g j i User Manual Deltec Cozmo™ Insulin Pump
Congratulations! You have selected the Deltec Cozmo™ Insulin Pump to help you in the treatment of your diabetes. If you have questions about your insulin therapy or your health, contact your healthcare provider. Our staff at Deltec is available to help you 24-hours a day with the programming and operation of your pump. This manual provides information on programming, using and maintaining your Deltec Cozmo™ Insulin Pump.
ii Table of Contents Important Information Important safety information ................................................... 1 Warnings ........................................................................... 1 Cautions ............................................................................ 4 Explanation of symbols ............................................................ 6 Introduction ............................................................................ 7 Indications ....................
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 ........
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 .............
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.
2 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.
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.
4 Important Information 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.
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.
6 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.
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.
8 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.
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.
10 Important Information 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.
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.
12 Important Information 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.
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.
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.
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
Pump illustrations Figure 1 Figure 2 Battery cap Cartridge cap (Cartridge viewing window) Display Up key Touch Bolus button Left program key Right program key Down key (backlight) 15 About the Pump IR windows
16 About the Pump Description of features and buttons Battery cap (Figure 1) Holds the battery in place in the battery compartment. The pump uses one “AAA” (IEC LR03) alkaline battery. The approximate amount of battery life is displayed in the home screen, and an alarm is given when battery power is low. Keep extra batteries on hand. Display (Figure 1) The display (also referred to as the screen) shows all the programming, operating and alarm/alert information for the pump.
Features Vibration alert If you don’t want the pump to beep during alarms and alerts, you can program it to vibrate instead. This feature can be used in meetings, classrooms, etc. If you choose Vibrate, the “beep” that accompanies each key press is also disabled. Occlusion (blockage) sensor The occlusion sensor continuously tests for blockage that prevents insulin from being delivered. Cartridge sensor There is a sensor in the cartridge chamber that has 2 functions.
18 About the Pump Description of pump display & menus All programming, operating and alarm/alert information is shown in the display. Programming of the pump is menu driven, like a cell phone or ATM. Page 1 of the “home screen” shows the current basal pattern and rate. Page 2 shows the last bolus information. Additionally, you can use a computer and My Treatment Assistant™ to customize certain screens and settings on your pump.
Insulin remaining in the cartridge (approximate) Cozmo™ pump name (or “Personal” label, added using My Treatment Assistant™) Current status information of the pump { 37 Cozmo A 150u Basal: Pattern 1 Rate: 1.150 u/hr Press the b and/or c keys to move through the home screen pages.
20 About the Pump Deltec accessories Deltec offers a variety of products for use with your pump. A complete list of accessories with ordering information is included in the materials supplied with your pump. Cartridge You must use the Deltec Cozmo™ 3mL (300 unit) Insulin Cartridge (reorder number 21-1750) with the pump. Deltec cartridges are latex free. ☞ Caution: Use only Deltec Cozmo™ 3mL Insulin Cartridges; other manufacturers’ products will not work with the Deltec Cozmo™ pump.
Before using the pump for the first time Inserting a battery, programming the regional settings (if required), and setting the time and date are the first things you need to do when you get your pump. During typical use, you can expect an alkaline battery to last approximately 1 month (the “Vibrate” alert uses up battery power faster). Insert a battery 21 About the Pump ☞ Caution: Do not use NiCad, nickel metal hydride, carbon zinc (heavy duty), lithium or any rechargeable batteries.
22 About the Pump Self Tests During the self tests, the pump’s internal computer performs tests on all the major hardware, computer, and electronic systems. ☞ Warning: 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.
Attach the belt clip (Optional) Pinch the clip open and attach it to your clothing waist band or belt (see Figure 8). Slide the pump into the belt clip with the keypad facing out (see Figure 6). D. Zurn, 2002-10-21 «belt-clip-rear.eps» Figure 6 D. Zurn, 2002-10-22 Figure 8 D. Zurn, 2002-10-21 «belt-clip-rotated.eps» You can rotate the clip to whatever position is most comfortable for you (see Figure 7).
24 About the Pump Pump settings The Pump Settings menu allows you to perform certain setup functions, such as setting the time and date, setting up how the pump alarms, and personalizing certain features. (Program Lock is also included in the Pump Settings menu, but is discussed later in this chapter on page 32.) ☞ Warning: 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.
Regional Setting Start at home screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.
26 About the Pump Time and date ☞ Warning: 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. Start at home screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.
