OmniPod UST200 User Manual
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OmniPod UST200 User Manual

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Summary of Contents for OmniPod UST200

  • Page 1 MyOmniPod.com...
  • Page 2 Frequency Address Telephone and Fax Email Address OmniPod System Start Date: _ _________________________ Health Insurance PDM Model: UST200 Serial Number: _________________ Emergency Services Name Dial 911 (USA only; not available in all communities) Address Insulet Corporation 9 Oak Park Drive Bedford, MA 01730 •...
  • Page 3 Model: UST200...
  • Page 4 © 2010 Insulet Corporation. All rights reserved. OmniPod is a registered trademark of Insulet Corporation. U.S. Patent No. 6,740,059. FreeStyle is a registered trademark of Abbott Laboratories. NovoLog is a registered trademark of Novo Nordisk A/S. Humalog is a registered trademark of Eli Lilly and Company. Apidra is a registered trademark of Sanofi Aventis.

  • Page 5: Table Of Contents

    The OmniPod Starter Kit ........
  • Page 6 Contents Enter insulin-to-carbohydrate ratio ......13 4 Understanding and Delivering Bolus Doses ... 29 Enter correction factor .
  • Page 7 Contents Gather equipment and supplies ......44 Ratios/factors/targets......... 64 Deactivate the current Pod .
  • Page 8 Lance your forearm, upper arm, hand, thigh, or calf..88 Your Role: Safely Using the OmniPod System... . . 105 Fill the blood glucose test strip with blood ....89 Daily Diabetes Management Activities .
  • Page 9 The Communication Process ......129 OmniPod System Options and Settings....143 Failure During Pod Activation or Operation .
  • Page 10 Customer’s Bill of Rights and Responsibilities....153 OmniPod System Label Symbols......147 Limited Warranty for the Personal Diabetes Manager .

  • Page 11: Introduction

    This User Guide is intended for use only with PDM cutaneous (below the skin) delivery of insulin at set and variable model UST200. To learn which version of the PDM rates for the management of diabetes mellitus in persons requir- you have, turn it over.

  • Page 12: You And Your Healthcare Provider

    System properly. you. You and your healthcare provider The OmniPod System is designed to use rapid-act- Work with your healthcare provider to establish diabetes man- ing U-100 insulin. The following U-100 rapid-acting agement guidelines and settings that best fit your needs. These...

  • Page 13: Your Role: Safely Using The Omnipod System

    Your healthcare provider is a valuable resource. You will rely on management to enjoy the outstanding control, freedom, and him or her for a lot of critical information about your OmniPod flexibility that is possible with the OmniPod System. System, especially during the first few weeks and months. When...

  • Page 14: About This User Guide

    Screen alarm/alert information. Offers a suggestion for successful use A physical button on the PDM, such as the Button of the OmniPod Insulin Management Home/Power button. System. An image on the PDM screen that indi- Icon cates a menu option or item of informa- tion.

  • Page 15: Your New Omnipod Insulin Management System

    (CSII) therapy changes in daily routine. The OmniPod System is a great option in a way no conventional insulin pump can. The System’ s innova- for people with diabetes who require insulin.

  • Page 16: How Does The Omnipod System Work

    Manager. The cannula is inserted only once with each Pod. Automated cannula insertion With the OmniPod System, you don’t have to insert the infusion The Personal Diabetes Manager (PDM) is a wireless, handheld set manually or carry around a separate inserter. You simply press device that: a button on the PDM and the Pod’...

  • Page 17: Suggested Bolus Calculation

    Record keeping Calculating bolus doses has never been easier. After you check Another convenient part of the OmniPod System is record keep- your blood glucose, enter the carbs for your snack or meal. Based ing. Paper charts are useful, but sometimes they can be on your individual settings, the System displays a suggested inconvenient to carry or use.

  • Page 18: The Pod

    Your New OmniPod Insulin Management System ■ ■ The Pod The Personal Diabetes Manager The Pod (Figure 1-1) is applied to your skin with an adhesive All Pod operations are programmed and controlled through the backing, similar to a Band-Aid®.

  • Page 19: Buttons That Program And Control The Omnipod System

    Your New OmniPod Insulin Management System Buttons that program and control the OmniPod System Button Action Button Action User Info/ Home/ Pressing opens a User Info/Support screen Pressing and holding turns the PDM on and Support Power that displays additional information about the off.

  • Page 20: Primary Screens

    Your New OmniPod Insulin Management System Primary screens Status screen Messages on the screen either: Lists the System’s current operating status. • Tell you how the System is operating From top to bottom, the Status screen displays: • List menu choices •...

  • Page 21: Safety Features

    • My records menu to review insulin delivery, blood glucose The OmniPod System also performs safety checks on the PDM. history, alarm history, carb history, and personal user informa- If it detects any problems in the PDM or the Pod—or in commu- tion nication between them—it informs you with beeps and on-...

  • Page 22: Alerts And Alarms

    Your New OmniPod Insulin Management System Alerts and alarms For your safety, the OmniPod System provides a range of alerts and alarms to tell you that your attention is needed, or to warn you of hazardous situations. See Chapter 6, Using the Personal Diabetes Manager, for a description of alerts and reminders and how to set them.

  • Page 23: Getting Started

    OmniPod System. your individual needs. Inadequate training or improper If you are a first-time OmniPod System user, you need to meet setup could put your health and safety at risk. with your healthcare provider for training and System setup before using it.

  • Page 24: Set Up The Personal Diabetes Manager (Pdm)

    Getting Started ■ Set Up the Personal Diabetes Manager (PDM) The diagram inside the compartment shows you which direction to insert the batteries (Figure 2-2). Chapter 6 describes the PDM options in detail. The instructions in this chapter are simplified to help you get started. Do not use any other type of batteries than AAA Turn on the PDM alkaline batteries to power the PDM.

  • Page 25: The Omnipod Setup Wizard

    1. Use the Up/Down Controller buttons to increase or You can adjust these settings later as your needs decrease the time. (If you prefer a 24-hour clock, press 12/ change or you fine-tune your OmniPod System. See 24hr.) Then press Next. “OmniPod System Options and Settings” in the 2.

  • Page 26: Enter Basal Settings

    Getting Started Enter basal settings Enter blood glucose sound setting and BG goal 1. Choose a maximum basal rate, then press Next. (The default 1. To set the sound for the blood glucose meter, choose On or maximum basal rate is 3 U/hr.) Off, then press Next.

  • Page 27: Enter Target Blood Glucose Value

    Getting Started Enter target blood glucose value e. Use the Up/Down Controller buttons to enter the “cor- rect above” value or correction threshold (the BG value 1. Use the Up/Down Controller buttons to enter a target blood above which you want the PDM to suggest a correction glucose (BG) value, then press Next.

  • Page 28: Enter Correction Factor

    Getting Started 2. To save the ratio, press Done. To change the ratio, select the You can define correction factors for up to 4 time segments. segment you wish to change and press Edit. To enter additional correction factors, choose [add new], then: You can define up to 4 insulin-to-carbohydrate time seg- ments.

