Page 2 Address Address Telephone and Fax Telephone and Fax Email Address Email Address OmniPod System Start Date: _ ___________________________ PDM Model UST4 Serial Number: _____________________ Emergency Services: Dial 911 (USA only; not available in all communities) Insulet Corporation 9 Oak Park Drive, Bedford, MA 01730...
Page 3 © 2012 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. Third-party trademarks used herein are the trademarks of their respective owners. 14421-AW Rev C...
Page 4: Table Of Contents
The OmniPod Starter Kit ........
Page 5 Contents Personalized Basal Programs ........17 Bolus Presets .
Page 6 Contents 6 Using the Personal Diabetes Manager ....61 Set the Backlight time-out ........75 The ID Screen .
Page 7 Advisory Alarms ..........125 Your Role: Safely Using the OmniPod System....106 Hazard Alarms .
Page 8 Failure During Request for Status ......135 OmniPod System Label Symbols ......151 Failure During Bolus Cancellation .
Page 9: Introduction
UST400. To learn which version of the PDM you have, turn it over. On the back of the PDM, look Symbols for “UST400. ” If you see it, this is the correct User Guide. If you do not see “UST400” on the back of the Symbol...
Page 10: Conventions And Terms
Keep pressing a button until its function is Hold complete. Indication The OmniPod ® Insulin Management System is intended for sub- A list of options on the PDM. Options allow Menu you to perform tasks.
Page 11: Contraindications
Humalog®, or Apidra®. Novolog® is compatible with test is performed correctly. the OmniPod System for use up to 72 hours (3 days). Before using a different insulin with the OmniPod Contraindications...
Page 12: Your Role: Safely Using The Omnipod System
User Guide, call your tiple patients. healthcare professional. Your Role: Safely Using the OmniPod System Parts of the device are considered biohazardous and can potentially transmit infectious diseases, even Pump therapy requires substantial caregiver involvement, after you have performed cleaning and disinfection.
Page 13 OmniPod System so easy to use. Your healthcare provider is a valuable resource. You will rely on him or her for a lot of critical information about your OmniPod Do NOT attempt to use the OmniPod® Insulin Man- System, especially during the first few weeks and months.
Page 14: 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 15: How Does The Omnipod System Work
PDM separately in a backpack, briefcase, or purse. With the precise, personalized doses of insulin into your body through a OmniPod Insulin Management System, you don’t have to worry small flexible tube (called a cannula), based on instructions that about snagging, tangling, or feeling tethered by tubing.
Page 16: A Fully-Integrated Design With Blood Glucose Monitoring
Automated cannula insertion Personalizing your System With the OmniPod System, you don’t have to insert the infusion set manually or carry around a separate inserter. You simply press You can personalize your OmniPod System in other ways, too: a button on the PDM and the Pod’...
Page 17: 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, sim- All Pod operations are programmed and controlled through the ilar to an adhesive bandage. Personal Diabetes Manager (PDM; Figure 1-2).
Page 18: 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 and holding turns the PDM on and off. Pressing opens a User Info/Support screen that Power Support displays additional information about the cur-...
Page 19: Primary Screens
Your New OmniPod Insulin Management System Primary screens identify when you first turn it on. You can personalize the ID screen by adding your name and choosing its color. (See , for Messages on the screen either: details on customizing your PDM.) You must acknowledge the •...
Page 20 Your New OmniPod Insulin Management System If a Pod has not yet been activated (during Pod changes), Home screen the screen displays “No active Pod. Would you like to acti- Lists all the major menus (Figure 1-6). vate a Pod now?” (See Chapter 5, Using the Pod, for details •...
Page 21: Safety Features
Alerts and alarms An occlusion is a blockage or interruption in insulin delivery. If For your safety, the OmniPod System provides a range of alerts the OmniPod System detects an occlusion, it sounds a hazard and alarms to tell you that your attention is needed, or to warn alarm and prompts you to deactivate and change your Pod (see you of hazardous situations.
Page 22: 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 23: The Setup Wizard
You can adjust these settings later as your needs direction to insert the batteries (Figure 2-2). change or as you fine-tune your OmniPod System. To get started, press Next on the Wizard's Welcome Screen to Do not use any other type of batteries than AAA begin setting up your PDM.
Page 24: Select The Id Screen Color
Getting Started 2. Press the middle Soft Key (labeled with the right arrow) to Figure 2-3 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.
Page 25: Enter Basal Settings
Getting Started Figure 2-4 Figure 2-5 Figure 2-6 3. Press Confirm to accept the basal program you have set Enter basal settings (Figure 2-6). 1. Choose a maximum basal rate, then press Next. (The default 4. Press Done to confirm the basal program shown on the maximum basal rate is 3 U/hr.) screen.
Page 26: Enter Blood Glucose Sound Setting And Bg Goal
Getting Started temporary basal rates in units per hour. Or choose Off to turn Enter target blood glucose value off the temporary basal feature. For details about setting tem- 1. Use the Up/Down Controller button to enter a target blood porary basal’...
Page 27: Enter Minimum Bg Allowed For Use In Bolus Calculation
Getting Started e. Press Confirm to accept the target BG profile you have set Enter insulin-to-carbohydrate ratio (Figure 2-7). 1. Use the Up/Down Controller buttons to enter your insulin- to-carbohydrate ratio, then press Next. (Insulin-to-carbohy- f. When you have finished entering segments, press Done. drate ratio is the number of carbs covered by 1 unit of insulin.) To see Press Save to accept the target BG profile you have set.
