User's Manual

ManualsBrandsInsulet ManualsElectronicsUST600 PDM

Table Of Contents

Contacts and Important Information

Name

Address

Telephone and Fax

Email Address

Name

Address

Telephone and Fax

Email Address

Name

Address

Telephone Number(s)

Policy Number

Name

Address

Telephone and Fax

Email Address

OmniPod System Start Date: ____________________________

PDM Model UST600 Serial Number: _____________________

Emergency Services:

Dial 911 (USA only; not available in all communities)

Insulet Corporation

9 Oak Park Drive, Bedford, MA 01730

Customer Care (24 hours/7 days): 800-591-3455

When calling from outside the United States: 781-457-5098

Customer Care Fax: 877-467-8538

Web site: MyOmniPod.com

Doctor

Nurse/Educator

Health Insurance

Pharmacy

Use the spaces below to record important health and product information.

Summary of content (174 pages)

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Contacts and Important Information Use the spaces below to record important health and product information.
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© 2013 Insulet Corporation. All rights reserved. OmniPod is a registered trademark of Insulet Corporation. U.S. Patent No. 6,740,059. Third-party trademarks used herein are the trademarks of their respective owners.
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Contents Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii About This User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Conventions and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix Important Information . . . . . . . . . . . . . . . . . . . . .
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Contents Personalized Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Create a basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Enable an existing basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Change, rename, copy, or delete a basal program . . . . . . . . . . . 21 Temporary Basal Rates and Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 What is a temporary basal rate? . . . . .
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Contents Safe storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . The ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Insulin gauge and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Contents User Information/Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 Add or change user information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 9 Living with Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Your Role: Safely Using the OmniPod System. . . . . . . . . . . . . . . . . . . 90 Daily Diabetes Management Activities . . . . . . . . . . . . . . . . . . . . . . . . . 90 Check your blood glucose frequently.
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Contents OmniPod System Options and Settings . . . . . . . . . . . . . . . . . . . . . . . 129 Pod Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130 Accuracy Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Flow rate error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Personal Diabetes Manager Specifications . . . . . . . . . . . . . . . . . . . .
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Introduction n About This User Guide Symbols Symbol viii Term Meaning Warning Describes potential serious adverse reactions, or indicates conditions that could cause death or serious injury. Caution Caution: Consult accompanying documents. Note Provides helpful information. Tip Offers a suggestion for successful use of the OmniPod® Insulin Management System. This User Guide is intended for use only with PDM model UST600. To learn which version of the PDM you have, turn it over.
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Introduction Screen displays shown in this User Guide are for illustrative purposes only and should not be considered suggestions for user settings. Consult with your healthcare provider to determine the appropriate settings for you. Convention/Term Meaning Icon An image on the PDM screen that indicates a menu option or item of information. A table of screen icons appears in the Appendices.
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Introduction Contraindications Insulin pump therapy is NOT recommended for people who are either: • Unable to perform at least four (4) blood glucose tests per day • Unable to maintain contact with their healthcare provider • Unable to use the System according to instructions The OmniPod System should NOT be used in a hyperbaric chamber as there is a potential for an explosion. There are active electronics inside the Pod and PDM, and a hyperbaric chamber has high concentrations of oxygen.
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Introduction If you are having symptoms that are not consistent with your blood glucose test and you have followed all instructions described in this User Guide, call your healthcare professional. n Your Role: Safely Using the OmniPod System Pump therapy requires substantial caregiver involvement, especially among children. Work with your healthcare provider to establish diabetes management guidelines and settings that best fit your, or your child’s, needs.
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Introduction Your healthcare provider will give you all the tools and training you need to be successful with the OmniPod Insulin Management System. However, in the end, your success depends on YOU. You must become actively involved in your own diabetes management to enjoy the outstanding control, freedom, and flexibility that is possible with the OmniPod System.
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CHAPTER 1 Your New OmniPod Insulin Management System n Insulin Delivery with the OmniPod System The OmniPod® Insulin Management System is an innovative continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy in a way no conventional insulin pump can. The System’s innovative design and features allows you to live your life—and manage your diabetes—with unprecedented freedom, comfort, convenience, and ease.
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1 Your New OmniPod Insulin Management System n How Does the OmniPod System Work? The Pod is a small, lightweight, self-adhesive device that you fill with insulin and wear directly on your body. The Pod delivers precise, personalized doses of insulin into your body through a small flexible tube (called a cannula), based on instructions that you program into its wireless companion, the Personal Diabetes Manager. The cannula is inserted only once with each Pod.
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Your New OmniPod Insulin Management System You can also enter your own favorite foods, snacks, or entire meals as “carb presets.” Presets contain the grams of carbohydrate in the food item or meal. Next time you eat this same food, you don’t have to count the carbs; just select your carb preset and the System does the calculating for you. The System stores up to 36 carb presets.
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1 Your New OmniPod Insulin Management System n The Pod n The Personal Diabetes Manager The Pod (Figure 1-1) is applied to your skin with an adhesive, similar to an adhesive bandage. All Pod operations are programmed and controlled through the Personal Diabetes Manager (PDM; Figure 1-2).
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Your New OmniPod Insulin Management System 1 Buttons that program and control the OmniPod System Button Action Home/ Power Pressing and holding turns the PDM on and off. When the PDM is on, pressing this button (quickly/briefly) displays the Home screen, from which you can choose a menu item or view the Status screens (shown later in this chapter). Up/Down Controller Pressing and releasing scrolls through a list of available menu options or numbers, so you can pick the one you want.
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1 Your New OmniPod Insulin Management System Primary screens Messages on the screen either: • Let you identify your PDM • Tell you how the System is operating • List menu choices • Explain how to perform certain tasks The System’s primary screens are the ID screen (Figure 1-3), the Status screen (Figure 1-4), and the Home screen (Figure 1-6 on the next page). Figure 1-3 Figure 1-4 ID screen The System displays an ID screen to make the PDM easy to 6 identify when you first turn it on.
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Your New OmniPod Insulin Management System If a Pod has not yet been activated (during Pod changes), the screen displays “No active Pod. Would you like to activate a Pod now?” (See Chapter 5, Using the Pod, for details on activating a Pod.) Status support screen From the Status screen, press the User Info/Support button to see details about the current insulin on board (IOB) in your body (Figure 1-5). See page 31, for additional information describing insulin on board (IOB).
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1 Your New OmniPod Insulin Management System n Safety Features Table 1: Minimum time The OmniPod System’s state-of-the-art design includes the latest safety technology. Its built-in safety features include: Automatic priming, safety checks, and insertion Every time you activate a new Pod, the System automatically primes and performs a safety check on the Pod, then inserts and primes the cannula (see Chapter 5, Using the Pod).
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CHAPTER 2 Getting Started n The OmniPod Starter Kit Your initial shipment contains everything you need to begin using the OmniPod System. If you are a first-time OmniPod System user, you need to meet with your healthcare provider for training and System setup before using it. To get a head start on learning about your new OmniPod System, review this User Guide. If you have a basic understanding of the System in advance, you will get more out of your training sessions.
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2 Getting Started Figure 2-1 Figure 2-2 n The Setup Wizard The first time you turn on the Personal Diabetes Manager, the Setup Wizard comes on automatically. Although setup is easy with the Wizard, if you are a first-time user, your healthcare provider must guide you through the process. Setup takes only a few minutes and is easy to do: • Use the Up/Down Controller buttons to increase or decrease a number, or to move up or down a list.
