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1 | Manual | Users Manual | 26.52 KiB | February 05 2002 |
MiniMed Personal Pump Communicator REF MMT-3150 Personal Pump Communicator (English)
** NOTE **
Please refer to the physician and patient manual for instructions for use and detailed information regarding the Medtronic MiniMed Implantable Pump System. INTRODUCTION The Medtronic MiniMed Implantable Pump System is a sophisticated combination of technologies developed to address the requirements of continuous intraperitoneal insulin delivery for patients with Insulin Dependent Diabetes Mellitus
(IDDM). The system is comprised of: Implantable Pump, Side Port Catheter, Personal Pump Communicator, and accessory syringe, needle, template, and pipette. The pump and catheter are designed for implantation. The Personal Pump Communicator is designed to provide the patient a variety of insulin delivery options. The accessory items are specifically designed to facilitate refill of the implanted pump and pump functions. INDICATIONS FOR USE The Medtronic MiniMed Personal Pump Communicator is intended to be used with the Medtronic MiniMed Implantable Pump. Specific indications for use of the Implantable Pump System are provided in the Implantable Pump Package Insert. CONTRAINDICATIONS The Medtronic MiniMed Implantable Pump System is contraindicated in patients who:
Are unwilling or unable to monitor their blood/glucose level at least four times per day. Are unwilling or unable to make programming modifications to the pump based on glucose level readings. Are unable or unwilling to administer insulin by other means if necessary. Are unable or unwilling to comply with the guidance and advice of the treating physician and other healthcare providers. Reside at or travel (other than by commercial aircraft) at elevations above 8000 feet. Have other medical or mental conditions which may place the patient at risk. Are unwilling or unable to return for routine insulin refill
(approx. 2-3 months) according to dosage. Present current or history of sensitivity to titanium alloy or silicone materials used in the manufacture of system implanted components. PRECAUTIONS Patients should always maintain conventional insulin supplies in the event of pump and or Personal Pump Communicator
(PPC) failure. Delivery of insulin can become impaired due to pump failure or catheter occlusion. In the event of impaired insulin delivery, replacement of the pump or catheter may be required. Physicians should review Physicians Manual for full description of Pump replacement procedure and catheter clearing procedures. The Medtronic MiniMed Pump and Catheter Implants should NOT be used if damaged prior to or during implantation procedures. The pump should not be placed in contact with other metal implants. WARNINGS Physicians should be completely familiar with the function of the pump, catheter, and personal pump communicator prior to use of this device. Patients should be provided a complete copy of the Patient Manual and have demonstrated the ability to program the Personal Pump Communicator (PPC), recognize and respond to safety alarms, and care of the device prior to discharge. The Medtronic MiniMed Implantable Pump System should not be exposed to therapeutic ultrasound. Exposure to ultrasound therapy may cause damage to the pump that may not be apparent. Only special U400 insulins may be used in the Medtronic MiniMed Implantable Pump System. Use of other insulin types may cause damage to the pump mechanism resulting in impaired insulin delivery or pump failure. Any unauthorized changes or modifications made to any component of the system may prevent effective use of that and other components. POSSIBLE ADVERSE EFFECTS The Medtronic MiniMed Implantable Pump System has undergone an extensive clinical evaluation. Evaluation of the system spanned a period of ten years and involved over 600 subjects in the United States and Europe. Though over delivery of insulin did not occur during the ten year evaluation period, there is a potential for such occurrence. The following are specific adverse effects which should be understood by the physician and explained to the patient. These do not include all adverse effects which can occur with surgery in general or with the use of this devise, but are important considerations particularly in the treatment of people with diabetes. The general surgical risks as well as operative site cosmetic risks should be explained to the patient prior to surgery. Abdominal Pain Abnormal Healing Infection Necrosis Retinal Disorder Abnormal Liver Function Ileus Inflammation at Refill Site Hyperglycemia Hypoglycemia Ketoacidosis Foreign Body Reaction Skin Disorder Urinary Disorder Psychiatric Decompensation Skin Erosion Kidney Disorder Pocket Lymph Edema Pump Failure Catheter Occlusion/
Encapsulation Battery depletion PPC Failure DEVICE PACKAGING The Medtronic MiniMed Personal Pump Communicator (PPC) is packaged in a specially prepared carton to secure the product from damage. A 1.5v battery (replaceable power source) has been included in the carton. The Personal Pump Communicator should not be used if there are obvious signs of damage to the device. PRESCRIPTION DEVICE Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. FCC Notice This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference and
(2) This device must accept any interference received, including interference that may cause undesirable operation. CAUTION: Any changes or modifications not expressly approved by Medtronic MiniMed could void your ability to operate the equipment. Medtronic MiniMed 2007 Implantable Pump System Limited Warranty The Medtronic MiniMed 2007 Implantable Pump and Personal Pump Communicator are components of the Medtronic MiniMed Implantable Pump System designed for the long-term, intraperitoneal infusion of insulin in the intensive treatment of insulin dependent diabetes mellitus (IDDM) with the use of a peritoneal catheter, also a component of the system. Pumps include an exhaustible power source which will ultimately cease to function, requiring replacement of the entire pump. No representation is made regarding the longevity of the power supply. Causes of pump or catheter failure include but are not limited to: premature battery failure; changes in product performance characteristics; medical complications; catheter occlusion. The improper handling or filling of pumps, the use of drugs other than special U-400, or other intervening acts may also result in pump or catheter failure, despite all due care in design, manufacture and testing prior to sale. Therefore, no representation or warranty is made that cessation of pump or catheter function will not occur. Moreover, because the implantation of any device is always subject to inherent risks, no representation can be made that the human body will not react adversely to the implantation or presence of the pump and/or catheter. Medtronic MiniMed hereby warrants solely to the original purchaser of the Pump and Personal Pump Communicator the following:
1. Should the pump fail to function within normal tolerances due to a defect in materials or workmanship within a period of six (6) years, commencing with the date of the implant of the pump, Medtronic MiniMed will issue a credit equal to the percentage purchase price, as defined below, against the purchase of another pump requested as its replacement, or, at the option of Medtronic MiniMed, provide a replacement pump at no charge. The percentage shall be 100% for pumps that fail within four (4) years of implant. The percentage shall be reduced by either (i) 4% for each month beyond the forty-eighth month that the pump functions within normal tolerances, or (ii) 1% for each 1 ml of medication delivered beyond 200 ml of medication, whichever percentage is greater. The credit issued hereunder shall be provided to purchaser of 2. the replacement pump. As used herein, Purchase Price shall mean the lesser of the original or replacement pump purchase price, as evidenced by the Medtronic MiniMed invoice, or the purchase price of the currently functionally comparable Medtronic MiniMed pump. In no way shall the Purchase Price include any VAT, sales or other tax paid in relation to the pump. To qualify for this limited warranty, the pump must be implanted 3. before its use before date contained in its packaging; replaced pumps must be returned to Medtronic MiniMed and shall be the sole property of Medtronic MiniMed and the use of the pump, including the medication infused thereby, must be in accordance with the manuals shipped with the pump. All explanted pumps returned to Medtronic MiniMed must be prepared and shipped in the manner described in the Physician Manual. Proper preservation of the pump is required for accurate post-implant analysis. 4. Should the Personal Pump Communicator fail to function within normal tolerances due to a defect in materials or workmanship within a period of three (3) years, commencing with the date of implant, Medtronic MiniMed will either repair or replace the Personal Pump Communicator, at the sole discretion of Medtronic MiniMed. For Personal Pump Communicators that have been damaged as a result of abuse or neglect, the owner will be charged for repair or replacement. The Limited Warranty is limited by its express terms. THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES AND THIS WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES. NEITHER MEDTRONIC MINIMED NOR ITS SUPPLIERS OR DISTRIBUTORS SHALL BE LIABLE FOR ANY GENERAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THE SALE, MANUFACTURE OR USE OF THE PRODUCT SOLD HEREUNDER. MEDTRONIC MINIMED MAKES NO WARRANTIES, EXPRESS OR IMPLIED (INCUDING, BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTIBILITY OR FITNESS OF THE PRODUCTS FOR ANY PURPOSE OR REASON) WITH RESPECT TO THE PUMP SOLD UNDER THIS WARRANTY, EXCEPT AS CONTAINED IN THIS LIMITED WARRANTY. NO PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC MINIMED TO ANY REPRESENTATION, CONDITION OR WARRANTY, EXCEPT AS SPECIFICALLY SET FORTH HEREIN. In no event shall this Limited Warranty apply to any Pump or Personal Pump Communicator replaced after the end of the period specified in Paragraphs 1 and 4 above. This Limited Warranty is not applicable to catheters, side ports or other accessories used with the Pump. Some jurisdictions do not allow the exclusion or limitation of incidental or consequential damages, so the limitations or exclusions herein may not apply. This Limited Warranty gives you specific legal rights, and you may have other rights which vary from jurisdiction to jurisdiction. Products covered by the Warranty include:
MMT-2007C Implantable Pump MMT-3150 Personal Pump Communicator USA Northridge, CA
(818) 362-5859 To order supplies
(818) 843-6687 FAX (818) 364-0968 EUROPE Medtronic MiniMed S.A. 63, Rue Marius Autan 92300 Levallois-Perret, France Tel: (33)-(01)-47-59-76-60 FAX (33)-(01)-47-59-76-77 www.minimed.com These products are covered by one or more of the following U.S. patents:
[U.S.]4,373,527; [U.S.]4,395,259; [U.S.]4,525,165;
[U.S.]4,568,250; [U.S.]4,569,641; [U.S.]4,573,994;
[U.S.]4,619,653; [U.S.]4,636,150; [U.S.]4,731,051;
[U.S.]4,776,842; [U.S.]5,167,633; [U.S.]5,176,644;
[U.S.]5,197,322; [U.S.]5,217,442; [U.S.]5,257,971;
[U.S.]5,460,618; [U.S.]5,466,218; [U.S.]5,514,103;
[U.S.]5,527,307; [U.S.]5,559,828; [U.S.]5,797,733;
[U.S.]5,915,929 Patents also exist in a number of foreign countries and other U.S., international, and foreign patent applications are pending. SYMBOL REF MEANING DO NOT RE-USE READ INSTRUCTIONS FOR USE STERILIZED WITH ETHYLENE OXIDE REFERENCE/RECORD NUMBER STORAGE TEMPERATURE RANGE FRAGILE PRODUCT 0459 MARKING AUTHORIZED TYPE CF OPEN HERE 07/01 6021029-003
1 | Patient Manual | Users Manual | 883.71 KiB | February 05 2002 |
Medtronic MiniMed 2007C Implantable Insulin Pump System Patient Manual These product(s) are covered by one or more of the following U.S. Patents:
4,373,527 4,568,250 4,619,653 4,776,842 5,197,322 5,460,618 5,527,307 5,915,929 4,395,259 4,569,641 4,636,150 5,167,633 5,217,442 5,466,218 5,559,828 4,525,165 4,573,994 4,731,051 5,176,644 5,257,971 5,514,103 5,797,733 Patents also exist in a number of foreign countries and other U.S., international, and foreign patent applications are pending. D9196020-011 2/01 Table of Contents i CHAPTER 1 The Medtronic MiniMed 2007C Implantable Insulin Pump System . 1 Introduction . 1 MiniMed help line . 2 Description of the system . 2 Implantable insulin pump . 3 Medication reservoir . 4 Pumping mechanism . 4 Antenna . 4 Microelectronics . 5 Battery . 5 Tone transducer . 5 Side port catheter . 6 Personal pump communicator (PPC) . 7 Special insulin . 9 CHAPTER 2 Safety Features . 11 Pump safety features . 11 Safe telemetry . 11 ii Alarms . 11 Negative pressure reservoir . 11 PPC safety features . 12 Programming sequence . 12 Maximum dosage limits . 12 Alarms and messages . 12 CHAPTER 3 Implanting the MiniMed 2007C Pump System . 13 Hospitalization . 13 Pre-operative procedures . 13 Implantation procedures . 14 Post-operative procedures . 14 Follow-up . 15 Pump refills . 16 Insulin used with the implantable pump . 16 Pump refill procedure . 16 CHAPTER 4 Programming Your Pump . 17 Introduction . 17 PPC screen icons . 18 PPC buttons . 19 Main programming screen . 20 Programming a bolus . 20 Set an immediate bolus (variable bolus option isoff) . 21 Set an immediate bolus (variable bolus option is on)
. 22 Set a square wave bolus . 23 iii Set a dual wave bolus . 25 Review the bolus history . 27 Suspend mode . 27 Program basal rates . 28 Set one basal rate . 28 Set multiple basal rates . 29 Set a temporary basal rate . 30 Stop a temporary basal rate . 31 Personal events . 32 Preset events . 32 Additional events . 32 History . 33 Pump setup . 35 Time and date . 35 Auto off . 36 Alarms . 37 Self Test . 38 Basal delivery patterns . 39 Initialize PPC to pump . 40 Pump setup II . 40 Exit setup menu . 40 Pump setup II . 41 Turn on the audio bolus feature . 41 Use audio bolus in the main menu . 42 Turn on the variable bolus feature . 42 Set a maximum bolus . 43 iv Set a maximum basal rate . 44 Set time format . 44 Personal event
. 45 Pump setup . 45 Exit setup menu . 45 CHAPTER 5 Alarms and Messages . 47 The pump alarms . 47 The PPC alarms . 48 Alarm type 1 . 48 Alarm type 2 . 48 Pump alarms . 49 Alarm feedback . 49 Pump low battery . 49 Depleted pump battery . 50 System error . 50 Pump self test fail
. 50 PPC alarms . 51 PPC low battery . 51 PPC depleted battery . 52 PPC needs servicing . 52 Low reservoir . 53 Empty reservoir . 53 Communication error . 54 Battery replacement . 54 v Pump suspended . 54 Auto off . 56 Hourly maximum exceeded . 56 Personal Pump Communicator messages . 57 CHAPTER 6 Warnings and Precautions . 59 Warnings . 59 Electrotherapy . 59 Diagnostic ultrasound . 59 Ultrasound therapy . 60 Diagnostic radiation . 60 Therapeutic radiation . 60 Magnetic resonance imaging . 60 Pump and catheter under-delivery . 60 Pump electronic or alarm malfunction . 61 Reservoir level warnings . 61 Environmental conditions . 61 Precautions . 63 Blood glucose monitoring . 63 Conventional insulin supplies . 63 Physicians instructions . 63 PPC . 64 Maximum dosages . 64 Battery change . 64 Proper PPC positioning . 64 vi Physical activities to avoid . 65 Emergency plan . 65 Adverse reactions . 66 Hyperglycemia . 66 Hypoglycemia . 66 Pump pocket infection . 67 Pump pocket seroma . 67 CHAPTER 7 Important Self-Care . 69 Blood glucose monitoring . 69 Meal plan . 70 Daily activities . 70 Exercise . 70 Travel . 71 MiniMed information card . 71 CHAPTER 8 PPC Care and Maintenance . 73 Installing/replacing the main battery . 73 Physical protection . 75 Cleaning the outer surface of your PPC . 76 CHAPTER 9 Technical Specifications . 77 Medtronic MiniMed 2007C Implantable Insulin Pump System . 77 Implantable Insulin Pump (MMT-2007C) . 77 Personal Pump Communicator (MMT-3132) Side Port Catheter
. 79
. 80 1 CHAPTER 1 The Medtronic MiniMed 2007C Implantable Insulin Pump System Introduction This manual is a reference guide for both you and your support network of family and friends. It is important that other people in your support net-
work know how to use the Medtronic MiniMed 2007C Implantable Insu-
lin Pump System, so they can be of assistance if the need arises. Throughout the manual you will see note comments which provide important information about the Medtronic MiniMed 2007C System. If you have a question not covered in the manual, please talk with your doc-
tor. Your doctor knows the most about your medical condition and can give you the best answers to your questions about your diabetes treat-
ment. NOTE: Before you can use the Medtronic MiniMed 2007C System, you will be trained. This training will teach you about implantable insulin pump ther-
apy, and how to operate the Medtronic MiniMed 2007C System. This manual can be used to help, but not replace, your training. 2 The Medtronic MiniMed 2007C Implantable Insulin Pump System Medtronic MiniMed help line Medtronic MiniMed provides a 24-hour help line for assistance. Clinical Services personnel are trained to answer questions you may have about the Medtronic MiniMed 2007C System. When Calling From:
Outside the United States Primary Number 1-818-576-5040 Within the United States 1-800-826-2099 Alternate Number 1-818-362-5958 1-818-362-5958 Description of the system The Medtronic MiniMed 2007C Implantable Insulin Pump System is an
"open-loop" system, which means you must test your blood glucose in accordance with the method and frequency recommended by your physi-
cian. Based on the results of your blood glucose testing, you can program the Pump with desired reates of delivery by using the Personal Pump Communicator (PPC). The system consists of four components:
Implantable Insulin Pump Side Port Catheter Personal Pump Communicator (PPC) Special Insulin
The Medtronic MiniMed 2007C Implantable Insulin Pump System 3 Implantable insulin pump The Implantable Insulin Pump (Pump) is a round disc, 8.1 cm (3.2 inches) in diameter and 2.0 cm (0.8 inches) thick. The Pump weighs 131 grams
(4.6 ounces) when empty. The outside case of the Pump is made of tita-
nium. Titanium is a biocompatible metal used in many types of implant-
able medical devices. The Pump contains an insulin fill port, located at the center of the disc. The fill port is used for rinsing and filling the Pump with insulin, and for diagnostic procedures. Figure 1: The Implantable Insulin Pump 4 The Medtronic MiniMed 2007C Implantable Insulin Pump System The Pump has six major components: the medication reservoir, the pump-
ing mechanism, the antenna, the microelectronics, the battery, and the tone transducer. The following figure shows the interior of the Pump
. Figure 2: Interior of the Implantable Insulin Pump Medication reservoir The medication reservoir holds the insulin and is refilled with a special syringe through the Pump fill port. Pumping mechanism The pumping mechanism takes insulin from the medication reservoir and delivers it through a catheter into your body. The pumping mechanism delivers the same amount of insulin every time it pumps. The amount of insulin delivered in each stroke of the pump mechanism is called the stroke volume. The Medtronic MiniMed 2007C Implantable Insulin Pump System 5 Antenna The pump antenna receives the radio signals from the PPC and delivers the PPCs programmed message to the microelectronics of the Pump. Microelectronics The microelectronics are designed to control the pumping mechanism so that you receive the amount of insulin you have programmed the Pump to deliver. You tell the microelectronics what to do by using your PPC. The microelectronics also store pump specifications and programming history information in its memory. Battery The battery supplies power to the pumping mechanism and microelec-
tronics. It is a lithium carbon mono-fluoride battery specially designed for the Implantable Insulin Pump. Tone transducer The tone transducer is a Pump safety feature. It emits audible beeps to confirm your Pump is operating properly. It also alerts you when your Pump needs attention. 6 The Medtronic MiniMed 2007C Implantable Insulin Pump System Side port catheter The Side Port Catheter (catheter) is a soft plastic tube, made of polyethyl-
ene-lined silicone rubber. The Catheter delivers insulin from the Pump into your peritoneal cavity. Intraperitoneal insulin is rapidly absorbed by your body and is used to regulate your blood sugar. Your doctor can use the Catheters radio-opaque stripe to help locate it on an X-ray. The Catheter has a subcutaneous part and an intraperitoneal part as shown in the following figure. Subcutaneous Part Intraperitoneal Part Figure 3: Side Port Catheter The Medtronic MiniMed 2007C Implantable Insulin Pump System 7 Personal pump communicator (PPC) The Personal Pump Communicator (PPC) is a hand-held device which allows you to send commands to your Pump and receive Pump informa-
tion using RF telemetry (radio waves). The PPC is 8.9 cm (3.5 inches) long, 7.0 cm (2.8 inches) wide and 2.0 (0.8 inches) thick and weighs 115 grams (4.06 ounces). The PPC uses one AA 1.5 volt alkaline battery as the main power source, and a lithium back-up battery which saves the PPC memory when the main battery is depleted or being changed. The PPC has an easy-to-read screen. Programming information is entered using a four button keyboard. The four buttons and their functions are described in Chapter 4. See Figure 4. Figure 4: Personal Pump Communicator (PPC) 8 The Medtronic MiniMed 2007C Implantable Insulin Pump System To send a command to the Pump, place the PPC near the Pump. With your PPC you can:
Deliver an immediate, square wave or dual wave insulin bolus to compensate for meals. Boluses can be programmed by reading the screen or listening to beeps (audio bolus) Deliver one or many basal rates in a daily pattern Preprogram three different daily basal patterns Deliver a temporary basal rate Suspend the Pump Record Personal Events Program an Automatic Off Your PPC also stores important information in its memory (120 days of data). This information includes:
Current time and date Time, date and amount of the last meal bolus Current basal rate Daily insulin totals (basal and bolus) Clinical history Insulin amount remaining in the Pump Maximum bolus allowed Maximum basal rate allowed Insulin concentration used NOTE: The PPC issued to you by your doctor can be used only with your Implantable Insulin Pump. Do not attempt to use any other PPC to program your Pump, unless specifically instructed to do so by your doctor.
The Medtronic MiniMed 2007C Implantable Insulin Pump System 9 Special insulin The Medtronic MiniMed 2007C Implantable Insulin Pump System uses a special insulin, purified and concentrated exclusively for implantable pump use. The insulin is HOE 21 PH U-400, manufactured by Aventis. Only Aventis HOE 21 PH U-400 may be used in the Medtronic MiniMed 2007C Implantable Insulin Pump System. 10 The Medtronic MiniMed 2007C Implantable Insulin Pump System CHAPTER 2 Safety Features 11 Pump safety features Safe telemetry Alarms Your Pump will respond only to telemetry commands from your PPC. Your Pump will not change when exposed to electromagnetic fields, such as microwave ovens, garage door openers, airport security systems, and television or video remote controls. The most important safety feature of your Pump is its self-checking cir-
cuitry. If your Pump is not working properly, it will signal you with an alarm message on the PPC screen and then automatically turn itself off. This feature ensures that your Pump will always deliver insulin in a con-
trolled, predictable manner. Negative pressure reservoir The Pump reservoir has a negative pressure (vacuum) which will draw in fluids. In the event of a Pump malfunction, this vacuum assures your insu-
lin will stay in the reservoir. Dont worry, there are multiple safety fea-
tures to assure that your body fluids wont enter the Pump. Only the pumping mechanism can overcome this negative pressure and deliver insulin to your body. 12 Safety Features PPC safety features Programming sequence In order to send a command to your Pump, your PPC must be properly positioned nearby and a series of programming steps must be followed. Maximum dosage limits Your doctor will program maximum dose limits into your PPC. The pro-
grammed maximum basal rate and bolus amount will protect you from an insulin overdose, in the event of a programming mistake. Alarms and messages Your PPC prompts you with many easy-to-read messages on its screen. Also, the PPC emits beeps to notify you of certain conditions, such as bat-
tery status, programming errors, and a low or empty pump reservoir. These messages and alarms are discussed further in Chapter 5, entitled, Alarms and Messages. 13 CHAPTER 3 Implanting the MiniMed 2007C Pump System Hospitalization You will be admitted to the hospital to have your Medtronic MiniMed 2007C Implantable Insulin Pump System surgically implanted and stabi-
lized in your tissue. Your Pump System will also be programmed and tested prior to your leaving the hospital. Your hospitalization will consist of three types of procedures:
Pre-Operative Procedures Implantation Procedures Post-Operative Procedures Pre-operative procedures You will have blood drawn, be given diagnostic procedures, and possibly other tests before your scheduled surgery date. You should ask your doc-
tor what tests will be required before your Pump is implanted. You may also meet with an Anesthesiologist or Surgeon prior to the surgery. The Pump will be implanted in your abdominal area. Your doctor will dis-
cuss the exact location of implantation with you. The choice of a Pump site may depend upon the catheter location, how your body is shaped, and whether or not you have had any previous abdominal surgery, such as an appendectomy.
14 Implanting the MiniMed 2007C Pump System The Pump may be implanted using either local or general anesthesia. This decision will be made by you, your doctor, the Surgeon, and the Anesthe-
siologist. If local anesthesia is chosen, you will be awake during the implantation but the pump site will be numbed. Under general anesthesia, you will be kept asleep during the procedure by the anesthesiologist. Implantation procedures The Surgeon will make an incision through your skin and create a pocket in which to place the Pump. The Pump is then inserted under the fatty tissue just beneath your skin. The Surgeon will then secure the Pump in your tissue to prevent movement. A very small opening will be made in your abdominal muscle wall through which the Surgeon will thread the Side Port Catheter into your peritoneal cavity. After the Catheter is posi-
tioned and the Pump is secured, the Surgeon will use sutures to close the incision in your skin. Bandages are used to protect the incision until it heals. Some Surgeons may want you to wear a binder over the implant site for a short time to minimize post-operative swelling. Post-operative procedures The length of your hospital stay will be determined by your doctor. Your stay will depend upon how quickly you heal, and how quickly you learn to use the Medtronic MiniMed 2007C Implantable Insulin Pump System. Before your admission to the hospital, your doctor or a nurse will teach you how to use your PPC to program the Pump. Before leaving the hospi-
tal, you must become proficient in understanding and using your PPC to program the Pump. You should:
Fully understand how to use your PPC. Demonstrate appropriate responses to warning messages and alarms from your PPC. Be able to identify signs and symptoms your doctor wants you to report. Have completed a Patient Emergency Information Card, which indicates you have an implantable pump and provides emergency phone numbers.
Implanting the MiniMed 2007C Pump System 15 Ask your doctor to complete and return your Device Registration Card to MiniMed. This card contains the Pump and Catheter serial numbers, which are needed for device tracking by MiniMed. Schedule an appointment with your doctor for your first follow-
up visit. Read Chapter 5, Alarms and Messages, and ask your doctor to explain anything you dont understand. Follow-up Before you leave the hospital, your doctor will schedule an appointment for your first follow-up office visit. Your healthcare team will also keep in close contact with you during the first few weeks following implantation. Frequent adjustments in your insulin delivery are often required for sev-
eral weeks following implantation. NOTE: ALWAYS keep your PPC with you. During office visits, a member of the healthcare team will check the status of your Pump. Only YOUR PPC can be used to check YOUR Pump. Your post-implant recovery will be similar to recovery from other surgical procedures. You will need to obtain adequate rest, eat a nutritious diet, and avoid individuals who are suffering from infections or viruses. Recovery times vary among individuals, but most people recover fully in a few weeks. Your physician will ask you to call if you are not feeling well, particularly if you have an elevated temperature or if you notice any redness or drainage around your incision site.
16 Implanting the MiniMed 2007C Pump System Pump refills Insulin used with the implantable pump Aventis, located in Frankfurt, Germany, is the manufacturer of the insulin used in your Implantable Insulin Pump. This insulin, HOE 21 PH U-400, is specifically designed for implanted pumps. No other insulin should be put in your Pump. Pump refill procedure It is important that the time between your Pump refills should not exceed 90 days. Refilling your Pump is a sterile procedure. Your doctor or a nurse will first disinfect your skin directly over the Pump. All equipment that will touch your skin during the refill procedure is sterile to minimize the risk of infection. Your doctor or a nurse may now numb the disinfected skin area with a local anesthetic. A short needle will then be inserted through your skin to locate the fill port of the Pump. Then a longer needle will be inserted into the Pump fill port through the inside of the shorter needle. The doctor or nurse will then empty unused insulin from the Pump and refill it with new Aventis, HOE 21 PH U-400 insulin. 17 CHAPTER 4 Programming Your Pump Introduction You will program your Implantable Insulin Pump with your PPC. The PPC transmits information by RF telemetry (radio waves) to your Pump. With your PPC you can:
Deliver an immediate, square wave or dual wave insulin bolus to compensate for meals. Boluses can be programmed by reading the screen or listening to beeps (audio bolus) Deliver one or many basal rates in a daily pattern Preprogram three different daily basal rate patterns Deliver a temporary basal rate Suspend the Pump Program an Automatic Off Adjust the tone frequency of the PPC and the audible alarms of the Pump. NOTE: Your PPC has been designed for easy use (See chapter 5 for a list of the PPC commands). You must follow a specific sequence of steps and hold the PPC near the Pump to deliver a command. Therefore, you cannot unintentionally program your Pump.