Beep or Vibrate Choose Beep or Vibrate* to signal alarms and alerts. Then, if using Beep, decide how loud the beep is. Low is quietest and High is loudest. It is factory preset to High. Start at the home screen Choose Beep/Vibrate, then press Select Basal Pattern Load History Pump Settings Pump Settings Menu Time and Date Beep/Vibrate Program Lock Personalize Press Menu Cozmo Basal: Pattern 1 Rate: 1.
28 About the Pump Personalizing alerts The pump allows you to set up certain alarms and alerts the way you prefer. These alerts/alarms are associated with treatment considerations, personal preference and safety, and can be personalized uniquely for each user. Discuss with your healthcare provider what uses and settings are appropriate for you. All of the settings are factory preset, so you are not required to change any of them.
should occur. For example, if you eat breakfast every day between 7:00AM and 9:00AM, you could select 6:45AM for the “Start” time, and 9:15AM for the “End” time. Then if the pump detects that no bolus was delivered during that period, the pump will give an alert.
About the Pump 30 Start at home screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.150 u/hr Press Home Choose Pump Settings, then press Select Basal Pattern Load History Pump Settings Choose Yes or No, then press Next.
Start at Home screen Stopping and restarting insulin delivery Cozmo Basal: Pattern 1 Rate: 1.150 u/hr You can stop and restart insulin delivery from the home screen. Press Stop Select delivery to stop ☞ Warning: 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.
32 About the Pump Program Lock Program Lock allows you to prevent anyone from entering the menu without the proper code. You can still troubleshoot most alarms. Choose Pump Settings, then press Select Start at Home screen Basal: Pattern 1 Rate: 1.150 u/hr Press Home Basal Pattern Load History Pump Settings be able to enter the menu without the proper code. Touch Bolus is also not allowed when the pump is locked.
Unlocking the menu You can use an item in the menu without turning off the Program Lock by following the procedure below. To turn the Program Lock off, you need to follow the procedure on page 32, but at the “Program Lock / Lock program” screen, choose No. Start at home screen Cozmo Basal: Pattern 1 Rate: 1.150 u/hr Press Menu Lock Code 0 Cancel Next> Enter code (the number 17), then press Next Meal Bolus Correction Bolus Temporary rate Basal Pattern Use any menu item.
34 About the Pump Notes: ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ _____
What’s In This Section? Loading a cartridge Meal bolus Standard bolus (units of insulin): setup Standard bolus: delivery Carbohydrate bolus: setup Carbohydrate bolus: delivery Basal patterns Personalizing basal patterns Editing basal patterns Using basal patterns 3 Using the Pump -Basics
Loading a cartridge The Load feature in the pump menu takes you through each step needed to load a filled cartridge in the pump and start delivering insulin. ☞ Warning: 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 insulin.
36 Using the Pump - Basics 2. Attaching an infusion set and loading a filled cartridge into the pump ☞ Warning: 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). 1.
4. Open the pump’s Load menu and load cartridge. NOTE: You will not be able to load a cartridge that contains less than 20 units (the sensor may have trouble sensing the cartridge amount). Start at Home screen Choose Load, then press Select Press Menu Cozmo Basal: Pattern 1 Rate: 1.
38 Using the Pump - Basics Not ready Pushrod must move forward. Remove cartridge then press OK FastForward Please wait... OK No cartridge detected Cartridge missing or overfilled Install cartridge to confirm sensor Cancel Confirm Sensor Confirmed Now pushrod must move forward Remove carridge then press OK OK *In order for the pump to assure that the cartridge is correctly connected to the pushrod, the pushrod must start in a forward position.
D. Zurn, 2002-10-18 «12-cartridge-cover-luer.eps» 5. Verify, by looking through the cartridge viewing window, that the cartridge is properly attached to the pushrod. Fasten the cartridge cap back onto the pump. Make sure the rib on the cap lines up with the rib on the pump, indicating the cap is secured (see Figure 12).
40 Using the Pump - Basics 3. Fill the tubing Filling forces insulin from the cartridge into the infusion set tubing and pushes air out of the tubing. Filling is complete when you see insulin come out of the end of the tubing and all air is removed. The amount of insulin used to fill the tubing is not counted as part of your daily totals. ☞ Warning: Never use Fill tubing when the infusion set is connected to your body, or you could deliver an unintended bolus.
4. Choosing an access site and inserting the access device • Choose an access site. Anywhere you would normally inject insulin can be used as an access site, including your abdomen, hips, buttocks, upper thighs, etc. Choose an area where you have a sufficient layer of subcutaneous fat. Avoid areas that may be rubbed by clothing (waistband, etc.), and stay at least 2 inches (5cm) away from your belly button.
