35 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization Set alarms Alarms alert the user in the event the PPC or Pump recognizes an insulin delivery problem. The Alarm Feedback screen must always be in the “ON” position. 1. Press ACT to enter the “ALARMS” menu. ALARMS 2. The PPC has three alarm options, two audible tones (Low/High) and a vibrate mode. Press the ▲ and ▼ buttons to select the desired alarm, then press ACT.
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Dmp9196021-011_c.book Page 36 Thursday, April 4, 2002 8:15 AM 36 Personal Pump Communicator (PPC) Set maximum bolus, basal rate and time display format This programming is performed in the “SETUP II” menus. These screens allow healthcare professionals to limit the maximum amount of insulin a patient can deliver, either when taking a bolus or setting a new basal rate. Access to the “SETUP II” menus is through the “SETUP PUMP” screen. 1. Press SEL until the “SETUP PUMP” screen is displayed.
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Dmp9196021-011_c.book Page 37 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization 6. Press ACT and the screen will change to “SET TIME FORMAT.” Press the ▲ and ▼ buttons to select either a 12 hour (AM/ PM) or 24 hour (military time) format, and then press ACT. SET TIME FORMAT 12/24 HOUR 7. Place the PPC near the Pump and com- plete the communication process. The PPC screen will return to the “PERSONAL EVENTS” screen. Allow the PPC to time out and return to the Time/ Date screen.
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Dmp9196021-011_c.book Page 38 Thursday, April 4, 2002 8:15 AM 38 Personal Pump Communicator (PPC) Lock maximum bolus/basal, enter personal ID and password, stop Pump To access the Supervisor Mode press SEL until the “SETUP PUMP” screen is displayed. Then press and hold down the ▲ and ▼ buttons simultaneously until the “ENTER SUPERVISOR PASSWORD” screen appears. WARNING ! Patients should not be given the Supervisor Mode password, to avoid the accidental programming of a large priming bolus (99.
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Dmp9196021-011_c.book Page 39 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization 4. Place the PPC near the Pump and com- plete the communication process. The PPC screen will automatically advance to the “PERSONAL ID” screen. Press ACT. PPC COMMUNICATING 5. The first of the 32 possible ID locations is flashing. Enter the patient ID (alphanumeric) by pressing the ▲ and ▼ buttons and then ACT after each entry. Continue to press ACT, activating each “0” until the screen changes.
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Dmp9196021-011_c.book Page 40 Thursday, April 4, 2002 8:15 AM 40 Personal Pump Communicator (PPC) Program a basal rate 1. From the Time/Date screen, press SEL until the “BASAL RATE” screen is displayed. Preset delivery pattern “A”, a basal rate of 0.2 U/H, and the word “NOW” is flashing. Press ACT. 08:26 OCT 12 2. A “1” now appears to the right of the “A” indicating that this programming will BASAL RATE : A NOW effect the 1st basal change within the “A” 00:00 0.
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Dmp9196021-011_c.book Page 41 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization 5. The PPC will briefly display the calcu- lated total basal dose for 24 hours, based on the values and times entered in the Basal Rate programming screen. In this example, the total basal dose is 4.8 U/day. 24 HOUR TOTAL 4.
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Dmp9196021-011_c.book Page 42 Thursday, April 4, 2002 8:15 AM 42 Personal Pump Communicator (PPC) Part 2: Additional PPC programming features Main menu This second part will develop how to program the additional features that the patient or the healthcare professional can activate. Program a bolus A properly initialized PPC is now ready to program a bolus. The PPC/Pump allows you to set and deliver a bolus of insulin whenever needed.
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Dmp9196021-011_c.book Page 43 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 3. Press ACT and the “CONFIRM” screen is displayed, with the screen flashing. Confirm the bolus amount by pressing ACT again. CONFIRM IMM 2.6U 4. Place the PPC near the Pump and com- plete the communication process. PPC COMMUNICATING 5. When the bolus programming is com- plete, the PPC will beep once and then briefly display the amount of insulin currently delivered. 08:13 BOLUS Jan 02 0.
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Dmp9196021-011_c.book Page 44 Thursday, April 4, 2002 8:15 AM 44 Personal Pump Communicator (PPC) Set a normal bolus with the variable bolus feature turned on 1. From the Time/Date screen press SEL until the “BOLUS” screen is displayed. The last bolus value programmed and the Time and Date will be flashing. 08:13 BOLUS IMM -- U Jan 02 EXT -- U 2. Press ACT and the “SET BOLUS TYPE” screen appears. If “NORMAL” is not flashing, use the ▲ and ▼ buttons to select “NORMAL.” Press ACT.
