Model 1800 Deltec Cozmo User Manual

Table of contents

Tips for practical pumping Sick day management...41 General guidelines...41 Insulin pump tips during illness...41 Troubleshoot your infusion site/set and your pump during illness...41 Travel guidelines...43 Airport screening guidelines...43 Preparing for your trip...43 Supplies for travel...43 Adjusting for exercise and activity...44 Personalizing your Deltec Cozmo® insulin pump for exercise and activity...45 General tips...45 Wearing your Deltec Cozmo® insulin pump during exercise/activity...46 Using temporary basal rates for exercise...46 Disconnecting your Deltec Cozmo® insulin pump during exercise/activity...47 Emergency room guidelines ...48 Emergency room guidelines for physicians ...48 Prompt treatment of hyperglycemia is essential ...49 X-rays, MRIs and CAT scans...49 Tips for outpatient procedures and outpatient surgery (Including dental procedures/surgery)...50 Before your procedure or surgery...50 X-rays, MRIs and CAT scans...50 If you continue to wear your pump during your procedure or surgery...50 After your outpatient procedure/surgery...51 Inpatient hospital tips...52 Insulin pump therapy in the hospital ...52 Circumstances warranting temporary discontinuation of insulin pump therapy . ...52

Updates to the Manual...iii

Symbols and Glossary of Terms Explanation of symbols...3 Glossary of terms...4

Important Information Important safety information...9 Warnings...9 Cautions...12

Preparing for CozMore® Introduction...17 Preparing for CozMore®...17 If you have comments, questions, or problems…...17 Preparing for your pump start...18 Prior to pump start day...18 Pump start day ...18 What to wear...18 What to bring...18 Deltec Cozmo® insulin pump bolus options...19 Carbohydrate counting basics...20 What is carbohydrate?...20 What is carbohydrate counting?...20 Why count carbohydrate?...20 How do you count carbohydrates?...20 Counting carbohydrate grams...20 Reading a nutrition label...21 Counting carbohydrate servings...21 Managing your food portions...21 Tools for carbohydrate counting...21 Meal bolus...22 Insulin-to-carbohydrate ratio...22 The Rule of 500...22 How to adjust your insulin-to-carbohydrate ratio and meal bolus...23 Guidelines for adjusting insulin-to-carbohydrate ratio...23 Correction bolus...24 Correction bolus variables...24 TDD (Total Daily Dose) of insulin...24 Target blood glucose ...24 Correction factor(s)...24 The 1800 Rule...24 Duration of insulin action...25 Duration of insulin action: percentage...25 Insulin on board...26 Low blood glucose (hypoglycemia)...27 High blood glucose (hyperglycemia) and ketonuria...28 How to prevent...28 Causes...28 Symptoms...28 Treatment...29 What to carry in your everyday pack...29

Introduction to the pump Indications...57 Contraindications...57 Delivery features...57 Basal rates...57 Meal bolus...57 Correction bolus...58 Disconnect feature...58 Hypo Manager™ feature...58 Other features...58 Pediatric use...59 Pump illustrations...61 Features and buttons...61 Battery cap with o-ring...61 Display...61 Left and right programming keys...62 Touch bolus button...62 b and c keys...62 Cartridge cap...62 Infrared (IR) windows...62 Features...63 Vibration alert ...63 Occlusion (blockage) sensor ...63 Cartridge sensor ...63 Watertight ...63 History ...63

Infusion sets Infusion site selection and infusion set change ...33 Changing your infusion set...34 Frequently asked questions and tips...35 Other tips...37 iv

Delivering insulin

The CozMore® Insulin Technology System...63 CoZmonitor® Blood Glucose Module...63 CoZmanager® 2.0 PC Communications Software...64 Accessories...64 Cartridge...64 Infusion sets...64 Infrared (IR) adapter...64 Before using the pump for the first time...65 Insert a battery...65 Self tests...67 Practicing cartridge loading...68 Fill the cartridge with air...69 Load it into the pump...69 Additional alert screens that may appear...70 Removing a cartridge from the pump...71 The pump display and menus...72 Screensaver and backlight...73 Menus...73 Editing values...73 “Timeout” feature...73 A sample “Home” screen...74 Sample “menu” screens...74 Navigating the pump main menu...75 Conventions used in this manual...78

