OMNIPOD SYSTEM QUICK START GUIDE

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1 Insulin Management System OMNIPOD SYSTEM QUICK START GUIDE

2 3 SIMPLE STEPS AND YOU ARE ON YOUR WAY. > NEW OMNIPOD CUSTOMERS, PLEASE COMPLETE THE SETUP PROCESS WITH YOUR HEALTHCARE PROVIDER. > CURRENT OMNIPOD CUSTOMERS, PLEASE FIRST RETRIEVE YOUR SETTINGS USING GETTING YOUR SETTINGS FOR YOUR NEXT-GENERATION PDM BROCHURE FOR GUIDANCE.

3 1 SET UP YOUR PDM Set up your Personal Diabetes Manager (PDM) using the OmniPod Setup Wizard. For this step, you will need an accurate clock, such as your watch, alarm clock, or mobile phone. You will also need the personal settings from your current PDM to enter in the next-generation PDM. > If you are a current OmniPod customer, take these settings from your blue PDM. Follow the instructions in the GETTING YOUR SETTINGS FOR YOUR NEXT-GENERATION PDM brochure to find and record the settings you need to use. > If you are a new OmniPod customer, you must complete the setup process with your healthcare provider, using settings from your Pump Therapy Order Form Insert the AAA batteries included with your PDM. The Setup Wizard appears the first time you turn on your PDM. It will guide you through the setup process. Follow the prompts on each screen to set: > Your ID name the name you will use to identify your next-generation black PDM > Your ID screen colour you can choose from white, green, blue, orange, or purple > Current time and date > Maximum basal rate > Initial basal rate and/or program > Temporary basal method > Blood glucose (BG) sound setting and BG goal > Suggested bolus calculations and associated targets, ratios, and factors (if applicable) > Bolus increment > Maximum bolus > Extended bolus method > Low reservoir volume alert > Pod expiration notification 1 2 Welcome to the OmniPod Insulin Management System! Press Next to set up your Personal Diabetes Manager (PDM) Next

4 2 ACTIVATE A NEW POD Once your PDM is set up, it will ask if you would like to activate a Pod. Follow the instructions on your PDM to activate a new Pod Assemble the following supplies: > PDM > Unopened Pod > Alcohol swabs > Vial of room temperature rapid-acting U-100 insulin Wash your hands with soap and water. Clean the top of the insulin vial with an alcohol swab. Remove the fill needle and syringe from the Pod package. Twist the fill needle clockwise onto the top of the syringe. Do not use any other type of needle or filling device besides the syringe provided with each Pod. Remove the syringe protective cap from the needle. Draw air into the syringe equal to the amount of insulin you will use. You must fill your syringe with at least 85 units of insulin. Insert the needle into the vial and inject air. Turn the vial upside down and slowly withdraw insulin from it. Do not fill syringe beyond 200 units. Tap or flick the filled syringe to remove any bubbles. To ensure proper communication between the Pod and PDM, place the Pod back in the original packaging tray and put it to the right of and touching the PDM. Remove the needle from the vial and insert it into the Pod insulin fill port. An arrow on the white paper backing points to the fill port. Do not inject insulin into any other location on the Pod. Leave the Pod in the tray while you are filling it with insulin.! To ensure proper fill, do not insert the fill syringe at an angle into the fill port. Inject insulin into the fill port. The Pod will beep twice. Remove the needle from the insulin fill port. Replace the needle s protective cap and remove the needle from the fill syringe. NEVER inject air into the fill port. Doing so may result in unintended or interrupted insulin delivery. NEVER use a Pod if you feel resistance while depressing the plunger of the fill syringe. This condition can result in interrupted insulin delivery. Press Next on the PDM. The system performs a series of safety checks and automatically primes the Pod ,8 9 Fill a new pod with insulin. After filling pod, listen for 2 beeps, then press Next. NOTE: Do not remove needle cap at this time. Cancel Next