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Getting Started Enter your PDM ID 1. Use the Up/Down Controller buttons to scroll through the list of characters. An up-and-down-arrow symbol on the screen indicates the character you are changing. 2. Press the middle Soft Key (labeled with the right arrow) to move the underscore to the next character. 3. Enter each character one at a time. For example, if you want to enter your name, you might enter J, a, n, e, [space], S, m, i, t, h.
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2 Getting Started 3. 4. 5. 6. Choose the current month, then press Next. Enter the current day of the month, then press Next. Choose the date format you prefer, then press Next. Press Confirm, to save the date and time settings (Figure 2-4 on the next page). The initial basal program created with the Setup Wizard is named basal 1. You can change the name in the Settings > Basal Programs menu (see Chapter 3, Understanding and Adjusting Basal Rates).
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Getting Started 5. Press Save to accept the basal program you have set. To see the basal program as a list, press List. To return to the graphic view, press Graph. 6. Choose a temporary basal feature, then press Next. Choose % to show temporary basal rates as a percent increase or decrease of your current basal rate. Choose U/hr to show temporary basal rates in units per hour. Or choose Off to turn off the temporary basal feature.
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2 Getting Started c. Enter an end time for the target BG segment, then press Next. d. Enter a target blood glucose value, then press Next. Use the Up/Down Controller buttons to enter the “correct above” value or “correction threshold” (the BG value above which you want the PDM to suggest a correction bolus), then press Next. e. Press Confirm to accept the target BG profile you have set (Figure 2-7) f. When you have finished entering segments, press Done. 4.
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Getting Started 4. Press Save to accept the ratios you have set. Enter correction factor 1. Use the Up/Down Controller buttons to enter how much one unit of insulin decreases your blood glucose, then press Next. Press Confirm, then continue to step 2. 2. To save the correction factor, press Done. To change the factor, select the segment you wish to change and press Edit. You can define correction factors for up to 8 time segments. To enter additional correction factors, choose [add new], then: a.
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2 Getting Started Select bolus increment and enter maximum bolus 1. Choose a bolus increment (how much each press of the Up/Down Controller buttons will increase or decrease a bolus amount)—either 0.05, 0.10, 0.50, or 1.00 units of insulin—then press Next. 2. Choose the maximum bolus you can give at one time, then press Next. The maximum bolus default is 10 units. Check with your healthcare provider before adjusting these settings.
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CHAPTER 3 Understanding and Adjusting Basal Rates n What Is a Basal Rate? A basal rate is a small base or background amount of insulin that is delivered, at a preset rate, continuously for a specified period of time. Even without eating, our bodies need a small, constant supply of insulin for normal daily living. In people without diabetes, the pancreas continuously delivers this basal insulin.
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3 Understanding and Adjusting Basal Rates In addition to normal daily changes, insulin needs can vary with different routines or days of the week. For example, regular school or workday routines may differ from weekend routines, and insulin needs may differ, too. With your healthcare provider, you will decide on the basal rates that best match your lifestyle and insulin needs.
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Understanding and Adjusting Basal Rates b. Press the middle Soft Key (labeled with the right arrow) to move the underscore to the next character. c. Enter each character one at a time. For example, if your weekend schedule is different from your weekday schedule, you might enter W, e, e, k, e, n, d (Figure 3-3). (A blank character or space is the first and last option in the scrolling menu.) Figure 3-3 d. Press Next.
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3 Understanding and Adjusting Basal Rates Basal rates outside the changed segment do not change. Figure 3-5 Figure 3-6 e. Repeat steps a–d for each new segment and rate you want, then press Done. Press and hold the Power button to turn the screen back on. In some cases, if it has been less than 5 minutes since the screen timed out, pressing the Power button returns you to the same screen you were using. If it has been longer than 5 minutes, the PDM brings you to the Status screen. 8.
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Understanding and Adjusting Basal Rates 3. Choose the program you want from the list (Figure 3-7), then press Enable. Figure 3-7 3 As a safety feature, you cannot enable a new basal program while a temporary basal program is in process (see “Temporary Basal Rates and Presets” later in this chapter); you must first cancel the active temporary basal program. Change, rename, copy, or delete a basal program 1. On the Home screen, use the Up/Down Controller buttons to choose Settings; then press Select. 2.
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3 Understanding and Adjusting Basal Rates Figure 3-8 Figure 3-9 3. Enter a start time for the segment you want to change, then press Next. 4. Enter an end time for this segment, then press Next. 5. Enter a basal rate for the new segment, then press Enter. 6. Review this new segment for accuracy, then press Confirm. 7. To save the newly entered segment into the basal program, press Save (Figure 3-10). If you want to make additional edits, repeat steps 2–5.
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Understanding and Adjusting Basal Rates To rename a basal program 1. After choosing a program from the list, choose Rename, then press Select. 2. Press the Up/Down Controller buttons to enter the characters that spell out the new name you want. Press the middle soft key (labeled with the right arrow) to move the underscore to the next character, then press Save. To delete a basal program 1. After choosing a program from the list, choose Delete and then press Select. 2.
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3 Understanding and Adjusting Basal Rates You can set a temporary basal rate for a duration of 30 minutes to 12 hours. Once the time limit is reached, the Pod automatically returns to the active basal program. Pod and PDM do not need to be close to each other. When using units per hour, the OmniPod System allows you to set temporary basal rates from 0.0 U/hr, up to your max basal rate.
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Understanding and Adjusting Basal Rates 6. Press Confirm to start the temporary basal rate shown on the screen (Figure 3-14 – in this example, 25% more basal insulin will be delivered for 0.5 hours). The Pod beeps to indicate that the temporary basal rate is running. Figure 3-13 3 Figure 3-15 Figure 3-14 Cancel a one-time temporary basal rate 1. On the Home screen, use the Up/Down Controller buttons to choose Suspend/cancel, then press Select. 2.
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3 Understanding and Adjusting Basal Rates a. Press the Up/Down Controller buttons to scroll through the list of characters. An up-and-down arrow symbol on the screen indicates the character you are changing. b. Press the middle Soft Key to move the underscore to the next character. c. Enter each character one at a time. For example, if you take an aerobics class two nights a week, you might enter A, e, r, o, b, i, c, s (Figure 3-16).
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Understanding and Adjusting Basal Rates Figure 3-17 Figure 3-18 3 Change, rename, or delete a temporary basal preset 1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press Select. 2. Choose Presets, then press Select. 3. Choose Temp basal presets, then press Select. 4. Choose a temporary preset from the list, then press Edit. You cannot edit, change, or delete a temporary basal preset that is actively running. To change a temporary basal preset 1.
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3 Understanding and Adjusting Basal Rates 2. Enter a new rate (or new percent change), for the preset, then press Next. 3. Enter a new duration for the preset, then press Save. 4. Press Done. To rename a temporary basal preset 1. Choose Rename, then press Select. 2. Press the Up/Down Controller buttons to enter the characters that spell out the name you want, then press Save. 3. Press Done. To delete a temporary basal preset 1. Choose Delete, then press Select. 2.
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CHAPTER 4 Understanding and Delivering Bolus Doses n What Is a Bolus? A bolus is an extra dose of insulin, delivered when needed to: • Match the carbohydrates (sugar content) in a meal or snack— also known as a meal bolus • Lower blood glucose when it gets too high—also known as a correction bolus This extra dose is in addition to the basal rate delivered throughout the day and night (see Chapter 3, Understanding and Adjusting Basal Rates).
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4 Understanding and Delivering Bolus Doses n Bolus Dose Options n Suggested Bolus Calculator So that you can fully enjoy freedom and flexibility in your life, the OmniPod System offers the following bolus dose options: Suggested bolus calculator: When you want the System to calculate your suggested bolus, based on your personal settings, your current blood glucose, the amount of insulin still active in your body from previous boluses, and the grams of carbohydrate (“carbs” for short) you are about to eat.
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Understanding and Delivering Bolus Doses Figure 4-1 Figure 4-2 How a suggested bolus is calculated The suggested bolus calculator estimates the suggested amount for each bolus portion based on your personal settings and inputs.