Loading a cartridge...131 Gather your supplies...131 Fill the cartridge...132 Load it into the pump...132 Attach and fill the tubing...134 Insert the access device and fill the cannula...134 Stopping and restarting insulin delivery...136 Stopping insulin delivery from the Blood Glucose home screen...137 Stopping insulin delivery from home screen 2...138 Delivering a meal bolus...139 Standard bolus delivery using units of insulin ...139 Standard bolus delivery using grams of carbohydrate...140 Touch Bolus delivery...142 Enhanced Meal Maker® bolus delivery...143 Extended bolus delivery...144 Stopping an extended bolus...146 Combination bolus delivery...147 Stopping a combination bolus...149 Delivering a correction bolus (main menu)...149 The Hypo Manager™ feature...150 Editing basal patterns...152 Using basal patterns...154 Using the temporary rate...155 Stopping a temporary rate...156 Weekly schedule...157 Edit basal patterns...157 Edit meal alerts...159 Edit schedule...160 Temporary basal pattern...161 Disconnect...163 Reconnect...164 Reconnecting early...164 Automatic reconnect...165

Setup Setup...83 Choices for pump programming . ...83 QuickStart™ feature...84 Meal bolus...84 Correction bolus...84 Basal patterns...85 Pump Settings...89 Time and date...89 Beep or vibrate...90 Program lock...91 Unlocking the menu...92 Pump ID...93 Personalize...94 Personalizing alerts...94 History...98 Regional settings...101 Display...102 Advanced...103 Delivery...105 Meal bolus...105 Bolus duration...106 CozFoods™ list...106 Enhanced Meal Maker® carbohydrate calculating feature...106 Correction bolus...110 Correction factor...110 Target blood glucose...110 Increase correction based on blood glucose...110 Display “insulin on board” home screen . ...110 Basal patterns...114 Temporary rate...115 CoZmanager® 2.0 PC Communication Software...118 Notes...127

Help About alarms (beep/vibrate settings)...171 Troubleshooting...172 Alarms and alerts...172 Other messages...180 Cleaning your pump...187 Servicing your pump...187 Disconnecting from your Deltec Cozmo® insulin pump...188 When you disconnect from your Deltec Cozmo® pump for two hours or less...188 When you disconnect from your Deltec Cozmo® pump for an extended period of time...188 Your pump and...188 Extreme temperatures . ...188 Water...188 Contact sports...188 Your basal rates, boluses, and...189 Your weight...189 Your level of exercise...189 Your growth (children and teens)...189 Your menstrual period...189 Starting new medications/supplements...189 If you drop your pump or hit it hard...190

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Blood glucose testing

Resources

Blood glucose testing and history...193 The CoZmonitor® Blood Glucose Module...193 Using the BG menu...194 Enter BG value...194 Notes...196

Patient resources for insulin pump therapy...233

Technical information Pump development standards...237 Specifications...240 General specifications (nominal)...240 Delivery specifications...241 Main menu...241 Meal Bolus...241 Correction Bolus...241 Meal Maker® feature (enhanced)...241 Temporary Rate...242 Basal Pattern...242 Weekly Schedule...242 Load . ...242 History...242 Setup...243 Personalization using CoZmanager® 2.0 PC Communications Software...247 Accuracy test results...248 Safety features and fault detection...249 Hardware safety features...249 Watchdog timer circuit...249 Motor drive/motor watchdog circuit ...249 Voltage detector circuit...249 Software safety features...250 Hardware-related software safety features...250 Program memory check...250 RAM memory check...250 Motor circuit check...250 Keypad encoder check...250 Data handling and software safety features...250 Data stored in RAM...250 Data stored in NOVRAM...250 Data used in calculations...250 Timer data registers . ...250 Inspecting the pump...251 Collect separately...252 Limited Warranty ...253

