Insulet Omnipod GO User Manual
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Insulet Omnipod GO User Manual

Insulet Omnipod GO User Manual

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Omnipod GO
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Summary of Contents for Insulet Omnipod GO

  • Page 1 User Guide Omnipod GO ™...

  • Page 2: Contacts And Important Information

    Omnipod GO™ Insulin Delivery Device User Guide Contacts and Important Information Customer Care 1-800-591-3455 — 24 hours/7 days 1-978-600-7850 when calling from outside the United States of America Customer Care Fax: 877-467-8538 Website: omnipod.com Address: Insulet Corporation 100 Nagog Park, Acton MA 01720 Emergency Services: Dial 911 (USA only;...
  • Page 3 © 2023 Insulet Corporation. Insulet, Omnipod, the Omnipod logo, Omnipod GO, and the Omnipod GO logo are trademarks or registered trademarks of Insulet Corporation. All rights reserved. All other trademarks are the property of their respective owners. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation.

  • Page 4: Table Of Contents

    Chapter 1: Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.1. Welcome to Your Omnipod GO™ Pod ....2 1.2. Learning Resources .

  • Page 5: Contents

    Contents Chapter 4: Taking Care of Your Pod and Your Diabetes . . . . . . . . 51 4.1. Pod and Insulin Storage ......52 4.2. Pods and the Environment .

  • Page 6: Chapter 1: Introduction

    1.1 Welcome to Your Omnipod GO™ Pod . . . . . . . . . . . . . . . . .

  • Page 7: Welcome To Your Omnipod Go™ Pod

    Use the following resources to learn how to use the Omnipod GO Pod. • This User Guide • Quick Start Guide • Instructional videos at: https://www.omnipod.com/go/start If you feel unsure about how to use the Omnipod GO Pod after using these resources, call Customer Care.

  • Page 8: About This User Guide

    Customer Care. This User Guide is provided to help you understand the features and functions of the Omnipod GO Pod. It provides step by step instructions on how to properly use the Pod, as well as important warnings and cautions to ensure your safety during use.

  • Page 9: Terminology

    1 Introduction 1.4. Terminology Term Description Blockage (occlusion) An interruption in insulin delivery. A blockage may result from blocked tubing, Pod malfunction, or from using old or inactive insulin. Blood glucose The amount of glucose, or sugar, in the blood. Blood A device used to check blood glucose.
  • Page 10 Introduction 1 Insulin A hormone that helps the body use glucose for energy. The beta cells of a pancreas make insulin when the pancreas is functioning typically. Ketoacidosis Diabetic ketoacidosis (DKA) is a serious (Diabetic condition in which extremely high blood ketoacidosis, glucose and a severe lack of insulin cause or DKA)

  • Page 11: Indications For Use

    • are unable to maintain contact with their healthcare provider. • are unable to use the Omnipod GO Pod according to instructions. • do NOT have adequate hearing and/or vision to allow recognition of Pod lights and sounds that signify alerts and alarms.
  • Page 12 Fiasp (insulin aspart), Humalog (insulin lispro), Admelog (insulin lispro), or Lyumjev (insulin lispro-aabc) in the Omnipod GO Pod as they have been tested and found to be safe for use with the Omnipod GO Pod. If you have questions about using other insulins, contact your healthcare provider.
  • Page 13 AVOID administering insulin, such as by injection or inhalation, while wearing an active Pod as this could result in low glucose. The Omnipod GO Pod cannot recognize insulin administered outside the Pod. Consult your healthcare provider about how long to wait after manually administering insulin before you begin using the Omnipod GO Pod.

  • Page 14: General Precautions

    Introduction 1 Warning: DO NOT use the Omnipod GO Pod in oxygen rich environments (greater than 25% oxygen), which include home or surgical areas that use supplementary oxygen and hyperbaric chambers. Hyperbaric, or high pressure, chambers are sometimes used to promote healing of diabetic ulcers, or to treat carbon monoxide poisoning, certain bone and tissue infections, and decompression sickness.
  • Page 15 Though the Omnipod GO Pod is safe to use at atmospheric pressures typically found in airplane cabins during flight, the atmospheric pressure in an airplane cabin could change during flight, which may affect the Pod's insulin delivery.