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Dmp9196021-011_c.book Page 45 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features Set a square wave bolus A Square Wave Bolus of insulin is delivered evenly over a preset period of time, from 30 minutes to 4 hours. A Square Wave Bolus may be desirable when eating long meals such as banquets or receptions, high fat meals, or to compensate for gastroparesis. During a Square Wave Bolus, the programmed basal rate is also delivered.
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Dmp9196021-011_c.book Page 46 Thursday, April 4, 2002 8:15 AM 46 Personal Pump Communicator (PPC) 6. Place the PPC near the Pump and com- plete the communication process. 7. When the bolus programming is com- plete, the PPC will beep once and then briefly display the amount of insulin currently delivered. PPC COMMUNICATING 16:06 JAN 03 BOLUS 0.0U The Pump will beep at each of the first five strokes (if audio feedback is ON). The PPC beeps at the end of the bolus.
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Dmp9196021-011_c.book Page 47 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features Set a dual wave bolus The Dual Wave Bolus programs a Normal Bolus immediately followed by a Square Wave Bolus. To access this feature you must first turn the Variable Bolus feature ON in the SETUP II menu. 1. From the Time/Date screen, press SEL. The “BOLUS” screen is displayed, showing the last bolus programmed with the time and date flashing.
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Dmp9196021-011_c.book Page 48 Thursday, April 4, 2002 8:15 AM 48 Personal Pump Communicator (PPC) 6. Press ACT and the “CONFIRM BOLUS” screen is displayed, with the screen flashing. Confirm the Dual Wave Bolus by pressing ACT again. CONFIRM BOLUS IMM EXT 2.0u 2.0u 2:00 7. Place the PPC over the pump and com- plete the communication process. PPC COMMUNICATING 8. When the bolus programming is com- plete, the PPC will beep once and then briefly display the amount of insulin currently delivered.
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Dmp9196021-011_c.book Page 49 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features Review bolus history To review the type, amount, time and day of your last 512 insulin boluses. 1. From the Time/Date screen, press SEL. The “BOLUS” screen is displayed, showing the last bolus programmed. Use the ▲ and ▼ buttons to display previous boluses, along with the time and day each bolus was delivered.
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Dmp9196021-011_c.book Page 50 Thursday, April 4, 2002 8:15 AM 50 Personal Pump Communicator (PPC) Programming a basal rate Basic basal rate programming was described in earlier in this chapter. This section describes additional basal rate options. Programming basal delivery pattern The PPC allows three basal delivery patterns. One such basal pattern could be used for a working day, another for a weekend day, etc.
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Dmp9196021-011_c.book Page 51 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features Setting basal rate profiles in each delivery pattern Each of the basal delivery patterns is a set of up to 48 basal rates, one for each half-hour of the day. 1. Press SEL until the “BASAL RATE” screen is displayed. A basal pattern is selected (for example Pattern A). Press ACT. BASAL RATE : A NOW 0.2U/H 00:00 2.
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Dmp9196021-011_c.book Page 52 Thursday, April 4, 2002 8:15 AM 52 Personal Pump Communicator (PPC) 5. A “3” now appears on the screen with “SET TIME.” Follow the same procedure previously described and program a new profile. If no additional profiles are needed change the flashing time to dashes (by pressing ▼ ) and press ACT. SET TIME BASAL RATE : 05:00 3 0.2u/h 6. The screen will indicate “PPC COMMU- NICATING.” Place the PPC near the Pump and complete the communication process.
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Dmp9196021-011_c.book Page 53 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 3. Press ACT and “SET AMOUNT” screen appears. The amount of the Temporary Basal Rate is now flashing. Press the ▲ and ▼ buttons to enter a delivery amount. Press ACT again. SET AMOUNT TEMP BASAL 1.5u/h 00:30 4. Place the PPC near the Pump and com- plete the communication process. 5. When the communication is complete, the Pump will beep once.
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Dmp9196021-011_c.book Page 54 Thursday, April 4, 2002 8:15 AM 54 Personal Pump Communicator (PPC) Stop a temporary basal rate 1. From the Time/Date screen press SEL until the “TEMP BASAL” screen is displayed. Press ACT and the “SET DURATION” appears, with the time duration flashing. Press ▼ once until it resets to dashes. Then press ACT. SET DURATION TEMP BASAL --- --1.5u/h 2. Place the PPC near the Pump and com- plete the communication process. PPC COMMUNICATING 3.