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4 Understanding and Delivering Bolus Doses n Deliver a Normal Bolus Deliver a bolus when suggested bolus calculator is On 1. After you check your blood glucose, you will need to enter your blood glucose manually. On the Home screen, choose Bolus, then press Select. First, be sure to write down the BG value on a piece of paper. Use the Up/Down Controller buttons to enter your current BG value, then press Yes if you want this value to be used by the suggested bolus calculator.
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Understanding and Delivering Bolus Doses Figure 4-4 Figure 4-5 In the Suggested Bolus screen (Figure 4-5),“adjusted for Insulin on Board (IOB)” appears only when Insulin on Board (IOB) is a factor in the calculation. To view detailed information about the calculations used for this suggested bolus, press the User Info/Support button and scroll through the information screens. Press Close to return to the Suggested Bolus screen. 4 3. If you are going to eat now: a.
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4 Understanding and Delivering Bolus Doses Figure 4-6 Figure 4-7 5. Press Confirm to begin the bolus delivery (Figure 4-8 below). Figure 4-8 If the reverse correction feature is turned On and if your blood glucose level is below your target, the System subtracts a correction amount from the meal portion of the bolus. If the reverse correction setting is turned Off, the System does not subtract anything for a blood glucose level below your target. 4.
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Understanding and Delivering Bolus Doses As a safety feature, the OmniPod System only allows you to give a bolus at or below the maximum bolus dose you have set. See Chapter 6, Using the Personal Diabetes Manager, for information on resetting your maximum bolus dose. If suggested bolus calc is On, you can enter a temporary manual override to make an adjustment above your max bolus limit (Figure 4-1 and Figure 4-2). Consult your healthcare provider before changing this setting.
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4 Understanding and Delivering Bolus Doses Figure 4-11 Figure 4-12 As a safety feature, the correction bolus is always delivered first and cannot be extended. Only the meal bolus can be extended. For example: Total bolus = 5 units Correction bolus: 1 unit Meal bolus: 4 units Deliver now = 2 units correction bolus: 1 unit meal bolus: 1 unit Extend = 3 units meal portion: 3 units n Cancel Active Boluses 4. If the blood glucose reminders feature is turned On, you can now set a blood glucose reminder. 5.
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Understanding and Delivering Bolus Doses Figure 4-13 Figure 4-14 4 n Replace an Extended Bolus You can replace one extended bolus with another. The System tells you how much of the first bolus has not yet been delivered. 1. After you see your suggested bolus, press Extend instead of Enter (see Figure 4-9 on Page 35). 2. Press Yes to cancel the active extended bolus (Figure 4-15). Or press Back to return to the Suggested Meal Bolus screen.
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4 Understanding and Delivering Bolus Doses You can add what remained of the old extended bolus to the new one. Bolus presets are available only when the suggested bolus calculator feature is turned Off. (If the suggested bolus calculator is turned On, you can still use carb presets. See “Carb Presets” on Page 40.) Figure 4-17 n Bolus Presets Bolus presets are bolus amounts that you program for frequent use.
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Understanding and Delivering Bolus Doses d. Press Next. 6. Enter the new bolus preset amount, up to the maximum bolus you entered during setup; then press Next. Figure 4-18 4 3. Press Enter to confirm the bolus preset amount, or, if necessary, use the Up/Down Controller buttons to adjust the bolus amount. 4. Press Confirm to deliver the bolus shown on the screen. Figure 4-19 Change, rename, or delete a bolus preset 1.
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4 Understanding and Delivering Bolus Doses Cancel an active bolus preset 1. Press and hold the Power button to turn on the PDM (To check the Pod status, refer to page 57 for detailed instructions. The ID screen must be confirmed before you can check Pod status.), if it is not already on. An on-screen message appears as long as a bolus is being delivered. 2. Press Cancel. The Pod beeps to confirm the bolus is cancelled.
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Understanding and Delivering Bolus Doses These additional units are not required. If you prefer not to enter them, simply press Next repeatedly to skip through the screens. Figure 4-20 Change or edit a carb preset 1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press Select. 2. Choose Presets, then press Select. 3. Choose Carb presets, then press Select. 4. Choose the category of the preset you want to change, then press Select (Figure 4-21).
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4 Understanding and Delivering Bolus Doses To edit a carb preset 1. Choose the carb preset you want to change, then press Edit. 2. Press Edit again on the next screen. 3. To rename the carb preset, press the Up/Down Controller buttons to enter the characters that spell out the name you want, then press Next. To “erase” characters, press either Up or Down until you reach the end of the characters, which gives you the option to choose a blank space. 4.
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Understanding and Delivering Bolus Doses The screen displays a list of main food categories (Figure 4-23a and Figure 4-23b). 3. To choose directly from the food categories, choose a main category, then press Select. Choose a subcategory, then press Select. Choose a food item from the subcategory, then press View. Figure 4-23a 4 The screen displays the food item’s: • Name • Serving size • Grams of carbohydrate, fiber, fat, and protein • Total calories 5.
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CHAPTER 5 Using the Pod n The Pod Change Process Replace the Pod at least once every 48–72 hours or up to 200 units of insulin (2–3 days). Refer to the insulin labeling and follow your healthcare provider’s directions for how often to replace your Pod. If you like, you can set the Personal Diabetes Manager (PDM) to notify you when it is time to replace the Pod (see Chapter 6, Using the Personal Diabetes Manager).
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Using the Pod • Because insulin Pods use only rapid-acting insulin, users are at increased risk for developing hyperglycemia (high blood glucose) if insulin delivery is interrupted. If it is untreated, severe hyperglycemia can quickly lead to diabetic ketoacidosis (DKA). DKA can cause symptoms such as breathing difficulties, shock, coma, or death. If insulin delivery is interrupted for any reason, you may need to replace the missing insulin usually with an injection of rapid-acting insulin.
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5 Using the Pod 4. If an extended bolus or temporary basal or both are actively running, you will see a message similar to that shown in Figure 5-3. Press Confirm to accept the cancellation. Or press Back to return to the More actions menu. Figure 5-3 Figure 5-4 b. Use soap and water to remove any adhesive that remains on the skin or, if necessary, use an adhesive remover. c. Discard the used Pod according to local waste disposal regulations. 6. After removing the old Pod, press Next. 7.
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Using the Pod Fill a new Pod Figure 5-7 5 Figure 5-8 Before filling a Pod, ensure that no other Pods are being activated within 24 inches of your PDM. Before filling a Pod with insulin, ensure that the Pod is above 50° Fahrenheit (10° Celsius). If the Pod has been exposed to temperatures below 50° F (10° C), then allow the Pod to be brought back to room temperature before filling it with insulin. 1. Use an alcohol prep swab to clean the top of the insulin vial, then discard the prep swab. 2.
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5 Using the Pod 5. Draw air into the syringe up to the amount of insulin you want. 6. Insert the needle into the insulin vial and inject the air. This makes it easier to withdraw insulin from the vial. 7. Turn the vial and syringe upside down. Withdraw insulin from the vial into the syringe, expelling any and all air or air bubbles. Fill at least to the MIN (minimum) fill line (Figure 5-9). Refer to the Care Giver Guide as an additional reference.
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Using the Pod 9. Depress the syringe plunger to completely empty the insulin into the Pod. The Pod will beep, indicating that the System is ready to proceed to the next step. NEVER use a Pod if you feel resistance when you depress the plunger. This condition can result in interrupted insulin delivery. 10. Remove the needle from the insulin fill port. The port is selfsealing; insulin will not leak after the needle is removed. 11.
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5 Using the Pod Figure 5-11 Figure 5-12 Select the infusion site Before applying a new Pod, you must first select an appropriate infusion site. Due to ease of access and viewing, the abdomen is often used. Your healthcare provider may suggest other potential sites that, like the abdomen, typically have a layer of fatty tissue, such as the hip, back of upper arm, upper thigh, or lower back (Figure 5-13 and Figure 5-14 on the next page).
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Using the Pod Figure 5-13: Adult 5 Figure 5-14: Youth Front Back Front Back 51
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5 Using the Pod To help avoid condensation from occurring in the viewing window, make sure both your Pod and your insulin are at room temperature. Figure 5-15 Prepare the infusion site You can reduce the risk of infection at the infusion site by following aseptic technique and disinfecting the infusion site. Before applying a new Pod, always: 1. Wash hands with soap and water. 2. Use soap to wash the infusion site. Antibacterial soap may irritate skin, especially at the infusion site.
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Using the Pod • If you are unsure the Pod is ready to be applied to the site, press “Discard” and do not use it (Figure 5-16 & Figure 517). Select a new Pod. Figure 5-16 Figure 5-13 5 Figure 5-18 Figure 5-17 Figure 5-13 Do not remove the needle cap until you are instructed to do so by the PDM. When you remove the needle cap, a drop of insulin may be visible at the end of the cannula or in the well. 3.