  • Page 16: Important User Information

    A red warning icon is shown before each warning. A yellow caution icon is shown before each caution statement. You, an adult with diabetes, are the intended user of the Omnipod GO Pod. It is very important that you review all instructions in this User Guide before using the Omnipod GO Pod.

  • Page 17: Emergency Kit

    Several new, sealed Omnipod GO Pods • A signed letter from your healthcare provider explaining that you need to carry insulin supplies and the Omnipod GO Pod • Phone numbers for your healthcare provider and/or physician in case of an emergency...

  • Page 18: Healthcare Provider Dosing Considerations

    If you're already using insulin, your healthcare provider may consider reducing your prescribed daily insulin rate when you start using the Omnipod GO Pod. Your healthcare provider may change your prescription to a different option for your Pod as your insulin needs change.

  • Page 19: Understanding Your Pod's Daily Insulin Rate And Your

    Color Key: CMYK yyyy-mm-dd T1234567 yyyy-mm-dd Die line, UDI or Variable Data - Insulet Corporation | 100 Nagog Park Acton, MA 01720 USA Non-printable information 1.800.591.3455 | 1.978.600.7850 | omnipod.com Assembled in China | PT-000771-10-AW Rev. 004 2/23 Omnipod GO-15...
  • Page 20 02/17/2023 Note: Die lines and hidden layers do not print. yyyy-mm-dd T1234567 yyyy-mm-dd Insulet Corporation | 100 Nagog Park Acton, MA 01720 USA 1.800.591.3455 | 1.978.600.7850 | omnipod.com Color Key: Assembled in China | PT-000771-20-AW Rev. 004 02/23 CMYK Die line, UDI or Variable Data -...
  • Page 21 File date: 02/17/2023 T1234567 yyyy-mm-dd Note: Die lines and hidden layers do not print. Insulet Corporation | 100 Nagog Park Acton, MA 01720 USA 1.800.591.3455 | 1.978.600.7850 | omnipod.com Assembled in China | PT-000771-30-AW Rev. 004 02/23 Color Key: CMYK...
  • Page 22 Introduction 1 Omnipod GO-40 units per day (104 POD-INS-I1-4025 1060 hPa 5023778 700 hPa yyyy-mm-dd T1234567 yyyy-mm-dd Insulet Corporation | 100 Nagog Park Acton, MA 01720 USA 1.800.591.3455 | 1.978.600.7850 | omnipod.com Assembled in China | PT-000771-40-AW Rev. 004 02/23...
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  • Page 24: Chapter 2: Applying Or Removing A Pod

    Chapter 2: Applying or Removing a Pod Contents 2.1 About the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 2.2 About the Fill Syringe and Fill Needle .

  • Page 25: About The Pod

    3 days. Consult with your healthcare provider if you feel your insulin needs to be adjusted. Tip: Read this entire chapter and use the Learning Resources listed on page 2 before using the Omnipod GO Pod for the first time and any time you need a refresher about the process.
  • Page 26 Applying or Removing a Pod 2 Flat end is marked with the prescribed daily insulin rate (see page 25) Adhesive tape Status light (green, amber, or red) Cannula viewing window BOTTOM Fill port Air vent Paper covering the adhesive tape (2 pieces) Hard plastic tab...
  • Page 27 2 Applying or Removing a Pod Warning: DO NOT allow small children or pets access to small parts, such as the Pod and its accessories, including the hard plastic tab. Small parts could be swallowed and pose a choking hazard. If ingested or swallowed, these small parts could cause internal injury or infection.

  • Page 28: About The Fill Syringe And Fill Needle

    Review the daily insulin rate marked on your syringe to confirm that you have the correct fill syringe for your Pod. For example, if your prescription is marked 25 U/day and your Pod is marked Omnipod GO-25, then your syringe should also be marked 25 U/day. Caution: NEVER use insulin that is expired or cloudy in the Pod as it may be damaged.