42 Using the Pump - Basics 5. Fill cannula Filling the cannula is an important step if you are using an infusion set that has a separate access device (needle or cannula). It delivers a small amount of insulin that fills the access device. If you do not fill the cannula, there is a delay in insulin delivery once the pump is started as the access device fills.
6. Set site change reminder and restart delivery The Site Change reminder screens appear here if turned on in Pump Settings / Personalize / Alert (see page 28). Setting the site change reminder will cause the pump to beep (or vibrate) to remind you that it is time to change your infusion set and access site. ☞ Warning: You should not change your access site right before bed, as you would be unaware of any problems with the site.
44 Using the Pump - Basics Meal Bolus ☞ Warning: You should receive specific training on programming and delivering a meal bolus. Please carefully read all instructions and talk to your healthcare provider. There are two different ways to program and deliver a meal bolus, depending on what works best for you. They are: Standard bolus: programmed in units of insulin. You must also decide how you want the pump to “increment,” or count when you are programming a bolus.
Standard bolus (units of insulin): setup Choose Pump Settings, then press Select Start at Home screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.
46 Using the Pump - Basics Standard bolus: delivery Start at Home screen Cozmo Basal: Pattern 1 Rate: 1.150 u/hr Meal Bolus Correction Bolus Temporary rate Basal Pattern Press Select Standard Extended Bolus Press Select (If a Correction Bolus is set to display in Meal Bolus) Meal Bolus Meal Bolus Delivering Bolus: x.xxu 0.
Carbohydrate bolus: setup Choose Pump Settings, then press Select Start at Home screen 3 7 Cozmo A Basal: Pattern 1 Rate: 1.
48 Using the Pump - Basics Carbohydrate bolus: delivery Start at Home screen Cozmo Basal: Pattern 1 Rate: 1.150 u/hr Press Menu (Menu appears only if more than one bolus type is available) Bolus Menu Meal Bolus Correction Bolus Temporary rate Basal Pattern Standard Extended Bolus (If a Correction Bolus is set to display in Meal Bolus) Carbohydrates Press Select Carbohydrates 25 Delivering Bolus: x.xxu 0.
Basal patterns ☞ Warning: You should receive specific training on programming and using basal patterns. Please carefully read all instructions and talk to your healthcare provider. These settings should be programmed before you actually program (edit) the individual basal patterns. The pump allows up to 4 basal patterns, each of which can contain up to 48 time/rate “segments.
50 Using the Pump - Basics Personalizing basal patterns Start at Home screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.
Editing basal patterns ☞ Warning: 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. ☞ Warning: 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 significant weight loss or weight gain, etc.
52 Using the Pump - Basics Editing basal patterns Choose a pattern to edit, then press Select* Select Basal Start at Pattern, then Home screen Press press Select Menu Cozmo Basal: Pattern 1 Rate: 1.
Using basal patterns Many of the screens in the Basal Pattern menu can be personalized by programming the pump or by using My Treatment Assistant™. If the screens on your pump have been personalized, they will be different than those shown here. It is also possible to program the pump to display only specified basal patterns. Talk to your Choose Basal Pattern, then press Select Start at home screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.
54 Using the Pump - Basics Notes: ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ____________________________________________
What’s In This Section? About the alarms (beep/vibrate settings) Troubleshooting Alarms Alerts Other Messages Cleaning your pump Servicing your pump Troubleshooting health problems Low blood glucose High blood glucose Diabetic Ketoacidosis (DKA) Skin infections Tips for sick days Sick day plan 4 Help Personal pump removal guidelines Your pump & Extreme temperatures Water Contact sports Your basal rates, boluses & Your weight Your level of exercise Your growth Your mestrual period Starting new medications/
About the alarms (Beep/Vibrate settings) The pump can be set to “Beep” or “Vibrate” when an alert or alarm occurs (see chapter 2, page 27). With Beep selected, the pump beeps when you press a key. When Vibrate is selected, the pump will not beep (or vibrate) when keys are pressed. (NOTE: the battery is used much more quickly when you use Vibrate.) There are several types of alarm tones/vibration patterns: • Continuous alarm: Indicates a problem which caused insulin delivery to be stopped.
56 Help Troubleshooting Alarms Message in display What it means / Alarm How to make it stop Battery depleted Delivery stopped Insert a new battery Delivery stops. The battery does not have enough power for the pump to work. Continuous alarm; or, if power is too low, 2 beeps repeated continuously. You must change the battery immediately.
Alarms - continued Message in display Cartridge removed Press OK to begin load process What it means / Alarm How to make it stop Delivery stops. Pump detected that cartridge was removed or not properly installed. Continuous alarm. Press OK. Disconnect the tubing from the access device. Correctly load a cartridge onto the pushrod and prime the tubing (see page 35). Cartridge very low Basal is delivering No bolus allowed or bolus suspended The cartridge is nearly empty.
