Quick Start Guide

for Patients

To use LibreView you will need:

A computer with a compatible Windows or Mac operating system
The corresponding data cable for the device, if applicable
A compatible glucose monitoring device

Using LibreView in partnership with your healthcare professional will give you greater insights into your glucose levels and enable you to more effectively manage your diabetes. Using the FreeStyle LibreLink mobile app* or uploading your compatible FreeStyle glucose devices directly into LibreView allows you to send results to your healthcare network easily and securely.

Not all devices, mobile apps, and reports are available in all regions. Units of measurement are for purposes of illustration and will be available as applicable per region. Note that only FreeStyle Libre and related products can be uploaded to Mac computers.

Creating a LibreView Account

You can create an individual account from an email invitation or directly on the LibreView website.

  1. Go to www.libreview.com and click Sign Up

  2. Select LibreView Account

  3. Select your country of residence

  4. Agree to the Terms of Use

  5. Agree to the Privacy Notice

  6. Fill out your information

  7. Select Next on the sign up screen in LibreView to complete your account setup

Your email address will be your username.

Minimum System Requirements

LibreView can be used just to view data, or to also upload data. The minimum system configuration required to use LibreView as a data viewer is:

Windows 7 SP1, Windows 8.1 or Windows 10 Anniversary update (and higher)

  • Display resolution of 1024 x 768 pixels or greater.

  • Internet Explorer 11, Firefox release 32.0, or Chrome release 37.0

  • 1 Ghz processor (dual/multi-core recommended)

  • 2 GB RAM

  • Internet connection with 0.5 Mbps download speed

  • We recommend using the most up-to-date version of your browser. Please note, at this time, Microsoft Edge is not a supported browser.

Mac OS X Yosemite (10.10) or higher

  • Display resolution of 1024 x 768 pixels or greater

  • Safari release 10.1 or Chrome release 37.0 or higher

  • 1 Ghz processor (dual/multi-core recommended)

  • 2 GB RAM

  • Internet connection with 0.5 Mbps download speed

In order to upload data, you must install the LibreView Device Drivers (LDD) when prompted. Uploading data requires the following additional system specifications:

Windows LDD 3.1.0 and higher

  • Windows 7 SP1, Windows 8.1 or Windows 10 April 2018 update (and higher)

  • Will install if not present .Net Framework 4.7.2 and Microsoft Visual C++ 2017 Redistributable (x86)

  • 8 GB+ RAM and 200 MB free disk space

  • Internet connection with 1 Mbps upload speed

  • Local Administrator account

Mac LDD 1.1.0 and higher

  • Mac OS X Yosemite (10.10) or higher

  • 8 GB+ RAM and 200 MB free disk space

  • Internet connection with 1 Mbps upload speed

  • Local Administrator account

Installing Device Drivers

LibreView requires a one-time download and installation of a device drivers file that recognizes the glucose monitoring device when it is plugged in to the computer. Make sure you are using the most up-to-date version of your internet browser when starting the download.

  1. From the Upload screen, click the Select to Upload button under Upload a Device

  2. In the window that appears, click on the Download button specific to your computer's operating system

  3. Wait for the file to download onto your computer

  4. Open the downloaded file by clicking on it and allowing it to run

  5. Follow the prompts to complete the installation

Note: The downloaded file will appear and the bottom of the screen for Chrome and Internet Explorer users and the top right of the screen for Firefox and Safari users. If you are not using a personal computer, you may need your IT Administrator to grant permission for the download and installation.

Links to the latest LibreView Device Drivers are also available on the LibreView Support website. Search for the "Install LibreView Device Drivers" topic and follow the instructions to download and install the drivers.

Uploading from Apps

LibreView Device Drivers are not required to upload data from FreeStyle LibreLink apps into LibreView. If you only upload data with the FreeStyle LibreLink app, you do not need to install the drivers.

Uploading a USB Device

Once the device drivers are downloaded and installed, you can plug in a compatible device using the corresponding cable and start uploading data.

Things to note before uploading:

  • LibreView is compatible with Abbott Diabetes Care devices only.

  • Make sure the device's battery is charged and the device screen shows "computer mode" when plugged into a USB port.

  • Make sure you have the right USB cable for your device. A cable that you use for a different device may not work.