18 Programming Your Pump Your PPC has been specifically pre-programmed for use with your Pump. Do not use another PPC to program your Pump. You must keep your PPC with you at all times because it is the only way to program your Pump. Remember, you must measure your blood sugar at least four times each day, according to the method recommended by your doctor. You must then use the results of your blood sugar tests to determine the appropriate dose of insulin to be delivered by your Pump. PPC screen icons Your PPC has an easy-to-read dot matrix liquid crystal display (LCD). The main PPC screen displays the time (12hr. or 24hr. format), month, day, and a variety of icons. The type and purpose of these icons are as fol-
lows:
Icon Description The bell icon is displayed when the PPC receives a RF telemetry message from the Pump. The icon may indicate the Pump or PPC has detected a fail-
ure, or the Pump is in a SUSPEND mode or STOPPED. The reservoir icon is composed of 4 segments that indicate how full the Pump reservoir is, based on the history of the Pump delivery. The PPC shows a spinning icon while insulin delivery is in progress. When the Pump delivers a bolus amount, the pattern will show three deliv-
ery segments. When the Pump delivers a basal rate, the pattern will show one delivery segment. When the Pump is not delivering, all four segments will be displayed. Programming Your Pump 19 PPC buttons PPC programming information is entered using four buttons:
Buttons SEL ACT LLLL UP ARROW MMMM DOWN ARROW Description Means SELECT. The SEL button allows you to step through and view each of the option screens. Means ACTIVATE. The ACT button activates programming changes you wish to make. As a safety check, you must press ACT to complete any programming changes. You will always hear a single beep after you have successfully activated a change. Allows you to make changes to the screen settings by scrolling to higher values. You must then press the ACT button for a change to be activated. This button has a Sound Icon. When the AUDIO BOLUS feature is turned on, the LLLL button allows you to program an Audio Bolus. Allows you to make changes to the screen settings by scrolling to lower values. You must then press the ACT button for a change to be activated. This button has a Light Icon which turns on the backlight. With the dis-
play illuminated, you can program your Pump in dark areas. The back-
light remains on for 4 seconds after each MMMM press. Communicating PPC 1. When commands are programmed the PPC will talk to the Pump. When this occurs the following screen will dis-
played. 2. The word COMMUNICATING will blink to indicate a communication is taking place. PPC COMMUNICATING 20 Programming Your Pump Main programming screen The Main programming screen is used to program features you will use every day, such as a Meal Bolus or Basal Rate, or putting your Pump in the Suspend mode. Programming a bolus Using the PPC, you can program the Pump to deliver a bolus of insulin whenever you need it. The Pump System has several special features which allow you to customize the programming and delivery of a bolus:
Immediate Bolus (programmed by reading the PPC screen or lis-
tening to beeps, using the Audio Bolus). Square Wave Bolus Dual Wave Bolus NOTE: To program a Square Wave or Dual Wave Bolus, you must turn on the Variable Bolus programming option (program ON in the SETUP II menu). Otherwise, only an Immediate Bolus can be given. The Variable Bolus option is programmed by your doctor.
Programming Your Pump 21 Set an immediate bolus (variable bolus option isoff) 1. From the Time/Date screen, press SEL until the BOLUS screen is displayed. The Time and Date will be flashing, and the last bolus is displayed. 2. Press ACT and SET BOLUS appears, and the dashes or previous bolus under IMM start flashing. 3. Use the LLLL and MMMM buttons to enter an immediate bolus amount. 08:23 Jan 02 BOLUS IMM 10 PROG EXT U
--
--
U SET BOLUS IMM
--
U 4. Press ACT and the screen shows CON-
FIRM IMM. If the number you entered for the immediate bolus is correct, press ACT to confirm it. This value will now be programmed into the Pump. If the number was not correct, wait for the screen to return to Time/Date and then repeat this procedure to enter the correct value. IMM 2.6U CONFIRM 5. Place the PPC near the Pump to complete the programming. The PPC will beep once and display 0.0 units. PPC COMMUNICATING 6. 08:23 JAN 04 If the Alarm Feedback feature is ON, the Pump will beep during each of the first five strokes. The PPC will beep when the bolus delivery is complete. Three segments of the insulin delivery icon will be displayed and will spin slowly during the bolus delivery. By pressing SEL you can see the amount of insulin being delivered. 0.0U BOLUS 22 Programming Your Pump Set an immediate bolus (variable bolus option is on) 1. From the Time/Date screen press SEL until the BOLUS screen is displayed. The last bolus value programmed and the Time and Date will be flashing. 2. Press ACT and SET BOLUS TYPE appears. Use the LLLL and MMMM buttons to choose NORMAL. 3. Press ACT and IMM appears with the dashes underneath flashing. 4. Use the LLLL and MMMM buttons to enter an immediate bolus amount 5. Press ACT and the screen shows CON-
FIRM IMM. 6. 7. If the number was not correct, wait for the screen to return to Time/Date and then repeat this procedure to enter the correct value. If the number you entered for the immedi-
ate bolus is correct, press ACT to con-
firm it. Place the PPC near the Pump to complete the programming. 8. The PPC will beep once and display the amount of insulin delivered. If the Alarm Feedback feature is ON, the Pump will beep during each of the first five strokes. 9. The PPC will beep when the bolus deliv-
08:23 Jan 04 BOLUS IMM
--
EXT
--
U U
--
SET BOLUS TYPE NORMAL SET BOLUS IMM
--
U CONFIRM IMM 2.6U PPC COMMUNICATING 08:23 JAN 04 BOLUS 0.0U ery is complete. Three segments of the insulin delivery icon will be displayed and spinning slowly during the bolus delivery. By pressing SEL you can see the amount of insulin being delivered. Programming Your Pump 23 Set a square wave bolus A Square Wave Bolus is delivered evenly over a time period you set, from 30 minutes to 4 hours. A Square Wave Bolus is useful during long meals, high fat meals, or if you have gastroparesis. During a Square Wave Bolus, your Basal Rate insulin continues to be delivered. To access Square Wave Bolus you must first turn the Variable Bolus fea-
ture "ON" in the SET UP II menu. 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. 2. Press ACT and SET BOLUS TYPE appears. 3. Use the LLLL and MMMM buttons to choose SQUARE. 4. Press ACT and the dashes underneath EXT will appear flashing. 5. Use the LLLL and MMMM buttons enter an extended bolus amount. 6. Press ACT and dashes will appear under the bolus amount you just entered. 08:23 Jan 04 BOLUS IMM 10 PROG EXT U
--
--
U SET BOLUS TYPE SQUARE SET BOLUS SET BOLUS IMM
--
IMM
--
U U U SET BOLUS IMM
--
EXT
--
U EXT 4.0U EXT 4.0U
--
24 Programming Your Pump 7. Use the LLLL and MMMM buttons to enter a time duration that you would like the Square Wave Bolus to last. 8. Press ACT and the screen shows CONFIRM EXT asking you to confirm the extended bolus and time duration. SET BOLUS IMM
--
U U CONFIRM IMM
--
EXT 4.0U 02:00 EXT 4.0U 02:00 9. If the numbers you entered are correct, press ACT to confirm them. These values will now be programmed into the Pump. If either number is not cor-
rect, wait for the screen to return to Time/Date and then repeat this procedure to enter the correct values. 10. Place the PPC near the Pump to complete the programming. 11. The PPC will beep once and display the amount of insulin being delivered. If the Alarm Feedback feature is ON, the Pump will beep during each of the first five strokes. PPC COMMUNICATING 08:23 JAN 04 BOLUS 0.0U 12. The PPC will beep when the bolus delivery is complete. Three seg-
ments of the insulin delivery icon will be displayed and will spin slowly during the bolus delivery. By pressing SEL you can see the amount of insulin being delivered. Programming Your Pump 25 Set a dual wave bolus Variable Bolus Option Must be ON. The Dual Wave Bolus allows you to deliver an Immediate Bolus immedi-
ately followed by a Square Wave Bolus. 1. From the Time/Date screen press SEL until the BOLUS screen is displayed. The last bolus value programmed will be shown and the Time and Date will be flashing. 2. Press ACT and SET BOLUS TYPE appears. 3. Use the LLLL and MMMM buttons to choose DUAL. 08:23 Jan 04 BOLUS IMM
--
EXT
--
U U PROG
--
SET BOLUS TYPE DUAL 4. Press ACT and IMM appears with the dashes underneath flashing. 5. Use the LLLL and MMMM buttons enter an imme-
diate bolus amount 6. Press ACT and the dashes underneath EXT will appear flashing. 7. Use the LLLL and MMMM buttons enter an extended bolus amount. SET BOLUS IMM 2.0U SET BOLUS IMM 2.0U EXT 2.0U 8. Press ACT and dashes will appear under the extended bolus amount you just entered. SET BOLUS IMM 2.0U EXT 2.0U
--
26 Programming Your Pump 9. Use the LLLL and MMMM buttons to enter a time duration that you would like the extended bolus to last. 10. Press ACT and the screen shows CONFIRM asking you to confirm the immediate bolus, extended bolus, and time duration. 11. If the numbers you entered are correct, press ACT to confirm them. These values will now be programmed into the Pump. If any number is not correct, wait for the screen to return to Time/Date and then repeat this procedure to enter the correct values. SET BOLUS IMM 2.0U EXT 2.0U 02:00 CONFIRM IMM 2.0U EXT 2.0U 02:00 PPC COMMUNICATING 12. Place the PPC near the Pump to complete the programming. The PPC will beep once and display the amount of insulin being delivered. 08:23 JAN 04 BOLUS 0.0U 13. If the Alarm Feedback feature is ON, the Pump will beep during each of the first five strokes. 14. The PPC will beep when the bolus delivery is complete. Three seg-
ments of the insulin delivery icon will be displayed and spinning slowly during the bolus delivery. By pressing SEL you can see the amount of insulin being delivered. Programming Your Pump 27 Review the bolus history You can review the bolus type, bolus amount, time and day of your last 512 insulin boluses. 1. From the Time/Date screen press SEL until the BOLUS screen is displayed. The last bolus value programmed and the time and date will be flashing. 2. Press the MMMM button once to display the 08:23 Jan 04 BOLUS IMM 5.6U PROG EXT
--
--
U previous bolus and the time and date it was delivered. Each additional MMMM press will display the next previous bolus delivery. Suspend mode Suspend Mode allows you to cancel bolus programming. In suspend mode the pump will still deliver a basal rate of approximately 0.2u/hr. 1. From the Time/Date screen press SEL until the SUSPEND PUMP screen is shown. SUSPEND PUMP 2. Press ACT. 3. Place the PPC near the Pump to complete the programming. When communication is finished the Pump will beep 3 times. PPC COMMUNICATING 4. All four segments of the insulin delivery icon will be displayed. 08:13 OCT 02 PUMP SUSPENDED 5. To restart the Pump, press SEL and ACT. 28 Programming Your Pump Program basal rates Your Basal Rate provides you with approximately 50 percent of your daily insulin needs. A Basal Rate is normally delivered all the time, throughout the day and night. Your PPC can tailor your Basal Rates to meet your changing insulin needs throughout the day. If you want to, the PPC can deliver a different Basal Rate every 30 minutes throughout the day. For some people, one Basal Rate will work fine. Other people find that multiple Basal Rates will help them respond better to their insulin needs. You should discuss with your doctor the number and amount of Basal Rates that are best for you. Set one basal rate 1. From the Time/Date screen press SEL until the BASAL RATE screen is dis-
played. Basal Delivery Pattern A and the current Basal Rate appear. The word NOW also appears and is flashing. 2. Press ACT and 1 appears to the right of A indicating that you will now program first Basal Rate 1 in Basal Delivery Pattern A. The Basal Rate is flashing. 3. Use the LLLL and MMMM buttons to enter a new Basal Rate. 4. Press ACT and the screen displays SET TIME, indicating you will now program a start time for Basal Rate 2 The time is flashing. BASAL RATE : A NOW 0.2U/H 00:00 SET RATE BASAL RATE : A 00:00 1 0.2U/H SET RATE BASAL RATE: A
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00:30 2 U/H 5. Use the LLLL and MMMM buttons to change time to dashes. 6. To enter one Basal Rate, press ACT 2 times. Programming Your Pump 29 NOTE: In 24 hr. display mode, 00:00 indicates a start the time of MIDNIGHT. In 12hr. display mode, screen will read 12:00am. 7. Place the PPC near the Pump to complete the programming. The screen will display PPC communicating. 8. The screen will calculate and briefly dis-
play the total daily Basal insulin from the Basal Rates you have programmed. PPC COMMUNICATING 24 HOUR TOTAL 4.8U Set multiple basal rates 1. From the Time/Date screen press SEL until the BASAL RATE screen is dis-
played. Basal Delivery Pattern A and the current Basal Rate appear. The word NOW also appears and is flashing. 2. Press ACT and 1 appears to the right of A indicating you will now program Basal Rate 1 in Basal Delivery Pattern A. The Basal Rate is flashing. 3. Use the LLLL and MMMM buttons to enter a new Basal Rate. 4. Press ACT and the screen displays SET TIME, indicating you will now program a start time for Basal Rate 2 The time is flashing. 5. Use the LLLL and MMMM buttons to enter a new start time. BASAL RATE : A NOW 0.2U/H 00:00 SET RATE BASAL RATE : A 00:00 1 0.2U/H SET RATE BASAL RATE : A
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04:30 2 U/H 30 Programming Your Pump NOTE: In 24 hr. display mode, 00:00 indicates a start the time of MIDNIGHT. In 12hr. display mode, screen will read 12:00am. 6. Press ACT and SET RATE and 2 appears, indicating you will now program Basal Rate 2 in Basal Delivery Pattern A. The Basal Rate is flashing. 7. Use the LLLL and MMMM buttons to enter a Basal Rate and start time for Basal Rate #2. 8. Continue this procedure until all desired Basal Rates and start times are pro-
grammed. Then press MMMM and ACT. 9. Place the PPC near the Pump to complete the programming. 10. The screen will calculate and briefly dis-
play the total daily Basal insulin from the Basal Rates you have programmed. SET RATE BASAL RATE : A
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05:00 2 U/H PPC COMMUNICATING 24 HOUR TOTAL 4.8U NOTE: To set multiple basal pro-
files in the other patterns
(A, B, C), select the pattern in Setup II menu and follow the above procedure. Set a temporary basal rate A Temporary Basal Rate is often used when a brief change in basal deliv-
ery is required, for example during exercise. 1. From the Time/Date screen press SEL until the TEMP BASAL screen is dis-
played. TEMP BASAL
--
--
U/H Programming Your Pump 31 2. Press ACT and SET DURATION appears with the start time flashing. SET DURATION TEMP BASAL 3. Use the LLLL and MMMM buttons to enter a Tem-
00:30 porary Basal Rate.
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U/H 4. Press ACT and SET AMOUNT appears with the Temporary Basal Rate flashing. SET AMOUNT TEMP BASAL 00:30 1.5U/H 5. Use the LLLL and MMMM buttons to enter a new start time for the Temporary Basal Rate, then press ACT again. 6. Place the PPC near the Pump to complete the programming. PPC COMMUNICATING NOTE: When your Pump is delivering a Temporary Basal Rate, pressing SEL will display TEMP BASAL. This will remind you that the Temporary Basal Rate feature is currently active. Stop a temporary basal rate 1. From for the Time/Date screen press SEL until the TEMP BASAL screen is dis-
played. 2. Press ACT and SET DURATION will appear with the time flashing. 3. Press the MMMM button until the time is set to dashes, then press ACT. 4. Place the PPC near the Pump to complete the programming. SET AMOUNT TEMP BASAL
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1.5U/H PPC COMMUNICATING 32 Programming Your Pump 5. When the communication is finished, SET AMOUNT will appear with the dashes flashing. Allow the PPC to return to the Time/Date screen or press ACT. The Temporary Basal Rate is now can-
celed. SET AMOUNT TEMP BASAL
--
--
U/H Personal events This feature appears in the Main menu if it has been activated to "ON" in the Pump Setup II menu. The Personal Event menu allows you to enter important events during the day. Preset events You can enter the following preset codes for these popular events:
1 = meal 2 = snack 3 = sick 4 = exercise. Additional events Codes A, B and C can be used to record other events. Be sure to document the events listed for A, B, and C. NOTE: Events that happened in the past or present can be entered. 1. From the Time/Date screen, press SEL until the SET PERSONAL EVENTS screen is displayed. 2. Press ACT and the screen will change to SET EVENT with MEAL flashing. EVENT _ _
Programming Your Pump 33 3. Use the LLLL and MMMM buttons to select the event you want to enter: MEAL, SNACK, SICK, EXERCISE, A, B, C. SET EVENT MEAL 4. Press ACT and the time will appear flash-
ing. 5. Use the LLLL and MMMM buttons to enter the time that the event occurred. 6. Press ACT to enter the event in the PPC memory. 08:32Am SET TIME EVENT MEAL History The History menu allows you to look at important Pump data, such as the amount of insulin remaining in the Pump reservoir or total insulin deliv-
ery since the last refill. The History menu contains the following options:
Med Remaing, Insulin Total Basal Bolus, Clinical Hist PPC, Clinical His-
tory Pump, Est Pump Battery. To read Pump Data perform the following steps. 1. From the Time/Date screen, press SEL until the HISTORY screen is displayed. 2. Press ACT and the screen with change to READ PUMP DATA with the entire screen flashing. 3. Press ACT, and then place the PPC near the Pump. History data in the Pump will be transferred to the PPC. READ PUMP DATA
............................................ .................................10057 PPC COMMUNICATING 34 Programming Your Pump 4. The screen will automatically change to MED REMAINING. The amount of insulin in the Pump reservoir is reported in units. 5. Press SEL and the screen will change to INSULIN TOTAL. The amount of Basal Rate and Bolus insulin delivered is reported for the day indicated. 6. Press the MMMM button to review insulin delivery rates for other days. 7. Press SEL and the CLINICAL HIS-
TORY PPC screen is shown. Ask your doctor what the numbers mean. 8. Press the MMMM button to review other days. 9. Press SEL to find the CLINICAL HIS-
TORY PUMP screen. Ask your doctor what the numbers mean. Press the MMMM but-
ton to review other days. 10. Press SEL and the screen will change to the EST PUMP BATT display. This screen indicates the energy left in the Pump battery. Ask your Physician what the numbers mean. 11. Press SEL and the screen will read EXIT HISTORY. Press ACT to return to the Time/Date screen. MED REMAINING 7263 U Jan 02 INSULIN BASAL 9 U TOTAL BOLUS 22 U 6:26 Jan 02 CLINICAL HISTORY PPC 11 6:26 Jan 02 CLINICAL HISTORY PUMP 14 Jan 02 EST PUMP BATTERY LD NO LD 2.7V 2.9 V EXIT HISTORY Programming Your Pump 35 Pump setup This screen permits access to other Pump SETUP features. These fea-
tures are normally programmed for you by your doctor or nurse. To reach the SETUP PUMP menu, press SEL until the SETUP PUMP screen is displayed, then ACT to access the SETUP screens. Time and date The time and date settings must be correct. The PPC uses the time and date to calculate your total daily insulin and display Pump history. 1. From the Time/Date display, press SEL until the SETUP PUMP screen is dis-
played. 08:32 Jan 02 SET 2000 TIME-DATE 2. Press ACT two times. The hour digits will begin flashing. Use the LLLL and MMMM but-
tons to select the current hour. 3. Press ACT again, and the minute digits will begin flashing. Use the LLLL and MMMM buttons to select the current minute. 4. Repeat this programming process again to select the current year, month and day. 5. At the conclusion of programming press ACT, and then place the PPC near the Pump. When the communication process is complete, the PPC will automatically move to the next screen, AUTO OFF. PPC COMMUNICATING 36 Programming Your Pump Auto off AUTO OFF sets an alarm on your PPC, to remind you if you have not programmed your Pump recently. The AUTO OFF alarm can be set between 1 and 16 hours. To turn off "Auto Off" program set the time to dashes. 1. From the SETUP PUMP screen, press ACT then SEL. 2. The screen will display AUTO OFF with flashing dashes. Press ACT. 3. Use the LLLL and MMMM buttons to select the number of hours before an Auto Off alarm occurs. 4. Press ACT. In this example, a time dura-
AUTO OFF
--
HRS SET AUTO OFF 10 HRS tion of 10 hours was selected. The PPC will alarm if you did not program your Pump during the past 10 hours. 5. Place the PPC near the Pump. The PPC will beep once when the communication is completed. PPC COMMUNICATING Programming Your Pump 37 Alarms There are three PPC Alarm options, two audible tones (Low/High) and a vibrate mode. ALARMS will alert you if either the PPC or Pump recognizes a prob-
lem. Your doctor or nurse will make sure the ALARM FEEDBACK screen is in the ON position. Vibrate only for alarms, all programming feedback from PPC is done with beeps. NOTE: If you want the PPC to vibrate instead of beep, the PPC battery will only last 6 weeks instead of 8 weeks, under conditions of normal use. 1. Press ACT to enter the ALARMS menu. ALARMS 2. Press the LLLL and MMMM buttons to select the type of alarm you want, then press ACT. 3. The screen will now display SET PPC FEEDBACK. This setting should always be ON. Press ACT. 4. Place the PPC near the Pump. When the communication is completed, the PPC will change to SELF TEST and then timeout to the Time / Day screen. SET PPC ALARM TYPE LOW/HIGH/VIBRATE SET ALARM FEEDBACK ON/OFF PPC COMMUNICATING 38 Programming Your Pump Self Test Your doctor may ask you to run a diagnostic test of your Pump System. SELF TEST will send messages between your PPC and Pump to check their operation. NOTE: Notify your doctor if any of these Self Test events do not occur. If the PPC displays a MiniMed logo and software number, the PPC has re-started but has a low bat-
tery. Replace the battery immediately. 1. From the SETUP PUMP screen, press SEL until the SELF TEST screen is displayed. SELF TEST 2. Press ACT. 3. Place the PPC near the Pump and com-
plete the communication process. 4. Verify the following events occur:
PPC COMMUNICATING The Pump will beep four times. The PPC backlight will turn on. The PPC will sound a long changing tone. The PPC will vibrate. The PPC will beep once. The PPC screen display all possible icons and numbers. Programming Your Pump 39 5. If your PPC and Pump pass the Self Test, the display will change to PPC PASSED/PUMP PASSED. After several seconds, the screen will change back to the Time/Date screen. PPC PUMP PASSED PASSED Basal delivery patterns The PPC allows you to program three different basal delivery patterns (A, B, C). Pattern A is preset at the factory. Patterns B and C can be pro-
grammed from the SETUP PUMP menus. Each basal rate pattern can accept up to 48 different basal rates, one for each half-hour of the day. These are programmed from the "Basal Rate" screen in the Main Pro-
gramming menu. Basal patterns can be used to follow your normal daily routines. For example, separate patterns could be programmed for a typical work day, weekend day, and travel day. 1. From the SETUP PUMP screen, press SEL until the DELIVERY PATTERN A screen is displayed. Press ACT. DELIVERY PATTERN A 2. Press SEL again until the DELIVERY PATTERN screen appears. Press ACT and the screen will change to SET DELIVERY PATTERN. 3. Press the LLLL and MMMM buttons to select pat-
tern A, B or C. 4. Press ACT. Place the PPC near the Pump and allow the communication to com-
plete. SET DELIVERY PATTERN A,B,C PPC COMMUNICATING NOTE: The PPC will automatically return to the Time/
Date screen. Press SEL until the BASAL RATE screen is displayed. The pattern you have selected will appear on this screen. 40 Programming Your Pump Initialize PPC to pump This screen initializes your PPC to your Pump. Your doctor will normally perform this programming for you. Contact your doctor, if you need to have your PPC replaced. Pump setup II SETUP II is another programming menu. SETUP II features are used less often than the features in SETUP. SETUP II features are explained in the next section. Exit setup menu From the SETUP screen, press SEL until the EXIT SETUP MENU screen is displayed. Press ACT. The PPC will return to the Time/Date screen. Programming Your Pump 41 Pump setup II The SETUP II screen allows you to program additional features into your PPC. Your doctor will normally program SETUP II features for you. 1. From the SETUP screen, press SEL until the SETUP II screen is displayed. Turn on the audio bolus feature The AUDIO BOLUS feature allows you to deliver a bolus without looking at the PPC screen. There are two Audio Bolus amounts you can deliver, 0.4U and 0.8U. With each press of the LLLL button, the PPC will beep one time (0.4U setting) or two times (0.8U setting). 1. From the SETUP II screen, press ACT. The AUDIO BOLUS screen appears. 2. Press ACT, and the screen changes to SET AUDIO BOLUS with ON flash-
ing. 3. Use the LLLL and MMMM buttons to choose ON to turn on the Audio Bolus feature. Choose OFF to turn the Audio Bolus off. Press ACT again. NOTE: If OFF is chosen, press-
ing the L and M buttons will have no effect. 4. If ON was chosen, the SET STEP AUDIO BOLUS screen appears, with a bolus amount of 0.4U flashing. AUDIO BOLUS 0.4U ON SET AUDIO BOLUS 0.4U ON SET STEP AUDIO BOLUS 0.4U ON 42 Programming Your Pump 5. Use the LLLL and MMMM buttons to choose a bolus amount of either 0.4U or 0.8U. 6. Press ACT. AUDIO BOLUS will now appear on the PPC Main Menu. Use audio bolus in the main menu NOTE: When an audio bolus is being delivered, the LLLL button will not work. From the Time/Date screen press LLLL button. The PPC will beep one or two times, depending upon the bolus amount set (0.4U or 0.8U). 1. Count the number of beeps to determine how much insulin you want to program. 2. Press ACT, and the beeps repeat to con-
firm the bolus amount you have entered. 3. Press ACT twice, and the PPC will pro-
gram the Pump. The PPC will beep once when the communication is completed. SET BOLUS IMM 1.2U PPC COMMUNICATING Turn on the variable bolus feature If OFF is chosen, the Variable Bolus feature will not be available. 1. From the SETUP II menu, press SEL until the VARIABLE BOLUS screen is displayed. VARIABLE BOLUS ON/OFF Programming Your Pump 43 2. Press ACT and the screen changes to SET VARIABLE BOLUS. The word ON is flashing. 3. Use the LLLL and MMMM buttons to select ON or OFF. 4. Place the PPC near the Pump and com-
plete the communication. If ON was chosen, the Variable Bolus option will appear in the Main Menu / Bolus screen. SET VARIABLE BOLUS ON PPC COMMUNICATING Set a maximum bolus Your doctor will decide if you should use this feature. Setting a maximum bolus amount will protect you from over-delivering insulin in case you make a programming mistake. 1. From the SETUP II menu, press SEL until the MAX BOLUS screen is dis-
played. 2. Press ACT and the screen will change to SET MAX BOLUS, with the dashes flashing. MAX BOLUS
--
U SET MAX BOLUS
--
U 3. Use the L L L Land MMMM buttons to enter a maxi-
mum bolus amount (0.0U to 25.0U), then press ACT. 4. Place the PPC near the Pump and com-
PPC COMMUNICATING plete the communication. The PPC screen will automatically change to the MAX BASAL RATE screen and then times out to the Time/Date screen if no further action is taken. 44 Programming Your Pump Set a maximum basal rate Your doctor will decide if you should use this feature. Setting a maximum basal rate will protect you from over-delivering insulin in case you make a programming mistake. 5. After setting a maximum bolus, the MAX BASAL screen appears with the maximum basal rate flashing. 6. Use the L L L Land MMMM buttons to enter a maxi-
mum basal rate (0.2U/h to 35.0U/h), then press ACT. 7. Place the PPC near the pump and com-
plete the communication. The PPC screen will automatically change to the TIME FORMAT screen. SET MAX BASAL RATE 0.2U/H PPC COMMUNICATING Set time format 1. From the SETUP II screen, press SEL until the SET TIME FORMAT screen is displayed. 2. Use the L L L Land MMMM buttons to select either a 12 hour (12:00am) or 24 hour (00.00) time format, then press ACT. 3. Place the PPC near the pump and com-
plete the communication. The PPC screen will change to the PERSONAL EVENTS screen. SET TIME FORMAT 12/24 HOUR PPC COMMUNICATING Programming Your Pump 45 Personal event To activate this feature located in the Main Menu it must be "ON."
1. From the "SET UP II" screen, press SEL until the "PERSONAL EVENTS" screen is displayed. PERSONAL EVENT 2. Press ACT and the SET PERSONAL EVENTS screen is displayed and "OFF" is blinking. SET PERSONAL EVENT 3. Use the L and M buttons to select ON or OFF. Press ACT. 4. Place the PPC near the Pump and complete the communications. The PPC screen will change to "PUMP SET UP."
PPC COMMUNICATING OFF OFF Pump setup This screen allows you to return to the Setup mode by pressing ACT. If you press SEL the screen will change to EXIT SET UP MENU. Exit setup menu This screen allows you to return to the Main Menu, Time/Date screen by pressing ACT. 46 Programming Your Pump 47 CHAPTER 5 Alarms and Messages The Medtronic MiniMed 2007C Implantable Insulin Pump System is equipped with various alarms and messages that ensure the correct func-
tion of the system. The pump alarms The Implantable Insulin Pump has an alarm system which beeps when an error condition occurs. The beeps are audible through the skin and alert you that the Pump needs attention. The Pump will alarm consists of 4 tones each minute for 10 minutes then, 4 double tones each minute for 10 minutes and repeat pattern. Upon hearing the alarm, you need to commu-
nicate with your PPC to determine the alarm condition and call your Phy-
sician. Use the Read Pump Data option to communicate to the pump. The alarm can be cleared by pressing SEL and ACT. 48 Alarms and Messages The PPC alarms The PPC has three types of alarms, audible or vibrate alarms and visual alarms. This chapter will describe, for each alarm condition, which screen message appears. Some alarms can be cleared by pressing SEL then ACT. The difference between these alarms will be explained later in this chapter. Two audible or vibrate alarm types are used:
Alarm type 1 If the PPC is set to vibrate, the vibrator will be turned on for 3 seconds every minute until the condition is cleared. If the PPC is set to audible, the PPC will beep 6 times every minute for 30 minutes. If the alarm is not cleared in 30 minutes, the PPC will beep 6 alternating tones. The PPC will continue to do so every minute until the condition is cleared. Alarm type 2 If the PPC is set to vibrate, the vibrator will be turned on for 3 seconds every minute while the condition exists. If the PPC is set to audible, the PPC 6 will beep 3 times every 30 min-
utes while the condition exists. Alarms and Messages 49 Pump alarms Alarm feedback The Alarm Feedback function allows you to verify the Pump and the Pump beeper is operating normally. When Alarm Feedback is pro-
grammed YES, the Pump will beep on each of the first five Pump strokes:
Following a change in the delivery regimen, for example when completing a meal Bolus and then changing to a Basal Rate. After the Alarm Feedback function is programmed YES. Alarm Feedback will stay on until programmed back to NO. Pump low battery The Implantable Insulin Pump battery is designed to last approximately seven years during conditions of normal use (see Chapter 9, Technical Specifications). Battery life may vary somewhat depending upon your insulin delivery requirements. When battery energy becomes low, a volt-
age sensor in the Pump will trigger the Pump Low Battery Alarm. A Pump Low Battery Alarm indicates there is approximately eight weeks of battery energy remaining. PPC Display Type of Alarm PUMP LOW BATTERY 1 Pump Alarm In 24 hours if no PPC communication You can clear this condition and your Pump will continue to operate nor-
mally. However, you should notify your doctor as soon as possible. Your doctor will then schedule a Pump replacement, and may switch you back to conventional insulin therapy.
