2 Understanding PDM and Pod Function Bolus Calculator examples For an explanation of IOB, see page 160. For an explanation of the correction and meal bolus equations, see page 162. Example 1: Eating 45 g carbs, BG of 150 mg/dL is above target, no IOB Duration of Insulin Action = 4 hours. You have not delivered a bolus in the past 4 hours, so there is no IOB (no meal IOB, no correction IOB).
Understanding PDM and Pod Function 12 Example 2: Not eating, BG of 150 mg/dL is above target, 1 U meal IOB, 1 U correction IOB Duration of Insulin Action = 4 hours. Three hours ago, you delivered an 8 U bolus (4 U meal bolus, 4 U correction bolus) because you were eating and had a high blood glucose reading. Now, three hours after the 8 U bolus, there are 2 U of IOB left (1 U meal IOB, 1 U correction IOB).
12 Understanding PDM and Pod Function Example 3: Eating 45 g carbs, BG of 100 mg/dL is at target, 1 U meal IOB Duration of Insulin Action = 4 hours. Three hours ago, you delivered a 4 U bolus (4 U meal bolus) because you were eating. There was no correction bolus because your blood glucose was at your Target BG. Now, three hours later and just before your next meal, there is 1 U of IOB from the previous meal, which is a 1 U meal IOB.
Understanding PDM and Pod Function 12 Example 4: Eating 60 g carbs, BG of 150 mg/dL is above target, 1 U correction IOB Duration of Insulin Action = 2 hours. One hour ago, you delivered a 2 U bolus to correct a high blood glucose. Because you were not eating at that time and did not enter a carbohydrate value into the Bolus Calculator, this was a 2 U correction bolus. Now, one hour later, you are about to eat.
12 Understanding PDM and Pod Function Example 5: Reverse correction on, eating 45 g carbs, BG of 75 mg/dL is below target, no IOB Duration of Insulin Action = 2 hours. You have not given yourself a bolus in the past 2 hours, so there is no IOB (no meal IOB, no correction IOB). Correction Bolus - 0.5 U BG = 75, Target BG = 100 Correction Factor = 50 (75 -100) / 50 = - 0.
Understanding PDM and Pod Function 12 Calculations for History Summaries This section lists the calculations for the summary data shown on the one day and multiple day history screens. Blood glucose summaries The calculations used for the blood glucose summaries include readings from a paired BG meter and manually-entered readings, with the exception that they do not include control solution records. The calculations do include any HI and LO readings unless otherwise noted.
12 Understanding PDM and Pod Function Insulin delivery summaries Bolus insulin calculations include Bolus Calculator boluses and manuallycalculated boluses. If you cancel an immediate or extended bolus before it completes, only the amount actually delivered is included in the calculation. Basal insulin calculations includes insulin delivered according to the active Basal Program adjusted for periods when a temp basal was running, insulin was suspended, or there was no active Pod.
CHAPTER 13 Living with Diabetes Warning: If you are unable to use the Omnipod DASH™ System according to instructions, you may be putting your health and safety at risk. Talk with your healthcare provider if you have concerns about using the Omnipod DASH™ System. Before deciding on the Omnipod DASH™ System, you and your healthcare provider discussed the benefits of the Omnipod DASH™ System, as well as the responsibilities that come with insulin pump therapy. Remember: safe use begins and ends with you.
13 Living with Diabetes Warnings: If an infusion site shows signs of infection: • Immediately remove the Pod and apply a new Pod at a different infusion site. • Contact your healthcare provider. Treat the infection according to instructions from your healthcare provider. If you see blood in your cannula, check your blood glucose more frequently to ensure insulin delivery has not been affected. If you experience unexpected elevated blood glucose levels, change your Pod.
Living with Diabetes 13 Prepare for Emergencies Tip: Ask your healthcare provider to help you develop plans for handling emergency situations, including what to do if you cannot reach your healthcare provider. Warning: Keep an emergency kit with you at all times to quickly respond to any diabetes emergency. Prepare an emergency kit to keep with you at all times.
13 Living with Diabetes Keep supplies accessible On airplanes, trains, and buses, keep these items with you, rather than checking them: • Personal Diabetes Manager (PDM) • Extra Pods • An emergency kit • 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 DASH™ System • Prescriptions for all medications • Medications and supplies with their original prescription label Not
Living with Diabetes 13 Airport security Prepare for your travel: • Airport security checks and screening procedures may change, so review the airport website and the TSA website for travel updates before your trip. • Arrive at the airport 2-3 hours before your flight. • Have your insulin management supplies easily accessible to ensure that airport security checks run smoothly.