58 Help Alarms - continued Message in display Q No key pressed in xx:xx hours. Pump will stop and alarm in 30 seconds ! This is an insulin pump Pump is stopped Medical help may be required What it means / Alarm How to make it stop Delivery will stop in 30 seconds unless you press Cancel. Attention alarm. Press Cancel. This is the notification of the Automatic Off alarm. If you do not press Cancel, the pump will activate the Automatic Off alarm in 30 seconds. This is the Automatic Off alarm.
Alerts - continued Message in display What it means / Alarm How to make it stop Cartridge Volume Low Change cartridge soon The amount of insulin left in the cartridge is low. Alert repeats at intervals until Cartridge Very Low alarm occurs. Attention alarm. Press OK. Replace the cartridge as soon as practical. It is time to test your BG level to make sure it is within your target range. Attention alert. Press OK. Perform BG testing. If it is within your target range, do nothing.
60 Help Alerts - continued Message in display What it means / Alarm How to make it stop The pump has calculated that the “Current Blood Glucose” you entered would result in a BG level below your target. No correction bolus will be suggested. Attention alarm. Press OK. Due to “insulin on board” (from 1 or more previous boluses which are still affecting your BG level), the pump has calculated a 0 (zero) bolus at this time.
Alerts - continued Message in display Program Defaulted Setup of cartridge volume required With no cartridge present, press Next What it means / Alarm How to make it stop All pump settings have been reset to the default values, and the cartridge volume needs to be rechecked to make sure it will be displayed correctly on the home screen. Attention alarm. Remove the cartridge (if present), then press Next.
62 Help Other messages Message in display What it means / Alarm How to make it stop Temp. Rate Incomplete Remaining Duration: xx.xxhr Rate: xx.xxx% Continue? Your pump was delivering a Temporary Rate when power was lost. Attention Alarm. To continue delivering the temporary rate, press Yes. If you do not want to continue the temporary rate, press No.
Messages - continued Message in display What it means / Alarm How to make it stop No cartridge detected Cartridge missing or overfilled. Install cartridge to confirm sensor You have attempted to use the “Load” portion of the load cartridge menu, but no cartridge is detected. It may also mean that you filled the cartridge too full (more than 300 units). Single alarm.
64 Help Messages - continued Message in display What it means / Alarm How to make it stop Temporary Rate Active Editing basal pattern will end remaining temporary rate You have attempted to edit a basal pattern while a temporary rate is active. Single alarm. Press OK to cancel the temporary rate and edit basal pattern, or press Cancel to continue temporary rate.
Cleaning your pump Routinely clean your pump to prevent buildup of dirt or dried fluids. Try to wipe spills off the pump right away to avoid a sticky buildup, which will be harder to wipe off later. When cleaning your pump, ONLY use a sponge or soft cloth with a solution of warm water and a mild soap, such as liquid dish or hand soap. ☞ Caution: 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).
66 Help Servicing your pump Should your pump become damaged or broken, or if it is not working properly, you will need to call Deltec, Inc. to arrange to have the pump replaced. Before sending the pump, make sure that you have a complete record of all your pump settings so that you can program the replacement pump correctly when it arrives.
Troubleshooting health problems Low blood glucose (hypoglycemia) Blood glucose 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. Some causes of low blood glucose include too much insulin given, increased activity/ exercise, decreased food/meal frequency, and alcohol consumption.
68 Help High blood glucose (hyperglycemia) Problem Corrective Action Blood glucose level higher than target. Signs and symptoms include: increased thirst, frequent urination, blurred vision and high BG reading upon testing. See the table at right and on the following pages for some possible causes of high blood glucose. Blockage (occlusion) See Troubleshooting Pump Alarms, this chapter. Increased food/ meal frequency Deliver a Correction bolus to lower your BG level.
Infusion Set and/or Access Site problems : Problem Corrective Action Problem Corrective Action Poor insulin absorption Check access site for lumps, scarring or bruising (hypertrophied areas). Move the access site, if necessary. Needle/cannula dislodged If needle/cannula is dislodged, change infusion set and access site. Access site red, itchy, irritated; bumps or nodules at site Deliver a Correction bolus to lower your BG level. Move the access site, if necessary.
70 Help 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.
Skin infections Skin infections may be experienced when using an insulin pump because the cannula or needle remains in place for 2 to 3 days. It is vital that proper aseptic technique be used. Signs and symptoms may include: redness, swelling, soreness, drainage, and/or the skin may feel warm to the touch Treatment: immediately change your infusion set and access device, and switch to a new access site well away from the original site. Contact your healthcare provider.
