Medtronic MiniMed 2007D Implantable Insulin Pump System Physician’s Manual
© 2003, Medtronic MiniMed. All rights reserved. Medtronic MiniMed™ is a trademark of Medtronic MiniMed Dual Wave™ is a trademark of Medtronic MiniMed Square Wave™ is a trademark of Medtronic MiniMed Steri-strip® is a registered mark from 3M Aventis® is a registered mark from Aventis Pharmaceutical Genapol® is a registered mark from Aventis Pharmaceutical Luer Lok® is a registered mark from BD and Co. This device is protected under one or more of the following U.S.
i Table of contents CHAPTER 1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Implantable Insulin Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Insulin medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ii Program a basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Part 2: Additional PPC programming features . . . . . . . . . . . . . . . . . . . . . . . 23 Main menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Program a bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Set a Normal bolus with the Variable Bolus feature turned off . . . . . . . .
iii Set an Audio Bolus from the main menu bolus screen . . . . . . . . . . . . . . 41 Variable Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Maximum Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Maximum Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Time display format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iv Fill the Pump with insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Measure stroke volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Prepare the Side Port Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Performing the surgical procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Pre-operative evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
v CHAPTER 7 Warnings and precautions . . . . . . . . . . . . . . . 81 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Electrotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Diagnostic ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Ultrasound therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
vi Initialize alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 PPC not initialized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Battery replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Initialize to factory defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Pump stopped . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
vii General procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Locating the pump fill port and the side port . . . . . . . . . . . . . . . . . . . . . 111 Accessing the pump inlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Venting the Medtronic MiniMed refill syringe (optional) . . . . . . . . . . . 113 APPENDIX E Pump rinse procedure . . . . . . . . . . . . . . . . . . . . 115 Supplies and solutions . . . . . . . . . . . . . . . . . .
viii Flush side port catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 Remove rinse buffer and fill with insulin . . . . . . . . . . . . . . . . . . . . . . . 133 Equilibrate and pull insulin through system . . . . . . . . . . . . . . . . . . . . . 134 Remove guide needles and record refill amount . . . . . . . . . . . . . . . . . . 135 Program new basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ix List of figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Figure 8: Figure 9: Figure 10: Figure 11: Figure 12: Figure 13: Figure 14: Figure 15: Figure 16: Figure 17: Figure 18: Figure 19: Implantable Insulin Pump and Personal Pump Communicator (PPC) . . . . . . . . . . . . . . . 1 The Implantable Insulin Pump . . . . . . . . . . . . . . . . . . . . 3 Interior of the Implantable Insulin Pump . . . . . . . . . . . . 4 The Intraperitoneal Catheter and Side Port . . . . . . . .
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1 CHAPTER 1 Description Introduction The Medtronic MiniMed 2007D Implantable Insulin Pump System, shown in Figure 1, brings together sophisticated new technologies to provide continuous intraperitoneal insulin therapy for patients with Insulin Dependent Diabetes Mellitus (IDDM).
2 Description This manual is intended for use by the physician, surgeon, nurse specialist and all other members of the healthcare team who care for patients with the Medtronic MiniMed 2007D Implantable Insulin Pump System. The Medtronic MiniMed 2007D Implantable Insulin Pump System can be used with special U-400 insulin formulations specifically labeled for use with the Medtronic MiniMed Implantable Insulin Pump System.
Description 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. A tangential Side Port Catheter is attached to the Pump prior to implant, using a locking connector (see Figure 2).
4 Description 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, cyclopentane gas and 20µm filter. Figure 3 shows the interior components of the Pump. Figure 3: Interior of the Implantable Insulin Pump The Medication Reservoir stores approximately 15 ml or 6,000 units of a special U-400 insulin.
Description The Pumping Mechanism is a solenoid-operated, hermetically-welded pulsatile system. The pumping mechanism is designed to seal automatically to prevent leakage both into and out of the reservoir under physiologic temperatures and pressures. The mechanism is designed to provide an insulin delivery accuracy of within 10% from its labeled stroke volume. Individual Pumps are calibrated to one of seventeen different stroke volumes, ranging from 0.42 µL to 0.58 µL per stroke, in increments of 0.01 µL.
6 Description Side Port Catheter The Side Port Catheter (Catheter) transports insulin from the Pump into an individual’s peritoneum where it is absorbed. The Catheter is made of polyethylene-lined silicone rubber, which is biocompatible with subcutaneous and intraperitoneal tissues and supports the stability of the special insulin.
Description Personal Pump Communicator (PPC) The Personal Pump Communicator (PPC) is the hand-held component of the Medtronic MiniMed 2007D 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. Additionally, the PPC stores important programming information in its memory.
8 Description
9 CHAPTER 2 Indications and contraindications Indications for use The Medtronic MiniMed 2007D Implantable Insulin Pump System is indicated for intraperitoneal administration of exogenous insulin in patients with diabetes mellitus. The model 2007D Pump can only be used with special U-400 Insulin formulations specifically labeled for use with the Medtronic MiniMed Implantable Insulin Pump Infusion System.
10 Indications and contraindications Possible adverse effects The model 2007D is essentially identical to the model 2007C Pump except for the change in gas needed to maintain negative pressure in the reservoir. Evaluation of components used in the Medtronic MiniMed 2007C system has spanned a period of approximately 4 years and involved approximately 380 patients from both the U.S. and Europe.
11 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. The PPC cannot be used by the patient until it has been initialized by the healthcare professional. This chapter of the manual is divided in two parts: The first part (Part 1) will describe the PPC/PUMP system initialization process that will be performed the day prior to implant.
12 Personal Pump Communicator (PPC) Certain features of the PPC such as programming and dosing limits can be set only by the healthcare professional in a password-protected mode called the Supervisor Mode. Information pertaining to initializing the PPC and entering the PPC Supervisor Mode is not included in the Patient User Manual. PPC buttons SEL (Select) The SEL button steps through each of the displays and menus.