Viewing history History...199 Viewing history in the History menu...200 Bolus Summary...201 View blood glucose history (quick access)...202 View bolus history (quick access)...203 Viewing, saving, printing and e-mailing History Reports using the CoZmanager® 2.0 PC Communications Software...204

Finetuning your settings Finetuning...209 Basal rate adjustments...209 Guidelines for testing your basal rate(s)...209 Overnight basal test...210 Daytime basal tests ...210 Basal testing...210 Test setup...210 Activating a basal test...212 Performing a basal test...213 Checking the status of a basal test...213 Ending a basal test early...214 Viewing basal test history...215 Viewing test history on the pump...216 Therapy effectiveness scorecard...217 What is standard deviation and what does it tell me?...218 Viewing basal test history using the CoZmanager® 2.0 software...219 Notes...220

Frequently asked questions (FAQ) Topic: Backlight...223 Topic: Battery in pump...223 Topic: Bolus delivery...225 Topic: CoZmonitor® module tips...226 Topic: CoZmanager® 2.0 PC Communications Software tips...228 Topic: History logs...228 Topic: Infusion sets and cartridges...229 Topic: Tips for “Cartridge Removed” alarm on translucent pumps...230

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Explanation of symbols

Glossary of terms

1

Symbols and Glossary of Terms

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Symbols and Glossary of Terms

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.

>

Serial number

g1

Attention, see instructions for use

J

Type CF equipment (protection from electric shock)

IPX8

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

D

Date of manufacture

8

On product packaging: Use by

W 6 <

6

A

Home screen page number/name

G H K J I E F

Meal Bolus (menu) Correction Bolus (menu) Temporary Rate (menu) Basal Pattern (menu) Load (menu) History (menu) Setup (menu) Weekly Schedule (menu) Basal Testing (menu) Disconnect (menu)

On pump display: Wait

Reconnect (menu)

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

Meal Maker (menu) Category (CoZmanager® 2.0 software)

Catalog number

Meal (CoZmanager® 2.0 software)

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

Q ! Z

Press to manually turn display backlight on when the pump is asleep Appears in pump display, with a message, to indicate a question you must answer before programming can continue Appears in pump display, along with a message, as an indicator of an alarm condition Collect separately

Approximate battery life remaining

Full (CoZmanager® 2.0 software) Warning (CoZmanager® 2.0 software) Bolus completed (Bolus Summary report) Bolus ended early (Bolus Summary report)

U S T X

Keep dry Handle with care Keep from direct sunlight Storage/transport temperature range

9

Latex free

5

Dansk

0

Italiano

n

Press b or c keys to move through menu/settings

/

Deutsch

3

Nederlands

8

Ελληνικά

6

p

Top of menu; press c key to move through menu

Norsk

-

English

>

Polski

o

Bottom of menu; press b key to move through menu

1

Español

2

Português

7

Suomi

4

Svenska

D

Press Touch Bolus button

.

Français

L

中文

1

Approximate insulin left in cartridge

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Symbols and Glossary of Terms

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: 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 infusion 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: Basal rates are programed to deliver insulin continuously over 24 hours, providing a background of insulin at all times. 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. Blood glucose levels average 100 mg/dl (5.5 mmol/L) for someone without diabetes. Your healthcare provider will help you 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. See also Carbohydrate Meal Bolus, Combination Bolus, Correction Bolus, Disconnect Bolus, Extended Bolus, Standard Bolus, Touch Bolus and Units of Insulin Meal Bolus. Cannula: A small, soft tube, inserted into the body, through which insulin is delivered. Cartridge: The container that holds the insulin. The Deltec Cozmo® 3 mL Insulin Cartridge looks like a small syringe. Carbohydrate Meal Bolus: A meal bolus programmed using grams of carbohydrates. The Deltec Cozmo® insulin pump allows you to program the amount of carbohydrate in your meal or snack, and then the pump will calculate the appropriate amount of insulin to deliver. The feature works especially well for people who count carbohydrate. The carbohydrate meal bolus uses your