  • Page 29: Enter The Duration Of Insulin Action

    Getting Started Enter the duration of insulin action Set low reservoir alert 1. Use the Up/Down Controller buttons to enter the duration 1. Choose the level of insulin in the reservoir at which the of insulin action (how long insulin lasts in your body), then PDM should give you an alarm.
  • Page 30 MyOmniPod.com detailed instructions. Among these resources are an online copy of this User Guide and the My OmniPod System Information You may want to adjust the PDM screen time-out form, which you will also find at the end of this and backlight time-out.

  • Page 31: Understanding And Adjusting Basal Rates

    For people insulin. A sample basal program with three basal segments using the OmniPod Insulin Management System, the Pod mim- might be: ics a healthy pancreas by delivering insulin at the rate that you’ve programmed into the Personal Diabetes Manager (PDM).

  • Page 32: Create A Basal Program

    Understanding and Adjusting Basal Rates In addition to normal daily changes, insulin needs can vary with 1. On the Home screen, use the Up/Down Controller buttons different routines or days of the week. For example, regular to choose Settings; then press Select. school or workday routines may differ from weekend routines, 2.
  • Page 33 Understanding and Adjusting Basal Rates b. Press the middle soft key (labeled with the right arrow) to As a safety feature, the words “Invalid basal program move the underscore to the next character. name” (Figure 3-4) appear if the name you entered does not have at least one character or if the name is c.

  • Page 34: Enable An Existing Basal Program

    Understanding and Adjusting Basal Rates Basal rates outside the changed segment do not Figure 3-5 Figure 3-6 change. 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.

  • Page 35: Change, Rename, Copy, Or Delete A Basal Program

    Understanding and Adjusting Basal Rates 3. Choose the program you want from the list (Figure 3-7), then As a safety feature, you cannot enable a new basal press Enable. program while a temporary basal preset is in process (see “Temporary Basal Rates and Presets” later in this Figure 3-7 Figure 3-8 chapter);...
  • Page 36 Understanding and Adjusting Basal Rates 2. Choose the segment to change, then press Edit (Figure 3-9). To rename a basal program 1. After choosing a program from the list, choose Rename, then press Select. Figure 3-9 Figure 3-10 2. Press the Up/Down Controller buttons to enter the charac- ters that spell out the new name you want.

  • Page 37: Temporary Basal Rates And Presets

    ■ Temporary Basal Rates and Presets 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. When using percent rate, you can set temporary basal rates...

  • Page 38: Cancel A One-Time Temporary Basal Rate

    Understanding and Adjusting Basal Rates 3. Enter the temporary basal rate in either units per hour (Figure Cancel a one-time temporary basal rate 3-11) or percent change (Figure 3-12), depending on how 1. On the Home screen, use the Up/Down Controller buttons you chose to show the rates;...

  • Page 39: Create A Temporary Basal Preset

    3. Choose Temp basal presets, then press Select. 4. Choose [add new], then press New. 5. To use the OmniPod System’ s default naming system, simply press Next. The default naming system automatically assigns program names in numerical order, such as temp basal 1, temp basal 2, temp basal 3.

  • Page 40: Enable An Existing Temporary Basal Preset

    Understanding and Adjusting Basal Rates Enable an existing temporary basal preset Cancel an active temporary basal preset 1. On the Home screen, use the Up/Down Controller buttons 1. On the Home screen, use the Up/Down Controller buttons to choose Temp basal; then press Select. to choose Suspend/cancel;...
  • Page 41 Understanding and Adjusting Basal Rates To change a temporary basal preset To rename a temporary basal preset 1. Choose Edit, then press Select (Figure 3-16). 1. Choose Rename, then press Select. 2. Press the Up/Down Controller buttons to enter the charac- Figure 3-16 ters that spell out the name you want;...

  • Page 42: Maximum Basal Rate

    Understanding and Adjusting Basal Rates ■ Maximum Basal Rate What is the maximum basal rate? The maximum basal rate is a safety feature that limits the basal rate (U/hr) that the Pod can deliver. Once you enter it into the PDM memory, the maximum applies to both regular basal pro- grams and temporary basal rates.

  • Page 43: Understanding And Delivering Bolus Doses

    • The type and amount of food you eat • Lower blood glucose when it gets too high—also known as a With the OmniPod System, it is easy to adapt to any situation. correction bolus With just a few button presses, you can adjust to unexpected or This extra dose is in addition to the basal rate delivered through- changing insulin needs.

  • Page 44: Bolus Dose Options

    Suggested Bolus Calculator So that you can fully enjoy freedom and flexibility in your life, the The suggested bolus calculator lets the OmniPod System recom- OmniPod System offers the following bolus dose options: mend your bolus based on your personal settings. To review or adjust these settings—including turning the suggested bolus...

  • Page 45: Deliver A Normal Bolus

    The amount of time insulin remains “on board” or “active” depends on what you set for your duration of insulin action. The OmniPod System can only subtract insulin on board from a suggested bolus when the current BG is known.
  • Page 46 Understanding and Delivering Bolus Doses A blood glucose value is current for up to 10 minutes 2. If you are not going to eat now, press No (Figure 4-2). The after it is tested. So you can wait up to 10 minutes, Suggested Bolus screen appears (Figure 4-3).
  • Page 47 From there, select a carb preset you have previously entered (see “Carb Presets” later in this chapter), then press Select. The OmniPod System includes a reference Or press the User Info/Support button to view calculation food library. For more information, see information used for this suggested bolus.

  • Page 48: Deliver A Bolus Manually (Suggested Bolus Calc Is Off)

    4. If you have set the blood glucose reminder option to On and Deliver an Extended Bolus you want to add a reminder: The extended bolus feature lets the OmniPod System deliver a. Press Yes. some (or no) insulin now and the remainder over a period of b.
  • Page 49 Understanding and Delivering Bolus Doses If you have set the Extended bolus option to Off, 3. Enter the time (up to 8 hours, in 30-minute increments) over the PDM will not display the Extend soft key. For which to deliver the remainder of the bolus, then press Enter information on turning this feature on and off, see (Figure 4-7).

  • Page 50: Cancel Active Boluses

    Cancel Active Boluses delivered first and cannot be extended. Only the The OmniPod System is extremely flexible, so you can use it to meal bolus can be extended. For example: respond to your changing insulin needs. It is easy to cancel an...

  • Page 51: Bolus Presets

    3. Choose Bolus presets, then press Select. 4. Choose [add new], then press New. 5. To use the OmniPod System’ s default naming system, simply 3. Press OK to return to the Status screen. press Next. The default naming system automatically assigns program names in numerical order, such as bolus 1, bolus 2, bolus 3.

  • Page 52: Enable An Existing Bolus Preset

    Understanding and Delivering Bolus Doses Or, to give a different name to the program: 6. Enter the new bolus preset amount, up to the maximum bolus you entered during setup; then press Next. a. Press the Up/Down Controller buttons to enter the char- acters that spell the name you want.

