Beta Bionics iLet Bionic Pancreas System User Manual
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Beta Bionics iLet Bionic Pancreas System User Manual

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iLet
Bionic
®
Pancreas System
User Guide
LA000039 J

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Summary of Contents for Beta Bionics iLet Bionic Pancreas System

  • Page 1 iLet Bionic ® Pancreas System User Guide LA000039 J...
  • Page 2 Beta Bionics. © 2023 Beta Bionics, Inc. Beta Bionics® and iLet® are registered trademarks of Beta Bionics, Inc. 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 3: Table Of Contents

    System General Handling Preparing to Set Up Your iLet System Cleaning Your iLet Device Setting Up Your iLet System Insulin Set Enter Weight and Go Bionic iLet Bionic Pancreas System User Guide | iLet Bionic Pancreas System User Guide |...

  • Page 4: Important User Information

    1.1 About This User Guide 1.1.1 Overview The iLet Bionic Pancreas System consists of the iLet bionic pancreas (iLet ACE Pump with iLet Dosing Decision Software), its disposables, a continuous glucose monitor and an infusion set (see Section 2.2 Parts of Your iLet System for details).

  • Page 5: Indications For Use

    Communications Serial Number Commission Healthcare Provider Correction Factor Interoperable Alternate Controller iAGC Automated Glycemic Enabled Controller Electromagnetic Body Floating Compatibility iLet Bionic Pancreas System User Guide | important User information iLet Bionic Pancreas System User Guide | important User information...

  • Page 6: Insulin Compatibility

    (i.e., USB cables, insulin infusion sets with flexible tubing, needles, syringes, and cartridges). These parts can pose a strangulation or choking hazard or cause internal injury if swallowed. iLet Bionic Pancreas System User Guide | important User information iLet Bionic Pancreas System User Guide | important User information...

  • Page 7: General Warnings And Precautions

    If you are unsure about potential damage, discontinue the use of your iLet device and contact Beta Bionics. WARNING: Do not use the iLet ACE Pump and Dosing Decision Software in people under 6 years of age.
  • Page 8 This can cause missing severe hypoglycemia or hyperglycemia events. WARNING: If your AC power adapter or USB cable is damaged or lost, please contact Beta Bionics Customer Support for a replacement to ensure safe operation of the iLet device.

  • Page 9: Potential Risks

    Mobile App, and contact Beta Bionics customer service. Read and follow the instructions that accompany your insulin infusion set to determine safe iLet Bionic Pancreas System User Guide | important User information iLet Bionic Pancreas System User Guide | important User information...

  • Page 10: Compatible Icgms

    The Dexcom G6 sensors and transmitters are sold and shipped separately by Dexcom. General risks related to CGM sensor use, due to its insertion into the skin or skin adhesive, may iLet Bionic Pancreas System User Guide | important User information iLet Bionic Pancreas System User Guide | important User information...

  • Page 11: Getting To Know Your Ilet System

    System 2.1 iLet System Overview The iLet Bionic Pancreas System is a closed-loop system that delivers insulin based on input from an integrated continuous glucose monitor (iCGM) in order to automatically regulate blood-glucose (BG) levels (see Figure 1). The iLet System uses autonomous lifelong learning to calculate and deliver insulin doses and to continually adapt these doses to your changing insulin needs.

  • Page 12: Parts Of Your Ilet System

    Insulin Infusion Set: Contains the insulin infusion set base, flexible tubing, and inserter, and is used to attach the insulin infusion set base to your body iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...

  • Page 13: Ilet Device

    Micro-USB cable Touchscreen WARNING: If your AC power adapter or USB cable is damaged or lost, please contact Beta Bionics Status light Customer Support for a replacement to ensure safe operation of the iLet device. Your iLet device contains a rechargeable Power adaptor battery that is not replaceable.

  • Page 14: Features And Icons

    Drag the Unlock slider to the right to unlock the touchscreen (see Figure 7). iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...
  • Page 15 CGM sensor is stopped. CGM glucose value is not available. CGM sensor is warming up. iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...
  • Page 16 Tap on the graph icon in the upper righthand corner to switch back to the Graph screen. iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...