Personal Pump Communicator (PPC) • The PPC cannot be turned off. Once the battery has been installed, the PPC is on and remains on until the battery is removed. • Certain types of Radio Frequency (RF) generating equipment could affect PPC communication with the Pump. If you are experiencing communication difficulties, change locations. • The time and date settings must be correct to ensure appropriate calculation of insulin delivery and display of daily totals and activity history.
14 Personal Pump Communicator (PPC) 2. Press SEL then ACT, and place the PPC near the Pump. PPC COMMUNICATING 3. Wait a few seconds for the communication to complete. 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.
Personal Pump Communicator (PPC) Part 1: PPC/Pump system initialization The Implantable Insulin Pump arrives from Medtronic 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. The factory default values are as follows: Bolus delivery type: Normal Maximum bolus: 25.
16 Personal Pump Communicator (PPC) 3. When a communication link has been established, the screen will read, “PPC COMMUNICATING”, and then will change to the next screen. 4. “NO” is blinking. Check to make sure the serial number displayed on the screen matches the Pump serial number. Press either or once to change “NO” to “YES” and then press ACT. Place the PPC over the Pump. screen again reads “PPC COMMUNICATING”, and the PPC will beep 3 times at the end of the programming sequence.
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” screen is displayed, then press ACT two times. The first two digits of the time (hours) will be flashing. Use the and buttons to select the correct hour, then press ACT. The last two digits of the time (minutes) will be flashing.
18 Personal Pump Communicator (PPC) 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. SET PPC ALARM TYPE LOW/HIGH/VIBRATE 3. The screen will now display “SET ALARM FEEDBACK”.
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. Press ACT and press SEL to reach the “SETUP II” screen.
20 Personal Pump Communicator (PPC) 7. Place the PPC near the Pump and complete 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. PPC COMMUNICATING NOTE: Adding screens to the main menu, such as “PERSONAL EVENTS” increases the number of SEL button presses required to reach “SETUP PUMP.
Personal Pump Communicator (PPC) 4. Place the PPC near the Pump and complete 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 (alpha-numeric) by pressing the and buttons and then ACT after each entry. Continue to press ACT, activating each “0” until the screen changes. SET PERSONAL ID •••••••••••••••• • • • • • • • • • 20KOLO5 6.
22 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 effect the 1st basal change within the “A” pattern, (there are 3 patterns available [A, B, C] and 48 basal changes possible within each pattern). The flashing 0.
Personal Pump Communicator (PPC) Part 2: Additional PPC programming features Main menu This second part will describe 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. The PPC has several special features which allow you to customize the programming and delivery of boluses.
24 Personal Pump Communicator (PPC) Set a Normal bolus with the Variable Bolus feature turned off 1. From the Time/Date screen, press SEL. The “BOLUS” screen is displayed, with the time and date flashing. 08:13 Jas2 BOLUS IMM 10U EXT 10U -- PROG 2. Press ACT and the “SET BOLUS” screen appears. The dashes under “IMM” are flashing. Press the and buttons to enter an immediate bolus amount. SET BOLUS IMM __U 3. Press ACT and the “CONFIRM” screen is displayed, with the screen flashing.
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. SET BOLUS TYPE NORMAL 3. The “SET BOLUS” screen appears, with dashes under “IMM” flashing.
26 Personal Pump Communicator (PPC) 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 at banquets or receptions, high fat meals, or to compensate for gastroparesis. During a Square Wave Bolus, the programmed basal rate is delivered simultaneously to the bolus. To access this feature you must first turn the Variable Bolus feature “ON” in the “SETUP II” menu.
Personal Pump Communicator (PPC) 7. When the bolus programming is complete, the PPC will beep once and then briefly display the amount of insulin currently delivered. 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. Three segments of the insulin delivery icon will be displayed and spinning slowly during the bolus delivery. By pressing SEL you can read the amount of insulin delivered.
28 Personal Pump Communicator (PPC) 5. Blinking dashes will now appear under the bolus amount entered. Use the and buttons to enter a time duration for the Square Wave Bolus, in one-half hour increments from 30 minutes to four hours. SET BOLUS IMM 2.0U EXT 2:00 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.
Personal Pump Communicator (PPC) Suspend mode The Suspend Pump mode allows the user to cancel a bolus delivery, while still delivering a basal rate of 0.2 U/hr. 1. From the Time/Date screen, press SEL until the “SUSPEND PUMP” screen is displayed. Press ACT. The screen will display a flashing “SUSPEND PUMP” message. Press ACT again. SUSPEND PUMP 2. Place the PPC near the Pump and complete the communication process. PPC COMMUNICATING 3.
30 Personal Pump Communicator (PPC) Programming a basal rate Basic basal rate programming was described 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. Each of the basal delivery patterns is a set of up to 48 basal rates, one for each half-hour of the day. Pattern A is the factory pre-set.
31 Personal Pump Communicator (PPC) 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 00:00 0.2U/H 2. A “SET RATE” and “1” is now displayed to the right of the “A” indicating this programming will set the 1st basal rate within the “A” profile. The “0.
32 Personal Pump Communicator (PPC) 6. The screen will indicate “PPC COMMUNICATING.” Place the PPC near the Pump and complete the communication process. PPC COMMUNICATING 7. The screen will briefly display the calculated 24 hour basal dose based on the basal rate programming. In this example a total of “8.4U” will be delivered. 24 HOUR TOTAL 8.4U To set multiple basal profiles in the other patterns (A,B,C), select the pattern in "SETUP II" menu and follow the same procedure.
Personal Pump Communicator (PPC) 4. Place the PPC near the Pump and complete the communication process. 5. When the communication is complete, the Pump will beep once. The PPC screen will briefly show the “TEMP BASAL” screen before returning to the Time/Date screen. PPC COMMUNICATING 08:13 OCT 02 TEMP BASAL NOTE: When the Pump is delivering a Temporary Basal rate, the first screen displayed when SEL is pressed is “TEMP BASAL.
34 Personal Pump Communicator (PPC) Personal events This feature allows the user to enter event codes into the PPC memory, and record the time and date of entry. Preset event codes are: 1 = meal, 2 = snack, 3 = sick and 4 = exercise. In addition, other event codes A, B and C can be entered to record other important events. These other event codes should be documented prior to their use. To access the “EVENTS” screen in the main menu, “ON” must be activated in the “SETUP II” menu, “PERSONAL EVENTS” screen.
