Page 2 OmniPod System Start Date: _ ___________________________ PDM Model: ENT450 UK Serial Number: __________________ Distributor: Ypsomed Ltd. (UK) Blackwood Hall Business Park North Duffield, Selby, N. Yorks. YO8 5DD / United Kingdom info@ypsomed.co.uk Customer Care: Ypsomed Ltd. Service: 0800 092 6787...
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. 14518-5C-AW Rev A...
Page 4: Table Of Contents
Contents Introduction..........viii Occlusion detection.
Page 5 Contents 3 Understanding and Adjusting Basal Rates ....16 Cancel Active Boluses ......... . 36 What Is a Basal Rate? .
Page 6 Contents 6 Using the Personal Diabetes Manager ....59 Set the Screen time-out ........73 The ID Screen .
Page 7 Contents Remove the lancet......... . . 92 Water and Your Pod .
Page 8 Contents Failure During Pod Deactivation ......133 Insulin-on-board (IOB) calculation......142 Failure During Request for Status .
Page 9: Introduction
Introduction ■ About This User Guide This User Guide is intended for use only with PDM model ENT450. To learn which version of the PDM you have, turn it over. On the back of the PDM, look Symbols for “ENT450. ” If you see it, this is the correct User Guide.
Page 10: Conventions And Terms
Introduction Screen displays shown in this User Guide are for illustra- Convention/Term Meaning tive purposes only and should not be considered suggestions for user settings. Consult with your health- An image on the PDM screen that indi- Icon care provider to determine the appropriate settings for cates a menu option or item of informa- you.
Page 11: Contraindications
Introduction Abbott FreeStyle® test strips are used with the built-in FreeStyle The mylife OmniPod System is designed to use meter for the quantitative measurement of blood glucose in rapid-acting U-100 insulin. The following U-100 fresh whole capillary blood from the finger, upper arm and palm. rapid-acting insulin analogs have been tested and Abbott FreeStyle Control Solutions are used to verify that the found to be safe for use in the Pod: Novolog®/Novo-...
Page 12: Your Role: Safely Using The Mylife Omnipod System
Introduction The glucose meter and lancing device are for single- If you are having symptoms that are not consistent patient use. Do not share the device with anyone with your blood glucose test and you have followed including other family members. Do not use on mul- all instructions described in this User Guide, call your tiple patients.
Page 13 OmniPod System from your healthcare provider. Inadequate training setup or operation, you can call Customer Care 24 hours a day, 7 could put your health and safety at risk days a week. Customer Care: Ypsomed Ltd. Service: 0800 092 6787...
Page 14: Your New Mylife Omnipod Insulin Management System
CHAPTER 1mylife OmniPod Your New mylife OmniPod Insulin Management System ■ Insulin Delivery with the mylife OmniPod term health benefits of maintaining near-normal blood glucose levels have been widely recognized. System Continuous insulin delivery at preset rates eliminates the need The mylife OmniPod ®...
Page 15: How Does The Mylife Omnipod System Work
Your New mylife OmniPod Insulin Management System ■ How Does the mylife OmniPod System Work? No tubing There is no tubing connecting the Pod to the PDM. You wear the The Pod is a small, lightweight, self-adhesive device that you fill Pod comfortably and discreetly under your clothes.
Page 16: A Fully-Integrated Design With Blood Glucose Monitoring
Your New mylife OmniPod Insulin Management System Automated cannula insertion Record keeping With the mylife OmniPod System, you don’t have to insert the Another convenient part of the mylife OmniPod System is record infusion set manually or carry around a separate inserter. You sim- keeping.
Page 17: The Pod
Your New mylife 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 an adhesive bandage. palm-sized Personal Diabetes Manager (PDM;...
Page 18: Buttons That Program And Control The Mylife Omnipod
Your New mylife OmniPod Insulin Management System Buttons that program and control the mylife OmniPod System Button Action Button Action User Info/ Pressing opens a User Info/Support screen that Support Home/ displays additional information about the cur- Pressing and holding turns the PDM on and off. Power rent screen you are viewing.
Page 19: Primary Screens
Your New mylife OmniPod Insulin Management System Primary screens ID screen Messages on the screen either: The System displays an ID screen to make the PDM easy to iden- tify when you first turn it on. You can personalize the ID screen by •...