50 Alarms and Messages Depleted pump battery When there is no longer sufficient battery energy to power the Pump, the Pump Low Battery Alarm will cease. This means that insulin delivery has stopped. You must switch to another type of insulin therapy. System error The Implantable Insulin Pump has a sophisticated self-monitoring system that continuously checks for circuit faults. If the Pump detects a circuit error, it will beep and then automatically shut itself off. When this occurs, you must switch to your alternative insulin therapy estab-
lished between you and your doctor. Notify your doctor immediately of the System Error. PPC Display Type of Alarm Pump Alarm PUMP STOPPED 1 1 or 2 or 3 or 4 or 5 or 6 In 5 minutes if no PPC communication Pump self test fail During a SELF TEST, the Pump finds a malfunction. The Pump will stop delivering insulin. Clear the message by pressing SEL then ACT. You must switch to your alternative insulin therapy established between you and your doctor. Notify your doctor immediately of the Self Test Error. PPC Display PUMP SELF TEST FAIL Type of Alarm 1 Alarms and Messages 51 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. PPC low battery NOTE: If VIBRATE is selected, the PPC battery should last about six weeks. If the PPC determines that the vibrator is causing a low battery condition, it will automatically change the Alarm Mode to LOW VOLUME in order to extend battery life. If the PPC main battery (AA 1.5 volt alkaline) energy is low, the follow-
ing alarm display will appear:
PPC Display PPC LOW BATTERY Type of Alarm 1 You can clear this message by pressing SEL and then ACT, and then con-
tinue programming. There should be sufficient energy in the battery for at least 24 hours. For instructions on changing the battery, refer to Chapter 8, PPC Care and Maintenance. NOTE: If while programming the Pump, the PPC goes blank, the PPC beeps six times and then the
"CHECK PUMP STATUS" message appears, the PPC (AA 1.5v alkaline) battery needs to be replaced. For instructions, see "Installing/Replac-
ing the Main Battery" in Chapter 8. 52 Alarms and Messages PPC depleted battery When the PPC main battery (AA 1.5 volt alkaline) no longer has suffi-
cient energy to program the Pump, the following message will appear on the display:
PPC Display PPC DEPLETED BATTERY Type of Alarm 1 This message can only be cleared by replacing the PPC battery. For instructions on changing the battery, refer to Chapter 8. PPC needs servicing When the PPC back-up battery (lithium) energy becomes low, the follow-
ing message will be displayed:
PPC Display PPC NEEDS SERVICING Type of Alarm 1 You can clear this message by pressing SEL and ACT, and then continue programming. You should report this alarm to your doctor as soon as pos-
sible to schedule a PPC replacement. Be aware that if the PPC loses all power, it may lose its memory contents. Alarms and Messages 53 Low reservoir When the Pump calculates that less than 800 units (2 ml) of insulin remains in its reservoir, the following display will appear:
PPC Display LOW RESERVOIR Type of Alarm 1 Pump Alarm In 24 hours if no PPC communication You can clear this message by pressing SEL and ACT, and then continue programming. You should notify your doctor of the Low Reservoir mes-
sage, and schedule a Pump refill appointment as soon as possible. Empty reservoir When the Pump calculates that less that 400 units (1 ml) of insulin remains in its reservoir, the following display will appear:
PPC Display EMPTY RESERVOIR Type of Alarm Pump Alarm 1 In 24 hours if no PPC communication You can clear this message by pressing SEL and ACT, and then continue programming. The PPC Medication Remaining function reads calculated values only, and there may still be some insulin left in the Pump reservoir. You should be report this alarm to your doctor as soon as possible, and schedule an appointment for a Pump refill. It is important not to allow the pump to deplete its insulin supply as this may result in a catheter block-
age. 54 Alarms and Messages Communication error If programming is interrupted after partial transmission of a command, the PPC will display the following message on the display screen:
PPC Display TELEMETRY COMM ERROR 3 Type of Alarm 1 You should reposition the PPC near the pump, press SEL and ACT. The PPC will attempt to resume communication with the Pump. 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 CHECK PUMP STATUS Type of Alarm 1 Place the PPC near the pump, then press SEL and ACT. Allow the com-
munications to complete. NOTE: If while programming the Pump, the PPC goes blank, the PPC beeps six times and then the
"CHECK PUMP STATUS" message appears, the PPC (AA 1.5v alkaline) battery needs to be replaced. For instructions, see "Installing/Replac-
ing the Main Battery" in Chapter 8. Alarms and Messages 55 Pump suspended If the Pump operation has been suspended, the following message is dis-
played:
PPC Display PUMP SUSPENDED Type of Alarm 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 com-
plete. 56 Alarms and Messages Auto off If the AUTO OFF time interval elapses, the following message is dis-
played:
PPC Display AUTO OFF PUMP PUMP SUSPENDED Type of Alarm 1 The Pump will initiate the internal alarm sequence of four beeps every minute for 5 minutes, then double-beep 4 times every minute for 10 min-
utes, then repeating the pattern. The alarm is cleared by pressing SEL and ACT, place the PPC near the pump. The PPC will communicate with the Pump to reset the "Auto Off" duration. Hourly maximum exceeded If you attempt to deliver more than 2.5 times the pre-programmed bolus maximum in one hour, the following message to be displayed:
PPC Display HOURLY MAX EXCEEDED Type of alarm 1 Press SEL and ACT, place the PPC near the Pump and allow the commu-
nication to complete. You may exceed this limit by programming another bolus within 10 minutes. Alarms and Messages 57 Personal Pump Communicator messages Display Screen Message AUTO OFF PUMP PUMP SUSPENDED Message Meaning or Action Required Auto Off time interval has elapsed. Pump operation is suspended. BOLUS 0.0 u CHECK PUMP STATUS EMPTY RESERVOIR HOURLY MAX EXCEEDED LOW RESERVOIR PPC NEEDS SERVICING PPC DEPLETED BATTERY PPC LOW BATTERY PUMP LOW BATTERY PUMP RESET PUMP SELF TEST FAIL PUMP STOPPED 1 or 2 or 3 or 4or 5 or 6 A bolus has been programmed and is being delivered. The PPC battery has been replaced. The PPC needs to check the Pump status. The PPC has recognized the Pump has 400 units (1 ml) or less insulin remaining in its reservoir. Schedule a Pump refill as soon as possible. Allowing the reservoir to completely empty may damage the Pump. You attempt to deliver more than 2.5 times the bolus maximum in one hour. To clear the message, press SEL and ACT. You may exceed this limit by programming another bolus within 10 minutes. The PPC has recognized the Pump has 800 units (2 ml) or less insulin remaining in its reservoir. Schedule a Pump refill as soon as possible. Allowing the reservoir to completely empty may damage the Pump. The internal PPC backup battery is depleted. The PPC can be programmed. Replace the PPC as soon as possi-
ble. The PPC cannot be programmed. Replace the PPC AA 1.5 volt alkaline battery. The PPC can be programmed. Replace the PPC AA 1.5 volt alkaline battery. The Pump battery energy is low but still functioning. Schedule a replacement as soon as possible. The Pump was reprogrammed to the preset factory val-
ues. A Pump malfunction was detected during a Self Test. Notify your physician immediately. When the Pump recognizes a system malfunction, it automatically stops and insulin delivery ceases. Notify your physician immediately. 58 Alarms and Messages Display Screen Message PUMP SUSPENDED Message Meaning or Action Required The Pump is in suspend mode TELEMETRY COMM ERROR 3 The PPC and Pump are not communicating. Reposition the PPC over the Pump, then press SEL and ACT. If the error message persists, notify your physician immedi-
ately. 59 CHAPTER 6 Warnings and Precautions Warnings Electrotherapy The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with electrosurgical cutting tools, electrocoagulation, and car-
diac defibrillation medical equipment. Typical use of this type of device has not affected the Pump. However, after such procedures, you should test the Pump function (e.g., program SELF TEST) to determine that the Pump and PPC are operating properly. If the system is not performing correctly, contact your doctor. Diagnostic ultrasound The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with diagnostic ultrasound procedures. These procedures have no effect on the Pump. However, after such procedures, you should test the Pump function (e.g., program a SELF TEST) to determine that the Pump and PPC are operating properly. If the system is not performing correctly, contact your doctor. 60 Warnings and Precautions Ultrasound therapy The Medtronic MiniMed 2007C Implantable Insulin Pump System should not be exposed to therapeutic ultrasound procedures, such as lithotripsy. Exposure to ultrasound therapy may damage the Pump System. Diagnostic radiation The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with Computerized Tomography and X-ray. These procedures have no effect on the Pump. However, after such procedures, you should test the Pump function (e.g., program a SELF TEST) to determine that the Pump and PPC are operating properly. If the system is not performing correctly, contact your doctor. Therapeutic radiation The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested with therapeutic radiation. These procedures have no effect on the Pump. However, it is recommended not to focus therapeutic levels of radiation directly over the pump. After such procedures, you should test the Pump function (e.g., program a SELF TEST) to determine that the Pump and PPC are operating properly. If the system is not performing correctly, contact your doctor. Magnetic resonance imaging You cannot undergo Magnetic Resonance Imaging procedures with the MiniMed 2007C Implantable Pump System. Pump and catheter under-delivery Under-delivery or backflow may occur when insulin deposits collect in the pumping mechanism inside your Pump. These deposits affect the vac-
uum seal in the pumping mechanism, and can prevent some of the insulin from being delivered. If the pumping mechanism is unable to seal tightly, the pump will under-deliver its insulin. Warnings and Precautions 61 If your Pump is under-delivering its insulin, you may feel symptoms of hyperglycemia. If this occurs, you should contact your doctor immedi-
ately. Your doctor will instruct you how to manage your blood glucose levels until the Pump can be corrected. Another under-delivery condition is caused by body fluids or body tissue collecting at the tip of the Catheter. To correct a Catheter obstruction, your doctor may need to flush your Catheter with a sterile solution. Pump electronic or alarm malfunction If the Pumps electronic or alarm systems malfunction, Self Test circuitry will detect the malfunction and may stop the Pump. Notify your doctor immediately if this occurs. If your doctor cannot correct the malfunction, your Pump may need to be replaced and you will need to take alternative insulin therapy. Infection, skin erosion, unresolved backflow, or catheter occlusion may also require that your Pump or Catheter be removed or replaced. Reservoir level warnings Have your Pump refilled before the reservoir is empty. Alarms in the PPC will alert you to low and depleted reservoir levels. For more information on alarms and messages, see Chapter 7. If the low reservoir alarm sounds and you do not have a refill appointment scheduled within two weeks, call your doctor immediately to schedule a refill. Environmental conditions NOTE: If you are in doubt about whether a condition or situation will affect your Pump, contact your doc-
tor for advice. The Implantable Insulin Pump, like all microelectronic devices, should not be exposed to extreme electrical or magnetic fields or temperature extremes which may adversely affect the Pump and its insulin. Do not allow your Implantable Insulin Pump to be exposed to the following envi-
ronmental conditions:
62 Warnings and Precautions Physical damage to the Pump and the Pump pocket Altitudes greater than 2500 meters or 8,000 feet (skiing, hiking, sky-diving) Depths greater than 4 meters or 15 feet (scuba diving, etc.) Elevated temperatures (hot tubs, saunas) Avoid any sharp blows or pressure on the Pump. A direct blow may dam-
age the Pump or injure the Pump pocket. Extreme pressure on the Pump may cause the sutures and the tissue pocket to be damaged resulting in Pump migration and a possible dislodging of the Catheter. If you suspect that your Pump or Pump pocket have been damaged, you should contact your doctor immediately. You may need to wear a pressure bandage or reduce your level of physical activity until the Pump pocket heals com-
pletely. You may not reside at or travel to an elevation in excess of 8,000 feet, or dive below 15 feet. High altitudes and depths will change the Pumps insulin flow. This warning does not apply to commercial airline travel. Airline cabins are adequately pressurized at any altitude for Pump use. It is still possible to ski, dive or sky-dive with the proper precautions. Con-
sult with your doctor. Exposure to elevated temperatures in excess of 104F (i.e. hot tubs, sau-
nas), for longer than one hour, can effect the potency of the insulin and the function of your Pump System (see Pump and Catheter Under-delivery on the previous page). If you have any questions about an activity you are planning, you should contact your doctor for advice. This device may experience communication interruptions when operated at or near some airport facilities. This will not affect the operation of the pump, and it will continue delivery of insulin per previously programmed levels.
Warnings and Precautions 63 Precautions Blood glucose monitoring You must check your blood sugar at least four times daily, using a tech-
nique recommended by your doctor. Notify your doctor of any increased frequency of serious low or high excursions in your blood sugar. High blood sugar values may indicate under-delivery of insulin. If you experi-
ence symptoms of high blood sugar, check the programmed insulin deliv-
ery settings in your PPC and contact your doctor immediately. Conventional insulin supplies Carry conventional insulin supplies with you at all times, including insu-
lin and a means to inject it, in case your PPC is damaged, lost or inopera-
tive. Periodically review with your doctor your recommended insulin delivery procedure you should utilize in the event your MiniMed 2007 Implantable Pump System becomes inoperative. Physicians instructions Follow your doctors instructions about your insulin delivery. The range of insulin delivery with your PPC is a basal rate between 0.2 and 35 units per hour (U/H), and a maximum meal bolus of 25 units (U). Your doctor may narrow this range by programming maximum limits for your Basal Rate and Bolus. The alarm Hourly Maximum Exceeded will be dis-
played if you try to program more than 2.5 times the maximum bolus in one hour. 64 Warnings and Precautions PPC The PPC is an electronic device, and can be damaged if dropped. Do not get the PPC wet or take it into very hot or humid environments, such as steam baths or saunas. If the PPC is damaged, check the displays for proper operation by performing a SELF TEST. If the SELF TEST finds a problem, you will need to replace your PPC. For more information on the SELF TEST procedure, see Chapter 6, Warnings and Precau-
tions. Maximum dosages Your doctor may program specific limits for your Basal Rate and Meal Bolus. These maximum limits provide a regimen specific to your needs. Battery change Carry a fresh AA 1.5-volt alkaline battery with you at all times. The esti-
mated PPC main battery life is approximately 8 weeks, although this can be influenced by how often you program your Pump. If the Low Battery message appears, change the battery as soon as possible, preferably immediately. If the Depleted Battery Alarm occurs, the PPC will not func-
tion and you will no longer be able to program your Pump. Proper PPC positioning Keep the PPC near to the Pump during a programming sequence. Separa-
tion of the PPC and Pump may result in a partial transmission of a com-
mand. If this occurs, the PPC will alarm and display TELEMETRY COM ERROR on the screen. Warnings and Precautions 65 Physical activities to avoid Physical activities which are not permitted are those involving very hig-
hor low altitudes and pressure changes. Such activities include skiing,
(above 8,000 feet), sky diving, and scuba diving. When you must partici-
pate in such activities, discuss them with you physician who will provide treatment requirements, such as the temporary use of another method of insulin delivery, and will refill your Pump with buffer. Emergency plan Be fully informed and thoroughly understand what to do in an emergency. Carry your emergency card with you at all times. Additionally, it is important for individuals close to you, such as family, friends, and co-
workers, to know what to do if you are unable to treat yourself due to ill-
ness or injury. The following instructions should be used by your family or co-workers to set the Pump at the lowest basal rate while your doctor is consulted:
1. Press SEL until the PPC displays SUSPEND PUMP. 2. Press ACT, the PPC will indicate PPC COMMUNICATING. 3. Position the PPC near the Pump. 4. When programming is complete, the PPC will beep and the display will automatically return to the Time/Day screen. The message PUMP SUSPENDED will be displayed. The Pump will deliver a basal rate of approximately 0.2 U/h. In addition to the procedure above, review with family members the proper procedure for administering glucagon. It is important to closely monitor blood sugar levels on refill days. During a refill procedure, a very small amount of insulin may be deposited subcu-
taneously possibly resulting in hypoglycemia. 66 Warnings and Precautions Adverse reactions In clinical studies, adverse reactions associated with the Medtronic Min-
iMed 2007 Implantable Insulin Pump System included hypoglycemia, diabetic ketoacidosis hyperglycemia skin erosion, infection, abnormal healing, elevated anti-insulin antibodies, intestinal obstruction, post-oper-
ative discomfort and pain, and corrective surgery for Pump and Catheter malfunctions. Malfunctions in the order of frequency and seriousness include insulin aggregation resulting in Pump under-delivery, Catheter occlusion or tissue overgrowth, early Pump battery depletion (e.g., less than six years after implantation) and electronic Pump failure. Adverse events associated with the use of Aventis HOE 21 PH U-400 insulin are described in the package insert accompanying the insulin medication. Hyperglycemia Your Implantable Insulin Pump uses a special short-acting insulin, so your body will not have any reserve of long-acting insulin. Interruption of insulin delivery (due to Pump malfunction or clogging of the Catheter) or the sudden onset of stress (emotional upset, infection, etc.) may result in a rapid rise of blood sugar levels, and possibly the development of diabetic ketoacidosis (DKA). Check your blood sugar levels, and your urine for ketones, if you suspect a high glucose level. Supplemental insulin deliv-
ered by conventional means may be required. Establish a protocol with your doctor for rapidly identifying and treating hyperglycemia to avoid the onset of DKA. Hypoglycemia The best method for identifying hypoglycemia is testing your blood sugar levels. Establish a protocol with your doctor for identifying and treating symptoms of hypoglycemia to avoid an insulin reaction. Warnings and Precautions 67 Pump pocket infection Pump pocket infection, although rare, occur around the Pump implanta-
tion site. If you notice pain, redness, or swelling in the area of your Pump, contact your doctor immediately. Pump pocket infections may require the removal of your Pump. Pump pocket seroma A Pump pocket seroma is generally characterized by swelling around the area of implantation. It may occur after surgery or if a blow is received to the Pump site. If you notice swelling around your Pump, contact your doctor immediately. 68 Warnings and Precautions CHAPTER 7 Important Self-Care 69 Having a Medtronic MiniMed 2007 Implantable Insulin Pump System is only one aspect of an overall management program to treat your diabetes. There are many other requirements for achieving near normal blood glu-
cose levels. This manual presents general information regarding blood glucose moni-
toring, meal planning, exercise and other issues concerning your implant-
able Pump. You will be instructed more specifically on these self-care issues by your doctor, nurse, and dietitian. Be sure to discuss all questions with them as they are your best source of information. A support person such as a family member or friend should also read this manual and pay particular attention to the section entitled, Develop Emergency Plan in Chapter 6. Your support person should also be able to program the PPC to stop insulin delivery as described in Chapter 6. Blood glucose monitoring NOTE: Remember much of implantable pump therapy depends on accurate and frequent blood glucose monitoring. the success of Your Pump System does not monitor your blood glucose levels. You must continue to self-monitor your blood glucose at least four times daily, and then use this glucose information to program your Pump System. Blood 70 Important Self-Care glucose monitoring is the only way to determine if you are receiving the correct amount of insulin. You should test your blood glucose according to the method recommended by your doctor. If you begin to have a problem with glycemic control, it is very important to record your blood glucose measurements. A careful record may help determine if the problem is related to your Pump or another cause. Meal plan You will always receive some basal insulin from your Implantable Insulin Pump. When you program a meal bolus, this will be in addition to your basal rate. As with any insulin therapy, it is recommended that you keep some form of fast-acting sugar with you at all times to treat hypoglycemia. If you have any questions concerning your meal plan and insulin therapy, dis-
cuss them with your healthcare team as they are your best source of infor-
mation. Daily activities There are no restrictions on your normal work, school, social, or sexual activities unless you have a medical condition which does not allow such activities. Because your Pump is implanted, you may bathe and shower without any interruption in insulin therapy. However, your PPC is not waterproof and should be protected from getting damp or wet. Exercise You may participate in most physical activities with your MiniMed 2007 Implantable Pump Insulin System. Rough contact sports are not recom-
mended as Pump pocket injury may occur. Exercise may reduce your insulin requirements, therefore, you must check your blood glucose fre-
quently during periods of exercise. In addition, it may be necessary to reduce your basal rate during the exercise. Important Self-Care 71 Travel You may travel with your Medtronic MiniMed 2007C Implantable Insulin Pump System. All extended trips should be discussed with your doctor. It is safe to travel in a pressurized aircraft, which includes all commercial airlines. Security systems at airports will not affect your Pump, but you may be asked to show your Patient Emergency Information Card which explains the Pump and PPC. Remember to always carry conventional insulin supplies with you when you travel (insulin and syringes or an external Pump) in case of a medical emergency. MiniMed information card Your doctor will give you a Patient Emergency Information Card when you receive your Pump System. It provides information about your Pump, as well as important phone numbers in case of a medical emergency. Carry Your Information Card With You At All Times. It is also rec-
ommended that you wear a bracelet or necklace indicating that you wear an implantable insulin Pump. 72 Important Self-Care 73 CHAPTER 8 PPC Care and Maintenance Installing/replacing the main battery PPC Battery life is estimated to be approximately 8 weeks. Only AA 1.5 volt alkaline or lithium batteries are recommended for use with the PPC. To replace the PPC Main Battery:
1. Locate the battery door on the back of the PPC. 2. Slide the locking bar to the left. 3. Push the middle part of the PPC box (under the battery door) and lift by gently pulling up the battery door to unlatch. 4. Remove the old battery, noting the polarity. The PPC screen will be blank. 5. Position the new battery so the + and - markings on the battery match the polarity diagram in the battery compartment. 6. Close the battery door. 7. Slide the locking bar to the right. 8. The PPC screen reappears after 30 seconds:
74 PPC Care and Maintenance 9. The PPC will beep six times and display PPC/PUMP. 10. After a few seconds, the screen will change to CHECK PUMP STATUS. PPC PUMP 0 209 0 211 11. Press SEL and ACT, then place the PPC over the Pump. JAN O2 08:26 CHECK PUMP STATUS 12. Allow the communication to complete. PPC COMMUNICATING PPC Care and Maintenance 75 NOTE: When the PPC displays PPC LOW BATTERY, you can clear the message and continue program-
ming. There should be sufficient energy in the bat-
tery to communicate with the Pump for a minimum If while programming the Pump, the PPC goes blank, the PPC beeps six times and then the
"CHECK PUMP STATUS" message appears, the PPC (AA 1.5v alkaline) battery needs to be replaced. For instructions, see "Installing/Replac-
ing the Main Battery" in Chapter 8. Physical protection Protect the PPC from direct contact with water and moisture. Never take the PPC into a sauna or steam bath. If the PPC comes in contact with moisture where the battery compartment is wet, remove the battery and dry compartment thoroughly. Replace the battery and perform a SELF TEST. Protect the PPC from temperatures greater than 40 C (104 F). Do not leave the PPC in direct sunlight. Protect the PPC from cold temperatures less below freezing
(0C or 32F). Do not drop the PPC. Protect the PPC from sharp blows. Either could damage the electrical components of the PPC and affect its ability to program your implantable Pump.
76 PPC Care and Maintenance Cleaning the outer surface of your PPC If necessary, use a slightly damp cloth and mild soap to clean the outside of the PPC. Do not use a wet cloth or dip the PPC in any liquid. Moisture may harm the PPCs electrical components. Never use organic solvents or harsh detergents to clean the PPC. Always completely dry the PPC after cleaning. Never spray any cleaning solutions directly onto the PPC, espe-
cially the keyboard panel.