  • Page 17: Settings Menu

    Settings allow you to adjust features of your iLet device (see Figure 14). Figure 14 Figure 15 iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...
  • Page 18 Date - Adjust the date of your iLet device. Figure 24 Language - Choose a language for your iLet device. iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...

  • Page 19: History

    Tap Insulin History to view a list of iLet insulin history for total daily basal insulin and meal announcements (see Figure 29). Figure 27 Figure 29 iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...

  • Page 20: Volume

    System and contact your healthcare provider. iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...

  • Page 21: Preparing To Set Up Your Ilet System

    WARNING: DO NOT start to use your system without adequate training from your HCP and/or a certified iLet trainer. DO NOT change your settings without guidance from your HCP. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
  • Page 22 WARNING: Do not reuse iLet Cartridges. a. Tap CGM Sensor in the iLet Setup menu WARNING: Do not use cartridges other than those manufactured by Beta Bionics or the prefilled pharmacy dispensed drugs on the recommended list. Use of cartridges not recommended may b.
  • Page 23 1.8 mL (about halfway between the 1.5 mL and 2 mL marks). Figure 48 Figure 49 iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
  • Page 24 Remove the syringe needle from the insulin vial and set the vial aside. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
  • Page 25 WARNING: It can be unsafe to use accessories, detachable parts and materials not described in the instructions for use. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
  • Page 26 (see Figure 61). Figure 64 Figure 61 iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...

  • Page 27: Insulin Set

    Press & Hold screen. high BG could occur. d. Tap Next to finish. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...

  • Page 28: Enter Weight And Go Bionic

    Note that not all insulin infusion sets or cannula lengths may be available at the time of product launch. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...

  • Page 29: Living With Your Ilet System

    CGM sensor is offline. Refer to Section 4.3 When Your Sensor Is Offline for g. Attach the tubing to the iLet Connect. more details. iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...
  • Page 30 Follow the on-screen instructions to fill tubing as described in Section 3.2.3.9 Filling the Tubing. Figure 78 iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...
  • Page 31 • Bring your transmitter and your iLet device closer to each other to see if communication b. Tap the CGM icon automatically resumes within 15 minutes. iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...

  • Page 32: When Your Cgm Sensor Is Offline

    48 or 72 hours, you may choose to switch to the alternative therapy at any time with guidance from HCP for insulin dosing. iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...
  • Page 33 Figure 83 Figure 84 Figure 87 Figure 88 iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...

  • Page 34: Mobile Device

    App use. the iLet Mobile App user guide for more information at betabionics.com/resources. Figure 92 Figure 93 iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...

  • Page 35: Managing Highs And Lows

    CGM glucose levels continue to rise and/or stay high despite insulin dosing by the device • CGM glucose is above 300 mg/dl for 90 minutes or above 400 mg/dl once iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...
  • Page 36 • Make sure your Glucose Falling Quickly and Urgent Low Soon alarms are turned on. Consider treating with some rapid-acting carbohydrates when those alarms are triggered iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...

  • Page 37: Meal Announcements

    • Select the meal type based on what you consider to be breakfast, lunch, or dinner. iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...
  • Page 38 (see Figure 103). If this occurs, tap Dismiss. Wait up to five minutes before trying again. Figure 103 iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...
  • Page 39 A. No. If you eat a very low carb diet or no carbs at all, you should not announce meals. iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...

  • Page 40: Exercise

    – which is exactly what you were trying to avoid! dinner for your dinner. iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...

  • Page 41: Illnesses

    Consult with your healthcare team about how long you should be disconnected from the iLet iLet Bionic Pancreas System User Guide | Living with Your iLet System iLet Bionic Pancreas System User Guide | Living with Your iLet System...

  • Page 42: Responding To Alerts

    5 minutes. The alert will not stop until acknowledged or resolved. iLet Bionic Pancreas System User Guide | Responding to Alerts iLet Bionic Pancreas System User Guide | Responding to Alerts...

  • Page 43: Cgm And Glucose Alerts

    (Level 3) Quickly levels closely. Replace Your Replace with a new CGM and start a new Sensor sensor session. (Level 1) iLet Bionic Pancreas System User Guide | Responding to Alerts iLet Bionic Pancreas System User Guide | Responding to Alerts...