Page 28: Enter Correction Factor
Getting Started Enter correction factor Set reverse correction 1. Use the Up/Down Controller buttons to enter how much 1. To set reverse correction, use the Up/Down Controller one unit of insulin decreases your blood glucose, then press buttons to choose On or Off, then press Next. Next.
Page 29: Set Extended Bolus Doses
Getting Started 2. Choose the maximum bolus you can give at one time, then You can press and hold the Power button to turn off the press Next. PDM at any time during setup. Otherwise, it turns off automatically after 5 minutes. If you do not complete the The maximum bolus default is 10 units.
Page 30: Understanding And Adjusting Basal Rates
In people without diabetes, the segments, or basal segments, each delivering a different rate of pancreas continuously delivers this basal insulin. 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...
Page 31: Create A Basal Program
Understanding and Adjusting Basal Rates In addition to normal daily changes, insulin needs can vary with 2. Choose Basal programs (Figure 3-1), then press Select. different routines or days of the week. For example, regular school or workday routines may differ from weekend routines, Figure 3-1 Figure 3-2 and insulin needs may differ, too.
Page 32 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 33: 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 34: 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 program is in pro- cess (see “Temporary Basal Rates and Presets” later in this chapter);...
Page 35 Understanding and Adjusting Basal Rates 3. Enter a start time for the segment you want to change, then Figure 3-8 Figure 3-9 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.
Page 36: Temporary Basal Rates And Presets
Understanding and Adjusting Basal Rates To rename a basal program To delete a basal program 1. After choosing a program from the list, choose Rename, then 1. After choosing a program from the list, choose Delete and press Select. then press Select. 2.
Page 37: Enable A One-Time Temporary Basal Rate
In this example, 25% MORE insulin will be delivered). 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 Figure 3-11 Figure 3-12 rate.
Page 38: Cancel A One-Time Temporary Basal Rate
4. Choose [add new], then press New. to choose Suspend/cancel, then press Select. 5. To use the OmniPod System’ s default naming system, simply 2. Choose Cancel temp basal (Figure 3-15), then press Select. press Next. The default naming system automatically assigns program names in numerical order, such as temp basal 1, 3.
Page 39: Enable An Existing Temporary Basal Preset
Understanding and Adjusting Basal Rates a. Press the Up/Down Controller buttons to scroll through Capitals and lowercase letters are considered the the list of characters. An up-and-down arrow symbol on same. the screen indicates the character you are changing. b. Press the middle Soft Key to move the underscore to the 6.
Page 40: Cancel An Active Temporary Basal Preset
Understanding and Adjusting Basal Rates Change, rename, or delete a temporary basal preset Figure 3-17 Figure 3-18 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.
Page 41: Maximum Basal Rate
Understanding and Adjusting Basal Rates 2. Enter a new rate (or new percent change), for the preset, then 2, Getting Started). You can change it later as you fine-tune your press Next. System settings or when your needs change. 3. Enter a new duration for the preset, then press Save. Change the maximum basal rate 4.
Page 42: 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 43: 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 44: How A Suggested Bolus Is Calculated
The OmniPod System can only subtract insulin on board The settings used to calculate a suggested bolus are: (IOB) from a suggested bolus when the current BG is •...
Page 45: Deliver A Normal Bolus
Understanding and Delivering Bolus Doses Deliver a Normal Bolus When your blood glucose result reads “HIGH” or “LOW, ” the suggested bolus calculator will be disabled. Deliver a bolus when suggested bolus calculator is On 1. After you check your blood glucose, the PDM displays the If you use a separate blood glucose meter—not the results (Figure 4-3;...
Page 46 Understanding and Delivering Bolus Doses 3. If you are going to eat now: Figure 4-4 Figure 4-5 a. Press Yes (Figure 4-4), enter the number of carbohydrates you are about to eat, then press Enter. b. On the next screen, review the BG and carb values to make sure they are correct, and then press Confirm (Figure 4-6 on the next page).
Page 47: Deliver A Bolus Manually (Suggested Bolus Calc Is Off)
Understanding and Delivering Bolus Doses b. Enter the time for the reminder, then press OK. 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 Deliver a bolus manually (suggested bolus calc is Off)
Page 48: Deliver An Extended Bolus
Understanding and Delivering Bolus Doses As a safety feature, the OmniPod System only allows Figure 4-9 Figure 4-10 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.
Page 49: Cancel Active Boluses
3 units Cancel Active Boluses The OmniPod System is extremely flexible, so you can use it to 4. If the blood glucose reminders feature is turned On, you respond to your changing insulin needs. It is easy to cancel an can now set a blood glucose reminder.
Page 50: Replace An Extended Bolus
Understanding and Delivering Bolus Doses Replace an Extended Bolus Figure 4-14 Figure 4-13 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).
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 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 d. Press Next. 3. Press Enter to confirm the bolus preset amount, or, if neces- sary, use the Up/Down Controller buttons to adjust the 6. Enter the new bolus preset amount, up to the maximum bolus amount.
