LumiraDx Platform Manuel utilisateur
Platform User Manual
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Platform User Manual
On the packaging and on the identication plate of the Instrument you may
encounter the following symbols, shown here with their meaning:
Symbols
Temperature limitation
Manufacturer
In vitro diagnostic medical device
This product contains electrical and electronic components that
may contain materials which, if disposed with general waste, could
be damaging to the environment. Residents of the European
Union must follow specic disposal or recycling instructions for this
product. Residents outside the European Union must dispose or
recycle this product in accordance with local laws or regulations
that apply.
Catalogue Number
Serial Number
“CE Mark “. The product is in compliance with all relevant
European Directives and Regulations. Refer to Declaration of
Conformity for full details.
Caution - Consult Instructions for Use. Refer to safety-related
warnings and precaution notes in the Instructions for Use
accompanying this product, e.g. Platform User Manual, Test Strip
Product Insert or Quality Control Pack Insert.
Indicates that the Instrument can be potentially infectious due to
the samples or reagents used.
Direct current - Indicates that the Instrument is suitable for direct
current only and to identify relevant terminals.
Universal Serial Bus (USB) Port
Near Field Connectivity (NFC) – Indicates the presence of the
Radio Frequency (RFID) reader.
Identies the power button to power on or power o the Instrument.
Consult Instructions for Use
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The icons and buttons that appear on the touch-screen during normal
operation of the LumiraDx Instrument are shown here, along with their respective
meanings.
Instrument icons and buttons
Indicates the patient’s biological sample.
Return to the home screen.
Info button - used to reveal additional information, such as test or
patient information.
Indicates which elds barcode scanning is available as a means
of data input.
When pressed as a button, displays barcode scanning instructions.
Indicates when the Instrument is connected to Connect Manager.
Notication - Highlights an area which requires attention.
Caution - Highlights an error or precautionary statement which
requires attention. Refer to safety-related warnings and precaution
notes in the Instructions for Use accompanying this product, e.g.
Platform User Manual, Test Strip Product Insert or Quality Control
Pack Insert.
Indicates the status of the battery.
Displayed when the battery is in a charging state.
Icon which acts as a button - clears the text input eld of all data.
Indicates the high end of the touch-screen brightness slider.
Indicates the low end of the touch-screen brightness slider.
Volume (high)
Volume (low)
Indicates a text eld which can perform a search function.
Indicates conrmation of a completed action.
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Abbreviations
CDC Centers for Disease Control and Prevention
EHR Electronic Health Record
HCP Health Care Professional
ID Identication
QC Quality Control
RFID Radio-Frequency Identication
UK United Kingdom
USB Universal Serial Bus
WHO World Health Organization
HIS Hospital Information Service
LIS Laboratory Information Service
DOB Date of Birth
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Important safety information
Healthcare professionals need to adhere to standard precautions when using
the LumiraDx Platform 1,2,3. All parts of the LumiraDx Instrument and LumiraDx Test
Strips should be considered potentially infectious aer use and are capable of
transmitting pathogens between patients and healthcare professionals 4.
The Instrument should be disinfected aer use with each patient 4. The
Instrument may only be used for testing multiple patients when standard
precautions and the manufacturer’s disinfection procedures are followed. Full
cleaning and disinfecting procedures are described in the “Cleaning and
Disinfecting” chapter in this Platform User Manual.
A clean pair of gloves should be worn before testing each patient.
Wash hands thoroughly with soap and water before putting on a new pair of
gloves and performing the next patient test.
Only use auto-disabling, single use lancing devices.
Dispose of all Test Strips used for patient or Quality Control testing safely in
accordance with local regulations and procedures.
The LumiraDx Instrument contains a neodymium magnet. Although the
risk of interference with implanted devices such as pacemakers is minimal
we recommend that patients with an implanted device should maintain a
distance of at least 15 cm between the LumiraDx Instrument and their heart
device.
This User Manual and its content is copyright of LumiraDx Group Limited, 2018 - ©
All rights reserved, worldwide. Content should be used for use of the LumiraDx
Products only and in line with instructions provided. You may not, except with our
express written permission, distribute or commercially exploit the content. Nor
may you transmit it or store it in any other form of electronic retrieval system other
than for the purpose of use of the LumiraDx Instrument or LumiraDx Test Strips.
Information provided is subject to change without notice.
LumiraDx UK Ltd
Dumyat Business Park
Alloa FK10 2PB UK
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Overview of the LumiraDx Platform
The LumiraDx Platform is a point of care system which is used for in vitro
diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx
Test Strip for the required test. This allows healthcare professionals to perform tests
using small sample volumes and to view results quickly on the Instrument touch-
screen. Information about test duration and test performance can be found in
the LumiraDx Test Strip Product Inserts.
The LumiraDx Instrument is intended to be for multi patient use and should be
disinfected aer use on each patient.
The LumiraDx Instrument can be used in Standalone mode, providing test
results on the touch-screen. Single or multiple Instruments can be connected to
the LumiraDx Connect Manager for extended functionality and conguration.
LumiraDx EHR Connect can enable the transfer of patient test results to the
Electronic Health Record (EHR).
The LumiraDx Platform comprises:
Contained within this pack Available separately
• LumiraDx Instrument • LumiraDx Test Strips
• LumiraDx Quality Controls
• LumiraDx Barcode Scanner
LumiraDx Connect diagnostic connectivity solution:
• LumiraDx Connect Manager
• LumiraDx Connect App (for iOS and Android)
• LumiraDx Connect Hub
• LumiraDx EHR Connect
The mode of operation and selection of Platform components is dependent on
the following requirements of the organization:
• Types of tests to be performed
• Number of testing sites and users
• System administration, integration, and data transfer to the EHR
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Contents
Symbols
Instrument icons and buttons
Abbreviations
Important safety information
Overview of the LumiraDx Platform
About this Platform User Manual
1 Introduction
1.1 Intended use
1.2 Important information
1.3 Summary of the test procedure
1.4 Principles of operation
1.5 Storage and operating conditions
1.6 Warnings
1.7 Precautions
1.8 Help and support
2 Getting Started
2.1 Unpacking
2.2 Powering the Instrument on and o
2.3 Instrument self-check
2.4 User ID
2.5 Operating mode and rst time setup
2.6 The LumiraDx Instrument
2.7 Power supply
2.8 LumiraDx Lot Calibration File installation
2.9 Extended functionality and operating modes
3 Preparation for Testing
3.1 Handling Test Strips
3.2 Inserting and removing Test Strips
3.3 Sample collection
3.4 Sample application using direct nger stick sampling
3.5 Sample application using other sample types
3.6 Quality Control solution application
4 Instrument Operation
4.1 Home screen
4.2 Settings Menu
4.3 Standalone Instrument First Time Setup
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