Page 20 Your New mylife 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
Your New mylife OmniPod Insulin Management System ■ Safety Features Typical Maximum Minimum time time time The mylife OmniPod System’ s state-of-the-art design includes the latest safety technology. Its built-in safety features include: 5.00 U Bolus 156 seconds 198 seconds 115 seconds Automatic priming, safety checks, and insertion 1.00 U/hr basal...
Page 22: Getting Started
CHAPTER 2 Getting Started ■ Set Up the Personal Diabetes Manager Chapter 6 describes the PDM options in detail. The instructions in this chapter are simplified to help you get started. (PDM) If you are a first-time mylife OmniPod System user, you need to Turn on the PDM meet with your healthcare provider for training and System 1.
Page 23: The Setup Wizard
Getting Started 2. Insert two (2) new AAA alkaline batteries into the compart- • Press the Soft Key labeled Next, Select, Done, or Save to con- ment. Never use rechargeable batteries. tinue to the next screen. • Press Back to return to the previous screen. The diagram inside the compartment shows you which direction to insert the batteries (Figure 2-2).
Page 24: Set Date And Time
Getting Started Set date and time 6. Choose a temporary basal feature, then press Next. Choose % to show temporary basal rates as a percent increase or 1. Use the Up/Down Controller buttons to increase or decrease of your current basal rate. Choose U/hr to show decrease the time.
Page 25: Set The Suggested Bolus Calculator
Getting Started Set the suggested bolus calculator b. Enter a start time for the target BG segment, then press Enter. 1. To set the suggested bolus calculator feature, choose On or Off, then press Next. c. Enter an end time for the target BG segment, then press Next.
Page 26: Enter Correction Factor
Getting Started 2. To save the ratio, press Done. To change the ratio, select the a. Press New. segment you wish to change and press Edit. b. Enter a start time for the segment, then press Next. You can define up to 8 insulin-to-carbohydrate time seg- c.
Page 27: Select Bolus Increment And Enter Maximum Bolus
Getting Started Set low reservoir advisory The duration-of-insulin-action setting is used to 1. Choose the level of insulin in the reservoir at which the calculate the amount of insulin on board (IOB) from a PDM should give you an alarm. Choose from 10 to 50 units previous correction bolus or meal bolus when you in 5-unit increments, then press Next.
Page 28 Getting Started Your healthcare provider will help you fill and apply your first Pod. The process is easy because on-screen messages walk you through every step. Please refer to Chapter 5, Using the Pod, for detailed instructions. You may want to adjust the PDM screen time-out and backlight time-out.
Page 29: Understanding And Adjusting Basal Rates
CHAPTER 3 Understanding and Adjusting Basal Rates ■ What Is a Basal Rate? certain times. For example, one person may need to deliver a higher rate of insulin during the early morning and a lower rate A basal rate is a small base or background amount of insulin that during the late evening.
Page 30: 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 31 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 32: 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 33: 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 A diamond icon (♦) appears next to the program that press Enable. is active. You cannot select the active program to enable it, because it is already running. Figure 3-7 4.
Page 34 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 35: 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 36: Enable A One-Time Temporary Basal Rate
Understanding and Adjusting Basal Rates You can set a temporary basal rate for a duration of 30 minutes to Figure 3-11 Figure 3-12 12 hours. Once the time limit is reached, the Pod automatically returns to the active basal program. Pod and PDM do not need to be close to each other.
Page 37: Cancel A One-Time Temporary Basal Rate
Understanding and Adjusting Basal Rates Cancel a one-time temporary basal rate Create a 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 Suspend/cancel, then press Select. to choose Settings, then press Select.
Page 38: Enable An Existing Temporary Basal Preset
Understanding and Adjusting Basal Rates Enable an existing temporary basal preset Figure 3-14 1. On the Home screen, use the Up/Down Controller buttons to choose Temp basal, then press Select. 2. Choose the temporary basal preset you want to use from the list (Figure 3-15), then press Select.
Page 39: Cancel An Active Temporary Basal Preset
Understanding and Adjusting Basal Rates Cancel an active temporary basal preset To change a temporary basal preset 1. On the Home screen, use the Up/Down Controller buttons 1. Choose Edit, then press Select (Figure 3-17). to choose Suspend/cancel;, then press Select. Figure 3-17 2.
Page 40: Maximum Basal Rate
Understanding and Adjusting Basal Rates ■ To rename a temporary basal preset Maximum Basal Rate 1. Choose Rename, then press Select. 2. Press the Up/Down Controller buttons to enter the charac- What is the maximum basal rate? ters that spell out the name you want, then press Save. The maximum basal rate is a safety feature that limits the basal rate (U/hr) that the Pod can deliver.