  • Page 29: Before You Fill And Apply Your Pod

    5. If the insulin or Pod is below 50°F (10°C), allow it to warm up to room temperature before proceeding. 6. Confirm that you are using the correct Omnipod GO Pod prescribed to you. Look for the prescribed daily insulin rate on the package.

  • Page 30: Using The Right Pod And Fill Syringe

    Die line, UDI or Variable Data - Non-printable information units per day (104 POD-INS-I1-3025 1060 hPa 5023778 700 hPa yyyy-mm-dd T1234567 yyyy-mm-dd Insulet Corporation | 100 Nagog Park Acton, MA 01720 USA 1.800.591.3455 | 1.978.600.7850 | omnipod.com Assembled in China | PT-000771-30-AW Rev. 004 02/23...

  • Page 31: Select The Pod Site (Infusion Site)

    2 Applying or Removing a Pod 2.5. Select the Pod Site (Infusion Site) Caution: ALWAYS rotate (change) Pod sites to help prevent Pod site complications like scar tissue and infection. Rotating Pod sites reduces the risk of scarring. Using a site with scar tissue can lead to problems with insulin absorption.

  • Page 32: Understand Pod Positioning

    Applying or Removing a Pod 2 2.6. Understand Pod Positioning Depending on which Pod site you select, there are different ways to position the Pod. Select a Pod site and check the following table to see how to position the Pod. Note: Use only 1 Pod on your body at a time.

  • Page 33: Prepare The Pod Site

    Caution: USE ONLY a fill syringe that came with the Omnipod GO Pod prescribed for you. Never use a different syringe to fill the Pod. Using the wrong syringe to fill the Pod could result in...
  • Page 34 Applying or Removing a Pod 2 Clean the insulin bottle and assemble the fill syringe 1. Use an alcohol prep swab to clean the top of the insulin bottle. 2. Leaving the Pod in its tray, remove the 2 pieces of the fill syringe from the packaging.

  • Page 35: Fill The Pod

    Pod. The fill syringe is intended for single use only and should be used only with the Omnipod GO Pod it is packaged with. Failure to follow these instructions may result in damage to your Pod.
  • Page 36 Applying or Removing a Pod 2 To Fill the Pod with Insulin After you fill the Pod with insulin, the Pod will immediately prepare to insert the cannula 3 minutes after you see the Pod's amber light. After filling, do not delay in completing the steps needed to apply the Pod to your skin.

  • Page 37: Take Actions To Apply The Pod Properly While The Amber Light Is Flashing

    2 Applying or Removing a Pod 2.10. Take Actions to Apply the Pod Properly While the Amber Light is Flashing After the Pod is filled with insulin, wait to confirm the cannula insertion timer lights and sounds are working. When you hear the Pod beep and see the Pod's blinking amber light, you have confirmed they work.

  • Page 38: Remove (Snap Off) The Pod's Hard Plastic Tab

    Applying or Removing a Pod 2 2.11. Remove (Snap Off) the Pod's Hard Plastic Tab Hold the Pod securely as you snap off the Pod's hard plastic tab. Before You Remove the Hard Plastic Tab Before you remove the hard plastic tab, hold the Pod properly and securely: 1.

  • Page 39: Remove (Peel Off) The Paper From The Adhesive Tape

    2 Applying or Removing a Pod 2.12. Remove (Peel Off) the Paper from the Adhesive Tape The adhesive tape on the bottom of the Pod is covered by 2 small pieces of paper (the paper backing), each with a paper pull tab. Remove the paper backing as follows: 1.