72 Help My sick day plan Emergency supplies ______________________________________________ ______________________________________________ Always have emergency supplies on hand. The supplies should include: ______________________________________________ • emergency contact phone numbers ______________________________________________ • medical ID (bracelet, etc.
Personal pump removal guidelines Your pump &: ______________________________________________ Extreme temperatures ______________________________________________ Insulin in the cartridge can freeze if exposed to temperatures below 32˚F (0˚C) and can lose its potency. If you are outside in very cold temperatures for any length of time, keep the pump next to your body and covered by warm clothing.
74 Help minutes. Dry the pump off with a clean towel when you are finished. If swimming in salt water, rinse the pump in tap water and then dry it off with a clean towel to prevent a salt buildup on the pump’s outer shell and display. You must use a watertight dressing on your access site when entering the water. Contact sports When participating in sports, particularly contact sports, talk to your healthcare provider about whether you need to remove your pump.
Herbal supplements may also have an effect on your health. Never begin taking any herbal supplement without first discussing it with your healthcare provider. If you drop your pump or hit it hard If you drop your pump or hit it against something hard, you will need to immediately look it over carefully to make sure it is not damaged.
76 Help Notes: ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ _______________
What’s In This Section? Programming and using these features Correction bolus Personalizing the correction bolus Delivering a correction bolus Touch bolus Making touch bolus available Delivering a touch bolus Extended bolus Making extended bolus available Delivering an extended bolus Stopping an extended bolus 5 Using the Pump -More Features Combination bolus Making combination bolus available Delivering a combination bolus Stopping a combination bolus Temporary rate Personalizing the temporary rate Usin
Programming and using these features ☞ Warning: Programming and using the features de- scribed in this chapter includes information that may require a greater understanding of insulin pump therapy and should not be attempted without help from your healthcare provider. ☞ Warning: Programming many of these settings can only occur after testing and fine-tuning so that you get the best possible results from insulin pump therapy. You should receive specific training on programming and using the pump.
78 Using the Pump - More Features Once your duration of insulin action is correctly programmed, when you use the correction bolus feature any still active insulin in your Bolus to adjust BG body from a previous bolus will 9 mg/dl plus be taken into consideration and 2.50u meal the screen that tells you the bolus amount recommended u shows that the amount was reduced for insulin on board reduced due to this “insulin on
Personalizing the correction bolus Start at home screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.
80 Using the Pump - More Features Delivering a correction bolus (main menu*) Start at Home screen Cozmo Basal: Pattern 1 Rate: 1.150 u/hr Meal Bolus Correction Bolus Temporary Rate Basal Pattern Choose Correction Bolus, then press Select Current Blood Glucose 172 mg/dl Factor: 1 unit per 25 mg/dl Target: 130 mg/dl To cancel bolus before it is complete, press Cancel.
Touch Bolus The Touch Bolus feature allows you to bypass the menu when delivering a meal bolus. It is called the Touch Bolus since you can program and deliver a bolus using sound or vibrations, without having to look at the pump’s screen. The Touch Bolus button, on the side of the pump, is pressed to activate and use Touch Bolus.
82 Using the Pump - More Features Making Touch Bolus available Choose Pump Settings, then press Select Start at Home Screen Choose Delivery, then press Select Pump Settings Menu Time and Date Beep/Vibrate Program Lock Personalize Personalize Menu Alerts History Regional Settings Delivery Press Menu Cozmo Basal: Pattern 1 Rate: 1.
Delivering a Touch Bolus Delivering a Touch Bolus is performed by pressing the Touch Bolus button on the side of the pump. A Touch Bolus can only be initiated when the pump is at the screensaver or home screen. The first press of the button causes the pump to beep or vibrate twice to indicate you are now ready to program and deliver a touch bolus. Then, each press of the button will adjust the size of the bolus by a predefined increment.
84 Using the Pump - More Features 4. When the number of beeps or vibrations is correct, press and hold the Touch Bolus button until it beeps or vibrates once (to indicate delivery has started and you can let go of the button). After the bolus delivers, the pump returns to the home screen and beeps or vibrates twice to indicate that the bolus is complete. Touch Bolus Carbohydrate 25 gm Amount Press Touch Bolus button once (2 beeps or 2 vibrations); amount screen appears Touch Bolus 2.
Extended Bolus Some meals release glucose into the bloodstream slowly. The extended bolus is designed to deliver the bolus of insulin over this extended period. The extended bolus can be used when you eat a high protein or high fat meal, when you eat over a prolonged period (such as at a banquet), or if you have gastroparesis. NOTE: Once you press Deliver to begin delivering an extended bolus, the pump will wait until the next “3 minute” interval (for example 12:00, 12:03, 12:06, etc.).