Page 41: Understanding And Delivering Bolus Doses
CHAPTER 4 Understanding and Delivering Bolus Doses ■ What Is a Bolus? • Your correction threshold, the BG level above which you would like to take insulin to reduce an elevated blood A bolus is an extra dose of insulin, delivered when needed to: glucose •...
Page 42: Bolus Dose Options
Understanding and Delivering Bolus Doses ■ ■ 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 mylife OmniPod System mylife OmniPod System offers the following bolus dose options: recommend your bolus based on your personal settings.
Page 43: How A Suggested Bolus Is Calculated
Understanding and Delivering Bolus Doses The inputs used to calculate a suggested bolus are: Figure 4-1 Figure 4-2 • current BG • carbs entered • insulin on board (IOB) A suggested bolus can have a correction bolus only, a meal bolus only, or both.
Page 44: Deliver A Normal Bolus
Understanding and Delivering Bolus Doses ■ Deliver a Normal Bolus A blood glucose value is current for up to 10 minutes after it is tested. So you can wait up to 10 minutes, restart the bolus process, and not have to retest your Deliver a bolus when suggested bolus calculator is On blood glucose in order to include it in the suggested 1.
Page 45 Understanding and Delivering Bolus Doses 2. If you are not going to eat now, press No (Figure 4-4). The To view detailed information about the calcula- Suggested Bolus screen appears (Figure 4-5). Press Enter to tions used for this suggested bolus, press the User accept the suggested bolus.
Page 46: Deliver A Bolus Manually (Suggested Bolus Calc Is Off)
Understanding and Delivering Bolus Doses 4. If you have set the blood glucose reminder option to On and Figure 4-6 you want to add a reminder: a. Press Yes. b. Enter the time for the reminder, then press OK. 5. Press Confirm to begin the bolus delivery. Deliver a bolus manually (suggested bolus calc is Off) 1.
Page 47: Deliver An Extended Bolus
Understanding and Delivering Bolus Doses ■ Deliver an Extended Bolus If you have set the Extended bolus option to Off, the PDM will not display the Extend Soft Key. For The extended bolus feature lets the mylife OmniPod System information on turning this feature On and Off see deliver some (or no) insulin now and the remainder over a period Chapter 6, Using the Personal Diabetes Manager.
Page 48 Understanding and Delivering Bolus Doses 3. Enter the time (up to 8 hours, in 30-minute increments) over As a safety feature, the correction bolus is always which to deliver the remainder of the bolus, then press Enter delivered first and cannot be extended. Only the (Figure 4-9).
Page 49: Cancel Active Boluses
Understanding and Delivering Bolus Doses ■ Cancel Active Boluses If the bolus has already been completely delivered, the “Delivering bolus” message and Cancel do not The mylife OmniPod System is extremely flexible, so you can use appear, but the Status screen does appear. it to respond to your changing insulin needs.
Page 50: Bolus Presets
Understanding and Delivering Bolus Doses 2. Press Yes to cancel the active extended bolus (Figure 4-13). Figure 4-15 Or press Back to return to the Suggested Meal Bolus screen. Figure 4-13 Figure 4-14 ■ Bolus Presets 3. Press Confirm (Figure 4-14). Bolus presets are bolus amounts that you program for frequent use.
Page 51: Create A Bolus Preset
Understanding and Delivering Bolus Doses Create a bolus preset Figure 4-16 Figure 4-17 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 Bolus presets, then press Select. 4.
Page 52: Change, Rename, Or Delete A Bolus Preset
Understanding and Delivering Bolus Doses 4. Press Confirm to deliver the bolus shown on the screen. Pod status.), if it is not already on. An on-screen message appears as long as a bolus is being delivered. Change, rename, or delete a bolus preset 2.
Page 53: Change Or Edit A Carb Preset
Understanding and Delivering Bolus Doses 6. To use the mylife OmniPod System’ s default naming system, Figure 4-18 simply press Next. The default naming system automatically assigns program names in numerical order, such as carb pre- set 1, carb preset 2, carb preset 3. Or, to give a different name to the program: a.
Page 54: Delete A Carb Preset
Understanding and Delivering Bolus Doses 3. Choose Carb presets, then press Select. 3. To rename the carb preset, press the Up/Down Controller buttons to enter the characters that spell out the name you 4. Choose the category of the preset you want to change, then want, then press Next.