Page 53: Cancel An Active Bolus Preset
5. Choose [add new], then press New. Pod status.), if it is not already on. An on-screen message 6. To use the OmniPod System’ s default naming system, simply appears as long as a 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 These additional units are not required. If you prefer not Change or edit a carb preset to enter them, simply press Next repeatedly to skip 1. On the Home screen, use the Up/Down Controller buttons through the screens.
Page 55: Delete A Carb Preset
Press Next after each entry. The OmniPod System includes a reference library of over 1,000 These additional units are not required. If you prefer common food items. The library shows each item’ s grams or car-...
Page 56 Understanding and Delivering Bolus Doses The screen displays a list of main food categories (Figure 4-23a The screen displays the food item’ s : and Figure 4-23b). • Name 3. To choose directly from the food categories, choose a main •...
Page 57: Using The Pod
CHAPTER 5 Using the Pod The Pod Change Process • wash your hands • clean the insulin vial with an alcohol prep swab Replace the Pod at least once every 48–72 hours or up to • clean the infusion site with soap and water or an alcohol 200 units of insulin (2–3 days).
Page 58: Gather Equipment And Supplies
Using the Pod • Because insulin Pods use only rapid-acting insulin, users are If you are a first-time OmniPod System user, your at increased risk for developing hyperglycemia (high blood healthcare provider will guide you through the steps glucose) if insulin delivery is interrupted. If it is untreated, for initializing and applying your first Pod.
Page 59 Using the Pod 4. If an extended bolus or temporary basal or both are actively b. Use soap and water to remove any adhesive that remains running, you will see a message similar to that shown in on the skin or, if necessary, use an adhesive remover. Figure 5-3.
Page 60: Fill A New Pod
Using the Pod Fill a new Pod Figure 5-7 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°...
Page 61 Using the Pod 5. Draw air into the syringe up to the amount of insulin you Figure 5-9 Figure 5-10 want. 6. Insert the needle into the insulin vial and inject the air. This makes it easier to withdraw insulin from the vial. 7.
Page 62 The fill syringe is intended for single use only and should be used only with the OmniPod System. 12. After you fill the Pod, it will beep twice. After hearing the beeps, PDM and Pod should be adjacent and touching,...
Page 63: Select The Infusion Site
Using the Pod Select the infusion site Figure 5-11 Figure 5-12 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 next page).
Page 64 Using the Pod Figure 5-13: Adult Figure 5-14: Youth Front Back Front Back...
Page 65: Prepare The Infusion Site
Using the Pod To help avoid condensation from occurring in the Figure 5-15 viewing window, make sure both your Pod and your insulin are at room temperature. Prepare the infusion site You can reduce the risk of infection at the infusion site by follow- ing aseptic technique and disinfecting the infusion site.
Page 66 Using the Pod • If you are unsure the Pod is ready to be applied to the site, Figure 5-18 press “Discard” and do not use it (Figure 5-16 & Figure 5- 17). Select a new Pod. Figure 5-13 Figure 5-16 Figure 5-13 Figure 5-17 3.
Page 67: Insert Cannula And Begin Insulin Delivery
Using the Pod Insert cannula and begin insulin delivery Figure 5-19 Figure 5-13 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.
Page 68 Using the Pod The Pod automatically inserts the soft cannula below your skin. It Check the infusion site after insertion to ensure takes a few seconds to complete this process. Once the cannula that the cannula was properly inserted. The PDM is inserted, the Pod delivers a prime bolus to fill the cannula with will automatically remind you to check your insulin (Figure 5-22).
Page 69 Using the Pod 2. Press Yes if you can see that the cannula is properly inserted. Figure 5-24 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.
Page 70: Check Pod Status
Using the Pod Check Pod Status time or date). The OmniPod System lets you suspend all insulin delivery for up to 2 hours. While in suspension, the Pod beeps To check Pod status, if the PDM is turned Off, press and hold the...
Page 71 Using the Pod 4. At the end of the suspend time, a Pod Advisory alarm occurs Figure 5-29 (Figure 5-28). 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.
Page 72: Resume Insulin Delivery
Using the Pod Resume Insulin Delivery Avoid Infusion Site Infections 1. On the Home screen, use the Up/Down Controller buttons • Always wash your hands and use the aseptic technique to pre- to choose Resume (Figure 5-30), then press Select. pare the infusion site before applying a Pod.
Page 73: Water And Your Pod
Using the Pod Do NOT expose a Pod to direct sunlight for long peri- Do not expose your Pod to water at depths greater ods of time. It is recommended that you remove your than 25 feet or for more than 60 minutes. Check Pod prior to using hot tubs, whirlpools, or saunas.
Page 74: Using The Personal Diabetes Manager
CHAPTER 6 Using the Personal Diabetes Manager 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.
Page 75: Insulin Gauge And Display
Using the Personal Diabetes Manager • Time, date, and result of last blood glucose checked or Next to the insulin gauge, the PDM displays the number of units entered manually remaining in the Pod. As long as more than 50 units remain, the gauge displays “50+ U.
Page 76: The System Setup Menu
Pod. The System setup menu lets you personalize the settings that 2. On the Home screen, use the Up/Down Controller buttons control the OmniPod System. These include: to choose Settings; then press Select. • Date and time 3.
Page 77: Reset The Time
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 3.
Page 78: Bolus Calcs