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 0000000000000000 0000000000010057 2. Place the PPC near the Pump and complete the communication process.
36 Personal Pump Communicator (PPC) 7. Press SEL and the screen will change to “EST PUMP BATT”. This screen indicates the Pump battery status, during no-load (battery power is not used) and load (extended communication sequence) conditions. The Pump is set to alarm for low battery when the loaded (LD) voltage is at or below 2.5 volts. SEL and the screen will read “EXIT HISTORY.” Press ACT. The PPC will return to the Time/Date screen. Jan 02 EST PUMP BATTERY NO LD LD 2.9V 2.7V 8.
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. Time and Date This feature is previously described in this Chapter.
38 Personal Pump Communicator (PPC) Alarms This feature is previously described in this Chapter. 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 complete the communication process. PPC COMMUNICATING 3.
Personal Pump Communicator (PPC) Basal delivery pattern This feature is previously described in this Chapter. 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 System initialization of this Chapter. Setup II “SETUP II” permits access to an additional group of Setup menus for the Pump.
40 Personal Pump Communicator (PPC) 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. The AUDIO BOLUS “AUDIO BOLUS" screen is shown. ON 2.
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 two times for PPC the 0.8U bolus.
42 Personal Pump Communicator (PPC) Maximum Bolus This feature is previously described in this Chapter. Maximum Basal Rate This feature is previously described in this Chapter. Time display format This feature is previously described in this Chapter. Personal Events This feature is previously described in this Chapter. Pump Setup This screen allows the user to return to the setup mode "TIME/DATE" screen by pressing ACT. Exit Setup Menu Press SEL 7 times in the SETUP II mode.
Personal Pump Communicator (PPC) Supervisor mode To access Supervisor Mode (by a health care professional only) press SEL 6 times in the "SETUP PUMP" screen, then press and hold the and buttons simultaneously. Hold them down until the screen changes the "ENTER SUPERVISOR PASSWORD" screen. Refill The refill procedure will be described in Chapter 5 “Pump Refill Procedure.
44 Personal Pump Communicator (PPC) 6. The calculated accuracy will be displayed briefly. Record this value on the refill form. CALCULATED ACCURACY __% Priming WARNING ! A priming bolus is not intended as a therapeutic bolus. It should only be 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.
45 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 complete 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 PRIMING OCT 12 0.0U NOTE: The PPC will alarm every minute during the Priming Bolus.
46 Personal Pump Communicator (PPC) Diagnostic rate WARNING ! A diagnostic rate is intended for use only when the Pump is filled with rinse 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.
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 complete the communication process. PPC COMMUNICATING 8. The words “DIAGNOSTIC RATE” appear briefly on the screen.The PPC then returns to the Time/Date screen. NOTE: Press SEL and the “DIAGNOSTIC RATE.
48 Personal Pump Communicator (PPC) 3. When the Supervisor Password is successfully entered, the screen will change to “PUMP REFILL”. Press SEL until the “INITIALIZE TO FACTORY DEFAULTS” screen appears. 4. Press ACT and the word “CONFIRM” will appear. Press ACT again to activate. INITIALIZE TO FACTORY DEFAULTS INITIALIZE TO FACTORY DEFAULTS CONFIRM 5. Place the PPC over the Pump and complete the communication process. 6. The PPC will now read “PUMP SUSPENDED.” Press SEL then ACT.
Personal Pump Communicator (PPC) Stop Pump This screen allows the Physician to stop the operation of the Pump. 1. From the “PUMP REFILL” screen in the Supervisor Menu, press SEL until the “STOP PUMP” screen appears. STOP PUMP 2. Press ACT and the word “CONFIRM” appears highlighted with the entire screen flashing. Press ACT again to confirm. CONFIRM STOP PUMP 3. Place the PPC near the Pump and allow the communication to complete. 4. The PPC will beep four times to confirm the “STOP PUMP” command.
50 Personal Pump Communicator (PPC) Personal Pump Communicator messages Display Screen Message Message Meaning or Action Required AUTO OFF PUMP SUSPENDED Auto Off time interval has elapsed. Pump operation is suspended. BOLUS 0.0U 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. LOW RESERVOIR The PPC has recognized the Pump has 800 units (2 ml) or less insulin remaining in its reservoir.
Personal Pump Communicator (PPC) Display Screen Message Message Meaning or Action Required TELEMETRY COMM ERROR 3 The PPC and Pump are not communicating. Reposition the PPC over the Pump, then press SEL and ACT. If the error message persists, contact Medtronic MiniMed. TELEMETRY COMM ERROR 20 Move the PPC away from any other Pump and perform the request again. Technical history codes In the “HISTORY” menu, the user can access clinical history from the PPC and the Pump.
52 Personal Pump Communicator (PPC) Clinical Event Code Clinical Event Code Refill Divide Error 29 Refill Invalid Calculation 30 Divide by 0 31 EEPROM Error 32 Bad EEPROM 33 Main Battery Low 34 Temporary Basal Rate 37 Check Pump Status 38 Invalid Concentration 40 Battery Removed 42 Invalid Stroke Volume 41 Clinical history Pump codes Clinical Event Code Clinical Event Code IP Communication Error 1 Charge Time Too Long 2 Post-Fire Voltage Reading too High 3 Over-Delivery
53 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. The Implantable Insulin Pump may be programmed through the outer tray of the sterile package.
54 Pump implantation • One (1) Pump System: PPC, Pump and Side Port Catheter • Sterile markers and Steri-Strips® • Three (3) refill Kits - MMT-4105: • 1 kit to remove shipping fluid from Pump • 1 kit to fill the Pump with U-400 INSULIN (to rinse the pump) • 1 kit to fill the Pump with U-400 INSULIN (final insulin fill) • One (1) 3 mL syringe (fluid barrier) • Three (3) Medtronic MiniMed refill needles, MMT-4102 • Three (3) 18 gauge needles • One (1) Implant Worksheet • One (1) Back-up Pump System: PPC, Pu
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. Draw approximately 4 mL of RINSE BUFFER into the refill syringe. 5.