  • Page 53: Cancel An Active Bolus Preset

    5. Choose [add new], then press New. not already on. An on-screen message appears as long as a 6. To use the OmniPod System’ s default naming system, simply bolus is being delivered. press Next. The default naming system automatically assigns 2.

  • Page 54: Change Or Edit A Carb Preset

    Understanding and Delivering Bolus Doses b. Press the middle soft key (the right arrow) to move the 7. Enter the grams of carbohydrate in the meal, then press Next. underscore to the next character. 8. If you want, enter the grams of fiber, fat, and protein in the c.

  • Page 55: Delete A Carb Preset

    Understanding and Delivering Bolus Doses To change the category for a carb preset 3. To rename the carb preset, press the Up/Down Controller buttons to enter the characters that spell out the name you 1. Choose the carb preset you want to move to another cate- want, then press Next.

  • Page 56: Reference Food Library

    Reference Food Library Figure 4-16a Figure 4-16b The OmniPod System includes a reference library of over 1,000 common food items. The library shows each item’ s carbohydrate, fat, protein, fiber, and calories for a single portion. You can use this information to determine the carbs for a meal or snack you are going to eat.

  • Page 57: Using The Pod

    CHAPTER 5 Using the Pod ■ The Pod Change Process • Clean the infusion site with soap and water. • Keep sterile materials away from any possible germs. Refer to the insulin labeling and follow your healthcare provider’ s • Do NOT use a Pod if you are sensitive to or have allergies to directions for how often to replace the Pod.

  • Page 58: Gather Equipment And Supplies

    (DKA). • An unopened Pod • Alcohol prep swab If you are a first-time OmniPod System user, your healthcare provider will guide you through the steps for initializing and applying your first Pod. Do NOT attempt to apply or use a Pod until you have been trained by your healthcare provider.
  • Page 59 Using the Pod 4. If an extended bolus or temporary basal or both are actively Figure 5-5 Figure 5-6 running, you will see the message in Figure 5-3. Press Con- firm to accept the cancellation. Or press Back to return to the More actions menu. Figure 5-3 Figure 5-4 b.

  • Page 60: Fill A New Pod

    Using the Pod Fill a new Pod 3. Pull outward to remove the protective cap from the needle (Figure 5-8). Save the cap; you will need it later. Before filling a Pod with insulin, ensure that the Pod is above 50° Fahrenheit (10° Celsius). If the Pod has Use care after removing the needle cap and been exposed to temperatures below 50°...
  • Page 61 Using the Pod 7. Turn the vial and syringe upside down. Withdraw insulin from To ensure proper fill, do not insert fill syringe at an the vial into the syringe, expelling any air bubbles. Fill at least angle into the fill port. to the MIN (minimum) fill line (Figure 5-9).
  • Page 62 The fill syringe is intended for single use only and should be used only with the OmniPod System. 13. After you fill the Pod, it will beep twice. After you hear the beeps, press Next (Figure 5-11).

  • Page 63: Select The Infusion Site

    Using the Pod Select the infusion site Figure 5-13: Adult/Youth 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 poten- tial 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 following page).

  • Page 64: Prepare The Infusion Site

    Using the Pod Prepare the infusion site Figure 5-14: Toddler You can reduce the risk of infection at the infusion site by follow- ing aseptic technique and disinfecting the infusion site. Before applying a new Pod, always: 1. Wash hands with soap and water. 2.

  • Page 65: Apply The New Pod

    Using the Pod Apply the new Pod 2. Using the pull tabs, remove and discard the white paper backing from the adhesive tape (Figure 5-16). Prepare the Pod for applying to your infusion site: 3. Apply the Pod to the prepared infusion site. Press firmly to 1.

  • Page 66: Insert Cannula And Begin Insulin Delivery

    Using the Pod 4. After you securely apply the Pod, press Next (Figure 5-17). Insert cannula and begin insulin delivery 1. To insert the soft cannula, press Start (Figure 5-18). Figure 5-17 Figure 5-18 Figure 5-19 The adhesive is designed for one-time use. Once removed, a Pod cannot be reapplied.
  • Page 67 Using the Pod The Pod automatically inserts the soft cannula below your Check the infusion site after insertion to ensure skin. It takes a few seconds to complete the insertion process. that the cannula was properly inserted. It is also a Once the cannula is inserted, the Pod delivers a prime bolus to good idea to check your blood glucose about fill the cannula with insulin (Figure 5-20).

  • Page 68: Check Pod Status

    Using the Pod ■ 2. Press Yes if you can see that the cannula is properly inserted. Check Pod Status The PDM returns to the Status screen. To check Pod status, if the PDM is turned off, press and hold the Or press No if you see a problem with the cannula.

  • Page 69: Suspend Insulin Delivery

    Sometimes you may need to briefly stop insulin delivery (for then press Enter. example, when editing an active basal program or changing the time or date). The OmniPod System lets you suspend all insulin Figure 5-23 Figure 5-24 delivery for up to 2 hours. While in suspension, the Pod beeps once every 15 minutes, reminding you that insulin delivery is suspended.

  • Page 70: Resume Insulin Delivery

    Using the Pod ■ At the end of the suspend time, a Pod Advisory alarm occurs Resume Insulin Delivery (Figure 5-25). 1. On the Home screen, use the Up/Down Controller buttons to choose Resume (Figure 5-26); then press Select. Figure 5-25 Figure 5-26 2.

  • Page 71: Get The Most From Your Pod

    Using the Pod ■ Get the Most From Your Pod Water and your Pod The Pod is watertight to a depth of 25 feet for up to 60 minutes (IPX8). After exposure to water, rinse off the Pod with clean water Avoid extreme temperatures and gently dry it with a towel.

  • Page 72: Using The Personal Diabetes Manager

    CHAPTER 6 Using the Personal Diabetes Manager ■ The Status Screen Figure 6-1 When a Pod is active and the PDM is turned on, the PDM estab- lishes communication with the Pod to obtain a status check. During the status check, the PDM collects information from the Pod about bolus deliveries, active basal programs, and Pod expi- ration.

  • Page 73: Insulin Gauge And Display

    Using the Personal Diabetes Manager If a Pod has not yet been activated (as during Pod changes), PDM settings the screen displays “No active Pod. Would you like to acti- You can adjust the PDM settings to meet your individual needs. vate a Pod now?”...

  • Page 74: The System Setup Menu

    The System setup menu lets you personalize the settings that Occasionally, you need to change date and time settings (for control the OmniPod System. These include: example, to adjust for daylight savings time or after resetting the PDM). As a safety feature, you can change date and time settings •...

  • Page 75: Reset The Date

    You and your healthcare provider entered initial bolus and basal System settings using the Setup Wizard. Using the System setup menu, you can edit all the OmniPod System bolus and basal set- tings as your needs change. Check with your healthcare provider before making any changes.

