FSL-2 FDA Clears Reader for Abbotts FreeStyle Libre User Guide

FSL-2 FDA Clears Reader for Abbotts FreeStyle Libre

Specifications

• System: FreeStyle Libre 2
• Age Requirement: Suitable for anyone with diabetes over the age of 4
• Sensor Placement: Back of the upper arm
• Components: Applicator, Sensor, FreeStyle LibreLink app, FreeStyle Libre 2 blue reader

Product Usage Instructions

• Use the applicator to place the sensor on the back of your upper arm as instructed.
• Download and install the FreeStyle LibreLink app on your compatible smartphone. Register with LibreView to share your sugar level data.
• You can read your sugar levels using either the FreeStyle LibreLink app or the FreeStyle Libre 2 blue reader. Choose one device to set alarms for sugar level variations.
• If you prefer alarms on your phone, start the sensor with the app. For alarms on the reader, start the sensor with the FreeStyle Libre 2 blue reader.
• In some cases, a finger prick test may still be required if you experience symptoms that differ from the sensor readings or alarms.

FAQ

• Q: What age group is the FreeStyle Libre 2 system suitable for?
• A: The system is designed for individuals with diabetes over the age of 4, including both children and adults.
• Q: How does the sensor of the FreeStyle Libre 2 system work?
• A: The sensor placed on the back of the upper arm reads changes in interstitial fluid to provide continuous sugar level monitoring without finger pricks.

Introduction

• The FreeStyle Libre 2 system is an easy way for people with diabetes to check their sugar levels.
• Sugar comes from the food we eat and our bodies turn it into energy using something called ‘insulin’.
• Most people’s bodies make their own insulin, but diabetes is a disease where your body either:
  • can’t make enough insulin or
  • can’t make any insulin at all.
• People with diabetes have to check their sugar levels and inject the right amount of insulin to deal with it.
• They check their sugar levels by pricking their finger and testing their blood.

FreeStyle Libre 2 System

• The FreeStyle Libre 2 system can check your sugar levels without a finger prick test.
• Instead it uses a sensor on your body, on the back of your upper arm.
• A sensor is a small device that can read changes in the liquid just underneath your skin.
• Sometimes you will still need to do a finger prick test if you feel different to what the reading and alarm are saying.
• This information explains:
  • more about the FreeStyle Libre 2 system
  • how to get started using the sensor
  • how to use the FreeStyle Libre 2 system to help manage your diabetes.

Who is the FreeStyle Libre 2 System for?

• The FreeStyle Libre 2 system is for anyone with diabetes over the age of 4.
• This can be either Type 1 diabetes or Type 2 diabetes.
• Type 1 diabetes is where your body can’t make any insulin.
• Type 2 diabetes is where your body can’t make enough insulin.

Children

• An adult over 18 should help children aged 4 to 12 to use the system properly.
• An adult should also help anyone aged between 4 and 12 to:
• understand the information from the FreeStyle Libre 2 system
• decide what to do next.

This is the FreeStyle Libre 2 System

• Applicator. You use this to put the sensor on the back of your upper arm.

• Sensor. This goes onto the back of your upper arm.
  The sensor will:

• help to measure your sugar levels by reading changes in the liquid just underneath your skin.

• connect with your FreeStyle Libre 2 blue reader or certain phones to sound an alarm when your sugar levels are too high or too low. See more about setting alarms on page 19.

• FreeStyle LibreLink app. This is an app you can download onto your phone. It receives information from your sensor.
• An app is a computer programme that you have on your phone to help you do something.
• You will need to register with LibreView to share your sugar levels.
• You can get more information about which phones work with the system on our website: Click here

• FreeStyle Libre 2 blue reader. You need this if you don’t have the right sort of phone to use the app.
• The reader also receives information from your sensor.
• The reader can sound an alarm when your sugar levels are too high or too low, when it is turned on.
• You can use both your phone and the reader to read your sensor. But you can only choose one of them to sound an alarm.
• If you want the alarms on your reader, you need to start the FreeStyle Libre 2 sensor with the FreeStyle Libre 2 blue reader.
• If you want your alarms on your phone, you need to start the FreeStyle Libre 2 sensor with the app on your phone.