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5 Using the Pod Figure 5-13 5-19 Figure a. Insert cannula and begin insulin delivery 1. To insert the soft cannula, press Start (Figure 5-20). If you are applying a Pod in a place that does not have a lot of fatty tissue or is very lean, pinch the skin around the Pod (Figure 5-21) after you press Start and hold it until the cannula inserts. Occlusions may result in lean areas if you do not use this technique. The soft cannula is tinted light blue. b.
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Using the Pod The Pod automatically inserts the soft cannula below your skin. It takes a few seconds to complete this process. Once the cannula is inserted, the Pod delivers a prime bolus to fill the cannula with insulin (Figure 5-22). Figure 5-17 Figure 5-22 Figure 5-23 5 Check the infusion site after insertion to ensure that the cannula was properly inserted. The PDM will automatically remind you to check your blood glucose 1.5 hours after each Pod change (Figure 5-24 on the next page).
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5 Using the Pod Figure 5-24 2. Press Yes if you can see that the cannula is properly inserted. The PDM returns to the Status screen. Press No if you see a problem with the cannula. The PDM instructs you to deactivate the new Pod (Figure 5-26). Press Discard to restart the process with a new Pod. Figure 5-19 5-26 Figure When you see the pink slide insert in this position, it means that the cannula is inserted (Figure 5-25).
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Using the Pod n Check Pod Status To check Pod status, if the PDM is turned Off, press and hold the Power button to display the ID screen, then press Confirm to display the Status screen. If the PDM is On, press Back until you reach the Status screen. (If you press and hold the Power button, you will turn off the PDM instead.) Or, from the Home screen, press Status. The PDM automatically checks the status of the Pod.
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5 Using the Pod 4. At the end of the suspend time, a Pod Advisory alarm occurs (Figure 5-28). Figure 5-29 If a temporary basal or extended bolus is in process, the menu item will read Suspend/cancel instead, and options for cancelling these programs also appear in the menu. If these options appear, choose Suspend insulin delivery. Figure Figure5-27 5-20 Figure 5-28 5. To resume your programmed basal rate, press OK (Figure 5-29). The Advisory alarm repeats every 15 minutes until you press OK.
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Using the Pod n Resume Insulin Delivery n Avoid Infusion Site Infections 1. On the Home screen, use the Up/Down Controller buttons to choose Resume (Figure 5-30), then press Select. • • Figure 5-30 Figure 5-23 • • • 5 Always wash your hands and use the aseptic technique to prepare the infusion site before applying a Pod. Do not apply a Pod to any area of the skin with an active infection. If you are unsure whether to use a specific site, ask your healthcare provider.
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5 Using the Pod Do NOT expose a Pod to direct sunlight for long periods of time. It is recommended that you remove your Pod prior to using hot tubs, whirlpools, or saunas. These conditions could expose the Pod to extreme temperatures and may also affect the insulin inside the Pod. Remember to check your blood glucose levels frequently before and after removing the Pod. Check with your healthcare provider for guidelines on removing the Pod for extended periods.
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CHAPTER 6 Using the Personal Diabetes Manager n The ID Screen Figure 6-1 Figure 6-2 When you first turn on the PDM, it displays the identification (ID) screen (Figure 6-1), which allows you to identify that the PDM is yours. You can personalize the ID screen by adding your name and choosing its color. You must acknowledge the ID screen before you can use the PDM. It is important that you always identify the PDM as yours before you use it.
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6 Using the Personal Diabetes Manager • Time, date, and total amount of last bolus delivered • Amount of insulin on board (IOB), if suggested bolus calculator is in use • Name and rate of active basal program or temp basal program • “Ext bolus,” the amount of insulin and the delivery time remaining if an extended bolus is being delivered • “INSULIN SUSPENDED” if insulin delivery has been suspended • Time and date when the Pod will expire If a Pod has not yet been activated (as in during Pod changes), the sc
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Using the Personal Diabetes Manager Figure 6-3 6 You and your healthcare provider entered initial System settings using the Setup Wizard (see Chapter 2, Getting Started). After setup, you can use the System setup menu to customize or change those settings, as described in this chapter. n Reset the Date or Time Occasionally, you need to change date and time settings (for example, to adjust for daylight savings time or after resetting the PDM).
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6 Using the Personal Diabetes Manager Reset the time 1. To enter the current time, press the Up/Down Controller buttons. Press and hold the button to increase or decrease the time faster. 2. Press 12/24 hr to choose either a 12-hour or 24-hour clock, then press Enter (Figure 6-4). Figure 6-4 Figure 6-5 Reset the date 1. Press the Up/Down Controller buttons to choose the current year, then press Next. 2. Choose the current month, then press Next. 3. Choose the current day, then press Next. 4.
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Using the Personal Diabetes Manager 3. Choose Bolus/basal/calcs, then press Select. 4. Choose one of the options (Figure 6-6a and Figure 6-6b), then press Select. Each option is described below. Figure 6-6a Figure 6-6b Bolus calcs When the suggested bolus calculator is turned Off and you want to turn it On, press On and follow these steps: 1. Target BG and correct-above value—You can edit existing time segments and add segments, up to a total of 8. 6 a.
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6 Using the Personal Diabetes Manager Figure 6-7 5. Reverse correction—Choose On or Off, then press Next. 6. Insulin action (duration)—Use the Up/Down Controller buttons to choose a duration of insulin action, then press Done. 7. Press OK. Ratios/factors/targets When the suggested bolus calculator is turned On, you can view and change all the settings using the Ratios/factors/targets menu option.
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Using the Personal Diabetes Manager When the suggested bolus calculator is turned Off, the Ratios/factors/targets option does not appear in the Bolus/basal/calcs menu. 1. Target BG and correct-above value—You can edit existing segments and add segments, up to a total of 8. a. To edit an existing target BG time segment, choose the segment, then press Edit. Use the Up/Down Controller buttons to choose a new start time, end time, target BG value, and correct-above value (correction threshold).
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6 Using the Personal Diabetes Manager Temp basal Choose %, U/hr, or Off to set the mode for temporary basal rates and presets, then press Select. Extended Choose %, Units, or Off to set the mode for extended boluses, then press Select. Bolus increment Choose 0.05, 0.10, 0.50, or 1.00 units for bolus increments, then press Select. Max bolus Use the Up/Down Controller buttons to enter the maximum bolus dose you can take, then press Enter.
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Using the Personal Diabetes Manager The Low reservoir alert will escalate to an Empty reservoir hazard alarm when insulin is depleted. Be sure to respond to the alert when it occurs. Auto-off: Alerts you if the PDM does not receive a Pod status within a predefined period of time. Obtain Pod status by pressing and holding the PDM’s Power button. Choose a time period from 1 to 24 hours, in 1-hour increments, or choose Off. The default setting is Off. Refer to page 57 to check Pod status and to Confirm ID.
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6 Using the Personal Diabetes Manager Custom reminders: Displays text reminders that you enter, at times that you select. You can choose to receive a notification Daily, One time only, or Off. You can change or delete these notifications at any time. Set alerts and reminders 1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press Select. 2. Choose System setup, then press Select. 3. Choose Alerts/reminders, then press Select. 4.
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Using the Personal Diabetes Manager To delete a Bolus reminder a. Choose the bolus reminder you wish to delete, then press Edit. b. Choose Delete then press Select. c. Press Delete to remove the bolus reminder. 7. For Custom reminders • Use the Up/Down Controller buttons to choose [add new], then press New. • To use the OmniPod System’s default naming system, simply press Next. The default naming system automatically assigns names in numerical order, such as alert 1, alert 2, alert 3.
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6 Using the Personal Diabetes Manager n Change Blood Glucose Settings You can adjust blood glucose (BG) meter settings: • BG goal lower and upper limits (for BG history) • Manage BG tags list 1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press Select. 2. Choose System setup, then press Select. 3. Choose BG meter, then press Select. 4. Choose the setting you want to change (Figure 6-11), then press Select.
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Using the Personal Diabetes Manager 1. To hide or show a standard BG tag, choose the tag, and press Show (if it is marked as hidden) or Hide. Tags you choose to show will be check marked; hidden ones will not be. 2. To add a custom tag, choose [add new] at the end of the list of custom tags, then press New. In the Edit name screen, either: a. Press Save to save the new tag with the default name, custom tag1, custom tag2, and so on; or b.
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6 Using the Personal Diabetes Manager Backlight time-out: The backlight is on by default while you are using the PDM. The time-out setting dims the backlight and causes the screen to dim when you have not used it within the time interval that you set. Set at the lowest setting to maximize battery life. Figure 6-13 Figure 6-14 For extra brightness on the PDM screen, press and hold the User Info/Support button (?) for 2 seconds. This enables a “bright mode.