77 CHAPTER 9 Technical Specifications Medtronic MiniMed 2007C Implantable Insulin Pump System Implantable Insulin Pump (MMT-2007C) Component Diameter Reservoir Volume 2.0 cm (0.8 inches) Weight - Empty Insulin - Concentration Stroke Volume Basal Rate Basal Patterns Meal Bolus Bolus Duration Performance Specification Thickness 8.1 cm (2.3 inches) 13 ml to 15 ml 131 gm (4.6 ounces) Aventis HOE 21 PH U-400 0.42 to 0.58 l per stroke 0.17 to 0.23 units per stroke 0.2 to 35.0 units per hour (U/h) 3 Patterns of up to 48 basal rates each. 0.2 to 25.0 units Immediate, Square Wave (30 minutes to 4 hours), or both together. Audio Bolus 78 Technical Specifications Component Temporary Basal Rate Diagnostic Rate Power Supply Battery life Audio Alarms Performance Specification 0.2 to 35.0 units per hour 30 minute increment duration 30 minutes up to 24 hours delay 10 to 150 U/h Lithium - Carbon Monofluoride Battery See graph below. Low Battery Nearly Depleted Battery System Error Safety Features Negative Pressure Reservoir with Passive Filling Materials Pump Shutdown and Alarm with System Error (unique code sequences) Titanium Housing, Polyethylene-lined Silicone Rubber Catheter Technical Specifications 79 Average Pump Service Life vs. Daily Insulin Delivery
(U-400 Insulin Delivered After 6 Month Shelf Life)
) s r a e Y
(
e f i L p m u P 14 13 12 11 10 9 8 7 6 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 Daily Insulin Delivery (Units) Personal Pump Communicator (MMT-3150) Component Height Length Width Weight Main Power Source Main Battery Life Backup Battery Backup Battery Life Performance Specification 8.9 cm (3.5 inches) 7.0 cm (2.8 inches) 2.0 cm (0.8 inches) 115 gm (4.0 ounces) 1.5 Volt Alkaline Battery Type AA Approximately 8 weeks, depending upon usage Lithium Battery (MMT-4207) 3 years minimum with no AA battery installed Operating Temperature 0C to 40C (32F to 104F) 80 Technical Specifications Component Storage Temperature Messages Performance Specification
-0C to 30C ( 32F to 86F) Auto Off in 5 min / Auto Off Pump Suspended Check Pump Status Communication Error Download Complete Empty Reservoir Hourly Maximum Exceeded Low Reservoir PPC Not initialized PPC Needs Servicing PPC Low Battery PPC Depleted Battery Pump Self Test Fail Pump Reset Pump Stopped Pump Version Error Telemetry Communications Error Technical Specifications 81 Side Port Catheter MMT- 4027A Length Proximal:
Distal:
MMT- 4024A Length Proximal:
Distal:
Material Sideport 11.8 1.3 cm (4.7 0.5 inches) 17.8 0.7 cm (7.0 0.3 inches) 11.8 1.3 cm (4.7 0.5 inches) 10.2 0.4 cm (4.0 0.2 inches Polyethylene-lined Silicone Rubber Polysulfone, Silicone Septum This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Operation of this device is authorized by the FCC under the FCC ID OH22007C (Implantable Pump) and 0H23150 (PPC). Any changes or modifications to the system not expressly approved by MiniMed could void the users authority to operate the system. 82 Technical Specifications
1 | Patient Manual Cover | Users Manual | 1.00 MiB | February 05 2002 |
2007C IMPLANTABLE INSULIN PUMP SYSTEM
1 | Physician Manual Cover | Users Manual | 1.00 MiB | February 05 2002 |
2007C IMPLANTABLE INSULIN PUMP SYSTEM
1 | Physician Part1 | Users Manual | 2.56 MiB | February 05 2002 |
Dmp9196021-011_c.book Page 1 Thursday, April 4, 2002 8:15 AM Table of Contents 1 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 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 . 34 Set alarms . 35 Set maximum bolus, basal rate and time display format . 36 Lock maximum bolus/basal, enter personal ID and password, stop Pump .38 Program a basal rate . 40 Part 2: Additional PPC programming features . 42 Main menu . 42 Program a bolus . 42 Set a normal bolus with the variable bolus feature turned off . 42 Set a normal bolus with the variable bolus feature turned on . 44 Set a square wave bolus . 45 Set a dual wave bolus . 47 Review bolus history . 49 Suspend mode . 49 Programming a basal rate . 50 Programming basal delivery pattern . 50 Setting basal rate profiles in each delivery pattern . 51 Program a temporary basal rate . 52 Set a temporary basal rate . 52 Stop a temporary basal rate . 54 Personal events . 54 History . 56 Setup Pump . 58 Auto off . 58 Self test . 59 Initialize PPC to Pump . 60 Setup II . 60 Exit setup menu . 60 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 . 62 Variable bolus . 62 Refill . 64 Priming . 65 Diagnostic rate . 67 Initialize to factory defaults . 69 Download software . 70 Stop Pump . 72 Supervisor password . 72 Exit supervisor . 73 Personal Pump communicator messages . 73 Clinical history codes . 75 Clinical history pump codes . 75 CHAPTER 4 Pump Implantation . 77 Preprogramming and pre-testing the pump . 77 Registration card . 77 Supplies and solutions . 78 Emptying and filling the Pump . 79 Remove shipping fluid from the Pump . 80 Rinse the Pump with insulin (IN1) . 82 Fill the Pump with insulin . 85 Measure stroke volume . 86 Prepare the Side Port Catheter . 88 Performing the surgical procedure . 93 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 . 95 Post-operative x-rays . 96 CHAPTER 5 Pump Refill Procedure . 97 Introduction . 97 Supplies and solutions . 98 Prepare for pump refill . 99 Perform the refill procedure . 100 Fill out the refill form . 100 Label syringes . 100 Prepare the refill syringe for emptying the Pump . 100 Prepare the refill syringe for filling the Pump . 101 Empty the Pump . 102 Refill the Pump . 104 Calculate extracted and refill amounts . 106 Calculate refill accuracy . 106 CHAPTER 6 Explanting the Pump System . 107 Explant considerations . 107 Returning devices/components to MiniMed . 107 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 . 110 Diagnostic radiation . 110 Therapeutic radiation . 110 Elevated anti-insulin antibodies . 111 Environmental conditions . 111 Sterilization . 112 Precautions . 113 Emergencies and the use of conventional insulin supplies . 113 PPC reliability requirements . 113 Maximum dosages . 114 Electrical and magnetic fields . 114 CHAPTER 8 Adverse Reactions . 115 Adverse reactions . 115 Prevention . 116 CHAPTER 9 System Alarms and Messages . 117 Pump alarms . 118 Alarm feedback . 118 Pump low battery . 118 Depleted pump battery . 119 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 . 120 PPC depleted battery . 121 PPC needs servicing . 122 Low reservoir . 122 Empty reservoir . 122 Telemetry communication error . 123 Communication error during download . 123 Initialize alarm . 124 PPC not initialized . 125 Battery replacement . 125 Initialize to factory defaults . 126 Pump stopped . 126 Pump suspended . 126 Auto off . 127 Hourly maximum exceeded . 127 Pump alarm table . 128 CHAPTER 10 Troubleshooting Pump System Under-delivery 131 Diagnostic procedures . 131 Under-delivery caused by backflow . 131 Under-delivery caused by catheter occlusion . 132 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 . 137 Symbol dictionary . 137 Packaging . 138 Other Information . 140 APPENDIX B Implant Worksheet . 141 Implant worksheet form . 141 APPENDIX C Refill Form . 143 Pump refill data . 143 APPENDIX D Precautions and General Procedures . 145 Special note and precautions . 145 General procedures . 146 Locating the pump fill port and the side port . 147 Accessing the pump inlet . 148 Venting the Minimed refill syringe (optional) . 149 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 . 153 Program minimal basal rate . 153 Remove insulin from the Pump and fill with NaOH . 154 Equilibrate and pull NaOH through system . 156 Remove NaOH and fill with rinse buffer . 157 Equilibrate and pull rinse buffer through system . 159 Remove rinse buffer and fill with insulin . 159 Equilibrate and pull insulin through system . 161 Remove guide needles and record fill amount . 162 Program new basal rate . 162 APPENDIX F Side Port Catheter Flush Procedure . 163 Supplies and solutions . 163 Preparing for the procedure . 164 Record patients blood glucose . 165 Prepare syringes for emptying the Pump . 165 Prepare syringes for filling the Pump . 165 Prepare syringe for flushing the Side Port Catheter . 166 Flushing the Side Port Catheter . 167 Program minimal basal rate . 167 Remove insulin and fill with rinse buffer . 167 Equilibrate and pull rinse buffer through system . 169 Flush side port catheter . 170 Remove rinse buffer and fill with insulin . 170 Equilibrate and pull insulin through system . 172 Remove guide needles and record refill amount . 173 Program new basal rate . 174 Remove rinse buffer from catheter . 174 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 patients blood glucose . 176 Measuring stroke volume . 177 Record patients blood glucose . 179 APPENDIX H Pressure Measurement Using The Side Port Catheter . 181 Supplies and solutions . 182 Preparing for the procedure . 183 Record patients blood glucose . 184 Prepare syringes for emptying the pump . 184 Prepare syringes for filling the pump . 184 Prepare syringe for priming the test setup . 184 Measuring pressure in the side port . 185 Program minimal basal rate . 185 Remove insulin and fill with rinse buffer . 185 Equilibrate and pull rinse buffer through system . 186 Perform pressure test . 187 Remove rinse buffer and fill with insulin . 191 Equilibrate and pull insulin through system . 192 Remove guide needles and record refill amount . 194 Dmp9196021-011_c.book Page 10 Thursday, April 4, 2002 8:15 AM 10 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 intraperi-
toneal insulin therapy for patients with Insulin Dependent Diabetes Melli-
tus (IDDM). The development of the Medtronic MiniMed 2007C Implantable Insulin Pump System is the result of years of cooperative research and development between MiniMed and:
The Johns Hopkins University, Applied Physics Laboratory. U.S. National Aeronautics and Space Administration, Goddard Space Flight Center. U.S. National Institutes of Health. 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 2007C Implantable Insulin Pump System. The Medtronic MiniMed 2007C Implantable Insulin Pump System uses only special insulin formulations. The only insulin available today for use in the Pump is HOE 21 PH U-400, manufactured by Aventis. 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. Figure 1: Personal Pump Communicator (PPC) and Implantable Insulin Pump Dmp9196021-011_c.book Page 13 Thursday, April 4, 2002 8:15 AM Implantable Insulin Pump 13 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). Figure 2: The Implantable Insulin Pump The Implantable Insulin Pump is an advanced insulin infusion device with sophisticated microelectronics. It delivers a special insulin medication, using a pulsatile solenoid pumping mechanism that is hermetically sealed inside the biocompatible titanium case. Insulin delivery rates and profiles are programmed using an external device, the Personal Pump Communi-
cator (PPC). Specific information on the Implantable Insulin Pump fea-
tures is outlined in the following sections. 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 20m filter. Figure 3 shows the interior components of the Pump. Figure 3: Interior of the Implantable Insulin Pump Dmp9196021-011_c.book Page 15 Thursday, April 4, 2002 8:15 AM Implantable Insulin Pump 15 The Medication Reservoir stores approximately 15 ml or 6,000 units of a special U-400 insulin. Depending on an individuals insulin require-
ments, 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. This vacuum prevents any risk of insulin leakage in the event of a breach in the Pump case or reservoir. The reservoir is refilled with a special needle
(MiniMed Refill Needle MMT-4102). The fill port has a 20 micron filter to prevent particulate material from entering the Pump and a redundant septum and valve configuration to prevent entry of body fluids. The Pumping Mechanism is a solenoid-operated, hermetically-welded pulsatile system. The pumping mechanism is designed to seal automati-
cally to prevent leakage both into and out of the reservoir under physio-
logic temperatures and pressures. The mechanism is designed to provide an insulin delivery accuracy of +10% from its labeled stroke volume. Individual Pumps are calibrated to one of seventeen different stroke vol-
umes, ranging from 0.42 L to 0.58 L per stroke, in increments of 0.01 L. The Microelectronics act as the brain of the Pump. The microelectronics contain two microprocessors which monitor and control all pump-stroke activity. All commands delivered from the PPC via RF telemetry to the Pump are then acknowledged back at the PPC. The Pump has a large memory which stores Pump specifications and programming history. The Antenna receives radiowaves from the PPC and delivers PPC pro-
gramming commands to the Pump microelectronics. The Battery is a custom-made lithium carbon mono-fluoride power cell, which supplies energy to the pumping mechanism and microelectronics. It is similar to batteries used in pacemakers and is designed to provide 6 to 10 years of service, depending on the infusion rate (refer to pump specifi-
cations). The Tone Transducer emits beeps to indicate certain alarm conditions. These beeps are designed to be audible through the skin and can be set with the PPC to one of two volumes. The Pump can also be programmed to emit beeps that signal a programmed change in the medication delivery rate. 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. HOE 21 PH U-400 is a highly purified, semi-synthetic human insulin with 0.2% phenol as a preserving agent, glycerol as an isotonic compo-
nent, TRIS as a buffer, plus zinc and Genapol as stabilizing agents. HOE 21 PH U-400 is equivalent in mode of action to normal (soluble) insulin. A special U-400 insulin concentration has been developed for use in the Implantable Insulin Pump and is supplied in 10mL vials (400U/
mL) from Aventis. Side Port Catheter The Side Port Catheter (Catheter) transports insulin from the Pump into an individuals peritoneum where it is absorbed. The Catheter is made of polyethylene-lined silicone rubber, which is biocompatible with subcuta-
neous and intraperitoneal tissues and supports the stability of the special insulin. The Catheter is designed with two perpendicular sections: a proximal subcutaneous section which attaches tangentially to the Pump with a locking connector, and a distal section which is placed in the peri-
toneum (see Figure 4). To enable post-implant localization, a radioopaque stripe runs the length of the Catheter. Dmp9196021-011_c.book Page 17 Thursday, April 4, 2002 8:15 AM Implantable Insulin Pump 17 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 diag-
nostic 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. It also allows for the introduc-
tion of a needle to verify Pump stroke volume and permit non-surgical diagnoses of Catheter blockages by direct pressure measurement. 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. Additionally, the PPC stores important programming infor-
mation in its memory. Figure 5: Personal Pump Communicator (PPC) Dmp9196021-011_c.book Page 19 Thursday, April 4, 2002 8:15 AM Implantable Insulin Pump 19 The PPC has been designed so the physician and patient can:
Program basal infusion rates (48 basal rates, 3 different patterns) Deliver or suspend an immediate, square wave, or dual wave bolus of insulin Deliver or cancel a temporary basal rate Review the delivery history Enter personal events (meal, snack, exercise) Independent of the programming function, the PPC is able to receive and record certain programming data from the Pump. The recorded informa-
tion is accessible and can be displayed on the screen. Dmp9196021-011_c.book Page 20 Thursday, April 4, 2002 8:15 AM 20 Description of the Medtronic MiniMed 2007C Implantable Insulin Pump System 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. Contraindications for use The Medtronic MiniMed 2007C Implantable Insulin Pump System is con-
traindicated in patients who:
are unwilling or unable to monitor their blood glucose level at least four times per day. are unwilling or unable to make programming modifications to the Pump based on glucose level readings. are unable or unwilling to administer insulin by other means, if necessary. are unable or unwilling to comply with the guidance and advice of their treating physician and other healthcare providers. 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 accord-
ing to their dosage requirements (approximately once every 2-3 months). present or have a history of sensitivity to titanium alloy, polysulfone or silicone materials used in the implanted compo-
nents of the system. Possible adverse effects The MiniMed 2001 Implantable Insulin Pump System has undergone an extensive clinical evaluation. The model 2007C is essentially identical to the model 2001 Pump except for the use of updated electronics and bat-
tery. Evaluation of components used in the MiniMed 2001 System spanned a period of ten years and involved approximately 650 patients from both the U.S. and Europe. Although clinically relevant over-delivery of insulin did not occur during the ten year evaluation period, there is a potential for such an occurrence. The following are specific adverse effects which should be understood by the physician and explained to the patient. These do not include all adverse effects which can occur with surgery in general or with the use of this device, but are important considerations, particularly in the treatment of diabetic patients. The general surgical risks, as well as operative site cosmetic risks, should be explained to the patient prior to surgery. Dmp9196021-011_c.book Page 23 Thursday, April 4, 2002 8:15 AM Possible adverse effects 23 Abdominal Pain Abnormal Healing Infection Necrosis Retinal Disorder Abnormal Liver Function Ileus Inflammation at Refill Site Hyperglycemia Hypoglycemia Ketoacidosis Foreign Body Reaction Skin Disorder Urinary Disorder Psychiatric Decompensation Skin Erosion Kidney Disorder Pocket Lymph Edema Pump Failure Catheter Occlusion/Encapsulation Battery Depletion PPC Failure Dmp9196021-011_c.book Page 24 Thursday, April 4, 2002 8:15 AM 24 Indications and Contraindications 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 pro-
gramming features to control the Implantable Insulin Pump in the treat-
ment of IDDM. 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. The second part (Part 2) will describe how to use the additional features that the healthcare professional or patients can activate. 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. Reservoir Level Indicator Icon:
The reservoir icon is composed of 4 segments that indicate how full the Pump reservoir is, based on the history of Pump delivery. Insulin Delivery Icon:
The PPC simulates spinning the delivery icon when insulin delivery is in progress by displaying alternating patterns, the pattern changes every 4 seconds. When the Pump is delivering a bolus, the pattern will show three delivery segments. When the Pump is delivering a basal rate, the pattern will show one delivery segment. When the Pump is not delivering, all four segments will be displayed. 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. Dmp9196021-011_c.book Page 27 Thursday, April 4, 2002 8:15 AM PPC buttons Introduction 27 Select:SEL Activate:
ACT Activate:
Up and Down Arrows:
LLLL or MMMM Sound Icon the Up Arrow Light Icon the Down Arrow:
The SEL button steps through each of the displays and menus. The ACT button activates programming changes in the Pump, new information to be entered into the PPC mem-
ory, 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. The LLLL or MMMM arrows allow changes in the screen set-
tings. Pressing LLLL once will find the next highest set-
ting, and pressing MMMM once will find the next lowest setting. Holding down either button will rapidly scroll through the list of preset values. Desired values can then be programmed by pressing ACT. When the Audio Bolus feature is turned on, pressing LLLL allows programming an Audio Bolus. From the main operating screen, pressing MMMM once will turn on the backlight. The backlight allows the Pump to be programmed in the dark. The backlight will turn off automatically after four seconds. 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 COMMU-
NICATING. 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. The screen will then display PPC COMMUNICATING again. After a communication is established between the PPC and Pump and program information is successfully transferred to the Pump, the PPC will beep once and return to the Time/Date screen. Always press the PPC buttons slowly and firmly. Wait until the screen changes before pressing the button again. A flashing value on the screen means that the value is activated, and can be changed by pressing the arrow buttons. 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 expe-
riencing 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. Dmp9196021-011_c.book Page 29 Thursday, April 4, 2002 8:15 AM Install/Replace the main battery Introduction 29 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. Push the middle part of the PPC box (under the battery door) and lift by gently pulling up the battery door to unlatch. Remove the old battery, noting the polarity. The screen will be blank. Position the new battery so the + and - markings on the battery match the polarity diagram in the battery compartment. Close the battery door. Slide the locking bar to the right. The PPC screen will reappear within 30 seconds:
1. The PPC will beep 6 times, and after a few seconds, the screen will display CHECK PUMP STATUS. 2. Press SEL then ACT, and place the PPC near the Pump. 3. Wait a few seconds for the communica-
tion to complete. PPC 4 102 100 PUMP __ __ __ 08:26 JAN O2 CHECK PUMP STATUS PPC COMMUNICATING 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. NOTE: If while programming the PPC, the screen goes blank, the PPC beeps six times and then the CHECK PUMP STATUS message appears, the battery needs to be replaced. Dmp9196021-011_c.book Page 31 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization 31 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. The factory default values are as follows:
Bolus Delivery Type Maximum Bolus Audio Bolus Normal 25 U Off Audio Feedback Disabled Auto Off duration Basal Delivery Pattern Maximum Basal Rate Insulin Concentration Off A 35 U/H 400 U/ml Off Locked Maximum status Password Personal Events status Personal ID PPC alarm type Refill Amount Time Format Variable Bolus status Off YIQ8 OFF 000
(32 characters) High 25 g 12 hours Off 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 mar-
ried 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). PPC PUMP 4 162 100 __ __ __ 2. The screen now changes to, PPC NOT INITIALIZED, and the PPC will beep six times once every minute until the initial-
ization process is started. Press SEL and then ACT, then quickly place the PPC over the Pump. 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 LLLL or MMMM once to change NO to YES and then press ACT. Place the PPC over the Pump. 5. The screen again reads PPC COMMUNI-
CATING, and the PPC will beep 3 times at the end of the programming sequence. During this process, the PPC receives all of the factory preset values contained in the Pump memory. PPC NOT INITIALIZED PPC COMMUNICATING INITIALIZING "NO"
PPC to PUMP
.................................. .......................47568 PPC COMMUNICATING Dmp9196021-011_c.book Page 33 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization 33 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. 8. The screen now reads PUMP INITIALIZED. PPC COMMUNICATING PUMP INITIALIZED 9. Press SEL and then ACT again, and the PPC will display the Time/Date screen. 11:16 JAN O2 NOTE: When the alarm type is set to VIBRATE the beeps from the PPC during normal programming will be low volume. 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 screen is displayed, then press ACT two times. The first two digits of the time
(hours) will be flashing. Use the LLLL and MMMM buttons to select the correct hour, then press ACT. The last two digits of the time
(minutes) will be flashing. Use the LLLL and MMMM buttons to select the cor-
rect minute, then press ACT. Repeat the programming process to enter information for the year, month and day. 08:32 Jan 02 SET 2000 TIME-DATE 2. After completing the programming pro-
cess, quickly place the PPC near the Pump. The PPC will display PPC COMMUNICATING while transfer-
ring the time and date information to the Pump. The PPC will then move to the next screen, AUTO-OFF. Skip the AUTO-OFF screen by press-
ing SEL once to reach the next screen, ALARMS. PPC COMMUNICATING Dmp9196021-011_c.book Page 35 Thursday, April 4, 2002 8:15 AM Set alarms Part 1: PPC/Pump system initialization 35 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. 2. The PPC has three alarm options, two audible tones (Low/High) and a vibrate mode. Press the LLLL and MMMM buttons to select the desired alarm, then press ACT. 3. The screen will now display SET ALARM FEEDBACK. This setting should always be ON. Press ACT. 4. Place the PPC near the Pump. When the communication is completed, the PPC screen will change to SELF TEST and then to the Time/Date screen. NOTE: When the alarm type is set ALARMS SET PPC ALARM TYPE LOW/HIGH/VIBRATE SET ALARM FEEDBACK ON/OFF PPC COMMUNICATING to vibrate the beeps from the PPC during nor-
mal programming will be low volume. 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. Press ACT and press SEL to reach the SETUP II screen. Press ACT and then SEL to reach the MAX BOLUS screen.
-- u MAX BOLUS 2. Press ACT and the maximum bolus amount (units) will start flashing. Press the LLLL and MMMM buttons to change the maxi-
mum allowable bolus (0.0 to 25.0 units) and then press ACT again. 3. Place the PPC near the Pump and com-
plete the communication process. The PPC screen will automatically change to the MAX BASAL screen. 4. Press ACT and the screen will change to SET MAX BASAL RATE. The maxi-
mum basal amount will start flashing. Press the LLLL and MMMM buttons to change the maximum allowable basal rate (0.2 to 35.0 units/hour) and then press ACT again. 5. Place the PPC near the Pump and com-
plete the communication process. The PPC screen will automatically change to TIME FORMAT. SET MAX BOLUS
--- ----- u PPC COMMUNICATING SET MAX BASAL RATE 0.2u/h PPC COMMUNICATING Dmp9196021-011_c.book Page 37 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization 37 6. Press ACT and the screen will change to SET TIME FORMAT. Press the LLLL and MMMM 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 PER-
SONAL EVENTS screen. Allow the PPC to time out and return to the Time/
Date screen. NOTE: Adding screens to the main menu, such as PPC COMMUNICATING PERSONAL EVENTS increases the number of SEL button presses required to reach SETUP PUMP. 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 LLLL and MMMM buttons simultaneously until the ENTER SUPERVISOR PASSWORD screen appears. Patients should not be given the Supervisor Mode password, to avoid the accidental programming of a large priming bolus
(99.8 U) or diagnostic insulin rate. WARNING
!
1. The first zero will be flashing. Press the LLLL and MMMM buttons to select the first digit, then press ACT.The screen advances to the second zero. Press the LLLL and MMMM but-
tons to select the second digit, then press ACT. Repeat for the last two digits. The factory pre-set password is YIQ8. 2. Entry into the Supervisor Mode is indi-
cated by the screen PUMP REFILL. 3. Press SEL until the SET MAXIMUMS SCREEN is displayed, and then ACT to reach SET MAXIMUMS. Press the LLLL and MMMM buttons to select ON if the patient is not given access to this feature, or OFF if the patient is per-
mitted access. Press ACT again. ENTER SUPERVISOR PASSWORD 0000 PUMP REFILL SET MAXIMUMS OFF/ON Dmp9196021-011_c.book Page 39 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization 39 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. 5. The first of the 32 possible ID locations is flashing. Enter the patient ID (alpha-
numeric) by pressing the LLLL and MMMM but-
tons and then ACT after each entry. Con-
tinue to press ACT, activating each 0 until the screen changes. 6. Place the PPC near the Pump and com-
plete the communication process. 7. Press SEL until the SUPERVISOR PASSWORD screen is displayed. Then press ACT. PPC COMMUNICATING SET PERSONAL ID
.................................. ................20KOLO5 PPC COMMUNICATING SET SUPERVISOR PASSWORD Y1Q8 8. The screen now reads, SET SUPERVI-
SOR PASSWORD. Press ACT. Use the LLLL and MMMM buttons to enter a new supervi-
sor password (alphanumeric), pressing ACT after each entry. NOTE: Record the password in the patients chart. SET SUPERVISOR PASSWORD 0000 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 dis-
played. Preset delivery pattern A, a basal rate of 0.2 U/H, and the word NOW is flashing. Press ACT. 08:26 OCT 12 BASAL RATE : A NOW 00:00 0.2u/h 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 0.2 U/H indicates the value can be changed. Use the LLLL and MMMM but-
tons to change the value and then press ACT. NOTE: 00:00 indicates a start time of MIDNIGHT in 24hr. display mode. In 12hr. display mode, the screen indicates the start time as 12:00am. 3. The screen now displays SET TIME, and a time of 00:30 or 12:30 am (24 or 12 hour respectively) and a 2. If one basal is all that will be used, press ACT two times. If more than one basal rate is to be programmed, enter a start time and amount of the new basal rate for that time period, then press ACT and enter the new basal rate. The user can enter a new basal rate at 30 minute intervals, up to 48 basal rates. SET RATE BASAL RATE: A
-- U/H 00:30 4. Place the PPC near the Pump and com-
plete the communication process. PPC COMMUNICATING Dmp9196021-011_c.book Page 41 Thursday, April 4, 2002 8:15 AM Part 1: PPC/Pump system initialization 41 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 4.8U 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. The PPC has several special features which allow you to custom-
ize the programming and delivery of boluses. Normal Bolus and Audio Bolus Square Wave Bolus Dual Wave Bolus NOTE: To use the Variable bolus programming options,
(e.g. square, dual), this option needs to be pro-
grammed ON in the SETUP II menu. If it is not ON only the default bolus, Normal bolus, will be available. 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 Jan 02 BOLUS IMM EXT 10 U -- U PROG --
2. Press ACT and the SET BOLUS screen appears.The dashes under IMM are flashing. Press the LLLL and MMMM buttons to enter an immediate bolus amount. SET BOLUS IMM
-- U Dmp9196021-011_c.book Page 43 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 43 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 cur-
rently delivered. 08:13 Jan 02 BOLUS 0.0U The Pump will beep at each of the first five strokes (if audio feedback is ON). The PPC beeps and 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 deliv-
ered. 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. 2. Press ACT and the SET BOLUS TYPE screen appears. If NORMAL is not flashing, use the LLLL and MMMM buttons to select NORMAL. Press ACT. 3. The SET BOLUS screen appears, with dashes under IMM flashing. Use the LLLL and MMMM buttons to enter an immediate bolus amount. 4. Press ACT and the CONFIRM screen is displayed, with the screen flashing. Confirm the bolus amount by pressing ACT again. 5. Place the PPC near the Pump and com-
plete the communication process. 08:13 Jan 02 BOLUS IMM EXT
-- U -- U SET BOLUS TYPE NORMAL SET BOLUS IMM
--- --- U CONFIRM IMM 2.6u PPC COMMUNICATING 6. When the bolus programming is com-
plete, the PPC will beep once and then briefly display the amount of insulin cur-
rently delivered. 08:23 JAN 04 0.0U BOLUS 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. Dmp9196021-011_c.book Page 45 Thursday, April 4, 2002 8:15 AM Set a square wave bolus Part 2: Additional PPC programming features 45 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 desir-
able 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. 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, show-
ing the last bolus programmed with the time and date flashing. 2. Press ACT and the SET BOLUS TYPE screen appears. Press the LLLL and MMMM but-
tons to select SQUARE. Press ACT. 3. The BOLUS screen appears, with dashes under EXT flashing. Use the LLLL and MMMM buttons to enter an extended bolus amount. Press ACT. 4. Blinking dashes will now appear under the bolus amount entered. Use the LLLL and MMMM buttons to enter a time duration for the Square Wave Bolus, in one-half hour increments from 30 min-
utes to four hours. 5. Press ACT and the CONFIRM BOLUS screen is displayed, with the screen flash-
ing. Confirm the Square Wave Bolus by pressing ACT again. 08:13 Jan 02 BOLUS IMM EXT 10 U -- U PROG --
SET BOLUS TYPE SQUARE SET BOLUS IMM EXT
-- U 4.0U SET BOLUS IMM EXT
-- U 4.0U 2:00 CONFIRM BOLUS IMM EXT
-- U 4.0U 2:00 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. PPC COMMUNICATING 7. When the bolus programming is com-
plete, the PPC will beep once and then briefly display the amount of insulin cur-
rently 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. Dmp9196021-011_c.book Page 47 Thursday, April 4, 2002 8:15 AM Set a dual wave bolus Part 2: Additional PPC programming features 47 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, show-
ing the last bolus programmed with the time and date flashing. 2. Press ACT and the SET BOLUS TYPE screen appears. Press the LLLL and MMMM but-
tons to select DUAL. Press ACT. 3. The BOLUS screen appears, with dashes under IMM flashing. Use the LLLL and MMMM buttons to enter the immediate portion of the Dual Wave Bolus. Press ACT. 4. The BOLUS screen now shows dashes flashing under EXT. Use the LLLL and MMMM buttons to enter the extended portion of the Dual Wave Bolus. Press ACT. 5. Blinking dashes will now appear under the bolus amount entered. Use the LLLL and MMMM buttons to enter a time duration for the Square Wave Bolus, in one-half hour increments from 30 min-
