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eversense XL User Manual

eversense XL
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Smart TransmitterSensor
User Guide
A guide for using the Eversense XL
Continuous Glucose Monitoring System
Mobile App

Table of Contents

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eversense XL Specifications

General IconGeneral
Sensor LifeUp to 180 days
Warm-up Period24 hours
Data TransmissionBluetooth
Mobile App CompatibilityiOS and Android
Glucose Measurement Range40 to 400 mg/dL
TypeContinuous Glucose Monitoring (CGM)
AlertsHigh/Low glucose alerts
Sensor TypeImplantable fluorescence-based glucose sensor

Summary

Introduction to Eversense XL CGM System

Help and Support

Provides contact information for product questions and troubleshooting issues.

Eversense XL CGM System Components

Details the sensor, smart transmitter, and mobile app components of the system.

System Requirements

Lists the necessary mobile device and app requirements for system operation.

Indications for Use

Outlines the intended purpose and patient population for the CGM system.

Contraindications

Conditions where the system should not be used.

Benefits and Risks of CGM Use

Warnings

Critical safety precautions and warnings for system use.

Cautions

Important cautionary advice for system usage and maintenance.

Getting Started with Your System

Charge your Smart Transmitter

Step-by-step instructions for charging the smart transmitter.

Download and Install the App

Guide to downloading and installing the Eversense mobile application.

Set up the App - Account Creation, Pairing and Settings

Create account, pair, and configure app settings.

Inserting and Linking the Sensor

Link the smart transmitter and sensor

Process for linking the transmitter and sensor via the app.

Using the Smart Transmitter

Daily Use

Key tips and guidelines for daily operation of the smart transmitter.

Secure the Smart Transmitter over Inserted Sensor

Step-by-step instructions for attaching the transmitter to the sensor.

Turn the Smart Transmitter ON and OFF

Procedure for powering the smart transmitter on and off.

Calibrating the System

Calibration Phases

Details the Initialisation and Daily calibration phases.

How To Calibrate

Step-by-step guide for performing system calibration.

Using the App

Get To Know the “My Glucose” Screen

Overview of the main display screen and its elements.

Menu Options

Navigation options available in the app menu.

Customising Your Settings

Setting Glucose Target Levels

Set personal glucose target ranges for monitoring.

Setting Glucose Alert Levels

Customize alert thresholds for low and high glucose levels.

Setting Predictive Alerts

Set advance warnings for glucose events.

Alert Descriptions

Alerts and Notifications

Describes vibration patterns and app indicators for alerts.

Alert Descriptions and Actions

Details specific alerts and required actions.

Event Log

Log Specific Events

Log glucose meter tests.

Meals

Log meal details including type and carbs.

Insulin

Log insulin units and type.

Reports

Weekly Modal Summary

Glucose summary over seven days.

Glucose Pie Chart

Time spent within/below/above glucose targets.

Share My Data

Eversense Data Management Software (DMS) Program

Web-based application for data analysis.

Sync

Manage automatic and manual data syncing.

Product and General Information on the App

About section of the Main Menu

Access product info, transmitter, sensor details via the app.

Viewing Eversense XL Data on the Apple Watch

Glance View

Display app data on Apple Watch using Glance view.

About the Sensor

Insertion Steps

Step-by-step sensor insertion by doctor.

Removal Steps

Step-by-step sensor removal by doctor.

Travel

Safety issues when traveling

Traveling with CGM system through airport security.

Troubleshooting

Smart Transmitter

FAQs on transmitter operation and issues.

Connection with Smart Transmitter

Pairing and troubleshooting connection issues.

Calibration

Troubleshooting common calibration issues.

App

FAQs regarding app functionality and issues.

Device Performance

Clinical Study Performance - PRECISE STUDY

Details results from a clinical study evaluating system performance.

Overall System Performance Compared to YSI

System readings vs. YSI measurements across glucose ranges.

Clarke Error Grid Analysis

Accuracy assessment using Clarke Error Grid.

Technical Specifications

Sensor

Specifications for the Eversense XL Sensor.

Smart Transmitter

Specifications for the Eversense XL Smart Transmitter.

Electrical and Safety Standards

Information on electromagnetic immunity and safety.

Eversense Smart Transmitter Limited Warranty (Terms)

Details of the smart transmitter limited warranty.

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