iLet® Bionic Pancreas System User Guide

Manufacturer Beta Bionics, Inc. 11 Hughes Irvine, CA 92618 USA Customer Service Tel +1-855-745-3800 Email [email protected] Equipment covered in this User Guide iLet® Bionic Pancreas iLet Cartridge iLet Connect iLet Charge The information, text and/or images within this document, or any portion thereof, may not be copied, displayed, downloaded, distributed, modified, reproduced, republished or retransmitted in any electronic medium or in hard copy, or derivative work created based on such images, text, or documents, without express written consent of Beta Bionics. This section serves as...

Welcome to the Beta Bionics family! The iLet® Bionic Pancreas System is an insulin delivery system that automatically regulates blood glucose (BG) levels. The iLet Bionic Pancreas System is the same as the iLet System, which uses autonomous lifelong learning to calculate and deliver insulin doses and to continually adapt these doses to your changing insulin needs. Read and follow the instructions in this user guide before you start to use the iLet System. Need any help? Contact your healthcare provider or contact our Beta Bionics customer service team. Important Contacts and Numbers iLet Bionic...

Important User Information 1 About This User Guide 1 Working With Your Healthcare Provider 4 Important Pediatric and Caregiver User Information 5 General Warnings and Precautions 6 Getting to Know Your iLet System 13 iLet System Overview 13 Parts of Your iLet System 14 Getting Started With Your iLet System 31 Preparing to Set Up Your iLet System 32 Setting Up Your iLet System 33 Enter Weight and Go Bionic 49 Living with Your iLet System 50 What to Expect from Your iLet System 50 Maintaining your iLet System 51 When Your CGM Sensor is Offline 60 Managing Highs and Lows 65 iLet System Alerts Overview...

Always Have an Emergency Kit 93 Verify Proper Functionality 94 Cleaning Your iLet Device 95 The Bionic Pancreas Pivotal Trial 97 The Insulin-Only Bionic Pancreas Extension Study 114 iLet Dosing Decision Software 121 iLet System Specifications (iLet Device, CGM Sensor, and CGM Transmitter) 125 iLet Device Specifications 126 iLet System Delivery Accuracy 129 Quality of Wireless Service and Data Security 145 FCC Notice Concerning Interference 146 iLet Device Warranty 148 iLet Cartridge Warranty 149 iLet Infusion Set Warranty 150 iLet Connect Warranty 152 iLet Bionic Pancreas System User Guide

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About This User Guide 1. 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). This user guide provides important information on how to operate your iLet Bionic Pancreas System (iLet System). It provides step-by-step instructions on how to safely set up, manage, and care for your iLet System. It also provides important safety information including...

About This User Guide In this user guide there are two kinds of safety statements: I WARNING: Statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device. I CAUTION: Statement that alerts the user to the possibility of a problem with the device associated with its use or misuse (i.e., device malfunction). The "iLet Bionic Pancreas System" is the same as the "iLet System". The "iLet Device" is made of the "iLet ACE Pump" and "iLet Decision Dosing Software". Continuous Glucose Integrated Continuous iCGM Glucose...

1.2 Indications for Use The person with diabetes is an intended operator of the iLet bionic pancreas, which consists of the iLet ACE Pump and the iLet Dosing Decision Software. The iLet bionic pancreas is for use according to the following: • For a single person only • For people with type 1 diabetes mellitus • For people 6 years of age or older • For use with a compatible iCGM The Indications for Use for the iLet ACE Pump and iLet Dosing Decision Software are explained here: The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input...

Insulin Compatibility determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. iLet Dosing Decision Software is intended for the management of type 1 diabetes mellitus in people 6 years of age or older. iLet Dosing Decision Software is intended for single patient use and requires a prescription. 1.3 Insulin Compatibility The iLet ACE Pump and iLet Dosing Decision Software are designed to use rapid-acting U-100 insulin. The following U-100 rapid acting insulin analogs have been...

Important Pediatric and Caregiver User Information 1.5 Important Pediatric and Caregiver User Information The following recommendations are meant to help younger users and others who require a caregiver and their caregivers to program, manage, and maintain the iLet System. • It is the responsibility of the healthcare provider and caregiver to decide if the user is appropriate for treatment with the iLet System. • Users may accidentally press or tap the touchscreen, leading to unintentional insulin delivery. Consider using the Limited Access feature, which is an optional, user-settable passcode,...

General Warnings and Precautions 1.6 General Warnings and Precautions WARNING: Do not use the iLet ACE Pump and Dosing Decision Software if you are unable or unwilling to test blood glucose (BG) levels with an SMBG meter when input from the iCGM is not available. WARNING: Do not use the iLet ACE Pump and Dosing Decision Software if you are unable or unwilling to recognize and respond to iLet safety alerts. WARNING: Do not use the iLet System if you are taking hydroxyurea, also known as Hydrea. This medication is sometimes used in the treatment of blood disorders and some kinds of cancer. The...