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Provides an overview of the user guide's content, including operation, setup, safety, and warranty.
Details the intended users, medical conditions, and requirements for operating the iLet bionic pancreas.
Lists compatible U-100 rapid-acting insulins, such as NovoLog and Humalog, for the iLet device.
Explains the role of healthcare providers in managing diabetes and setting up the iLet System.
Offers recommendations for younger users and their caregivers regarding the iLet System's management.
Outlines essential safety precautions and warnings for the proper and safe use of the iLet System.
Details potential risks associated with system failures, including hypoglycemia, hyperglycemia, and DKA.
Lists compatible integrated continuous glucose monitors (iCGMs) that can be used with the iLet System.
Explains the iLet Bionic Pancreas System as an automated insulin delivery system.
Identifies and describes the main components of the iLet System and its disposable parts.
Details the iLet device, its physical components, and the process for charging the device.
Describes key features like the Home Screen, notifications, and glucose status indicators.
Explains how to navigate the settings menu to adjust device features, preferences, and alerts.
Guides users through initial preparations before turning on and setting up the iLet device.
Provides step-by-step instructions for initial device setup, including alerts and task lists.
Details the procedure for setting up the CGM sensor and pairing it with the iLet device.
Explains how to prepare and fill the iLet insulin cartridge with insulin before insertion.
Guides users on inserting the insulin infusion set and filling the cannula with insulin.
Instructs users on entering body weight and initiating the iLet System's autonomous operation.
Describes the iLet System's operation, user experience, and how it adapts to changing glucose levels.
Outlines essential maintenance steps for the iLet System to ensure proper function and diabetes care.
Explains actions and alerts when the CGM sensor is offline, including BG-run mode procedures.
Guides users on manually entering BG values for calibration or when CGM data is unavailable.
Explains pairing a smartphone with the iLet device using the iLet Mobile App for updates and data.
Provides guidance on managing high and low glucose levels while using the iLet System effectively.
Explains how to announce meals to the iLet System for accurate insulin dosing based on meal type and size.
Provides guidance on managing glucose levels during and after exercise with the iLet System.
Advises on actions to take when becoming ill, including notifying a healthcare provider about CGM fluctuations.
Describes how the iLet device alerts users to important issues and the different alert levels.
Details specific alerts related to CGM and glucose readings, including necessary actions to take.
Lists alerts related to the CGM transmitter, such as battery status and pairing issues.
Explains alerts related to insulin levels in the cartridge and potential delivery issues.
Describes alerts related to the iLet device's battery charge and the need for recharging.
Lists reminders for essential tasks such as device setup, cartridge changes, and tubing fills.
Lists essential supplies to carry for managing diabetes effectively with the iLet System.
Guides users on performing daily checks to ensure the iLet System is functioning correctly.
Provides essential precautions for handling the iLet device and its components safely.
Explains the proper procedures for cleaning the iLet device and its touchscreen.
Introduces the clinical performance data and findings for the iLet Bionic Pancreas System.
Summarizes the goal, design, participant criteria, and methodology of the clinical study.
Presents baseline characteristics of adult and pediatric participants involved in the clinical study.
Details the primary clinical outcomes measured, such as changes in HbA1c levels and glucose control.
Presents secondary clinical outcomes, including time in CGM range and average CGM glucose levels.
Lists adverse events reported during the clinical study and their incidence rates.
Reports on trial completion rates and the system usage adherence by study participants.
Discusses the safety findings of using manual BG entries instead of CGM data for system input.
Explains the algorithms, modes of operation, and functionality of the iLet Dosing Decision Software.
Lists technical specifications for the iLet device, CGM sensor, and transmitter, including operating conditions.
Details technical specifications for the iLet device itself, such as size, weight, and power.
Details the accuracy of basal and bolus insulin delivery performed by the iLet System.
Provides explanations for various symbols used throughout the iLet Bionic Pancreas System User Guide.
Discusses electromagnetic emissions, immunity, and compatibility considerations for the iLet System.
Covers wireless service quality, data security, and Bluetooth connectivity of the iLet System.
Provides FCC compliance information and notices regarding radio frequency interference.
Outlines the warranty terms and conditions applicable to the iLet Bionic Pancreas Device.
Details the warranty coverage for the iLet Bionic Pancreas insulin cartridge.
Explains the warranty terms and conditions for the iLet Bionic Pancreas insulin infusion sets.
Covers the warranty for the iLet Connect Luer adapters and their usage.
Describes the policy and procedures for returning products purchased from Beta Bionics.
General| Device Type | Bionic Pancreas System |
|---|---|
| Manufacturer | Beta Bionics |
| Connectivity | Bluetooth |
| Mobile App | Yes |
| Type | Closed-loop system |
| Power Source | Rechargeable battery |
| Regulatory Status | FDA approved |
| Water Resistance | IPX7 |
| Indication | Type 1 Diabetes |
| Insulin Delivery | Automated |
| Glucagon Delivery | Automated |
| Glucose Sensor Compatibility | Dexcom G6 CGM |
| Bolus Method | Automated |
| Basal Delivery | Automated |
| Function | Automated insulin and glucagon delivery |
| Compatibility | Dexcom G6 CGM |
| Insulin Compatibility | Lispro, Aspart |
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