  • Page 40: Apply The Pod

    Applying or Removing a Pod 2 2.14. Apply the Pod Caution: DO NOT use a Pod and its fill needle under the following conditions, as this could increase your risk of infection. • The sterile package is damaged or is found open. •...
  • Page 41 2 Applying or Removing a Pod 1. After you have inspected the Pod, be ready to position it as described below for your chosen site. Pod Site How to Position the Pod Abdomen Horizontal or diagonal Horizontal or diagonal Lower back Horizontal or diagonal Buttocks Horizontal or diagonal...
  • Page 42 Applying or Removing a Pod 2 Tip: ALWAYS apply the Pod as directed. If you are applying a Pod in a place that does not have a lot of fatty tissue, squeeze the skin around the Pod until after the Pod has inserted the cannula. Blockages (occlusions) may result if you do not use this technique for lean areas.
  • Page 43 2 Applying or Removing a Pod 4. Check the Pod site. Verify that there is no wetness or scent of insulin. The presence of either may indicate that the cannula has not been properly inserted or has dislodged. 5. Check the Pod light. When the Pod's light has started blinking green, that means that the cannula has been deployed and your Pod is working.

  • Page 44: Remove A Pod

    Applying or Removing a Pod 2 Caution: ALWAYS check often to make sure insulin is not leaking from your Pod site. If you touch the area around the Pod and notice wetness or notice the scent of insulin on your fingers afterwards, this could mean that insulin is not being absorbed.

  • Page 45: More Information About Pod Use

    2 Applying or Removing a Pod Remove the Pod from your body: 1. Gently lift the edges of the adhesive tape from your skin and remove the entire Pod. Tip: Remove the Pod slowly to help avoid possible skin irritation. 2.
  • Page 46 Applying or Removing a Pod 2 Caution: ALWAYS follow these steps in preparing your Pod site. If your site is not cleaned properly or if your hands are dirty, you increase your risk of infection. • Wash your hands. • Clean the top of the insulin bottle with an alcohol prep swab.
  • Page 47 Pod and Pod light more frequently when in loud environments for prolonged periods of time. Failure to respond to the alerts and alarms from your Omnipod GO Pod could result in under-delivery of insulin, which can lead to high glucose.

  • Page 48: Chapter 3: Understanding Pod Lights And Sounds And Alarms

    Chapter 3: Understanding Pod Lights and Sounds and Alarms Contents 3.1 Introduction to How the Pod Communicates . . . . . . . . . . . . . 44 What do the Red, Amber or Green Pod Light Colors Mean? .

  • Page 49: Introduction To How The Pod Communicates

    Pod and Pod light more frequently when in loud environments for prolonged periods of time. Failure to respond to the alerts and alarms from your Omnipod GO Pod could result in under-delivery of insulin, which can lead to high glucose.

  • Page 50: What Do The Red, Amber Or Green Pod Light Colors Mean

    Understanding Pod Lights and Sounds and Alarms 3 What do the Red, Amber or Green Pod Light Colors Mean? The Pod light colors mean the following: • Red: Change your Pod. It is not delivering insulin. • Amber (Yellow): During Pod setup, apply the Pod to your body according to instructions within 3 minutes.

  • Page 51: During Pod Setup

    3 Understanding Pod Lights and Sounds and Alarms If you have removed a Pod and it continues to sound an alarm, you can silence it as described on page 50. Caution: DO NOT use a Pod if it does not show the normal lights and sounds for setup and insulin delivery described in this User Guide.
  • Page 52 Understanding Pod Lights and Sounds and Alarms 3 During Pod Setup (continued) Pod Light Pod Sound What it means What to do Color: Amber 1 beep The 3 minute Apply the new Pod blinking countdown to your body as Time: starts.

  • Page 53: During Pod Use

    3 Understanding Pod Lights and Sounds and Alarms 3.3. During Pod Use A Pod delivers insulin for 3 days (72 hours). The Pod will blink green when you start using it and during the delivery time. Your Pod won't beep while it is delivering insulin. During Pod Use Pod Light What it means...
  • Page 54 Understanding Pod Lights and Sounds and Alarms 3 When the Pod Has Stopped Pod Light Pod Sound What it What to do means Color: Red A set of 3 beeps Red light 1. Remove blinking followed by a set means to your Pod.

  • Page 55: Silencing Alarms

    3 Understanding Pod Lights and Sounds and Alarms When the Pod Has Stopped (continued) Pod Light Pod Sound What it What to do means No light No sound. The Pod you 1. Remove have been your Pod. wearing has 2. Apply not been a new delivering...