56 Pump implantation Rinse the Pump with insulin (IN1) 1. Remove the second refill syringe from the refill kit package. 2. 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”. 3. Draw 20 mL of INSULIN (two vials) into the refill syringe. 4. Remove the 18 gauge needle and expel all air bubbles in the syringe. 5. Close the stopcock. 6. Retract the plunger until it locks into place.
Pump implantation Figure 7: Venting the syringe head space 2. With the stopcock closed, insert the refill needle into the Pump fill port. 3. 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. 4.
58 Pump implantation 6. Insert the refill needle back into the Pump fill port with the stopcock closed. 7. Open the stopcock and empty the Pump. Allow 30 seconds after the INSULIN level appears to have stopped rising in the refill syringe to assure the Pump is completely emptied. 8. Close the stopcock and remove the syringe. Fill the Pump with insulin 1. Remove another refill syringe (IN2) from a refill kit package. 2.
Pump implantation 16. Remove the IN2 syringe and prepare for aspiration without expelling any fluid. Obtain a vacuum by pulling back on the plunger until it locks. Press the lock into the plunger groove to be sure it is firmly secured. 17. Reenter the Pump fill port with the stopcock closed. 18. Open the stopcock and withdraw 2 mL in order to activate the negative pressure safety feature of the Pump. Close the stopcock and remove the syringe. 19. Weigh the IN2 syringe to calculate the Pump refill amount.
60 Pump implantation Figure 8: Testing Pump stroke volume with a pipette 6. Insert the pipette into the hub. A meniscus of fluid will be present in the pipette. This should be done on a flat surface with the pipette/tubing assembly horizontal (see Figure 8). 7. Note the exact location of the fluid meniscus in the pipette. 8. Measure the stroke volume by noting the volume displaced by a minimum of 10 pulses. Record the total volume delivered and the number of pulses on the Implant Worksheet.
Pump implantation 3. (See Figure 9.) Remove the plastic tubing and tubing retainer from the Pump outlet. Remove the tubing retainer by rotating it one-quarter turn clockwise to disengage it from the connector flange. Then lift and remove the tubing and retainer together from the Pump outlet. Dispose of the tubing and retainer.
62 Pump implantation 4. Inspect the outlet of the Pump for debris. Debris, especially fibers, left in the fluid path will compromise the function of the Catheter check valve. Rinse the outlet tube of the Pump with water from a syringe, if necessary. Avoid wiping the Pump with gauze or drapes that will leave fibrous debris. 5. Pull the locking bar out and gently push the Catheter straight down onto the Pump outlet. Never twist the connector. 6.
Pump implantation 10. At the end of the bolus, rinse the outside of the Pump thoroughly with sterile water to remove traces of INSULIN. The Catheter tip should not be placed in the water. Protect the Pump with sterile drapes until the surgeon is ready to implant it. Verify that the priming bolus is finished or canceled prior to the implantation. The Pump and Catheter are now ready for implantation.
64 Pump implantation Performing the surgical procedure Pre-operative evaluation The Pump implant depth should not exceed 5 cm (2 inches) beneath the surface of the skin. If the Pump is implanted too deeply in the subcutaneous tissue it may be difficult to access the refill port. Formation of the pump pocket Pump implantation can be performed either under local or general anesthesia. After satisfactory anesthesia, a pre-selected abdominal site is prepped and draped in the customary surgical method.
Pump implantation Figure 11: Example of Pump placement 65
66 Pump implantation Catheter placement The Catheter is not designed to be tunneled subcutaneously. The Catheter insertion should be at the extreme edges of the Pump pocket. At a site not directly beneath the Pump, the layers of abdominal musculature are divided to expose the peritoneum. Concentric purse string sutures are placed and the peritoneum is exposed with a 1 cm incision. The distal tip of the Catheter is placed in the peritoneal space.
Pump implantation Post-operative management Post-operative hospitalization After implantation, the surgical incision should be inspected for any signs of unusual swelling, tenderness, pain, or drainage. Potential post-operative complications include Pump pocket seroma, wound dehiscence, wound infection, and catheter dislodgment. Length of post-operative hospitalization depends upon how rapidly the patient adjusts to the Pump and how quickly blood glucose levels stabilize.
68 Pump implantation
69 Pump refill procedure CHAPTER 5 Introduction Initial appointments for Pump Refills should be made with patients at the time of implantation. Subsequent appointments should be made in advance, normally during each refill procedure. The Pump stores approximately 6,000 units of insulin medication and typically requires a refill every two to three months. In order to maintain the physical stability of the insulin, the Pump must be refilled at a maximum interval of no more than 90 days.
70 Pump refill procedure Supplies and solutions The refill kit (MMT-4105) is intended exclusively for use with the Medtronic MiniMed 2007D Implantable Insulin Pump System. The refill kit consists of a specially designed syringe and stopcock for removing fluids from and placing fluids into the Pump. Use only refill needles (MMT-4102) available from Medtronic MiniMed to perform all Pump refill procedures.
Pump refill procedure Prepare for pump refill NOTE: Before beginning any refill, rinse, flush, or pressure measurement procedure, carefully read Appendix D, Precautions and General Procedures. WARNING ! Never push on the refill syringe plunger to fill the Pump. When the refill needle is properly seated in the Pump fill port, the vacuum in the Pump reservoir will draw the insulin from the syringe into the reservoir.
72 Pump refill procedure Perform the refill procedure Fill out the refill form Fill out the top part of the Refill Form (Appendix C) with the patient’s I.D., refill date, insulin lot number, previous refill volumes, insulin medication remaining, and the name of the person performing the refill procedure. This information can be helpful for diagnostic purposes.
Pump refill procedure Prepare the refill syringe for filling the Pump 1. Firmly attach a stopcock to the IN refill syringe and attach an 18 gauge needle to the stopcock. Draw 20 ml of U-400 insulin into the syringe. 2. Expel all air from the refill syringe. Close the stopcock and remove the 18 gauge needle. 3. 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. 4.