Using the Personal Diabetes Manager 3. Choose Bolus/basal/calcs, then press Select. a. To edit an existing target BG time segment, choose the segment, then press Edit. Use the Up/Down Controller 4. Choose one of the options (Figure 6-6a and Figure 6-6b), then buttons to choose a new start time, end time, target BG press Select.
Page 79: Ratios/Factors/Targets
Using the Personal Diabetes Manager 5. Reverse correction—Choose On or Off, then press Next. Figure 6-7 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.
Page 80 Using the Personal Diabetes Manager When the suggested bolus calculator is turned Off, the Press Next after each entry. Ratios/factors/targets option does not appear in the b. Review the segment to ensure it is correct, then press Bolus/basal/calcs menu. Confirm. c.
Page 81: Temp Basal
Choose %, U/hr, or Off to set the mode for temporary basal rates In addition to automatic safety alarms (see Chapter 10, Alerts and and presets, then press Select. Alarms), the OmniPod System offers a number of personal set- tings to help you manage your diabetes. These features are Extended optional.
Page 82 Pod. Be sure to respond to the alert when it your instructions, so you become familiar with the operation of occurs. the OmniPod System and feel confident that you are getting the insulin you need. These notifications include: Turning the PDM on by inserting a blood glucose •...
Page 83: Set Alerts And Reminders
Using the Personal Diabetes Manager Custom reminders: Displays text reminders that you enter, at 5. For all except Bolus reminders and Custom reminders, times that you select. You can choose to receive a notification choose the desired option or set the desired value, then press Daily, One time only, or Off.
Page 84 • Use the Up/Down Controller buttons to choose [add new], then press New. • To use the OmniPod System’ s default naming system, sim- ply press Next. The default naming system automatically assigns names in numerical order, such as alert 1, alert 2, alert 3.
Page 85: Change Blood Glucose Meter Settings
Using the Personal Diabetes Manager Change Blood Glucose Meter Settings Change BG goal limits To change the BG goal limits, press Edit, change either or both You can adjust blood glucose (BG) meter settings: values, then press Save. • BG goal lower and upper limits (for BG history) Manage the blood glucose tags list •...
Page 86: Change Bg Sound
Using the Personal Diabetes Manager 1. To hide or show a standard BG tag, choose the tag, and press Customize the Personal Diabetes Manager Show (if it is marked as hidden) or Hide. Additional options let you customize how the PDM operates: Tags you choose to show will be check marked;...
Page 87: Set Pdm Options
Using the Personal Diabetes Manager Backlight time-out: The backlight is on by default while you are Figure 6-13 Figure 6-14 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.
Page 88: Set Pdm Lock
Using the Personal Diabetes Manager To change the ID screen color: Set Diagnostic Functions 1. Choose Screen color, then press Select. The Diagnostics screen allows you to instantly confirm how the 2. Use the Up/Down Controller buttons to choose a color, then System is working or to completely update settings entered dur- press Select.
Page 89: Diagnostic Options
Using the Personal Diabetes Manager Diagnostic options Figure 6-15 Figure 6-16 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. To check alarms 1.
Page 90: Set A Reminder To Vibrate
Using the Personal Diabetes Manager Set a Reminder to Vibrate Get the Most from Your PDM For certain reminders, you can choose vibration instead of beeps Keep it handy or vibration followed by beeps, instead of only beeps. If you acti- Wireless communication technology means you don’t have to vate it, the PDM will vibrate for: keep the PDM right next to the Pod for the Pod to work.
Page 91: 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 (4.4°C) or above 104°F (40°C).
Page 92: Checking Your Blood Glucose
CHAPTER 7 Checking Your Blood Glucose The Built-in FreeStyle® Blood Glucose Meter Never attempt to test your blood glucose while your PDM is connected via USB cable to a computer. With the FreeStyle® blood glucose meter, checking your blood Doing so could result in electrical shock. glucose requires a very small sample size, 0.3 microliters of blood.
Page 93: The Freestyle® Blood Glucose Test Strips
For detailed storage and usage information, refer to the instructions provided on the test strip package insert package insert in the box containing the test strip vial. before using the OmniPod System and FreeStyle accessories. The cap or vial contains drying agents that may be...
Page 94: When To Perform A Control Solution Test
Checking Your Blood Glucose When to perform a control solution test on the bottle, as well as the date to discard it and begin using a new bottle. You should perform a control solution test: • When you suspect that your meter or test strips are not work- Ensure accurate control solution results ing properly •...
Page 95: Performing A Control Solution Test
Checking Your Blood Glucose If control solution results are out of this range, REPEAT THE TEST. Figure 7-2 Out-of-range control solution results Out-of-range test results may be caused by: Top, to insert into meter • Expired or bad control solution FreeStyle®...
Page 96 Checking Your Blood Glucose Figure 7-4 Figure 7-3 From some PDM screens, you cannot access the Free- 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 97 Checking Your Blood Glucose 6. Gently touch only ONE EDGE of the test strip to the control If BG sound is set to On, the PDM beeps twice. The result solution. Specifically, apply the control solution to the test appears on the screen. strip edge next to one of the dark-colored half-circles (Figure 7.
Page 98: Performing A Blood Glucose Reading
Checking Your Blood Glucose 9. Compare the control solution test result to the range printed Figure 7-9 on the test strip vial label. If the result does not fall within the range, repeat the test. If the result still does not fall within the range, call Insulet’...