Living with Diabetes can be used at atmospheric pressures as low as 700 hPA, which is lower than the typical pressure in airplane cabins. Avoid Lows, Highs, and DKA Act promptly at the first sign of hypoglycemia, hyperglycemia, or diabetic ketoacidosis. The easiest and most reliable way to avoid these conditions is to check your blood glucose often. General precautions • Keep careful records and discuss changes and adjustments with your healthcare provider.
Living with Diabetes 13 Tip: Hypoglycemia unawareness is a condition in which you do not realize when your blood glucose level is low. If you are prone to hypoglycemia unawareness, you may want to use the PDM’s blood glucose reminder and check your blood glucose more frequently (see "Check BG after Bolus reminders" on page 110). Tip: Make sure your blood glucose is at least 100 mg/dL before driving or working with dangerous machinery or equipment.
13 Living with Diabetes blood glucose levels to rise too high. Contact your healthcare provider as needed for guidance. Possible causes of hypoglycemia Suggested action Confirm that the correct Basal Program is active. Incorrect Basal Program Confirm that the PDM time is set correctly. Consult your healthcare provider about adjusting your Basal Programs or using a temp basal. Take bolus with food. Incorrect bolus timing or bolus too large Check blood glucose before giving a meal bolus.
Living with Diabetes 13 Possible causes of hypoglycemia Alcohol consumption Suggested action Check blood glucose frequently, especially before going to bed. Consult your healthcare provider for guidance. Hyperglycemia (high blood glucose) Pods use rapid-acting insulin, so you have no long-acting insulin in your body. If an occlusion (interruption of insulin delivery from the Pod) occurs, your blood glucose can rise rapidly.
13 Living with Diabetes • Before, during, and after exercise • As directed by your healthcare provider To treat hyperglycemia (high blood glucose) Always check your blood glucose levels frequently while treating hyperglycemia. You don’t want to over-treat the condition and cause your blood glucose level to drop too far. 1. Check your blood glucose level. The result will help you to find out how much insulin is needed to return your blood glucose to your blood glucose goal. 2.
Living with Diabetes 13 Possible causes of hyperglycemia Infected infusion site Suggested action Deactivate and remove the used Pod. Apply a new Pod in a different location and consult your healthcare provider. Deactivate and remove the used Pod. Dislodged cannula Empty Pod Apply a new Pod in a different location. Note: Avoid sites near a waistband, belt, or other areas where friction may dislodge the cannula. Deactivate and remove the used Pod. Apply a new Pod in a different location.
13 Living with Diabetes Possible causes of hyperglycemia Suggested action Weight loss or gain or menstrual cycle Consult your healthcare provider for guidance. or pregnancy Diabetic ketoacidosis (DKA) Pods use rapid-acting insulin, so you have no long-acting insulin in your body. If insulin delivery from the Pod is interrupted (an occlusion), your blood glucose can rise rapidly and lead to diabetic ketoacidosis (DKA).
Living with Diabetes 13 To treat DKA • Once you have begun treatment for high blood glucose, check for ketones. Check for ketones any time your blood glucose is 250 mg/dL or above. • If ketones are negative or trace, continue treating for high blood glucose. • If ketones are positive and you are feeling nauseated or ill, immediately contact your healthcare provider for guidance. • If ketones are positive but you are not feeling nauseated or ill, replace the Pod, using a new vial of insulin.
13 Living with Diabetes Exercising, playing sports, or working hard Check your blood glucose levels before, during, and after exercising, playing sports, or doing unusually hard physical labor. The Pod’s adhesive keeps it securely in place for up to 3 days. However, if necessary, several products are available to enhance adhesion. Ask your healthcare provider about these products. Avoid getting body lotion, creams, or oils near the infusion site; these products may loosen the adhesive.
Appendix Troubleshooting PDM Startup While unlikely to happen with normal use, certain button press combinations during PDM startup can cause the PDM to display Boot Mode or Safe Mode. Even when the PDM is in Boot Mode, the Pod continues delivering insulin according to the instructions it was given. Safe Mode does not affect PDM or Pod functionality. Return to normal PDM operation as follows: Boot Mode If your PDM screen displays, "Select Boot Mode", then do the following: 1.