  • Page 76: Bolus Calcs

    Using the Personal Diabetes Manager 4. Choose one of the options (Figure 6-5a and Figure 6-5b), then Bolus calcs press Select. Each option is described below. When the suggested bolus calculator is turned Off and you want to turn it On, press On and follow these steps: 1.
  • Page 77 Using the Personal Diabetes Manager 3. Insulin to carb (IC) ratio—You can edit existing time seg- c. When you have completed all time segments, press ments and add segments, up to a total of four. Done, then Save. a. To edit an existing IC ratio time segment, choose the seg- 4.

  • Page 78: Ratios/Factors/Targets

    Using the Personal Diabetes Manager Ratios/factors/targets 1. Target BG and correct-above value—You can edit existing segments and add segments, up to a total of four. When the suggested bolus calculator is turned On, you can view and change all the settings using the Ratios/factors/targets a.

  • Page 79: Temp Basal

    Using the Personal Diabetes Manager c. When you have completed all time segments, press Extended Done, then Save. Choose %, Units, or Off to set the mode for extended boluses, then press Select. 4. Correction factor—You can edit existing time segments and add segments, up to a total of four.

  • Page 80: Alerts And Reminders

    Pod status to the PDM. In addition to automatic safety alarms (see Chapter 10, Errors, Advisories, and Hazard Alarms), the OmniPod System offers a Many hazard alarms (such as Auto-off) will cause number of alerts and reminders that you can set to help you manage your diabetes.

  • Page 81: Set Alerts And Reminders

    4. Choose the reminder or alert you want to set (Figure 6-8), instructions, so you become familiar with the operation of the then press Select. OmniPod System and feel confident that you are getting the insulin you need. These alerts include: Figure 6-8 •...
  • Page 82 New. • If you chose On, you are taken to a new screen where you • To use the OmniPod System’ s default naming system, sim- can add, edit or delete reminders: ply press Next. The default naming system automatically...

  • Page 83: Change Blood Glucose Meter Settings

    Using the Personal Diabetes Manager ■ Change Blood Glucose Meter Settings Figure 6-9 Figure 6-10 You can adjust blood glucose (BG) meter settings: • BG goal lower and upper limits (for BG history) • Manage BG tags list • BG sound—On or Off 1.

  • Page 84: Manage The Blood Glucose Tags List

    Using the Personal Diabetes Manager Manage the Blood Glucose Tags List 1. To hide or show a standard BG tag, choose the tag, and press Show (if it is marked as hidden) or Hide. You can create up to 15 custom blood glucose tags and hide any of the standard tags you do not plan to use.

  • Page 85: Customize The Personal Diabetes Manager

    Using the Personal Diabetes Manager ■ Customize the Personal Diabetes Manager For extra brightness on the PDM screen, press and hold the User Info/Support button (?) for 2 seconds. Additional options let you customize how the PDM operates: This enables a “bright mode. ” The screen will remain in this mode until the PDM times out or you turn it off.

  • Page 86: Set Diagnostic Functions

    Using the Personal Diabetes Manager Set the Screen time-out 4. Choose one of the options (Figure 6-13), then press Select. Choose a time interval, then press Select. Figure 6-13 When the screen times out and goes black, turn it on again by pressing the Home/Power button.

  • Page 87: Diagnostic Options

    Using the Personal Diabetes Manager Diagnostic options If the PDM fails to beep, immediately call Customer 1. On the Home screen, use the Up/Down Controller buttons Care at 800-591-3455 (from outside the United to choose Settings, then press Select. States, 781-457-5098). If a Pod is active and fails to beep, change the Pod immediately (see Chapter 5, 2.

  • Page 88: Get The Most From Your Pdm

    Using the Personal Diabetes Manager ■ Get the Most from Your PDM Figure 6-14 Figure 6-15 Keep it handy Wireless communication technology means you don’t have to keep the PDM right next to the Pod for the Pod to work. Once you set your basal program, the Pod continues to deliver your basal program 24 hours a day, regardless of the location of the PDM.

  • Page 89: Avoid Extreme Temperatures

    Using the Personal Diabetes Manager Avoid extreme temperatures Only connect a USB cable to your PDM when down- Extreme operating temperatures can affect PDM batteries and loading data to a computer. Other PDM functions are interfere with System operation. Avoid using the PDM in temper- disabled while a USB cable is connected, and the atures below 40°F (5°C) or above 104°F (40°C).

  • Page 90: Checking Your Blood Glucose

    • When your healthcare provider advises you to do so Most healthcare providers rec- Keep the OmniPod Insulin Management System and ommend checking on your the FreeStyle® accessories away from young children, hand, arm, or leg when blood...

  • Page 91: The Freestyle® Blood Glucose Test Strips

    Only use FreeStyle® test strips and FreeStyle® control to another vial or any other container. solution with the OmniPod System. Using other brands of test strips and control solutions with the • Never store individual test strips outside the vial.

  • Page 92: The Freestyle® Control Solution

    You should perform a control solution test: date. Write this date on the side of the control solution bottle. For • When you first get your OmniPod System, before doing a example, if you open the control solution on January 15, count blood glucose test forward 3 months to April 15.

  • Page 93: Out-Of-Range Control Solution Results

    Results from FreeStyle® control solution tests do 1. The OmniPod System may not be working properly. not reflect your blood glucose level. 2. Do not use the System to test your blood glucose.

  • Page 94: Performing A Control Solution Test

    Checking Your Blood Glucose ■ Performing a Control Solution Test If you need to adjust the code number after the PDM has moved to the next screen, just press the Up/Down 1. Grasp the bottom of the test strip with the name “FreeStyle®” Controller buttons.
  • Page 95 Checking Your Blood Glucose From some PDM screens, you cannot access the Free- Figure 7-6 Figure 7-7 style® blood glucose meter. For example, you cannot use the meter while you are activating a Pod or when an alert, alarm, or communication error screen is dis- played.
  • Page 96 Checking Your Blood Glucose The “Checking” screen appears while the sample is process- 6. To mark the result as a control solution result rather than a ing (Figure 7-8). The strip-port light turns off when the sam- blood glucose test: ple is accepted.

  • Page 97: Performing A Blood Glucose Test

    Checking Your Blood Glucose 9. Remove the test strip. If the strip-port light was turned on, it Figure 7-10 now turns off. If you remove the test strip before this step, you will still see the available soft keys. Cocking handle Be sure to discard used test strips.

  • Page 98: Prepare The Lancing Device

    Checking Your Blood Glucose Prepare the lancing device 4. Replace the cap until it snaps or clicks into place (Figure 7-14). Be careful not to touch the exposed needle on the lancet. 1. Snap off the cap on the lancing device at an angle (Figure 7-11).

  • Page 99: Insert The Blood Glucose Test Strip

    Checking Your Blood Glucose 5. The lancing device offers four different depth settings. Level 1 6. Pull out the dark gray cocking handle until it clicks (Figure 7- is the shallowest depth; level 4 is the deepest. Move the dial 16).