  • Page 44: Insulin Delivery Alerts

    What to do Recharge iLet Medium Only 5% or lower charge remaining. Charge Soon (Level 3) your iLet as soon as possible. iLet Bionic Pancreas System User Guide | Responding to Alerts iLet Bionic Pancreas System User Guide | Responding to Alerts...

  • Page 45: Reminders

    Your started but have not completed the Insulin Fill Medium fill cannula process. Tap Finish Now to Cannula (Level 3) complete it. iLet Bionic Pancreas System User Guide | Responding to Alerts iLet Bionic Pancreas System User Guide | Responding to Alerts...

  • Page 46: Troubleshooting

    • Rapid-acting insulin vial and syringes or a rapid-acting insulin pen If your power supply is working but the iLet device still does not turn on, contact Beta Bionics • Basal insulin vial and syringes or a basal insulin pen for additional assistance.

  • Page 47: Care Information

    1 minute per week. • Keeping your touchscreen clean makes it more responsive to touch. iLet Bionic Pancreas System User Guide | Care information iLet Bionic Pancreas System User Guide | Care information...

  • Page 48: Clinical Performance

    Of the 165 children enrolled, 112 were randomly assigned to the iLet group and 53 were The following data represent the clinical performance of the iLet Bionic Pancreas System (iLet). randomly assigned to the Standard of Care group. Children in the iLet group all used Novolog The Bionic Pancreas Pivotal Trial (REF 1) included adults with type 1 diabetes 18 years of age or Humalog, whichever they used as part of their usual care (n=112).

  • Page 49: Demographics

    4 (4%) 3 to <6 months ago 1 (2%) 1 (<1%) 0 (0%) ≥ 6 months ago 36 (67%) 55 (48%) 55 (51%) iLet Bionic Pancreas System User Guide | Clinical Performance iLet Bionic Pancreas System User Guide | Clinical Performance...
  • Page 50 105 (94%) 52 (98%) c-Peptide * (ng/mL) Mean (SD) 0.039 ± 0.115 0.042 ± 0.098 <0.007 n (%) 77 (79%) 34 (72%) iLet Bionic Pancreas System User Guide | Clinical Performance iLet Bionic Pancreas System User Guide | Clinical Performance...

  • Page 51: Primary Endpoints

    In adults, the average baseline-adjusted difference in HbA1c was –0.5% in the iLet group using Fiasp versus the Standard of Care group after 13 weeks. iLet Bionic Pancreas System User Guide | Clinical Performance iLet Bionic Pancreas System User Guide | Clinical Performance...

  • Page 52: Secondary Endpoints

    Percent of time CGM glucose levels were below 54 mg/dL, were between 70–180 mg/dL, and mean CGM glucose levels over 13 weeks are shown in Table 3. iLet Bionic Pancreas System User Guide | Clinical Performance iLet Bionic Pancreas System User Guide | Clinical Performance...
  • Page 53 Novolog or Humalog and the Standard of Care group was larger in study participants with higher baseline HbA1c. iLet Bionic Pancreas System User Guide | Clinical Performance iLet Bionic Pancreas System User Guide | Clinical Performance...

  • Page 54: Adverse Effects

    These devices and instructions were not provided to 10 0 iLet Bionic Pancreas System User Guide | Clinical Performance iLet Bionic Pancreas System User Guide | Clinical Performance...
  • Page 55 107 (100%) 112 (98%) 54 (100%) 112 (100%) 53 (100%) 0 (0%) 2* (2%) 0 (0%) 0 (0%) 0 (0%) iLet Bionic Pancreas System User Guide | Clinical Performance iLet Bionic Pancreas System User Guide | Clinical Performance 10 3...

  • Page 56: Intervention Compliance

    Dexcom G6 Transmitter The trial completion rate was extremely high, with 99% of the 440 participants completing the Issue 13-week final visit. Use rate of the iLet Bionic Pancreas System was very high and the system iLet iLet Alarm Issue...

  • Page 57: References

    Finally, when the CGM is offline, the iLet Dosing Decision Software remembers the latest basal dosing that it learned, allows the user to make meal announcements in exactly the same way 10 6 iLet Bionic Pancreas System User Guide | Clinical Performance iLet Bionic Pancreas System User Guide | Technical information...
  • Page 58 BG Mode, The iLet Dosing Decision Software will respond to BG No CGM glucose values with autonomous insulin doses. 10 8 iLet Bionic Pancreas System User Guide | Technical information iLet Bionic Pancreas System User Guide | Technical information 10 9...