Appendix Summary of Settings and Options The options for the various Omnipod DASH™ Insulin Management System settings are: Time format 12-hour or 24-hour clock. Time zones GMT-11:00 to GMT+13.00. Date format MM/DD/YY DD/MM/YY MM.DD.YY DD.MM.YY YY-MM-DD Screen time-out 30, 60, 120 seconds. Default is 30 seconds. PIN 4 digits from 0 to 9. Maximum Basal Rate 0.05-30 U/hr. Default is 3.00 U/hr. Basal rate Units/hr. Range: 0 U/hr to Maximum Basal Rate in 0.05 U/hr increments. Basal Programs Maximum of 12.
Appendix Reverse Correction Duration of insulin action Maximum Bolus size Extended bolus Bolus preset MY FOODS list Custom foods Suspend Low reservoir volume advisory Pod expiration notification Auto-off timer History screen display Language On or Off. Default is On. 2 to 6 hours in 30-minute increments. Default is 4 hours. 0.05-30 U. %, Units, or Off. Default is Off. 30 minutes to 8 hours in 30-minute increments. Maximum of 7. Cannot exceed the Maximum Bolus. Maximum of 50 items.
Appendix Storage atmospheric pressure: 700 hPA to 1060 hPA Non-pyrogenic: Fluid pathway only Type BF applied part: Protection from electrical shock Maximum infusion pressure: 35 psi Maximum volume infused under single fault conditions: 0.0 U Flow Capability: Basal: Programmable by the user in 0.05U increments up to 30.0 U per hour Bolus Rate: 1.5 units per minute. Dose range from 0.05 to 30.0 units Delivery accuracy (tested per IEC 60601-2-24): Basal: ± 5% at rates ≥ 0.05 U/hr Bolus: ± 5% for amounts ≥ 1.
Appendix PDM Specifications Size: 2.48” wide x 5.1” long x 0.39” high (6.3 cm x 13.0 cm x 1.0 cm) Weight: 6.17 oz (175 grams) Screen active area: 4.0" diagonal ± 5% (10.
Appendix Protection from Over-infusion or Under-infusion The Pod software monitors the infusion rate. If an error that would result in overor under-infusion is detected and cannot be corrected, insulin delivery stops, and an alarm sounds. Occlusion detection An occlusion is a blockage or interruption in insulin delivery from the Pod. If the Omnipod DASH™ System detects an occlusion, it sounds a hazard alarm and prompts you to deactivate and change your Pod.
Appendix Omnipod DASH™ System Label Symbols The following symbols appear on the Omnipod DASH™ System or its packaging: Symbol Meaning Single use only Consult accompanying documents Sterilized using ethylene oxide Date of manufacture Batch code Use by date Reference number Serial number Symbol Meaning MR unsafe Do not use if package is damaged Type BF applied part Manufacturer Keep dry Storage temperature, Operational temperature Storage relative humidity, Operational relative humidity Storage atmospher
Appendix Omnipod DASH™ System Notice Concerning Interference The Omnipod DASH™ Insulin Management System (both the Pod and the PDM) complies with Part 15 of the Federal Communications Commission (FCC) Rules. Operation is subject to the following two conditions: 1. These devices may not cause harmful interference. 2. These devices must accept any interference received, including interference that may cause undesirable operation.
Appendix safety, performance, and electromagnetic compatibility (increased emission and decreased immunity). Care should be taken if the Omnipod DASH™ System is used adjacent to other electrical equipment; if adjacent use is inevitable, such as in work environments, the Omnipod DASH™ System should be observed to verify normal operation in this setting. The Omnipod DASH™ System communicates by low level RF energy.
Appendix Electromagnetic Immunity The System is intended for use in the electromagnetic environment specified below. You should observe these requirements in the use of the System. Immunity against Compliance IEC 60601-1-2 level (of this test level device) Electromagnetic environment ElectroStatic contact Discharge, ESD discharge: (IEC 61000-4-2) ± 8 kV air discharge: ± 15 kV Power frequency magnetic fields 50/60 Hz (IEC 61000-4-8) 30 A/m Radiated RF 10 V/m at (IEC 61000-4-3) 80 MHz– 2.
Appendix Customer's Bill of Rights Mission Statement Insulet Corporation is dedicated to designing, developing, and distributing products that provide superior treatment options and lifelong health benefits for people with diabetes. Scope of Services Insulet Corporation’s scope of services is limited to providing the Omnipod DASH™ Insulin Management System.