Page 99: Prepare The Lancing Device
Checking Your Blood Glucose Prepare the lancing device Figure 7-12 Figure 7-13 1. Snap off the cap on the lancing device at an angle (Figure 7-10). Figure 7-10 Figure 7-11 4. Replace the cap until it snaps or clicks into place (Figure 7-13). Be careful not to touch the exposed needle on the lancet.
Page 100: Insert The Blood Glucose Test Strip
Checking Your Blood Glucose From some PDM screens, you cannot access the Free- Figure 7-14 Figure 7-15 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 101: Set The Blood Glucose Test Strip Code
Checking Your Blood Glucose If you do not start the test within 2 minutes, the PDM To change the code number, press the Up/Down Controller powers off. To restart the PDM, take out the unused strip buttons until the number matches the number on your vial. The and reinsert it, or simply press and hold the Power button numbers are between 1 and 50.
Page 102: Lance Your Upper Arm Or Hand
Checking Your Blood Glucose 2. Set the depth setting on the lancing device (Figure 7-20). Figure 7-22 Figure 7-23 Figure 7-20 Figure 7-21 2. Set the depth setting on the lancing device (Figure 7-22). 3. Lightly touch the lancing device (with the cap) against the 3.
Page 103: Fill The Blood Glucose Test Strip With Blood
Measurements obtained from alternate site testing should not be used to calculate insulin doses with the OmniPod System. Avoid lancing areas with obvious veins or moles to avoid excess bleeding. Also avoid lancing areas where tendons or bones stick out (for example, hand bones).
Page 104 Checking Your Blood Glucose Do not: Figure 7-27 Figure 7-26 • Press the strip against the test site • Scrape the blood onto the strip • Apply blood to the flat side of the strip • Apply blood to the strip when it is out of the meter •...
Page 105: Remove The Lancet
Checking Your Blood Glucose 2. If after 5 seconds the PDM does not display “Checking, ” the 5. Remove the test strip. If the strip-port light was turned on, it sample may be too small. If needed, add more blood to the now turns off.
Page 106: Blood Glucose Results And The Suggested Bolus
Checking Your Blood Glucose Blood Glucose Results and the Suggested Bolus Figure 7-32 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: Editing Tags
Checking Your Blood Glucose 1. On the Home screen, use the Up/Down Controller buttons 3. Use the Up/Down Controller buttons to choose a reading, to choose More actions, then press Select. then press Tag (Figure 7-33). A User Info/Support icon (?) is shown to the right of any reading to which you have already 2.
Page 108: Low And High Blood Glucose Readings
Checking Your Blood Glucose Low and High Blood Glucose Readings Figure 7-34 Figure 7-35 WARNINGS! “LOW” or “HIGH” blood glucose readings can indicate a poten- tially serious condition requiring immediate medical attention. If left untreated, this situation can quickly lead to diabetic keto- acidosis (DKA), shock, coma, or death.
Page 109: High Readings
Checking Your Blood Glucose High readings WARNINGS! If your reading is above 500 mg/dL, the PDM displays “HIGH Check for ketones!” This indicates severe hyperglycemia (high • Severe dehydration and excessive water loss may cause false blood glucose). falsely elevated results. If you believe you are suffering from High reading with symptoms severe dehydration, consult your healthcare provider imme- If you get a “HIGH Check for ketones!”...
Page 110 • Do not use during xylose-absorption testing. • Measurements obtained from alternate site testing should not be used to calculate insulin doses with the OmniPod System. • The lancing device is for individual use only and must not be shared.
Page 111: Understanding Your Records
CHAPTER 8 Understanding Your Records Record Keeping Special symbols in record screens In the record screens, you may encounter several special symbols: Record keeping is an important part of successful diabetes man- Records with a question-mark symbol next to them have agement.
Page 112: Insulin Delivery Records
Understanding Your Records 4 The record for this item is “unconfirmed. ” Figure 8-1 Figure 8-2 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”...
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. Figure 8-9 Figure 8-10 Readings with a question mark icon (?) next to them have additional information available (Figure 8-7). To see this infor- mation, use the Up/Down Controller buttons to choose the reading.
Page 116: Alarm Records
Alarm Records you have entered (Figure 8-13 on the next page). The PDM lists the entire alarm history for the OmniPod System. 3. Press the Up/Down Controller buttons to see additional The PDM can store over 90 days’ worth of alarm records.
Page 117: All Records
The user information screen also displays product information 1. On the Home screen, use the Up/Down Controller buttons for your OmniPod System (make, model, serial number). You can- to choose My records, then press Select. not change this information.
Page 118: Add Or Change User Information
Understanding Your Records The User Info/Support icon is also displayed on Figure 8-15 Figure 8-16 the suggested bolus screen. For information about the support information displayed on these screens, see Chapter 4, Understanding and Deliver- ing Bolus Doses. 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.
Page 119: Living With Diabetes
If you have questions or doubts about agement System according to instructions, you may being able to safely use the OmniPod System at any time, consult be putting your health and safety at risk. Talk with your healthcare provider immediately.
Page 120: Check Your Blood Glucose Frequently
Living with Diabetes Check your blood glucose frequently If an infusion site shows signs of infection: When you routinely check your blood glucose level, you can iden- 1. Immediately remove the Pod and apply a new tify and treat high or low blood glucose before it becomes a one at a different site (see Chapter 5, Using the Pod).