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Dmp9196021-011_c.book Page 55 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 2. Press ACT and “ON” or “OFF” begins flashing. PERSONAL ON/OFF EVENTS 3. Use the ▲ and ▼ buttons to select “ON”, then press ACT again. The “PERSONAL EVENTS” screen will now appear on the main menu. Allow the PPC to return to the Time/Date screen. SET PERSONAL ON/OFF EVENTS 4. To set an event: From the Time/Date screen press SEL until the “EVENT” screen is displayed then press ACT.
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Dmp9196021-011_c.book Page 56 Thursday, April 4, 2002 8:15 AM 56 Personal Pump Communicator (PPC) History Historical Pump data, such as insulin medication remaining, amount of bolus and basal delivery since the last refill, etc., can be accessed and read on the PPC. 1. From the Time/Date screen press SEL until the “HISTORY” screen is displayed. Press ACT and the “READ PUMP DATA” screen will appear flashing. Press ACT again. READ PUMP DATA 000000000000000000000000 000000000000000000010057 2.
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Dmp9196021-011_c.book Page 57 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 6. Press SEL and the screen will change to “CLINICAL HISTORY PUMP”. Use the ▲ and ▼ buttons to review Pump events. 6:26 Jan 02 CLINICAL HISTORY PUMP 14 7. Press SEL and the screen will change to Jan 02 “EST PUMP BATT”. This screen indiEST PUMP BATTERY NO LD LD cates the Pump battery status, during no2.9 V 2.
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Dmp9196021-011_c.book Page 58 Thursday, April 4, 2002 8:15 AM 58 Personal Pump Communicator (PPC) Setup Pump The “SETUP PUMP” screen permits access to the primary Setup menus for the Pump. Setup features discussed previously in this chapter are referenced here. Other Setup features not previously discussed are presented here. Press SEL until the “SETUP PUMP” screen is displayed, then press ACT to access the SETUP menus.
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Dmp9196021-011_c.book Page 59 Thursday, April 4, 2002 8:15 AM Setup Pump Self test 1. Self Test allows the user to perform a diagnostic test of the Pump and PPC operating system. Messages are relayed between the PPC and Pump. From the “SETUP PUMP” screen, press ACT. Press SEL until the “SELF TEST” screen is displayed. Press ACT. SELF TEST 2. Place the PPC near the Pump and com- plete the communication process.
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Dmp9196021-011_c.book Page 60 Thursday, April 4, 2002 8:15 AM 60 Personal Pump Communicator (PPC) Initialize PPC to Pump From the “SETUP PUMP” screen press ACT until “INITIALIZE PPC TO PUMP” is displayed. This option “marries” the PPC to the Pump, and it is used to initialize a new PPC. For initialization programming follow the steps described in, Part 1: PPC/Pump sytem initialization. Setup II “SETUP II” permits access to an additional group of Setup menus for the Pump.
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Dmp9196021-011_c.book Page 61 Thursday, April 4, 2002 8:15 AM Setup II Setup II Audio bolus The Audio Bolus feature allows the user to deliver a bolus without looking at the PPC screen. There are two Audio Bolus increments, 0.4U and 0.8U. With each press of the ▲ button, the PPC will beep one time (0.4U setting) or two times (0.8U setting), depending on the delivery amount selected per button press. Activating the audio bolus feature 1. From the “SETUP II” screen, press ACT.
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Dmp9196021-011_c.book Page 62 Thursday, April 4, 2002 8:15 AM 62 Personal Pump Communicator (PPC) Set an audio bolus from the main menu bolus screen 1. From the Time/Date screen press the ▲ button. The PPC beeps either one or two times, depending upon the audio bolus step amount set. The user counts the number of beeps to determine how much insulin was programmed. SET BOLUS IMM 0.8U 2. In this example the PPC was programmed for a 0.8U increment, and the PPC beeps PPC two times for the 0.8U bolus.
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Dmp9196021-011_c.book Page 63 Thursday, April 4, 2002 8:15 AM Setup II Place the PPC near the Pump to complete communication. If “ON” was chosen the Variable Bolus option is now available in the Main Menu/Bolus screen. PPC COMMUNICATING NOTE: If “OFF” is chosen, theVariable Bolus option (Square, Dual) will not be available in the (Main Menu) Bolus screen.