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specific insulin-to-carbohydrate ratio(s) to calculate your meal or snack bolus Combination Bolus: A meal bolus that combines the features of a standard meal bolus with an extended bolus. A percent of the bolus, which you specify, is delivered immediately, and the remainder of the bolus is delivered over an extended period of time. The combination bolus on the Deltec Cozmo® insulin pump is best used when you eat foods like pizza that contain both carbohydrate (crust) and protein/fat (meat, cheese), or if you are planning to eat over a period of time. When you activate the combination bolus feature on your Deltec Cozmo® insulin pump, you can program it to deliver the extended portion of your combination bolus over 15 minutes to 8 hours. Correction Bolus: A bolus given to reduce or correct a high blood glucose level. Occasionally, everyone with diabetes experiences a high blood glucose level. The correction bolus on the Deltec Cozmo® insulin pump allows you to easily and consistently correct occasional high blood glucose specific to your insulin needs and your correction factor. Correction factor: The amount one unit of insulin will lower your blood glucose. CozFoods™ food list: CozFoods™ is a list of foods that can be customized and sent to the pump using the CoZmanager® 2.0 software. You can customize foods, meals and serving sizes for up to 600 food entries. Then once you have sent CozFoods™ to the pump and activated the enhanced Meal Maker® feature, when programming a bolus you select a meal or food (up to 12) and the pump calculates your bolus size based on the carbohydrate in the food(s). CozFoods™ is only available if you are using the Grams of Carbohydrate meal bolus, and can only be created in the CoZmanager® 2.0 software. CoZmanager® 2.0 PC Communications Software: A Microsoft® Windows®-based computer program designed for use with the Deltec Cozmo® insulin pump. With the CoZmanager® 2.0 software, you can perform pump programming, print or e-mail history reports and pump settings, and save pump and delivery history. CSII: Continuous subcutaneous insulin infusion. Dawn phenomenon: A rise in the early morning blood glucose level due to the activity of hormones in the body.

Symbols and Glossary of Terms 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 effectively use insulin. Diabetes team: You are the captain of the team that includes one or more of the following: your doctor, diabetes educator, nutritionist and support team. Diabetic ketoacidosis (DKA): A life-threatening condition requiring hospital treatment 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. Disconnect: The Disconnect feature allows you to manage being disconnected from the pump to cover missed basal insulin. It prompts you to deliver a disconnect bolus before disconnecting and gives a reminder to reconnect, and prompts you to deliver a reconnect bolus. DKA: See Diabetic ketoacidosis. 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. Extended bolus: A meal bolus delivered over an extended period of time. The extended bolus feature on the Deltec Cozmo® insulin pump is useful when you eat a high protein/fat meal like a large steak dinner or pizza; if you are eating over an extended period of time, like a brunch or banquet; if you are eating certain foods such as drinking a latte or eating popcorn; or if you have gastroparesis. When you activate the extended bolus feature on your pump, you can set it to deliver your bolus over 15 minutes up to 8 hours. Your healthcare provider may provide you with specific suggestions. Keeping records will help determine when and how to best use the extended bolus feature. These are general guidelines: fast

food-bolus over one hour; ethnic food (Chinese, Italian or Mexican)-bolus over two hours; pizza-bolus over a minimum of three hours. Factor: One of two or more values used in a mathematical formula. The pump uses certain factors when making calculations, for instance the correction 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 thirst, frequent urination, blurred vision and high blood glucose reading upon testing. Hypo Manager™: The Hypo Manager™ feature is part of the Correction Bolus function, and allows you to manage low blood glucose by recommending carbohydrate. If you have enabled Hypo Manager™, bolus programming is monitored and if you enter a low blood glucose or the pump calculates that your blood glucose is low or will go low, the Hypo Manager™ feature offers a recommendation for how many grams of fast-acting carbohydrate you should consume to bring your blood glucose up to target. 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, 0.1, 0.5, or 1 units). Then when you program a bolus, the pump counts up or down using the increment you have chosen.

