Deltec Cozmo User Manual

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Table of Contents Important Information Important safety information ... 1 Warnings ... 1 Cautions ... 4 Explanation of symbols ... 6 Introduction ... 7 Indications ... 7 Contraindications ... 7 Delivery features ... 7 Basal rates ... 7 Meal bolus ... 8 Correction bolus ... 8 Other features ... 8 Glossary of terms ... 9 Pediatric use ... 13 About this manual ... 14

About the Pump Pump illustrations ... 15 Description of features and buttons ... 16 Battery compartment ... 16 Display ... 16 Programming keys ... 16 Up and down keys (b / c) ... 16 Touch bolus button ... 16 Cartridge cap ... 16 Infrared (IR) windows ... 16

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Features ... 17 Vibration alert ... 17 Occlusion (blockage) sensor ... 17 Cartridge sensor ... 17 Watertight ... 17 History ... 17 Description of pump display & menus ... 18 Deltec accessories ... 20 Cartridge ... 20 Infusion sets ... 20 Infrared (IR) adapter ... 20 Before using the pump for the first time ... 21 Insert a battery ... 21 Self tests ... 22 Attach the belt clip (Optional) ... 23 Pump settings ... 24 Regional settings ... 24 Time and date ... 26 Beep or Vibrate ... 27 Personalizing alerts ... 28 Suspending and restarting insulin delivery ... 31 Program Lock ... 32 Unlocking the menu ... 33 Notes ... 34

Using the Pump - Basics Loading a cartridge ... 35 Supplies required ... 35 1. Filling the cartridge ... 35

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2. Attaching an infusion set and loading a filled cartridge into the pump ... 36 3. Fill the tubing ... 40 4. Choosing an access site and inserting the access device ... 41 5. Fill the cannula ... 42 6. Set site change reminder and restart delivery ... 43 Meal Bolus ... 44 Standard bolus (units of insulin): setup ... 45 Standard bolus: delivery ... 46 Carbohydrate bolus: setup ... 47 Carbohydrate bolus: delivery ... 48 Basal patterns ... 49 Personalizing basal patterns ... 50 Editing basal patterns ... 51 Using basal patterns ... 53 Notes ... 54

My DKA plan ... 70 Skin infections ... 71 Tips for sick days ... 71 My sick day plan ... 72 Emergency supplies ... 72 Personal pump removal guidelines ... 73 Your pump &: Extreme temperatures ... 73 Water ... 73 Contact Sports ... 74 Your basal rates, boluses & Your weight ... 74 Your level of exercise ... 74 Your growth (children & teens) ... 74 Your menstrual period ... 74 Starting new medications / supplements ... 74 If you drop your pump or hit it hard ... 75 Notes ... 76

Help

Using the Pump - More Features

About the alarms (Beep/Vibrate settings) ... 55 Troubleshooting ... 56 Alarms ... 56 Alerts ... 58 Other messages ... 62 Cleaning your pump ... 65 Servicing your pump ... 66 Troubleshooting health problems ... 67 Low blood glucose (hypoglycemia) ... 67 High blood glucose (hyperglycemia) ... 68 Diabetic Ketoacidosis (DKA) ... 70

Programming and using these features ... 77 Correction Bolus ... 77 Personalizing the correction bolus... 79 Delivering a correction bolus (main menu) ... 80 Touch Bolus ... 81 Making Touch Bolus available ... 82 Delivering a Touch Bolus ... 83 Extended Bolus ... 85 Personalizing the extended bolus ... 86 Delivering an extended bolus ... 87 iii

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iv Stopping an extended bolus ... 88 Combination Bolus ... 89 Personalizing the combination bolus ... 90 Delivering a combination bolus ... 91 Stopping a combination bolus ... 92 Temporary Rate ... 93 Personalizing the temporary rate ... 94 Using the temporary rate ... 95 Stopping a temporary rate ... 96 Notes ... 97

History & Communications History ... 99 Personalizing history ... 100 Viewing history on the pump ... 101 Communications ... 102 My Treatment Assistant™ PC Communications System .. 102 Notes ... 104