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Using the Personal Diabetes Manager To change the ID screen color: 1. Choose Screen color, then press Select. 2. Use the Up/Down Controller buttons to choose a color, then press Select. Set PDM lock Choose On or Off, then press Select. If you choose On, other PDM options and most other soft keys are locked and will not respond to button presses. To use them, you must first set PDM lock to Off. Set the Screen time-out Choose a time interval, then press Select.
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6 Using the Personal Diabetes Manager Diagnostic options 1. On the Home screen, use the Up/Down Controller buttons to choose Settings, then press Select. 2. Choose System setup, then press Select. 3. Choose Diagnostics, then press Select. Figure 6-15 Figure 6-16 To check alarms 1. Choose Check alarms, then press Select. 2. Press OK. The PDM beeps three times and vibrates three times. If a Pod is active, it beeps three times then sounds the alarm tone for 5 seconds.
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Using the Personal Diabetes Manager n Set a Reminder to Vibrate For certain reminders, you can choose vibration instead of beeps or vibration followed by beeps, instead of only beeps. If you activate it, the PDM will vibrate for: • Blood Glucose reminders • Missed Bolus reminders • Custom reminders • “No active Pod” reminders The PDM cannot be set to vibrate for hazard or advisory alarms. To change the type of notification 1. Use the Up/Down Controller buttons to choose Settings, then press Select. 2.
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6 Using the Personal Diabetes Manager Avoid extreme temperatures Extreme operating temperatures can affect PDM batteries and interfere with System operation. Avoid using the PDM in temperatures below 40°F (4.4°C) or above 104°F (40°C). Only connect a USB cable to your PDM when downloading data to a computer. Other PDM functions are disabled while a USB cable is connected, and the PDM cannot communicate with the Pod.
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CHAPTER 7 Entering Blood Glucose Information into Your PDM n Entering Blood Glucose Readings Manually You can enter blood glucose readings into the PDM. 1. On the Home screen, use the Up/Down Controller buttons to choose More actions, then press Select. 2. Choose Add BG reading, then press Select. 3. Use the Up/Down Controller buttons to enter the BG reading from your separate meter.
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7 Entering Blood Glucose Information into Your PDM Figure 7-1 4. Use the Up/Down Controller buttons to choose the first tag you want, then press Select (Figure 7-2). A diamond icon appears next to selected tags, as in“Pre-meal” in the figure. You can select up to two tags for each BG reading. 80 Figure 7-2 Figure 7-3 5. To remove a selected tag, highlight it and press Clear. (The soft key changes from Select to Clear when you highlight the tag.) 6. Press OK to return to the list of readings. 7.
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Entering Blood Glucose Information into Your PDM n Blood Glucose Results and the Suggested Bolus Calculator 7 Figure 7-4 If the suggested bolus calculator feature is turned on, you can use your stored blood glucose value with it. 1. Press the Home key to return to the main menu. 2. Use the Up/Down Controller buttons to choose Bolus, then press Select. See “Suggested Bolus Calculator” in Chapter 4, Understanding and Delivering Bolus Doses.
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CHAPTER 8 Understanding Your Records n Record Keeping Record keeping is an important part of successful diabetes management. The Personal Diabetes Manager (PDM) helps simplify this task. It automatically stores records of insulin delivery history, blood glucose readings, alarms and carbohydrates. The PDM can store over 5,000 records or approximately 90 days’ worth of information. Once the memory is full, new information begins to replace the oldest information.
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Understanding Your Records 4 The record for this item is “unconfirmed.” When you power on the PDM, it will request a status update from the active Pod and then update the insulin history. If the PDM does not receive a status update from the Pod, the PDM will update history with “unconfirmed” records. The next time the PDM receives a status update, it will update these records. Figure 8-1 8 Figure 8-2 This insulin delivery item spans midnight. The date given is the start date.
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8 Understanding Your Records Figure 8-3 Figure 8-4 For a temporary basal program, the display shows the % adjustment that have been made to the default basal rate (active or current). So, in Figure 8-3, “1.10 temp U/hr (+10%)” means that you delivered a temporary basal of 1.10 units per hour, which was 10% more than the default basal. (Notice that two hours later, the basal rate returns to the default.) Also, the “Pod activated” entry shows what time you applied a new Pod.
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Understanding Your Records n Blood Glucose Records Figure 8-5 8 Figure 8-6 The PDM stores blood glucose records for the past 90 days. You can choose to view individual readings, single-day trends with individual readings, or trends for the previous 7, 14, 30, 60 or 90 days. View single-day trends 1. On the Home screen, use the Up/Down Controller buttons to choose My records, then press Select. 2. Choose BG history, then press Select.
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8 Understanding Your Records In the List view, press Event to select individual readings. Readings with a question mark icon (?) next to them have additional information available (Figure 8-7). To see this information, use the Up/Down Controller buttons to choose the reading. Then press the User Info/Support button to view details about that reading (Figure 8-8). Figure 8-7 Figure 8-10 Figure 8-8 4. Press Close to return to the List view. 5. Press Graph to see a graph of the data (Figure 8-9).
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Understanding Your Records Figure 8-11 Figure 8-12 8 2. Choose Alarm history, then press Select. The PDM displays the date, time, and type of each alarm (Figure 8-12). 3. Press the Up/Down Controller buttons to see additional screens. 4. Choose an alarm record, then press User Info/Support to see more information. n Carbohydrate Records 6. Press Back to return to the single-day trends. n Alarm Records The PDM lists the entire alarm history for the OmniPod System.
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8 Understanding Your Records Figure 8-13 Figure 8-14 3. Press the Up/Down Controller buttons to see additional days. Press Event to use the Up/Down Controller buttons to scroll through the list of information on the screen. Press Day to use the Up/Down Controller for dates. n User Information/Support n All Records The PDM displays the combined insulin delivery, blood glucose, alarm and carbohydrate records. 1. On the Home screen, use the Up/Down Controller buttons to choose My records, then press Select.
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Understanding Your Records The User Info/Support icon is also displayed on the suggested bolus screen. For information about the support information displayed on these screens, see Chapter 4, Understanding and Delivering Bolus Doses. Figure 8-15 8 Figure 8-16 Add or change user information The first line of My Info displays the information that was entered for the ID screen during your PDM setup.
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CHAPTER 9 Living with Diabetes n Your Role: Safely Using the OmniPod System Before deciding on the OmniPod® Insulin Management System, you and your healthcare provider discussed the advantages and benefits of the OmniPod System, as well as the responsibilities that come with insulin pump therapy. Remember: safe use begins and ends with you. If you have questions or doubts about being able to safely use the OmniPod System at any time, consult your healthcare provider immediately.
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Living with Diabetes Check your blood glucose frequently When you routinely check your blood glucose level, you can identify and treat high or low blood glucose before it becomes a problem (see “Avoid lows, highs, and DKA” later in this chapter).
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9 Living with Diabetes n Prepare for Emergencies Keep an emergency kit with you at all times to quickly respond to any diabetes emergency. The kit should include: • Several new, sealed Pods • Extra new PDM batteries (at least two AAA alkaline) • A vial of rapid-acting U-100 insulin (See the warning on page x of the Introduction for insulins approved for use in the OmniPod System.
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Living with Diabetes n Traveling and Vacationing Plan for changing time zones If you’re planning a vacation or business trip to a different time zone, you may need to adjust your basal rate programs. For changes of just a few hours, basal rate adjustments are minor and easy to calculate. For long-distance travel, however, figuring out the correct program can be more challenging. Your healthcare provider can help with these adjustments.
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9 Living with Diabetes • • A signed letter from your healthcare provider explaining you need to carry insulin supplies and OmniPod equipment Prescriptions for all medications and supplies with original prescription labels Screening Procedures The TSA offers the option of requesting a visual inspection of your medical supplies rather than putting them through the X-ray. This must be requested before the screening process begins.
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Living with Diabetes n Avoid lows, highs, and DKA You can avoid most risks related to using the OmniPod System by practicing proper techniques and by acting promptly at the first sign of trouble. You can avoid potential problems by knowing the signs of hypoglycemia (low blood glucose), hyperglycemia (high blood glucose), and diabetic ketoacidosis (DKA). The easiest and most reliable way to avoid these conditions is to check your blood glucose often.