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Symbols and Glossary of Terms Infusion set: The tubing that is attached to the end of the cartridge, through which the insulin is delivered into the body. Infusion site: The area on the body into which the cannula or needle of the infusion set is inserted. Also called the access site. 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 two microprocessors (computer chips) which continuously monitor each other to make sure the systems are working properly. Insulin-to-carbohydrate ratio: The number of grams of carbohydrate covered by each unit of insulin delivered. Your healthcare provider will help you determine your insulin-to-carbohydrate ratio. Ketonuria (Ketosis): A serious condition that indicates your body lacks insulin to move glucose into your cells for energy. The body begins to burn stored fat reserves for fuel. Ketones are produced when fat is burned (metabolized). Ketones can be detected in the blood and urine and are toxic to the body. If left untreated, high ketone levels can lead to diabetic ketoacidosis (DKA). See Diabetic ketoacidosis. 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, 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. Meal Bolus: An insulin dose given at the time of a meal to match the glucose from food eaten. See also Carbohydrate Meal Bolus, Combination Bolus, Extended Bolus, Standard Bolus, Touch Bolus and Units of Insulin Meal Bolus. mg/dl: Milligrams per deciliter. In the USA and certain other countries, your blood glucose level is typically measured in mg/dl. mmol/L: Millimoles per liter. The international standard for measuring blood glucose levels is mmol/L (except in the USA and certain other countries).

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Occlusion: Clog or blockage. Occlusions are associated with the infusion set and infusion site, and mean that insulin delivery is stopped or slowed. 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. Reconnect: The Reconnect feature is the reconnection portion of the Disconnect feature. Once your specified disconnect period has expired, you are prompted to reconnect to the pump and are able to deliver a bolus for the insulin that was missed during your disconnection period. Standard Bolus: The normal method of delivering a meal bolus. The standard bolus will deliver by units of insulin or by carbohydrate grams, depending on how you programmed your pump. Subcutaneous: The area of the body directly below the skin but above the muscle. The infusion set cannula or needle is inserted subcutaneously. Temporary Rate: A feature on the pump which allows you to temporarily increase or decrease the basal rate. Touch Bolus: A method where you can deliver a standard bolus without viewing the pump screen. The Touch Bolus button (on the right side of your Deltec Cozmo® insulin pump) will deliver by units of insulin or by carbohydrate grams, depending on how you personalized your pump. 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 effectively. Units of Insulin Meal Bolus: A meal bolus programmed by units of insulin. Your Deltec Cozmo® insulin pump allows you to easily program an amount of insulin and deliver it.

Important safety information • Warnings • Cautions

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Important Information

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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 Smiths Medical MD, 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 (they are contained within lines at top and bottom). The Help section (starting on page 171) contains information on troubleshooting pump alarms.

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. Smiths Medical 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 appropriate training in all its 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. • Smiths Medical MD, 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 rapid/short-acting U100 insulin, high blood glucose (hyperglycemia) can quickly (within 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. • Do not use pump cases that have a magnetic clasp. They can affect the internal electronics and cause delivery inaccuracy and/or system faults. • Hypoglycemia should be treated immediately- without treatment, hypoglycemia may lead to seizures or unconsciousness. • If left untreated, high ketone levels can lead to diabetic ketoacidosis (DKA), a life-threatening condition requiring hospital treatment. DKA can happen within a few hours when there is not enough insulin available, and can lead to unconsciousness or death. • Be sure to use appropriate infusion sets with the Deltec Cozmo® insulin pump. Using an inappropriate infusion set could result in disruption of insulin delivery. It is important to always test your blood glucose level one to two hours after attaching an infusion set to make sure that it is working properly. See the price list (provided in the carton with your pump) for a list of some recommended infusion sets and other accessories which can be used with your pump. • To avoid accidentally infusing insulin, disconnect the infusion set tubing from your 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). • Whenever you load a new cartridge and attach an infusion set, you should test your blood glucose level within one to two 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 and/or Custom blood glucose alerts to remind you to test your blood glucose level (see Personalizing Alerts, page 94).