utes to four hours. 08:13 Jan 02 BOLUS IMM EXT
--- --- U ---- ---- U
--- ---
SET BOLUS TYPE DUAL SET BOLUS IMM 2.0u SET BOLUS IMM EXT 2.0u 2.0u SET BOLUS IMM EXT 2.0u 2.0u 2:00 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 flash-
ing. Confirm the Dual Wave Bolus by pressing ACT again. 7. Place the PPC over the pump and com-
plete the communication process. CONFIRM BOLUS IMM EXT 2.0u 2.0u 2:00 PPC COMMUNICATING 8. When the bolus programming is com-
plete, the PPC will beep once and then briefly display the amount of insulin cur-
rently 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 visualize the amount of insulin delivered. Dmp9196021-011_c.book Page 49 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 49 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. 08:23 Jan 02 BOLUS IMM EXT
---- U --- --- U
--- ---
PROG The BOLUS screen is displayed, show-
ing the last bolus programmed. Use the LLLL and MMMM buttons to display pre-
vious boluses, along with the time and day each bolus was delivered. 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 com-
plete the communication process. PPC COMMUNICATING 08:13 OCT 12 PUMP SUSPENDED 3. When the communication is complete, the Pump will beep 3 times and the PPC screen will change to PUMP SUS-
PENDED. All four segments of the insulin delivery icon are shown. The PPC will beep every half-hour as long as the Pump remains suspended. NOTE: To restart the pump, press SEL. The PUMP SUSPENDED screen will begin flashing. Then press ACT. 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. 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. To access profiles B or C you must enter the SETUP I screens. 1. Press SEL until the PUMP SETUP screen is displayed. Press ACT. Press SEL again to access the basal rate profile screen, DELIVERY PATTERN. DELIVERY A PATTERN 2. Press ACT and the screen will change to SET DELIVERY PATTERN. Use the LLLL and MMMM keys select the pattern pre-
ferred; A, B, or C. Each pattern can con-
tain up to 48 different basal rates. Press ACT after choosing a pattern. 3. Place the PPC near the Pump and allow the communication to complete. SET DELIVERY A,B,C PATTERN PPC COMMUNICATING NOTE: When the PPC times out, press SEL until the BASAL RATE screen is displayed. The basal pattern selected in SETUP II will now appear to the right of BASAL RATE A, B, or C. Dmp9196021-011_c.book Page 51 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 51 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 SET RATE BASAL RATE : A 0.2U/H 00:00 2. A SET RATE and 1 is now displayed to the right of the A indicating this pro-
gramming will set the 1st basal rate within the A profile. The 0.2U/H is now flashing, indicating the value can be changed. Use the LLLL and MMMM arrow keys to program a new value, for example 0.4 U/H, and then press ACT. NOTE: 00:00 indicates a start time of MIDNIGHT in 24hr. display mode. 12:00am indicates a start time of MIDNIGHT in 12hr. display mode. 3. The screen now displays SET TIME, with a time of 00:30 or 12:30am flashing (24 or 12 hour respectively) and a 2. This screen allows the second basal rate to be set. Enter a start time for the 2nd basal rate within the A profile, for example 04:30. Press ACT. (Example: a second basal rate of 0.4U/
H starting at 04:30.) SET TIME BASAL RATE : A 2 04:30 0.4u/h 4. This screen changes to SET RATE again, indicating the 2nd basal rate can now be programmed. Use the LLLL and MMMM arrow buttons to enter a new rate, for example 0.2U/H, and then press ACT. SET TIME BASAL RATE : 2 04:30 0.4u/h 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 MMMM
) and press ACT. 6. The screen will indicate PPC COMMU-
NICATING. Place the PPC near the Pump and complete the communication process. 7. The screen will briefly display the calcu-
lated 24 hour basal dose based on the basal rate programming. In this example a total of 8.4U will be delivered. SET TIME BASAL RATE : 3 05:00 0.2u/h PPC COMMUNICATING 24 HOUR TOTAL 8.4u To set multiple basal profiles in the other pat-
terns (A,B,C), select the pattern in SETUP II menu and follow the same procedure. Program a temporary basal rate A Temporary Basal Rate is often used when a brief change in basal deliv-
ery is required, for example during exercise. Set a temporary basal rate 1. From the time and date display press SEL the TEMPORARY BASAL until screen is displayed. 2. Press ACT and the SET DURATION screen appears. The time duration of the Temporary Basal Rate is displayed as flashing dashes. Press the LLLL and MMMM but-
tons to enter a time duration, in 30 minute increments from 30 minutes to 24 hours. TEMP BASAL
--- --- --- --- u/h SET DURATION TEMP BASAL
--- --- u/h 00:30 Dmp9196021-011_c.book Page 53 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 53 3. Press ACT and SET AMOUNT screen appears. The amount of the Temporary Basal Rate is now flashing. Press the LLLL and MMMM buttons to enter a delivery amount. Press ACT again. 4. Place the PPC near the Pump and com-
plete the communication process. SET AMOUNT TEMP BASAL 1.5u/h 00:30 PPC COMMUNICATING 08:13 OCT 02 TEMP BASAL 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. NOTE: When the Pump is delivering a Temporary Basal rate, the first screen displayed when SEL is pressed is TEMP BASAL. The PPC will also beep every 30 minutes to alert the user that a Temporary Basal rate is currently active. 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 dis-
played. Press ACT and the SET DURA-
TION appears, with the time duration flashing. Press MMMM once until it resets to dashes. Then press ACT. 2. Place the PPC near the Pump and com-
plete the communication process. 3. When the communication is complete, the PPC will briefly return to the TEMP BASAL screen with the amount dashes flashing. Allow the PPC to return to the Time/Date screen. SET DURATION TEMP BASAL
--- --- 1.5u/h PPC COMMUNICATING SET AMOUNT TEMP BASAL
--- --- --- --- u/h 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 acti-
vated in the SETUP II menu, PERSONAL EVENTS screen. 1. From the Time/Date screen, press SEL until SETUP PUMP is displayed, then press ACT. Press SEL until SETUP II is displayed, then press ACT. Press SEL until PERSONAL EVENTS is screen is displayed. PERSONAL EVENTS OFF Dmp9196021-011_c.book Page 55 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 55 2. Press ACT and ON or OFF begins flashing. 3. Use the LLLL and MMMM 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. 4. To set an event: From the Time/Date screen press SEL until the EVENT screen is displayed then press ACT. The screen changes to SET EVENT with the word MEAL flashing. Use the LLLL and MMMM buttons to select the desired event. PERSONAL ON/OFF EVENTS SET PERSONAL ON/OFF EVENTS SET EVENT MEAL 5. Press ACT and the current time will 07:32Am SET TIME EVENT MEAL appear flashing. Use the LLLL and MMMM buttons to enter the time the event occurred. Press ACT when the proper time is dis-
played. Then allow the screen return to Time/Date. NOTE: Only historic or current event times can be entered. NOTE: If the Personal Events feature is turned OFF in SETUP II, events cannot be entered into the PPC. 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 dis-
played. Press ACT and the READ PUMP DATA screen will appear flash-
ing. Press ACT again. READ PUMP DATA 000000000000000000000000 000000000000000000010057 2. Place the PPC near the Pump and com-
plete the communication process. The PPC will acquire data from the Pump. 3. The screen will change to MED REMAINING, indicating the estimated amount of insulin medication remaining in the Pump. Record this number if required. 4. Press SEL and the screen will read INSULIN TOTAL. Delivered amounts of basal and bolus insulin medication are displayed for the date flashing on the screen. Use the LLLL and MMMM buttons to review other daily totals. 5. Press SEL and the screen will change to CLINICAL HISTORY PPC. Use the LLLL and MMMM buttons to review other PPC events. PPC COMMUNICATING MED REMAINING 2263 u Jan 02 INSULIN TOTAL BASAL BOLUS 9u 22u 6:16 Jan 02 CLINICAL HISTORY PPC 11 Dmp9196021-011_c.book Page 57 Thursday, April 4, 2002 8:15 AM Part 2: Additional PPC programming features 57 6. Press SEL and the screen will change to CLINICAL HISTORY PUMP. Use the LLLL and MMMM buttons to review Pump events. 6:26 Jan 02 CLINICAL HISTORY PUMP 14 7. Press SEL and the screen will change to EST PUMP BATT. This screen indi-
cates the Pump battery status, during no-
load (battery power is not used) and load
(extended communication sequence) con-
ditions. The Pump is set to alarm for low battery when the loaded (LD) voltage is at or below 2.5 volts. Jan 02 EST PUMP BATTERY NO LD LD 2.9 V 2.7V 8. Press SEL and the screen will read EXIT HISTORY. Press ACT. The PPC will return to the Time/Date screen. EXIT HISTORY 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 ref-
erenced 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. Auto off Auto Off is a safety feature, reminding the user to update insulin medica-
tion delivery programming in the Pump. An alarm can be set after a period of programming inactivity, from one to 16 hours. At the onset of the alarm the Pump will automatically be placed in SUSPEND mode. 1. From the SETUP PUMP screen, press ACT. Press SEL to reach the AUTO OFF screen, then press ACT. The screen will display AUTO OFF with flashing dashes/time. Use the LLLL and MMMM buttons to select the number of hours before an AUTO OFF alarm occurs. AUTO OFF
--- --- HRS 2. Press ACT. In this example, a time dura-
tion of 10 hours was selected. The PPC will alarm if the user did not attempt to program the Pump during the previous 10 hours and be placed in SUSPEND mode. 3. Place the PPC near the Pump and com-
plete the communication process.The PPC will beep once and return to the Time/Date screen. SET AUTO OFF 10 HRS PPC COMMUNICATING Dmp9196021-011_c.book Page 59 Thursday, April 4, 2002 8:15 AM Self test Setup Pump 59 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. 2. Place the PPC near the Pump and com-
plete the communication process. SELF TEST PPC COMMUNICATING Verify that the following events occur:
A series of tones will be heard from the Pump (4 beeps). An alarm tone will be heard from the PPC. The backlight on the PPC will turn on. The PPC screen will briefly activate all possible display icons, numbers, etc. The PPC will vibrate. NOTE: If the above test results do not occur or the screen displays irregular characters, please notify MiniMed. If the PPC displays the MiniMed logo and software version, the PPC has restarted due to a low battery. Replace the battery immediately. If all electronics pass the Self Test, the screen will automatically change to PPC PASSED/PUMP PASSED. After several seconds, the screen will return to the Time/Date screen. 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. From the SETUP PUMP screen, press ACT until the SETUP II screen is displayed. Setup II features are presented in the next section. Exit setup menu 1. From the SETUP pump screen, press SEL until the EXIT SETUP MENU screen is displayed. Press ACT. The PPC will return to the Time/Date screen. EXIT SETUP MENU Dmp9196021-011_c.book Page 61 Thursday, April 4, 2002 8:15 AM Setup II 61 Setup II Audio bolus The Audio Bolus feature allows the user to deliver a bolus without look-
ing at the PPC screen. There are two Audio Bolus increments, 0.4U and 0.8U. With each press of the LLLL 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 screen is shown. AUDIO BOLUS ON 0.4u 2. Press ACT, and the screen changes to SET AUDIO BOLUS with OFF/ON flashing. Use the LLLL and MMMM buttons to choose ON to activate the Audio Bolus feature or OFF to disable it. Then press ACT. SET AUDIO BOLUS 0.4u ON 3. If ON was chosen, the SET STEP AUDIO BOLUS appears with a step value of 0.4U or 0.8U flashing on the screen. Use the LLLL and MMMM buttons to choose between a step rate of 0.4U or 0.8U. Press ACT. The Audio Bolus fea-
ture is now activated. NOTE: If OFF is chosen, pressing the LLLL SET STEP AUDIO BOLUS 0.4u button will have no effect. 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 LLLL 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. PPC COMMUNICATING In this example the PPC was programmed for a 0.8U increment, and the PPC beeps two times for the 0.8U bolus. Press ACT and the audio sequence repeats to confirm the bolus amount. Press ACT twice and the Pump will be programmed. The PPC beeps once when the programming is com-
pleted. Place the PPC on the Pump to complete the communication process. NOTE: While an audio bolus is being delivered, the LLLL button will not function. Variable bolus To access the Variable Bolus feature enter SETUP II and press SEL one time. The BOLUS. Press ACT. screen will display VARIABLE VARIABLE BOLUS The screen will now display SET VARI-
ABLE BOLUS and ON or OFF will be flashing. Use the LLLL buttons to select ON or OFF, then Press ACT. and MMMM SET VARIABLE BOLUS ON Dmp9196021-011_c.book Page 63 Thursday, April 4, 2002 8:15 AM Setup II 63 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, the-
Variable Bolus option (Square, Dual) will not be available in the (Main Menu) Bolus screen. 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 Proce-
dure. 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 accu-
racy. 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. Use the LLLL and MMMM buttons to enter the weight (grams) of extracted insulin. Press ACT and the PPC prompts for the refill insulin amount. Use the LLLL and MMMM buttons to enter the weight (grams) of insulin refilled in the Pump. Press ACT. Confirm that the insulin concen-
tration defaults to U-400. Press ACT again. Place the PPC near the Pump to complete the process. The calculated accuracy will be displayed briefly. Record this value on the refill form. SET EXTRACTED AMOUNT
---- ---- g SET REFILL AMOUNT
---- ---- g SET INSULIN U400 CONCENTRATION PPC COMMUNICATING CALCULATED ACCURACY
---- ---- %
Dmp9196021-011_c.book Page 65 Thursday, April 4, 2002 8:15 AM Priming Setup II 65 WARNING
!
A priming bolus is not intended as a therapeu-
tic bolus. It should be only used when the Pump is not implanted. The Priming Bolus is used during the preparation of the Pump for implan-
tation. This feature Primes the Pump piston chamber, outlet port and Catheter. The Pump will pulse approximately 500 times during this func-
tion. To access this feature, the Pump must be in PUMP STOPPED mode. 1. From the PUMP STOPPED screen, press SEL. The screen will begin flash-
ing. 08:13 Oct 12 PUMP STOPPED 2. Press the LLLL and MMMM buttons at the same time until the ENTER SUPERVISOR PASSWORD screen appears. ENTER SUPERVISOR PASSWORD YIQ8 3. Re-enter the supervisor password, press-
ing ACT after each letter or number is entered. The factory preset password is:
YIQ8. If the password has been changed, enter the new password. When the Super-
visor Password is successfully entered, the screen will change to PUMP REFILL. Press SEL until the PRIMING screen appears. PRIMING PRIMING 4. Press ACT and NO appears flashing. Press the LLLL and MMMM buttons to change to YES, then press ACT. PRIMING NO 99.8u 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. 6. Place the PPC over the Pump and com-
plete the communication process. CONFIRM PRIMING YES 99.8u 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 0.0u NOTE: The PPC will alarm every minute during the Prim-
ing Bolus. The Priming Bolus can be terminated at any time by using the SUSPEND PUMP fea-
ture. Dmp9196021-011_c.book Page 67 Thursday, April 4, 2002 8:15 AM Setup II 67 Diagnostic rate A diagnostic rate is intended for use only when the Pump is filled with buffer. WARNING
!
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, 08:13 OCT 12 press SEL. The screen will begin flash-
ing. PUMP STOPPED 2. Press the LLLL and MMMM buttons at the same time until the ENTER SUPERVISOR PASSWORD screen appears. Re-enter the supervisor password, pressing ACT after each letter or number is entered. The factory preset password is: YIQ8. 3. When the Supervisor Password is suc-
cessfully entered, the screen will change to PUMP REFILL. Press SEL until the DIAGNOSTIC RATE screen appears. 4. Press ACT and the word SET appears flashing. Use the LLLL and MMMM buttons to enter a Diagnostic Rate (units/hour). 5. Press ACT and the word SET changes to DELIVER. NO also appears flashing. Use the LLLL and MMMM buttons change NO to YES, then press ACT. SET SUPERVISOR PASSWORD 0000 DIAGNOSTIC RATE
--- --- u/h SET DIAGNOSTIC RATE 10 u/h DELIVER DIAGNOSTIC RATE 10 u/h 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. 7. Place the PPC near the Pump and com-
plete the communication process. CONFIRM DIAGNOSTIC RATE 10 u/h PPC COMMUNICATING 8. The words DIAGNOSTIC RATE appear briefly on the screen.The PPC then returns to the Time/Date screen. 08:13 OCT 12 DIAGNOSTIC RATE NOTE: Press SEL and the PPC will indicate DIAGNOS-
TIC RATE. NOTE: Diagnostic Rate Delivery can be terminated at any time by using the SUSPEND PUMP feature. Dmp9196021-011_c.book Page 69 Thursday, April 4, 2002 8:15 AM Setup II 69 Initialize to factory defaults This feature resets all programmed parameters in the Pump to preset fac-
tory 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 flash-
ing. 08:13 oct 12 PUMP STOPPED 2. Press the LLLL and MMMM buttons at the same time until the ENTER SUPERVISOR PASSWORD screen appears. Reenter the Supervisor Password, pressing ACT after each letter or number is entered. The factory preset password is: YIQ8. 3. When the Supervisor Password is suc-
cessfully entered, the screen will change to PUMP REFILL. Press SEL until the INITIALIZE FACTORY DEFAULTS screen appears. TO 4. Press ACT and the word CONFIRM will appear. Press ACT again to activate. 5. Place the PPC over the Pump and com-
plete the communication process. ENTER SUPERVISOR PASSWORD 0000 INITIALIZE TO FACTORY DEFAULTS INITIALIZE TO FACTORY DEFAULTS CONFIRM PPC COMMUNICATING 6. The PPC will now read PUMP SUS-
PENDED. Press SEL then ACT. 08:13 OCT 02 PUMP SUSPENDED 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. 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. PPC COMMUNICATING 08:13 OCT 02 PUMP RESET Download software This feature has been disabled at the factory. 1. From the PUMP REFILL screen in the Supervisor menu, press SEL until the DOWNLOAD SOFTWARE screen appears. DOWNLOAD SOFTWARE Stop Pump This screen allows the Physician to stop the operation of the Pump. From the PUMP REFILL screen in the Supervisor Menu, press SEL until the STOP PUMP screen appears. STOP PUMP Press ACT and the word CONFIRM appears highlighted with the entire screen flashing. Press ACT again to confirm. CONFIRM STOP PUMP Dmp9196021-011_c.book Page 71 Thursday, April 4, 2002 8:15 AM Setup II 71 Place the PPC near the Pump and allow the communication to complete. 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. PPC COMMUNICATING 08:13 OCT 02 PUMP STOPPED Supervisor password If the password is lost, access the Supervisor Menu as follows :
Program the time to midnight (12:00 am or 00:00) and the date to January 01. Enter the password 0000 within one minute. If the password is not entered within one minute the time will be reset to midnight again. Record the new password in the patients chart. 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 AUTO OFF PUMP PUMP SUSPENDED BOLUS 0.0 u CHECK PUMP STATUS LOW RESERVOIR EMPTY RESERVOIR HOURLY MAX EXCEEDED PPC NEEDS SERVICING PPC LOW BATTERY Message Meaning or Action Required Auto Off time interval has elapsed. Pump operation is suspended. A bolus has been programmed and is being delivered. The PPC battery has been replaced. The PPC needs to check the Pump status. The PPC has recognized the Pump has 800 units (2 ml) or less insulin remaining in its reservoir. Schedule a Pump refill as soon as possible. Allowing the reservoir to completely empty may damage the Pump. The PPC has recognized the Pump has 400 units (1 ml) or less insulin remaining in its reservoir. Schedule a Pump refill as soon as possible. Allowing the reservoir to completely empty may damage the Pump. You attempt to deliver more than 2.5 times the bolus maximum in one hour. To clear the message, press SEL and ACT. You may exceed this limit by program-
ming another bolus within 10 minutes. The internal PPC backup battery is depleted. The PPC can be programmed. Replace the PPC as soon as possi-
ble. The internal PPC backup battery is low. The PPC can be programmed. Replace the PPC as soon as possible. PPC DEPLETED BATTERY PPC NOT INITIALIZED PPC LOW BATTERY PUMP LOW BATTERY The PPC cannot be programmed. Replace the PPC AA 1.5 volt alkaline battery. The PPC has not been initialized to a Pump. The PPC can be programmed. Replace the PPC AA 1.5 volt alkaline battery. The Pump battery energy is low but still functioning. Schedule a replacement as soon as possible. Dmp9196021-011_c.book Page 73 Thursday, April 4, 2002 8:15 AM Setup II 73 Display Screen Message PUMP INITIALIZED PRIMING XX U PUMP RESET PUMP SELF TEST FAIL PUMP STOPPED PUMP STOPPED 1 or 2 or 3 or 4or 5 or 6 PUMP SUSPENDED PUMP ERROR 0 or 1 COMM PUMP ERROR 40 or 41 TELEMETRY ERROR 3 TELEMETRY COMM ERROR 20 Message Meaning or Action Required The PPC has been married to a Pump . Press SEL and ACT. A Priming Bolus has been programmed and is being delivered. The Pump was reprogrammed to the preset factory val-
ues. A Pump malfunction was detected during a Self Test. Notify your physician immediately. The Pump is in stop mode. When the Pump recognizes a system malfunction, it automatically stops and insulin delivery ceases. Notify your physician immediately. The Pump is in suspend mode User attempts to initialize the PPC to a Pump that is not compatible with it. Clear by pressing SEL and ACT. Verify the personal ID of the Pump responding corre-
sponds to the personal ID entered into the PPC. The Pump has invalid data. The PPC will not initialize to Pump. The PPC and Pump are not communicating. Reposi-
tion the PPC over the Pump, then press SEL and ACT. If the error message persists, contact MiniMed. If the response is NO to the INITIALIZE PPC TO PUMP until this screen appears. Move the PPC away from any other Pump and perform the request again. 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 correspond-
ing events. Clinical history PPC/Pump codes Clinical Event Version Error No Response No Synchronization Invalid transmission Invalid Op code Bolus Total Error Bad Duplicates Stop Pump Alarm Prime Pump Alarm Max Clock Stealer Non Initialized PPC Pump Initialized Code 1 Clinical Event Time Out Code 2 3 5 7 9 13 15 17 19 21 23 25 Retry Packet Bad CRC RX Overflow TX Underflow Unknown IRQ Vector NMI Occurred Suspend Alarm Diagnostic Rate Alarm Exclusion List Full Min Clock Stealer Pump Self Test Error Pump Reset to Defaults 4 6 8 10 12 14 16 18 20 22 24 26 Dmp9196021-011_c.book Page 75 Thursday, April 4, 2002 8:15 AM Setup II 75 Clinical Event Download Failure Refill Divide Error Divide by 0 Bad EEPROM Main Battery Depleted Temporary Basal Rate Download Complete Invalid Stroke Volume IP Communication Error Post-Fire Voltage Reading too High Under-Delivery Error Auto Off Interval Exceeded Empty Reservoir Normal Delivery Mode Suspend Delivery Mode Priming Bolus Delivery Mode Code 27 29 31 33 35 Clinical Event Hourly Maximum Refill Invalid Calculation EEPROM Error Main Battery Low Back-up Battery Low Code 28 30 32 34 36 37 39 41 1 3 5 7 9 11 13 15 Check Pump Status Invalid Concentration Battery Removed Charge Time Too Long Over-Delivery Error Dead Battery Low Reservoir Low Battery Stop Delivery Mode Diagnostic Rate delivery mode Insulin Concentration Change 38 40 42 2 4 6 8 10 12 14 16 Dmp9196021-011_c.book Page 76 Thursday, April 4, 2002 8:15 AM 76 Personal Pump Communicator (PPC) Dmp9196021-011_c.book Page 77 Thursday, April 4, 2002 8:15 AM CHAPTER 4 Pump Implantation 77 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 implan-
tation. The Implantable Insulin Pump may be programmed through the outer tray of the sterile package. First, the PPC needs to be married to the Pump, then the Pump function is verified by performing the initializa-
tion procedure described in Chapter 3, PPC/Pump System Initialization. To ensure proper patient identification and device serial number tracking, the Registration Card that accompanies each Pump must be completed and promptly returned to MiniMed. Registration card 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 L sterile pipette (available non sterile from MiniMed) MMT-4104 One (1) sterile scalpel blade One (1) scale (0.01g resolution) One (1) sterile beaker (or sterile barrier towel) for weighing One (1) sterile bag for PPC 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) MiniMed refill needles, MMT-4102 Three (3) 18 gauge needles One (1) Implant Worksheet One (1) Back-up Pump System: PPC, Pump and Side Port Cathe-
ter Solutions One (1) bottle of sterile water, room temperature One (1) vial 10 mL rinse buffer (RB) Four (4) vials 10 mL Aventis HOE 21 PH U-400 INSULIN Dmp9196021-011_c.book Page 79 Thursday, April 4, 2002 8:15 AM Preprogramming and pre-testing the pump 79 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 institutions approved sterile procedures.
!
WARNING When you remove the Pump from the sterile box, do not remove the plastic tubing placed at the Pump outlet. Trim the distal part with a scalpel blade. This tubing will be used for the Stroke Volume Measurement procedure. DO NOT TRY TO REPLACE THE TUBING BACK ON THE PUMP OUTLET, or you can dis-
place or damage the O ring placed around the outlet. A sterile field is established in the operating room to prepare the RINSE BUFFER (RB) syringe and remove the shipping fluid from the pump. Document the Pump, Catheter and PPC serial numbers on the Implant Worksheet. 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. Draw approximately 4 mL of RINSE BUFFER into the refill syringe. 5. Fill the hub of the refill needle with RINSE BUFFER and firmly attach it to the stopcock, prime the needle and close the stopcock. Figure 6: Filling the Hub of the Refill Needle Dmp9196021-011_c.book Page 81 Thursday, April 4, 2002 8:15 AM Preprogramming and pre-testing the pump 81 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. Any time a refill nee-
dle is to be inserted into the Pump fill port, a fluid barrier must be present to prevent air from entering the Pump reservoir. 9. With the stopcock still closed, insert the RB syringe into the Pump fill port. Press down with at least one-half pound of force to open the inlet valve. As the needle passes through the septum and seats in the valve, you can feel approximately 0.5mm of movement as the valve is opened. 10. Open the stopcock and allow the syringe vacuum to empty the Pump of shipping fluid. Allow 30 seconds after the fluid level appears to have stopped rising in the refill syringe, to assure the Pump is com-
pletely emptied. Close the stopcock and remove the syringe. 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. 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. 17. Shake vigorously for a minimum of 30 seconds to degas the INSULIN. 18. Point the syringe tip upward and slowly open the stopcock to vent the syringe. 19. Release the locking ring on the refill syringe. 20. Expel air in the syringe and carefully observe to ensure no air bubbles remain in the syringe. If air bubbles are noted, repeat steps 15 - 20. 21. Fill the hub of the refill needle with INSULIN and attach it to the stopcock. 22. Prime the needle and close the stopcock. 23. Refill the fill port with the 3 mL RINSE BUFFER syringe, as needed, to maintain the fluid barrier. 24. Use the IN1 syringe containing the degassed INSULIN to fill the Pump. Dmp9196021-011_c.book Page 83 Thursday, April 4, 2002 8:15 AM Preprogramming and pre-testing the pump 83 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). Figure 7: Venting the Syringe Head Space 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. 29. Allow the Pump vacuum to draw the INSULIN into the reservoir. When the INSULIN stops moving, the Pump is filled. Close the stop-
cock and remove the syringe. 30. Prepare the IN1 syringe for aspiration. Remove any air from the syringe, prime the needle, close the stopcock and 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. A fluid barrier of at least 2 mL should remain in the syringe. 31. Press the refill needle back into the Pump fill port with the stopcock closed. 32. 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. 33. Close the stopcock and remove the syringe.
1 | Physician Part2 | Users Manual | 2.12 MiB | February 05 2002 |
Dmp9196021-011_c.book Page 85 Wednesday, April 3, 2002 5:04 PM Fill the Pump with insulin 85 1. Remove another refill syringe (IN2) from a refill kit package. 2. Firmly attach the two-way stopcock to the refill syringe and attach an 18 gauge needle to the stopcock. Label the syringe IN2. 3. Draw 20 mL of INSULIN (two vials) into the IN2 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. 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. Shake vigorously for a minimum of 30 seconds to degas the INSU-
LIN. 8. Point the syringe tip upward and slowly open the stopcock to vent the syringe. 9. Release the locking ring on the refill syringe. 10. Expel the air in the syringe and carefully observe it to ensure no air bubbles remain in the syringe. If air bubbles are noted, repeat steps 5 - 10. 11. Fill the hub of the refill needle with INSULIN and attach it to the stopcock. 12. Prime the needle and close the stopcock. 13. Place a sterile beaker or sterile barrier towel on the scale and tare it
(position balance at 0.) 14. Weigh the refill syringe and record the weight on the Implant Work-
sheet. Dmp9196021-011_c.book Page 86 Wednesday, April 3, 2002 5:04 PM 86 15. Press the refill syringe into the Pump fill port, open the stopcock and allow the Pump vacuum to draw INSULIN into the reservoir until the fluid level stops moving. Close the stopcock. 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 nega-
tive pressure safety feature of the Pump. Close the stopcock and remove the syringe. 19. Weigh the IN2 syringe to calculate the Pump refill amount. Subtract the weight after the fill and 2 mL withdrawal from the weight before the fill and record the difference on the Implant Worksheet. Measure stroke volume 1. Place the PPC in the sterile bag. Enter the Supervisor Mode. The screen displays PUMP REFILL. Press ACT until the SET REFILL AMOUNT screen appears. When filling the Pump for the first time, set the EXTRACTED AMOUNT to zero. Otherwise, enter the amount of insulin extracted. Then use the LLLL and MMMM buttons to enter the refill amount from the Implant Worksheet. Program the Pump. 2. Again, enter the Supervisor Mode and program STOP PUMP. From the screen PUMP STOPPED, press SEL. PUMP STOPPED will begin flashing. Press both the LLLL and MMMM buttons at the same time, until the screen changes to the password screen. Reen-
ter the password and the screen will change to PUMP REFILL. Press SEL to reach the PRIMING screen. NO will be flashing. Use the LLLL and MMMM buttons to select YES, then press ACT. When the word CONFIRM is highlighted, press ACT again. Place the PPC near the Pump to complete the communication process. Record the Dmp9196021-011_c.book Page 87 Wednesday, April 3, 2002 5:04 PM time the priming bolus was initiated on the implant worksheet. 87
!
WARNING If you have removed the plastic tubing placed on the Pump outlet, DO NOT TRY TO REPLACE THE TUBING BACK ON THE PUMP OUTLET. You can displace or damage the O ring placed around the outlet. To measure the stroke volume, you need to use the procedure described in Appendix G, after the Catheter has been attached. 3. Listen for five beeps and observe that fluid is being pumped from tub-
ing attached to the Pump outlet. 4. Attach the 18 gauge needle (from the 3 ml syringe filled with RINSE BUFFER) to the plastic tubing from the Pump outlet. 5. Remove the 3 ml syringe and fill the needle hub. 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/tub-
ing assembly horizontal. (see Figure 8). Figure 8: Testing Pump Stroke Volume with a Pipette 7. Note the exact location of the fluid meniscus in the pipette. 8. Measure the stroke volume by noting the volume displaced by a mini-
mum of 10 pulses. Record the total volume delivered and the number of pulses on the Implant Worksheet. Divide the total volume deliv-
ered by the total number of pulses used to deliver that volume. The volume per stroke must be between 0.40 and 0.60 L. Record this value on the Implant Worksheet. Dmp9196021-011_c.book Page 88 Wednesday, April 3, 2002 5:04 PM 88 Prepare the Side Port Catheter The Side Port Catheter (Catheter) is attached to the Pump before implantation; however, it must be primed with INSULIN and inspected before being attached to the Pump. WARNING
!
Never insert a needle into the connector end of the Catheter for priming or for testing. there may be a precision sealing surface in the connector that will be damaged by the insertion of any needle. 1. Keep the Catheter in its package until the Pump is prepared and stroke volume has been verified. Remove the Catheter from its sterile pack-
age and document the serial number on the Implant Worksheet. 2. Using the last insulin syringe (IN2) from the Pump preparation proce-
dure, enter the Catheter port cone and push a small volume of insulin out of the connector end of the Catheter. This primes the proximal portion of the Catheter and cleans any debris from the connector out-
let. Remove the syringe. 3. 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 tub-
ing and retainer. Dmp9196021-011_c.book Page 89 Wednesday, April 3, 2002 5:04 PM 89 Figure 9: Rotate Tubing Retainer Figure 9-2: Pull Tubing Retainer off Pump. Dmp9196021-011_c.book Page 90 Wednesday, April 3, 2002 5:04 PM 90 Step 4 Figure 9-3: Tubing and Retainer Removed. Inspect the outlet of the Pump for debris. Debris, espe-
cially 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. WARNING
!