74 Pump refill procedure Step 3A Step 3B 18G Guide Needle 2mm Refill Needle Septum Spring Valve Filter Step 3C Step 3A: Locate the port using the 18G guide needle slide the refill needle down the guide needle. Step 3B: Pull back approximately 2mm on the guide needle to enter the Pump. Step 3C: Apply firm pressure to move the valve back and allow the insulin to pass above the valve through the filter and into the reservoir.
Pump refill procedure 4. Actuate the valve by applying a gentle downward force on the refill needle. This depresses the valve approximately 0.5 mm. 5. Open the stopcock and allow residual insulin from the Pump to be drawn into the RB refill syringe. Maintain a downward pressure on the syringe to ensure that the inlet valve in the Pump remains open. Wait 30 additional seconds after the insulin level appears to have stopped rising in the RB refill syringe to ensure the Pump is completely emptied. 6.
76 Pump refill procedure Refill the Pump 1. Use the IN refill syringe containing 20 ml of degassed insulin, at room temperature. 2. Enter the Pump by passing the refill needle with the attached IN refill syringe through the 18 gauge guide needle. Pull back slightly (approximately 2 mm) on the 18 gauge needle to allow the refill needle to enter the Pump and actuate the inlet valve (see Figure 13). 3. Open the stopcock.
Pump refill procedure 5. Remove the IN syringe. Remove the 18 gauge needle and apply pressure to the insertion site. 6. Weigh the IN syringe and record on the Refill Form. Calculate extracted and refill amounts 1. Calculate the extracted amount by using the calculation section of the refill form. 2. Calculate the refill amount by using the calculation section of the refill form. 3.
78 Pump refill procedure
79 CHAPTER 6 Explanting the Pump System Explant considerations When the battery in the Pump is depleted or if acceptable glycemic control cannot be achieved, it may become necessary to explant the Pump system. Prior to explantation, it may be possible to perform interventions that could correct certain conditions. These procedures are described in Appendices E and F.
80 Explanting the Pump System Please take the necessary precautions when shipping the Pump System via commercial carrier to avoid damage to the Pump.
81 CHAPTER 7 Warnings and precautions Warnings The Physician should be completely familiar with the function of the Pump, Catheter, and PPC prior to use. Patients should be provided a complete copy of the Patient Manual and have demonstrated the ability to program the PPC, recognize and respond to safety alarms, and take care of the device prior to discharge.
82 Warnings and precautions Diagnostic ultrasound The Medtronic MiniMed 2007D Implantable Insulin Pump System has been tested during diagnostic ultrasound procedures. These procedures have no effect on Pump performance. However, patients should be instructed to test the Pump function (e.g., self test) after such procedures to determine that the Pump and PPC are operating properly. If the system is not performing correctly, contact Medtronic MiniMed.
Warnings and precautions Environmental conditions The Medtronic MiniMed 2007D Implantable Insulin Pump System should not be exposed to extreme electrical or magnetic fields. Although it is not possible to include every environmental condition that may affect the Pump, most are listed below. Please contact Medtronic MiniMed when in doubt if certain environmental exposure will affect the pump.
84 Warnings and precautions Physicians should instruct patients to avoid any sharp blows or pressure directly at the Pump location. A direct hit by an object such as a baseball may damage the Pump and/or injure the Pump pocket. Extreme pressure on the Pump may cause the sutures and the tissue pocket to be damaged. As a result, the Pump may move from its pocket and possibly dislodge from the Catheter. If the Pump has been damaged by such a blow, the patient should be instructed to contact their physician.
Warnings and precautions Precautions Emergencies and the use of conventional insulin supplies Physicians should advise patients who are implanted with the Medtronic MiniMed 2007D Implantable Insulin Pump System how to deal with emergency conditions such as hyperglycemia and hypoglycemia. Patients should always carry conventional insulin supplies with them, including insulin and a means to inject it, in the event of impaired insulin delivery by the Pump System.
86 Warnings and precautions Electrical and magnetic fields Common electrical and magnetic fields that do not affect the Pump include microwave ovens, satellite receiving dishes, common household appliances, security devices found in department stores and airports, standard medical Xrays, cellular phone, and radiowaves.
87 Adverse reactions CHAPTER 8 Adverse reactions In clinical studies, adverse reactions associated with the Medtronic MiniMed 2007D Implantable Pump included hypoglycemia, diabetic ketoacidosis, hyperglycemia, skin erosion, infection, abnormal healing, elevated anti-insulin antibodies, intestinal obstruction, post-operative discomfort and pain.
88 Adverse reactions
89 CHAPTER 9 System alarms and messages The Medtronic MiniMed 2007D Implantable Insulin Pump System is equipped with various alarms and messages that ensure the correct function of the system. The Implantable Insulin Pump alarm system will “beep” when certain conditions occur. The beeps are designed to be audible through the skin and alert the patient that the Pump needs attention.
90 System alarms and messages Pump alarms Alarm feedback The Alarm Feedback function allows the user to verify the Pump and Pump alarm are operating normally. Physicians can also use Alarm Feedback to measure the time intervals between Pump strokes to verify accurate insulin delivery.
System alarms and messages System error The Implantable Insulin Pump has a sophisticated self-monitoring system that periodically checks for circuit faults. If a fault should occur in the Pump electronics, insulin delivery will stop. Conventional insulin therapy must be initiated immediately. Notify Medtronic MiniMed immediately.
92 System alarms and messages PPC alarms The PPC offers a choice of two alarms, audible and vibrate. In addition, a screen message appears indicating the type of alarm condition that occurred. Low reservoir When the Pump calculates that less than 800 units (2ml) of insulin remains in its reservoir, the following display will appear: PPC Display Type of Alarm Pump Alarm LOW RESERVOIR 1 In 24 hours if no PPC communication Clear this message by pressing SEL and ACT.
System alarms and messages Initialize alarm Attempting to initialize a PPC to a Pump that is not compatible with it, results in one of the following messages. The physician should press SEL and ACT to clear the alarm, then verify the personal ID of the Pump is correct. PPC Display Type of Alarm PUMP ERROR 0 or 1 1 Attempting to initialize a PPC to a Pump that contains invalid stroke volume or insulin concentration information, results in one of the following messages to be displayed.