Technical Information Pump development standards ... 105 Specifications ... 106 General specifications (nominal) ... 106 Delivery specifications ... 108 Main Menu ... 108 Meal Bolus ... 108 Correction Bolus ... 109 Temporary Rate ... 110 Basal Pattern ... 111 Load Cartridge ... 111

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History ... 111 Pump Settings ... 112 Pump Settings / Personalize / Alerts ... 112 Regional Settings ... 113 Personalization using My Treatment Assistant™ ... 113 Accuracy test results ... 114 Trumpet curves ... 114 Safety features and fault detection ... 116 Hardware safety features ... 116 Watchdog timer circuit ... 116 Motor drive / motor watchdog circuit ... 116 Voltage detection circuit ... 117 Software safety features ... 117 Hardware-related software safety features ... 117 RAM memory check ... 117 Motor circuit check ... 118 Keypad encoder check ... 118 Data handling and software safety features ... 118 Data stored in RAM ... 118 Data stored in NOVRAM ... 118 Data used in calculations ... 119 Timer data registers ... 119 Inspecting the pump ... 119

Index Limited Warranty

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What’s In This Section? Important Safety Information Warnings and Cautions Explanation of symbols Introduction Glossary of terms Pediatric use About this manual

1 Important Information

Important safety information WARNING: Read this entire manual before using the Deltec Cozmo™ Insulin Pump. If you do not understand something or have any questions, ask your healthcare provider, or contact Deltec, Inc. Incorrect use of this pump, failure to follow the instructions and important information contained in this manual, or improper/inadequate troubleshooting can lead to death or serious injury. Warnings, cautions and other important safety information can be found in this section, and in bullet form throughout the manual (indicated by the ☞ symbol). The Help section (chapter 4, page 55) contains information on troubleshooting pump and health related problems, as well as other important information. WARNINGS ☞ The Deltec Cozmo™ Insulin Pump is designed only for Continuous Subcutaneous Insulin Infusion (CSII). Do not use this pump for any other type of therapy. It is not for use with blood or cellular blood products. Use the pump only as you have been trained, and as instructed in this manual. This manual describes how to use and troubleshoot the ☞ Deltec Cozmo™ Insulin Pump. Deltec does not, however, make any recommendations about any specific programming related to your diabetes therapy. You must work closely with your healthcare provider in programming the pump, and in determining whether certain features are appropriate for you. Before using the pump, you must receive

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appropriate training in all it’s functions and in troubleshooting problems. Regular medical checkups are required while you are using the Deltec Cozmo™ Insulin Pump for insulin therapy. ☞ Monitor your blood glucose levels regularly (at least 4 to 6 times per day, or as your healthcare provider recommends) so that high or low blood glucose levels can be identified quickly. Deltec, Inc. recommends that you have someone around ☞ you (family, friends, etc.) that understands diabetes and pump therapy, and can help you in the event of an emergency. Make sure they are familiar with any information given to you by your healthcare provider. If ☞ pump operation is interrupted for any reason, you must be prepared to inject insulin. Since the pump uses only short-acting U100 insulin, high blood glucose (hyperglycemia) can quickly (2 to 4 hours) develop into Diabetic Ketoacidosis (DKA). ☞ To avoid a risk of explosion, do not use the pump in the presence of flammable anesthetics or explosive gases. The ☞ Deltec Cozmo™ Insulin Pump and accessories include small component pieces that could pose a choking hazard to small children. Several hours before going to bed, make sure the cartridge ☞ contains enough insulin to last through the night. Do not use the “vibrate” alarm at night. If you are a very deep sleeper, you may want to set the audio volume to High (the loudest setting) before going to bed.