Uploading a USB Device:

  1. Connect your compatible device to a USB port on to your computer using the appropriate cable.

  2. Click the Select to Upload button

  3. Once the data is uploaded, the reports will automatically open

  4. Once the data is uploaded, it can be viewed anytime under the My Glucose section by clicking Glucose Reports.

Note: When you upload a device, you may need to allow your browser to access the Device Drivers file. Save time by ticking the box so your browser will remember your selection before selecting “Allow” or “Launch application”.

Note: If your healthcare professional uses LibreView, they will also be able to upload the data from your device during your appointments.

Viewing Reports

  1. From the My Glucose screen, click the Glucose Reports button to see your reports.

  2. Use the menu to navigate between the different available reports

Changing Report Settings

While viewing reports you can change the settings you'd like to use. You can also set default preferences for the reports by patient or Care Team member.

When you're viewing reports, use the buttons on the bottom of the screen to adjust your settings.

  1. You can change the report dates by clicking on the blue button that shows the date. The default setting will show data from the date of the most recent upload. Click Save to generate reports using the new settings.

  2. You can select the devices that are used in the report set by clicking the blue button that shows the device name. The default setting will show data from all devices that have data in the reporting period. Click Save to generate reports using the new settings.

  3. You can select the reports, adjust target ranges, change report parameters, and more by clicking the blue Report Settings button. Click Save to generate reports using the new settings.

To set new default report preferences, go to your Settings menu.

  1. Click the Settings Menu icon and go to Preferences

  2. Set your target ranges, glucose thresholds, and report display order for all reports

  3. Deselect any reports you don't need to view

  4. Your settings will be saved as you make changes

Note: Click Restore Defaults to return to the default report settings.

Share with your Healthcare Professional

LibreView allows you to easily share data with your healthcare professional when you connect with their LibreView Practice. When you are connected to their Practice, any data you upload to LibreView will be automatically stored and visible to your LibreView Care Team.

If you received an email invitation from your healthcare professional, follow the instructions in the email to allow the connection.

Otherwise, follow these steps to initiate the connection yourself.

  1. Ask your healthcare professional for their Practice ID. A Practice ID is a unique code associated with each LibreView Practice.

  2. In LibreView go to the Settings Menu and select Account Settings

  3. Click My Practices

  4. Enter the Practice ID from your healthcare professional and click Add. You should now see their information in your Practice list.

Note: To stop sharing data with a Practice, click Remove next to the Practice name in the list. Then confirm you want to proceed with removal.

Manage Account Information

Click the Settings Menu icon and select Account Settings to change your account information

  • Profile: Change your name, email, password, and other account information

  • Preferences: Set your Report Preferences

  • My Practices: Add or remove Practices that you share with

  • My Devices: See a list of all the devices that are associated with your account. Click Remove next to the device name in the list if you no longer want to display data from that device.

Helpful Resources

LibreView offers several resources to help you set up and use your LibreView account.

For Customer Support, contact the Abbott Diabetes Care Customer Support line for your country of residence


Argentina +0800-800-6334

Australia +61 1800 801 478

Austria +43 0800 222 775

Bahrain +973 172 41745

Belgium 0800 82106

Brazil 0800 703 0128

Canada 1-800-461-8481

Chile 800 802 226 / 22 3683080

Colombia 01800 5181895

Denmark 80 83 10 42

Finland +358 0800 772 355

France +33 800947909

Germany +49 8006365500

Greece 800-491423863

Hong Kong +852-5808-4196

Ireland +353 1800719995

Italy +39 800693000

Jordan +962 6 51 62 971

Kuwait 220 62972

Lebanon +961 1387 815

Luxembourg 0800 72 106

Mexico 55244175 / 018007112208

Netherlands +31 8002424400

New Zealand 0800 106 100

Oman 800 74396

Poland 800 388 700

Portugal 800860207

Qatar 00800 100869

Saudi Arabia 92000 3788

Singapore +65 1800 272 2881

South Africa 0800-222-688

Spain +34 900800726

Sweden +46 200439522

Switzerland +41 0800 10 21 02

Turkey 00800 142030043

United Arab Emirates 800 0178174

United Kingdom 08006123006

United States 855-786-4263

Intended Use and Regulatory Information

About

LibreView, version 3.0
(including LibreLinkUp, version 2.6)

catalogue

(01) 00860000502016

(10) 3.0 05 OCT 2019

LibreView Website

LVWebsite

LibreLinkUp Mobile App

LLUMobileApp

Foreword

Safety and efficacy are key cornerstones in the design and support of the LibreView system. Newyu takes its responsibilities as a medical device manufacturer seriously.