Page 55: Using The Pod
CHAPTER 5 Using the Pod ■ The Pod Change Process • To minimize the possibility of site infection, do NOT apply a Pod without first using aseptic technique. This means to: Replace the Pod at least once every 48–72 hours or up to 200 •...
Page 56: Gather Equipment And Supplies
Using the Pod • Because insulin Pods use only rapid-acting insulin, users are If you are a first-time mylife OmniPod System user, at increased risk for developing hyperglycemia (high blood your healthcare provider will guide you through the glucose) if insulin delivery is interrupted. If it is untreated, steps for initializing and applying your first Pod.
Page 57 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 the message in Figure 5-3. Press Con- on the skin or, if necessary, use an adhesive remover. firm to accept the cancellation.
Page 58: 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 59 Using the Pod 6. Insert the needle into the insulin vial and inject the air. This Figure 5-9 Figure 5-10 makes it easier to withdraw insulin from the vial. 7. Turn the vial and syringe upside down. Withdraw insulin from the vial into the syringe, expelling any and all air or air bub- bles.
Page 60 Using the Pod Do not use any other type of needle or filling The fill syringe is intended for single use only and device besides the syringe provided with each should be used only with the mylife OmniPod Pod. System. 9.
Page 61: 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 62 Using the Pod Figure 5-13: Adult Figure 5-14: Youth Front Back Front Back...
Page 63: Apply The New Pod
Using the Pod To help avoid condensation from occurring in the Apply the new Pod viewing window, make sure both your Pod and your Prepare the Pod for applying to your infusion site: insulin are at room temperature. 1. To remove the needle cap on the underside of the Pod, place your thumb on the bottom (flat edge) of the needle cap and Prepare the infusion site pull it upwards (Figure 5-15).
Page 64 Using the Pod • Pod is intact and in its original condition. For the Pod to work best, apply it: a. Crosswise or at a slight angle on your abdo- Verify cannula does not extend men, hip, lower back, or buttocks (in Figure 5- beyond adhesive backing once needle cap is removed.
Page 65: Insert Cannula And Begin Insulin Delivery
Using the Pod Insert cannula and begin insulin delivery The Pod’ s adhesive keeps it securely in place for up to 1. To insert the soft cannula, press Start (Figure 5-19). 3 days. However, if necessary, several products are available to enhance adhesion. Ask your healthcare Figure 5-19 Figure 5-20 provider about these products.
Page 66 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. You Once the cannula is inserted, the Pod delivers a prime bolus to should check your blood glucose 1.5 to 2 hours fill the cannula with insulin (Figure 5-21).
Page 67: Check Pod Status
Using the Pod When you see the pink slide insert in this position, it means that Figure 5-24 Figure 5-19 the cannula is inserted (Figure 5-23). Figure 5-23 Or press Back to return to the previous screen. NEVER inject insulin (or anything else) into the 2.
Page 68 Using the Pod ton, you will turn off the PDM instead.) Or, from the Home Extended boluses and temporary basal rates will be can- screen, press Status. celled when you suspend insulin delivery. The PDM automatically checks the status of the Pod. The PDM then displays the current reservoir volume, PDM battery level, 1.
Page 69: Resume Insulin Delivery
Using the Pod Figure 5-25 Figure 5-20 Figure 5-26 Figure 5-22 Figure 5-27 5. To resume your programmed basal rate, press OK. The Advisory alarm repeats every 15 minutes until you press OK. Insulin delivery will not resume until you press OK. If you do not press OK to resume insulin delivery, you could develop hyperglycemia (high blood glucose).
Page 70: Avoid Infusion Site Infections
Using the Pod ■ Resume Insulin Delivery • Do not apply a Pod to any area of the skin with an active infection. If you are unsure whether to use a specific site, ask 1. On the Home screen, use the Up/Down Controller buttons your healthcare provider.
Page 71 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 72: 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 73: Insulin Gauge And Display
Using the Personal Diabetes Manager • Amount of insulin on board (IOB), if suggested bolus calcula- Next to the insulin gauge, the PDM displays the number of units tor is in use remaining in the Pod. As long as more than 50 units remain, the gauge displays “50+ U.
Page 74: The System Setup Menu
Using the Personal Diabetes Manager You and your healthcare provider entered initial System settings Figure 6-3 using the Setup Wizard (see Chapter 2, Getting Started). After setup, you can use the System setup menu to customize or change those settings, as described in this chapter. ■...