  • Page 56: Chapter 4: Taking Care Of Your Pod And Your Diabetes

    Chapter 4: Taking Care of Your Pod and Your Diabetes Contents 4.1 Pod and Insulin Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 4.2 Pods and the Environment .

  • Page 57: Pod And Insulin Storage

    4.1. Pod and Insulin Storage The Omnipod GO Insulin Delivery Device has no user-serviceable parts. If you need assistance operating or maintaining the Omnipod GO Pod, call Customer Care. Always store your Pods in a safe place to ensure others cannot use them. Caution: DO NOT expose Pods or to extreme temperatures that are outside the temperature ranges shown on page 67.

  • Page 58: Cleaning Your Pod

    Taking Care of Your Pod and Your Diabetes Caution: NEVER use a blow dryer or hot air to dry the Pod. Extreme heat can damage the electronics. If you remove your Pod to avoid exposing it to extreme temperatures, remember to apply a new Pod as soon as you can. Note: Check with your healthcare provider for guidelines if you will not use a Pod for extended periods.

  • Page 59: Pod Site Checks

    4 Taking Care of Your Pod and Your Diabetes Caution: USE CAUTION while cleaning the Pod on your body. Hold the Pod securely so the cannula does not kink and the Pod does not loosen or fall off. 4.4. Pod Site Checks At least 3 times a day, or as advised by your healthcare provider, use the Pod's viewing window to inspect the Pod site.

  • Page 60: Being Aware Of Your Glucose

    Taking Care of Your Pod and Your Diabetes 4.5. Being Aware of Your Glucose Being aware of your glucose helps you manage your diabetes. Check your glucose once a day, or as advised by your healthcare provider. You may need to check your glucose: •...

  • Page 61: Keep Supplies Accessible

    Bottles (vials) of insulin (cargo area temperatures may affect insulin) • A signed letter from your healthcare provider explaining that you need to carry insulin supplies and the Omnipod GO Pod • Prescriptions for all medications • Medications and supplies with their original prescription label •...

  • Page 62: Airport Security

    Though the Omnipod GO Pod is safe to use at atmospheric pressures typically found in airplane cabins during flight, the atmospheric pressure in an airplane cabin could change during flight, which may affect the Pod's insulin delivery.

  • Page 63: Avoiding Low And High Glucose

    4.7. Avoiding Low and High Glucose You can avoid most risks related to using the Omnipod GO Pod by following the instructions in this User Guide for filling, applying, and using a Pod and by promptly treating any symptoms of low glucose.

  • Page 64: Symptoms Of Low Glucose

    Taking Care of Your Pod and Your Diabetes Symptoms of low glucose Never ignore the following symptoms, as they could be signs of low glucose: • Shakiness • Sudden hunger • Fatigue • Rapid heart rate • Unexplained sweating • Confusion •...

  • Page 65: High Glucose

    4 Taking Care of Your Pod and Your Diabetes Possible causes of Suggested action low glucose Confirm that you have the correct Pod. Incorrect Pod Consult your healthcare provider if you think your insulin dose may need to change. Prone to severe Consult your healthcare provider about low glucose hypoglycemia (low glucose) unawareness...
  • Page 66 Taking Care of Your Pod and Your Diabetes Possible causes Suggested action of high glucose Expired insulin Remove the used Pod. Apply a new Pod filled or insulin exposed from a new bottle of insulin. to extreme temperatures Pod site in or near Remove the used Pod.

  • Page 67: Handling Special Situations

    4 Taking Care of Your Pod and Your Diabetes 4.8. Handling Special Situations Exercising, Playing Sports, or Working Hard The Pod’s adhesive keeps it securely in place for up to 3 days (72 hours). However, if necessary, several products are available to help with peeling adhesive tape.

  • Page 68: Chapter 5: Troubleshooting

    Chapter 5: Troubleshooting Contents 5.1 Pod Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 5.2 Pod Complaints .

  • Page 69: Pod Issues

    5 Troubleshooting 5.1. Pod Issues Issue Possible Cause What you can do While filling the Pod, Pod not filled with If you filled the Pod, did not hear the enough insulin. using all the insulin 2 beep confirmation from the syringe that you filled to the "Fill Here"...