Page 121: Prepare For Emergencies
• A vial of rapid-acting U-100 insulin (See the warn- provider. ing on page x of the Introduction for insulins approved for use in the OmniPod System.) Water and Your Pod • Syringes for injecting insulin • Instructions from your healthcare provider about...
Page 122: Traveling And Vacationing
Living with Diabetes Traveling and Vacationing • Alcohol prep swabs • Written prescriptions for all medications and supplies (Generic medications may be easier to find than brand Plan for changing time zones names outside the U.S.) 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: Keep Supplies Accessible
Living with Diabetes • A signed letter from your healthcare provider explaining Visit the TSA Contact Center if you have any further questions or you need to carry insulin supplies and OmniPod equip- concerns. ment If the security detector goes off, tell the security screener that you •...
Page 124: Avoid Lows, Highs, And Dka
Living with Diabetes Avoid lows, highs, and DKA Symptoms of hypoglycemia Never ignore these symptoms: You can avoid most risks related to using the OmniPod System • Shakiness by practicing proper techniques and by acting promptly at the • Fatigue first sign of trouble.
Page 125: To Avoid Hypoglycemia (Low Blood Glucose)
If you are prone to hypoglycemia unawareness, unconscious. you may want to use the OmniPod System’ s blood glucose reminder and check your blood glucose Periodically check the expiration date of your glucagon more frequently.
Page 126 Living with Diabetes How much is 15 grams of carbohydrate? Even if you cannot check your blood glucose, do NOT Examples of fast-acting foods: wait to treat symptoms of hypoglycemia, especially if you are alone. Waiting to treat symptoms could Three 5-gram glucose tablets, or four 4-gram tablets lead to severe hypoglycemia, which can quickly lead 4 ounces (118 milliliters) of apple or orange juice...
Page 127 Living with Diabetes Possible causes of hypoglycemia (low blood glucose) Possible cause of low Suggested action Possible cause of low Suggested action blood glucose blood glucose Incorrect basal Confirm that correct basal program Incorrect target Consult healthcare provider about program is active.
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 blood glucose insulin in your body. If an occlusion (interruption of insulin deliv- ery from the Pod) occurs, your blood glucose can rise rapidly. Prolonged or intense Adjust insulin delivery as instructed exercise...
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 blood glucose blood glucose Expired insulin Deactivate and remove used Pod. Empty Pod Deactivate and remove used Pod. Apply a new Pod filled from a new Apply a new Pod in a different Insulin exposed...
Page 131 Living with Diabetes Possible cause of high Suggested action Possible cause of high Suggested action blood glucose blood glucose 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.
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: Alerts And Alarms
If you are having symptoms that are not consistent with your blood glucose test and you have followed The OmniPod System has a very important safety feature: It can all instructions described in this User Guide, call your check its own functions and let you know when something healthcare professional.
Page 136 Alerts and Alarms The following table explains what the message could mean and what you should do. Alert error message Possible causes Action Meter Error 1 • Blood sample is too small. 1. If you have symptoms, such as weakness, sweating, nervousness, headache or confusion, follow the recommendations of your health- •...
Page 137 Alerts and Alarms Alert 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: Alarms
All advisory alarms are time sensitive and require a response. Some advisory alarms escalate to hazard The OmniPod System provides alarms to make you aware of alarms if you do not respond within a certain time period (as serious or potentially serious conditions.
Page 139 Alerts and Alarms Use the form at the end of this User Guide to write If you ever need to return the PDM for repair or down all your settings from the Setup Wizard. If you replacement, contact your healthcare provider ever need to reset your PDM, having these settings for instructions on going back to treatment by handy will make setup very easy.
Page 140 Alerts and Alarms Alarm Type Source Beep Pattern Action Auto-off. Hazard Continuous tone. Pod has been deactivated. Insulin deliv- Alarm ery has stopped. Press OK to acknowl- Remove Pod now. edge. Change Pod. Check blood glucose. Low reservoir. Advisory 2 sets of beeps every minute for 3 Press OK to acknowledge.
Page 141 Alerts and Alarms Alarm Type Source Beep Pattern Action Pod expiration advisory. Advisory 2 sets of beeps repeat periodically. Press OK to acknowledge. Alarm Change Pod now. Repeats every 15 minutes during Change Pod. (See Chapter 5, Using the the last hour of the Pod’ s life and is Pod.) independent of the Expiration noti- fication that you can set.
Page 142 Alerts and Alarms Alarm Type Source Beep Pattern Action Occlusion detected. Hazard Continuous tone. Press OK to acknowledge. Alarm Insulin delivery stopped. Change Pod. Change Pod now. Check blood glucose. Pod Error. Hazard Continuous tone. This alarm occurs when the Pod detects Alarm an unexpected error.
Page 143 Alerts and Alarms Alarm Type Source Beep Pattern Action PDM Error. Hazard Continuous tone. This alarm occurs after the PDM is reset Memory corruption. Alarm and a memory corruption error occurs. Press OK to acknowledge. Press “OK” to reset PDM and delete all user set- Change Pod.
Page 144: Manual Shut-Off Of A Hazard Alarm
Alerts and Alarms Alarm Type Source Beep Pattern Action Pod deactivation required. Hazard Continuous tone. This alarm occurs after a PDM error Alarm occurs that requires the user to reset the Press “Ok” to deactivate. date and time. Press OK to acknowl- edge.