Page 75: Reset The Time
Using the Personal Diabetes Manager Reset the time Reset the date 1. To enter the current time, press the Up/Down Controller 1. Press the Up/Down Controller buttons to choose the cur- buttons. Press and hold the button to increase or decrease rent year, then press Next.
Page 76: 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 77: 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 78 Using the Personal Diabetes Manager When the suggested bolus calculator is turned Off, the tons to choose a new start time, end time, and IC ratio. Ratios/factors/targets option does not appear in the Press Next after each entry. Bolus/basal/calcs menu. b.
Page 79: Temp Basal
Using the Personal Diabetes Manager ■ Temp basal Alerts and Reminders 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 mylife OmniPod System offers a number of personal settings to help you manage your diabetes.
Page 80 Using the Personal Diabetes Manager Bolus reminders: Notifies you if you have not delivered a meal The Low reservoir alert will escalate to an Empty res- bolus, manually or using the suggested bolus calculator, ervoir hazard alarm when insulin is depleted. Be sure between the times you specify.
Page 81: 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 82 Using the Personal Diabetes Manager To delete a Bolus reminder Figure 6-10 a. Choose the bolus reminder you wish to delete, then press Edit. b. Choose Delete then press Select. c. Press Delete to remove the bolus reminder. 7. For Custom reminders •...
Page 83: 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 84: 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 85: Customize The Personal Diabetes Manager
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 86: Set Pdm Options
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 87: 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 88: 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 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 (4.4°C) or above 104°F (40°C).
Page 90: 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.
Page 91: The Freestyle® Blood Glucose Test Strips
Checking Your Blood Glucose ■ The FreeStyle® Blood Glucose Test Strips Do not use strips beyond the expiration date printed on the package, as this may cause inaccurate results. Complete information on the FreeStyle® test strips (such as interferences and performance) can be For detailed storage and usage information, refer to the found in the test strip package insert.
Page 92: 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 93: Performing A Control Solution Test
Checking Your Blood Glucose ■ If control solution results are out of this range, REPEAT THE TEST. Performing a Control Solution Test Out-of-range control solution results 1. Grasp the bottom of the test strip with the printed side facing Out-of-range test results may be caused by: up (Figure 7-2).
Page 94 Checking Your Blood Glucose From some PDM screens, you cannot access the Free- Figure 7-4 Figure 7-3 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 95 Checking Your Blood Glucose Figure 7-5 Figure 7-6 Figure 7-7 Figure 7-8 Do not apply control solution to both edges of the 5. Gently touch only ONE EDGE of the test strip to the control test strip. solution. Specifically, apply the control solution to the test strip edge next to one of the dark-colored half-circles (Figure 7-6).
Page 96: Performing A Blood Glucose Reading
Checking Your Blood Glucose You can select a maximum of 2 tags. 9. Remove the test strip. If the strip port light was turned on, it now turns off. If you remove the test strip before this step, you will still see the available soft keys.
Page 97: Prepare The Lancing Device
Checking Your Blood Glucose Prepare the lancing device Figure 7-9 1. Snap off the cap on the lancing device at an angle (Figure 7-10). Cocking handle Figure 7-10 Figure 7-11 Depth settings dial Depth indicator window Release button Clear cap, for testing sites other than the finger 2.
Page 98: Insert The Blood Glucose Test Strip
Checking Your Blood Glucose Figure 7-12 Figure 7-13 Figure 7-14 Figure 7-15 4. Replace the cap until it snaps or clicks into place (Figure 7-13). 5. Pull out the cocking handle until it clicks (Figure 7-15). (You Be careful not to touch the exposed needle on the lancet. may have already cocked the handle in step 2.
Page 99: Set The Blood Glucose Test Strip Code
Checking Your Blood Glucose From some PDM screens, you cannot access the Free- If you do not start the test within 2 minutes, the PDM Style® blood glucose meter. For example, you cannot powers off. To restart the PDM, take out the unused strip use the meter while you are activating a Pod or when and reinsert it, or simply press and hold the Power but- an alert, alarm or communication error screen is dis-...
Page 100 Checking Your Blood Glucose To change the code number, press the Up/Down Controller The code number on the screen should match the buttons until the number matches the number on your vial. The code number on the side of your test strip vial (Fig- numbers are between 1 and 50.
Page 101: Lance Your Forearm, Upper Arm, Or Hand
Checking Your Blood Glucose 5. Gently squeeze your finger, if needed, until a blood drop the several seconds (Figure 7-24). size of a pinhead forms. Figure 7-24 Lance your forearm, upper arm, or hand 1. To bring fresh blood to the surface of the test site, rub the site vigorously for a few seconds (Figure 7-22) until you feel it get- ting warm.
Page 102: Fill The Blood Glucose Test Strip With Blood
Checking Your Blood Glucose Avoid lancing areas with obvious veins or moles Figure 7-25 Figure 7-26 to avoid excess bleeding. Also avoid lancing areas where tendons or bones stick out (for example, hand bones). 7. If you see any signs of deterioration of the PDM (i.e. cracking separation, discolorations.) Please contact customer care.
Page 103 Checking Your Blood Glucose The lancing device is intended for individual use and Figure 7-27 Figure 7-28 should not be shared. If the device is being operated by a second person who is providing testing assis- tance to the user, the meter and lancing device should be decontaminated prior to use by the sec- ond person (see page 138).
Page 104 Checking Your Blood Glucose 3. To mark the result as a pre- or post-meal test, to indicate a Figure 7-29 Figure 7-30 level of exercise or to indicate other situations connected to this blood glucose reading, press Tag. Then: a. Use the Up/Down Controller buttons to select a tag, then press Select (Figure 7-31).You can select a second tag for the reading in the same way.
Page 105: Remove The Lancet
Checking Your Blood Glucose ■ Blood Glucose Results and the Suggested Bolus Figure 7-31 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 106: Entering Blood Glucose Readings Manually
Checking Your Blood Glucose 1. On the Home screen, use the Up/Down Controller buttons Figure 7-33 to choose More actions, then press Select. 2. Choose Add BG reading, then press Select. 3. Use the Up/Down Controller buttons to enter the BG read- ing from your separate meter.
Page 107 Checking Your Blood Glucose 3. Use the Up/Down Controller buttons to choose a reading, Figure 7-35 Figure 7-36 then press Tag (Figure 7-34). A User Info/Support icon (?) is shown to the right of any reading to which you have already assigned one or two tags.
Page 108: Low And High Blood Glucose Readings
Checking Your Blood Glucose ■ Low and High Blood Glucose Readings High readings If your reading is above 27.8 mmol/L, the PDM displays “HIGH Check for ketones!” This indicates severe hyperglycemia (high WARNINGS! blood glucose). “LOW” or “HIGH” blood glucose readings can indicate a poten- High reading with symptoms tially serious condition requiring immediate medical attention.
Page 109: Important Health-Related Information
Checking Your Blood Glucose ■ Important Health-Related Information other test sites and your finger after eating, taking insulin medication, or exercise. For additional information, consult your test strip product infor- • You may see changes in blood glucose in blood samples mation sheet.
Page 110: 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 111: Insulin Delivery Records
Understanding Your Records ✔ 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 112 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 113: 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 114: 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 115: Alarm Records
Understanding Your Records 2. Choose Alarm history, then press Select. Figure 8-11 Figure 8-12 The PDM displays the date, time, and type of each alarm (Figure 8-12). 3. Press the Up/Down Controller buttons to see additional screens. 4. Choose an alarm record, then press User Info/Support to see more information.
Page 116: All Records
Understanding Your Records 3. Press the Up/Down Controller buttons to see additional Figure 8-13 Figure 8-14 days. Press Event to use the Up/Down Controller buttons to scroll through the list of information on the screen. Press Day to use the Up/Down Controller for dates. ■...
Page 117 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 118: Living With Diabetes
CHAPTER 9 Living with Diabetes ■ Your Role: Safely Using the mylife OmniPod acidosis (DKA). (See “Avoid Lows, Highs and DKA” later in this chapter.) System • Keeping a diabetes emergency kit with you at all times. (See Before deciding on the mylife OmniPod ®...
Page 119: 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 120: Prepare For Emergencies
Living with Diabetes ■ Prepare for Emergencies • Phone numbers for your healthcare provider and/or doctor in case of an emergency Keep an emergency kit with you at all times to • Glucagon kit and written instructions for giving quickly respond to any diabetes emergency. The kit an injection if you are unconscious (see “Avoid should include: Lows, Highs and DKA”...
Page 121: Traveling And Vacationing
Living with Diabetes ■ Traveling and Vacationing • Glucagon kit (Make sure any person you are traveling with knows how to give the injection.) • Alcohol prep swabs Plan for changing time zones • Written prescriptions for all medications and supplies If you’re planning a vacation or business trip to a different time (Generic medications may be easier to find than brand zone, you may need to adjust your basal rate programs.
Page 122: Keep Supplies Accessible
Living with Diabetes To ensure airport security checks run smoothly, be sure you have removed because it is inserted with a catheter (needle) under the following items easily accessible: the skin. • All diabetes supplies in your carry-on luggage Visit the countries provincial airports website if you have any further questions or concerns.
Page 123: 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 mylife OmniPod • Shakiness System by practicing proper techniques and by acting promptly • Fatigue at the first sign of trouble.
Page 124 Living with Diabetes • Keep a glucagon injection kit with your emergency supplies. Hypoglycemia unawareness is a condition in which Teach friends and family members how to give a glucagon you do not realize when your blood glucose level is injection in case you have severe hypoglycemia and become low.
Page 125 Living with Diabetes How much is 15 grams of carbohydrate? Even if you cannot check your blood glucose, do NOT wait to treat symptoms of hypoglycemia, especially Examples of fast-acting foods: 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 126 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 127: 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 128 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 129 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 a new Pod filled from a new Apply a new Pod in a different Insulin exposed vial of insulin.
Page 130 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 131: 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 132: 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 133: 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 134: Alerts And Alarms
CHAPTER 10 Alerts and Alarms ■ Safety Checks 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 135 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 136 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 137: Alarms
Alerts and Alarms ■ Alarms alarms if you do not respond within a certain time period (as noted in the following table). The OmniPod System provides alarms to make you aware of Some advisory alarms are controlled by levels you set in the serious or potentially serious conditions.
Page 138 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 139 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 140 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 141 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 142 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 143: 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 144: Communication Failures
CHAPTER 11 Communication Failures ■ ■ The Communication Process Failure During Pod Activation or Operation When you turn on or use the Personal Diabetes Manager (PDM), When you send an instruction from the PDM—such as Start to it establishes communication with the active Pod. Usually, com- begin bolus delivery or Enable to begin using a different basal munication occurs quickly.
Page 145 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 146: 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 147: 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 148: 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 149 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 150: Appendix
Appendix The mylife OmniPod ® Insulin Management System has no user-serviceable parts. If you require assistance operating or main- taining the System, please call Customer Care. ■ ■ Pod Care and Maintenance Personal Diabetes Manager Care and Maintenance Storage Store unopened Pods in a cool, dry place. Extreme heat or cold Storage can damage Pods and cause them to malfunction.
Page 151: Cleaning And Disinfecting
Appendix Cleaning and disinfecting The PDM can be cleaned and disinfected up to twice a week over the course of the life of the device (4 years). Cleaning is to keep free from dirt, stains, or impurities; unsoiled. 1. Be sure to turn off your PDM before cleaning or disinfecting. Disinfecting is the process of destroying pathogenic organisms or rendering them inert.
Page 152: Replacing Batteries
Appendix Figure A-1 On average, a pair of batteries powers the PDM for 3 weeks. The battery life indicator on the PDM shows the battery power level. IR Port USB Port See “Personal Diabetes Manager Icons” later in this Appendix for the various battery power levels and their respective icons.
Page 153: 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 154: If You Drop The Pdm
Appendix If you drop the PDM If your PDM is damaged or not working as it should, The PDM is built to withstand reasonable amounts of abuse, but please call Customer Care for assistance. Be sure to shock or a severe impact can damage it. If you drop the PDM or if check your blood glucose frequently.
Page 155: 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 156 Appendix Example of meal insulin-on-board (IOB) Example 1 Duration of insulin action: 3 hours Current BG level: 8.4 mmol/L Time since previous meal bolus: 2 hours Carb intake: 0 grams of carbohydrate (carbs) Previous meal bolus: 4.5 units Meal (IOB): 1 units Correction insulin on board (IOB): 1 units 3 hours –...
Page 157: Calculator Guidelines
Appendix Example 3 Calculator guidelines Current BG level: 5.6 mmol/L When the suggested bolus calculator is turned On, the mylife Carb intake: 45 carbs OmniPod System applies these guidelines to the suggested Meal IOB: 1 unit bolus doses: Correction (IOB): 0 units •...
Page 158 Appendix • Correction IOB, which is insulin on board (active insulin) from a previous correction bolus, is then subtracted from the cur- rent correction bolus, if any remains, until it is zero. At that point, any remaining correction IOB is subtracted from the current meal bolus.
Page 159: Mylife Omnipod System Options And Settings
Appendix ■ mylife 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;...
Page 160: 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 Low reservoir volume 10 to 50 units in 5-unit increments Waterproof rating: IPX8 (25 feet for up to 60 minutes) indicator Default is 10.0 units...
Page 161: Accuracy Test Results
Appendix ■ 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 0.05 U/h at high oper- ating temperature.
Page 162: 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 163: Mylife Omnipod System Label Symbols
Appendix ■ mylife 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 Refer to Instruction Manual Community Sterilized by ethylene oxide Product is designed and manufactured in accor-...
Page 164: Personal Diabetes Manager Icons
Appendix ■ Personal Diabetes Manager Icons Icon Meaning Icon Meaning Basal program Battery empty Icon Meaning Icon Meaning “Lost” history User Information/ Power More actions record Support Bolus Communication “Unconfirmed” Temperature out of history record range Pod change Up/Down “Delivery Spans Active/default Midnight”...
Page 165: Mylife Omnipod System Notice Concerninginterference
Appendix ■ mylife OmniPod System Notice vant provisions of Directive 1999/5/EC. This ISM device complies with Canadian ICES-003 and IC-RSS-210. ConcerningInterference The mylife OmniPod Insulin Management System (both the Pod ■ Electromagnetic Compatibility and the Personal Diabetes Manager or PDM) complies with Part 15 of the FCC Rules.
Page 166 Appendix Care should be taken if the System is used adjacent to other elec- The mylife OmniPod System communicates with the following trical equipment; if adjacent use is inevitable, such as in work characteristics: environments, the System should be observed to verify normal Frequency: 433 Mhz, FSK modulation, with an effective radi- operation in this setting.
Page 167 Appendix Electromagnetic Immunity (Continued) Power Frequency mag- 3 A/m 400 A/m Suitable for most environments. Magnetic field strengths in netic fields 50/60 Hz excess of 400 A/m would be unlikely except in close proximity (IEC 61000-4-8) to industrial magnetic devices. Radiated RF 80 MHz–2.5 GHz 10 V/m...
Page 168 Electromagnetic Immunity (Continued) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Page 169: 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 170 Glossary Calorie Correction bolus 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 mylife OmniPod System calculates the correction bolus by taking the difference between your current blood glu- Cannula cose level and your target blood glucose value, then dividing the...
Page 171 Glossary Diabetes Control and Complications Trial (DCCT) A study by the National Institute of Diabetes and Digestive and One of the three main energy sources in food. (The other two are Kidney Diseases (NIDDK), conducted from 1983 to 1993 in carbohydrate and protein.) Fat is a concentrated source of energy, people with type 1 diabetes, which showed that good blood providing 9 calories per gram.
Page 172 Glossary Hemoglobin A1c (HbA1c) Insulin on board (IOB) (active insulin) The amount of insulin that is still “active” in the body from a previ- A test that measures a person’ s average blood glucose level over ous bolus dose. In the mylife OmniPod System, insulin on board the past 2 to 3 months.
Page 173 Glossary Ketoacidosis (diabetic ketoacidosis or DKA) Occlusion A very serious condition in which extremely high blood glucose A blockage or interruption in insulin delivery. levels and a severe lack of insulin cause the body to break down Prime bolus fat for energy. The breakdown of fat releases ketones into the An amount of insulin used to fill the cannula, preparing it to blood and urine.
Page 174 Glossary Sharps Target blood glucose (BG) level Any medical item that may cause punctures or cuts to those The ideal number at which you would like your blood glucose handling them. Sharps include needles, syringes, scalpel blades, level to be. The mylife OmniPod System uses this number in cal- disposable razors, and broken medical glassware.
Page 175: Index
Index auto-off alert..... . 67 create ......17 activate a new Pod.
Page 176 Index level......28, 164 suggested bolus calculator . . .29–34, one-time temporary basal rate..24 141–144 monitoring.
Page 177 Index user information ....104 test......80–83 bolus presets.
Page 178 Index bolus reminder....68 extreme temperatures....76 basal ......98 carb presets .
Page 179 Index color ......11 Bolus/basal/calcs ....63 set.
Page 180 Index enable ......23 PDM lock..... . 71–73 expiration reminder.
Page 181: Specifications
Index Ratios/factors/targets option ..64–65 resume insulin delivery ....57 shut-off, manual ....130 record keeping .
Page 182 Index on screen ..... . . 149 temporary basal ....12, 66 travel concerns .
Page 183 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 184 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 185 Notes _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________...

Ypsomed OmniPod my life User Manual

Introduction

1 Your New Mylife 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

Summary of Contents for Ypsomed OmniPod my life

Table of Contents