3 quick steps to put on a sensor

• Wash, clean and dry a place on the back of your arm.

• Get the applicator ready by:

  • peeling back the lid
  • unscrewing the cap
  • lining up the marks on the sensor applicator
  • pressing down firmly…
  • and then lifting. The sensor should come out of the plastic cover

• Put the sensor on the back of your upper arm by pressing the applicator firmly.

• Listen for the click. Wait for a few seconds and pull back slowly, leaving the sensor on your skin.

How to keep your sensor on

Easy does it
Be careful not to catch your sensor on a doorway, car door, seat belt or the edge of your furniture.
Pat dry
Take extra care when you dry yourself after a bath or shower.
Dress for success
Wear loose-fitting clothes around your sensor.

Exercise and sport
Be careful when you are doing exercise or sport.
Slow down
Be careful when you get dressed or undressed.
Hands off
Try not to play with, pull or touch the sensor while you are wearing it.

How the sensor works

• When the sensor goes onto the back of your arm, it gets information from under your skin.
• The thin fibre that goes under the skin on your arm is very short. Only 5 millimetres long.
• It doesn’t go as far as your bloodstream.

Interstitial fluid

• Just below the surface of your skin is a liquid called interstitial fluid.
• The sensor tests how much sugar there is in this interstitial fluid.
• The amount of sugar in the interstitial fluid is a good guide to your overall sugar levels.

The FreeStyle LibreLink app

• You need to download the FreeStyle LibreLink app onto your smartphone.

• A smartphone is a phone that connects to the internet.

• If you have an iPhone, you can download the FreeStyle LibreLink app by going to the App Store and searching for ‘FreeStyle LibreLink’.

• If you have any other type of smartphone you can download the app by going to Google Playstore and searching for ‘FreeStyle LibreLink’.

• You can get more information about which phones work with the system on our website: Click here

• You will need to be connected to the internet, or have mobile data, to download the app.

• You will need to register with LibreView to share your glucose data.

Starting your sensor

• You need to scan your sensor once to start getting information from your sensor on your app.

• Scanning is when you:

  • open the FreeStyle LibreLink app on your phone
  • put your phone close to the sensor on your arm.

• It will take about an hour to warm up, and then you will automatically start to get information about your sugar levels every minute on your phone.

• If bluetooth is not available, you will stop getting information automatically and should scan the sensor again.

• This will fill in up to 8 hours of any information that was missed.

• You can see your sugar levels on the app on your phone when your phone is close to you and connected to the sensor.

• Follow these steps to scan and start your sensor:

iPhones
If you have an iPhone:

• Open the app on your phone and tap the scan button.
• Touch the sensor with the top of your phone.
• Wait until you hear a tone and feel a vibration. This means that it has worked OK.
• You will need to have the sound on your phone switched on to hear the tone.
• You will need to have Bluetooth, notifications, sounds, vibrations and alarms turned on to use the alarm.

Other types of smartphone
If you have any other type of smartphone:

• Open the app on your smartphone.
• Hold the back of your phone near your sensor.
• Don’t move your phone until you hear the first tone and/or feel the vibration.
• Keep your phone near the sensor until you hear a second tone and/ or feel a vibration. This means that it has worked OK.
• You will need to have the sound on your phone switched on to hear the tones.
• You will need to have Bluetooth, notifications, sounds, vibrations and alarms turned on to use the alarm.

Learn how to manage your diabetes

You can see how well you are managing your diabetes on your FreeStyle LibreLink app.
On this screen you can see:

• An orange bar – this shows how much time your sugar levels have been very high.
• A yellow bar – this shows how much time your sugar levels have been too high or too low.
• A green bar – this shows how much time your sugar levels have been OK.
• A red bar – this shows how much time your sugar levels have been very low.

Setting an alarm on your phone

• You can set an alarm on your
• FreeStyle Libre 2 blue reader or phone – to go off when your sugar levels are too high or too low.
• You can only set an alarm on one device.
• It’s called a ‘glucose alarm’. Glucose is another word for sugar.
• To get an alarm on your phone, you need to scan your FreeStyle Libre 2 sensor with the app on your phone.