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9 Living with Diabetes Hypoglycemia unawareness is a condition in which you do not realize when your blood glucose level is low. If you are prone to hypoglycemia unawareness, you may want to use the OmniPod System’s blood glucose reminder and check your blood glucose more frequently. See “Alerts and Reminders” in Chapter 6, Using the Personal Diabetes Manager, for how to set the reminder.
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Living with Diabetes Even if you cannot check your blood glucose, do NOT wait to treat symptoms of hypoglycemia, especially if you are alone. Waiting to treat symptoms could lead to severe hypoglycemia, which can quickly lead to shock, coma or death. 1. If blood glucose is below 70 mg/dL, eat or drink 15 grams of fast-acting carbohydrate, such as glucose tablets, juice, or hard candy (see “How much is 15 grams of carbohydrate?” below). Do NOT use chocolate or candy bars to treat low blood glucose.
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9 Living with Diabetes Possible causes of hypoglycemia (low blood glucose) Possible cause of low blood glucose Incorrect basal program Incorrect bolus timing Bolus too large 98 Suggested action Possible cause of low blood glucose Confirm that correct basal program is active. Confirm that PDM time is set correctly. Consult your healthcare provider about adjusting your basal programs or using a temporary (temp) basal rate. Incorrect target blood glucose levels Take bolus with food.
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Living with Diabetes Possible cause of low blood glucose Suggested action Prolonged or intense exercise Adjust insulin delivery as instructed by your healthcare provider. Check blood glucose before, during and after activity and treat as necessary. Effects of exercise can last several hours—even a full day—after activity ends. Consult your healthcare provider about adjusting your basal programs or using a temporary (temp) basal rate.
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9 Living with Diabetes To avoid hyperglycemia (high blood glucose) Check your blood glucose at least 4–6 times a day (when you wake up, before each meal, and before going to bed).
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Living with Diabetes 9 Possible causes of hyperglycemia (high blood glucose) Possible cause of high blood glucose Suggested action Possible cause of high blood glucose Suggested action Expired insulin Deactivate and remove used Pod. Apply a new Pod filled from a new vial of insulin. Empty Pod Deactivate and remove used Pod. Apply a new Pod in a different location. Incorrect basal program Confirm that correct basal program is active. Confirm that PDM time is set correctly.
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9 Living with Diabetes Possible cause of high blood glucose Suggested action Possible cause of high blood glucose Suggested action High-protein or high-fat meal Calculate protein/fat intake and account for it in your bolus timing and bolus type. Consult healthcare provider about using the extended bolus option. Weight loss or gain Consult your healthcare provider for guidance.
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Living with Diabetes Diabetic ketoacidosis (DKA) Insulin Pods use rapid-acting insulin, so you have no long-acting insulin in your body. If insulin delivery from the Pod is interrupted (an occlusion), your blood glucose can rise rapidly and lead to diabetic ketoacidosis (DKA). DKA is a serious—but totally preventable—emergency that can occur if you ignore high blood glucose levels. If left untreated, DKA can cause breathing difficulties, shock, coma, and eventually death.
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9 Living with Diabetes n Handling Special Situations • Sick days Any physical stress can cause your blood glucose to rise, and illness is a physical stress. Your healthcare provider can help you make a plan for sick days. The following are only general guidelines. When you are ill, check your blood glucose more often (at least once every 2 hours) to avoid DKA. The symptoms of DKA are much like those of the flu.
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Living with Diabetes Be sure to check your blood glucose levels before removing the Pod and after applying a new one. Pods are designed for onetime use. Do not attempt to reapply a used Pod. If possible, avoid wasting Pods by planning removal times that coincide with a scheduled Pod replacement. If you will need to remove the Pod for more than 1 hour, ask your healthcare provider to recommend appropriate guidelines.
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CHAPTER 10 Alerts and Alarms n Safety Checks n Alarms The OmniPod System has a very important safety feature: It can check its own functions and let you know when something needs attention. When you turn on the Personal Diabetes Manager (PDM), the System automatically performs a series of safety checks. (Refer to page 57 for detailed instructions. The ID screen must be confirmed before you can check Pod status.
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Alerts and Alarms Advisory Alarms Advisory alarms tell you about a condition that requires your attention. Each advisory alarm beeps intermittently. When you hear an advisory alarm, first turn on the PDM to display the Status screen. The PDM communicates with the Pod, if necessary, and the screen displays a message describing the alarm and how to resolve it. All advisory alarms are time sensitive and require a response.
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10 Alerts and Alarms If you ever need to return the PDM for repair or replacement, contact your healthcare provider for instructions on going back to treatment by injections. Alarm Use the form at the end of this User Guide to write down all your settings from the Setup Wizard. If you ever need to reset your PDM, having these settings handy will make setup very easy. Type Source Beep Pattern Action End of insulin suspend. Press OK to resume basal rate delivery.
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Alerts and Alarms Alarm Auto-off. Remove Pod now. 10 Type Source Beep Pattern Action Hazard Alarm Pod and PDM Continuous tone. Pod has been deactivated. Insulin delivery has stopped. Press OK to acknowledge. Change Pod. Check blood glucose. Low reservoir. Replace Pod soon. (This is based on the volume level you selected.) Advisory Alarm Pod and PDM 2 sets of beeps every minute for 3 minutes. Repeats every 60 minutes until acknowledged. Escalates to Empty reservoir hazard alarm when empty.
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10 Alerts and Alarms Alarm Pod expiration advisory. Change Pod now. Type Source Beep Pattern Action Advisory Alarm Pod and PDM 2 sets of beeps repeat periodically. Press OK to acknowledge. Repeats every 15 minutes during the last hour of the Pod’s life and is independent of the Expiration notification that you can set. (See Chapter 6 “Using the PErsonal Diabetes Manager”). Change Pod. (See Chapter 5, Using the Pod.) Escalates to Pod expired hazard alarm. Pod expired. Insulin delivery stopped.
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Alerts and Alarms Alarm Type Source Beep Pattern Action Occlusion detected. Insulin delivery stopped. Change Pod now. Hazard Alarm Pod and PDM Continuous tone. Press OK to acknowledge. Pod Error. Insulin delivery stopped. Change Pod now. Hazard Alarm 10 Change Pod. Check blood glucose. Pod Continuous tone. This alarm occurs when the Pod detects an unexpected error. Press OK to acknowledge. Change Pod. Check blood glucose. PDM Error. Remove Pod now. Call Customer Care: 800-591-3455.
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10 Alerts and Alarms Alarm Type Source Beep Pattern Action PDM Error. Memory corruption. Press “OK” to reset PDM and delete all user settings. History records will not be deleted. Hazard Alarm PDM Continuous tone. This alarm occurs after the PDM is reset and a memory corruption error occurs. Press OK to acknowledge. System Error. Remove Pod now. Call Customer Care: 800-591-3455. Hazard Alarm Change Pod. Check blood glucose. Pod or PDM Continuous tone.
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Alerts and Alarms Alarm Type Pod deactivation required. Hazard Alarm Press “Ok” to deactivate. 10 Source Beep Pattern Action PDM Continuous tone. This alarm occurs after a PDM error occurs that requires the user to reset the date and time. Press OK to acknowledge. Change Pod. Check blood glucose. n Manual Shut-off of a Hazard Alarm If you respond to a hazard alarm but the PDM cannot communicate with the Pod to acknowledge or shut off the alarm, you can shut off the alarm manually. 1.
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CHAPTER 11 Communication Failures n The Communication Process n Failure During Pod Activation or Operation When you turn on or use the Personal Diabetes Manager (PDM), it establishes communication with the active Pod. Usually, communication occurs quickly. Occasionally, communication takes longer and the PDM displays the communication icon during that time in the upper left-hand corner of the current screen.
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Communication Failures Figure 11-1 Figure 11-2 2. Move across the room or to a different room. Then press Retry. a. If you press Retry within 2 minutes, the PDM tries to communicate with the Pod again. If it cannot communicate, it displays the same screen as in Figure 11-2, then finally the “Communication time-out” screen (Figure 11-3). Press OK to check the Pod status. Figure 11-3 11 Figure 11-4 b. If the status check fails, you will see the screen in Figure 11-4.
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11 Communication Failures 3. If at any point in this process the PDM can communicate again with the Pod, you will see either: a. Figure 11-5, indicating that your original instruction or command was successfully sent to the Pod. When you press OK, or within 5 seconds, the System displays the next screen in the command sequence you were entering. b. Figure 11-6, indicating that your last command was not sent to the Pod. Press OK.