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Important Information

☞ Make sure that all caregivers, including for instance

school personnel, daycare providers, etc., are familiar with the features of the pump, and can use and troubleshoot the pump. Make sure they are familiar with any information given to you by your healthcare provider. ☞ Deltec infusion sets are recommended for use with this pump. Pump operation and accuracy may not be assured if you use other manufacturers’ products. If ☞ there are any system problems, the pump will stop the tests and display an alarm screen letting you know there is a problem. If this happens, do not use the pump. The ☞ time and date must be set correctly, since basal patterns are time-based, and all of the history is stored based on time and date. Occasionally you will need to reset the time, for example, during daylight savings time or to adjust for a different time zone. ☞ When stopping delivery, remember that since the pump uses only short-acting insulin, your insulin level will start to fall and blood glucose level to rise very quickly (in as little as 90 minutes). You must test your blood glucose when stopping delivery for any length of time. Once the pump is locked, you will not be able to enter the ☞ menu without the proper code. Touch Bolus is also not allowed when the pump is locked. Make sure there is someone around who knows the proper code. Always use the pump’s Load feature when starting a new ☞ cartridge. This will assure that the cartridge is properly loaded and the tubing and access device are filled with in-

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sulin. ☞ Whenever you load a new cartridge and attach an infusion set, you must test your BG level within 1 to 2 hours to make sure that insulin is being properly delivered. If you do not test within this time-frame, and insulin delivery is delayed or blocked, you may develop hyperglycemia. If desired, you can use the Glucose Reminder alert to remind you to test your BG level (see Personalizing Alerts, page 28). Always use “aseptic” technique, particularly when work☞ ing with the cartridge, infusion set, catheter and access site. An increased risk of skin infection is associated with pump use, as the access device remains in place for 2 or more days (see “Aseptic Technique,” page 9). Always read the instructions for use provided with the ☞ insulin, catheter, infusion set, and any other accessory used with the Deltec Cozmo™ Insulin Pump. ☞ To avoid accidentally infusing insulin, disconnect the infusion set tubing from the access device (or site) before removing a used cartridge or replacing an infusion set. Never use the pump’s “load cartridge” or “fill tubing” features while an infusion set is connected to your body. You could deliver an unintended dose of insulin, resulting in low blood glucose (hypoglycemia). If ☞ not properly tightened, insulin could leak from the cartridge and infusion set connections and disrupt delivery (the insulin that leaks out is not being delivered into your body like it should be and, depending on how much insulin is leaking, could cause your BG level to rise). Signs

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of leakage can also mean opportunity for contamination leading to infection. ☞ Never use Fill tubing when the infusion set is connected to your body, or you could deliver an unintended bolus. Always remove all air from the cartridge and infusion ☞ set before starting insulin delivery. Air bubbles in the system can slow or stop insulin delivery. Check all connections carefully for leaks (wrapping a tissue around connections to check for moisture is a good technique), as leakage can slow or stop insulin delivery to the body, and allow an opening for contamination leading to infection. If insulin delivery is slowed or stopped, high blood glucose (hyperglycemia) will result. You ☞ should not change your access site right before bed, as you would be unaware of any problems with the site. You must test your BG level 1 to 2 hours after starting a new cartridge to make sure insulin is being properly delivered. ☞ You should receive specific training on programming and delivering a meal bolus and using basal patterns. Please carefully read all instructions and talk to your healthcare provider. It ☞ is vital to get the basal patterns correct. If a basal rate is too high or too low, all your insulin delivery throughout the day and night will be incorrect, including boluses. Many things can affect how your body uses insulin. To ☞ avoid problems, contact your healthcare provider before making big lifestyle changes, such as starting or stopping an intensive exercise program, or if you experience a signifi-

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cant weight loss or weight gain, etc. In these cases your basal rates may need to be modified. ☞ When returning a pump for service, you must be prepared to inject insulin with an insulin syringe or pen until the new pump arrives. Contact your physician if you require supplies, such as a prescription for intermediate- or long-acting insulin and syringes. You ☞ must not use the replacement pump until it is correctly personalized. Never stop taking your insulin because of illness. Even ☞ if you are too sick to eat, your body still needs insulin. ☞ During an illness, check your BG level before mealtime and every 2 to 4 hours. Check your urine for ketones until you feel better. Even though you are sick, you still need fluids, calories ☞ and carbohydrates. Drink 4 to 8 ounces of clear liquids containing sugar every 30 to 60 minutes. If ☞ you drop the pump or hit it against something hard, always inspect it carefully to make sure it is still working properly. Make sure the display is working correctly, and the cartridge, cartridge cap, battery cap and infusion set are connected correctly. Wrap a piece of tissue paper around the connections to check for moisture (which could indicate a leak). If there is damage to the pump outer shell (cracks, chips), the pump may no longer be watertight. ☞ If the display has missing or incomplete characters, or if the pump does not seem to be working correctly, stop using the pump immediately. Contact your healthcare pro-