  • Page 100: Set The Blood Glucose Test Strip Code

    Checking Your Blood Glucose 3. Insert only the top end of the strip into the test strip port, with Set the blood glucose test strip code the dark colored rectangle going into the meter (Figure 7-17 After you insert the strip, the PDM displays a code number and Figure 7-18).

  • Page 101: Lance Your Finger

    Checking Your Blood Glucose If you need to adjust the code number after the PDM 5. Gently squeeze your finger, if needed, until a blood drop the has moved to the next screen, just press the Up/Down size of a pinhead forms. Controller buttons.

  • Page 102: Lance Your Forearm, Upper Arm, Hand, Thigh, Or Calf

    Checking Your Blood Glucose Lance your forearm, upper arm, hand, thigh, or calf 4. Depress the release button. Do not lift up the lancing device; instead, continue to hold it and gradually increase pressure 1. To bring fresh blood to the surface of the test site, rub the site for several seconds (Figure 7-25).

  • Page 103: Fill The Blood Glucose Test Strip With Blood

    Checking Your Blood Glucose 2. Bring the strip to the blood sample at a slight angle Avoid lancing areas with obvious veins or moles, (Figure 7-27). to avoid excess bleeding. Also avoid lancing areas where tendons or bones stick out (for If you do not apply the sample within 10 seconds, the strip- example, hand bones and ankle bones).

  • Page 104: Wait For The Reading

    Checking Your Blood Glucose 2. If after 5 seconds the PDM does not display “Checking, ” the Do not: sample may be too small. If needed, add more blood to the • Press the strip against the test site same edge of the strip for up to 60 seconds from the time of •...

  • Page 105: Remove The Lancet

    Checking Your Blood Glucose 4. To mark the result as a pre- or post-meal test, to indicate a b. Press OK to return to the reading screen (Figure 7-31 on level of exercise, or to indicate other situations connected to the previous page), then press Next.

  • Page 106: Blood Glucose Results And The Suggested Bolus Calculator

    Checking Your Blood Glucose ■ Blood Glucose Results and the Suggested Bolus Figure 7-34 Calculator If the suggested bolus calculator feature is turned On when you check your blood glucose, the PDM will display the result. From here, press Next to enter carbs (if eating) and have the System calculate a suggested bolus.

  • Page 107: Entering Blood Glucose Readings Manually

    Checking Your Blood Glucose ■ ■ Entering Blood Glucose Readings Manually Editing Tags You can enter blood glucose readings manually into the PDM. Within 2 hours of a blood glucose reading, you can remove or This is particularly helpful if you use a separate blood glucose change a tag or add one.
  • Page 108 Checking Your Blood Glucose 4. Use the Up/Down Controller buttons to choose the first tag 6. Press OK to return to the list of readings. you want, then press Select (Figure 7-36). A diamond icon If no BG readings have been entered into the PDM within the appears next to selected tags, as in “Pre-meal”...

  • Page 109: Low And High Blood Glucose Readings

    Checking Your Blood Glucose ■ Low and High Blood Glucose Readings High readings If your reading is above 500 mg/dL, the PDM displays “HIGH Check for ketones!” This indicates severe hyperglycemia (high WARNINGS! blood glucose). High reading with symptoms “LOW” or “HIGH” blood glucose readings can indicate a poten- If you get a “HIGH Check for ketones!”...

  • Page 110: Important Health-Related Information

    Checking Your Blood Glucose ■ Important Health-Related Information • Blood circulation is different between the finger or palm (at the base of the thumb) and other test sites like the forearm, upper arm, hand, thigh, and calf. You may see differences in WARNINGS! blood glucose measurements between the other test sites and your finger or palm (at the base of the thumb) after eat-...

  • Page 111: Understanding Your Records

    CHAPTER 8 Understanding Your Records ■ Record Keeping The record for this item has been “lost. ” If the PDM can no longer communicate with an Record keeping is an important part of successful diabetes man- active Pod, then you must activate a new Pod. The agement.

  • Page 112: Insulin Delivery Records

    Understanding Your Records ■ Insulin Delivery Records Figure 8-1 Figure 8-2 The PDM stores: • Basal rates (including any rate changes and temporary basals) • Bolus doses (both normal and extended) • Dates, times, and how long insulin delivery was suspended, and dates and times when it was resumed •...
  • Page 113 Understanding Your Records Press Event to use the Up/Down Controller buttons to scroll Figure 8-3 Figure 8-4 through the list of information on the screen. Choose a record, then press the User Info/Support button to view details about that record. Record details may include insulin delivery that was interrupted due to a Pod alarm, Pod deacti- vation, or user cancellation.

  • Page 114: Blood Glucose Records

    Understanding Your Records ■ Blood Glucose Records Figure 8-5 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.

  • Page 115: View Multiple-Day Trends

    Understanding Your Records In the List view, press Event to select individual readings. View multiple-day trends Readings with a question-mark icon next to them have addi- 1. On the Home screen, use the Up/Down Controller buttons tional information available (Figure 8-7). To see this informa- to choose My records, then press Select.

  • Page 116: Alarm Records

    Alarm Records of the trends (Figure 8-11). (Graphs are not available for 60-, or The PDM lists the entire alarm history for the OmniPod System. 90-day trends.) Press Stats to return to the detail view. The PDM can store over 90 days’ worth of alarm records.

  • Page 117: All Records

    All Records The user information screen also displays contact information for The PDM displays the combined insulin delivery, blood glucose, Insulet Corporation and product information for your OmniPod alarm, and carbohydrate records. System (make, model, serial number). You cannot change this 1.

  • Page 118: Add Or Change User Information

    Understanding Your Records The User Info/Support icon is also displayed on the 4. Press the Up/Down Controller buttons to scroll through the suggested bolus screen. For information about the list of characters. An up-and-down-arrow symbol ( ) on the support information displayed on these screens, screen indicates the character you are changing.

  • Page 119: Living With Diabetes

    If you have questions or doubts about • Knowing how to contact your healthcare provider in case of being able to safely use the OmniPod System at any time, consult an emergency. your healthcare provider immediately.

  • Page 120: Daily Diabetes Management Activities

    Inspect the infusion site daily At least once a day, use the Pod’ s viewing window to inspect the To ensure proper OmniPod System operation and your contin- infusion site. Check the site for signs of infection, such as pain, ued good health: swelling, redness, discharge, or heat.

  • Page 121: Prepare For Emergencies

    • A vial of rapid-acting U-100 insulin (See the warn- what to do if you cannot reach your healthcare ing on page x of the Introduction for insulins provider. approved for use in the OmniPod System.) ■ Water and Your Pod • Syringes for injecting insulin •...

