Freestyle Libre 2 - User Manual

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Sensor Pack | Envase del sensor
Customer Service | Atención al cliente:
1-855-632-8658
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YYYY-MM-DD
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STEP 3
STEP 6
STEP 9
Get ReadyApply Sensor Prepare Sensor Applicator
Wash site using a plain soap,
dry, and then clean with alcohol
wipe. Allow site to air dry before
proceeding.
Peel lid completely o Sensor Pack.
Unscrew cap from Sensor Applicator.
CAUTION: Sensor codes
must match on Sensor Pack
and Sensor Applicator or
glucose readings will be
incorrect.
Select site on back of upper arm.
Do not use other sites as these may
result in inaccurate glucose readings.
Note: Avoid scars, moles, stretch
marks, lumps, and insulin injection
sites. To prevent skin irritation, rotate
sites between applications.
Refer to your User’s Manual for full system instructions and information.
Sensor
Pack
Place Sensor Applicator over site
and push down rmly to apply
Sensor.
CAUTION: Do not push down on
Sensor Applicator until placed
over prepared site to prevent
unintended results or injury.
Make sure Sensor is secure.
Discard used Sensor Applicator
and Sensor Pack according to
local regulations.
Gently pull Sensor Applicator
away from your body.
STEP 1
STEP 4
STEP 7
STEP 2
STEP 5
STEP 8
Line up dark mark on Sensor
Applicator with dark mark
on Sensor Pack. On a hard
surface, press down rmly
on Sensor Applicator until it
comes to a stop.
Sensor Applicator is ready to
apply Sensor.
CAUTION: Sensor Applicator
now contains a needle. Do not
touch inside Sensor Applicator
or put it back into Sensor Pack.
Lift Sensor Applicator out of
Sensor Pack.
Lid
Cap
Sensor
Sensor
Applicator
Codes on labels
must match
●
1 Assemble and Apply Sensor
to the back of your upper arm
●
2 Set up App
●
3 Use the App to scan your Sensor
After the start-up period, you can use
the App to check your glucose
iPhone
Download FreeStyle Libre 2
from App Store
Quick Start Guide for
FreeStyle Libre 2 app
A FreeStyle Libre product
Setup Overview
●
1 Assemble and Apply Sensor to the back of your upper arm

Summary

Assemble and Apply Sensor

Get Ready for Sensor Application

Select and prepare the application site on the upper arm for accurate glucose readings.

Prepare Sensor Applicator

Steps to prepare the sensor applicator by removing the lid, cap, and aligning marks.

Apply Sensor

Instructions for applying the sensor to the prepared site and securing it properly.

Set Up Your FreeStyle Libre 2 App

App Setup and Configuration

Guides through connecting the smartphone, entering personal settings, and reviewing permissions.

Scan Your Sensor with the App

Instructions on how to scan the sensor using the app to obtain glucose readings.

Manage Alarms with FreeStyle Libre 2

Setting Alarms

Steps to configure glucose alarm settings, including low, high, and signal loss alarms.

Using Alarms

Details on how to dismiss and interpret different types of glucose alarms and signal loss.

Overview

1. Function Description
2. Usage Features
3. Sensor Application
4. App Setup and Scanning
5. Alarm Management
6. Maintenance Features
7. Sensor Care
8. Site Rotation
9. Disposal
10. App Updates
11. Troubleshooting

The FreeStyle Libre 2 system is a continuous glucose monitoring (CGM) system designed to help individuals manage their diabetes by providing real-time glucose readings. This system typically consists of a small, disposable sensor worn on the back of the upper arm and a compatible smartphone app that acts as a reader. The system is designed for ease of use, allowing users to check their glucose levels quickly and discreetly without the need for routine fingerstick calibrations.

Function Description

The primary function of the FreeStyle Libre 2 system is to measure and store interstitial fluid glucose levels continuously. The sensor, once applied, automatically records glucose data throughout its wear period, typically up to 14 days. This data is then transmitted wirelessly to the FreeStyle Libre 2 app on a compatible smartphone when the user scans the sensor.

A key feature of the FreeStyle Libre 2 system is its ability to provide real-time glucose readings, glucose trend arrows, and a historical glucose graph. The real-time reading shows the user's current glucose level. The trend arrow indicates the direction and rate at which glucose is changing (e.g., rising quickly, falling slowly, stable). The glucose graph displays glucose patterns over several hours, allowing users to identify trends and make informed decisions about their diabetes management.

Beyond basic glucose monitoring, the FreeStyle Libre 2 system incorporates optional glucose alarms. These alarms are designed to notify users when their glucose levels fall below a set low threshold (Low Glucose Alarm), rise above a set high threshold (High Glucose Alarm), or drop to a critically low level (Urgent Low Glucose Alarm). The Urgent Low Glucose Alarm is a fixed alarm that cannot be modified or turned off, providing an essential safety feature. There is also a Signal Loss Alarm, which alerts the user if the sensor is not communicating with the app, prompting them to scan the sensor. These alarms can be customized by the user within the app, allowing them to set their preferred thresholds and choose alarm tones. The system also offers an "Override Do Not Disturb" option for alarms, ensuring critical alerts are heard even if the phone's sound is muted.