  • Page 70: Pod Complaints

    Troubleshooting Issue Possible Cause What you can do Pod light off During Pod setup Do one of the following: After filling the Pod, it is normal for the • If the Amber light Pod light to be off starts blinking for a short time soon after filling before it starts...
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  • Page 72: Appendix

    Appendix Pod Specifications Size: 1.53” wide x 2.05” long x 0.57” high (3.9cm x 5.2cm x 1.45cm) Weight (without insulin): 0.92 oz (26 grams) Duration of use: up to 72 hours Operating temperature range: Pod operating environment of 41°F to 104°F (5°C to 40°C). Note: The Pod temperature equilibrates from 73°F to 100°F (23°C to 38°C) when worn on the body.
  • Page 73 Flow Capability: Prime rate: 0.05 unit per second Basal: Factory pre-programmed rate by prescription as follows: Omnipod GO 10 Units/Day Pod provides 10 U/day at 0.42 U/hr. Omnipod GO 15 Units/Day Pod provides 15 U/day at 0.63 U/hr. Omnipod GO 20 Units/Day Pod provides 20 U/day at 0.83 U/hr.
  • Page 74 A blockage (occlusion) is an interruption in insulin delivery from the Pod. A blockage may result from blocked tubing, Pod malfunction, or from using old or inactive insulin. If the Omnipod GO Pod detects a blockage, it sounds a hazard alarm and its Pod light turns red to tell you to change your Pod.
  • Page 75 • Occlusion • Pod expiration Performance Characteristics The Omnipod GO Pod delivers continuous basal insulin. The following accuracy data was collected on basal delivery in laboratory studies performed by Insulet. Delivery performance characterization Insulin Delivery: To assess insulin delivery accuracy, 12 Pods were tested by delivering at low, medium, and high basal rates (10, 25, and 40 U/day).
  • Page 76 Appendix The graph below each table shows the minimum and maximum observed errors within the flow accuracy data for any given time period up to 25 hours. In other words, for a given duration of wear, the graph shows you the worst potential error in insulin delivery you could expect.
  • Page 77 Appendix For the following table and graph, the measurements were made using a Pod with a preset insulin rate of 25 U/day at a low operating temperature. The overall mean percentage flow error was 0.21% Medium Basal Rate Delivery Performance (25 U/day) Basal 1 hour 6 hours...
  • Page 78 Appendix For the following table and graph, the measurements were made using a Pod with a preset insulin rate of 40 U/day at a low operating temperature. The overall mean percentage flow error was 0.58%. High Basal Rate Delivery Performance (40 U/day) Basal 1 hour 6 hours...
  • Page 79 Appendix Symbols The following symbols appear on the Omnipod GO Pod's packaging: Symbol Meaning Symbol Meaning Single use only MR unsafe Consult Do not use if package accompanying is damaged documents Sterilized using Type BF applied part ethylene oxide Date of...
  • Page 80 Portable and mobile radio frequency (RF) communications equipment can affect the function of medical electrical equipment. Be careful when you use the Omnipod GO Pod close to other electrical equipment because potential electromagnetic or other interference could occur and affect the Pod or the other equipment. Try to minimize this interference by not using the equipment near the Pod.
  • Page 81 (including peripherals such as antenna cables and external antennas) closer than 12 inches (30 cm) to the Omnipod GO Pod, as degradation of the performance of this equipment could result. One exception is that if you use a wearable device, you should check that device's user guide.
  • Page 82 Appendix The frequencies and services listed in the table are representative examples in various locations where the Pod may be used. Frequency Band a) Service a) Modulation Maximum Distance IMMUNITY (MHz) (MHz) power (W) TEST LEVEL (V/m) 380– TETRA 400 Pulse modulation b)18Hz...
  • Page 83 Active during the design process and beyond, the cybersecurity program uses models to predict and prevent problems. Insulet conducts many annual reviews and audits to ensure policies and standards remain effective. If you...