94 System alarms and messages Battery replacement If the PPC main battery (AA 1.5V alkaline) has been replaced or the PPC recognizes the “PUMP STATUS” needs to be checked, the following message is displayed: PPC Display Type of Alarm CHECK PUMP STATUS 1 The user should reposition the PPC near the Pump, and then press SEL and ACT. The PPC will communicate with the Pump.
System alarms and messages Pump suspended 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 programming, press SEL and ACT, then place the PPC near the Pump and allow the communication to complete.
96 System alarms and messages Pump alarm table Alarm Condition Type of Alarm Pump Communications AUTO OFF 1 YES CHECK PUMP STATUS 1 YES EMPTY RESERVOIR 1 YES HOURLY MAX EXCEEDED 1 NO LOW RESERVOIR 1 YES PPC LOW BATTERY 1 NO PPC NOT INITIALIZED 1 YES PUMP INITIALIZED 1 NO PUMP LOW BATTERY 1 YES PUMP RESET 1 NO PUMP SELF TEST FAIL 1 NO PUMP ERROR 0 or 1 1 NO PUMP ERROR 40 or 41 1 NO PUMP STOPPED 1 or 2 or 3 or 4 or 5 or 6 1 YES PUMP SUSPENDED 2 YES PUMP STOPPE
97 CHAPTER 10 Troubleshooting Pump System under-delivery Potential under-delivery of insulin by the Medtronic MiniMed 2007D Implantable Insulin Pump System may result in an increase in daily programmed insulin usage, difficulty maintaining euglycemia, occasional hyperglycemia, and problems calculating refill accuracy. This chapter describes how to diagnose potential Pump System problems that may cause insulin under-delivery, and offers potential Pump and Catheter solutions to correct for under-delivery.
98 Troubleshooting Pump System under-delivery Under-delivery caused by catheter occlusion Under-delivery caused by Catheter occlusion can occur either abruptly or gradually. The insulin usage and clinical symptoms are identical to those of Pump under-delivery. Confirm a Catheter occlusion condition by performing a Pressure Measurement Procedure. Then perform the following procedures to clear the occlusion: • First, flush the Catheter by using the Side Port Catheter Flush Procedure outlined in Appendix F.
99 CHAPTER 11 Technical specifications Implantable Insulin Pump MMT-2007D Diameter 8.1 cm (3.2 inches) Thickness 2.0 cm (0.8 inches) Reservoir Volume 13 ml to 15 ml Weight - Empty 131 gm (4.6 ounces) Insulin - Concentration U-400 Stroke Volume 0.42 to 0.58 ul 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.
100 Technical specifications Personal Pump Communicator (PPC) model MMT-3160 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.
Technical specifications 101 Side Port Catheter MMT- 4027 Length Proximal: 11.8 ± 1.3 cm (4.7 ± 0.5 inches) Distal: 17.8 ± 0.7 cm (7.0 ± 0.3 inches) Proximal: 11.8 ± 1.3 cm (4.7 ± 0.5 inches) Distal: 10.2 ± 0.4 cm (4.0 ± 0.2 inches MMT- 4024 Length Material Polyethylene-lined Silicone Rubber Sideport Polysulfone, Silicone Septum The Implantable Pump System complies with European RF Regulations.
102 Technical specifications
103 Label information symbol dictionary APPENDIX A Do Not Reuse This Device Please Read “Important Information” Sterilized by Ethylene Oxide Manufacture Date (Year-Month) Lot Number Expiration Date (Use By Date) (Year-Month) REF MMT-XXXX SN Reference / Record Number (reorder number) Device Serial Number IEC Icon indicating equipment providing a particular degree of protection against electric shock (Type B) CE Marking CE Marking 0976 Radio Frequency (RF) is not harmonized
104 Packaging The icon on each label indicates the contents of the package. The number with the icon is the quantity. Descriptions of the icons are in the table below.
105 APPENDIX B Implant worksheet Implant worksheet form Please refer to “Implant Worksheet” attached.
Medtronic MiniMed Implant Worksheet Form Prep Date:_________ Center:_________ Patient Code:___ Patient name:_________________________________ Pump Label: Weight of full "IN 2" syringe before filling the reservoir:_____________________g (1) Weight of full "IN 2" syringe after filling the reservoir and removing 2ml from the pump:__________________ g (2) Total amount placed in the reservoir (1-2):_________________ g Verification of alarm feedback: yes / no Time delivery started, priming bolus:_____________ C
107 APPENDIX C Refill form Pump refill data Please refer to “Refill Data Form” attached.
Medtronic MiniMed Refill Worksheet Before the refill: U/384.
109 APPENDIX D Precautions and general procedures Special note and precautions Before beginning the implant, refill, stroke volume measurement, rinse/flush, or pressure measurement procedure, carefully read this Appendix and keep the information in mind as you perform each procedure. 1. All procedures should be performed using ASEPTIC TECHNIQUE. 2. Air in the Pump System has been shown to be a significant contributing factor to aggregation of insulin.
110 7. After the flush procedure, at least 13 units of RINSE BUFFER will remain in the distal portion of the catheter. Programmed bolus amounts to remove the RINSE BUFFER may be completed before the patient leaves the clinic. A prescribed INSULIN basal rate should be programmed when the system is clear of RINSE BUFFER. 8. Never push down on the plunger to fill the Pump.
111 Locating the pump fill port and the side port Template (MMT-4106) Placement on Skin with Guide Needles in Position Figure 15: Template and placement 1. Locate the Pump, then aseptically prep and drape the Pump area. Use topical or local anesthetic if desired. 2. To locate the Pump fill port, located in the center of the Pump, align the sterile template (MMT-4106) over the Pump by palpating the Pump circumference.