5 3 BEGIN INSULIN DELIVERY Follow the instructions on your PDM to begin insulin delivery Review the Pod placement section of the User Guide to help you decide where to place your Pod. Wash your hands with soap and water. Use an alcohol swab to clean the site. Let the site air dry thoroughly. Do not blow on the site to dry it. Remove the clear needle cap on the underside of the Pod when the PDM tells you to. Pull firmly upward on the outermost edge. Remove the white paper backing from the adhesive tape. If the Pod is wet or dirty or the adhesive backing is folded, press Discard on the PDM and begin again with a new Pod. Apply the Pod to your selected site when you have verified that the Pod is OK. Use your finger to seal around the adhesive edge. Press Next on the PDM. Press Start on the PDM. The needle is inserted to place a cannula under the skin. You will hear a click and feel a slight pinch. Look through the Pod viewing window to check the cannula. Check the infusion site to ensure that the cannula was properly inserted. Check the surface of the Pod; you should now be able to see the pink slide insert in the window on the top surface. If the cannula is not properly inserted, press No on the PDM. Press Discard to deactivate the Pod and begin the process with a new Pod. If the cannula is properly inserted, press Yes on the PDM. You should check your blood glucose 1.5 to 2 hours after each Pod change and check the infusion site periodically Press Start to insert cannula and begin basal delivery.! Before continuing with the OmniPod Insulin Management System, refer to your User Guide for detailed operating instructions. Start 7 Pod is active. basal 1 has been programmed. Check infusion site and cannula. Is cannula properly inserted? No Yes

6 HOW TO NAVIGATE THE SETUP WIZARD > Use the Up/Down Controller buttons to increase or decrease a number or to move up or down a list. > Press the soft key labeled Next, Select, Confirm, Save, or Done to continue to the next screen. > Press the soft key labeled Back or Cancel to return to the previous screen. Bolus More actions Temp basal My records Settings Suspend basal 1: Enter basal rate that starts at midnight U/hr Status Select Back Next Press Save to accept basal a 6a 12p 6p 12a Daily basal: 9.60 U Cancel Save List The function of each soft key shows on the screen above each button. The screens above represent a small sample of these functions. ENTER YOUR SETTINGS CAREFULLY It is very important to enter your settings accurately into your next-generation black PDM. Follow this Quick Start Guide carefully. Refer to your User Guide if you need additional information. If you have any questions about setting up your nextgeneration PDM, please call Customer Care. We are available 24 hours a day, 7 days a week at POD-INFO ( ). When calling from outside Canada, please call If you have any questions about your individual pump therapy settings, please contact your healthcare provider.

7 Pink Slide Insert Viewing Window Fill Port Adhesive Backing Soft Keys Info Button Needle Cap Up/Down Controller Buttons Home/Power Button Test Strip Port Safety Information Before deciding on the OmniPod Insulin Management System, patients must discuss with their healthcare practitioner the benefits and potential risks of the OmniPod Insulin Management System, as well as the responsibilities that come with insulin pump therapy. Indication The OmniPod Insulin Management System is intended for subcutaneous (below the skin) delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). Refer to User Guide for complete information 1 Contraindications Insulin pump therapy is NOT recommended for people who are either: Unable to perform at least four (4) blood glucose tests a day Unable to maintain contact with their healthcare provider Unable to use the OmniPod Insulin Management System according to instructions Do not use the integrated FreeStyle Blood Glucose Monitoring System for: Testing on newborns Testing arterial blood Diagnosing of or screening for diabetes mellitus Warnings The OmniPod System is designed to use rapid-acting U-100 insulin. Refer to the insulin labelling and follow your healthcare provider s directions for how often to replace the Pod. Not recommended for individuals with hearing loss; always verify ability to hear Pod/PDM alerts and alarms. The Pod and PDM may be affected by strong radiation or magnetic fields. Before having an X-ray, MRI, or CT scan (or any similar test or procedure), remove your Pod and put it and the PDM outside the treatment area. Monitor your blood glucose with the guidance of your healthcare provider. Undetected hyperglycemia or hypoglycemia can result without proper monitoring. If you are unable to use the System according to instructions, you may be putting your health and safety at risk. Talk with your healthcare provider if you have questions or concerns about using the System properly. Reference: 1 OmniPod Insulin Management System User Guide. Insulet Corporation, GlaxoSmithKline Inc. All rights reserved. OmniPod is a registered trademark of Insulet Corporation, used under license by GlaxoSmithKline Inc. PDM imagery is for illustrative purposes only. PDM screens may vary based on model or user settings. FreeStyle is a registered trademark of Abbott Diabetes Care Inc AW Rev A R1 10/13

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