  • Page 59: Ilet System Specifications (Ilet Device, Cgm Sensor, And Cgm Transmitter)

    110 grams Operating Conditions (iLet device, Temperature: 50°F (10°C) to 98.6°F (37°C) CGM sensor, CGM transmitter) Humidity: 15% to 90% RH non-condensing iLet Bionic Pancreas System User Guide | Technical information iLet Bionic Pancreas System User Guide | Technical information...
  • Page 60 Threshold, Insulin Output Type Qi Inductive Charger Prime Rate (Tested in 110 cm length < 60 seconds set) No alarms are disabled iLet Bionic Pancreas System User Guide | Technical information iLet Bionic Pancreas System User Guide | Technical information...

  • Page 61: Ilet System Delivery Accuracy

    (1.2 units) insulin delivery. The following accuracy data was collected on both types of delivery in 0.1 units/hr Setting) laboratory studies performed by Beta Bionics. The iLet inset™ I infusion set was used for all the Amount Delivered (Median) 0.09 units 0.55 units...
  • Page 62 Range 0/240 0/240 0/240 240/240 0/240 0/240 0/240 0/240 (0.0%) (0.0%) (0.0%) (100.0%) (0.0%) (0.0%) (0.0%) (0.0%) iLet Bionic Pancreas System User Guide | Technical information iLet Bionic Pancreas System User Guide | Technical information...

  • Page 63: Explanation Of Symbols

    ISO 15223-1 Ref 5.3.7 Limits ISO 15223-1 Ref 5. 1 .4 Use-by date ISO 7000-2607 Two-sided Operating Humidity Limits ISO 15223-1 Ref 5.3.8 iLet Bionic Pancreas System User Guide | Technical information iLet Bionic Pancreas System User Guide | Technical information...

  • Page 64: Electromagnetic Compatibility

    The iLet System is intended for use in the electromagnetic environment specified below. The information contained in this section is specific to the iLet Bionic Pancreas System. This Always make sure that the iLet System is used in such an environment.

  • Page 65: Electromagnetic Immunity

    5240 MHz, 5500 MHz, 5785 MHz: MHz, 5785 MHz: 9 9 V/m @ 217 Hz V/m @ 217 Hz Pulse Pulse modulation modulation iLet Bionic Pancreas System User Guide | Electromagnetic Compatibility iLet Bionic Pancreas System User Guide | Electromagnetic Compatibility...

  • Page 66: Quality Of Wireless Service And Data Security

    RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the System. iLet Bionic Pancreas System User Guide | Electromagnetic Compatibility iLet Bionic Pancreas System User Guide | Electromagnetic Compatibility...

  • Page 67: Fcc Notice Concerning Interference

    The transmitter has been approved by the Federal Communications Commission. There is Call Beta Bionics if any component or accessory of the iLet System needs replacement. no guarantee that it will not receive interference or that any particular transmission from the transmitter will be free from interference.

  • Page 68: Warranty

    Bionic Pancreas Device and does not apply to other products, remedy for this warranty is that Beta Bionics will, at its sole discretion, repair the or replace the accessories, to any third party pre-filled insulin cartridges, or CGM sensors or transmitters.

  • Page 69: Ilet Infusion Set Warranty

    This warranty shall be personal to the original end use purchaser. Any sale, rental or other transfer or use of the Beta Bionics Cartridge covered by this warranty to or by a user other than • damage is caused by use of the Infusion Set with any non-Beta Bionics insulin cartridge;...

  • Page 70: Returned Goods Warranty

    Beta Bionics; outer box. If Beta Bionics provides a label, the label must be attached or taped to the outer box. If no label is provided, Beta Bionics recommends shipping via insured ground service with a damage is caused by use of the Luer adapter with any non-Beta Bionics insulin cartridge;...
  • Page 71 Beta Bionics. © 2023 Beta Bionics, Inc. Beta Bionics® and iLet® are registered trademarks of Beta Bionics, Inc. All rights reserved. All other trademarks are the property of their respective owners. The use of thirdparty trademarks does not constitute an endorsement of imply a relationship or...

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