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Important Information • There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) infusion sets and cartridges. Dispose of used batteries, infusion sets, cartridges, and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply. • It is very important to ROTATE YOUR SITE AND CHANGE YOUR INFUSION SET EVERY TWO TO THREE DAYS, OR AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. Site rotation and infusion set changes help prevent decreased insulin absorption and infections that could lead to uncontrolled blood glucose levels. • Never stop taking your insulin because of illness. Even if you are too sick to eat, your body still needs insulin. Follow the guidelines and any specific instructions given to you by your healthcare provider. • Insulin pump therapy should be maintained if the patient is alert and able to take responsibility for the insulin pump. Interrupting the delivery of insulin via the pump without providing an alternate delivery of insulin may lead to the rapid development of hyperglycemia, ketonuria or DKA due to a lack of insulin. • Interrupting the delivery of insulin via the pump without providing an alternate delivery of insulin may lead to the development of hyperglycemia (high blood glucose). Untreated hyperglycemia and lack of insulin can lead to ketones in the urine (ketonuria), coma, and death. • Make sure that all caregivers, including 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. • The Deltec Cozmo® insulin pump and accessories include small component pieces that could pose a choking hazard to small children. • The cartridge cap, battery cap and Luer connections are not childproof. Tampering with them can result in over- or under-delivery of insulin.

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• Make sure that the battery cap is fully tightened to avoid an interruption in battery power which can cause the pump to power down and stop the delivery of insulin. A prolonged interruption in the delivery of insulin can result in serious patient injury or death. • If there are any system problems during pump startup, 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. • If there is any damage to the lip and/or threads of the cartridge compartment or cartridge cap, incorrect delivery may result since you may not be able to properly tighten the cartridge cap onto the pump. • Because the method of saving values varies by screen, you should review the program before beginning delivery. • The time and date must be set correctly, since basal patterns, weekly schedule, insulin to carb ratios, correction factors, target blood glucose and some alerts 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. • It is vital that the settings used by the Correction Bolus are correct. You must work closely with your healthcare provider to correctly program these settings. • Talk to your healthcare provider to determine your Correction Bolus Factor(s), Duration of Insulin Action and Target Blood Glucose. • You should receive specific training on programming and using basal patterns. Please carefully read all instructions and talk to your healthcare provider. • Once the pump is locked, you will not be able to enter the menu or stop the pump 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. • The Advanced features can be complex and may not be suitable for every pump user. Talk to your healthcare provider to determine if these features are suitable for you, and do not use the features until you thoroughly understand how they work.

Important Information • You should receive specific training on programming and delivering a meal bolus. Please carefully read all instructions and talk to your healthcare provider. • You should receive specific training on programming and using basal patterns. Please carefully read all instructions and talk to your healthcare provider. • Discuss your individual insulin needs with your healthcare provider. • It is vital that you use the correct serving size and carbohydrate amounts when creating the CozFoods™ list, or bolus amounts (which will be calculated based on the values you use) could be higher or lower than you need and could lead to low or high blood glucose (respectively). • Always use the pump’s Load feature when starting a new cartridge. This will assure that the cartridge is properly loaded. • Always use aseptic technique, particularly when working 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 two or more days (see Aseptic Technique, page 4). • Always read the Instructions For Use provided with the insulin, cartridge, infusion set, and any other accessory used with the Deltec Cozmo® insulin pump. • Make sure the connectors are securely tightened. If not securely tightened, insulin could leak from this connection which could result in high blood glucose (hyperglycemia), as well as leaving an opening for contamination that could lead 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 because sometimes the leak is too small or too slow to actually see a drop of insulin form), as leakage can slow or stop insulin delivery to the body, and allow an opening for contamination leading to infection. If

