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Beta Bionics iLet User Manual

Beta Bionics iLet
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LA000081_D
iLet
®
Bionic
Pancreas System
User Guide

Table of Contents

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Beta Bionics iLet Specifications

General IconGeneral
Power SourceRechargeable battery
Intended UseFor people with type 1 diabetes
Control AlgorithmAdaptive, learning algorithm
User InterfaceTouchscreen
ConnectivityBluetooth
Insulin CompatibilityRapid-acting insulin
Glucose Sensor CompatibilityDexcom G6
UsageWorn on the body
Regulatory StatusFDA approved
CompatibilityDexcom G6 CGM

Summary

Important User Information and Safety

About This User Guide

Overview of the user guide, its purpose, and how to use it.

Indications, Warnings, and Risks

Intended use, critical warnings, precautions, and potential risks of the iLet System.

Getting to Know Your iLet System

System Overview and Parts

Explains the iLet System components, their functions, and how they work together.

iLet Device Features and Settings

Details the iLet Device, its touchscreen, charging, and configuration options.

Setting Up Your iLet System

Initial Setup Procedures

Step-by-step guide for initial device setup, including turning on and entering settings.

CGM Sensor and Cartridge Setup

Detailed instructions for pairing CGM sensors and installing insulin cartridges.

Enter Weight and Go Bionic

Finalizing setup by entering body weight and activating the system's autonomous dosing.

Living with Your iLet System

Automated Insulin Delivery

Understanding how the system delivers insulin and what to expect during use.

System Maintenance and Alerts

Procedures for replacing components, handling offline sensors, and responding to system alerts.

Managing Glucose Levels and Activities

Strategies for managing glucose during exercise, illness, highs, lows, and meal announcements.

Troubleshooting and Technical Information

Troubleshooting and Verification

Steps to resolve issues, verify system functionality, and prepare for emergencies.

System Specifications and Accuracy

Technical details, performance data, and accuracy of the iLet System's insulin delivery.

Electromagnetic Compatibility and Warranty

Electromagnetic Compatibility

Information on EMC, RF emissions, and FCC compliance for the iLet System.

Warranty Information

Details on the warranty coverage for the iLet Device, cartridges, and other components.

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