86 Using the Pump - More Features Personalizing the extended bolus Choose Pump Settings, then press Select Start at Home Screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.
Delivering an extended bolus Start at Home screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.150 u/hr Meal Bolus Correction Bolus Temporary rate Basal Pattern Choose Extended Bolus,t hen press Select Bolus Menu Standard Extended Combination
88 Using the Pump - More Features Stopping an extended bolus Start at Home screen Select delivery to stop Cozmo All Delivery Temporary Rate Extended Press Stop Basal: Pattern 1 Rate: 1.150 u/hr Select> Choose Extended, then press Select Extended Bolus Press Yes Remaining Amount: 1.
Combination Bolus The combination bolus combines the features of the standard and extended bolus, which can be used when your meal consists of both rapidly and slowly absorbed carbohydrates, such as pizza. You program a percentage of the bolus to be delivered immediately, then the remainder over a programmed period of time. NOTE: Once you press Deliver to begin delivering a combination bolus, the pump will wait until the next “3 minute” interval (for example 12:00, 12:03, 12:06, etc.).
90 Using the Pump - More Features Personalizing the combination bolus Choose Pump Settings, then press Select Start at Home Screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.
Delivering a combination bolus Start at Home screen Press Select Press Menu Cozmo Basal: Pattern 1 Rate: 1.150 u/hr Meal Bolus Correction Bolus Temporary rate Basal Pattern Delivering Bolus: x.xxu 0.75 u Cancel Home> Select> Choose Combination, Then press Select Bolus Menu Standard Extended Combination Combination Bolus Combination Bolus Amount: 1.
92 Using the Pump - More Features Stopping a combination bolus Start at Home screen Select delivery to stop Cozmo Basal: Pattern 1 Rate: 1.150 u/hr Select> Choose Combination, then press Select Combination Bolus Press Yes Remaining Amount: 1.
Temporary Rate Temporary Rate allows you to temporarily raise or lower your basal rate. This feature can be useful when you need less insulin (for example, during exercise), or when you need more insulin (for example, when you are sick). ☞ Warning: Discuss your individual insulin needs with your healthcare provider. You can program a temporary rate using “Percent” or “Units/Hr.
Using the Pump - More Features 94 Personalizing the temporary rate Choose Pump Settings, then press Select Start at Home screen Press Menu Cozmo Basal: Pattern 1 Rate: 1.
Using the temporary rate Start at Home screen Select Temporary Rate, then press Select Press Menu Select type, then press Select * Basal: Pattern 1 Rate: 1.150 u/hr Meal Bolus Correction Bolus Temporary Rate Basal Pattern Temporary Rate Menu Standard Exercise Temp Rate 3 Select> Select> Temporary Rate Temporary Rate Duration: 00:30 hr Rate: 100 % Duration: 00:30 hr Rate: 0.
Using the Pump - More Features 96 Stopping a temporary rate Start at Home screen Select delivery to stop Cozmo Press Stop Basal: Pattern 1 Rate: 0.950 u/hr Temp Rate Active Select> Choose Temporary Rate, then press Select Temporary Rate Cozmo Basal: Pattern 1 Rate: 1.150 u/hr Press Yes Remaining Time: 0.
Notes: ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ _________________________
98 Using the Pump - More Features Notes: ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ _____________________________________
What’s In This Section? History Personalizing history Viewing history on the pump Communications My Treatment Assistant™ PC Communications System 6 History & Communications
History daily total for a number of days (you specify 2 to 30 days), and calculates an average. The pump stores history in 2 ways: The available history reports are: • by the delivery date; the pump stores delivery information for the previous 90 days • as events; the pump stores information for the previous 2000 events.
100 History & Communications Personalizing history Choose Pump Start at Settings, then Home screen Press press Select Menu Cozmo Basal: Pattern 1 Rate: 1.
Viewing history on the pump Once the reports are set to display in the menu, you can view them as part of History in the main menu. port.” You must wait until there is enough data stored in history. When your pump is new, you must allow enough time for the pump to accumulate data.
102 History & Communications Communications My Treatment Assistant™ PC Communications System My Treatment Assistant™ is a Microsoft® Windows®based program that allows the pump to communicate with a computer. My Treatment Assistant™ consists of 3 parts: • Personalize - personalize is set up like the pump menu.
For specific information on installing My Treatment Assistant™ on your computer and connecting your pump to the computer, please see the Getting Started booklet supplied with My Treatment Assistant™. In order for the pump to communicate with a computer, your computer must have an IR adapter.