  • Page 122: Traveling And Vacationing

    Living with Diabetes ■ Traveling and Vacationing • Insulin syringes or pens in case you need injections • Several vials of insulin or insulin cartridges if you use a pen Plan for changing time zones • Glucagon kit (Make sure any person you are traveling with knows how to give the injection.) If you’re planning a vacation or business trip to a different time zone, you may need to adjust your basal rate programs.

  • Page 123: Minimize Airport Security Delays

    • Personal Diabetes Manager (PDM) • A signed letter from your healthcare provider explaining that • An emergency kit you need to carry insulin supplies and OmniPod System • Vials of insulin (cargo area temperatures may affect insulin) equipment • A copy of your healthcare provider’s letter (see “Minimize air- •...

  • Page 124: Avoid Lows, Highs, And Dka

    Hypoglycemia unawareness is a condition in which you do not realize when your blood glucose level is You can avoid most risks related to using the OmniPod System low. If you are prone to hypoglycemia unawareness, by practicing proper techniques and by acting promptly at the you may want to use the OmniPod System’...
  • Page 125 Living with Diabetes To avoid hypoglycemia (low blood glucose) Always carry medical identification (emergency wallet card) and wear an emergency medical neck- Make sure your blood glucose is at least 100 mg/dL lace or bracelet such as the Medic Alert tag. (See the before driving or working with dangerous machinery end of the Appendicesfor address, telephone, and or equipment.
  • Page 126 Living with Diabetes 1. If blood glucose is below 70 mg/dL, eat or drink 15 grams of How much is 15 grams of carbohydrate? fast-acting carbohydrate, such as glucose tablets, juice, or Examples of fast-acting foods: hard candy (see “How much is 15 grams of carbohydrate?” Three 5-gram glucose tablets, or four 4-gram tablets below).
  • Page 127 Living with Diabetes Possible causes of hypoglycemia (low blood glucose) Possible cause of low Suggested action Possible cause of low Suggested action Incorrect basal Confirm that correct basal program Incorrect target Consult healthcare provider about program is active. blood glucose levels refining these settings as needed.

  • Page 128: Hyperglycemia (High Blood Glucose)

    Living with Diabetes Hyperglycemia (high blood glucose) Possible cause of low Suggested action Insulin Pods use rapid-acting insulin, so you have no long-acting insulin in your body. If an occlusion (interruption of insulin deliv- Prolonged or intense Adjust insulin delivery as instructed ery from the Pod) occurs, your blood glucose can rise rapidly.
  • Page 129 Living with Diabetes To avoid hyperglycemia (high blood glucose) 4. Check blood glucose again after 2 hours. Check your blood glucose at least 4–6 times a day (when you 5. If blood glucose levels have not decreased, take a second wake up, before each meal, and before going to bed).
  • Page 130 Living with Diabetes Possible causes of hyperglycemia (high blood glucose) Possible cause of high Suggested action Possible cause of high Suggested action Expired insulin Deactivate and remove used Pod. Empty Pod Deactivate and remove used Pod. Apply new Pod filled with insulin Apply a new Pod in a different Insulin exposed from a new vial.
  • Page 131 Living with Diabetes Possible cause of high Suggested action Possible cause of high Suggested action High-protein or Calculate protein/fat intake and Weight loss or gain Consult your healthcare provider high-fat meal account for it in your bolus timing for guidance. Menstrual cycle and bolus type.

  • Page 132: Diabetic Ketoacidosis (Dka)

    Living with Diabetes Diabetic ketoacidosis (DKA) To avoid DKA Insulin Pods use rapid-acting insulin, so you have no long-acting The easiest and most reliable way to avoid DKA is by checking insulin in your body. If insulin delivery from the Pod is interrupted your blood glucose at least 4–6 times a day.

  • Page 133: Handling Special Situations

    Living with Diabetes ■ Handling Special Situations • Follow your healthcare provider’ s guidelines for taking addi- tional insulin on sick days. • Drink plenty of noncaffeinated fluids to prevent dehydration. Sick days Any physical stress can cause your blood glucose to rise, and ill- If you are well enough to eat, drink sugar-free bever- ness is a physical stress.

  • Page 134: X-Rays, Mris, And Ct Scans

    Living with Diabetes Be sure to check your blood glucose levels before removing the Surgery or hospitalization Pod and after applying a new one. Pods are designed for one- For scheduled surgeries or hospitalization, you should tell the time use. Do not attempt to reapply a used Pod. doctor/surgeon or hospital staff about your insulin Pod.

  • Page 135: Errors, Advisories, And Hazard Alarms

    Safety Checks Blood Glucose Meter Error Messages The OmniPod System has a very important safety feature: It can These messages let you know about an error in the blood glu- check its own functions and let you know when something cose meter, test strip, sample, or results.
  • Page 136 Errors, Advisories, and Hazard Alarms Error message Possible causes Action Meter Error 1 • Blood sample is too small. 1. If you have symptoms such as weakness, sweating, nervousness, head- ache, or confusion, follow the recommendations of your healthcare • Problem with the test strip. provider for treating hypoglycemia.
  • Page 137 Errors, Advisories, and Hazard Alarms Error message Possible causes Action Meter Error 3 • Incorrect test procedure. 1. Be sure you see the Blood Drop and Test Strip symbols on the display For example, putting blood screen before you apply blood or control solution. on the test strip before 2.

  • Page 138: Advisory Alarms

    Errors, Advisories, and Hazard Alarms ■ Advisory Alarms Some advisory alarms are controlled by levels you set in the Set- tings screen. One example is the level at which the Low Advisory alarms tell you about a condition that requires your reservoir volume alarm sounds.
  • Page 139 Errors, Advisories, and Hazard Alarms Alarm Source Beep Pattern Action End of insulin suspend. 2 sets of beeps every minute for 3 minutes. Press OK to resume insulin delivery at programmed basal rate. Press “Ok” to resume basal Repeats every 15 minutes until insulin delivery is rate delivery.

  • Page 140: Hazard Alarms

    Errors, Advisories, and Hazard Alarms ■ Hazard Alarms Due to the serious nature of hazard alarms, you must act promptly to resolve them. Hazard alarms occur either when the Pod is in a very serious con- 1. Acknowledge the alarm condition by pressing dition or something is wrong with the PDM.
  • Page 141 Press OK to acknow- ledge. Insulin delivery stopped. Among these resources are an online copy of this User Guide and the My OmniPod System Information Change Pod. Change pod now. form, which you will also find at the end of this Check blood glucose.
  • Page 142 Errors, Advisories, and Hazard Alarms Alarm Source Action Alarm Source Action Pod deactivation required. Press OK to acknow- PDM Error. Press OK to acknow- ledge. ledge. Press “Ok” to deactivate. Press “Ok” to reset clock. Change Pod. Reset clock. Check blood glucose. Check blood glucose.