Appendix 5. Receive continued service. 6. Select the medical equipment supplier of your choice. 7. Make informed decisions regarding your care planning. 8. Understand what services will be provided to you. 9. Obtain an explanation of charges, including policy for payment. 10. Agree to or refuse any part of the plan of service or plan of care. 11. Voice complaints without fear of termination of service or other reprisals. 12. Have your communication needs met. You have the responsibility to: 1.
Appendix Limited Express Warranty, Disclaimer, and Limitation of Remedies for the PDM and Pods LIMITED EXPRESS WARRANTY, DISCLAIMER OF IMPLIED WARRANTIES AND LIMITATION OF REMEDIES FOR THE OMNIPOD DASH™ INSULIN MANAGEMENT SYSTEM PERSONAL DIABETES MANAGER AND PODS (United States of America) LIMITED EXPRESS WARRANTY COVERAGE Limited Warranty Coverage for the Omnipod DASH™ System Personal Diabetes Manager Subject to the terms and conditions stated herein (“Limited Express Warranty”), Insulet Corporation warra
Appendix Warranty. Unless Insulet Corporation elects to repair the PDM (which may include, but is not limited to, a repair kit, replacement part(s) Insulet Corporation may provide, or an over-the-air software update) or refers you to a third party, you must obtain a prior authorization and return the PDM or the Pod to Insulet Corporation. The PDM or Pod must be properly packaged and returned to Insulet Corporation according to the instructions provided in the Return Merchandise Authorization, or RMA, Kit.
Appendix ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE EXPRESSLY DISCLAIMED. IN NO EVENT SHALL INSULET CORPORATION, ITS SUPPLIERS, DISTRIBUTORS, SERVICE PROVIDERS, AND/OR AGENTS BE LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES CAUSED BY A DEFECT IN THE PDM OR A POD OR BY A BREACH OF THE ABOVE LIMITED EXPRESS WARRANTY, WHETHER SUCH CLAIM IS BASED IN WARRANTY, CONTRACT, TORT, OR OTHERWISE.
Appendix HIPAA Privacy Notice THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.
Appendix Family, Friends and Emergencies: If you require emergency treatment and we are unable to obtain your consent, we may disclose your Medical Information to a family member or relative who is involved in your care. Marketing: We may use or disclose your Medical Information to provide you with marketing communications about the health-related products and services that we provide, and about products, services, treatment or healthcare providers that may be of interest to you.
Appendix Criminal Activity: Consistent with applicable federal and state laws, we may disclose your Medical Information, if we believe the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. We may also disclose Medical Information if it is necessary for law enforcement authorities to identify or apprehend an individual.
Appendix You Have the Right to Request a Restriction of Your Medical Information: You may ask us not to use or disclose any part of your Medical Information for the purposes of treatment, payment or healthcare operations. You may also request that any part of your Medical Information not be disclosed to family members or friends who may be involved in your care or for notification purposes as described in this HIPAA Privacy Notice.
Appendix Our Duties Generally: We are required by law to maintain the privacy and security of your Medical Information and to provide you with notice of our legal duties and privacy practices with respect to Medical Information, and to notify you if there is a breach resulting in disclosure of your unsecured Medical Information. Revisions and Modifications: We may change this HIPAA Privacy Notice at any time.
Glossary A1c (see Hemoglobin A1c) Activation: The process of waking up a Pod and pairing it to a PDM so that the Pod only responds to commands from that PDM. Advisory alarm: Intermittent vibrations or beeps accompanied by a message advising about an action that you may want to take to prevent a serious problem. Aseptic technique: A method for maintaining sterilization and preventing contamination. Basal Program: A daily schedule for continuous insulin delivery.
Glossary Carbohydrate (carbs): One of the three main energy sources in food. (The other two are protein and fat.) Foods that contain carbohydrates include starches, sugars, vegetables, fruits, and dairy products. Correction bolus: An amount of insulin taken to compensate for high blood glucose levels. Correct Above threshold: The blood glucose level above which you would like to take insulin to reduce an elevated blood glucose.
Glossary soon as confirmation is received from the Pod, the PDM displays the actual (not estimated) bolus amount. Extended bolus: The delivery of a meal bolus dose steadily over an extended period of time. Fat: One of the three main energy sources in food. (The other two are carbohydrate and protein.) Fat contains 9 calories per gram. Foods high in fat include oils, margarine, salad dressings, red meat, and whole-milk dairy foods. Fiber: The indigestible part of plant foods.
Glossary Insulin on board (IOB) (active insulin): The amount of insulin that is still “active” in the body from a previous bolus dose. The Bolus Calculator tracks IOB for you. The amount of time insulin remains “on board” or “active” depends on your Duration of Insulin Action setting. Ketoacidosis (see diabetic ketoacidosis) Ketones: Acidic by-products that result from the breakdown of fat for energy.