104 History & Communications Notes: ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ __________________________________________
What’s In This Section? Pump development standards Pump specifications Description of pump safety systems Inspecting the pump 7 Technical Information Myriad
Pump development standards AAMI ID26: 1998 - Medical Electrical Equipment — Part 2: Particular requirements for the safety of infusion pumps and controllers ANSI/AAMI HE48: 1993 - Recommended Practice — Human factors engineering guidelines and preferred practices for the design of medical devices. (February 5, 1988 version) Design guideline.
106 Technical Information ment 1 (1996; Amendment 2 (1996) CISPR14 (1993) - International Special Committee on Radio Interference, limits and methods of measurement of radio interference characteristics of household electrical appliances, portable tools and similar electrical apparatus.
Bolus volume at blockage (occlusion) release: Approximately 4 units Power source: One AAA (IEC LR03) alkaline battery. ☞ 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.
108 Technical Information Blockage (occlusion) alert: 18 psi ± 5psi Bolus accuracy at set value of 0.1u: ± 15% (measurement error ± 10%) Bolus accuracy at set value of 25u: ± 1.5% (measurement accuracy ± 0.5%) Maximum volume infused under single fault condition: Less than 2 units Delivery rate during bolus: Approximately 0.05 units per second minimum, 1.
Bolus increment: 0.05 units, 0.10 units, 0.50 units or 1.00 units Default: 0.
110 Technical Information mmol/L: 0.2 to 12 mmol/L in the following increments: • 0.2 to 1.5 mmol/L in increments of 0.05 mmol/L • 1.5 to 5 mmol/L in increments of 0.25 mmol/L • 5 to 12 mmol/L in increments of 0.5 mmol/L Default: 2.75 mmol/L Duration of insulin action: 02:00 to 08:00 hours in 00:15 increments Default: 03:00 Target blood glucose: mg/dl: 80 to 150 mg/dl in 5 mg/dl increments Default: 150 mg/dl mmol/L: 4.4 to 8.3 mmol/L in 0.1 mmol/L increments Default: 8.
Basal Pattern User can edit (4 patterns, each with a possible 48 time/rate segments) and start using basal patterns Delivery Specifications: Time: Midnight to 11:30PM in 00:30 increments or Midnight to 23:30 in 00:30 increments Default: --:-Rate: 0.00 u/hr (units/hour) or 0.05 u/hr to basal rate maximum Default: 0.
112 Technical Information Averages: User chooses number of days to average over: 2 to 30 days in 1 day increments Default: 7 days Pump Settings / Personalize / History Display in menu: Delivery summary: Yes or No Default: No Average delivery summary: Yes or No Default: No Basal as Percent of TDD (Total Daily Dose): Yes or No Default: No Avg basal as Percent of TDD: Yes or No Default: No Bolus history: Yes or No Default: No Complete history: Yes or No Default: No Pump Settings Time and Date: Allows user t
Default: 08:00 Display site reminder: Yes or No Default: No Missed Meal Bolus Alerts: User can program up to 4; active alerts indicated by ;: Yes or No Default: No If Yes, user determines interval start and end time to monitor for bolus: 12:00AM (00:00) to 11:30PM (23:30) in 00:30 increments Default: 12:00AM (00:00) Regional Settings Time Format: 12-hour or 24-hour Default: 12-hour Date Format: mm/dd/yy or dd/mm/yy Default: mm/dd/yy Number format: Decimal shown as Period or Comma Default: Period 113 Tech
Technical Information 114 Accuracy test results The following graphs are designed to show flow accuracy of the pump against given time periods. All graphs were plotted using a Deltec Cozmo™ 3mL Insulin Cartridge (21-1750) and Deltec Cozmo™ Essential Infusion Set (21-7200). 15 minutes 1455 minutes (24 hours, 25 minutes) 2.00 units/hr Programmed rate: 0.025 0.020 0.015 0.010 2002-Nov-15 D. Zurn «Graph Startup Cozmo 2.eps» 0.005 0.
Flow rate from startup Time interval: Total time: Programmed rate: 0.0009 0.0008 0.0007 0.0006 Flow 0.0005 (ml/hr) 0.0004 0.0003 0.0002 0.0001 0.0000 15 minutes 1485 minutes (24 hours, 45 minutes) 0.05 units/hr Flow rate error Programmed rate: Average flow rate: Mean flow error: 40 Startup Curve 30 Epmax 20 % Error of Flow 10 60 150 330 570 T (min) 930 0 -10 -20 0 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 T (min) -30 -40 115 0.05 units/hr 0.05 units/hr -00.