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vider for health advice and Deltec, Inc. for information on servicing your pump. Be prepared to inject insulin with an insulin syringe or pen. ☞ Programming and using the features described in the “Using the Pump - More Features” chapter includes information that may require a greater understanding of insulin pump therapy and should not be attempted without help from your healthcare provider. Programming many of the settings in the “Using the Pump ☞ More Features” chapter can only occur after testing and finetuning so that you get the best possible results from insulin pump therapy. You should receive specific training on programming and using the pump. Please carefully read all instructions and talk to your healthcare provider. Talk to your healthcare provider to determine your cor☞ rection bolus factor and your duration of insulin action. ☞ When you first start using the Touch Bolus feature, you should always take the pump out so you can view the screens as you program them. Then, once you are comfortable with how it works, you can program and deliver a bolus without even taking the pump out. To ☞ use the Extended bolus feature, you will need to determine the length of time it takes your body to begin using these types of meals as blood glucose. Talk to your healthcare provider before attempting to use this feature. ☞ To use the Combination bolus feature, you will need to determine the length of time it takes your body to begin using these types of meals as blood glucose. Talk to your

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healthcare provider before attempting to use this feature. ☞ Discuss your individual insulin needs with your healthcare provider.

Cautions

☞ Avoid strong electromagnetic fields, like those present

with Magnetic Resonance Imaging (MRI) and direct xray, as they can affect how the pump works. If you cannot avoid them, you must take the pump off. Do not expose the pump directly to ultrasound. ☞ Do not use the pump in hyperbaric chambers as they will affect how the pump works and may also cause damage to the pump. Do ☞ not use cell phones in close proximity to the pump. Interference with the pump electronics by cell phones can occur. If a cell phone interferes with the pump, the pump will generate a System Fault alarm. ☞ To avoid damage when storing the pump, first remove the battery and cartridge. Place the pump in the original carton and keep it away from cold, heat, and dampness. After 30 days, your personal programming will be lost and you will need to reprogram your pump. The ☞ pump may experience problems if operated in conditions where temperatures are lower than 35.6˚F (2˚C) or higher than 104˚F (40˚C), when relative humidity (non-condensing) exceeds 90%, and when atmospheric pressure is lower than 10.2 PSI (70 kPa) (10,000 feet above sea level) or higher than 15.4 PSI (106 kPa). If you experience prob-

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lems, remove the pump from use. ☞ The pump may be damaged if stored in environments where temperatures are lower than –4˚F (–20˚C) or higher than 140˚F (60˚C), when relative humidity (non-condensing) exceeds 90%, and when atmospheric pressure is lower than 10.2 PSI (70 kPa) (10,000 feet above sea level) or higher than 15.4 PSI (106 kPa). Do ☞ not use NiCad, nickel metal hydride, carbon zinc (heavy duty), lithium or any rechargeable batteries. They will not power the pump properly, and the battery life indicator on the home screen may not show the correct amount. Use ☞ only Deltec Cozmo™ 3mL Insulin Cartridges; other manufacturers’ products will not work with the Deltec pump. ☞ Strong household cleaners and chemicals will damage the pump’s outer shell if applied directly or indirectly (on your hands, for instance). Avoid the following in particular: • Household cleaners (such as Formula 409®) • Jewelry cleaner • Petroleum-based products (such as gasoline or GooGone®) • Products that contain high levels of D.E.E.T. (such as Deepwoods Off® insect repellent) ☞ Never use abrasive cleaners, solvents, bleach, scouring pads or sharp instruments when cleaning your pump, as they can scratch, discolor or damage the pump’s outer shell. If the display is scratched, it may be difficult to read and you will need to have it replaced. If the outer shell is chipped or cracked, it will no longer be watertight and will

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require service. ☞ Never use steam or very hot water (exceeding 120˚F [49˚C]) in an attempt to sterilize the pump. Never put your pump in the dishwasher. Exposing the pump to these high temperatures could damage the pump’s electronics and result in the need to service your pump.