  • Page 84 Scope of Services Insulet Corporation’s scope of services is limited to providing the Omnipod GO Pod. Compliance The Omnipod GO Insulin Delivery Device is manufactured and distributed by Insulet Corporation.
  • Page 85 Any change of address or telephone number, whether permanent or temporary. Warranty LIMITED EXPRESS WARRANTY, DISCLAIMER OF IMPLIED WARRANTIES AND LIMITATION OF REMEDIES FOR THE OMNIPOD GO POD (United States of America) LIMITED EXPRESS WARRANTY COVERAGE Limited Warranty Coverage for the Omnipod GO Pods...
  • Page 86 Pods and, in the event a Pod is replaced, the warranty period shall not be extended or reset. Thus, if Insulet replaces a Pod under this Limited Express Warranty, the warranty coverage for the replacement Pod shall...
  • Page 87 WARRANTY OF THE POD IS YOUR EXCLUSIVE REMEDY AND THE ENTIRE OBLIGATION OF INSULET. THIS EXCLUSIVE REMEDY SHALL NOT BE DEEMED TO HAVE FAILED ITS ESSENTIAL PURPOSE SO LONG AS INSULET IS WILLING AND ABLE TO REPAIR OR REPLACE A POD WITH DEFECTS IN MATERIALS OR WORKMANSHIP IN THE MANNER PRESCRIBED BY THE ABOVE LIMITED EXPRESS WARRANTY.
  • Page 88 Insulet and you, superseding all prior warranties and agreements, oral or written, and all other communications relating to any defect in, failure or other malfunction in an Omnipod GO Pod. No employee, agent or other representative of Insulet or any other party is authorized to make any product warranty or agreement applicable to an Omnipod GO Pod in addition to those made in the foregoing.
  • Page 89 Appendix Uses and Disclosures of Your Medical Information Related to the Treatment and Services Provided By Us Treatment, Payment and Health Care Operations: We may use your Medical Information for treatment, to obtain payment for treatment, for administrative purposes, and to evaluate the quality of care that you receive without your authorization.
  • Page 90 Appendix agencies that oversee the healthcare system, government benefit programs, other government regulatory programs and civil rights laws. Food and Drug Administration: We may disclose your Medical Information to a person or company as directed or required by the Food and Drug Administration: (i) to collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological...
  • Page 91 Appendix facility and your physician created or received your Medical Information in the course of providing care to you, and disclosure is necessary for (i) providing you with health care; (ii) the health and safety of you, other inmates, or others at the correctional institution;...
  • Page 92 Appendix Information pertains solely to a healthcare item or service for which you or someone (other than the health plan) on your behalf, has paid us in full. If we agree to the requested restriction, we may not use or disclose your Medical Information in violation of that restriction unless it is needed to provide emergency treatment.
  • Page 93 Privacy Officer or with the Secretary of Health and Human Services at 200 Independence Avenue, S.W. Washington, D.C. 20201 or by calling (877) 696-6775. Insulet will not retaliate against you for filing such a complaint. Effective Date: August 11, 2004 Revision Dates: April 1, 2009, September 20, 2013, April 22, 2014, September 2, 2014, and September 15, 2022.

  • Page 94: Index

    Index avoiding 60 hypoglycemia 58–62 air bubbles 29 avoiding 59 airport security 57 symptoms 59 alarms treating 58 silencing 50 allergy to acrylic adhesive 22, 23 aseptic technique 24 indications for use 6 infusion site guidelines for selection 26 blockage detection 69 MRIs 62 cannula 67...
  • Page 95 Index safety electrical 75–88 specifications, technical Pod 67 sports 62 storing Pod specifications 67 supplies travel 56 surgery 62 swimming 53 symptoms hypoglycemia 58 temperature insulin 24, 52 Pod 24, 67 U-100 insulin 7 water and the Pod 53 website i X-rays 57...
  • Page 96 Insulet Corporation 100 Nagog Park Acton, MA 01720 1-800-591-3455 | 1-978-600-7850 omnipod.com Pod shown without the necessary adhesive. 2797 PT-000863-AW Rev. 009 5/23...

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