Page 145: Communication Failures
• Too far from the Pod—The PDM and Pod should be side by side while priming during activation. • Interrupted by outside interference—See the “OmniPod System Notice Concerning Interference” in the Appendix. As a safety feature, the communication distance be- tween the Pod and PDM is reduced during activation.
Page 146 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 the screen in Figure Retry. 11-4. Press OK to try checking Pod status again or press Discard to begin the deactivation process.
Page 147: 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 148: 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 149: 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 150 Communication Failures If your PDM is damaged or not working as Figure 11-14 Figure 11-15 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.
Page 151: Appendix
Appendix The OmniPod ® Insulin Management System has no user-serviceable parts. If you require assistance operating or maintaining the System, please call Customer Care. Pod Care and Maintenance Personal Diabetes Manager Care and Maintenance Storage Storage Store unopened Pods in a cool, dry place. Extreme heat or cold When you are not actively using the Personal Diabetes Manager can damage Pods and cause them to malfunction.
Page 152: Cleaning And Disinfecting
Appendix Cleaning and disinfecting stand additional cleaning steps of up to 2 times per week over the 4 year use life. Cleaning is to keep free from dirt, stains, or impurities; unsoiled. Disinfecting is the process of destroying pathogenic organisms 1.
Page 153: Replacing Batteries
Appendix On average, a pair of batteries powers the PDM for 3 weeks. The Figure A-1 battery life indicator on the PDM shows the battery power level. IR Port See “Personal Diabetes Manager Icons” later in this Appendix for USB Port the various battery power levels and their respective icons.
Page 154: If The Pdm Becomes Submerged In Water
Appendix 3. Replace the battery door. When your PDM alerts you that battery power is getting 4. Turn the PDM face up. The PDM powers on automatically. low, the PDM will maximize remaining battery life by: The PDM is now ready to use. Dispose of the old batteries in •...
Page 155: If You Drop The Pdm
If you are unable to use your PDM to check your BG, have a back up meter on hand to check your BG. To order all OmniPod System products and supplies, call Cus- If your PDM is damaged or not working as it tomer Care.
Page 156: Suggested Bolus Calculator Examples And Guidelines
Appendix Suggested Bolus Calculator Examples and Meal bolus calculation Guidelines Carbs entered ÷ insulin-to-carb (IC) ratio Example of meal bolus A suggested bolus is equal to the sum of a correction bolus and meal bolus, then adjusted for insulin on board, if applicable. Carbs entered: 45 grams of carb Examples of each of these elements are shown below.
Page 157 Appendix Example of meal insulin-on-board (IOB) Example 1 Duration of insulin action: 3 hours Current BG level: 150 mg/dL Time since previous meal bolus: 2 hours Carb intake: 0 grams of carbohydrate (carbs) Previous meal bolus: 4.5 units Meal IOB: 1 unit 3 hours –...
Page 158 Appendix Example 3 Example 4 Current BG level: 100 mg/dL Current BG level: 150 mg/dL Carb intake: 45 carbs Carb intake: 60 carbs Meal IOB: 1 unit Meal IOB: 0 units Correction IOB: 0 units Correction IOB: 1 unit Correction bolus: 100 mg/dL (current) – 100 mg/dL (target) = 0 Correction bolus: 150 mg/dL (current) –...
Page 159: Calculator Guidelines
• The calculated insulin on board is rounded up to the nearest 0.05U. When the suggested bolus calculator is turned On, the OmniPod System applies these guidelines to the suggested bolus doses: • A reverse correction only occurs if the meal bolus is greater than 0.00U.
Page 160: Omnipod System Options And Settings
Appendix OmniPod System Options and Settings Blood glucose meter sound On or Off Time 12-hour or 24-hour clock Default is On Date MM/DD/YY Suggested bolus calculator On or Off DD/MM/YY Default is On MM.DD.YY Target BG value and 8 time segments; 70 to 200 mg/dL DD.MM.YY...
Page 161: Pod Specifications
Appendix Storage temperature range: 32° F to 86° F (0° C to 30° C) Bolus presets Carbohydrate presets Reservoir volume (deliverable): 200 units Suspend 30 minutes to 2 hours Cannula insertion depth: 6.5mm 10 to 50 units in 5-unit increments Low reservoir volume Waterproof rating: IPX8 (25 feet for up to 60 minutes) indicator...
Page 162: Accuracy Test Results
Appendix 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.
Page 163: Personal Diabetes Manager Specifications
Appendix Personal Diabetes Manager Specifications Blood Glucose Meter Specifications Size: 2.4" wide x 4.4" long x 0.98" high (6.21cm x 11.25cm x Assay method: Coulometric electrochemical sensor 2.5cm) Calibration: Plasma equivalent Weight (with batteries): 125 grams (4.41 oz) Hematocrit: 15% to 65% Screen: 1.4"...
Page 164: Omnipod System Label Symbols
Appendix 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 Prescription home-use IVD Rx ONLY Refer to Instruction Manual Sterilized by ethylene oxide Personal Diabetes Manager Icons Manufacture date: (year–month)
Page 165: Omnipod System Notice Concerning Interference
Support communications. There are no guarantees that interference will not occur in a particular installation. If the OmniPod System does Blood Glucose Meter – “Unconfirmed” Temperature out of cause harmful interference to radio and television reception, the...
Page 166: Electromagnetic Compatibility
(increased emission and decreased immunity). OmniPod System. The numbers provided will not guarantee Care should be taken if the System is used adjacent to other elec- faultless operation but should provide reasonable assurance of trical equipment;...
Page 167 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.