112 Accessing the pump inlet (See Figure 16.) To enter the Pump fill port or the side port, make sure the refill syringe stopcock is closed, then pass the Medtronic MiniMed refill needle (MMT- 4102) through the 18 gauge guide needle. Pull back slightly (approximately 2 mm) on the guide needle to allow the Medtronic MiniMed refill needle to enter the Pump fill port or the side port. The refill needle entry opens the inlet valve of the Pump fill port.
113 Venting the Medtronic MiniMed refill syringe (optional) In order to fill the Pump, it may be necessary to vent the headspace in the Medtronic MiniMed refill syringe. Refill syringes do not have lubricant on the syringe housing or on the plunger tip. Some syringes may be “sticky” and require the venting procedure described below to assist the vacuum in the Pump to overcome this condition. To vent, hold the syringe with the refill needle pointing down.
114
115 APPENDIX E Pump rinse procedure The purpose of this procedure is to dissolve insulin deposits within the Pump reservoir, pumping mechanism, and the Side Port Catheter “port.” Supplies and solutions Prior to performing this procedure, assemble the necessary supplies and solutions as outlined below: Supplies • Steri-Strips® and markers • Local anesthesia (if necessary) • Sharps container • Safety glasses • PPC • Oral or IV glucose • Glucose monitoring equipment • Drapes • One (1) scale - 0.
116 Solutions • 50 ml. sterile 0.1M NaOH (0.4 grams NaOH per 100 ml of Sterile water for injection) MMT-9005 • Seven (7) 10 ml vials, rinse buffer solution, MMT-2008 • Five (5) 10 ml vials, U-400 Insulin WARNING ! The 0.1M of NaOH used in this procedure can cause permanent eye damage. Safety glasses must be worn during this procedure.
117 Preparing for the procedure NOTE: Before beginning any refill, flush, stroke volume measurement, carefully read Appendix D, Precautions and General Procedures, and keep this in mind as you perform each procedure. In order to prepare for the Side Port Catheter rinse and flush procedure, a total of seven syringes will need to be labeled and then prepared with different solutions.
118 Program minimal basal rate Place the PPC in a sterile bag and program the Pump to “SUSPEND” mode, the basal rate will be 0.2 U/h. Remove insulin from the Pump and fill with NaOH INSULIN is removed from the Pump and then the Pump is filled with NaOH. The following volumes are used: • Syringe 1 - 5 ml RINSE BUFFER • Syringe 2 - 20 ml NaOH • Syringe 3 - 30 ml NaOH Follow the steps below to perform this procedure: Syringe 1: Rinse Buffer - Degassed 1. Prime the needle.
119 WARNING ! The 0.1M NaOH used in this procedure can cause permanent eye damage. Safety glasses must be worn during this procedure. Syringe 2: NaOH - Degassed 1. Prime the needle. Close the stopcock 2. Enter the Pump with the refill needle. 3. Open the stopcock and allow the Pump to fill completely with NaOH. When the fluid level stops moving, the Pump is filled. 4. Close the stopcock. Remove the syringe. 5. Prepare syringe 2 for aspiration. Remove the air from the syringe.
120 Equilibrate and pull NaOH through system The reservoir pressure in the Pump is equilibrated with outside ambient pressure and NaOH is pulled through the pumping mechanism. This procedure uses the following volumes in syringes 3 and 1: • Syringe 3 with residual NaOH from the previous section. • Syringe 1 with 5 ml insulin/buffer mixture from previous section. Syringe 3: NaOH - Residual 1. Verify that the stopcock on syringe 3 is open. Syringe 1: Insulin - Residual 1. Prime the needle.
121 Remove NaOH and fill with rinse buffer The NaOH is removed from the Pump and the system is filled with RINSE BUFFER. This procedure uses the following volumes in syringes 3, 4, and 5: • Syringe 3 with residual of at least 5 ml NaOH from previous step • Syringe 4 with 20 ml RINSE BUFFER • Syringe 5 with 30 ml RINSE BUFFER Syringe 3: NaOH - Residual 1. Prepare syringe for aspiration. 2. Close the stopcock and obtain a vacuum by pulling back on the plunger until it locks.
122 8. When the time has elapsed, close the stopcock and remove the syringe and set aside. Syringe 5: Rinse Buffer - Degassed 1. Prime the needle. Close the stopcock. 2. Enter the Pump fill port with the refill needle. 3. Open the stopcock and allow the Pump to fill completely with RINSE BUFFER. When the fluid level stops moving, the Pump is filled. When the pump is filled, approximately 10 ml of RINSE BUFFER will remain in the syringe.
123 boluses to obtain 1 ml. Discard syringe 4 and set aside syringe 5 to be used later to remove RINSE BUFFER. Remove rinse buffer and fill with insulin The RINSE BUFFER is removed from the Pump fluid system and the system is filled with INSULIN. This procedure uses the following volumes in syringes 5, 6, and 7: • Syringe 5 with residual RINSE BUFFER from the previous steps • Syringe 6 with 20 ml INSULIN • Syringe 7 with 30 ml INSULIN Syringe 5: Rinse Buffer - Residual 1. Prime the needle.
124 7. Open the stopcock, remove the INSULIN. After the fluid level stops moving, wait an additional 30 seconds for all the INSULIN and air to be removed. 8. When the time has elapsed, close the stopcock and remove the syringe. Discard all but 5 ml of solution. Remove any air, prime needle and close stopcock. Set aside the syringe. Syringe 7: Insulin - Degassed 1. Prime the needle on syringe 7. Weigh and record the combined weight of syringes 6 and 7 on the Refill Form. 2. Close the stopcock.
125 Equilibrate and pull insulin through system The reservoir pressure in the Pump is equilibrated with outside ambient pressure and INSULIN is pulled through the fluid system. This procedure uses the following volumes in syringes 6 and 7: • Syringe 7 with residual INSULIN from previous step. • Syringe 6 with 5 ml solution. To perform this procedure with syringes 6 and 7, follow the steps below: Syringe 7: Insulin - Residual 1.
126 Remove guide needles and record fill amount At this point, the 18 gauge guide needles should be removed and the refill amount should be calculated and recorded. Follow the steps below: 1. Remove the 18 gauge guide needles. Apply pressure to the needle insertion sites. 2. Weigh syringes 6 and 7 and record on the refill form. Subtract the combined weight from the weights obtained in step 14 of the section, “Remove RINSE BUFFER and Fill with Insulin.” The result is the new refill amount. 3.
