26 Frequently Asked Questions and Troubleshooting Pod will directly receive CGM values wirelessly and automate insulin delivery depending on your needs. The system is designed to continue delivering insulin in the absence of your Controller or smartphone, so you will not be alerted that the Pod and display device are out of range of one another if you choose to leave your Controller and/ or smartphone behind.
Frequently Asked Questions and Troubleshooting 26 To delete the Omnipod 5 App: 1. Open Google Play. 2. Tap Menu. 3. Tap My apps & game. 4. Tap on the app or game. 5. Tap Uninstall. 26.8. Device Complaints If you have a problem with your System, contact Customer Care at 1-800-5913455. You may be asked to share device data. To share device data: 1. Ensure a working Wi-Fi connection. 2. Go to: Menu button ( ) > About 3. Tap Send files to Customer Care. 4. Enter the PIN provided by Customer Care.
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Appendix Summary of Settings and Options The options for the various Omnipod 5 Automated Insulin Delivery System settings are: Time format 12-hour Time zone GMT-11:00 to GMT+13.00. Daylight Savings Time ON or OFF. Default based on date and time zone. Date format MM/DD/YYYY Screen time-out 30, 60, 120 seconds. Default is 30 seconds. PIN 4 digits from 0 to 9. Dexcom G6 transmitter 6 characters. serial number Maximum Basal Rate Select one value between 0.05-30 U/hr in 0.05 U/hr increments. Default is 3.
Appendix Correct Above threshold Maximum of 8 segments; Target Glucose to 200 mg/ dL in 1 mg/dL increments. Minimum Glucose for 50 to 70 mg/dL in 1 mg/dL increments Calculations Default is 70 mg/dL. Insulin-to-carb (IC) Maximum of 8 segments; 1 to 150 g carb/U in ratio 0.1 g carb/U increments. Correction (sensitivity) Maximum of 8 segments; 1 to 400 mg/dL in 1 mg/dL factor increments. Default is 50 mg/dL. Reverse Correction ON or OFF. Default is ON. Duration of insulin 2 to 6 hours in 30-minute increments.
Appendix IP (Ingress Protection) rating for moisture and dust: : IP28 (protected from touch by fingers and objects 12.5 millimeters or larger; protected from water to a depth of up to 25 feet (7.6 meters) for up to 60 minutes) Insulin concentration: U-100 Alarm type: Audible.
Appendix Controller Specifications Size: 5.67" high x 2.66" wide x 0.49" deep (143.92 mm x 67.57 mm x 12.33 mm) Weight: 5.82 oz (165 grams) Screen active area: 2.21" wide x 4.75" high (56.16 mm x 120.
Appendix Protection from Over-Infusion or Under-Infusion The Pod software monitors the infusion rate. If an error that would result in overinfusion or under-infusion is detected and cannot be corrected, insulin delivery stops, and an alarm sounds. Blockage (occlusion) detection Warning: ALWAYS monitor your glucose and follow your healthcare provider's treatment guidelines when you stop receiving insulin due to a blockage (occlusion).
Appendix Performance Characteristics The Omnipod 5 insulin pump delivers insulin in two ways: basal insulin delivery (continuous) and bolus insulin delivery. The following accuracy data was collected on both types of delivery in laboratory studies performed by Insulet. Delivery performance characterization Basal Delivery: In order to assess basal delivery accuracy, 12 Pods were tested by delivering at low, medium, and high basal rates (0.05, 1.00, and 30.0 U/hr). Water was used as a substitute for insulin.
Appendix Bolus Delivery: In order to assess bolus delivery accuracy, 12 Pods were tested by delivering a minimum, intermediate, and maximum bolus amount (0.05, 5.00, and 30.0 Units). Water was used as a substitute for insulin. The water was pumped into a container on a scale and the weight of the liquid delivered was used to assess pumping accuracy. The following table summarizes the typical bolus performance observed for the requested minimum, intermediate, and maximum size bolus for all pumps tested.
Appendix The tables below show for each requested bolus size, the range of amount of insulin that was observed delivered compared to the requested amount. Each table provides the number and percent of delivered bolus sizes observed within the specified range. Amount of Insulin Delivery for a Minimum (0.05 U) Bolus Request Amount (Units) (% of settings) Number and percent of boluses within range Amount (Units) (% of settings) Number and percent of boluses within range 352 <0.0125 0.01250.
Appendix Amount of Insulin Delivery for an Intermediate (5.00 U) Bolus Request Amount (Units) (% of settings) Number and percent of boluses within range Amount (Units) (% of settings) Number and percent of boluses within range <1.25 1.25-3.75 3.75-4.50 4.50-4.75 4.75-5.25 (<25%) (25-75%) (75-90%) (90-95%) (95-105%) 0/300 (0%) 0/300 (0%) 1/300 (0.3%) 4/300 (1.3%) 287/300 (95.7%) 5.25-5.50 5.50-6.25 6.25-8.75 8.75-12.50 >12.