Page 168 Appendix Electromagnetic Immunity (Continued) Radiated RF 80 MHz–2.5 GHz 10 V/m Portable and mobile RF communications equipment should (IEC 61000-4-3) be used no closer to any part of the System than the recom- mended separation distance calculated from the equation applicable to the frequency of the transmitter as below.
Page 169 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 communi- cations equipment (transmitters) and the System, as recommended below, according to the maximum output power of the com- munications equipment.
Page 170: 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 171: Customer's Bill Of Rights And Responsibilities
Appendix Customer’s Bill of Rights and Responsibilities You have the responsibility to: 1. Ask questions about any part of the plan of service or plan of You have the right to: care that you do not understand. 1. Receive considerate and respectful service. 2.
Page 172: Limited Warranty For The Personal Diabetes Manager
Appendix 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 173: Hipaa Privacy Notice
Appendix HIPAA Privacy Notice Uses and Disclosures of Your Medical Information Related to the Treat- ment and Services Provided by Us Treatment, Payment, and Health Care Operations: We may use your Medi- THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION IS USED AND DIS- cal Information for treatment, to obtain payment for treatment, for CLOSED AND HOW YOU CAN GET ACCESS TO IT.
Page 174 Appendix Additional Categories of Uses and Disclosures Legal Proceedings: We may disclose your Medical Information in the course of any judicial or administrative proceeding, in response to an order of a Required by Law: We may use or disclose your Medical Information to the court or administrative tribunal (to the extent such disclosure is expressly extent that applicable law requires the use or disclosure of such Medical authorized), in certain conditions in response to a subpoena, discovery...
Page 175: Your Rights
Appendix Workers’ Compensation: We may disclose your Medical Information as You May Have the Right to Amend Your Medical Information: authorized to comply with workers' compensation laws and other similar, If you believe that the Medical Information we have about you is incorrect legally established programs.
Page 176: Our Duties
Appendix You Have the Right to Request to Receive Confidential Communications Revisions and Modifications: We may change our HIPAA Privacy Notice at from Us by Alternative Means or at an Alternative Location: We will accom- any time. Before we make a significant change in our policies, we will modate reasonable requests to receive confidential communications from change this HIPAA Privacy Notice and post our new notice (the “Revised us by alternate means or at an alternative location.
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 The items in the food library are derived from the USDA data- base, USDA National Nutrient Database for Standard Reference. Extended bolus A feature of the OmniPod System that allows a meal bolus dose to Glucose be given over an extended period of time.
Page 180 The amount of insulin that is still “active” in the body from a previ- which is proportional to the amount of glucose in the blood. ous bolus dose. In the OmniPod System, insulin on board (IOB) is considered in two parts: the Insulin on Board (IOB) from a previ- Hyperglycemia (high blood glucose) ous correction bolus and the IOB from a previous meal bolus.
Page 181 BG goal you need to deliver one unit of insulin to cover every fifteen after a meal. The OmniPod System calculates a meal bolus by grams of carbohydrate you eat. dividing the grams of carbohydrates you are about to eat by your 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 BG reminder ..... .68 edit segment or rate ....22 activate a new Pod.
Page 184 Index test strip......87 change......39 carb presets .
Page 185 Index clock correction bolus ... 31, 143, 165 diabetes, diabetes mellitus ..166 12-hour or 24-hour....64 correction factor.
Page 186 Index electromagnetic compatibility 153–156 fat ....... . . 166 carbohydrates ....103 electromagnetic fields .
Page 187 65, 67, 168 medical electrical equipment. 153–156 OmniPod System ..... 2 interruption in communication..78 one-time temporary basal rate ..24 IV Prep wipes .
Page 188 Index options settings ......62 flow rate error ....149 Bolus calcs .
Page 189: Specifications
Index all ....... 104 soft reset ....See reset PDM blood glucose.
Page 190 Index hyperglycemia ....115 cancel ......27 hypoglycemia.
Page 191 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. Basal Program 1 Basal Program 2 Name _________________________________ Rate Name _________________________________ Rate 12:00 AM to ________ ___________ U/hr 12:00 AM to ________ ___________ U/hr...
Page 192 My PDM Settings Duration of Insulin Action Temp Basal Presets Time that insulin will remain “active” in the body Name Rate (circle from a previous bolus. ___________ hrs measurement) ________________________________________ ________ U/hr or % ________________________________________ ________ U/hr or % ________________________________________ ________ U/hr or % Correction Factor ________________________________________...
Page 193 My Notes _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________...
Page 194 Bedford, MA 01730 USA 800.591.3455 / 781.457.5098 MyOmniPod.com © 2012 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: UST400 14421-AW Rev C...

OmniPod UST400 User Manual

Introduction

1 Your New Omnipod Insulin Management System

2 Getting Started

3 Understanding and Adjusting Basal Rates

4 Understanding and Delivering Bolus Doses

5 Using the Pod

6 Using the Personal Diabetes Manager

7 Checking Your Blood Glucose

8 Understanding Your Records

9 Living with Diabetes

10 Alerts and Alarms

11 Communication Failures

Appendix

Glossary

Index

Quick Links

Need help?

Questions and answers

Related Manuals for OmniPod UST400

Summary of Contents for OmniPod UST400