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Dmp9196021-011_c.book Page 64 Thursday, April 4, 2002 8:15 AM 64 Personal Pump Communicator (PPC) Refill The refill procedure will be described in Chapter 5 “Pump Refill Procedure.” The following screens are used at the end of this procedure, and allow you to enter the new refill volume and to calculate the refill accuracy. The "PUMP REFILL" screen appears when you access the Supervisor Mode. Press ACT. PUMP REFILL The PPC prompts for the residual amount of insulin removed from the Pump.
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Dmp9196021-011_c.book Page 65 Thursday, April 4, 2002 8:15 AM Setup II Priming WARNING ! A priming bolus is not intended as a therapeutic bolus. It should be only used when the Pump is not implanted. The Priming Bolus is used during the preparation of the Pump for implantation. This feature “Primes” the Pump piston chamber, outlet port and Catheter. The Pump will pulse approximately 500 times during this function. To access this feature, the Pump must be in “PUMP STOPPED” mode. 1.
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Dmp9196021-011_c.book Page 66 Thursday, April 4, 2002 8:15 AM 66 Personal Pump Communicator (PPC) 5. The word “CONFIRM” now appears. Press ACT to activate the factory preset priming bolus of 99.8U. CONFIRM PRIMING YES 99.8u 6. Place the PPC over the Pump and com- plete the communication process. PPC COMMUNICATING 7. The progress of the Priming Bolus can be verified by pressing SEL. The Priming Bolus takes approximately 10 minutes to complete. 08:13 OCT 12 PRIMING 0.
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Dmp9196021-011_c.book Page 67 Thursday, April 4, 2002 8:15 AM Setup II Diagnostic rate WARNING A diagnostic rate is intended for use only when the Pump is filled with buffer. ! The Diagnostic Rate feature is used to help “diagnose” Pump delivery problems. Fill the Pump with rinse buffer before using this feature. To access this feature, the Pump must be in the “PUMP STOPPED” mode. 1. From the “PUMP STOPPED” screen, press SEL. The screen will begin flashing. 08:13 OCT 12 PUMP STOPPED 2.
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Dmp9196021-011_c.book Page 68 Thursday, April 4, 2002 8:15 AM 68 Personal Pump Communicator (PPC) 6. The entire screen will be flashing. Press ACT again to confirm the Diagnostic Delivery Rate. CONFIRM DIAGNOSTIC RATE 10 u/h 7. Place the PPC near the Pump and com- plete the communication process. PPC COMMUNICATING 8. The words “DIAGNOSTIC RATE” appear briefly on the screen.The PPC then returns to the Time/Date screen.
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Dmp9196021-011_c.book Page 69 Thursday, April 4, 2002 8:15 AM Setup II Initialize to factory defaults This feature resets all programmed parameters in the Pump to preset factory default values. To access this feature, the Pump must be in the “PUMP STOPPED” mode. 1. From the “PUMP STOPPED” screen, press SEL. The screen will begin flashing. 2. Press the ▲ and ▼ buttons at the same time until the “ENTER SUPERVISOR PASSWORD” screen appears.
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Dmp9196021-011_c.book Page 70 Thursday, April 4, 2002 8:15 AM 70 Personal Pump Communicator (PPC) 7. Place the PPC over the Pump and com- plete the communication process. PPC COMMUNICATING 8. The PPC now displays the “PUMP RESET” screen, and beeps six times every minute until the Pump is restarted. Press SEL then ACT. The PPC returns to the Time/Date screen. The Pump may now be reprogrammed. 08:13 OCT 02 PUMP RESET Download software This feature has been disabled at the factory. 1.
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Dmp9196021-011_c.book Page 71 Thursday, April 4, 2002 8:15 AM Setup II Place the PPC near the Pump and allow the communication to complete. PPC COMMUNICATING The PPC will beep four times to confirm the “STOP PUMP” command. To restart the Pump, press SEL and “PUMP STOPPED” will start to flash. Press ACT. Place the PPC near the Pump. When the communication is complete, the PPC returns to the Time/Date screen.
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Dmp9196021-011_c.book Page 72 Thursday, April 4, 2002 8:15 AM 72 Personal Pump Communicator (PPC) Exit supervisor To exit the Supervisor Programming Menu, press SEL until the “EXIT SUPERVISOR” screen appears, then press ACT. Personal Pump communicator messages Display Screen Message Message Meaning or Action Required AUTO OFF PUMP PUMP SUSPENDED Auto Off time interval has elapsed. Pump operation is suspended. BOLUS 0.0 u A bolus has been programmed and is being delivered.