Appendix Omnipod 5 System Label Symbols The following symbols appear on the Omnipod 5 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 2 Protects persons against access to hazardous parts with fingers and protects against solid foreign object ingress of diameter 12.5 mm or greater; Submersible: Waterproof to 25 feet (7.
Appendix Symbol 22 Meaning Protects persons against access to hazardous parts with fingers and protects against solid foreign object ingress of diameter 12.
Appendix Quality of Service The Omnipod 5 System includes two wireless transmission pathways. Insulet defines the quality of service of the Omnipod 5 System for each of the two pathways: Omnipod 5 App to Pod wireless communication definition Successful transfer of commands, data, and alarms between the Controller or smartphone running the Omnipod 5 App and Pod when in communication range (within 5 ft during normal operation).
Appendix General Notes The Omnipod 5 System has been tested and found to have acceptable immunity to emissions from RFID and EAS systems. The Omnipod 5 System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should ensure that it is used in such an environment.
Appendix Electromagnetic Emissions This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should ensure that is used in such an environment. Emissions Compliance according to Electromagnetic environment RF Emissions (CISPR11) Group 1 The Pod, Controller, and CGM emit lowlevel electromagnetic energy (RF) in order to communicate. Although unlikely, nearby electronic equipment may be affected.
Appendix Electromagnetic Immunity Electrical Fast ± 2 kV power ± 2 kV Mains power quality should be that of a Transient/burst supply lines power typical domestic, commercial, or hospital supply lines environment.
Appendix Electromagnetic Immunity Voltage Dips, Short Interruptions, Voltage Variations on Power Supply input lines (IEC 61000-4-11) 70% UT (30% dip in UT) for 25/30 cycles 0% UT (100% dip in UT) for 1 cycle at 0 degrees 0% UT (100% dip in UT) for 0.5 cycles at 0, 45, 90, 135, 180, 225, 270, and 315 degrees 0% UT (100% dip in UT) for 250/300 cycles 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 450 430– 470 GMRS 460, FRS 460 FM c) ±5 kHz deviation 1 kHz sine 2 0.3 28 710 704– 787 LTE Band 13, 17 Pulse modulatio n b) 217 Hz 0.2 0.3 9 800960 GSM 800/900, TETRA 800. ODEM 820, CDMA 850, LTE Band 5 Pulse modulation b) 18 Hz 2 0.3 28 1700– G GSM 1800, CDMA 1900, GSM 1900, DECT, LTE Band 1, 3, 4, 25; UMTS Pulse 2 modulatio n 217 Hz 0.3 28 745 780 810 870 930 1720 1990 1845 1970 2450 24502570 Bluetooth Pulse WLAN, modulation 802.
Appendix This table lists the immunity levels at specific test frequencies for Proximity Magnetic Fields Range of 9 kHz to 13.56 MHz Test Frequency Modulation Immunity Test Level (A/m) 30kHz a) CW 8 134.2 kHz Pulse modulation b) 2.1 kHz 65 c) 13.56 MHz Pulse modulation b) 7.5 c) a) This test is applicable only to ME equipment and ME systems intended in a HOME HEALTHCARE ENVIRONMENT. b) The carrier shall be modulated using a 50% duty cycle square wave signal.
Appendix 1-978-600-7850). For all other questions, concerns, or complaints, please contact us between the hours of 8:30 am and 6:00 pm Eastern Time, Monday through Friday, at 1-800-591-3455 (from outside the United States, 1-978-600-7850). We will respond immediately whenever possible; some issues may take up to 14 days to resolve. CHAP Accredited Insulet Corporation has been accredited by the Community Health Accreditation Program (CHAP) since 2007.
Appendix 5. Notify us immediately of: a. Equipment failure, damage, or need of supplies. b. Any change in your prescription or physician. c. Any change or loss in insurance coverage. d. Any change of address or telephone number, whether permanent or temporary.
Appendix LIMITED EXPRESS WARRANTY TERMS AND CONDITIONS Claim Procedure To be eligible for this Limited Express Warranty, you must notify Insulet of the claimed defect with the Controller or the Pod within the applicable warranty periods by calling Customer Care at 1-800-591-3455 (from outside the USA: 1-978-600-7850). For a claim involving the Controller, you must provide the Controller serial number and a description of the claimed defect.
Appendix DISCLAIMER OF IMPLIED WARRANTIES AND LIMITATION OF REMEDIES REPAIR OR REPLACEMENT AS PROVIDED UNDER THE ABOVE LIMITED EXPRESS WARRANTY OF THE CONTROLLER OR 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 CONTROLLER OR A POD WITH DEFECTS IN MATERIALS OR WORKMANSHIP IN THE MANNER PRESCRIBED BY THE ABOVE LIMITED EXPRESS WARRANTY.