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Important Information

Explanation of symbols Below is a list of symbols you will see on (or on the packaging of) the Deltec Cozmo™ Insulin Pump and accessories, as well as explanations of what the symbols mean. SN Serial number

!O J IPX8

Q

Appears in pump display, with a message, to indicate a question you must answer before programming can continue

Attention! See instructions for use

! y

Type CF equipment (protection from electric shock)

1

Latex free

n

Press b or c keys to move through menu/settings

p o

Top of menu; press b key to move through menu

Watertight when submerged to 8 feet (2.4 meters) for 30 minutes or to 12 feet (3.6 meters) for 3 minutes

D H

Date of manufacture

W

On Pump Display: Wait

On Product Packaging: Use by

Z

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician

REF

Reorder number

Indicates that the product was designed and B or A manufactured in accordance with applicable standards/guidelines and may be sold in the EU (European Union)

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D

Appears in pump display, along with a message, as an indicator of an alarm condition. Dispose of used batteries in an environmentally safe manner, and according to any regulations that may apply

Bottom of menu; press c key to move through menu Press Touch Bolus button

1 6

Approximate insulin left in cartridge

G H K

Meal Bolus (menu)

A

Approximate battery life remaining Home screen page number

Correction Bolus (menu) Temporary Rate (menu)

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J I E F

Basal Pattern (menu)

Introduction

Load (menu)

Congratulations! You have selected the Deltec Cozmo™ Insulin Pump to help you in the treatment of your diabetes.

History (menu) Pump Settings (menu)

U S T X ☞

Indications

Keep dry

The Deltec Cozmo™ Insulin Pump is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes.

Handle with care

Contraindications

Keep from direct sunlight

The pump is not indicated for anyone who cannot or will not test blood glucose levels at least 4 times per day, as well as maintaining regular contact with their diabetes team.

Storage temperature range Important safety information, warnings and cautions

Delivery features The pump is used to deliver insulin in two ways, as basal insulin and as bolus insulin.

Basal rates The pump is programmed to deliver a steady background flow of insulin called the “basal rate.” You can program up to 4 separate basal rate patterns. Each pattern can contain up to 48 time/rate segments to meet your insulin needs throughout the day and night. • You decide which patterns to display in the menu, and also choose a name for each pattern from a predetermined list. Or, you can use My Treatment Assistant™ PC Communica-

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Important Information

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Important Information

tion System to create a name for each pattern. • The pump also offers a “Temporary Rate” feature which allows you to program a temporary basal rate on the pump.

Meal bolus The pump is programmed to deliver a “bolus” of insulin to match food eaten. • You decide how you want to program a meal bolus, either by entering the number of units of insulin you want delivered, or by entering the amount of carbohydrate in your meal/snack for the pump to calculate and recommend how much insulin is needed to cover the meal/snack. • The pump also has an “Extended bolus” and a “Combination bolus” feature. The extended bolus is delivered over a longer period of time (which you specify), and may be used for high fat or protein meals, or if you have gastroparesis. The combination bolus delivers a percentage of the bolus (which you specify) right away, then the rest is delivered over a longer period like the extended bolus. If you choose not to use these features, you can program the pump so that they are not displayed in the menu. • The pump has an alternate, discrete method of delivering a meal bolus, called the “Touch Bolus,” which is initiated by pressing the Touch Bolus button on the side of the pump. This feature can also be turned off if you choose not to use it.