Use caution when removing debris from the outlet of the Pump. There is a precision rubber seal on the outlet that will be dam-
aged by handling with surgical instru-
ments. Step 5 Pull the locking bar out and gently push the Catheter straight down onto the Pump outlet. Never twist the connector. Dmp9196021-011_c.book Page 91 Wednesday, April 3, 2002 5:04 PM 91 Step 6 Only after the Catheter is seated, squeeze the connector, 1, firmly against the Pump between the thumb and fore-
finger of one hand. Then push the locking bar, 2, into place with the thumb of the other hand. Figure 10: Proper Attachment of the Side Port Catheter to Pump Dmp9196021-011_c.book Page 92 Wednesday, April 3, 2002 5:04 PM 92 Step 7 Step 8 Step 9 Verify the Catheter is securely attached to the Pump. Look into the connector and observe the position of the locking bar with respect to the Pump connector outlet. Check the side port connector hub for abnormalities
(e.g., cracks, misalignment.) Using the IN2 refill syringe, enter the Catheter side port cone and push a small amount of INSULIN out the Cath-
eter tip. Verify that no insulin flow is observed at Pump/
Catheter interface. Remove and reseat Catheter if flow is noted. Remove the syringe. Confirm insulin delivery from the tip of the Catheter and note it on the Implant Worksheet. The INSULIN will form a dome on the tip of the Catheter. Pulsatile delivery will not be obvious. If the priming bolus has already ended, program an immediate bolus (about 20 units) to confirm delivery. (This bolus may be canceled after delivery is verified.) Step 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 sur-
geon 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. Dmp9196021-011_c.book Page 93 Wednesday, April 3, 2002 5:04 PM 93 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 subcutane-
ous 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 anes-
thesia. After satisfactory anesthesia, a pre-selected abdominal site is prepped and draped in the customary surgical method. A transverse or longitudinal incision is made and deepened through the skin and subcutaneous tissue. Care should be taken in choosing the loca-
tion of the incision so the suture line is next to but not over the Pump inlet fill port or the Catheter side port. A subcutaneous blunt dissection is per-
formed to create a pocket large enough to accommodate the Pump. Meticulous hemostasis should be established with electrocautery. Figure 11 indicates a possible Pump placement and corresponding inci-
sion sites. The Pump is secured to the fascia of the abdominal musculature using the three suture tabs provided. Securing the Pump with all three suture tabs is recommended, as it will prevent migration, rotation or inversion in the pocket and possible dislodgment of the Catheter. Dmp9196021-011_c.book Page 94 Wednesday, April 3, 2002 5:04 PM 94 Figure 11: Example of Pump Placement Dmp9196021-011_c.book Page 95 Wednesday, April 3, 2002 5:04 PM Catheter placement 95 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 muscula-
ture 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. The flange of the Catheter is sutured firmly to the fascia of the abdominal musculature. Sutures should only be placed on the reinforced flange of the Catheter. Sutures must not be placed directly on the Catheter itself. Never trim or cut the tip of the Catheter. WARNING
!
The implant site should be irrigated with an antibiotic solution. Inter-
rupted absorbable sutures should be used to approximate the subcutane-
ous tissues and the skin closed with a running subcuticular absorbable suture. The wound is dressed using standard surgical technique. At the end of the surgery, place an abdominal binder over the implant site. This binder must be worn until the capsule has formed (about 1 month.) The binder is recommended because it will obtain a better cosmetic result and minimize the post operative swelling. 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-opera-
tive 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 Dmp9196021-011_c.book Page 96 Wednesday, April 3, 2002 5:04 PM 96 stabilize. During post-operative hospitalization, the Pump can be repro-
grammed to accommodate the needs of the patient. As post-operative stress decreases, insulin requirements may decline. It may be necessary to make several changes in insulin delivery rates during the first few days following implantation. Patients must be thoroughly educated in all aspects of follow-up care with the Pump. The MiniMed Patient Manual should be used to supplement patient education. Prior to discharge, patients should:
Fully understand how to use their PPC;
Know what to do in the event of Pump or PPC difficulties;
Have scheduled their first refill appointment;
Have set an appointment for their first follow-up visit;
Post-operative x-rays The Catheter has been designed with a radio-opaque stripe for identifica-
tion after implantation. A lateral and anterior X-ray is recommended after implantation to locate and document the position of the Catheter. This radiograph should be kept with the patients records for future reference. Dmp9196021-011_c.book Page 97 Wednesday, April 3, 2002 5:04 PM CHAPTER 5 Pump Refill Procedure 97 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 approx-
imately 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. The PPC will display warning messages to alert the patient of calculated low or emptied reservoir volumes. The low reservoir message will appear when the PPC calculates that 800
(2 ml) or fewer units of insulin medication remain in the Pump. The empty reservoir message will appear when the PPC calculates that 400 or fewer units (1 ml) of insulin remain. The time to medication depletion depends upon the delivery rate of the Pump. WARNING
!
The Pump refill procedure should always be scheduled in advance of PPC low reservoir or empty reservoir messages. Dmp9196021-011_c.book Page 98 Wednesday, April 3, 2002 5:04 PM 98 Pump Refill Procedure Supplies and solutions The refill kit (MMT-4105) is intended exclusively for use with the Medtronic MiniMed 2007C Implantable Insulin Pump System. The refill kit consists of a specially designed syringe and stopcock for removing flu-
ids from and placing fluids into the Pump. Use only refill needles (MMT-
4102) available from MiniMed to perform all Pump refill procedures. This 22 gauge needle, featuring a rounded, lubricated tip and a beveled side hole, has been specially developed to mate with the Pump fill port. Use of other needles may result in damage to the Pump septum in the fill port, and may allow body fluids to enter the Pump. WARNING
!
Below is a list of the supplies and solutions necessary to perform the refill procedure:
Supplies:
Steri-Strips and Markers The Patients PPC Glucose Monitoring Equipment Drapes One (1) Scale (0.01 gram resolution) One (1) 250 ml Sterile Beaker One (1) Port Locating Template - MMT-4106 Two (2) Refill Kits - MMT-4105 Three (3) MiniMed MMT-4102 Refill Needles (Extra needles should be available for use.) Four (4) Sharp 18 Gauge Regular Bevel Needles Solutions:
One (1) 10 ml Vial, Aventis Rinse Buffer Solution Two (2) 10 ml Vials, Aventis HOE 21 PH, U-400 Insulin Dmp9196021-011_c.book Page 99 Wednesday, April 3, 2002 5:04 PM Prepare for pump refill Introduction 99 NOTE: Before beginning any refill, rinse, flush, or pres-
sure measurement procedure, carefully read Appendix D, Precautions and General Proce-
dures. 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. To prepare for emptying and refilling the Pump, perform the following steps:
Use the HISTORY feature of the PPC to determine the amount of insulin medication remaining in the Pump. Make sure that ACT is pressed on the READ PUMP DATA screen to update PPC history from the Pump. Record this value on the refill work-
sheet (Appendix C). Prepare a sterile field. The physician should scrub, mask and glove for the refill procedure. Refilling the Pump is an aseptic procedure.
(See Appendix D, Precautions and General Procedures.) Aseptic skin preparation of the patients Pump refill site should be performed using your institutions standard operating proce-
dures. Dmp9196021-011_c.book Page 100 Wednesday, April 3, 2002 5:04 PM 100 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 patients I.D., refill date, insulin lot number, previous refill volumes, insulin medi-
cation remaining, and the name of the person performing the refill proce-
dure. This information can be helpful for diagnostic purposes. Label syringes Use a sterile marker and Steri-Strips to label one refill syringe RB
(rinse buffer syringe) and the other IN (insulin syringe). Prepare the refill syringe for emptying the Pump 1. Firmly attach the stopcock to the RB refill syringe and attach the 18 gauge needle to the stopcock. Check connections to ensure they are secure. Draw 5 ml of Rinse Buffer into the RB refill syringe. 2. Expel all air bubbles from the refill syringe. Remove the 18 gauge needle from the stopcock. 3. Fill the hub of the refill needle with Rinse Buffer from the RB refill syringe and attach it to the stopcock. Prime the refill needle completely. Close the stopcock. 4. Obtain the weight and record it on the Refill Form. Set the syringe aside. Figure 12: Filling the Hub of the Refill Needle Dmp9196021-011_c.book Page 101 Wednesday, April 3, 2002 5:04 PM Perform the refill procedure 101 Prepare the refill syringe for filling the Pump 1. Firmly attach the stopcock to the IN refill syringe and attach an 18 gauge needle to the stopcock. Draw 20 ml of Aventis HOE PH 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. Shake vigorously for a minimum of 30 seconds. 5. Point the syringe tip upward and slowly open the stopcock to allow air to enter the syringe. 6. Release the locking ring on the refill syringe. With the syringe pointed upward, push on the plunger to expel the air and prime the stopcock. 7. Open the stopcock and prime the refill needle. Attach the refill needle to the stopcock. Close the stopcock. 8. Inspect the syringe to ensure there are no air bubbles. If air bubbles are noted, remove the refill needle and repeat steps 2 - 7. 9. Weigh the refill syringe and record on the refill form. 10. Set the syringe aside. Dmp9196021-011_c.book Page 102 Wednesday, April 3, 2002 5:04 PM 102 Pump Refill Procedure Empty the Pump 1. Obtain a vacuum in the RB syringe by pulling back on the plunger until it locks. Press the lock into the plunger groove and be sure it is firmly secured. 2. Locate the fill port by centering the template over the Pump. The cen-
ter hole in the template should be directly over the Pump fill port. Insert the 18 gauge guide needle into the Pump fill port. Local anes-
thesia may be used prior to insertion of the 18 gauge needle. 3. Press the primed refill needle (attached to the RB syringe) into the Pump fill port, by sliding it through the 18 gauge guide needle. Pull back slightly (approximately 2 mm) on the guide needle to allow the refill needle to enter the Pump fill port and actuate the inlet valve. 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 com-
pletely emptied. 6. When all residual insulin is withdrawn from the Pump, close the stop-
cock. Remove the RB refill syringe. NOTE: Do not remove the 18 gauge guide needle. 7. Weigh the RB syringe and record on the refill form. Dmp9196021-011_c.book Page 103 Wednesday, April 3, 2002 5:04 PM Perform the refill procedure 103 Step3A Septum Spring Step3B 18G Guide Needle 2mm Refill Needle Valve Filter Step 3A: Locate the port using the 18Ga guide needle slide the refill needle down the guide needle. Step 3B: Pull back approxiamately 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. Step3C Figure 13: Operation of the Pump Inlet Valve Dmp9196021-011_c.book Page 104 Wednesday, April 3, 2002 5:04 PM 104 Pump Refill Procedure Refill the Pump 1. Use the IN refill syringe containing 20 ml of degassed insulin. 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 nee-
dle to enter the Pump and actuate the inlet valve (see Figure 13). 3. Open the stopcock. Maintain downward pressure on the IN refill syringe to ensure the inlet valve in the Pump remains open. Allow the Pump to draw in insulin until the fluid level stops moving. Close the stopcock. 4. Remove the IN syringe and prepare for aspiration without expelling any fluid by pulling back on the plunger until it locks. Re-enter the Pump, open the stopcock and withdraw 2 ml in order to activate the negative pressure safety feature of the Pump. Dmp9196021-011_c.book Page 105 Wednesday, April 3, 2002 5:04 PM Perform the refill procedure 105 OPTIONAL Use this step only if the plunger is not moving dur-
ing the fill of the reservoir. With the refill nee-
dle pointing down, vent syringe head space by pull-
ing back firmly on the plunge until the second sealing ring on the black rubber cap passes beyond the hole
(see Figure 14). vent the Figure 14: Venting the MiniMed Refill Syringe 5. Remove the IN syringe. Remove the 18 gauge needle and apply pres-
sure to the insertion site. 6. Weigh the IN syringe and record on the Refill Form. Dmp9196021-011_c.book Page 106 Wednesday, April 3, 2002 5:04 PM 106 Pump Refill Procedure 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. Enter the extracted amount (amount withdrawn as calculated on the refill worksheet at line E) and the refill amount (as calculated on the refill worksheet at line G) into the PPC (see Chapter 3). Calculate refill accuracy The PPC automatically calculates the refill accuracy following the PPC refill programming. You can also follow the calculation section of the refill form to calculate the refill accuracy. Enter the refill accuracy value (IN %) on the line provided on the refill form. It is important to record this value to evaluate the functioning of the Pump system. Dmp9196021-011_c.book Page 107 Wednesday, April 3, 2002 5:04 PM 107 CHAPTER 6 Explanting the Pump System Explant considerations When the battery in the Pump is depleted or if acceptable glycemic con-
trol 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. If all appropriate interventions have been exhausted without an acceptable outcome, please contact MiniMed prior to scheduling a Pump explanta-
tion. Returning devices/components to MiniMed Explanted Pumps and Catheters or other components should be returned to MiniMed for evaluation. Please call MiniMed and obtain a Returned Materials Authorization (RMA) number prior to each return. Explanted devices must be sealed in an appropriate biohazard container and packed with a gauze pad soaked with sterile saline. The shipping con-
tainer should be water tight. Chemical and reliability analysis require that the device not dry out during transportation. Dmp9196021-011_c.book Page 108 Wednesday, April 3, 2002 5:04 PM 108 Explanting the Pump System Be certain to include required patient information as well as the RMA number, date, and reason for the explant and place all pertinent documen-
tation in a water tight document package. Put the RMA number on the shipping label. Please take the necessary precautions when shipping the Pump System via commercial carrier to avoid damage to the Pump. Please return explanted Pump Systems to:
United States:
MiniMed Inc. 18000 Devonshire Street Northridge, CA 91325 Telephone: 1-818-578-6700 or Europe:
MiniMed S.A. 30, Boulevard Vital Bouhot 92200 Neuilly-sur-Seine, France Telephone: 33 (1) 46 43 16 16 Dmp9196021-011_c.book Page 109 Wednesday, April 3, 2002 5:04 PM CHAPTER 7 Warnings And Precautions 109 Warnings Electrotherapy The Physician should be completely familiar with the function of the Pump, Catheter, and PPC prior to use. Patients should be provided a com-
plete copy of the Patient Manual and have demonstrated the ability to pro-
gram the PPC, recognize and respond to safety alarms, and take care of the device prior to discharge. The Implantable Insulin Pump can only be used with MMT-4027A and 4024A Side Port Catheters. Only Aventis HOE 21 PH U-400 insulin may be used in the Medtronic MiniMed 2007C Implantable Insulin Pump System. Use of other insulin types may cause damage to the Pump mechanism resulting in impaired insulin delivery or Pump failure. Any unauthorized changes or modifications made to any component of the Medtronic MiniMed 2007C Implantable Insulin Pump System may prevent effective use of that and other components. The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested in close proximity with electrosurgical, electrocoagulation, and cardiac defibrillation medical equipment. Typical use of this type of device has not affected the Pump. However, patients should be instructed Dmp9196021-011_c.book Page 110 Wednesday, April 3, 2002 5:04 PM 110 Warnings And Precautions to test Pump function (e.g., program a bolus and then cancel the bolus) after such procedures, to determine that the Pump and PPC are operating properly. If the system is not performing correctly, contact MiniMed. Diagnostic ultrasound The Medtronic MiniMed 2007C 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., program a bolus and then cancel the bolus) after such procedures, to determine that the Pump and PPC are operating properly. If the system is not performing correctly, contact MiniMed. Ultrasound therapy The Medtronic MiniMed 2007C Implantable Insulin Pump System should not be exposed to therapeutic ultrasound procedures, such as lithotripsy. Exposure to ultrasound therapy may damage the Pump, and not be imme-
diately apparent. Diagnostic radiation The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested during diagnostic radiation procedures, such as Computed Tomography and X-ray. These procedures have no effect on Pump perfor-
mance. However, patients should be instructed to test the Pump function
(e.g., program a bolus and then cancel the bolus) after such procedures, to determine that the Pump and PPC are operating properly. If the system is not performing correctly, contact MiniMed. Therapeutic radiation The MiniMed 2007 Implantable Insulin Pump has been tested during therapeutic radiation procedures. These procedures have no effect on Pump performance. However, patients should be instructed to test the Pump function (e.g., program a bolus and then cancel the bolus) after such procedures, to determine that the Pump and PPC are operating prop-
erly. If the system is not performing correctly, contact MiniMed. Dmp9196021-011_c.book Page 111 Wednesday, April 3, 2002 5:04 PM Warnings 111 Elevated anti-insulin antibodies The result of clinical investigations suggest a small population of patients may develop anti-insulin antibodies when using the MiniMed 2007 Implantable Pump System and HOE 21 PH U-400 insulin. Patients with multiple autoimmune disorders may be more susceptible to developing high titers of anti-insulin antibodies, which in turn may cause symptoms. There was no correlation between length of exposure to the study drug and the resultant titer of anti-insulin antibodies. Elevated levels of anti-
insulin antibodies alone have been proven not to interfere with diabetes management using continuous intraperitoneal insulin infusion with this system. Environmental conditions The Medtronic MiniMed 2007C 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 MiniMed when in doubt if certain environmental exposure will affect the pump. DO NOT EXPOSE THE MINIMED 2007 IMPLANTABLE INSULIN PUMP SYSTEM TO ANY OF THE FOLLOWING CONDITIONS Magnetic Resonance Imaging (MRI) Procedures. Lithotripsy Treatment. Large Rotating Magnetic Fields - - - - Refers to large industrial rotat-
ing magnetic fields, such as those found in Industrial Power Plants. Magnets Held Directly Over the Pump. High Power Radio or Satellite Transmitting Towers. Altitudes Above 2,400 meters (8,000 feet). The Medtronic MiniMed 2007C Implantable Insulin Pump System is not designed for use at elevations above 2,400 meters (8,000 feet). Use of the Pump System at higher elevations may result in insulin over delivery, which may cause personal injury or death. Therefore, patients who live at Dmp9196021-011_c.book Page 112 Wednesday, April 3, 2002 5:04 PM 112 Warnings And Precautions elevations above 8,000 feet or 2,400 meters should not use the Pump. Patients who use the Pump and who plan to travel to an elevation above 2,400 meters (8,000 feet) should first have their Pump reservoir emptied of insulin, and they must self-administer insulin by other means for the duration of the trip and until their Pump reservoir is refilled again. This warning does not apply to travel on commercial aircraft because normal cabin pressurization is adequate to ensure proper operation of the Pump. Diving Below 7.6 Meters (25 Feet). Physical Damage to the Pump or Pump Pocket. 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. Physicians may order a pressure ban-
dage or a reduction in the patients physical activity until the pump pocket reheals completely. Exposure to Extreme Body Temperatures Exposure to elevated body temperature in excess of 104F (40C) will compromise the negative pressure reservoir safety feature of the MiniMed 2007 Implantable Pump. Glucose levels should be monitored closely if this occurs. Sterilization The Pump, Catheter and the refill kit are sterilized with ethylene oxide
(EtO). The Pump System is NOT Reusable. If the sterile package has been opened, damaged or tampered with DO NOT USE the packaged device. Dmp9196021-011_c.book Page 113 Wednesday, April 3, 2002 5:04 PM Precautions 113 NOTE: Do Not Re-Sterilize the Implantable Insulin Pump NOTE: Do Not Re-Sterilize the Side Port Catheter NOTE: Do Not Re-Sterilize Components of the Refill Kit. The Pipette (MMT -4104), may be resterilized using autoclave or EtO. The Template MMT-4106 may be resterilized using steam autoclave or EtO. This template is made from polycarbonate plastic and will have a limited life in steam autoclave cycle. The template will not withstand dry heat autoclave cycles. Precautions Emergencies and the use of conventional insulin supplies Physicians should advise patients who wear the Medtronic MiniMed 2007C Implantable Insulin Pump System how to deal with emergency conditions such as hyperglycemia. Patients should always carry conven-
tional insulin supplies with them, including insulin and a means to inject it, in the event of impaired insulin delivery by the Pump System. Delivery of insulin can become impaired due to a failure of a Pump and/or PPC, or a Catheter occlusion. Replacement of the Pump, PPC or Catheter may be required. Physicians should review the Pump replacement and Catheter clearing procedures in this Physicians Manual PPC reliability requirements The PPC is a sensitive electronic device, and can incur physical damage. If the PPC is dropped or receives an impact, immediately perform a SELF TEST to check the displays for proper operation. If the PPC does not dis-
play correctly, a replacement PPC is required. Patients should initiate alternative diabetes management until a replacement PPC is received. The PPC housing is not watertight and it may malfunction if immersed in water. Condensing humidity conditions such as steam rooms should also be avoided, because condensation can also damage the PPCs micro-
Dmp9196021-011_c.book Page 114 Wednesday, April 3, 2002 5:04 PM 114 Warnings And Precautions electronics. If either situation occurs, contact MiniMed immediately and arrange for the repair or replacement of the PPC. If the PPC is acciden-
tally splashed, sprayed or immersed, remove excess moisture with a soft towel and then place the PPC in a warm place to thoroughly dry. When dry, perform a SELF TEST. If the PPC does not display correctly, call MiniMed to replace the device. Maximum dosages The physician can program specific limitations to insulin Basal Rates and Bolus amounts, as well as total daily insulin usage. These limitations pro-
vide some control of patients ability to program their insulin regimens, and to avoid overdosing. 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, stan-
dard medical X-rays, cellular phone, and radiowaves. Dmp9196021-011_c.book Page 115 Wednesday, April 3, 2002 5:04 PM CHAPTER 8 Adverse Reactions 115 Adverse reactions In clinical studies, adverse reactions associated with the Medtronic Min-
iMed 2007C Implantable Pump included hypoglycemia, diabetic ketoaci-
dosis, hyperglycemia, skin erosion, infection, abnormal healing, elevated anti-insulin antibodies, intestinal obstruction, post-operative discomfort and pain, and corrective surgery for Pump and Catheter malfunctions. Pump System malfunctions in order of frequency and seriousness include insulin aggregation resulting in Pump under-delivery, Catheter occlusion or tissue overgrowth, premature depletion of the Pump battery, and failure of Pump electronics. Adverse events associated with the use of Aventis HOE 21 PH U-400 insulin are described in the package insert accompa-
nying the insulin medication. Dmp9196021-011_c.book Page 116 Wednesday, April 3, 2002 5:04 PM 116 Adverse Reactions Prevention The majority of adverse reactions in patients using the Medtronic MiniMed 2007C Implantable Pump System can be prevented by teaching patients dependable blood glucose monitoring. The patient plays a signif-
icant role in diagnosing and correcting Pump System performance prob-
lems. Should Pump performance change, the patient would be able to detect a change in blood glucose levels. WARNING
!
Patients should be instructed to contact their physicians office, if they experience unresolvable difficulties with the Pump System. Emergency patient visits and diagnostic procedures may be necessary to correct adverse conditions.
1 | Physician Part3 | Users Manual | 745.32 KiB | February 05 2002 |
Dmp9196021-011_c.book Page 117 Wednesday, April 3, 2002 5:06 PM 117 CHAPTER 9 System Alarms and Messages The Medtronic MiniMed 2007C Implantable Insulin Pump System is equipped with various alarms and messages that ensure the correct func-
tion 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. For severe alarm con-
ditions the Pump will alarm 4 tones each minute for 10 minutes then, 4 double tones each minute for 10 minutes and repeat the pattern. Upon hearing the alarm, the patient must communicate with the PPC, to deter-
mine the alarm condition. The alarm can be cleared by pressing SEL then ACT. The following descriptions explain the alarm conditions the system may encounter. The PPC has three types of alarms: audible, vibrate and visual alarms. The chapter will describe for each alarm condition, which screen message appears and the vibrate or audible alarm associated with it. Two audible or vibrate alarm types are used:
Alarm Type 1:
If the PPC is set to vibrate, the vibrator will be turned on for 3 seconds every minute for 30 minutes. If the PPC is set to audible, the PPC will beep 6 times every minute for 30 minutes. If the alarm is not cleared in 30 minutes, the PPC will beep 6 alternating tones. The PPC will continue to do so every minute. Dmp9196021-011_c.book Page 118 Wednesday, April 3, 2002 5:06 PM 118 System Alarms and Messages Alarm Type 2:
If the PPC is set to vibrate, the vibrator will be turned on for 3 seconds every 30 minutes while the condition exists. If the PPC is set to audible, the PPC will beep 3 times every 30 minutes while the condition exists. Some alarms can be cleared by pressing SEL then ACT. 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 Feed-
back to measure the time intervals between Pump strokes to verify accu-
rate insulin delivery. When Alarm Feedback is programmed YES, the Pump will beep on each of the first five Pump strokes:
Following a change in the delivery regimen, for example when completing a meal Bolus and then changing to a Basal Rate, or at the start of a bolus. After the Alarm Feedback function is programmed YES. Alarm Feedback will stay on until programmed back to NO. Pump low battery The Implantable Insulin Pump battery is designed to last approximately ten years during conditions of normal use (see Chapter 11, Technical Specifications). Battery life may vary somewhat depending upon a users insulin delivery requirements. When battery energy becomes low, a volt-
age sensor in the Pump will trigger the Pump Low Battery Alarm. A Pump Low Battery Alarm indicates there is approximately eight weeks of battery energy remaining. Dmp9196021-011_c.book Page 119 Wednesday, April 3, 2002 5:06 PM Pump alarms 119 PPC Display Type of Alarm Pump Alarm PUMP LOW BATTERY 1 In 24 hours if no PPC communication The Pump Low Battery alarm can be cleared and the Pump will continue to operate normally. However, users should be instructed to report the alarm immediately to their physician. A Pump replacement or resumption of conventional insulin therapy should then be scheduled. Depleted pump battery When there is no longer sufficient battery energy to power the Pump, the Pump Low Battery Alarm will cease and insulin delivery will stop. Alter-
nate insulin therapy must be initiated. 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. Using the PPC Supervisor Mode, the phy-
sician should use the DOWNLOAD SOFTWARE feature to reprogram the Pump from software in the PPC memory. Notify MiniMed immedi-
ately. PPC Display Type of Alarm Pump Alarm PUMP STOPPED 1 or 2 or 3 or 4 or 5 or 6 1 In 5 minutes if no PPC communication Dmp9196021-011_c.book Page 120 Wednesday, April 3, 2002 5:06 PM 120 System Alarms and Messages Pump self test fail If during a SELF TEST the Pump presents a malfunction, the insulin delivery will stop. Clear the message by pressing SEL then ACT. Notify MiniMed immediately. PPC Display PUMP SELF TEST FAIL Type of Alarm 1 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. PPC low battery If the PPC main battery (AA 1.5 volt alkaline) energy is low, the follow-
ing alarm display appears each time a new function is programmed:
PPC Display PPC LOW BATTERY Type of Alarm 1 Clear this message by pressing SEL and then ACT. While the battery should have sufficient energy for a few additional programming com-
mands, the battery should be changed as soon as possible. For instruc-
the battery, (see Chapter 3, Personal Pump tions on changing Communicator). WARNING
!