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Dmp9196021-011_c.book Page 73 Thursday, April 4, 2002 8:15 AM Setup II Display Screen Message Message Meaning or Action Required PUMP INITIALIZED The PPC has been “married” to a Pump . Press SEL and ACT. PRIMING A Priming Bolus has been programmed and is being delivered. XX U PUMP RESET The Pump was reprogrammed to the preset factory values. PUMP SELF TEST FAIL A Pump malfunction was detected during a Self Test. Notify your physician immediately. PUMP STOPPED The Pump is in stop mode.
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Dmp9196021-011_c.book Page 74 Thursday, April 4, 2002 8:15 AM 74 Personal Pump Communicator (PPC) Clinical history codes In the “HISTORY” menu, the user can access clinical history from the PPC and the Pump. Each number code corresponds to a particular event. The following table lists each of the number codes with their corresponding events.
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Dmp9196021-011_c.book Page 77 Thursday, April 4, 2002 8:15 AM 77 CHAPTER 4 Pump Implantation Preprogramming and pre-testing the pump Every Implantable Insulin Pump is fully tested before shipment and is accompanied by a package insert indicating the measured stroke volume and Pump type. Prior to shipping, each Pump is filled with sterile rinse buffer to assure sterility. Programming of the Pump may be performed a day before Pump implantation.
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Dmp9196021-011_c.book Page 78 Thursday, April 4, 2002 8:15 AM 78 Pump Implantation Supplies and solutions Before preparing the Pump, be sure to read Appendix D, Precautions and General Procedures. Assemble the necessary materials prior to starting the procedure: Supplies • One (1) 100 µL sterile pipette (available non sterile from MiniMed) MMT-4104 • One (1) sterile scalpel blade • One (1) scale (0.
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Dmp9196021-011_c.book Page 79 Thursday, April 4, 2002 8:15 AM Preprogramming and pre-testing the pump Emptying and filling the Pump To prepare the Pump for implantation, the Pump must be emptied and then filled twice and tested with insulin. These procedures are performed in the operating room prior to implanting the patient. As this is a surgery, all supplies and required equipment should be prepared in accordance with the institution’s approved sterile procedures.
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Dmp9196021-011_c.book Page 80 Thursday, April 4, 2002 8:15 AM 80 Pump Implantation Remove shipping fluid from the Pump 1. Using aseptic technique, open the Pump sterile package. Do not remove the plastic tubing from the Pump outlet. Trim the distal part of the tubing with the scalpel blade. 2. Remove the refill syringe from the refill kit package. 3. Firmly attach the two-way stopcock to the refill syringe and attach an 18 gauge needle to the stopcock. 4.
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Dmp9196021-011_c.book Page 81 Thursday, April 4, 2002 8:15 AM Preprogramming and pre-testing the pump 6. Retract the plunger until it locks into place. This should be no further than 55 mL. Do not go beyond the vent hole. Press the lock into the plunger groove to be sure it is firmly secured. 7. Fill one 3 mL syringe with RINSE BUFFER (RB) and attach a needle. 8. Fill the Pump fill port using the 3 mL syringe.
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Dmp9196021-011_c.book Page 82 Thursday, April 4, 2002 8:15 AM 82 Pump Implantation Rinse the Pump with insulin (IN1) 11. Remove the second refill syringe from the refill kit package. 12. Firmly attach the two-way stopcock to the refill syringe and attach an 18 gauge needle to the stopcock. Use the sterile marker to label the syringe, “IN1”. 13. Draw 20 mL of INSULIN (two vials) into the refill syringe. 14. Remove the 18 gauge needle and expel all air bubbles in the syringe. 15. Close the stopcock. 16.
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Dmp9196021-011_c.book Page 83 Thursday, April 4, 2002 8:15 AM Preprogramming and pre-testing the pump OPTIONAL 25. Use this step only if the plunger is not moving forward while filling the reservoir. 26. With the refill needle pointing down, vent the syringe head space by pulling back firmly on the plunger until the second sealing ring on the black rubber cap passes beyond the vent hole (see Figure 7).
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Dmp9196021-011_c.book Page 84 Thursday, April 4, 2002 8:15 AM 84 Pump Implantation 27. With the stopcock closed, press the refill needle into the Pump fill port. 28. Open the stopcock. Maintain downward pressure on the barrel of the syringe to ensure the inlet valve of the Pump remains open. WARNING ! Never push on the refill syringe plunger to fill the Pump. When the refill needle is properly seated in the fill port of the Pump, the vacuum in the reservoir will draw the insulin from the syringe.