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Communication Failures 2. Press Discard. The PDM will consider the Pod lost and ask whether you want to activate a new Pod. If you have an unconfirmed correction bolus when you discard a Pod, then the bolus calculator will be temporarily disabled. In this situation, the bolus calculator is disabled until the duration-of-insulin-action period passes (Figure 11-8). If you have any questions, call Customer Care.
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11 Communication Failures If the Pod has expired, you will see the screen in Figure 11-11 instead. n Failure During Bolus Cancellation When you instruct the PDM to cancel a bolus, if the PDM cannot send your instruction to the Pod within a few seconds, it displays the “Communication error” screen (Figure 11-12). Figure 11-11 Figure 11-12 At either “Pod status not available” screen, press Home to return to the Home screen or press Status to send another status request. 118 Figure 11-13 1.
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Communication Failures If your PDM is damaged or not working as expected, call Customer Care for assistance. Be sure to check your blood glucose frequently. Remove your Pod and contact your healthcare provider for treatment guidelines to follow after you remove it. 3. Move across the room or to a different room. Then either: a. Press Discard to begin the deactivation process. b. Press Retry to repeat the attempts to communicate with the Pod. The PDM tries to communicate with the Pod again.
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Appendix The OmniPod® Insulin Management System has no user-serviceable parts. If you require assistance operating or maintaining the System, please call Customer Care. n Pod Care and Maintenance n Personal Diabetes Manager Care and Maintenance Storage Store unopened Pods in a cool, dry place. Extreme heat or cold can damage Pods and cause them to malfunction. If Pods are exposed to extreme temperatures, inspect them carefully before use. Pods are sterile unless packaging is opened or damaged.
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Appendix Cleaning and disinfecting Cleaning is to keep free from dirt, stains, or impurities; unsoiled. Disinfecting is the process of destroying pathogenic organisms or rendering them inert. Keep your PDM USB port free of debris and liquids. Dirt, dust, blood, and control solution can impair the functionality of your PDM or damage it. If the battery compartment becomes soiled, gently shake out the debris or use a dry, lint-free cloth to remove it.
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Appendix Figure A-1 IR Port USB Port Buttons Battery Compartment (Reverse Side) Replacing Batteries The PDM requires two (2) AAA alkaline batteries. You can purchase them at any grocery, hardware or convenience store. AAA alkaline batteries are the preferred battery to power the PDM. Do not use any other type of batteries. Never use old or used batteries; the PDM may not work properly. Using any kind of batteries other than alkaline may reduce battery life and cause damage to the PDM.
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Appendix When your PDM alerts you that battery power is getting low, the PDM will maximize remaining battery life by: • Turning off your vibration alert (if set) • Disabling bright mode Once the batteries are replaced, these functions resume. If the batteries run out, date and time are at risk. DO NOT remove the old batteries until you have new ones at hand. The PDM protects date and time for up to 2 hours after the batteries run out or are removed. To replace batteries 1.
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Appendix If you drop the PDM The PDM is built to withstand reasonable amounts of abuse, but shock or a severe impact can damage it. If you drop the PDM or if it is otherwise subjected to severe impact: 1. Inspect the outside of the PDM for visible signs of damage. 2. Press and hold the Power button to see whether the PDM turns on and whether the LCD screen is damaged. 3. Inspect the inside of the battery compartment for visible signs of damage. 4.
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Appendix n Suggested Bolus Calculator Examples and Guidelines A suggested bolus is equal to the sum of a correction bolus and meal bolus, then adjusted for insulin on board, if applicable. Examples of each of these elements are shown below.
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Appendix Example of meal insulin-on-board (IOB) Duration of insulin action: 3 hours Time since previous meal bolus: 2 hours Previous meal bolus: 4.5 units 3 hours – 2 hours = 1 hour 1 hours ÷ 3 hours = 1/3 1/3  4.5 units = 1.5 units meal IOB In other words, two hours after your previous meal bolus, you have received 3 units of insulin from it; 1.5 units of insulin are still working to cover your meal.
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Appendix Example 3 Current BG level: 100 mg/dL Carb intake: 45 carbs Meal IOB: 1 unit Correction IOB: 0 units Correction bolus: 100 mg/dL (current) – 100 mg/dL (target) = 0 0 ÷ 50 (CF) = 0 units Meal bolus: 45 (carbs) ÷ 15 (IC ratio) = 3 units Suggested bolus dose = 0 (correction) + 3 (meal) – 0 (IOB) = 3U Example 4 Current BG level: 150 mg/dL Carb intake: 60 carbs Meal IOB: 0 units Correction IOB: 1 unit Correction bolus: 150 mg/dL (current) – 100 mg/dL (target) = 50 50÷ 50 (CF) = 1 unit Meal bolus: 60 (c
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Appendix Calculator guidelines When the suggested bolus calculator is turned On, the OmniPod System applies these guidelines to the suggested bolus doses: • Suggested bolus doses are rounded down to the nearest 0.05U. • If the total of the suggested bolus calculation (correction bolus plus meal bolus) is less than zero, the suggested bolus dose is 0.00U.
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Appendix n OmniPod System Options and Settings 12-hour or 24-hour clock MM/DD/YY DD/MM/YY MM.DD.YY DD.MM.YY YY.MM.DD YY-MM-DD Maximum basal rate 30 U/hr Default is 3.00 U/hr Basal programs 7 Basal rate segments 24 per program Basal rate increment 0.
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Appendix Suspend Low reservoir volume indicator Pod expiration alert Auto-off alert PDM lock History storage Language 30 minutes to 2 hours 10 to 50 units in 5-unit increments Default is 10.0 units 1 to 24 hours in 1-hour increments Default is 4 hours 1 to 24 hours or Off in 1-hour increments Default is Off On or Off Default is Off 5400 records/90 days English n Pod Specifications Size: 1.53" wide x 2.05" long x 0.57" high (3.9cm x 5.2cm x 1.45cm) Weight (without insulin): 25 grams (0.
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Appendix n Accuracy Test Results The following graph is designed to show flow accuracy of the Pod against given time periods. Flow rate error The following trumpet curve shows the accuracy of the delivery rate in relation to the observation period. The measurements were made using a Pod with a basal rate of 0.05 U/h at high operating temperature. The overall mean percentage flow error was 1.40%.
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Appendix n Personal Diabetes Manager Specifications Size: 2.4" wide x 4.4" long x 0.98" high (6.21cm x 11.25cm x 2.5cm) Weight (with batteries): 125 grams (4.41 oz) Screen: 1.4" wide x 1.9" long (3.6cm x 4.8cm); 2.4" diagonal (6.1cm) LCD Battery: Powered by 2 AAA alkaline batteries Battery life: Approximately 3 weeks Operating temperature range: 40° F to 104° F (4.4° C to 40° C) Storage temperature range: -20.
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Appendix n OmniPod System Label Symbols Symbol Meaning Symbol Meaning Do not reuse this device; single-use only Storage temperature Caution: Consult accompanying documents Do not use if package is damaged Refer to Instruction Manual Sterilized by ethylene oxide Manufacture date: (year–month) Lot number Rx ONLY Prescription home-use IVD n Personal Diabetes Manager Icons Icon Meaning Icon Meaning Power More actions Reference/reorder number Bolus Communication Device serial number Type BF m
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Appendix Icon Meaning (Alternating) Hazard alarm Meaning n OmniPod System Notice Concerning Interference Insulin gauge The OmniPod Insulin Management System (both the Pod and the Personal Diabetes Manager or PDM) complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. These devices may not cause harmful interference. 2. These devices must accept any interference received, including interference that may cause undesirable operation.
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Appendix n Electromagnetic Compatibility The information contained in this section (such as separation distances) is, in general, specifically written with regard to the OmniPod System. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference.
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Appendix Electromagnetic Emissions This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that is used in such an environment. Emissions Compliance according to Electromagnetic environment RF Emissions (CISPR 11) Group 2 The Pod and the PDM emit low level electromagnetic energy (RF) in order to communicate. Although unlikely, nearby electronic equipment may be affected.
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Appendix Radiated RF (IEC 61000-4-3) 80 MHz–2.5 GHz Electromagnetic Immunity (Continued) 10 V/m Portable and mobile RF communications equipment should be used no closer to any part of the System than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter as below. Recommended separation distance: d=1.17 P 150 KHz to 80 MHz d=0.35 P 80 MHz to 800 MHz d=0.7 P 800 MHz to 2.
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Appendix Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the System You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System, as recommended below, according to the maximum output power of the communications equipment.
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Appendix n Customer Bill of Rights Mission Statement Insulet Corporation is dedicated to designing, developing, and distributing products that provide superior treatment options and lifelong health benefits for people with diabetes. Scope of Services Insulet Corporation’s scope of services is limited to providing the OmniPod Insulin Management System.