127 APPENDIX F Side Port Catheter flush procedure When delivery of insulin is impaired due to catheter tip obstruction, the Catheter may be flushed using 5 - 10 ml of RINSE BUFFER, MMT-2008. Supplies and solutions Prior to performing this procedure, assemble the necessary supplies and solutions as outlined below: Supplies • Steri-Strips® and markers • Local anesthesia • Sharps container • PPC • Oral or IV glucose • Glucose monitoring equipment • Drapes • One (1) scale - 0.
128 Solutions • Seven (7) 10 ml vials, Rinse Buffer Solution, MMT-2008 • Five (5) 10 ml vials, U-400 Insulin NOTE: One-handed flush with a 10-20 mL syringe only. Preparing for the procedure NOTE: Before beginning any refill, flush, stroke volume measurement, carefully read Appendix D, Precautions and General Procedures, and keep this in mind as you perform each procedure.
129 Prepare syringes for emptying the Pump Syringe 1 is used for emptying the Pump. Prepare syringe 1 as described in the "Precautions and General Procedures" section in Appendix D of this manual. Label the syringe per table 2. After the syringe is prepared, weigh the syringe and enter the weight on the Refill Form. Prepare syringes for filling the Pump During the Catheter flush procedure, syringes 2, 3, 5, and 6 are used for filling the Pump.
130 Flushing the Side Port Catheter Program minimal basal rate Place the PPC in a sterile bag and program the pump to “SUSPEND” mode, the basal rate will be 0.2 U/h. Remove insulin and fill with rinse buffer The INSULIN is removed from the Pump and the system is filled with RINSE BUFFER. This procedure uses the following volumes in syringes 1, 2, and 3: • Syringe 1 with 5 ml RINSE BUFFER • Syringe 2 with 20 ml RINSE BUFFER • Syringe 3 with 30 ml RINSE BUFFER Syringe 1: Rinse Buffer 1.
131 3. Open the stopcock and allow the Pump to fill completely with RINSE BUFFER. When the fluid level stops moving, the Pump is filled. 4. Close the stopcock and remove the syringe. 5. Prepare syringe 2 for aspiration. Obtain a vacuum by pulling back on the plunger until it locks. Press the lock into the plunger groove and be sure it is firmly secured. 6. Re-enter the Pump. 7. Open the stopcock and remove the RINSE BUFFER.
132 1. Prime the needle. Close the stopcock. 2. Obtain a vacuum by pulling back on the plunger until it locks. Press the lock into the plunger groove to be sure it is firmly secured. 3. Enter the side port with the stopcock closed. 4. Open the stopcock. 5. Program and deliver a 4 unit bolus to open the valve in the Pump mechanism. 6. Observe syringe 3. When the level of the RINSE BUFFER approaches 2 mL, close the stopcock to prevent air from entering the Pump. Observe syringe 2.
133 NOTE: This is the only time a plunger should be manually pushed down. Remove rinse buffer and fill with insulin The RINSE BUFFER is removed from the Pump fluid system and the system is filled with insulin. This procedure uses the following volumes in syringes 3, 5, and 6: • Syringe 3 with residual RINSE BUFFER from the previous step • Syringe 5 with 20 ml INSULIN • Syringe 6 with 30 ml INSULIN Syringe 3: Rinse Buffer - Residual 1. Prime the needle. Close the stopcock. 2.
134 7. Open the stopcock and remove the INSULIN. After the fluid level stops moving, wait an additional 30 seconds for all INSULIN and air to be removed. 8. When the time has elapsed, close the stopcock and remove the syringe. Discard all but 5 mL of the solution. Remove the air and set aside the syringe. Syringe 6: Insulin - Degassed 1. Weigh and record the combined weight of syringes 5 and 6 on the Refill Worksheet. Prime the needles. 2. Close the stopcocks.
135 5. Press SEL. When the PPC screen is flashing “PUMP SUSPEND” press ACT. The system is now in normal mode. 6. Using the PPC, program and deliver a 4 unit bolus. 7. Observe syringe 6. If the level of INSULIN approaches 2 mL, close the stopcock to prevent air from entering the Pump. Observe syringe 5. At least 1 mL of INSULIN must pass into syringe 5 to be sure that all of the RINSE BUFFER is removed from the side port.
136 Remove rinse buffer from catheter Approximately 13 units of RINSE BUFFER remain in the distal Side Port Catheter. Depending on blood glucose values, program the appropriate bolus amount to remove the RINSE BUFFER from the Catheter. Release the patient when blood glucose levels are stable.
137 APPENDIX G Stroke volume measurement If under-delivery of insulin is noted during a refill procedure or suspected due to blood glucose control, it may be useful to verify the proper stroke volume of the Pump by accessing the side port. In this procedure, a pipette is attached to a stopcock and refill needle. This system is inserted into the side port. The insulin pulses in the pipette are measured to calculate the pump stroke volume.
138 • One (1) sterile stopcock - 3 way Solutions • One (1) 10 mL vial, Rinse Buffer Solution, MMT-2008 Preparing for the procedure NOTE: Before beginning any refill, flush, stroke volume measurement, carefully read Appendix D, Precautions and General Procedures, and keep this in mind as you perform each procedure. Record patient’s blood glucose Record the patient’s blood glucose value at the start of the procedure. Monitor blood glucose every 30 minutes, or as needed. Measuring stroke volume 1.
139 3. Insert the needle into the side port. 4. Turn the stopcock as shown in Figure 19. 5. Program a high rate bolus (approximately 20 units) and measure the stroke volume over 20 pulses in the pipette. 6. Cancel the bolus at the end of the measurement. 7. Turn the stopcock back to the position shown in Figure 19 to close. Remove the apparatus.
140 Record patient’s blood glucose It is likely that some insulin is pumped out of the Catheter and into the patient in this procedure. Monitor the patient’s blood glucose and release the patient only after blood glucose values are stable.