Glossary Segments: Defined periods of time during a 24-hour day. Segments are used to define basal segments in a Basal Program, and also to define Target BG segments, IC Ratio segments, and Correction Factor segments. Sensitivity factor (see Correction Factor) Sync: The act of transferring information between two paired devices. For example, when the PDM syncs with a paired blood glucose meter, the meter transfers any recent blood glucose readings to the PDM.
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Index A B About screen 19 activate Basal Program 78 Pod 37–50 temp basal 75 temp basal preset 77 active insulin.
Index history records 90–98 Target BG 118, 158–172 blood glucose reading from paired meter 51 manual entry 53 tags 54 understanding the screen display 55 Bluetooth setting 100 Bolus Calculator bolusing with 57 disabled 62, 157 sample calculations 162 settings 117–119 understanding 156–172 bolus, extended based on blood glucose 57 based on carbs 57–62 cancel 65 entering units of insulin 62–63 manually-calculated 62–63 progress 64 replace 65 setting 117 understanding 155 using the Bolus Calculator 57–62 bolus
Index custom reminder notification 131 setting 112 D damaged PDM 141 Dashboard tab 12 data entry, how to 5 date and time 102–104 deactivate Pod 38 default settings 188 diabetes emergency kit 175 diabetic ketoacidosis 37, 184 diagnostic functions check alarms 105 reset PDM 105 discard Pod 134, 147 DISPLAY app 100 distance between Pod and PDM 42 DKA.
Index I IC Ratio 119, 157 identify correct Pod 40 illness 185 immediate bolus. See bolus, immediate indications for use xii infection, infusion site 49, 173 infusion site avoid infections 49 guidelines for selection 44 inspection 48 preparation 46 initial PDM setup 21–36 insulin amount left in Pod 9 cleared for use xii fill syringe 41 history records 92–98 rapid-acting vs. long-acting 184 schedule. See Basal Program storage 137 suspend and resume 79 insulin action.
Index responding to 122 software update 131 numbers, entering 5 O occlusion alarm 126 detection 192 preventing 47 Omnipod DISPLAY app 100 ongoing bolus, modifying 65 operating temperature 139, 189, 191 orientation, Pod 47 P paired BG meter how to pair 114 interaction with PDM 149 renaming 115 syncing BG data 51 unpairing 115 PDM and water 139 care 138 diagram 3 dropped or damaged 141 electrical interference 140 kit 21 model number i, xi replacement 141 reset 105 screen time-out 101 serial number 19 settin
Index using 62 preset, temp basal create 85 delete 87 edit 86 rename 86 using 77 Product Support. See Customer Care program reminder setting 112 R range, BG Goal 114 rapid-acting insulin xii, 184 recharge PDM battery 141 records. See history records reminders.
Index software update notification 131 setting 106 software version, PDM 107 sound or vibration 124 specifications, technical PDM 191 Pod 189 sports 186 starter kit 21 status bar 9 status check, Pod 146 storing PDM location 139 specifications 191 storing Pod location 137 specifications 189 suggested bolus calculator.
Index W wake up PDM 10 warranty 199 water and the PDM 139 and the Pod 138 website i Wi-Fi setting 100 Wireless update 106, 131 X X-rays 177, 186 220
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My PDM Settings Use these pages to keep track of your important PDM settings. Remember to update your information if you change or add PDM settings.
My PDM Settings Insulin-to-Carbohydrate Ratio (IC Ratio) Correction Factor Correction Factor for each time segment midnight 1 unit of insulin IC Ratio for each time decreases BG by segment 1 unit of insulin covers to mg/dL midnight to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb Duration of Insulin Action hrs Time that insulin remains “active” in the body after a bolus Temp Bas
My Notes
TM OMNIPOD DASH USER GUIDE *Up to 72 hours of insulin delivery Insulet Corporation 100 Nagog Park Acton, MA 01720 1.800.591.3455 | 1.978.600.7850 www.myomnipod.com © 2018 - 2020 Insulet Corporation. Omnipod, the Omnipod logo, Podder, DASH, and the DASH logo, are trademarks or registered trademarks of Insulet Corporation. All rights reserved. Reference #: PDM-USA1-D001-MG-USA1 FCC ID: RBV-041 FCC ID: RBV-SAW 2797 18296-ENG-AW Rev.