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Appendix Customer’s Bill of Rights and Responsibilities You have the right to: 1. Receive considerate and respectful service. 2. Receive service without regard to race, creed, national origin, sex, age, disability, sexual orientation, illness, or religious affiliation. 3. Expect confidentiality of all information pertaining to you, your medical care and service. Please review our HIPAA Privacy Notice later in this section. 4. Receive a timely response to your request for service. 5.
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Appendix n Limited Warranty for the Personal Diabetes Manager Limited Warranty Coverage Insulet Corporation warrants to the original purchaser (“you”) that the Personal Diabetes Manager (the “PDM”) will be free from defects in materials and workmanship, under normal use and conditions, for a period of four (4) years from the date of purchase.
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Appendix n HIPAA Privacy Notice THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION IS USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO IT. PLEASE REVIEW IT CAREFULLY.
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Appendix Additional Categories of Uses and Disclosures Required by Law: We may use or disclose your Medical Information to the extent that applicable law requires the use or disclosure of such Medical Information. Where the use and/or disclosure of Medical Information is by law, the use or disclosure will be made in compliance with the law and will be limited to the relevant requirements of the law. You will be notified, as required by law, of any such uses or disclosures.
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Appendix Workers’ Compensation: We may disclose your Medical Information as authorized to comply with workers' compensation laws and other similar, legally established programs. Inmates: We may use or disclose your Medical Information if you are an inmate of a correctional facility and your physician created or received your Medical Information in the course of providing care to you.
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Appendix You Have the Right to Request to Receive Confidential Communications from Us by Alternative Means or at an Alternative Location: We will accommodate reasonable requests to receive confidential communications from us by alternate means or at an alternative location. We may also limit this accommodation by asking you for information as to how payment will be handled or specification of an alternative address or other method of contact.
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Glossary A1c (see Hemoglobin A1c) Advisory alarm Notification by the PDM that a serious condition exists. Aseptic technique A method for maintaining sterilization and preventing contamination. Basal program One or more basal rates that together cover a 24-hour period from midnight to midnight. Basal rate A small base or background amount of insulin that is delivered, at a preset rate, continuously for a specified period of time. Basal rates are measured in units per hour (U/hr).
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Glossary Calorie A unit of measurement used to express the energy value of food. Calories come from carbohydrate, protein, fat, and alcohol. Cannula A small, thin tube inserted below the skin, which serves to introduce a liquid medication into the body. Carbohydrate (carb) One of the three main nutrients found in food. (The other two are protein and fat.) Foods that contain carbohydrates include starches, sugars, vegetables, fruits, and dairy products.
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Glossary Diabetes Control and Complications Trial (DCCT) A study by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), conducted from 1983 to 1993 in people with type 1 diabetes, which showed that good blood glucose control significantly helped prevent or delay diabetes complications. Diabetes, diabetes mellitus A condition characterized by hyperglycemia (high blood glucose) resulting from the body’s inability to use blood glucose for energy.
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Glossary Hazard alarm Notification by the PDM and Pod that a dangerous condition exists. Healthcare provider A professional who practices medicine or teaches people how to manage their health. All healthcare providers are a resource for valuable diabetes management information. Hemoglobin A1c (HbA1c) A test that measures a person’s average blood glucose level over the past 2 to 3 months.
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Glossary Insulin-to-carbohydrate ratio (IC Ratio) Number of grams of carbohydrate covered by one unit of insulin. For example, if your insulin-to-carbohydrate ratio is 1:15, then you need to deliver one unit of insulin to cover every fifteen grams of carbohydrate you eat. In vitro Literally, “in glass.” Refers to a biological function taking place in a laboratory dish rather than in a living organism.
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Glossary Reverse correction (negative correction) Using an individual’s correction factor (sensitivity factor), the reverse correction is a calculation that reduces a portion of a meal bolus dose when the patient’s blood glucose level is below their blood glucose target. This feature is an option in the OmniPod® Insulin Management System, which should be turned on or off according to the advice of a healthcare provider. Sensitivity factor (see correction factor) Subcutaneous Under the skin.
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Index A activate a new Pod. . . . . . . . . . . . . . .46–50 active insulin . . . . . . See insulin on board add basal segment or rate . . . . . . . . . . . . .22 bolus reminder. . . . . . . . . . . . . . . . . . . .70 custom reminders. . . . . . . . . . . . . . . . .71 user information . . . . . . . . . . . . . . . . . .89 adhesive . . . . . . . . . . . . . . . . . . . . . . 4, 53–54 remover . . . . . . . . . . . . . . . . . . . . . . . . . . .46 advisory alarms . . . . . . . . . .
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Index cancel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36 dose. . . . . . . . . . . . . . . . . . . . . . . . . .29, 146 extended. . . . . . . . . . . . . . . . . . . . . . 30, 35 history . . . . . . . . . . . . . . . . . . . . . . . . . . . .84 manual delivery. . . . . . . . . . . . . . . . . . .34 normal . . . . . . . . . . . . . . . . . . . . . . . . 30, 32 presets . . . . . . . . . . . . . . . . . . . 38–40, 146 ratios/factors/targets. . . . . . . . . . . . . .66 reminders . . . . . . . .
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Index complications, diabetes-related . 1, 147 confidence reminders . . . . . . . . . . . . . . .69 contact information . . . . . . . . . . . . . . . . .88 continuous subcutaneous insulin infusion . . . . . . . . . . . . . . . . . . . . . . . . . 147 copy basal program . . . . . . . . . . . . . . . . .23 correct-above value . . . . .See correction threshold correction bolus . . . . . . . . . . . 31, 125, 147 correction factor . . . . . 15, 29, 66, 67, 147 correction IOB . . . . . . . . . . . . . . . . . . .
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Index extreme temperatures. . . . . . . . . . . . . . .78 F failure . . . . . . . See communication failure fat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 fiber . . . . . . . . . . . . . . . . . . . . . . . . . . . .41, 148 fill syringe. . . . . . . . . . . . . . . . . . . . . . . . 47–49 Flow accuracy Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Flow rate error . . . . . . . . . . . . . . . . . . . . . 131 food library .
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Index K ketoacidosis . . . . . . . . . . . . . . . . . . . . . . See DKA ketones . . . . . . . . . . . . . . . . . . . . . . . .103, 150 L long-acting insulin. . . . . . . . . . . . . . . . . 103 low battery alert . . . . . . . . . . . . . . . . . . . 122 low reservoir advisory . . . . . . . . . . . . . . .16 low reservoir alert . . . . . . . . . . . . . . 109, 68 lows, highs, and DKA, avoid. . . . . . . . . .95 M manual shut-off of hazard alarm. . . 113 maximum basal rate . . . . . . . . . . . . . . . . .
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Index Status screen. . . . . . . . . . . . . . . . . . 61–62 storage. . . . . . . . . . . . . . . . . . . . . . . . . . 120 submerged in water. . . . . . . . . . . . . . .77 version . . . . . . . . . . . . . . . . . . . . . . . . . . . viii PDM error hazard alarm . . . . . . . . . . . 112 PDM lock . . . . . . . . . . . . . . . . . . . . . . .73, 120 set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75 PDM options, System setup. . . . . . . . . .74 personal contact information. . . . . . .
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Index electrical . . . . . . . . . . . . . . . . . . . 135–138 safety checks . . . . . . . . . . . . . . . . . . . . . . 106 screen time-out. . . . . . . . . . . . . . . . . . . . . .73 set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75 sensitivity factor . . See correction factor set backlight time-out . . . . . . . . . . . . . . . .75 ID screen . . . . . . . . . . . . . . . . . . . . . . . . . .74 PDM lock. . . . . . . . . . . . . . . . . . . . . . . . . .75 screen time-out . . . . . .
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Index U Up/Down Controller buttons . . . . . . . . . 5 User Guide symbols. . . . . . . . . . . . . . . . . . viii User Info/Support button . . . . . . . . . . . . . . . . . . . . . . . . . 5, 88 icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . .89 V vacation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93 W warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . 141 water . . . . . . . . . . . . . . . . .
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My PDM Settings Use this form to keep track of your important PDM settings. Remember to update your information as you change or add settings.
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My PDM Settings Duration of Insulin Action Time that insulin will remain “active” in the body from a previous bolus. Temp Basal Presets Name ___________ hrs Correction Factor Correction factor for each time segment defined, starting at midnight.
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My Notes _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _______________________________________________________________