How to set an alarm on your phone

• Open the FreeStyle LibreLink app
• Tap ‘Alarms’ in the menu
• Touch ‘Low Glucose Alarm’ and turn on alarm

• Scroll to select ‘Low Glucose Value’
• Touch ‘Alarm Tone’ and choose what sound you want to hear when the alarm goes off
• Set your ‘High Glucose Alarm’ by selecting ‘High Glucose Alarm’ from ‘Alarms’ menu and scroll to select ‘High Glucose Value’
• Make sure bluetooth on your phone is turned on for the alarm to work.
• Your phone must also be within 6 metres of the sensor, with nothing in the way that might block the signal.

How to set an alarm on your FreeStyle Libre 2 blue reader

• You cannot set an alarm on your reader if you have already set the alarm on your phone.

• If you want the alarms on your reader instead, you need to start the FreeStyle Libre 2 sensor with the FreeStyle Libre 2 blue reader, not your phone.

• To set the alarm on your reader:

• Touch the ‘Settings’ symbol

• Touch ‘Alarms’ then change ‘Alarm Settings’

• Turn on the alarm

• Use the arrows to set low and high glucose alarms

• See your current alarm settings

• Adjust sound and vibration. This is where you can choose what sound you hear when the alarm goes off

• Your FreeStyle Libre 2 blue reader will need to be within 6 metres of the sensor, with nothing in the way that might block the signal.

Your reading

• When you look at your phone, you will see a number on the app. This number is called a ‘reading’.

• The reading tells you what your sugar levels are.

• There is also a graph which tells you if the sugar level has changed over the last 8 hours.

• And there is an arrow that tells you if the sugar level is going up, down or staying the same.

• By tapping this symbol you will go to a screen that gives you more information.

• This information will help you to decide what to do next.

• Your doctor will tell you how to use the information from the reading and the arrows, to decide if you need insulin.

LibreView

• LibreView is a website where you can see how well you are managing your diabetes.
• You will have your own account. This keeps your information private. You can share the information about your diabetes with your doctor and health team.
• The website can show you the information in a way that you can see how well you are doing.
• You can register today at:  www.LibreView.com.
• There is information on the website about what your computer needs to be able to run LibreView.

If you have a FreeStyle Libre 2 blue reader
You can download the information from your sensor by connecting your FreeStyle Libre 2 blue reader to a computer with your yellow cable.

If you are using the FreeStyle LibreLink app on your phone
The information from the app will be uploaded to the LibreView website automatically when your phone is connected to the internet.

You need to set up a LibreView account

• Go to: www.LibreView.com
• Click on ‘Sign up’.
• Choose the LibreView account for patients and follow the instructions on the screen.
• You will need to connect your account to your doctor’s account on LibreView.

To upload information from your reader to LibreView

• Connect your reader to your computer with the yellow cable.
• Press ‘Begin upload’.
• Follow the instructions on the screen.
• You should upload information from your blue reader onto your computer at least once every 90 days.

Driving

There are Government rules about driving if you have diabetes.

Group 1

• You are allowed to use the FreeStyle Libre 2 system for driving a Group 1 vehicle.

• Group 1 means smaller vehicles, like a car or motorbike.

• You must scan your sensor before you drive a Group 1 vehicle.

• But you must also check your sugar levels with a finger prick test if:

• your sugar level is 4 mmol/L or below

• your sugar level is going up or down quickly

• you start to feel a bit unwell

• you feel different to what the reading is saying

• you feel your sugar levels are low or going down.

For more information and training

• If you need more information please call the Abbott Customer Careline on: 0800 170 1177
• This telephone line is open:
• Monday to Friday, 8:00 am to 8:00pm
• Saturday, 9:00 am to 5:00 pm. Or you can go to our website: www.freestyle.abbott/uk-en.

Training
You can get more information with our online training. You can find out more about this at: MyFreeStyle | Abbott

CONTACT

• ADC-36284 V4.0 01/2024
• Easy Read by easy-read-online.co.uk

© 2024 Abbott. The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott.

References

• Home | FreeStyle Libre | Abbott
• Diabetes and driving - GOV.UK
• LibreView
• User Manuals - United Kingdom
• MyFreeStyle | Abbott

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