  • Page 143: Communication Failures

    Figure 11-2 on the next page. • Too far from the Pod—It must be within 24" (61 cm) when you are entering or changing settings. • Interrupted by outside interference—See the “OmniPod System Federal Communications Commission (FCC) Notice Concerning Interference” in the Appendices.
  • Page 144 Communication Failures Figure 11-1 Figure 11-2 Figure 11-3 Figure 11-4 2. Move across the room or to a different room. Then press b. If the status check fails, you will see Figure 11-4. Press OK Retry. to try checking Pod status again, or press Discard to begin the deactivation process.

  • Page 145: Failure During Pod Deactivation

    Communication Failures ■ 3. If at any point in this process the PDM can communicate Failure During Pod Deactivation again with the Pod, you will see either: To review the deactivation process, see “Deactivate the current a. Figure 11-5, indicating that your original instruction or Pod”...

  • Page 146: Failure During Request For Status

    Communication Failures ■ 2. Press Discard. The PDM will consider the Pod lost, and ask Failure During Request for Status whether you want to activate a new Pod. If you turn on the PDM or press Status and the PDM cannot If you have an unconfirmed correction bolus when you communicate with the Pod, it displays a communication icon discard a Pod, then the bolus calculator will be temporar-...

  • Page 147: Failure During Bolus Cancellation

    Communication Failures ■ If the Pod has expired, you will see the screen in Failure During Bolus Cancellation Figure 11-11 instead. 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”...
  • Page 148 Communication Failures 3. Move across the room or to a different room. Then either: 4. If at any point in this process the PDM can communicate again with the Pod, you will see Figure 11-15. The message a. Press Discard to begin the deactivation process. indicates that your original instruction to cancel the bolus b.

  • Page 149: Failure During A Hazard Alarm

    Communication Failures ■ Failure During a Hazard Alarm Figure 11-17 Figure 11-18 If you respond to a hazard alarm (see Chapter 10, Errors, Adviso- ries, and Hazard Alarms), but the PDM cannot communicate with the Pod to acknowledge or shut off the alarm, you can shut off the alarm manually.

  • Page 150: Appendices

    Appendices The OmniPod Insulin Management System has no user-serviceable parts. If you require assistance operating or maintaining the System, please contact Customer Care at 800-591-3455 (from outside the United States, 781-457-5098). ■ ■ Pod Care and Maintenance Personal Diabetes Manager Care and Maintenance...

  • Page 151: Cleaning

    Appendices Cleaning The PDM automatically alerts you when its battery power gets low (see Figure A-1). When you see the “Low PDM battery” alert, You can clean the outside of the PDM with a clean, damp cloth. press OK to turn off the alert. Replace the batteries as soon as you can.

  • Page 152: If The Pdm Becomes Submerged In Water

    Appendices The diagram inside the compartment shows you If the batteries run out, data in the memory is at risk. which direction to insert the batteries. DO NOT remove the old batteries until you have new ones at hand. The longer the batteries are removed, the more the memory is at risk.

  • Page 153: If You Drop The Pdm

    See the warranty coverage on page 155. Ordering supplies You can order all OmniPod System products and supplies directly from Insulet Corporation. You can order them by calling 800-591-3455 (from outside the United States, 781-457-5098), Monday-Friday, 8:30am–8pm Eastern Time.

  • Page 154: Suggested Bolus Calculator Examples

    Appendices ■ Suggested Bolus Calculator Examples Meal bolus calculation Carbs entered ÷ insulin-to-carb (I/C) ratio A suggested bolus is equal to: Example of meal bolus correction bolus + meal bolus – insulin on board. Carbs entered: 45 grams of carb Examples of each of these elements are shown below.

  • Page 155: Examples Of Suggested Bolus Calculations

    Appendices Examples of suggested bolus calculations Correction bolus: 150 mg/dL (current) – 100 mg/dL (target) = 50 The examples below use these settings: 50 ÷ 50 (CF) = 1 unit • Target BG: 100 mg/dL Meal bolus: 45 (carbs) ÷ 15 (I/C ratio) = 3 units •...

  • Page 156: Calculator Guidelines

    • A reverse correction only occurs if the meal bolus is greater than 0.00U. When the suggested bolus calculator is turned On, the OmniPod System applies these guidelines to the suggested bolus doses: • If your blood glucose value is below the target blood glucose value and you have set reverse correction to On, the sug- •...

  • Page 157: Omnipod System Options And Settings

    Appendices ■ OmniPod System Options and Settings 12-hour or 24-hour clock Blood glucose meter sound On or Off Time Default is On Default is 12-hour Suggested bolus calculator On or Off Date MM/DD/YY Default is On DD/MM/YY Target BG value and 4 time segments;...

  • Page 158: Pod Specifications

    Appendices ■ Pod Specifications Bolus presets Carbohydrate presets Size: 1.6" wide x 2.4" long x 0.7" high Suspend 30 minutes to 2 hours (4.1cm x 6.2cm x 1.7cm) Low reservoir volume 10 to 50 units in 5-unit increments Weight (with full reservoir): 34 grams (1.2 oz) indicator Default is 10.0 units Operating temperature range: 40°...

  • Page 159: Accuracy Test Results

    Appendices ■ Accuracy Test Results Flow rate error The following trumpet curve shows the accuracy of the delivery The following graphs are designed to show flow accuracy of the rate in relation to the observation period. The measurements Pod against given time periods. were made using a Pod with a basal rate of 1.0 U/h at high oper- ating temperature.

  • Page 160: Personal Diabetes Manager Specifications

    Appendices ■ ■ Personal Diabetes Manager Specifications Blood Glucose Meter Specifications Size: 2.5" wide x 4.5" long x 1.0" high (6.4cm x 11.4cm x 2.5cm) Assay method: Coulometric electrochemical sensor Weight (with batteries): 125 grams (4.4 oz) Calibration: Plasma equivalent Screen: 1.4"...

  • Page 161: Omnipod System Label Symbols

    Appendices ■ OmniPod System Label Symbols Symbol Meaning Symbol Meaning Storage temperature Do not reuse this device; single-use only Do not use if package is damaged Caution: Consult accompanying documents Authorized Representative in the European Consult instructions for use Community Sterilized by ethylene oxide ■...

  • Page 162: Omnipod System Federal Communications Commission (Fcc) Notice Concerning Interference

    “Unconfirmed” communications. There are no guarantees that interference will Home screen history record not occur in a particular installation. If the OmniPod System does “Delivery Spans Active/default cause harmful interference to radio and television reception, the Midnight”...

  • Page 163: Electromagnetic Compatibility

    Appendices ■ Electromagnetic Compatibility Care should be taken if the OmniPod System is used adjacent to other electrical equipment; if adjacent use is inevitable, such as in The information contained in this section (such as separation work environments, the OmniPod System should be observed to distances) is, in general, specifically written with regard to the verify normal operation in this setting.
  • Page 164 The OmniPod System is suitable for use in all establishments includ- Emissions Classification ing domestic establishments. Electromagnetic Immunity The OmniPod System is intended for use in the electromagnetic environment specified below. You should observe these require- ments in the use of the OmniPod System. IEC 60601-1-2 Compliance level...
  • Page 165 Portable and mobile RF communications equipment should (IEC 61000-4-6) 150 kHz to 80 Mhz be used no closer to any part of the OmniPod System than the recommended separation distance calculated from the equa- tion applicable to the frequency of the transmitter as below.
  • Page 166 OmniPod System You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communi- cations equipment (transmitters) and the OmniPod System, as recommended below, according to the maximum output power of the communications equipment.