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Correction bolus • The correction bolus is used to lower high Blood Glucose (BG) levels. A correction bolus can be displayed in the main menu, as part of the meal bolus, both, or neither if you choose not to use the feature. It can be programmed in either mg/dl or mmol/L, whichever you use when testing your BG levels.

Other features The pump has a large display (or screen) where all programming, operating and alarm information is displayed. Programming of the pump is menu-driven, like an ATM or cell phone. The pump is powered by one “AAA” (IEC LR03) alkaline battery, which is readily available at most grocery stores, hardware stores, drug stores, electronic stores, and any other stores that sell AAA replacement batteries. Average battery life (depending on how your pump is programmed and used) is approximately 1 month. ☞ Caution: Do not use NiCad, nickel metal hydride, carbon zinc (heavy duty), lithium or any rechargeable batteries. They will not power the pump properly, and the battery life indicator on the home screen may not show the correct amount. The pump is watertight, so you do not have to remove the pump when showering or bathing, and allows unlimited swimming activities. When diving, the pump is watertight to a depth

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of 8 feet (2.4 meters) for 30 minutes or 12 feet (3.6 meters) for 3 minutes. Pump and delivery history is automatically tracked by the pump, and can be viewed in the History menu (see page 99 in chapter 6 of this manual for a list of available history). The pump has a Program Lock feature which allows you to lock out the menu. This feature helps prevent tampering with the pump. The pump requires the use of the Deltec Cozmo™ 3mL Insulin Cartridge and one of the Deltec Insulin Infusion Sets.

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Glossary of Terms The following is a list of terms that you should know before reading this manual, because the manual uses these terms often: Access site: The area on the body into which the cannula or needle of the infusion set is inserted. Aseptic technique: Aseptic technique is used to minimize the risk of infection. Use aseptic technique when working with the cartridge, infusion set, cannula/needle and preparing the access site. Wash your hands thoroughly with soap and water. Do not touch or blow directly on any part that comes in contact with insulin (the “fluid path”). Make sure the area (counter or tabletop, etc.) where you are working is clean. BG level: See Blood Glucose Level. Basal Pattern: A 24 hour sequence of basal rates. Basal rate: The amount of insulin delivered continuously over 24 hours a day, providing a background of insulin at all times. The user programs the basal rate to deliver insulin continuously. The rate programmed is intended to keep the blood glucose within the user’s target range between meals and overnight. The basal rate is measured in units per hour (u/hr). Blood Glucose level (BG level): The amount of glucose in the blood. BG levels average 100 mg/dl (5.5 mmol/L) for someone without diabetes. Your healthcare provider will help you

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determine a “target range” for your blood glucose level. Bolus: An insulin dose given at the time of a meal to match the glucose from food eaten or to lower the blood glucose level when it’s higher than the target range. Cannula: A small, soft tube, inserted into the body, through which insulin is delivered. Cartridge: The container that holds the insulin. The Deltec Cozmo™ 3mL Insulin Cartridge looks like a small syringe. Combination Bolus: The combination bolus combines the features of a regular meal bolus with an extended bolus. Part of the bolus (which you specify) is delivered immediately, then the rest of the bolus is delivered over an extended period (which you also specify). The combination bolus can be used when eating a meal that contains both rapidly and slowly absorbed carbohydrates, such as pizza. Correction Bolus: An insulin dose given to lower the blood glucose level when it’s higher than the target range. Correction bolus factor: This is a mathematical formula used to calculate the amount of insulin you need to correct or lower a high blood glucose. The formula takes into account your current blood glucose, your target blood glucose, the amount 1 unit of insulin will lower your blood glucose and your duration of insulin action. The calculation will recommend the amount of insulin you need to lower your blood glucose to target.