If VIBRATOR is selected, the PPC bat-
tery should last about six weeks during nor-
mal use conditions. If the PPC determines that the vibrator is causing a low battery condition, it will automatically change the Alarm Mode to LOW VOLUME in order to extend battery life. Dmp9196021-011_c.book Page 121 Wednesday, April 3, 2002 5:06 PM Pump alarms 121 NOTE: If while programming the PPC, the screen goes blank, the PPC beeps six times and then the CHECK PUMP STATUS message appears, the battery needs to be replaced. (See Chapter 3 for instructions, Install/Replace the Main Battery). PPC depleted battery When the PPC main battery (AA 1.5 volt alkaline) no longer has suffi-
cient power to program the Pump, the following message will appear on the display:
PPC Display PPC DEPLETED BATTERY Type of Alarm 1 This message can only be cleared by replacing the PPC battery. For instructions on changing the battery, (refer to Chapter 3, Personal Pump Communicator). Dmp9196021-011_c.book Page 122 Wednesday, April 3, 2002 5:06 PM 122 System Alarms and Messages PPC needs servicing When the PPC internal battery (lithium) energy becomes low, the follow-
ing message will be displayed:
PPC Display PPC NEEDS SERVICING Type of Alarm 1 Clear this message by pressing SEL and ACT. Users should be instructed to report this alarm to their physician as soon as possible and have their PPC replaced. If the PPC loses all power, it may also lose information stored in memory. Low reservoir When the Pump calculates that less than 800 units (2 ml) of insulin remains in its reservoir, the following display will appear:
PPC Display LOW RESERVOIR Type of Alarm 1 Pump Alarm In 24 hours if no PPC communication Clear this message by pressing SEL and ACT. Users should be instructed to report this alarm to their physician as soon as possible and schedule an appointment for a Pump refill. Empty reservoir When the Pump calculates that less that 400 units (1ml) of insulin remains in its reservoir, the following display will appear :
PPC Display EMPTY RESERVOIR Type of Alarm 1 Pump Alarm In 24 hours if no PPC communication Dmp9196021-011_c.book Page 123 Wednesday, April 3, 2002 5:06 PM Pump alarms 123 Clear this message by pressing SEL and ACT, and then continue pro-
gramming. Users should be instructed to report this alarm to their physi-
cian as soon as possible and schedule an appointment for a Pump refill. It is important not to allow the Pump to deplete its insulin supply as this may result in catheter blockage. Telemetry communication error If programming is interrupted after partial transmission of a command, the PPC will display the following message on the display screen:
PPC Display Type of Alarm TELEMETRY COMM ERROR3 1 Reposition the PPC near the Pump, and then press SEL and ACT. The PPC will attempt to resume communication with the Pump. Dmp9196021-011_c.book Page 124 Wednesday, April 3, 2002 5:06 PM 124 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 PUMP ERROR 0 or 1 Type of Alarm 1 Attempting to initialize a PPC to a Pump that contains invalid stroke vol-
ume or insulin concentration information, results in one of the following messages to be displayed. Contact MiniMed for instructions. PPC Display PUMP ERROR 40 or 41 Type of Alarm 1 Responding NO to the INITIALIZE PPC TO PUMP screen eight consecutive times, results in the following message to be displayed. Step away from any other Pump in the area and perform the request again. PPC Display TELEMETRY ERROR 20 Type of Alarm 1 Dmp9196021-011_c.book Page 125 Wednesday, April 3, 2002 5:06 PM Pump alarms 125 PPC not initialized If the PPC is not initialized to a Pump, the following message is dis-
played:
PPC Display PPC NOT INITIALIZED Type of Alarm 1 When successfully completing a PPC initialization, the following mes-
sage is displayed:
PPC Display PUMP INITIALIZED Type of Alarm 1 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 CHECK PUMP STATUS Type of Alarm 1 The user should reposition the PPC near the Pump, and then press SEL and ACT. The PPC will communicate with the Pump. NOTE: If while programming the PPC, the screen goes blank, the PPC beeps six times and then the CHECK PUMP STATUS message appears, the battery needs to be replaced. (See Chapter 3 for instructions, Install/Replace the Main Battery.) Dmp9196021-011_c.book Page 126 Wednesday, April 3, 2002 5:06 PM 126 System Alarms and Messages Initialize to factory defaults When the Pump is reinitialized to its factory default settings, the follow-
ing message is displayed:
PPC Display PUMP RESET Type of Alarm 1 Pump stopped If the Pump is intentionally stopped, the following message is displayed:
PPC Display PUMP STOPPED Type of Alarm 2 To restart the Pump, press SEL and ACT, and then place the PPC near the Pump and allow the communication to complete. The Pump can only be stopped in the Supervisor Mode. Pump suspended If the Pump operation has been suspended, the following message is dis-
played:
PPC Display PUMP SUSPENDED Type of Alarm 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 com-
plete. Dmp9196021-011_c.book Page 127 Wednesday, April 3, 2002 5:06 PM Pump alarms 127 Auto off If the AUTO OFF time interval elapses in the Pump, and the PPC rec-
ognizes this condition, the following message is displayed:
PPC Display AUTO OFF PUMP PUMP SUSPENDED Type of Alarm 1 Press SEL and ACT, and then place the PPC near the Pump and allow the communication to complete. The PPC then communicates with the Pump to reset the AUTO OFF duration. If five more minutes elapse, the Pump will initiate the internal alarm sequence of a beep every 15 seconds for 10 minutes, then double-beeps every 15 seconds for 10 minutes, then repeating the pattern. The alarm is cleared by pressing SEL and ACT. Hourly maximum exceeded Attempting to deliver more than 2.5 times the pre-programmed bolus maximum in one hour, causes the following message to be displayed:
PPC Display HOURLY MAX EXCEEDED Type of Alarm 1 Press SEL and ACT, and then place the PPC near the Pump and allow the communication to complete. The patient may exceed the pre-programmed bolus limit by programming another bolus within 10 minutes. Dmp9196021-011_c.book Page 128 Wednesday, April 3, 2002 5:06 PM 128 System Alarms and Messages Pump alarm table Alarm Condition AUTO OFF CHECK PUMP STATUS EMPTY RESERVOIR HOURLY MAX EXCEEDED LOW RESERVOIR PPC DEPLETED BATTERY PPC NEEDS SERVICING PPC LOW BATTERY PPC NOT INITIALIZED PUMP INITIALIZED PUMP LOW BATTERY PUMP RESET PUMP SELF TEST FAIL PUMP ERROR 0 or 1 PUMP ERROR 40 or 41 PUMP STOPPED 1 or 2 or 3 or 4 or 5 or 6 Type of Alarm Pump Communications 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 YES YES YES NO YES NO NO NO YES NO YES NO NO NO NO YES Dmp9196021-011_c.book Page 129 Wednesday, April 3, 2002 5:06 PM Pump alarms 129 PUMP SUSPENDED PUMP STOPPED TELEMETRY COMM ERROR TELEMETRY COMM ERROR 20 2 2 1 1 YES YES YES NO Dmp9196021-011_c.book Page 130 Wednesday, April 3, 2002 5:06 PM 130 System Alarms and Messages Dmp9196021-011_c.book Page 131 Wednesday, April 3, 2002 5:06 PM 131 CHAPTER 10 Troubleshooting Pump System Under-delivery Potential under-delivery of insulin by the Medtronic MiniMed 2007C Implantable Insulin Pump System may result in an increase in daily pro-
grammed 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 solu-
tions to correct for under-delivery. Diagnostic procedures When refill procedures reveal the possibility of a Pump System under-
delivery problem, diagnostic procedures must be performed to verify if there is a problem with either the Pump or Catheter. The Stroke Volume Measurement Procedure tests Pump function, while the Pressure Mea-
surement Procedure tests Catheter patency. These diagnostic procedures should be performed according to the steps outlined in Appendix G and Appendix H, respectively. Under-delivery caused by backflow Backflow results in the inverted flow of insulin through the Pump Sys-
tem. Backflow is caused by insulin deposits that compromise valve integ-
rity, and allow the negative reservoir pressure (vacuum) to pull insulin back into the reservoir. To compensate for this under-delivery, the user can program appropriate increases in their basal rates and bolus amounts. Dmp9196021-011_c.book Page 132 Wednesday, April 3, 2002 5:06 PM 132 Troubleshooting Pump System Under-delivery Backflow conditions are characterized by increases in daily programmed insulin usage, difficulty in maintaining euglycemia, increasingly negative refill accuracy and sometimes hyperglycemia. Conform a backflow con-
dition by performing the Stroke Volume Measurement Procedure. Then rinse the Pump System with NaOH solution to dissolve insulin deposits, following the Pump Rinse Procedure outlined in Appendix E. 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 per-
forming 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. If the Flush Procedure is unsuccessful, replace the Catheter. Catheter replacement surgery should be performed in a manner similar to the initial Pump System implantation. PPC initialization will not be nec-
essary. However, after the Catheter replacement, Pump function and delivery verifications must be performed. Dmp9196021-011_c.book Page 133 Wednesday, April 3, 2002 5:06 PM 133 CHAPTER 11 Medtronic MiniMed 2007C Implantable Insulin Pump System Implantable Insulin Pump MMT-2007C Diameter Thickness Reservoir Volume Weight - Empty Insulin - Concentration Stroke Volume Basal Rate Basal Patterns Meal Bolus Bolus Duration Temporary Basal Rate Diagnostic Rate Power Supply Battery life 8.1 cm (3.2 inches) 2.0 cm (0.8 inches) 13 ml to 15 ml 131 gm (4.6 ounces) Aventis HOE 21 PH U-400 0.42 to 0.58 ml per stroke 0.17 to 0.23 units per stroke 0.2 to 35.0 units per hour (U/h) 3 patterns of up to 48 basal rates each. 0.2 to 25.0 units Immediate, Square Wave (30 minutes to 4 hours), or both together. Audio Bolus 0.2 to 35.0 units per hour 30 minute increment duration 30 minutes up to 24 hours delay 10 to 150 U/h Lithium - Carbon Monofluoride Bat-
tery See Figure 1 Dmp9196021-011_c.book Page 134 Wednesday, April 3, 2002 5:06 PM 134 Medtronic MiniMed 2007C Implantable Insulin Pump System Audio Alarms Safety Features Materials in contact with tissue Low Battery Nearly Depleted Battery System Error Negative Pressure Reservoir with Passive Filling Pump Shutdown and Alarm with Sys-
tem Error (unique code sequences) Titanium, Silicone Rubber Personal pump communicator (PPC) model MMT-3150 Height Length Width Weight Main Power Source Main Battery Life Backup Battery Backup Battery Life Operating Temperature 8.9 cm (3.5 inches) 7.0 cm (2.8 inches) 2.0 cm (0.8 inches) 115 gm (4.0 ounces) 1.5 Volt Alkaline Battery Type AA 6-8 weeks Lithium Battery 3 years minimum with no AA battery installed 0C to 40C (32F to 104F) Dmp9196021-011_c.book Page 135 Wednesday, April 3, 2002 5:06 PM Storage Temperature Messages Side Port Catheter MMT- 4027A Length MMT- 4028A Length Material Sideport 135 0C to 30C ( 32F to 86F) Auto Off in 5 min / Auto Off Pump Suspended Check Pump Status Communication Error Download Complete Empty Reservoir Hourly Maximum Exceeded Low Reservoir PPC Not initialized PPC Needs Servicing PPC Low Battery PPC Depleted Battery Pump Self Test Fail Pump Reset Pump Stopped Pump Version Error Telemetry Communication Error 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 Polyethylene-lined Silicone Rubber Polysulfone, Silicone Septum Dmp9196021-011_c.book Page 136 Wednesday, April 3, 2002 5:06 PM 136 Medtronic MiniMed 2007C Implantable Insulin Pump System This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Operation of this device is authorized by the FCC under the FCC ID OH22007C (Implantable Pump) and OH23150 (PPC). Any changes or modifications to the system not expressly approved by MiniMed could void the users authority to operate the system. Average Pump Service Life vs. Daily Insulin Delivery
(U-400 Insulin Delivered After 6 Month Shelf Life)
) s r a e Y
(
e f i L p m u P 14 13 12 11 10 9 8 7 0 10 20 50 40 30 70 Daily Insulin Delivery (Units) 60 80 90 100 Figure 15: Average Pump Battery Life Dmp9196021-011_c.book Page 137 Wednesday, April 3, 2002 5:06 PM APPENDIX A Label Information 137 Symbol dictionary 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) Reference / Record Number (reorder number) Device Serial Number REF MMT-XXXX SN Dmp9196021-011_c.book Page 138 Wednesday, April 3, 2002 5:06 PM 138 IEC Icon indicating equipment provid-
ing a particular degree of protection against electric shock (Type B) CE Marking/Notified Body Authoriza-
tion 0459 0168 Packaging The icon on each label indicates the contents of the package. The number with the icon is the quantity. MiniMed 2007C Implantable Insulin Pump MiniMed 3150 Personal Pump Communicator Dmp9196021-011_c.book Page 139 Wednesday, April 3, 2002 5:06 PM 139 MiniMed 4024A and 4027A Side Port Catheter MiniMed 4105 Refill Kit MiniMed 4102 Refill Needles Dmp9196021-011_c.book Page 140 Wednesday, April 3, 2002 5:06 PM 140 Other Information Manufactured by:Medtronic MiniMed Distributed in the United States by:Medtronic MiniMed Inc. Distributed in Europe by:Medtronic MiniMed S.A. - Paris, France CE Marking:
Notified Body:GMED - France Notified Body Authorizations:0459, 0168 Year of Initial CE Authorization:2000 Dmp9196021-011_c.book Page 141 Wednesday, April 3, 2002 5:06 PM APPENDIX B Implant Worksheet 141 Implant worksheet form Please refer to Implant Worksheet attached. B a s a l r a t e p r o g r a m m e d w i t h P P C
:
_ _ _ _ _ _ _ _ U
/
h M a x i m u m s
(
l o c k e d
/
u n l o c k e d
)
:
_ _ _ _ _ _ A l a r m f e e d b a c k
"
O N
"
:
_ _ M a x m e a l b o l u s
:
_ _ _ _ _ _ _ _ U M a x b a s a l r a t e
:
_ _ _ _ _ _ _ _ _ _ _ _ U
/
h P a t i e n t C o m m u n i c a t o r I D
:
_ _ _ _ _ _ _ _ S u p e r v i s o r C o d e
:
_ _ _ _ _ _ _ _ _ P P C L a b e l
:
C a t h e t e r L a b e l
:
C o m m u n i c a t o r
-
s e t t i n g s
:
I n s u l i n L o t N u m b e r
:
_ _ _ _ _ _ _ _ _ P u m p L a b e l
:
P a t i e n t n a m e
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D a t e
:
_ _ _ _ _ _ _ _ _ _ C e n t e r
:
_ _ _ _ _ _ _ _ _ P a t i e n t C o d e
:
_ _ _ _ _ _ _ _ _ _ _ _ i i M n M e d I m p l a n t W o r k s h e e t D m p 9 1 9 6 0 2 1
-
0 1 1 _ c
. b o o k P a g e 1 4 2 W e d n e s d a y
, A p r i l 3
, 2 0 0 2 5
:
0 6 P M C o m p l i c a t i o n s
:
P u m p o r i e n t a t i o n
:
V e r i f i c a t i o n o f t h e d e l i v e r y f r o m t h e c a t h e t e r t i p
:
y e s
/
n o C a t h e t e r t y p e
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ P u m p t y p e
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ C a t h e t e r f i x a t i o n
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ P u m p f i x a t i o n
:
_ _ _ _ _ _ _ _ _ _ A n e s t h e s i a
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ P o c k e t d e p t h
:
_ _ _ _ _ _ _ _ _ c m D a t e
:
_ _ _ _ _ _ _ _ _ _ _ _ _ S u r g e o n n a m e
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ C a l c u l a t e d s t r o k e v o l u m e
:
c
) c a l c u l a t e d s t r o k e v o l u m e
(
b
/
a
)
:
_ _ _ _ _ _ _ _ _ _ b
) t o t a l v o l u m e d e l i v e r e d
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ a
) n u m b e r o f s t r o k e s d e l i v e r e d
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ V e r i f i c a t i o n o f a l a r m f e e d b a c k
:
y e s
/
n o i T m e d e l i v e r y s t a r t e d
, p r i m i n g b o l u s
:
_ _ _ _ _ _ _ _ _ _ _ _ _ T o t a l a m o u n t p l a c e d i n t h e r e s e r v o i r
(
1
-
2
)
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g i n g 2 m l f r o m t h e p u m p
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
2
) W e i g h t o f f u l l
"
I N 2
"
s y r i n g e a f t e r f i l l i n g t h e r e s e r v o i r a n d r e m o v
-
W r e s e r v o i r
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
1
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"
I N 2
"
s y r i n g e b e f o r e f i l l i n g t h e 1 4 2 Dmp9196021-011_c.book Page 143 Wednesday, April 3, 2002 5:06 PM APPENDIX C Refill Form 143 Pump refill data Please refer to Refill Data Form attached.
*
C o r r e c t e d f o r d e n s i t y o f i n s u l i n
=
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
E
)
=
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
-
(
A
) _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
-
(
D
) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g A m o u n t w i t h d r a w n R e f i l l A m o u n t
(
B
) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
C
) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g W e i g h t o f
"
I N
"
a f t e r p u m p f i l l e d a n d 2 m l w i t h d r a w n
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
D
) W e i g h t o f f i l l e d
"
I N
"
s y r i n g e
:
_ _ _ _ _ _ _ _ _ _ _ _ _ g
(
C
) D
/
M
/
Y S c h e d u l e n e x t r e f i l l v i s i t
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ E s t i m a t e d r e f i l l p e r i o d
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D a y s P e r c e n t a g e d i f f e r e n c e
:
R e f i l l a c c u r a c y
(
l i n e 5
/
l i n e 4
, t h e n x 1 0 0
)
:
_ _ _ _ _ _ _ _
%
A v e r a g e d a i l y i n s u l i n u s e
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ U
/
d U s a b l e u n i t s o f i n s u l i n
(
G x 3 8 4
. 6
)
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ U D i f f e r e n c e b e t w e e n a c t u a l a n d t h e o r e t i c a l a m o u n t u s e d
(
l i n e 4
-
l i n e 3
)
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
5
)
(
l i n e 1
-
r e m a i n i n g d o s e f r o m P P C
(
F
) T h e o r e t i c a l a m o u n t u s e d
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
4
) A c t u a l a m o u n t u s e d
(
l i n e 1
-
l i n e 2
)
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
3
) R e s i d u a l a m o u n t w i t h d r a w n
(
E
)
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
2
) P r e v i o u s r e f i l l a m o u n t
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
1
) W e i g h t o f
"
R B
"
s y r i n g e a f t e r i n s u l i n w i t h d r a w n
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ g
(
B
) R i n s e B u f f e r
"
R B
"
_ _ _ _ _ _ _ _ D m p 9 1 9 6 0 2 1
-
0 1 1 _ c
. b o o k P a g e 1 4 4 W e d n e s d a y
, A p r i l 3
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:
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"
R B
"
s y r i n g e
:
_ _ _ _ _ _ _ _ _ _ _ _ _ g
(
A
) I n s u l i n
"
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"
_ _ _ _ _ _ _ B e f o r e t h e r e f i l l
:
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/
3 8 4
. 6
=
_ _ _ _ _ _ _ _ _ g
(
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*
D a t e
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D a t a
:
C e n t e r
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ P h y s i c i a n n a m e
:
_ _ _ _ _ _ _ _ _ _ _ _ I n s u l i n r e m a i n i n g f r o m P P C
:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
(
F
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:
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ P a t i e n t c o d e
:
_ _ _ _ _ _ _ _ i i M n M e d R e f i l l W o r k s h e e t 1 4 4
1 | Physician Part4 | Users Manual | 2.58 MiB | February 05 2002 |
Dmp9196021-011_c.book Page 145 Wednesday, April 3, 2002 5:07 PM 145 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 contribut-
ing factor to aggregation of insulin. Proper degassing of all solutions that enter the Pump is essential. Read the insert in the syringe packag-
ing about the degassing procedure. 3. When using the refill kit, never release the syringe-locking ring while there is a vacuum within the refill syringe. The plunger of the syringe will snap back forcefully and may rupture the syringe and eject the contents. 4. It is important that the syringe needle is perpendicular to the fill port to prevent binding when entering or exiting. 5. The Side Port Catheter attachment site contains up to 20 units of INSULIN. The distal portion of the Catheter and the tubing can con-
tain up to 13 units of INSULIN. However, the INSULIN in the Pump fluid pathway and the side port receptacle can be cleared by following the procedure to pull RINSE BUFFER through the side port. During Dmp9196021-011_c.book Page 146 Wednesday, April 3, 2002 5:07 PM 146 a flush procedure to push out a catheter tip blockage, the 13 units in the distal catheter will be delivered to the patient. The 13 units can be managed by programming cautions bolus amounts prior to the proce-
dure, or with the use of oral or IV glucose as needed during the proce-
dure. Individual patient response to INSULIN bolus amounts must be considered. 6. Patient blood glucose monitoring must be performed during, and up to one hour after the procedure. Oral and intravenous glucose should be available for glycemic management. 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. When the MiniMed refill needle is properly seated in the fill port, the vacuum in the reser-
voir will draw the fluid from the syringe. 9. Each step of the procedure will list the syringes and appropriate fluids needed for that step. It is suggested that the syringes be prepared and labeled prior to the start of the procedure. 10. The Side Port Catheter is intended to be accessed only during the implant procedure, the combined rinse/flush procedure, the catheter flush procedure, and for diagnostic procedures. The catheter is not intended to provide access to the peritoneum for bolus injections of fluids or for withdrawal of body fluids. General procedures Before beginning any of the procedures, be sure you are familiar with the general techniques for locating the Pump fill port and the Side Port Cath-
eter, accessing the Pump inlet, venting the refill syringe, and preparing the syringes. Dmp9196021-011_c.book Page 147 Wednesday, April 3, 2002 5:07 PM Special note and precautions 147 Locating the pump fill port and the side port Figure 16: Template and Placement on Skin with Guide Needles in Position 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. Then insert an 18 gauge needle into the central Pump fill port as shown in below:
3. To locate the side port, palpate around the circumference of the Pump. It is helpful to grasp the side port between the thumb and index finger when aligning the template. 4. Using the template as a guide, insert the second 18 gauge needle into the side port as shown. The side port can be accessed by inserting the guide needle just inside the outer edge of the side port connection. Dmp9196021-011_c.book Page 148 Wednesday, April 3, 2002 5:07 PM 148 This outer edge is raised around the outer aspect of the side port, in order to help guide the needle into the port. Accessing the pump inlet To enter the Pump fill port or the side port, make sure the refill syringe stopcock is closed, then pass the MiniMed refill needle (MMT- 4102) through the 18 gauge guide needle. Pull back slightly (approximately 2 mm) on the guide needle to allow the 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. After passing through the septum and seating in the valve, you can feel the increased force, about 0.5 pounds, required to move the valve 0.5 mil-
limeter to open. Maintain this downward pressure in the pump fill port to ensure that the inlet valve remains open. In the case of the side port, a downward pressure is not required after the needle is completely inserted. Figure 17: Inlet Valve Dmp9196021-011_c.book Page 149 Wednesday, April 3, 2002 5:07 PM Special note and precautions 149 Venting the Minimed refill syringe (optional) In order to fill the Pump, it may be necessary to vent the headspace in the 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. Vent the syringe headspace by pulling back firmly on the plunger until the second sealing ring on the rubber cap passes beyond the vent hole as shown in Figure 18. Figure 18: Venting the Refill Syringe Dmp9196021-011_c.book Page 150 Wednesday, April 3, 2002 5:07 PM 150 NOTE: Be sure that the plunger is retracted far enough that the vent hole is exposed. The syringe must be held with the needle facing down and used within 10 minutes once it is vented. If this time limit is exceeded, repeat the degassing procedure. Dmp9196021-011_c.book Page 151 Wednesday, April 3, 2002 5:07 PM APPENDIX E Pump Rinse Procedure 151 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 - 0.01 gram resolution One (1) 250 ml sterile beaker One (1) sterile bag for PPC (intestinal or cassette bags work well) One (1) Side port locating template, MMT-4106 Seven (7) Refill kits, MMT-4105 Dmp9196021-011_c.book Page 152 Wednesday, April 3, 2002 5:07 PM 152 Seven (7) MiniMed MMT-4102 refill needles. (Extra needles should be available to use as needed) Eight (8) sharp 18 gauge regular bevel needles Solutions 50 mLs sterile 0.1 M NaOH (0.4 grams NaOH per 100 ml of Sterile water for injection) Seven (7) 10 ml vials, Aventis rinse buffer solution Five (5) 10 ml vials, Aventis HOE 21 PH, U-400 Insulin The 0.1 M of NaOH used in this proce-
dure can cause permanent eye dam-
age. Safety glasses must be worn during this procedure. WARNING
!
Dmp9196021-011_c.book Page 153 Wednesday, April 3, 2002 5:07 PM 153 Preparing for the procedure NOTE: Before beginning any refill, flush, stroke volume measurement, carefully read Appendix D, Precau-
tions 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 dif-
ferent solutions. Table 1 defines the syringe numbers and corresponding solutions:
Syringe #
Syringe Type Refill Refill Refill Refill Refill Refill Refill Volume 5 ml 20 ml 30 ml 20 ml 30 ml 20 ml 30 ml Solution RINSE BUFFER NaOH NaOH RINSE BUFFER RINSE BUFFER INSULIN INSULIN Prepare syringes for emptying the Pump Syringe 1 is used for emptying the Pump. Label and prepare syringe 1 per Table 1. Prepare syringes for filling the Pump During the Catheter rinse/flush procedure, syringes 2, 3, 4, 5, 6, and 7 are used for filling the Pump. Each of these syringes needs to be labeled with its solution and syringe number, and then filled and degassed per Table 1. 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. Dmp9196021-011_c.book Page 154 Wednesday, April 3, 2002 5:07 PM 154 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 1. Prime the needle. Weigh the syringe and record the weight on the refill form (Line A). 2. Close the stopcock. 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 Pump with the refill needle. 4. Open the stopcock; withdraw the INSULIN. After the INSULIN appears to have stopped rising in the syringe, wait an additional 30 seconds to make sure all of the INSULIN and air is removed. NOTE: Air in the Pump System has been shown to be a significant contributing factor to aggregation of INSULIN. Proper degassing of all solutions that enter the Pump is essential. 5. When the 30 second time has elapsed, close the stopcock, remove the syringe. Weigh the syringe and record the weight on the refill form. Discard the INSULIN in the syringe except for a 5 ml barrier. This syringe will be used to pull NaOH through the side port. Attach and prime a new refill needle. Dmp9196021-011_c.book Page 155 Wednesday, April 3, 2002 5:07 PM 155 WARNING
!