Appendix 5 Automated Insulin Delivery System products shall constitute acknowledgement of and consent to the Disclaimer of Implied Warranties and the Limitation of Remedies. Rev: January 2021 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 Appointment Reminder and Other Communications: We may use or disclose your Medical Information without your prior written authorization to provide you or others with, among other things, (i) appointment reminders; (ii) product/supply reorder notifications; and/or (iii) information about treatment alternatives or other health-related products and services that we provide.
Appendix occurred as a result of criminal conduct, (v) in the event that a crime occurs on the premises of the practice, and (vi) medical emergency in which it is likely that a crime has occurred. Research: We may disclose your Medical Information to researchers when their research has been approved by an institutional review board that has reviewed the research proposal and established protocols to ensure the privacy of your Medical Information.
Appendix https://omnipod.com/images/upload/HIPAA_Privacy_Notice_Request_Form.pdf and follow the directions included on that form. We will respond to your request in a reasonable amount of time. Please contact our Privacy Officer if you have questions about requesting an amendment to your Medical Information.
Appendix https://omnipod.com/images/upload/HIPAA_Privacy_Notice_Request_Form.pdf and follow the directions included on that form. 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.
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Index A About screen 50 Action Item Notifications App Use Blocked 176 Attention 178 Connect to a Wireless Network 179 Daylight Saving Time Change 180 Device Has Been Modified 181 Device Not Compatible 183 Not Enough Storage 184 Omnipod 5 Error 185 Stop Optimizing Battery Usage 187 Turn Bluetooth ON 188 Turn Do Not Disturb Access ON 189 Turn Lock Screen Security ON 190 Turn Notifications ON 192 Turn On Automatic Date and Time 191 Update Omnipod 5 - App No Longer Supported 193 Update Omnipod 5 - Software Upda
Index blood glucose HIGH and LOW results 116, 277 Target Glucose 250, 256–268 Bluetooth controller 124 turn on 188 Bolus Calculator disabled 255 sample calculations 263 using CGM 243 bolus, extended cancel 235 deliver 246 progress 234 setting 250 bolus, immediate cancel 235 deliver 245 flow rate 345 progress 234 bolus, missed. See missed bolus notification brightness, screen 125 C cancel bolus 235 cannula 92, 344 carb-to-insulin ratio.
Index enter Automated Mode 298 entering text 32 estimated bolus 143 exercise 224 expiration, Pod 128, 200 Advisory Alarm 172 extended bolus cancel 235 deliver 246 progress 234 setting 132, 250 F first Pod in Automated Mode 298 flat rate (U/hr) setting change setting 132 temp basal 110 flow rate accuracy 345 G glucagon kit 14, 218 Glucose urgent low glucose alert 175 H Hazard Alarms 163–170 HIPAA privacy notice 365 history records carbs 138–146 glucose 138–146 insulin, basal and bolus 138–146 hospitalizat
Index available tasks within 52 MRIs 225 N navigation shorthand 34 negative IOB advisory alert 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 306, 308 network connectivity 124 new basal program 99 not compatible application 176 device 183, 185, 189 OS (operating system) 185 not enough storage 184 Notifications Action Item Notification.
Index activating 105 settings airplane mode 124 Bolus Calculator 250–252 check BG after bolus 236 Correct Above 250 Correction Factor 252 custom reminders 130 Duration of Insulin Action 252 extended bolus configuration 250 IC Ratio 251 lock screen image 125 lock screen message 125 low reservoir 128 Maximum Basal Rate 132 Maximum Bolus 250 Minimum Glucose for Calcs 251 PIN 125 Pod expiration 128 Pod Shut-Off 129 program reminders 129 Reverse Correction 252 screen brightness 125 screen time-out 125 summary 34
Index unlock controller 38 Urgent Low Glucose advisory alert 175 USB cable 207 V vacation 215 vibration or sound notifications 157 W wake up controller 38 warranty 362 water and the Controller 206 and the Pod 205 X X-rays 215 378
Index 379
My Settings Notes Use these pages to keep track of your important settings. Remember to update your information if you change or add settings.
My Settings Insulin-to-Carbohydrate Ratio (IC Ratio) Correction Factor Correction Factor for each time segment midnight 1 unit of insulin decreases glucose by IC Ratio for each time segment 1 unit of insulin covers g carb to mg/dL midnight to to mg/dL 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 g carb Duration of Insulin Action hrs Time that insulin remains “active” in the body after a bolus Temp Bas
My Notes
® Omnipod 5 Automated Insulin Delivery System User Guide Insulet Corporation 100 Nagog Park Acton, MA 01720 1-800-591-3455 | 1-978-600-7850 omnipod.com Pod shown without the necessary adhesive. FCC ID: 2ADINN5004L Controller FCC ID: RBV-029 Pod FCC ID: RBV-029C SAW Pod Reference #: PDM-USA-H001-MG PT-000369-AW Rev.