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CSII: Continuous Subcutaneous Insulin Infusion. DKA: See Diabetic Ketoacidosis. Dawn phenomenon: A rise in the early morning blood glucose level due to the activity of hormones in the body. Diabetes: A disease resulting in the body not being able to produce or properly use insulin. In Type 1 diabetes, the body no longer produces insulin. In Type 2 diabetes, the body loses the ability to properly use insulin. Diabetes team: You are the captain of the team that includes one or more of the following: your doctor, nurse educator, nutritionist and support team. Diabetic ketoacidosis (DKA): A serious condition that occurs when there is not enough insulin to allow the glucose in the blood to be used by the cells in your body for energy. The cells begin to burn the body’s stored fat reserves for fuel. Ketones are produced when fat is burned and these ketones change the chemistry of the body. Ketones can be detected using a blood or urine test. DKA can happen within a few hours when there is not enough insulin available, and can lead to unconsciousness and death. Duration of insulin action: A certain amount of time insulin is active and available in the body after it has been given by a subcutaneous bolus. Talk with your healthcare provider to help you determine your duration of insulin action through blood glucose testing.

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Extended bolus: A meal bolus delivered over an extended period of time. The extended bolus can be used when you eat a high fat or high protein meal, if you’re eating over an extended period of time (such as a banquet), or if you have gastroparesis. Factor: One of two or more values used in a mathematical formula. The pump uses certain “factors” when making calculations, for instance the correction bolus factor. Fluid path: The areas inside the cartridge and infusion set that come into direct contact with the insulin. These areas include the inside of the tubing and connectors, the inside and tip of the needle and cannula, and the inside and tip of the cartridge. To help protect against infection, never touch or blow directly on any part of the fluid path. Gastroparesis: A diabetes complication resulting in the slowing of food digestion. Gestational diabetes: A form of diabetes that develops in women during pregnancy. Glucose: The main source of fuel for the body. Foods containing carbohydrate are the main source of glucose in the body, although foods containing protein also provide some glucose. Foods containing fat also have an effect on blood glucose. High blood glucose (hyperglycemia): Blood glucose level higher than target. Signs and symptoms include: increased

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thirst, frequent urination, blurred vision and high BG reading upon testing. Increment: An added (or subtracted) amount. On the pump, you personalize how you want the pump to increment bolus amounts (carbohydrate increments of 1, 2, 3, 4, 5, 10 or 15 grams; units of insulin by 0.05, 0.10, 0.50, or 1.00 units). Then when you program a bolus, the pump counts up or down using the increment you have chosen. Infusion set: The tubing that is attached to the end of the cartridge, through which the insulin is delivered into the body. Insulin pump: A small electromechanical medical device designed specifically for delivering precise amounts of insulin into the body in the treatment of diabetes. The Deltec Cozmo™ Insulin Pump systems are controlled by 2 microprocessors (computer chips) which continuously monitor each other to make sure the systems are working properly. Insulin to carb ratio: The number of grams of carbohydrate covered by each unit of insulin delivered. Your healthcare provider will help you determine your insulin to carb ratio. Ketones: A substance in the blood resulting in a change in the acid base balance of the blood. Ketones can be tested in the blood and urine. Low blood glucose (hypoglycemia): Blood glucose level lower than target. Signs and symptoms may include: shakiness,

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sweating, dizziness, cold or clammy skin, looking pale, tingling and numbness in hands or around lips, mood changes. Low blood glucose may lead to loss of consciousness. mg/dl: Milligrams per deciliter. In the USA, your BG level is typically measured in mg/dl. mmol/L: Millimoles per liter. mmol/L is the international (except in the USA) standard for measuring BG levels. My Treatment Assistant™ PC Communication System: A (Microsoft® Windows®-based) computer program designed for use with the Deltec Cozmo™ Insulin Pump. Through My Treatment Assistant™, you can perform pump programming, print or e-mail history reports and pump settings, and save pump and delivery history. Occlusion: Clog or blockage. Occlusions are associated with the infusion set and access site, and mean that insulin delivery is stopped. Blockage can be caused by a number of things, including the tubing being pinched or kinked, the cannula or needle being blocked, as well as other reasons. Pushrod: On the Deltec Cozmo™ Insulin Pump, the cartridge is attached to the pushrod and, when the pump is started, the motor causes the pushrod to move forward and push insulin through the infusion set into your body. Subcutaneous: The area of the body directly below the skin but above the muscle. The infusion set cannula or needle is

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inserted subcutaneously. Temporary Rate: A feature on the pump which allows you to temporarily increase or decrease the basal rate. Type 1 diabetes: Type 1 diabetes refers to the condition where specialized “beta” cells in the pancreas are destroyed, and the body is unable to produce insulin. Type 2 diabetes: Type 2 diabetes refers to the condition where the body, while it is still able to produce insulin, loses its ability to use that insulin.