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insulin delivery is slowed or stopped, high blood glucose (hyperglycemia) will result. You should not change your infusion site right before bed, as you would be unaware of any problems with the site. You must test your blood glucose level one to two hours after starting a new cartridge or changing your infusion site to make sure insulin is being properly delivered. When stopping delivery, remember that since the pump uses only rapid/short-acting insulin, your insulin level will start to fall and blood glucose level to rise very quickly (in as little as 60 minutes). You must test your blood glucose when stopping delivery for any length of time. Talk to your healthcare provider about what you need to do if pump delivery is stopped for longer than one hour. 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 and Combination bolus features, 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. It is vital that the basal patterns are entered correctly. If a basal rate is too high or too low, all your insulin delivery throughout the day and night will be incorrect. Many things can affect how your body uses insulin. Contact your healthcare provider before making big lifestyle changes. For example, starting or stopping an intensive exercise program, or if you experience a significant weight loss or weight gain, etc. In these cases your basal rates may need to be modified. If your pump needs 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 a replacement pump until it is correctly personalized.

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Important Information • 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. Check your infusion site to make sure it is still properly connected to your body (if it looks like it was disturbed or the tape/dressing is pulled up you must assume it is no longer inserted properly and change your infusion set). 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 provider for health advice and CozMore® Customer Service for information on servicing your pump. Be prepared to inject insulin with an insulin syringe or pen. • Use of accessories other than those indicated or adjacent to other equipment may result in increased emissions or decreased immunity of the Pump. The user should verify normal operation of the pump in the configuration and environment in which it is to be used.

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Cautions • Do not use cell phones within 6 inches (15 cm) of 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 problems, remove the pump from use. • The pump may be damaged if stored or transported 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). • The CoZmonitor® module is NOT waterproof. Do not immerse the CoZmonitor® module in any liquid. Before bathing, swimming or any other water activity, you must remove the module from the pump. Heavy perspiration could also gain access to internal components. Allowing the CoZmonitor® module to get wet will cause it to stop working. Repeatedly exposing the CoZmonitor® module to liquids will result in you being charged for replacement modules. Contact CozMore® Customer Service for specifics. • Avoid strong electromagnetic fields, like those present with magnetic resonance imaging (MRI), direct x-ray, and ultrasound as they can affect how the pump works. If you cannot avoid them, you must take the pump off. • Do not use NiCd, 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.

Important Information • The CoZmonitor® Blood Glucose Module will only function when attached to the Deltec Cozmo® insulin pump and cannot be used as a standalone device or with any other insulin pump. • Use only Deltec Cozmo® 3 mL Insulin Cartridges; other manufacturers’ products will not work with the Deltec Cozmo® insulin pump. • The CoZmonitor® Blood Glucose Module will only function when attached to the Deltec Cozmo® Insulin Pump and cannot be used as a standalone device or with any other insulin pump. • Strong household cleaners and chemicals will damage the pump’s outer shell if applied directly or indirectly (if it is on your hands, for instance). Avoid the following in particular: ■ Perfumes and lotions ■ Household cleaners (such as Formula 409®) ■ Jewelry cleaner ■ Petroleum-based products (such as gasoline and GooGone®) ■ Products that contain high levels of DEET (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 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. • Do not use the pump in hyperbaric chambers as they will affect how the pump works and may also cause damage to the pump.

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Important Information

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Preparing for your pump start • Prior to pump start day • Pump start day Deltec Cozmo® Insulin Pump bolus options Carbohydrate counting basics • What is a carbohydrate? • What is carbohydrate counting? • Why count carbohydrate? • How do you count carbohydrates? • Counting grams of carbohydrate • Reading a nutrition label • Counting servings • Managing portions

Meal bolus • Insulin to carbohydrate ratio • Adjusting your insulin to carb ratio • Guidelines for adjusting your insulin to carb ratio Correction bolus • Correction bolus variables • Total daily dose • Target blood glucose • Correction factor(s) • Duration of insulin action • Insulin on board Low blood glucose High blood glucose What to carry in your everyday pack

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Preparing for CozMore®

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