  • Page 167: Customer Bill Of Rights

    Insulet Corporation’ s scope of services is limited to providing the 8:30am and 6:00pm Eastern Time, Monday through Friday, at 1- OmniPod Insulin Management System. The System consists of 800-591-3455 (from outside the United States, 781-457-5098). the handheld, wireless Personal Diabetes Manager (PDM), which We will respond immediately whenever possible;...
  • Page 168 Appendices 6. Select the medical equipment supplier of your choice. You have the responsibility to: 1. Ask questions about any part of the plan of service or plan of 7. Make informed decisions regarding your care planning. care that you do not understand. 8.

  • Page 169: Limited Warranty For The Personal Diabetes Manager

    Appendices ■ Limited Warranty for the Personal Diabetes THIS WARRANTY DOES NOT APPLY IF THE PDM HAS BEEN: Manager • changed or modified by any person or entity other than Insulet Corporation; • serviced or repaired by any person or entity other than Insulet Limited Warranty Coverage Corporation;...

  • Page 170: Hipaa Privacy Notice

    Appendices ■ HIPAA Privacy Notice authorization. To revoke a previously issued authorization, please send your request in writing, along with a copy of the THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION IS USED authorization being revoked, to our Privacy Officer. If a copy of AND DISCLOSED AND HOW YOU CAN GET ACCESS TO IT.
  • Page 171 Appendices Appointment Reminder and Other Communications: We may Public Health: We may disclose your Medical Information for use or disclose your Medical Information without your prior public health activities and purposes to a public health authority written authorization to provide you or others with, among that is permitted by law to collect or receive the information.
  • Page 172 Appendices repairs, or replacement, or lookback (including locating and noti- Criminal Activity: Consistent with applicable federal and state fying individuals who have received products that have been laws, we may disclose your Medical Information if we believe the recalled, withdrawn, or are the subject of lookback); or (iv) to con- use or disclosure is necessary to prevent or lessen a serious and duct post-marketing surveillance.

  • Page 173: Your Rights

    Appendices Required Uses and Disclosures: Under the law, we must make We will respond to your request in a reasonable amount of time. disclosures to you when required by the Secretary of the If your request is honored, we may charge a nominal fee for Department of Health and Human Services to investigate or photocopying expenses.
  • Page 174 Appendices Your request must state the specific restriction requested and to You Have the Right to Receive an Accounting of Certain whom you want the restriction to apply. We are not required to Disclosures We Have Made, if any, of Your Medical Information: agree to a restriction that you may request, but if we do agree to This right applies to disclosures for purposes other than the requested restriction, we may not use or disclose your Medi-...

  • Page 175: Our Duties

    Appendices Our Duties What To Do If You Have a Problem or Question Generally: We are required by law to maintain the privacy and If you have any questions relating to this HIPAA Privacy Notice or security of your Medical Information and to provide you with if you have a problem or complaint, please contact us by writing notice of our privacy practices with respect to Medical Information.

  • Page 176: Helpful Resources

    Appendices ■ Helpful Resources American Diabetes Association 1660 Duke Street • Alexandria, VA 22314 800-342-2383 www.diabetes.org International Association for Medical Assistance to Travelers List of doctors in foreign countries who speak English and who received post-graduate education in the US or Great Britain 417 Center Street •...

  • Page 177: Glossary

    Glossary A1c (see Hemoglobin A1c) BG goal A range of blood glucose levels that you are trying to achieve dur- Advisory alarm ing a certain period of the day. For example, you may want one Notification by the PDM that a serious condition exists. BG goal before meals, a different BG goal two hours after meals, and yet another BG goal for bedtime.
  • Page 178 A unit of measurement used to express the energy value of food. An amount of insulin taken to compensate for high blood glucose Calories come from carbohydrate, protein, fat, and alcohol. levels. The OmniPod System calculates the correction bolus by taking the difference between your current blood glucose level Cannula...
  • Page 179 OmniPod Insulin Management manage their health. All healthcare providers are a resource for System. valuable diabetes management information. Extended bolus A feature of the OmniPod System that allows a meal bolus dose to be given over an extended period of time.
  • Page 180 Talk with your healthcare provider to determine your duration of insulin action. Hypoglycemia (low blood glucose) The OmniPod System continually calculates the IOB to help A lower-than-normal level of glucose in the blood; generally prevent “stacking” of correction bolus doses, which is a major 70mg/dL or lower.
  • Page 181 BG goal on or off according to the advice of a healthcare provider. after a meal. The OmniPod System calculates a meal bolus by dividing the grams of carbohydrates you are about to eat by your Sensitivity factor (see correction factor) insulin-to-carbohydrate ratio.
  • Page 182 The ideal number at which you would like your blood glucose handling them. Sharps include needles, syringes, scalpel blades, level to be. The OmniPod System uses this number in calculating disposable razors, and broken medical glassware. Dispose of bolus doses.

  • Page 183: Index

    Index alert escalation ..... . 126 add segment or rate ....21 alerts and reminders.
  • Page 184 Index code ......80, 86 ratios/factors/targets ....64 bolus .
  • Page 185 Index bolus settings ..... 61 continuous subcutaneous insulin phone number ....ix, xi infusion .
  • Page 186 Index check alarms..... . . 72 temporary basal presets ... 26 reset PDM.
  • Page 187 Index hyperglycemia ..96, 105, 114–117, 166 resume......56 avoiding......115 suspend.
  • Page 188 My records......7 OmniPod System..... . . 2 customize .
  • Page 189 Index applying......51 prime bolus..... . .53, 167 rename change process.

  • Page 190: Specifications

    Index alerts and alarms....8 BG meter ......146 DKA .
  • Page 191 Index rename......27 time zones......108 temporary basal rate.
  • Page 192 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. This form, along with other resources, is available on the Insulet Corporation Web site, MyOmniPod.com. Basal Program 1 Basal Program 2 Name _________________________________...
  • Page 193 My PDM Settings Duration of Insulin Action Bolus Presets Time that insulin will remain “active” in the body Name Units from a previous correction bolus. ___________ hrs _____________ U ________________________________________ ________________________________________ _____________ U ________________________________________ _____________ U Correction Factor ________________________________________ _____________ U ________________________________________ _____________ U Correction factor for each time segment defined,...
  • Page 194 800.591.3455 / 781.457.5098 My OmniPod.com © 2010 Insulet Corporation. All rights reserved. Printed in USA. PDM imagery is for illustrative purposes only. PDM screens may vary based on model or user settings. Model: UST200 13705-AW Rev E No strings attached ™...

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