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Pediatric use Use of an insulin pump by pediatric patients should always be under the instructions of a physician, and requires supervision by a parent or a designated caregiver. The Deltec Cozmo™ Insulin Pump has many safety features that are designed with pediatric use in mind, and are described in this manual and summarized below: • Program Lockout: prevents user (or anyone else) from entering the pump menu to prevent changing pump programs. When program lockout is in use, to enter the menu you must use the code. Program lockout cannot be turned on or off unless you know the code. • A display in the home screen can be programmed using My Treatment Assistant™ PC Communications System to display emergency phone numbers to call should a problem arise. • A number of alerts and reminders specifically address pediatric use: • Missed meal bolus alert – pump alerts if a meal bolus is not given during time periods that are programmed into the pump. • Delivery limit alarm – programed to limit the amount of insulin that can be delivered over an hour.

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• Low cartridge volume alert – can be programmed to alert at selectable levels of insulin remaining in the cartridge. • Infusion set change reminder – alert that can be programmed to change infusion set and access site after selectable time period. • Delivery limits: • Maximum Bolus – programmed to limit the amount of insulin delivered in a bolus. • Maximum basal rate – programmed to limit the maximum programmable basal rate • Other features: • Basal rates can be programmed to 0.05 u/hr. Also, you can program and deliver a bolus in 0.05 units of insulin increment. These features provide more flexibility and safety for younger pediatric patients. • Parents or caregivers can easily recall pump delivery history to view all delivery events. • The pump can be programmed with different insulin to carbohydrate ratios and labeled for different meals - breakfast, lunch, dinner, snack. • Amount of meal bolus can be programmed in units of insulin or grams of carbohydrate. If using grams of car-

Important Information

PROOF (LR #3557), 2002-11-25

«5118-51A Cozmo User Manual»

14

Important Information

bohydrate, the user’s insulin to carbohydrate ratio is programmed into the pump and used to calculate the amount of insulin needed for a specified amount of carbohydrates, avoiding the paper and pencil calculations that are currently used. All of these features are described in detail in the manual. They can be activated at the physician, parent or caregivers discretion through the easy to use “menu” based personalization features of the pump or by using My Treatment Assistant™ PC Communications System. ☞ Warning: Make sure that all caregivers, including for instance school personnel, daycare providers, etc., are familiar with the features of the pump, and can use and troubleshoot the pump. Make sure they are familiar with any information given to you by your healthcare provider.

PROOF (LR #3557), 2002-11-25

About this manual The first part of this manual (Important Information, About the Pump, Using the Pump - Basics and Help) includes information on the basic operation and troubleshooting of the pump. This includes inserting batteries, setting the time and date, programming and using basal patterns, programming and delivering a meal bolus, and loading an insulin cartridge into the pump. For many pump users, these chapters contain the information you will primarily be concerned with during your basic training, and until you are more comfortable with your pump and have received appropriate training on the other features. The second part of the manual (Using the Pump - More Features, History & Communications) contains information on programming and using the pump’s other features. In order to program and use many of these features, a greater understanding of diabetes therapy is required. Technical Information contains pump specifications and descriptions of the pump’s internal safety systems. You do not need to be familiar with this information to use the pump. Throughout the manual are areas for writing notes, as well as for writing therapy information specific to you.

«5118-51A Cozmo User Manual»

What’s In This Section? Pump Illustrations Description of features and buttons Description of pump display and menus Deltec Accessories Before using the pump for the first time Insert a battery Self tests Attach the belt clip (optional) Pump Settings Regional Settings Time and date Beep or vibrate Personalizing alerts Suspending and restarting delivery Program lockout

2 About the Pump