LibreView includes the LibreView website and LibreLinkUp mobile app.

Intended Use

LibreView is intended for use by patients, caregivers and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management.

In other words:

LibreView is a secondary viewer and is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

LibreView is not intended to be used for immediate clinical decision making, and is not intended to replace self-monitoring practices as advised by a physician.

Home users should consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software.

Healthcare professionals should use information in the software in conjunction with other clinical information available to them.

When using the LibreLinkUp mobile app:

LibreLinkUp is not intended to be used by clinicians.

Patients should not rely on caregivers to notify them about low or high glucose.

Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system.

Any problems with the mobile device, NFC, wireless internet connection, mobile data connection, FreeStyle LibreLink, LibreLinkUp or LibreView could cause data to not be shared with caregivers, or delay transmission to caregivers.

LibreView (and thus LibreLinkUp) should be used only to give a secondary level of awareness and should not be expected to always communicate and transfer sensor glucose information.

Quality Management

ISO (INTERNATIONAL ORGANIZATION FOR STANDARDIZATION) 13485

Newyu services are considered a medical device in many global countries and regions. Alongside our security program, Newyu has achieved ISO (International Organization for Standardization) 13485 certification for our Quality Management Systems (QMS), covering our medical devices and related activities. ISO 13485 is a globally recognized quality standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Our certification encompasses our product life-cycle, including design and development, production, storage and distribution, and support.

21 CODE OF FEDERAL REGULATIONS (CFR) PART 820

The United States maintains one of the world’s most robust set of legislation and guidance concerning medical devices. There are similarities to ISO 13485 but also many differences. As a US-based device manufacturer, Newyu maintains compliance with the US Quality System Regulations (QSR) and registers our establishment with the FDA annually.

Vigilance

Any serious injury or death that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Global Regulatory Representatives

Newyu maintains our Quality Management System for our global product in support of regional registrations or approvals as required to place the device on the market.

Shown below are in-country representatives for regulatory affairs issues and incident reporting, including Newyu partners, sponsors or representatives where applicable.

If a country is available from the product as a country for registration, but is not listed below, most likely it is not a medical device or does not require registration in that country. Please contact LibreView support with any questions.

Manufacturer
MANUFACTURER

Newyu, Inc., 3452 Lake Lynda Dr. Suite 352, Orlando, FL 32817 USA

ARGENTINA

Class 1 device, Argentina Representative ABBOTT LABORATORIES ARGENTINA

PM number: 39-703

AUSTRALIA

Class 1 device, Australian Sponsor:

EMERGO AUSTRALIA, Level 20, Tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, Australia

ARTG ID: 296121

BRAZIL

Class II device, Brazil Importer of Record: Emergo Brazil Import Imp Distr de Prod Méd Hosp Ltda., CNPJ: 04.967.408/0001-98

Av. Francisco Matarazzo, 1.752, Salas 502/503, Água Branca, São Paulo-SP, CEP – 05001-200

BRAZILVIGILANCE@UL.COM

Resp Téc: Luiz Levy CRF-SP: 42415

ANVISA: 80117580705

COLOMBIA

Class IIa device, Colombia Importer of Record: Impomed S.A.S.

INVIMA registration number: IMVIMA 2018DM-008191

Europe
EUROPE

Class 1 device, EU Authorized Representative:

EMERGO EUROPE, Prinsessegracht 20, 2514 AP The Hague, The Netherlands

ISRAEL

Class 1 device, Israeli Registration Holder:

I.L.Emergo Israel Ltd., Tel: 02-6731634, 9 Andrei Sakharov St., Matam, P.O.B. 15401, Haifa 3190501

AMAR registration number: 24820088

NEW ZEALAND

Class 1 device, New Zealand Sponsor: CLINICAL & REGULATORY SERVICES LIMITED (CARSL)

WAND Reference: 171216-WAND-6PFS9Z

SAUDI ARABIA

Class 1 device, Saudi Authorized Representative:

MEDICAL SUPPLIES & SERVICE CO. LTD MEDISERV

SINGAPORE

Class A Exempt device, contact Manufacturer as above, imported by ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

TURKEY

Class 1 Exempt device, contact Manufacturer as above

UNITED ARAB EMIRATES

Class 1 device, UAE Authorized Representative: PHARMAWORLD STORE

UAE Registration DR/C/15481/2018