The 0.1 M NaOH used in this procedure can cause permanent eye damage. Safety glasses must be worn during this proce-
dure. Syringe 2: NaOH 6. Prime the needle. Close the stopcock 7. Enter the Pump with the refill needle. 8. Open the stopcock and allow the Pump to fill completely with NaOH. When the fluid level stops moving, the Pump is filled. 9. Close the stopcock. Remove the syringe. 10. Prepare syringe 2 for aspiration. Remove the air from the syringe. Close stopcock and 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. 11. Re-enter the Pump. 12. Open the stopcock and remove the NaOH. After the fluid level stops moving, wait an additional 30 seconds for all the NaOH to be removed. 13. When the time has elapsed, close the stopcock and remove the syringe. Discard syringe 2. Dmp9196021-011_c.book Page 156 Wednesday, April 3, 2002 5:07 PM 156 Syringe 3:NaOH (degassed) 14. Prime the needle. Close the stopcock. 15. Enter the Pump fill port with the refill needle. 16. Open the stopcock and allow the Pump to fill completely with NaOH. When the Pump is filled, approximately 10 ml will remain in the syringe. Leave this NaOH in the syringe, and leave this syringe in place for the next step. 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 pro-
cedure 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 . 2. Prime the needle. Close the stopcock . 3. 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. 4. Enter the side port with the stopcock closed. 5. Open the stopcock. 6. Program and deliver a 4 unit bolus to open the valve in the Pump mechanism. 7. Observe syringe 3. When the level of the NaOH approaches 2 ml, close the stopcock to prevent air from entering the Pump. Observe syringe 1. At least 1 ml of NaOH must pass into syringe 1 in order to thoroughly clean the Pump mechanism. If less than 1 ml enters, repeat Dmp9196021-011_c.book Page 157 Wednesday, April 3, 2002 5:07 PM 157 the bolus from Step 6, some pumps may require 3 successive bolus to obtain 1 ml. NOTE: In order to completely dissolve deposits in the Pump mechanism, it is important to maintain a vacuum with syringe 1 and deliver the entire bolus. 8. After the bolus, close the stopcock on syringe 1. Remove both syringes. Set aside syringe 3 for use in removing the NaOH from the Pump fill port in the next step. Discard syringe 1. 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 the 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. Press the lock into the plunger groove to be sure it is firmly secured. 3. Enter the Pump with the refill needle. 4. Open the stopcock and withdraw all the NaOH. After the NaOH appears to have stopped rising in the syringe, wait an additional 30 seconds to make sure all the NaOH and air is removed. 5. When the time has elapsed, close the stopcock, remove the syringe, and discard. Dmp9196021-011_c.book Page 158 Wednesday, April 3, 2002 5:07 PM 158 Syringe 4: Rinse Buffer degassed) 6. Prime the needle. Close the stopcock. 7. Enter the Pump with the refill needle and syringe. 8. Open the stopcock and allow the Pump to fill completely with RINSE BUFFER. When the fluid level stops moving, the Pump is filled. 9. Close the stopcock. Remove the syringe. 10. Prepare syringe 4 for aspiration. 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. 11. Re-enter the Pump. 12. Open the stopcock and remove the RINSE BUFFER. After the fluid level stops moving, wait an additional 30 seconds for all the RINSE BUFFER and air to be removed. 13. When the time has elapsed, close the stopcock and remove the syringe and set aside. Syringe 5: Rinse Buffer (degassed) 14. Prime the needle. Close the stopcock. 15. Enter the Pump fill port with the refill needle. 16. 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. Leave the RINSE BUFFER in the syringe and leave the syringe in place for the next step. Dmp9196021-011_c.book Page 159 Wednesday, April 3, 2002 5:07 PM 159 Equilibrate and pull rinse buffer through system The reservoir pressure in the Pump is equilibrated with outside ambient pressure and RINSE BUFFER is pulled through the fluid system. This procedure uses the following volumes in syringes 4 and 5:
Syringe 4 with RINSE BUFFER. Expel all RINSE BUFFER except 5 ml. Change refill needle if desired. Syringe 5 with residual RINSE BUFFER from previous step Syringe 5: Rinse Buffer 1. Verify that the stopcock on syringe 5 is open. 2. Prime the needle of syringe 4. Close the stopcock. 3. 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. 4. Enter the side port with the stopcock closed. 5. Open the stopcock. 6. To open the valve in the Pump mechanism, program and deliver a 4 unit bolus using the PPC. 7. Observe syringe 4. When at least 1 ml of RINSE BUFFER has entered syringe 4, close both stopcocks and remove the syringes. If less than 1 ml enters, repeat the bolus from Step 6. Some Pumps may require 3 successive 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 vol-
umes in syringes 5, 7, and 8:
Syringe 5 with residual RINSE BUFFER from the previous steps Syringe 6 with 20 ml INSULIN Dmp9196021-011_c.book Page 160 Wednesday, April 3, 2002 5:07 PM 160 Syringe 7 with 30 ml INSULIN Syringe 5: Rinse Buffer (residual) 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 Pump with the refill needle and syringe. 4. Open the stopcock and remove the RINSE BUFFER. After the fluid level stops moving, wait an additional 30 seconds to make sure all the RINSE BUFFER and air is removed. 5. When the time has elapsed, close the stopcock, remove the syringe, and discard. Syringe 6: Insulin (degassed) 6. Prime the needle. Close the stopcock . 7. Enter the Pump fill port with the refill needle and syringe. 8. Open the stopcock and allow the Pump to fill completely with INSU-
LIN. When the fluid level stops moving, the Pump is filled. 9. Close the stopcock and remove the syringe. 10. Prepare syringe 6 for aspiration. Prime needle and close stopcock. 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. 11. Re-enter the Pump. 12. 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. 13. When the time has elapsed, close the stopcock and remove the syringe. Discard all but 5 ml of solution. Remove any air, prime nee-
Dmp9196021-011_c.book Page 161 Wednesday, April 3, 2002 5:07 PM 161 dle and close stopcock. Set aside the syringe. Syringe 7: Insulin (degassed) 14. Prime the needle on syringe 7. Weigh and record the combined weight of syringes 6 and 7 on the Refill Form. 15. Close the stopcock. Enter the Pump fill port with the refill needle. 16. Open the stopcock and allow the Pump to fill completely with INSU-
LIN. When the fluid level stops moving, the pump is filled. When the Pump is filled, approximately 10 ml of INSULIN will remain in the syringe. Leave the syringe in place for the next step. 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 6: Insulin (residual) Syringe 7: Insulin (residual) 1. Maintain syringe 7 with approximately 10 ml of residual INSULIN in the Pump fill port. Verify that the stopcock on syringe 7 is open. 2. Prime the syringe 6 needle. Close the stopcock. 3. Obtain a vacuum in syringe 6 by pulling back on the plunger until it locks. Press the lock into the plunger groove to be sure it is firmly secured. 4. Enter the side port with syringe 6 - stopcock closed. 5. Open the stopcock on syringe 6. Dmp9196021-011_c.book Page 162 Wednesday, April 3, 2002 5:07 PM 162 6. Using the PPC, program and deliver a 4 unit bolus. 7. Observe syringe 7. If the level of INSULIN approaches 2 ml, close the stopcock to prevent air from entering the Pump. Observe syringe 6. At least 1 ml of INSULIN must pass into syringe 6 to assure removal of all the RINSE BUFFER from the side port. If less than 1 ml enters, repeat the bolus from Step 6, some Pumps may require 3 successive boluses to obtain 1 ml. 8. Close both stopcocks. Remove syringe 7 from the Pump. Set aside the syringe to be weighed. 9. With the stopcock closed, remove syringe 6 from the side port. Syringe 6 will have a vacuum from the previous step. Enter the Pump fill port with syringe 6 and open the stopcock to remove 2 ml. This will restore the negative pressure safety feature of the Pump. 10. Close the stopcock, remove syringe 6 from the Pump, and set it aside to be weighed. 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. Record the extracted and new refill amounts in the PPC. Program new basal rate Using the patients PPC, cancel the SUSPEND mode, to return to the nor-
mal patients basal rate and modify if needed. Dmp9196021-011_c.book Page 163 Wednesday, April 3, 2002 5:07 PM 163 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. 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 - 0.01 gram resolution One (1) 250 mL sterile beaker One (1) sterile bag for PPC (intestinal or cassette bags work well) One (1) Side port locating template, MMT-4106 Five (5) Refill kits, MMT-4105 Six (6) MiniMed MMT-4102 refill needles. (Extra needles Dmp9196021-011_c.book Page 164 Wednesday, April 3, 2002 5:07 PM 164 should be available to use as needed) Eight (8) sharp 18 gauge regular bevel needles One (1) 10 or 20 mL Luer Lock syringe One (1) stopcock - 2 way Solutions Seven (7) 10 mL vials, Aventis rinse buffer solution Five (5) 10 mL vials, aventis HOE 21 PH, 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, Precau-
tions 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 five different refill syringes and one 10 or 20 ml syringe will need to be labeled and prepared with different solutions. Table 2 defines the syringe numbers and corresponding solutions. Dmp9196021-011_c.book Page 165 Wednesday, April 3, 2002 5:07 PM 165 Table 2: Preparation and Labeling of Syringes Syringe #
#1 Syringe Type Refill Volume 5 mL
#2
#3
#4
#5
#6 Refill Refill 20 mL 30 mL 10ml or 20 ml 5-10 mL Refill Refill 20 mL 30 mL Solution RINSE BUFFER RINSE BUFFER RINSE BUFFER RINSE BUFFER INSULIN INSULIN Record patients blood glucose Record the patients blood glucose value at the start of the procedure. Monitor blood glucose every 30 minutes, or as needed. Prepare syringes for emptying the Pump Syringe 1 is used for emptying the Pump. Label and prepare syringe 1 per Table 2. Special attention should be observed regarding the Precautions and General Procedures section in Appendix D of this manual. 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 rinse/flush procedure, syringes 2, 3, 5, and 6 are used for filling the Pump. Each syringe should be labeled with its solution and syringe number, then filled and degassed per Table 2 and the General Pro-
cedures section in Appendix D of this manual. Dmp9196021-011_c.book Page 166 Wednesday, April 3, 2002 5:07 PM 166 Prepare syringe for flushing the Side Port Catheter During the Catheter flush procedure, syringe 4 is used for flushing the Side Port Catheter. This syringe needs to be labeled and then prepared by following the steps below:
1. Firmly attach a stopcock to the 10 or 20 ml Luer Lock connector of a 10 or 20 ml syringe. Then attach an 18 gauge needle to the stopcock. NOTE: Use only a 10-20 ml Luer Lock syringe for this the procedure. Smaller syringes will damage Catheter or Pump. 2. Draw 5-10 mL of RINSE BUFFER into the syringe. 3. Expel all air from the syringe. 4. Close the stopcock and remove the 18 gauge needle from the syringe. 5. Fill the hub of the MiniMed refill needle with RINSE BUFFER from the syringe and attach it to the syringe. 6. Prime the MiniMed refill needle completely. 7. Close the stopcock. 8. Set the syringe aside. Dmp9196021-011_c.book Page 167 Wednesday, April 3, 2002 5:07 PM 167 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 3: Rinse Buffer (residual) 1. Prime the needle and close the stopcock. Weigh the syringe. 2. 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. 3. Enter the Pump with the refill needle. 4. Open the stopcock and withdraw the INSULIN. After the INSULIN appears to have stopped rising in the syringe, wait an additional 30 seconds to make sure all of the INSULIN and air are removed. NOTE: Air in the Pump System has been shown to be a significant agonist to aggregation of INSULIN. Proper degassing of all solutions that enter the Pump is essential. 5. When the time has elapsed, close the stopcock, remove the syringe. Weigh the syringe and record the weight on the Refill Form. Dmp9196021-011_c.book Page 168 Wednesday, April 3, 2002 5:07 PM 168 Syringe 5: Insulin 6. Prime the needle and close the stopcock. 7. Enter the Pump with the refill needle. 8. Open the stopcock and allow the Pump to fill completely with RINSE BUFFER. When the fluid level stops moving, the Pump is filled. 9. Close the stopcock and remove the syringe. 10. 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. 11. Re-enter the Pump. 12. Open the stopcock and remove the RINSE BUFFER. After the fluid level stops moving, wait an additional 30 seconds for all the RINSE BUFFER and air to be removed. 13. When the time has elapsed, close the stopcock and remove the syringe. Syringe 3: Rinse Buffer 14. Prime the needle and close the stopcock . 15. Enter the Pump fill port with the refill needle. 16. Open the stopcock and allow the Pump to fill complete 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. Leave the RINSE BUFFER in the syringe, and leave the syringe in place for the next step. Dmp9196021-011_c.book Page 169 Wednesday, April 3, 2002 5:07 PM Equilibrate and pull rinse buffer through system 169 The reservoir pressure in the Pump is equilibrated with outside ambient pressure and RINSE BUFFER is pulled through the fluid system. This procedure uses syringes 2 and 3:
Syringe 2 with RINSE BUFFER. Expel all RINSE BUFFER except 5 mL. Change the refill needle if desired. Syringe 3 with residual RINSE BUFFER from the previous sec-
tion. Syringe 3: Rinse Buffer 1. Maintain syringe 3 with approximately 10 mL of RINSE BUFFER in the Pump fill port. Verify that the stopcock on syringe 3 is open. Syringe 2: Rinse Buffer (residual) 2. Prime the needle. Close the stopcock. 3. 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. 4. Enter the side port with the stopcock closed. 5. Open the stopcock. 6. Program and deliver a 4 unit bolus to open the valve in the Pump mechanism. 7. 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. When at least 1 mL of RINSE BUFFER has entered syringe 2 close both stopcocks and remove the syringes. If less than 1 ml enters, repeat the bolus from Step 6, some Pumps may require 3 successive boluses to obtain 1 ml. Discard syringe 2 and set aside syringe 3 to be used later to remove the RINSE BUFFER. Dmp9196021-011_c.book Page 170 Wednesday, April 3, 2002 5:07 PM 170 Flush side port catheter The Side Port Catheter is flushed using syringe 4 which is completely filled with RINSE BUFFER. NOTE: Approximately 13 units of INSULIN remain in the distal Side Port Catheter. This INSULIN will be delivered to the patient rapidly in the next three steps. Alternatively, the INSULIN may be removed prior to flushing by programming cautious bolus amounts. Closely monitor blood glucose during INSULIN delivery, and administer intravenous glucose, or glucagon as needed. 10-20 ml Syringe 4: Rinse Buffer 1. Prime the needle. Close the stopcock. 2. Enter the side port with the needle. 3. When the needle is firmly positioned in the side port, open the stop-
cock and quickly push the plunger all the way down. This should take no longer than one to two minutes. 4. After flushing, close the stopcock, remove and discard the syringe. 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 form 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 Dmp9196021-011_c.book Page 171 Wednesday, April 3, 2002 5:07 PM 171 Syringe 3: Rinse Buffer (residual) 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 and be sure it is firmly secured. 3. Enter the Pump with the refill needle and syringe. 4. Open the stopcock and remove the rinse buffer. After the fluid level stops moving, wait an additional 30 seconds to make sure all of the RINSE BUFFER and air is removed. 5. When the time has elapsed, close the stopcock, remove the syringe, and discard it. Syringe 5: Insulin 6. Prime the needle and close the stopcock. 7. Enter the Pump fill port with the refill needle. 8. Open the stopcock and allow the Pump to fill completely with INSU-
LIN. When the fluid level stops moving, the Pump is filled. 9. Close the stopcock and remove the syringe. 10. Prepare syringe 6 for aspiration. 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. 11. Re-enter the Pump. 12. 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. 13. 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. Dmp9196021-011_c.book Page 172 Wednesday, April 3, 2002 5:07 PM 172 Syringe 6: Insulin 14. Weigh and record the combined weight of syringes 5 and 6 on the Refill Form. Prime the needles. 15. Close the stopcock. Enter the Pump fill port with the refill needle. 16. Open the stopcock and allow the Pump to fill completely with INSU-
LIN. When the fluid level stops moving, the Pump is filled. Approx-
imately 10 mL of INSULIN will remain in the syringe. Leave the syringe in place for the next step. 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 5 and 6:
Syringe 6 with residual INSULIN from the previous step Syringe 5 with 5 mL solution Syringe 6: Insulin (residual) Syringe 5: Solution 1. Maintain syringe 6 with approximately 10 mL of residual insulin in the Pump fill port. Verify that the stopcock on syringe 6 is open. 2. Prime the syringe 5 needle and close the stopcock. 3. Obtain a vacuum in syringe 5 by pulling back on the plunger until it locks. Press the lock into the plunger groove and be sure it is firmly secured. 4. Enter the side port with syringe 5 - stopcock closed. 5. Open the stopcock on syringe 5. 6. Press SEL. When the PPC screen is flashing PUMP SUSPEND press ACT. The system is now in normal mode. Dmp9196021-011_c.book Page 173 Wednesday, April 3, 2002 5:07 PM 173 7. Using the PPC, program and deliver a 4 unit bolus. 8. 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. If less than 1 ml enters, repeat the bolus from Step 6, some Pumps may require 3 successive boluses to obtain 1 ml. 9. Close both stopcocks. Remove syringe 6 from the Pump. Set the syringe aside to be weighed. 10. With the stopcock closed, remove syringe 5 from the side port. It will have a vacuum inside from the previous step. Enter the Pump fill port with syringe 5 and open the stopcock and remove 2 ml. This will restore the negative pressure safety feature of the Pump. 11. Close the stopcock, remove syringe 5 from the Pump, and set it aside to be weighed. 12. Press SEL until the SUSPEND PUMP screen is displayed. Then Press ACT. Remove guide needles and record refill amount At this point, the 18 gauge guide needles should be removed, and the refill amount should be calculated and recorded. 1. Remove the 18 gauge guide needles and discard them. Apply pressure to the insertion sites. 2. Weigh syringes 5 and 6 and record the combined weight on the Refill Form. Subtract the combined weight from the weight obtained in step 14 of this section, Remove Rinse Buffer and Fill with Insulin. The result is the new refill amount. 3. Record the new and extracted refill amount in the PPC. Dmp9196021-011_c.book Page 174 Wednesday, April 3, 2002 5:07 PM 174 Program new basal rate Using the patients PPC, cancel the SUSPEND mode and allow the Pump to return to the patients original basal rate. 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. Dmp9196021-011_c.book Page 175 Wednesday, April 3, 2002 5:07 PM APPENDIX G Stroke Volume Measurement 175 If under-delivery of insulin is noted in a refill procedure or suspected due to blood glucose control, it may be useful to verify the proper stroke vol-
ume 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. Supplies and Solutions Prior to performing this procedure, assemble the necessary supplies and solutions as outlined below:
Supplies Local anesthesia Sharps container PPC Oral or IV glucose Glucose monitoring equipment Drapes 5 mL or 3 mL syringe One (1) sterile bag for PPC (intestinal or cassette bags work well) One (1) Side port locating template, MMT-4106 One (1) sterile 100 microliter pipette Dmp9196021-011_c.book Page 176 Wednesday, April 3, 2002 5:07 PM 176 One (1) MiniMed MMT-4102 refill needle. (Extra needles should be available to use as needed) One (1) sterile stopcock - 3 way Solutions One (1) 10 mL vial, Aventis rinse buffer solution Preparing for the Procedure NOTE: Before beginning any refill, flush, stroke volume measurement, carefully read Appendix D, Precau-
tions and General Procedures, and keep this in mind as you perform each procedure. Record Patients Blood Glucose Record the patients blood glucose value at the start of the procedure. Monitor blood glucose every 30 minutes, or as needed. Dmp9196021-011_c.book Page 177 Wednesday, April 3, 2002 5:07 PM 177 Measuring Stroke Volume 1. In a sterile field immediately before the procedure; prepare the appa-
ratus. Prime the stopcock, pipette, and needle. Figure 19: Measuring the Stroke Volume 2. Turn the stopcock to close off the needle. 3. Insert the needle into the side port. 4. Turn the stopcock. as shown in Figure 19. Dmp9196021-011_c.book Page 178 Wednesday, April 3, 2002 5:07 PM 178 Figure 20: Closed Stopcock 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 20 to close. Remove the apparatus. Dmp9196021-011_c.book Page 179 Wednesday, April 3, 2002 5:07 PM 179 Record Patients Blood Glucose It is likely that some insulin is pumped out of the Catheter and into the patient in this procedure. Monitor the patients blood glucose and release the patient only after blood glucose values are stable. Dmp9196021-011_c.book Page 180 Wednesday, April 3, 2002 5:07 PM 180 Dmp9196021-011_c.book Page 181 Wednesday, April 3, 2002 5:07 PM 181 APPENDIX H Pressure Measurement Using The Side Port Catheter If under-delivery of insulin is noted by increased insulin needs or by lower than expected actual usage at refills, you may suspect one of two causes:
Insulin deposits have led to under-delivery from the Pump. Catheter blockage has led to under-delivery from the Catheter Pressure measurement in the side port can detect pressure build-up due to Catheter tip obstruction. This test, along with the Stroke Volume test, helps to differentiate Pump problems from Catheter problems. NOTE: During this procedure, a 5 unit bolus is pro-
grammed. You need to monitor carefully the blood sugar pre/per/post procedure. Dmp9196021-011_c.book Page 182 Wednesday, April 3, 2002 5:07 PM 182 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 Safety glasses PPC Oral or IV glucose Glucose monitoring equipment Drapes One (1) scale - 0.01 gram resolution One (1) 250 ml sterile beaker One (1) sterile bag for PPC (intestinal or cassette bags work well) One (1) Side port locating template, MMT-4106 Five (5) Refill kits, MMT-4105 Nine (9) MiniMed MMT-4102 refill needles. (Extra needles should be available to use as needed) Two (2) 10 or 20 ml Luer Lock syringe One (1) stopcock - 2 way One (1) stopcock - 3 way Syringe filter with luer lock, 0.2 micro (long configuration - not disk configuration) Chart recorder Pressure monitor Pressure transducer Dmp9196021-011_c.book Page 183 Wednesday, April 3, 2002 5:07 PM 183 Solutions Seven (7) 10 ml vials, Aventis rinse buffer solution Five (5) 10 ml vials, Aventis HOE 21 PH, U-400 Insulin Preparing for the procedure NOTE: Before beginning any refill, flush, stroke volume measurement, or pressure measurement proce-
dure, 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 flush procedure, a total of five different refill syringes and one 10 - 20 ml syringe will need to be labeled and then prepared with different solutions. Table 3 defines the syringe numbers and corresponding solutions. Table 3: Preparation and Labeling of Syringes Syringe
#1
#2
#3
#4 10-20 ml
#5
#6 Labeling 60 ml 60 ml 60 ml 5 - 10 ml Solution RINSE BUFFER RINSE BUFFER RINSE BUFFER RINSE BUFFER 60 ml 60 ml INSULIN INSULIN Dmp9196021-011_c.book Page 184 Wednesday, April 3, 2002 5:07 PM 184 Record patients blood glucose Record the patients blood glucose value at the start of the procedure. Monitor blood glucose every 30 minutes, or as needed. Prepare syringes for emptying the pump Syringe 1 is used for emptying the Pump. Label and prepare syringe 1 per the Precautions and General Procedures section in Appendix D of this manual. After the syringe is prepared, weigh it and record the weight on the Refill Form. Prepare syringes for filling the pump During the pressure test procedure, syringes 2, 3, 5, and 6 are used for fill-
ing the Pump. Each of these syringes need to be labeled with its solution and syringe number, and then filled and degassed per the General Proce-
dures in Appendix D of this manual. Prepare syringe for priming the test setup During the pressure test procedure, syringe 4 is used to prime the needle, filter, and the 3-way stopcock. This syringe needs to be labeled and then prepared by following the steps below:
1. Attach an 18 gauge needle to the syringe. Draw 5 - 10 ml of RINSE BUFFER into the syringe. 2. Expel all air from the syringe. 3. Attach a 3-way stopcock to the syringe. 4. Turn the stopcock to close off the syringe. Dmp9196021-011_c.book Page 185 Wednesday, April 3, 2002 5:07 PM 185 Measuring pressure in the side port Program minimal basal rate Place the PPC in a sterile bag and program the Pump in 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. Prime the needle and 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 Pump with the refill needle. 4. Open the stopcock and withdraw the INSULIN. After the INSULIN appears to have stopped rising in the syringe, wait an additional 30 seconds to make sure all of the INSULIN and air is removed. 5. When the time has elapsed, close the stopcock, remove the syringe. Weigh the syringe and record the weight on the Refill Form. Syringe 2: Rinse Buffer 6. Prime the needle and close the stopcock. 7. Enter the Pump with the refill needle. 8. Open the stopcock and allow the Pump to fill completely with RINSE BUFFER. When the fluid level stops moving, the Pump is filled. Dmp9196021-011_c.book Page 186 Wednesday, April 3, 2002 5:07 PM 186 9. Close the stopcock and remove the syringe. 10. Prepare syringe 2 for aspiration. 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. 11. Re-enter the Pump. 12. Open the stopcock and remove the RINSE BUFFER. After the fluid level stops moving, wait an additional 30 seconds for all the RINSE BUFFER and air to be removed. 13. When the time has elapsed, close the stopcock and remove the syringe. Syringe 3: Rinse Buffer 14. Prime the needle and close the stopcock. 15. Enter the Pump fill port with the refill needle. 16. Open the stopcock and allow the Pump to fill complete 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. Leave the RINSE BUFFER in the syringe, and leave the syringe in place for the next step. Equilibrate and pull rinse buffer through system The reservoir pressure in the Pump is equilibrated with outside ambient pressure and RINSE BUFFER is pulled through the fluid system. This procedure uses the following volumes in syringes 2 and 3:
Syringe 2 with RINSE BUFFER. Expel all RINSE BUFFER except 10 ml. Change the refill needle if desired. Syringe 3 with residual RINSE BUFFER from the previous sec-
tion. Dmp9196021-011_c.book Page 187 Wednesday, April 3, 2002 5:07 PM 187 Syringe 3: Rinse Buffer (residual) 1. Verify that the stopcock on syringe 3 is open. 2. Prime the needle. Close the stopcock. 3. 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. 4. Enter the side port with the stopcock closed. 5. Open the stopcock. 6. Press SEL key. When PUMP SUSPENDED is flashing on the screen press ACT. This will place the system in normal mode. 7. Program and deliver a 4 unit bolus to open the valve in the Pump mechanism. 8. 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. When at least 1 ml of RINSE BUFFER has entered syringe 2. If less than 1 ml enters, repeat the bolus from Step 6, some Pumps may require 3 successive boluses to obtain 1 ml. Close both stopcocks and remove the syringes. Discard syringe 2 and set aside syringe 3 to be used later to remove the RINSE BUFFER. Perform pressure test Syringe 4: Rinse Buffer 1. Plug in the chart recorder and the monitor. Attach the monitor cables. The pressure gauge is set to 1 volt = 1 psi. When knob 2 is set to 6 volts, then the full scale reading on the paper chart is 6 psi. 2. Set the switches and knobs of the chart recorder as follows: Switch 1 to V position, Knob 2 to 6 volts full scale, Knob 5 t 6 cm/
minute setting, Switch 9 to _ _ _ icon (Direct Current) Dmp9196021-011_c.book Page 188 Wednesday, April 3, 2002 5:07 PM 188 3. Open the chart recorder cover at A. Remove the pen cap. Retain the pen cap as it must be replaced after the procedure to prevent the pen from drying out. 4. Inspect the tubing and the stopcock coming from the pressure trans-
ducer. It must be completely free of bubbles. Inject sterile water with a very long needle to displace any bubbles present. Use a syringe to add water to the stopcock to form a positive meniscus. 5. Assemble the following sterile components in a sterile field per :
Syringe, Filter, 3-way Stopcock, MiniMed refill needle (MMT-4102) Prime the stopcock, filter and needle using the RINSE BUFFER from the syringe. Form a positive meniscus on the end of the filter. 6. Carefully join the 2-way stopcock to the filter. A sterile person must hold the filter assembly and a non-sterile person must hold the stop-
cock. From this point, the sterile person will manipulate the needle and stopcock to perform the measurements. 7. Push switch 7 to I Pen. This puts the pen in contact with the paper. 8. Set the 0 adjustment. Maintain switch 3 to the right position and adjust the thumbwheel 4, until the pen is at 0. 9. Initialize the chart by pushing switch 6 to the right Prot momen-
tarily. The pen will write the chart settings. 10. Tape the transducer securely to a table or any stable surface roughly at the level of the implanted Pump. Hold the refill needle at the level of the patients pump and open both the 2-way and the 3-way stopcocks.
(The 3-way stopcock is opened to allow flow between the filter and needle but not to the syringe.) The monitor should display 0 (zero) or a very low number. Close both stopcocks. (The 3-way stopcock is opened between the syringe and the filter; the needle is closed.) Dmp9196021-011_c.book Page 189 Wednesday, April 3, 2002 5:07 PM 189 Figure 21: Attaching the Monitor Cables to the Chart Recorder Dmp9196021-011_c.book Page 190 Wednesday, April 3, 2002 5:07 PM 190 11. Slide switch 6 to its left position to start the paper. Fast forward the paper as necessary using switch 8. 12. Place the refill needle in the side port. 13. Program a bolus (5 units) and open both stopcocks. (The 3-way stop-
cock is opened between the filter and needle and the syringe is closed.) Maintain the needle in the side port without movement dur-
ing the entire bolus and observe the curve for the duration of the bolus and for 10 minutes after the bolus. If leakage is suspected, the 3-way stopcock may be turned so that the filter is off. If the pressure curve flattens, all of the connections between the transducer and the stop-
cock tight. leak are Figure 22: Normal Pressure Curve Example A flush of the Catheter tip can be performed at this time. (See Appendix F, Side Port Catheter Rinse Procedure). A repeat pressure tracing should be made subsequent to the flush. Place system in Suspend Mode by press-
Dmp9196021-011_c.book Page 191 Wednesday, April 3, 2002 5:07 PM ing ACT on the SUSPEND screen. Remove rinse buffer and fill with insulin 191 The RINSE BUFFER is removed from the Pump fluid system and the system is filled with INSULIN. This procedure uses the following vol-
umes in syringes 3, 5, and 6:
Syringe 3 with residual RINSE BUFFER from the previous steps Syringe 5 with 20 ml INSULIN Syringe 6 with 30 ml INSULIN Syringe 3: Rinse Buffer (residual) 1. Expel all air from the syringe and prime the needle. 2. Close the stopcock. 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 Pump with the refill needle and syringe. 4. Open the stopcock and remove the RINSE BUFFER. After the fluid level stops moving, wait an additional 30 seconds to make sure all of the RINSE BUFFER and air is removed. 5. When the time has elapsed, close the stopcock, remove the syringe, and discard. Syringe 5: Insulin 6. Prime the needle and close the stopcock. 7. Enter the Pump fill port with the refill needle. 8. Open the stopcock and allow the pump to fill completely with INSU-
LIN. When the fluid level stops moving, the Pump is filled. 9. Close the stopcock and remove the syringe. 10. Prepare syringe 6 for aspiration. Obtain a vacuum by pulling back on Dmp9196021-011_c.book Page 192 Wednesday, April 3, 2002 5:07 PM 192 the plunger until it locks. Press the lock into the plunger groove to be sure it is firmly secured. 11. Re-enter the Pump. 12. Open the stopcock and remove the INSULIN. After the fluid level stops moving, wait an additional 30 seconds for all the INSULIN and air to be removed. 13. 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 14. Weigh and record the combined weight of syringes 5 and 6 on the refill form. Prime the needles. 15. Close the stopcock. Enter the Pump fill port with the refill needle. 16. Open the stopcock and allow the Pump to fill completely with INSU-
LIN. When the fluid level stops moving, the Pump is filled. Approxi-
mately 10 ml of INSULIN will remain in the syringe. Leave the INSULIN in the syringe, and leave the syringe in place for the next step. 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 5 and 6:
Syringe 6 with residual INSULIN from the previous step Syringe 5 with 5 ml solution Syringe 5: Solution Syringe 6: Insulin (residual) Dmp9196021-011_c.book Page 193 Wednesday, April 3, 2002 5:07 PM 193 1. Maintain syringe 6 with approximately 10 ml of residual INSULIN in the Pump fill port. Verify that the stopcock on syringe 6 is open. 2. Prime the syringe 5 needle. Close the stopcock. 3. Obtain a vacuum in syringe 5 by pulling back on the plunger until it locks. Press the lock into the plunger groove to be sure it is firmly secured. 4. Enter the side port with syringe 5 - stopcock closed. 5. Open the stopcock on syringe 5. 6. Program and deliver a 4 unit bolus to open the valve in the Pump mechanism. 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. If less than 1 ml enters, repeat the bolus from Step 6, some Pumps may require 3 successive boluses to obtain 1 ml. 8. Close both stopcocks. Remove syringe 6 from the Pump. Set aside the syringe to be weighed. 9. With the stopcock closed, remove syringe 5 from the side port. Syringe 5 will have a vacuum inside from the previous step. Enter the Pump fill port with syringe 5 and open the stopcock to remove 2 ml. This will restore the negative pressure safety feature of the Pump. 10. Close the stopcock, remove syringe 5 from the Pump, and set it aside to be weighed. Dmp9196021-011_c.book Page 194 Wednesday, April 3, 2002 5:07 PM 194 Remove guide needles and record refill amount At this point, the 18 gauge guide needles should be removed, and the refill amount should be calculated and recorded. 1. Remove the 18 gauge guide needles and discard them. Apply pressure to the insertion sites. 2. Weigh syringes 5 and 6 and record their combined weight on the Refill Form. Subtract the combined weight from the weight obtained in step 14 of this section, Remove Rinse Buffer and fill with INSULIN. The result is the new refill amount. 3. Record the extracted and new refill amounts in the PPC. Using the patients PPC, cancel the SUSPEND mode, to return to the nor-
mal patients basal rate. D9196021-011 12/00
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2002-05-02 | 0.131 ~ 0.131 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2002-05-02
|
||||
1 | Applicant's complete, legal business name |
Medtronic MiniMed, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0006729248
|
||||
1 | Physical Address |
18000 Devonshire Street
|
||||
1 |
Northridge, California 91325-1219
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
d******@ckccertification.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
OH2
|
||||
1 | Equipment Product Code |
3150
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
M**** M****
|
||||
1 | Title |
Senior Engineering Manager, Product Verification
|
||||
1 | Telephone Number |
818-5********
|
||||
1 | Fax Number |
818-5********
|
||||
1 |
m******@medtronic.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
CKC Laboratories, Inc.
|
||||
1 | Name |
M**** C********
|
||||
1 | Physical Address |
5473A Clouds Rest
|
||||
1 |
Mariposa, California 95338
|
|||||
1 |
United States
|
|||||
1 | Telephone Number |
800-5******** Extension:
|
||||
1 | Fax Number |
209-9********
|
||||
1 |
s******@ckc.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
CKC Laboratories, Inc.
|
||||
1 | Name |
M******** C****
|
||||
1 | Physical Address |
5473A Clouds Rest
|
||||
1 |
Mariposa, California 95338
|
|||||
1 |
United States
|
|||||
1 | Telephone Number |
800-5******** Extension:
|
||||
1 | Fax Number |
209-9********
|
||||
1 |
s******@ckc.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Personal Pump Communicator | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
CKC Laboratories, Inc.
|
||||
1 | Name |
S****** B****
|
||||
1 | Telephone Number |
209-9******** Extension:
|
||||
1 | Fax Number |
866-7********
|
||||
1 |
r******@ckc.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 0.13100000 | 0.13100000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC