Page 2 Prescriptions Name Script # Name Dose Frequency Address Telephone and Fax Email Address OmniPod System Start Date __________________________ PDM Serial Number Health Insurance SN _____________________________ Emergency Services Name Dial 911 (USA only; not available in all communities) Address Insulet Corporation...
Page 3 User Guide...
Page 4 © 2007 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 Diabetes Care, Inc.
Page 5: Table Of Contents
The OmniPod Starter Kit ........
Page 6 Maximum Basal Rate........26 5 Using the OmniPod........40 What is the maximum basal rate?.
Page 7 Apply the new OmniPod........
Page 8 Blood Glucose Results and the Suggested Bolus Calculator 84 Water and Your OmniPod ........97 Low and High Blood Glucose Readings .
Page 9 Failure During Pod Activation or Operation ....122 OmniPod Specifications........136 Failure During Pod Deactivation.
Page 10 Contents Customer Bill of Rights........140 Uses and Disclosures of Medical Information.
Page 11: Introduction
• Testing arterial blood • Diagnosing diabetes Indication The OmniPod Insulin Management System is intended for sub- If you are unable to use the System according to cutaneous (below the skin) delivery of insulin at set and variable instructions, you may be putting your health and rates for the management of diabetes mellitus in persons requir- safety at risk.
Page 12: You And Your Healthcare Provider
Your healthcare provider is a valuable resource. You will rely on Correction or Sensitivity Factor: How much one unit of insulin him or her for a lot of critical information about your OmniPod will lower blood glucose. For example, if your sensitivity factor is System, especially during the first few weeks and months.
Page 13: Your Role: Safely Using The Omnipod System
About This User Guide Your healthcare provider will give you all the tools and training Conventions and Terms you need to be successful with the OmniPod Insulin Manage- ment System. However, in the end, your success depends on Convention/Term Meaning YOU.
Page 14: Conventions And Terms (Continued)
Indicates conditions that could cause are performing. Caution minor or moderate injury to you or damage to the device. Provides helpful information. Note Offers a suggestion for successful use of the OmniPod Insulin Management System. Home Food Library Power/Backlight...
Page 15: Your New Omnipod Insulin Management System
(CSII) therapy changes in daily routine. The OmniPod System is a great option in a way no conventional insulin pump can. The System’ s innova- for people with diabetes who require insulin.
Page 16: How Does The Omnipod System Work
It’ s all integrated Plus you’ll enjoy the safety, convenience, and freedom of: into the OmniPod. With the PDM, you can check your blood glu- cose level using FreeStyle® blood glucose test strips, but without the hassle of carrying a separate blood glucose meter.
Page 17: Suggested Bolus Calculation
Only use FreeStyle® test strips and FreeStyle® control Record keeping solution with the OmniPod System. Using other Another convenient part of the OmniPod System is record keep- brands of test strips and control solutions with the ing. Paper charts are useful, but sometimes they can be OmniPod System can produce inaccurate results.
Page 18: The Omnipod
■ The OmniPod The Personal Diabetes Manager The OmniPod (Figure 1-1) is applied to your skin with an adhe- All OmniPod operations are programmed and controlled through sive backing, similar to a bandaid. the palm-sized Personal Diabetes Manager (PDM; Figure 1-2).
Page 19: Buttons That Program And Control The Omnipod System
Your New OmniPod Insulin Management System Buttons that program and control the OmniPod System Button Action Button Action Blood Power/ Opens the Blood Glucose History screen. Pressing turns the screen on and off. Pressing Glucose Backlight and holding for 2 seconds activates the back-...
Page 20: Primary Screens
Your New OmniPod Insulin Management System Primary screens You can switch between Status screen 1 and Status screen 2 at any time by pressing the middle soft key on Messages on the screen either: either screen. • Tell you how the System is operating •...
Page 21 Temp basal is turned Off in Settings.) If an OmniPod has not yet been activated (as during pod changes), the screen displays “No active pod. Would you • My records menu to review insulin delivery, blood glucose like to activate a pod now?”...
Page 22: Safety Features
The OmniPod System also performs safety checks on the PDM. you of hazardous situations. If it detects any problems in the PDM or the OmniPod—or in See Chapter 6, Using the Personal Diabetes Manager, for a communication between them—it informs you with beeps and description of alerts and reminders and how to set them.
Page 23: Getting Started
Prepare and keep an emergency kit with you at all times to quickly respond to any diabetes emergency. For If you are a first-time OmniPod System user, you need to meet details, see Chapter 9, Living with Diabetes. with your healthcare provider for training and System setup before using it.
Page 24: Set Up The Personal Diabetes Manager (Pdm)
Getting Started ■ Set Up the Personal Diabetes Manager (PDM) 2. Insert two (2) new AAA alkaline batteries into the compart- ment. Chapter 6 describes the PDM options in detail. The instructions The diagram inside the compartment shows you which in this chapter are simplified to help you get started.
Page 25: The Omnipod Setup Wizard
You can adjust these settings later as your needs 4. Enter the current day, then press Next. change or you fine-tune your OmniPod System. See “OmniPod System Options and Settings” in the 5. Choose the date format you prefer, then press Next.
Page 26: Enter Blood Glucose Sound Setting And Bg Goal
Getting Started 3. Press Done to confirm the basal program shown on the The lower and upper BG limits are only used when screen. To add more basal segments to the program, or to viewing BG History (see Chapter 8, Record Keeping). change the rate shown, see Chapter 3, Understanding and Adjusting Basal Rates.
Page 27: Enter Minimum Bg Allowed For Use In Bolus Calculation
Getting Started If the suggested bolus calculator is On, a correction Enter minimum BG allowed for use in bolus calculation bolus will be suggested only when your BG is above 1. Use the Up/Down Controller button to enter a minimum the value shown in brackets on the screen.
Page 28: Enter Correction Factor
Getting Started Enter correction factor If you enter carbs and reverse corrections are On, the 1. Use the Up/Down Controller button to enter how much one System will subtract insulin from the suggested meal unit of insulin decreases your blood glucose, then press Next. bolus to compensate for a low blood glucose (below the BG target you set).
Page 29: Set Extended Bolus Doses
60 minutes, when you turn on the PDM again you will return to the beginning of the Setup • Press Yes if you are ready to activate a new OmniPod. See Wizard. Chapter 5, Using the OmniPod, to learn how to activate a new pod.
Page 30 Getting Started If you ever need to return the PDM for repair or replacement, contact your healthcare provider for instructions on going back to treatment by injections. You may want to adjust the PDM screen time-out and backlight time-out. For more information on how to do this, see Chapter 6, Using the Personal Diabetes Manager.
Page 31: Understanding And Adjusting Basal Rates
A sample basal program with three basal segments pancreas continuously delivers this basal insulin. For people might be: using the OmniPod Insulin Management System, the OmniPod mimics a healthy pancreas by delivering insulin at the rate that 12:00 am–8:00 am 0.60U/hr Between 12:00 am (midnight)
Page 32: Create A Basal Program
PDM, you only need to press a few buttons to pick the program default naming system automatically assigns program you want. The OmniPod continues to deliver insulin at those names in numerical order, such as basal 1, basal 2, basal 3.
Page 33 Understanding and Adjusting Basal Rates c. Enter each character one at a time. For example, if your 5. Enter the rate, in U/hr, for the first basal segment (from 0.05 to weekend schedule is different from your weekday sched- the maximum you entered during setup), then press Next. ule, you might enter W, e, e, k, e, n, d (Figure 3-3).
Page 34: Enable An Existing Basal Program
Understanding and Adjusting Basal Rates 7. Review the graph of the new basal program (Figure 3-5). Enable an existing basal program 1. On the Home screen, use the Up/Down Controller button Figure 3-5 Figure 3-6 to choose Settings; then press Select. 2.
Page 35: Change, Rename, Copy, Or Delete A Basal Program
5. To save the newly entered segment into the basal program, before editing an active basal program (see Chapter press Save (Figure 3-9). If you want to make additional edits, 5, Using the OmniPod.) Remember to resume deliv- repeat steps 2–5. ery after the edits are made.
Page 36: Temporary Basal Rates And Presets
Understanding and Adjusting Basal Rates To rename a basal program As a safety feature, you cannot delete the current basal program. 1. After choosing a program from the list, choose Rename, then press Select. 2. Press the Up/Down Controller button to enter the charac- ■...
Page 37: Enable A One-Time Temporary Basal Rate
% or U/hr. To change this setting, see Chapter 6, Using the Personal Diabetes Manager. When using units per hour, the OmniPod System allows you to set temporary basal rates from 0.0 U/hr, up to your max basal rate.
Page 38: Cancel A One-Time Temporary Basal Rate
3. Choose Temp basal presets, then press Select. Figure 3-12 4. Choose [add new], then press New. 5. To use the OmniPod System’ s default naming system, simply press Next. The default naming system automatically assigns program names in numerical order, such as temp basal 1, temp basal 2, temp basal 3.
Page 39: Enable An Existing Temporary Basal Preset
Understanding and Adjusting Basal Rates 6. Enter the new temporary basal rate (or percent change), then 3. If you want, change the duration for the temporary rate, in press Next. half-hour increments, then press Enter. 4. Press Confirm to begin the temporary basal rate shown on Figure 3-13 Figure 3-14 the screen.
Page 40: Maximum Basal Rate
What is the maximum basal rate? The maximum basal rate is a safety feature that limits the basal rate (U/hr) that the OmniPod can deliver. Once you enter it into the PDM memory, the maximum applies to both regular basal programs and temporary basal rates.
Page 41: Understanding And Delivering Bolus Doses
• The type and amount of food you eat also known as a meal bolus With the OmniPod System, it is easy to adapt to any situation. • Lower blood glucose when it gets too high—also known as a With just a few button presses, you can adjust to unexpected or correction bolus changing insulin needs.
Page 42: 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 43: Deliver A Normal Bolus
Understanding and Delivering Bolus Doses The settings used to calculate a suggested bolus are: The OmniPod System can only subtract insulin on board • target BG from a suggested bolus when the current BG is known. • insulin-to-carbohydrate (IC) ratio For formulas for each element of the suggested bolus calcula- •...
Page 44 From there, select a carb preset you have previously entered (see “Carb Presets” later in this chapter), then press Select. The OmniPod System includes a reference food library. For more information, see 2. If you are not going to eat now: “Reference Food Library”...
Page 45: Deliver A Bolus Manually (Suggested Bolus Calc Is Off)
Understanding and Delivering Bolus Doses Or press the Up/Down Controller button to change the 4. If you have set the blood glucose reminder option to On and bolus, then press Enter. you want to add a reminder: Or press the User Info/Support button to view the details a.
Page 46: Deliver An Extended Bolus
Understanding and Delivering Bolus Doses As a safety feature, the OmniPod System only allows If you have set the Extended bolus option to Off, you to give a bolus at or below the maximum bolus the PDM will not display the Extend soft key. For dose you have set.
Page 47 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 4-7).
Page 48: Cancel Active Boluses
The pod beeps to confirm the bolus is canceled. An on-screen message tells you how much insulin was delivered before The OmniPod System is extremely flexible, so you can use it to you canceled the bolus (Figure 4-10). respond to your changing insulin needs. It is easy to cancel an 3.
Page 49: Enable An Existing Bolus Preset
Understanding and Delivering Bolus Doses 5. To use the OmniPod System’ s default naming system, simply d. Press Next. press Next. The default naming system automatically assigns 6. Enter the new bolus preset amount, up to the maximum program names in numerical order, such as bolus 1, bolus 2, bolus you entered during setup;...
Page 50: Change, Rename, Or Delete A Bolus Preset
Understanding and Delivering Bolus Doses 3. Press Enter to confirm the bolus preset amount, or, if neces- Cancel an active bolus preset sary, use the Up/Down Controller button to adjust the bolus 1. Press the Power/Backlight button to turn on the PDM, if it is amount.
Page 51: Change Or Edit A Carb Preset
Meals, then press Select. 5. Choose [add new], then press New. 6. 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 carb preset 1, carb preset 2, carb preset 3.
Page 52: Delete A Carb Preset
Understanding and Delivering Bolus Doses 4. Choose the category of the preset you want to change, then To “erase” characters, press either Up or Down until you reach press Select (Figure 4-14). the end of the characters, which is a blank. 4.
Page 53: Reference Food Library
Reference Food Library Figure 4-16a Figure 4-16b The OmniPod System includes a reference library of over 1,000 common food items. The library shows each item’ s carbohydrate, fat, protein, fiber, and calories for a single portion. You can use this information to determine the carbs for a meal or snack you are going to eat.
Page 54: Using The Omnipod
• Do NOT apply or use an OmniPod if it is damaged in any way. • Because insulin pods use only rapid-acting insulin, users are A damaged pod may not work properly.
Page 55: Gather Equipment And Supplies
Figure 5-1 Use ONLY rapid-acting U-100 insulin with the OmniPod. NEVER use insulin that is cloudy; it may be old or inactive. Failure to use rapid-acting U-100 insu- lin, or using insulin that is old or inactive, may lead to hyperglycemia or diabetic ketoacidosis (DKA).
Page 56 Using the OmniPod 4. When you see the message, “Pod deactivated. Remove and Check the infusion site for signs of infection. discard the pod, ” (Figure 5-3), remove the old pod: See “Avoid Infusion Site Infections” later in this chapter.
Page 57: Fill A New Omnipod
Use care after removing the needle cap and Fill a new OmniPod exposing the fill needle. Before filling an OmniPod with insulin, ensure that the pod is above 50° Fahrenheit. If the pod has been Only use room temperature insulin when filling exposed to temperatures below 50°, then allow the...
Page 58 Using the OmniPod 4. Determine the amount of insulin you need to insert into the Figure 5-9 Figure 5-10 pod. For example, if you will use this pod for 48 hours, you need enough insulin to last you 48 hours. Your healthcare provider will help you determine the correct amount.
Page 59 5 minutes to indicate that time is passing. If you 13. After you fill the OmniPod, the pod will beep. After you hear do not set up the pod within 60 minutes, you must the beep, press Next (Figure 5-11).
Page 60: Select The Infusion Site
Using the OmniPod Select the infusion site Prepare the infusion site Before applying a new pod, you must first select an appropriate You can reduce the risk of infusion site infection by following infusion site. Due to ease of access and viewing, the abdomen is aseptic technique and disinfecting the infusion site.
Page 61: Apply The New Omnipod
Using the OmniPod Apply the new OmniPod The OmniPod’ s adhesive keeps it securely in place for up to 3 days. However, if necessary, several products Prepare the pod for applying to your infusion site: are available to enhance adhesion. Ask your health- 1.
Page 62: Insert Cannula And Begin Insulin Delivery
Using the OmniPod Insert cannula and begin insulin delivery The OmniPod automatically inserts the soft cannula below your skin. It takes a few seconds to complete the insertion 1. To insert the soft cannula, press Start (Figure 5-15). process. Once the cannula is inserted, the pod delivers a prime bolus to fill the cannula with insulin (Figure 5-16).
Page 63: Check Pod Status
Using the OmniPod ■ Once the soft cannula is inserted, the PDM indicates that the Check Pod Status pod is active and delivering insulin at the programmed basal To check pod status, press the Power/Backlight button to dis- rate (Figure 5-17).
Page 64: Suspend Insulin Delivery
Sometimes you may need to briefly stop insulin delivery (for then press Enter. example, when editing an active basal program or changing the time or date). The OmniPod System lets you suspend all insulin Figure 5-19 Figure 5-18 delivery for up to 2 hours. While in suspension, the pod beeps once every 15 minutes, reminding you that insulin delivery is suspended.
Page 65: Resume Insulin Delivery
Using the OmniPod At the end of the suspend time, a pod Advisory alarm occurs Figure 5-21 (Figure 5-20). Figure 5-20 ■ Avoid Infusion Site Infections To resume your programmed basal rate, press OK. • Always wash your hands and use aseptic technique to pre- pare the infusion site before applying a pod.
Page 66: Get The Most From Your Pod
Water and your OmniPod different location. Then call your healthcare provider. The OmniPod is watertight to a depth of 8 feet for up to 30 min- utes (IPX8). After exposure to water, rinse off the pod with clean • Change the pod at least once every 2–3 days, or as instructed water and gently dry it with a towel.
Page 67: Using The Personal Diabetes Manager
CHAPTER 6 Using the Personal Diabetes Manager ■ The Status Screens Figure 6-2 Figure 6-1 When a pod is active and the PDM is turned on, the PDM estab- lishes communication with the pod to obtain a status check. During the status check, the PDM collects information from the pod about bolus deliveries, current basal programs, and pod expiration.
Page 68: Insulin Gauge And Display
17 units remaining, you can either take a new pod with If an OmniPod has not yet been activated (as during pod you or change it before you leave for the day.
Page 69: Pdm Settings
You can adjust the PDM settings to meet your individual needs. The System setup menu lets you personalize the settings that 1. From the Status screens, press Home. control the OmniPod System. These include: 2. Use the Up/Down Controller button to choose Settings; • Date and time then press Select.
Page 70: Reset The Date Or Time
PDM). As a safety feature, you can change date and time settings only when the pod is deactivated or when insulin delivery is sus- pended (see Chapter 5, Using the OmniPod). 1. Suspend insulin delivery. If you are changing the pod, you can reset the date or time without suspending by changing the date or time before activating the new pod.
Page 71: Change Bolus And Basal Settings
You and your healthcare provider entered initial bolus and basal System settings using the Setup Wizard. Using the System setup menu, you can edit all the OmniPod System bolus and basal set- tings as your needs change. Check with your healthcare provider before making any changes.
Page 72 Using the Personal Diabetes Manager b. To add a segment, choose [add new], then press New. b. To add a segment, choose [add new], then press New. Use the Up/Down Controller button to choose a start Use the Up/Down Controller button to choose a start time, end time, target BG value, and correct-above value time, end time, and IC ratio.
Page 73: Ratios/Factors/Targets
Using the Personal Diabetes Manager Ratios/factors/targets 1. Target BG and correct-above value—You can edit existing segments and add segments, up to a total of four. When the suggested bolus calculator is turned On, you can view and change all the settings using the Ratios/factors/targets a.
Page 74: Temp Basal
Using the Personal Diabetes Manager c. When you have completed all time segments, press Extended Done, then Save. Choose Off, %, or Units to set the mode for extended boluses, then press Select. 4. Correction factor—You can edit existing time segments and add segments, up to a total of four.
Page 75: Alerts And Reminders
PDM on using the Power button. This alert can be especially the OmniPod System and feel confident that you are getting the reassuring if you are prone to hypoglycemia unawareness.
Page 76: Set Alerts And Reminders
Using the Personal Diabetes Manager • Bolus delivery started 4. Choose the reminder or alert you want to set (Figure 6-9a and Figure 6-9b), then press Select. • Bolus delivery completed • Extended bolus started Figure 6-9a Figure 6-9b • Extended bolus completed •...
Page 77 New. new], then press New. b. Choose a start time, then press Next. • To use the OmniPod System’ s default naming system, sim- c. Choose an end time, then press Save. ply press Next. The default naming system automatically...
Page 78: Change Blood Glucose Meter Settings
Using the Personal Diabetes Manager ■ Change Blood Glucose Meter Settings Figure 6-10 You can reset the blood glucose (BG) meter, including: • BG lower and upper limit goals (for BG history) • BG sound—Off or On Change meter settings 1.
Page 79: Customize The Personal Diabetes Manager
(special basal rates or giving boluses. software & hardware are required). See the OmniPod PathFinder Screen time-out: The screen goes blank after a time interval that User Guide for details about using this feature. For more informa-...
Page 80: Set Diagnostic Functions
Figure 6-13 Choosing Always on will drain the PDM battery sooner. Activate the Download See the OmniPod PathFinder User Guide for details about using this feature. (Special software & hardware are required). For more information, please call Customer Support at 800-591-3455 (from outside the United States, 781-457-5098).
Page 81: Diagnostic Options
2. Press OK. The PDM beeps three times. If a pod is active, it then beep, change the pod immediately (see Chapter 5, beeps three times. Using the OmniPod). Continued use of the System Check the alarm function at every pod change. when this occurs could put your health and safety at risk.
Page 82: Get The Most From Your Pdm
Communicating with the pod When you use the PDM to communicate with the OmniPod, Use the form at the end of this User Guide to write hold the PDM within 24'' (61 cm) of the pod. If you wear the pod down all your settings from the Setup Wizard.
Page 83: Avoid Extreme Temperatures
Using the Personal Diabetes Manager Avoid extreme temperatures Extreme operating temperatures can affect PDM batteries and interfere with System operation. Avoid using the PDM in temper- atures below 40°F (5°C) or above 104°F (40°C). Do not store or leave the PDM where it may be exposed to extreme temperatures, such as inside a car.
Page 84: Checking Your Blood Glucose
• When your healthcare provider advises you to do so or 0.3 microliter of blood— about the size of a pinhead. Keep the OmniPod Insulin Management System and the FreeStyle® accessories away from young children, Most healthcare providers rec- as they contain small parts that may be dangerous if ommend checking on your swallowed.
Page 85: The Freestyle® Blood Glucose Test Strips
Guide and practice the testing procedures before on the package, as this may cause inaccurate results. using the OmniPod System and FreeStyle® accesso- ries. Follow the guidance of a healthcare professional For detailed storage and usage information, refer to the for proper blood glucose monitoring.
Page 86: When To Perform A Control Solution Test
You should perform a control solution test: example, if you open the control solution on January 15, count • When you first get your OmniPod System, before doing a forward 3 months to April 15. This is the discard date to record...
Page 87: Out-Of-Range Control Solution Results
1. The OmniPod System may not be working properly. The control solution range is a target range for control 2. Do not use the System to test your blood glucose.
Page 88 Checking Your Blood Glucose 2. Insert the top of the test strip into the test strip port (Figure 3. Wait for the PDM to display “Apply a blood sample to the 7-4) until it stops. This turns on the PDM and displays the strip”...
Page 89 Checking Your Blood Glucose The “Checking” screen appears while the sample is process- b. Use the Up/Down Controller button to select Control ing (Figure 7-8). (Figure 7-9), then press Select. You can select a second tag for the test result in the same way. Figure 7-8 Figure 7-9 You can select a maximum of 2 tags.
Page 90: Performing A Blood Glucose Test
Checking Your Blood Glucose 8. Remove the test strip. Figure 7-10 If you remove the test strip before this step, you will still see the available soft keys. Cocking handle Be sure to discard used test strips. (You can only use test strips once.) Depth settings dial ■...
Page 91: Prepare The Lancing Device
Checking Your Blood Glucose Prepare the lancing device 4. Replace the cap until it snaps or clicks into place (Figure 7-14). Be careful not to touch the exposed needle on the lancet. 1. Snap off the cap on the lancing device at an angle (Figure 7-11).
Page 92: Insert The Blood Glucose Test Strip
Checking Your Blood Glucose 5. The lancing device offers four different depth settings. Level 1 Insert the blood glucose test strip is the shallowest depth; level 4 is the deepest. Move the dial Insert a new blood glucose test strip into the test strip port until it to the desired setting as shown in the depth indicator win- stops.
Page 93: Set The Blood Glucose Test Strip Code
Checking Your Blood Glucose To change the code number, press the Up/Down Controller Keep the blood glucose test strip vial away from chil- button until the number matches the number on your vial. The dren. The cap is a choking hazard. The cap or vial numbers are between 1 and 50.
Page 94: Lance Your Finger
Checking Your Blood Glucose Lance your finger Lance your forearm, upper arm, hand, thigh, or calf 1. To stimulate blood flow, keep your hand warm or lower your 1. To bring fresh blood to the surface of the test site, rub the site hand to waist level and gently massage your finger.
Page 95: Fill The Blood Glucose Test Strip With Blood
Checking Your Blood Glucose 4. Depress the release button. Do not lift up the lancing device; Fill the blood glucose test strip with blood instead, continue to hold it and gradually increase pressure 1. Make sure that the strip is in the PDM and the PDM is pow- for several seconds (Figure 7-25).
Page 96: Wait For The Reading
Checking Your Blood Glucose Use only one edge of the blood glucose test strip per test. Do Wait for the reading not apply blood to both edges (Figure 7-28). Only use strips 1. Do not lift up the strip until you hear 1 beep or see the word once.
Page 97 Checking Your Blood Glucose The time the test takes depends on your blood glucose level. To change a tagged result: Press Tag, select the tag The higher your glucose level, the longer it takes to get a you’d like to remove, then press Clear. result.
Page 98: Remove The Lancet
Checking Your Blood Glucose Remove the lancet If you use the suggested bolus calculator within 10 minutes after taking a blood glucose reading, the BG When you have finished testing, snap off the cap from the value will be automatically populated for use in the lancing device.
Page 99: Low And High Blood Glucose Readings
Checking Your Blood Glucose ■ Low and High Blood Glucose Readings High readings If your reading is above 500 mg/dL, the PDM displays “HIGH Check for ketones!” This indicates severe hyperglycemia (high WARNINGS! blood glucose). High reading with symptoms “Low” or “High” blood glucose readings can indicate a poten- If you get a “HIGH Check for ketones!”...
Page 100: Important Health-Related Information
Checking Your Blood Glucose ■ Important Health-Related Information • If you are experiencing symptoms that are not consistent with your blood glucose test and you have followed all instructions described in this User Guide, call your healthcare WARNINGS! provider immediately. •...
Page 101: Record Keeping
CHAPTER 8 Record Keeping ■ Record Keeping The record for this item has been “lost. ” If the PDM can no longer communicate with an Record keeping is an important part of successful diabetes man- active pod, then you must activate a new pod. The agement.
Page 102: Insulin Delivery History Records
Record Keeping ■ Insulin Delivery History Records 2. Choose Insulin delivery, then press Select (Figure 8-1). The PDM displays a summary of today’s information, The PDM stores: including total daily dose delivered, total boluses delivered • Basal rates (including any rate changes and temporary basals) and total basal amount delivered (Figure 8-2).
Page 103 Record Keeping 3. To review your basal history by day, press Basal. 4. To review your bolus history by day, press Bolus. The display shows the basal deliveries that have occurred for The display indicates whether the bolus was normal or the current day, in reverse time order (Figure 8-3).
Page 104: Blood Glucose History Records
Record Keeping ■ Blood Glucose History Records 3. Press List to see a list of the current day’s readings (Figure 8-6). The PDM stores blood glucose records for the past 90 days. You can choose to view individual readings, single-day trends and Figure 8-6 Figure 8-7 individual readings, or trends for the previous 7, 14, 30, 60, or 90...
Page 105: View Multiple-Day Trends
Alarm History Records days. The PDM displays the same details for multiple-days as for The PDM lists the entire alarm history for the OmniPod System. single days (Figure 8-8). The PDM can store over 90 days’ worth of alarm records.
Page 106: Carbohydrate History Records
Record Keeping ■ ■ Carbohydrate History Records All History Records The PDM displays the record of carbohydrates you have entered. The PDM displays the combined insulin delivery, blood glucose, alarm, and carbohydrate records. 1. On the Home screen, use the Up/Down Controller button to choose My records, then press Select.
Page 107: User Information/Support
Or follow the steps below to view the information. You can add or change the user information at any time. The user information screen also displays contact information for Insulet Corporation and product information for your OmniPod System (make, model, serial number). You cannot change this information.
Page 108: Living With Diabetes
If you have questions or doubts about • Knowing how to contact your healthcare provider in case of being able to safely use the OmniPod System at any time, consult an emergency. your healthcare provider immediately.
Page 109: Daily Diabetes Management Activities
Daily Diabetes Management Activities Inspect the infusion site daily At least once a day, use the OmniPod viewing window to inspect To ensure proper OmniPod System operation and your contin- the infusion site. Check the site for signs of infection, such as pain, ued good health: swelling, redness, discharge, or heat.
Page 110: Prepare For Emergencies
• Syringes for injecting insulin provider. • Instructions from your healthcare provider about how much insulin to inject if delivery from the OmniPod is interrupted • Blood glucose test strips • Ketone test strips • Lancing device and lancets • Glucose tablets or another fast-acting source of carbohydrate •...
Page 111: Water And Your Omnipod
Take enough supplies Keeping your emergency kit with you during trips or vacations The OmniPod is watertight to a depth of 8 feet for up to 30 is especially important (see “Prepare for Emergencies” earlier in minutes (IPX8). After the pod gets wet, rinse it off with clean this chapter).
Page 112: Minimize Airport Security Delays
• Personal Diabetes Manager (PDM) • A signed letter from your healthcare provider explaining that • An emergency kit you need to carry insulin supplies and OmniPod System • Vials of insulin (cargo area temperatures may affect insulin) equipment • A copy of your healthcare provider’s letter (see “Minimize air- •...
Page 113: Avoid Lows, Highs, And Dka
Hypoglycemia unawareness is a condition in which you do not realize when your blood glucose level is You can avoid most risks related to using the OmniPod System low. If you are prone to hypoglycemia unawareness, by practicing proper techniques and by acting promptly at the you may want to use the OmniPod System’...
Page 114 Living with Diabetes To avoid hypoglycemia (low blood glucose) Periodically check the expiration date of your glucagon kit to make sure it has not expired. Make sure your blood glucose is at least 100 mg/dL before driving or working with dangerous machinery Always carry medical identification (emergency or equipment.
Page 115 Living with Diabetes To treat hypoglycemia (low blood glucose) 5. Investigate possible cause for hypoglycemia to avoid similar problems in the future (see “Possible causes of hyperglyce- Any time your blood glucose is low, treat it immediately. Check it mia (high blood glucose)” on the next page). every 15 minutes while you are treating, to make sure you don’t overtreat the condition and cause blood glucose levels to rise How much is 15 grams of carbohydrate?
Page 116 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 117: 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 118 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 119 Living with Diabetes Possible causes of hyperglycemia (high blood glucose) Possible cause of high Suggested action Possible cause of high Suggested action Expired insulin Deactivate and remove used pod. Empty pod Deactivate and remove used pod. Apply new pod filled with insulin Apply a new pod in a different Insulin exposed from a new vial.
Page 120 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 121: Diabetic Ketoacidosis (Dka)
Living with Diabetes Diabetic ketoacidosis (DKA) To avoid DKA The easiest and most reliable way to avoid DKA is by checking Insulin pods use rapid-acting insulin, so you have no long-acting insulin in your body. If insulin delivery from the pod is inter- your blood glucose at least 4–6 times a day.
Page 122: Handling Special Situations
• Always continue your basal insulin, even if you are unable to The OmniPod’s adhesive keeps it securely in place for up to 3 eat. Contact your healthcare provider for suggested basal days.
Page 123: X-Rays, Mris, And Ct Scans
Living with Diabetes For some contact sports, you may want to remove the OmniPod. Surgery or hospitalization For scheduled surgeries or hospitalization, you should tell the Be sure to check your blood glucose levels before removing the doctor/surgeon or hospital staff about your insulin pod. It may pod and after applying a new one.
Page 124: Errors, Advisories, And Hazard Alarms
■ Safety Checks Blood Glucose Meter Error Messages The OmniPod System has a very important safety feature: These messages let you know about an error in the blood It can check its own functions and let you know when glucose meter, test strip, sample, or results. The PDM beeps something needs attention.
Page 125 Errors, Advisories, and Hazard Alarms Error message Possible causes Action • Blood sample is too small. 1. If you have symptoms such as weakness, sweating, Meter Error 1 nervousness, headache, or confusion, follow the rec- • Problem with the test strip. ommendations of your healthcare provider for treat- •...
Page 126 Errors, Advisories, and Hazard Alarms Error message Possible causes Action • Incorrect test procedure. For 1. Be sure you see the Blood Drop and Test Strip sym- Meter Error 3 example, putting blood on the bols on the display screen before you apply blood or test strip before inserting the control solution.
Page 127 Errors, Advisories, and Hazard Alarms Error message Possible causes Action • Blood sample was applied while 1. Retest using a new test strip. Do not press any Meter Error 6 the code number was being buttons or soft keys while applying blood or control changed.
Page 128: Advisory Alarms
Errors, Advisories, and Hazard Alarms ■ Advisory Alarms Some advisory alarms are controlled by levels you set in the Settings screen. One example is the level at which the Low Advisory alarms tell you about a condition that requires your reservoir volume alarm sounds.
Page 129 Pod expiration advisory 1 Repeats every 15 minutes until acknowl- Change pod (see Chapter 5, Using the edged. OmniPod). 2 sets of beeps that repeat periodically. Press OK to acknowledge. Pod expiration advisory 2 Repeats every 15 minutes during the last Change pod (see Chapter 5, Using the hour of the pod’...
Page 130 Errors, Advisories, and Hazard Alarms Alarm Source Beep Pattern Action 2 sets of beeps every minute for 3 minutes. Press OK to resume insulin delivery at End of suspend programmed basal rate. Repeats every 15 minutes until insulin delivery is resumed. 2 sets of beeps every minute for 15 minutes.
Page 131 Errors, Advisories, and Hazard Alarms Alarm Source Beep Pattern Action 2 sets of beeps every 5 minutes. Check the key described on the Stuck key detected screen. (In this example, the stuck key is the Home button.) Press the key to unstick it.
Page 132: Hazard Alarms
Errors, Advisories, and Hazard Alarms ■ Hazard Alarms For a hazard alarm caused by a PDM error or System error that displays “Call Customer Sup- Hazard alarms occur either when the pod is in a very serious port, ” remove the pod and call 800-591-3455 condition or something is wrong with the PDM.
Page 133 Errors, Advisories, and Hazard Alarms Alarm Source Action Alarm Source Action Press OK to Press OK to Empty reservoir Pod expired acknowledge. acknowledge. Change pod. Change pod. Check blood Check blood glucose. glucose. Press OK to Press OK to Occlusion detected Auto-off acknowledge.
Page 134 Errors, Advisories, and Hazard Alarms Alarm Source Action Alarm Source Action Press OK to Press OK to PDM error PDM error acknowledge. acknowledge. Change pod. Remove pod. Check blood Call Customer Sup- glucose. port at 800-591- 3455 (from outside the United States, 781-457-5098).
Page 135 OK, which silences the alarm. Change pod. 2. Deactivate and remove the current pod (see Check blood Chapter 5, Using the OmniPod). glucose. 3. Activate and apply a new pod (see Chapter 5, Using the OmniPod). If you ever need to return the PDM for repair or...
Page 136: Communication Failures
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 OmniPod. Usually, begin bolus delivery, or Enable to begin using a different basal communication occurs quickly.
Page 137 Communication Failures 1. Move the PDM close to the pod. The PDM will try to com- b. If the status check fails, you will see Figure 11-4. Press OK municate with the pod again. If communication still fails, you to try checking pod status again, or press Discard to will see the message in Figure 11-2.
Page 138: Failure During Pod Deactivation
To review the deactivation process, see “Deactivate the current a. Figure 11-5, indicating that your original instruction or OmniPod” in Chapter 5, Using the OmniPod. command was successfully sent to the pod. When you If you press Confirm to deactivate the current pod and the PDM...
Page 139: Failure During Request For Status
2. Press Skip to skip the communication process and immedi- beyond the expected completion time of the correction ately bring up Figure 11-9. bolus. If you have any questions, call Insulet Customer Support, 800-591-3455, 24 hours/7days (from outside If the pod has expired, you will see the screen in the United States, 781-457-5098).
Page 140: Failure During Bolus Cancellation
Communication Failures ■ Failure During Bolus Cancellation b. Press Retry to repeat the attempts to communicate with the pod. The PDM tries to communicate with the pod When you instruct the PDM to cancel a bolus, if the PDM cannot again.
Page 141: Failure During A Hazard Alarm
If you have any questions, call Insulet Customer Support, 800-591-3455, 24 hours/7 days (from outside the Manual alarm shut-off port United States, 781-457-5098).
Page 142: Appendices
Appendices ■ ■ OmniPod Care and Maintenance Personal Diabetes Manager Care and Maintenance Storage Storage Store unopened OmniPods in a cool, dry place. Extreme heat or When you are not actively using the Personal Diabetes Manager cold can damage pods and cause them to malfunction. If pods...
Page 143: Cleaning
Appendices Cleaning If the batteries run out, data in the memory is at risk. You can clean the outside of the PDM with a clean, damp cloth. DO NOT remove the old batteries until you have new ones at hand. The longer the batteries are Do NOT use IV Prep wipes, soap, detergent, or removed, the more the memory is at risk.
Page 144: If The Pdm Becomes Submerged In Water
Appendices 2. Insert 2 new AAA alkaline batteries into the compartment. If the PDM becomes submerged in water The PDM is not waterproof. Do not place it in water or leave it The diagram inside the compartment shows you near water where it can accidentally fall in. If it becomes sub- which direction to insert the batteries (Figure A-3).
Page 145: If You Drop The Pdm
(from outside the United States, 781-457-5098). instructions for use and expiration date. Ordering supplies You can order all OmniPod System products and supplies directly from Insulet Corporation. You can order them by calling 800-591-3455 (from outside the United States, 781-457-5098), Monday-Friday, 8:30am–8pm Eastern Time.
Page 146: Suggested Bolus Calculator Examples
Appendices ■ Suggested Bolus Calculator Examples Meal bolus calculation Carbs entered ÷ insulin-to-carb (I/C) ratio A suggested bolus is equal to: Example of meal bolus correction bolus + meal bolus – insulin on board. Carbs entered: 45 grams of carb Examples of each of these elements are shown below.
Page 147: Examples Of Suggested Bolus Calculations
Appendices Examples of suggested bolus calculations Correction bolus: 150 mg/dL (current) – 100 mg/dL (target) = 50 The examples below use these settings: 50 ÷ 50 (CF) = 1 unit • Target BG: 100 mg/dL Meal bolus: 45 (carbs) ÷ 15 (I/C ratio) = 3 units •...
Page 148: Calculator Guidelines
• A reverse correction only occurs if the meal bolus is greater than 0.00U. When the suggested bolus calculator is turned On, the OmniPod System applies these guidelines to the suggested bolus doses: • If your blood glucose value is below the target blood glucose value and you have set reverse correction to On, the sug- •...
Page 149: Omnipod System Options And Settings
Appendices ■ OmniPod System Options and Settings 12-hour or 24-hour clock Suggested bolus calculator On or Off Time Default is 12-hour Target BG value and 4 time segments; 70 to 200 mg/dL correction threshold in 1 mg/dL increments Date MM/DD/YY...
Page 150: Omnipod Specifications
Appendices ■ OmniPod Specifications Suspend 30 minutes to 2 hours Low reservoir volume 10 to 50 units in 5-unit increments Size: 1.6" wide x 2.4" long x 0.7" high indicator Default is 10.0 units 4.1cm x 6.2cm x 1.7cm) Pod expiration alert...
Page 151: Personal Diabetes Manager Specifications
Appendices ■ ■ Personal Diabetes Manager Specifications Blood Glucose Meter Specifications Size: 2.6" wide x 4.3" long x 1.0" high (6.6cm x 10.9cm x 2.5cm) Assay method: Coulometric electrochemical sensor Weight (with batteries): 115 grams (4.0 oz) Calibration: Plasma equivalent Screen: 1.75"...
Page 152: Omnipod System Label Symbols
Appendices ■ ■ OmniPod System Label Symbols Personal Diabetes Manager Icons Symbol Meaning Icon Meaning Icon Meaning Do not reuse this device. Single-use only. Bolus Communication Please read instructions for use (see User Guide). Pod change Communication failure Diagnostics/ Sterilized by ethylene oxide...
Page 153: Omnipod System Federal Communications Commission (Fcc) Notice Concerning Interference
Changes or modifications not expressly approved by Insulet could void the user’ s authority to operate the equipment. Both the OmniPod and the PDM generate, use, and can radiate radio frequency energy, and may cause harmful interference to radio communications. There are no guarantees that interfer- ence will not occur in a particular installation.
Page 154: Customer Bill Of Rights
Scope of Services questions, concerns, or complaints, please contact us between Insulet Corporation’ s scope of services is limited to providing the the hours of 8:30am and 6:00pm Eastern Time, Monday through OmniPod Insulin Management System. The System consists of...
Page 155 10. Agree to or refuse any part of the plan of service or plan of 3. Supply Insulet Corporation with insurance information nec- care. essary to obtain payment for services. 11. Voice complaints without fear of termination of service or 4.
Page 156: Limited Warranty For The Personal Diabetes Manager
(4) materials or workmanship. years from the date of purchase. If Insulet Corporation determines that the PDM is defective during the warranty period, Insulet Corporation will either Miscellaneous...
Page 157: Hipaa Privacy Notice
Appendices ■ HIPAA Privacy Notice authorization. To revoke a previously issued authorization, please send your request in writing, along with a copy of the THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION IS USED authorization being revoked, to our Privacy Officer. If a copy of AND DISCLOSED AND HOW YOU CAN GET ACCESS TO IT.
Page 158 Appendices Appointment Reminder and Other Communications: We may Public Health: We may disclose your Medical Information for use or disclose your Medical Information without your prior public health activities and purposes to a public health authority written authorization to provide you or others with, among that is permitted by law to collect or receive the information.
Page 159 Appendices repairs, or replacement, or lookback (including locating and noti- Criminal Activity: Consistent with applicable federal and state fying individuals who have received products that have been laws, we may disclose your Medical Information if we believe the recalled, withdrawn, or are the subject of lookback); or (iv) to con- use or disclosure is necessary to prevent or lessen a serious and duct post-marketing surveillance.
Page 160: Your Rights
Appendices Required Uses and Disclosures: Under the law, we must make We will respond to your request in a reasonable amount of time. disclosures to you when required by the Secretary of the If your request is honored, we may charge a nominal fee for Department of Health and Human Services to investigate or photocopying expenses.
Page 161 Appendices Your request must state the specific restriction requested and to You Have the Right to Receive an Accounting of Certain whom you want the restriction to apply. We are not required to Disclosures We Have Made, if any, of Your Medical Information: agree to a restriction that you may request, but if we do agree to This right applies to disclosures for purposes other than the requested restriction, we may not use or disclose your Medi-...
Page 162: Our Duties
HIPAA Privacy Notice until a Revised Furthermore, if you believe that Insulet has violated your privacy HIPAA Privacy Notice becomes effective. The Revised HIPAA rights with respect to your Medical Information, you have the...
Page 163: Helpful Resources
Appendices ■ Helpful Resources American Diabetes Association 1660 Duke Street • Alexandria, VA 22314 800-342-2383 www.diabetes.org International Association for Medical Assistance to Travelers List of doctors in foreign countries who speak English and who received post-graduate education in the US or Great Britain 417 Center Street •...
Page 164: Glossary
Glossary Glossary Blood glucose (see glucose) Blood glucose level A1c (see Hemoglobin A1c) The amount of glucose, or sugar, in the blood. In the United States, blood glucose levels are measured in milligrams per Advisory alarm deciliter (mg/dL). Notification by the PDM that a serious condition exists. Blood glucose meter Aseptic technique A device used to check blood glucose content.
Page 165 1 diabetes, which showed that good blood An amount of insulin taken to compensate for high or low blood glucose control significantly helped prevent or delay diabetes glucose levels. The OmniPod System calculates the correction complications. bolus by taking the difference between your current blood glu-...
Page 166 Extended bolus A test that measures a person’ s average blood glucose level over A feature of the OmniPod System that allows a meal bolus dose to the past 2 to 3 months. Also called glycosylated hemoglobin, the be given over an extended period of time.
Page 167 It is important to rule out ketoacidosis when you your duration of insulin action. experience symptoms that might otherwise indicate The OmniPod System continually calculates this number to help the flu. prevent “stacking” of correction bolus doses, which is a major Ketones cause of hypoglycemia.
Page 168 BG goal on or off according to the advice of a healthcare provider. after a meal. The OmniPod System calculates a meal bolus by dividing the grams of carbohydrates you are about to eat by your Sensitivity factor (see correction factor) insulin-to-carbohydrate ratio.
Page 169 Off or On in the PDM. Target blood glucose level The ideal number at which you would like your blood glucose level to be. The OmniPod System uses this number in calculating bolus doses. Temp basal A basal rate that is used to cover predictable, short-term changes in basal insulin need.
Page 170: Index
......22 activate a new OmniPod ..40–49 auto-off.
Page 171 Index checking ....ix, 70–86 presets ....34–36, 150 one-time temporary basal rate .
Page 172 ......72 deactivation . .See OmniPod deactivating check blood glucose ....70–86 test .
Page 173 Index avoiding......107 expiration shut off manually ....118 symptoms.
Page 174 Index symptoms ..... 70, 99 insulin, rapid-acting vs. long-acting . . 107 low blood glucose ..See hypoglycemia treating .
Page 175 BG goal ......65 pod ......See OmniPod storage .
Page 176 ..... . 48, 154 remove an OmniPod ..41–43, 109 alerts and alarms .
Page 177: Specifications
..23 OmniPod ......136 hypoglycemia....70, 99 test strips .
Page 178 Index screen ......93 water......68, 97, 130 Web site.
Page 179 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 180 My PDM Settings Duration of Insulin Action Bolus Presets Time that insulin will remain “active” in the body Name Units from a previous correction bolus. ___________ hrs ________________________________________ _____________ U ________________________________________ _____________ U ________________________________________ _____________ U Correction Factor ________________________________________ _____________ U ________________________________________ _____________ U Correction factor for each time segment defined,...

Insulet OmniPod User Manual

Introduction

1 Your New Omnipod Insulin Management System

2 Getting Started

3 Understanding and Adjusting Basal Rates

Understanding and Delivering Bolus Doses

Using the Omnipod

6 Using the Personal Diabetes Manager

7 Checking Your Blood Glucose

8 Record Keeping

9 Living with Diabetes

10 Errors, Advisories, and Hazard Alarms

11 Communication Failures

Appendices

Glossary

Index

Quick Links

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Questions and answers

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Summary of Contents for Insulet OmniPod

Table of Contents