The system is designed to provide a comprehensive overview of glucose data, which can be reviewed in the app's logbook, reports, and daily patterns. This data can include average glucose, time in target range, low glucose events, and daily graphs, all of which are valuable tools for users and their healthcare professionals to assess glucose control and adjust treatment plans.

Usage Features

The FreeStyle Libre 2 system emphasizes a user-friendly application and monitoring process.

Sensor Application:

The sensor application process is straightforward and involves a few key steps:

1. Site Selection: Users are instructed to select a site on the back of their upper arm. It is crucial to avoid areas with scars, moles, stretch marks, lumps, or insulin injection sites to ensure accurate readings. Rotating sites between applications is recommended to prevent skin irritation.
2. Site Preparation: The chosen site must be cleaned with plain soap and water, dried, and then wiped with an alcohol swab. The site should be allowed to air dry completely before proceeding.
3. Sensor Assembly: The sensor comes in two parts: the Sensor Pack and the Sensor Applicator. Users must ensure that the codes on the Sensor Pack and Sensor Applicator match before assembly. The lid is peeled off the Sensor Pack, and the cap is unscrewed from the Sensor Applicator.
4. Loading the Applicator: The Sensor Applicator is aligned with the Sensor Pack by matching dark marks on both components. The Sensor Applicator is then pressed down firmly onto the Sensor Pack on a hard surface until it comes to a stop. This action loads the sensor into the applicator.
5. Applying the Sensor: Once loaded, the Sensor Applicator is placed over the prepared site on the upper arm. Users are instructed to push down firmly on the Sensor Applicator to apply the sensor. It is important not to push down until the applicator is positioned correctly over the site to prevent unintended results or injury.
6. Removing the Applicator: After application, the Sensor Applicator is gently pulled away from the body, leaving the sensor securely attached to the arm. Users should then confirm that the sensor is secure.

App Setup and Scanning:

1. App Download and Setup: Users need to download the FreeStyle Libre 2 app from their smartphone's app store. After installation, they must ensure their smartphone is connected to Wi-Fi or a cellular network. The app guides them through setting up a LibreView account or logging into an existing one, entering personal settings, and reviewing legal information and permissions.
2. Sensor Start-up: To start a new sensor, users scan the sensor with their smartphone. The app will indicate when the sensor is starting up and the remaining time until it is ready for use. During this start-up period, users can navigate away from the app.
3. Glucose Monitoring: Once the start-up period is complete, users can scan their sensor at any time to get a glucose reading. The app displays the current glucose, trend arrow, and glucose graph. The scanning process typically involves holding the top of the iPhone near the sensor until a tone or vibration confirms a successful scan.

Alarm Management:

The app provides a dedicated "Alarms" section where users can customize their glucose alarm settings. This includes turning alarms on or off, setting high and low glucose thresholds, and selecting alarm tones. The Urgent Low Glucose Alarm is a mandatory safety feature that cannot be disabled. Users are advised to consult their healthcare professional before making changes to their alarm settings. When an alarm sounds, users can dismiss it by swiping or tapping within the app and then scanning their sensor to view their glucose reading.

Maintenance Features

The FreeStyle Libre 2 system is designed for minimal maintenance, primarily focusing on proper sensor application and disposal.

Sensor Care:

Once applied, the sensor is designed to be worn continuously for up to 14 days. It is water-resistant, allowing users to shower, bathe, and swim while wearing it. However, prolonged submersion or exposure to extreme temperatures should be avoided as per the user manual. Users should ensure the sensor remains securely attached to the arm throughout its wear period. If the sensor becomes loose or falls off prematurely, it should be replaced.

Site Rotation:

To prevent skin irritation and ensure optimal sensor performance, it is recommended to rotate the sensor application site on the back of the upper arm with each new sensor. This practice helps to avoid repeated stress on the same skin area.

Disposal:

After the 14-day wear period, or if a sensor needs to be removed prematurely, the used sensor and Sensor Pack should be discarded according to local regulations. The system is designed with disposable components, eliminating the need for cleaning or sterilizing the sensor itself.

App Updates:

While not a physical maintenance feature, keeping the FreeStyle Libre 2 app updated on the smartphone is crucial for optimal performance. App updates often include bug fixes, performance enhancements, and new features, ensuring the system functions correctly and provides the most accurate and reliable data.

Troubleshooting:

The system's design incorporates visual cues and alerts to help users troubleshoot common issues. For instance, the "codes on labels must match" instruction during assembly prevents errors. The Signal Loss Alarm prompts users to scan the sensor if communication is lost. If users encounter difficulties setting up the system, have questions about messages or readings, or experience any issues, they are advised to contact their healthcare professional or customer service for support.

In summary, the FreeStyle Libre 2 system offers a comprehensive, user-friendly, and low-maintenance solution for continuous glucose monitoring, empowering individuals with diabetes to manage their condition effectively through real-time data and customizable alerts.

Freestyle Libre 2 Specifications

General

Sensor Life	14 days
Scan Time	1 second
Connectivity	Bluetooth
Warm-up Time	1 hour
Operating Temperature	10°C to 45°C (50°F to 113°F)
Water Resistance	IP27
Meter Category	Continuous Glucose Monitoring
Alerts	High glucose, low glucose, signal loss
Glucose Reading Interval	1 minute
Compatibility	iOS and Android
Alarms	Yes (high and low glucose alarms)
Glucose Range	40 to 400 mg/dL