116 Technical Information Key hardware safety features include a watchdog timer circuit, motor driver and motor watchdog circuits, and a voltage detector circuit. Each safety circuit performs a unique function to ensure the overall safety of the pump. By setting a flag in the memory and not strobing the watchdog, the microprocessor can force a watchdog time out. After being reset, the microprocessor checks the status flag to see if this was a time out test.
verifies this function during the watchdog test described above. Voltage detector circuit Low voltage detection is performed by part of the watchdog circuit and by the microprocessor via software. 3 low voltage levels are detected. The first 2 levels are detected by software and the 3rd by hardware. The 1st level to be reached is the Low Battery Warning threshold, which occurs when the battery voltage decays to a point where less than 10% operating time is available.
118 Technical Information ent from the written data, the software stops insulin delivery, initiates an alarm (either beep or vibrate) and a system fault alarm message appears in the display. Motor circuit check At power up and at regular intervals thereafter, the motor circuit is checked to ensure that no power is being applied to the motor unless the motor is actually on.
Data used in calculations Calculations on data used in some way to control delivery of insulin are performed redundantly. The 2 calculated values are then compared. If the 2 values do not match, the software stops insulin delivery, initiates an alarm (either beep or vibrate) and a system fault alarm message appears in the display. Timer data registers The data in the Real Time Clock is checked at regular intervals.
120 Index Index A Access site 9, 41, 69 Accessories 20 belt clip 23 cartridge 20 infusion set 20 IR adapter 20 Accuracy test results 114 Alarms 27, 55, 57 Beep 27, 55 troubleshooting 56 Vibrate 27, 55 Alerts 28, 58 automatic off 28, 58 battery depleted 56 blockage 56 glucose reminder 2, 28, 35 low cartridge 28 missed meal bolus 28 site reminder 28 system fault 57 troubleshooting 58 Aseptic Technique 2, 9, 35, 71 Automatic Off alarm 28, 58 Bolus 10 D B C Backlight 18, 55 Basal Rate 9 & medication / s
display in menu 86 stopping 88 F Factor 11 Fill cannula 42 Fill tubing 40 Fluid path 9, 11 G Gastroparesis 11 Glucose Reminder 2, 28, 35 H History 9, 17, 99 reports 99 viewing 101 Home screen 18, 19 customizing 18 Hyperglycemia 3, 11, 41, 68 Hypoglycemia 2, 11, 35, 36, 67 I Increment 11 Infusion set 20, 69 Infusion set tubing 2, 20 121 Index air in tubing 3, 41 Leaks at connectors 3, 41, 75 Inspecting and testing the pump 119 IR adapter 20 IR windows 16 L Load Cartridge 1, 2, 35, 37 fill cannula 42
122 Index Regional Settings 24 date format 24 number format 24 time format 24 Restarting delivery 31 Delivery 108 General 106 Sports 74 Subcutaneous 12 Suspending delivery 31 Symbols 6, 18 System fault alert 57 S T Safety features and fault detection 116 hardware 116 motor drive 116 voltage detection 117 watchdog 116 Safety Information 1 Screensaver 18 Self tests 22 Servicing your pump 66 Sick days 71 Site Reminder 28, 43 Skin infections 71 Software safety features 117 hardware-related 117 keypad enco
Limited Warranty Deltec, Inc. (the “Manufacturer”) warrants to the Original end-user Purchaser that the Deltec Cozmo™ Insulin Pump (the “Pump”), excluding accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with this User’s Manual, for a period of four (4) years from the date of purchase by the Original end-user Purchaser.
124 Warranty sible for any incidental, special or consequential damages of any kind or nature caused by or arising out of a defect or malfunction of the Pump. Warranty Procedure Notice of the claimed warranty defect must be made in writing, fax or by telephone to the Manufacturer as follows: Attention: Deltec, Inc., 3183 Riverport Tech Center, Maryland Heights, MO 63043 U.S.A. Telephone: 1.800.826.9703. Facsimile: 1.800.209.2145 or if outside the USA contact your local distributor.
∂ Deltec, Inc. St. Paul, Minnesota 55112 USA www.DeltecCozmo.com Customer Service (USA, Canada): European Representative: Graseby Medical Ltd. WD24 4LG, UK Tel. +44 (0)1923 246434 1-800-826-9703 Fax: 1-800-209-2145 B Deltec Cozmo, Deltec Cozmo logo design, The Freedom to Be You and My Treatment Assistant are Deltec, Inc. trademarks. Microsoft® and Microsoft® Windows® are trademarks of Microsoft Corporation. I.V. Prep® is a registered trademark of Zeneca Pharmaceuticals, a business unit of Zeneca Inc.