LumiraDx Platform User manual

Platform User Manual

Contents
2
Contents
Symbols 5
Instrument Icons and Buttons 6
Abbreviations 7
Important Safety Information 8
Overview of the LumiraDx Platform 10
About this Platform User Manual 11
1 Introduction 12
1.1 Intended Use 12
1.2 Important Information 12
1.3 Summary of the Test Procedure 12
1.4 Principles of Operation 13
1.5 Storage and Operating Conditions 14
1.6 Warnings 15
1.7 Precautions 17
1.8 Help and Support 18
2 Getting Started 19
2.1 Unpacking 19
2.2 Powering the Instrument On and Off 19
2.3 Instrument Self-Check 19
2.4 User ID 20
2.5 Operating Mode and First Time Setup 20
2.6 The LumiraDx Instrument 21
2.7 Power Supply 22
2.8 LumiraDx Lot Calibration File Installation 23
2.9 Extended Functionality and Operating Modes 24
3 Preparation for Testing 25
3.1 Handling Test Strips 25
3.2 Inserting and Removing Test Strips 25
3.3 Sample Collection and Application 27
3.4 Applying a Sample to the Test Strip 27
3.5 Quality Control Solution Application 28
4 Instrument Operation 29
4.1 Home Screen 29
4.2 Settings Menu 30
4.3 Standalone Instrument First Time Setup 32
4.4 Connected Instrument First Time Setup 34
4.5 Display and Sound Preferences 36
4.6 Test Management 37

4.7 Performing a Patient Test 42
4.8 Quality Control 53
4.9 Performing a Quality Control Test 55
4.10 Result History 65
4.11 Onboard Quality Control 68
5 Cleaning and Disinfecting 70
5.1 Cleaning Procedure 72
5.2 Disinfecting Procedure 72
6 Soware Updates 74
6.1 Check Software Version 74
6.2 Performing a Software Update 76
7 Troubleshooting 78
8 Maintenance and Disposal 82
9 Instrument Specifications 83
10 Ancillary Devices 84
10.1 LumiraDx Barcode Scanner 84
10.2 LumiraDx Printer 89
10.3 LumiraDx Connect Hub 93
10.4 LumiraDx Connect App 93
10.5 LumiraDx Platform Instrument Base 94
11 Customer Services 95
11.1 Warranty 95
12 References 96
13 Compliance 97
13.1 Environmental Practices 97
13.2 Compliance 97
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Platform User Manual
• Please note: Instructions are combined with example screenshots. Some
screens may look different on the Instrument depending on the test or
mode of operation. All screens, test names and results displayed in this
Platform User Manual are intended only as examples.
• Refer to lumiradx.com/instrument for the most recent version of the
Platform User Manual.
• For In Vitro Diagnostic Use
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On the packaging and on the identification 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 specific 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 Product 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
Identifies the power button to power on or power off the Instrument
Consult Instructions for Use
Authorized representative in the European Community
Importer
Unique Device Identifier
5

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 fields 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
Indicates that the Instrument has an active connection to an
Electronic Health Record (EHR).
Indicates that the Instrument connection to an Electronic Health
Record (EHR) is not active
Notification - 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
Product 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 field 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 field which can perform a search function
Indicates confirmation 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 Identification
QC Quality Control
RFID Radio-Frequency Identification
UK United Kingdom
USB Universal Serial Bus
WHO World Health Organization
HIS Hospital Information System
LIS Laboratory Information System
DOB Date of Birth
RF Radio Frequency
RH Relative Humidity
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Important Safety Information
Healthcare professionals need to adhere to standard precautions when using the
LumiraDx Platform1,2,3.All parts of the LumiraDx Instrument and LumiraDx Test Strips
should be considered potentially infectious after use and are capable of transmitting
pathogens between patients and healthcare professionals4.
The Instrument should be disinfected at least once per day when in use or if
contamination is suspected, unless recommended otherwise for specific tests4.
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.
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, 2023.
© 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.
LumiraDx and Flame logo are protected trademarks of LumiraDx International LTD.
Full details of these and other registrations of LumiraDx can be found at lumiradx.com/IP.
All other trademarks are the property of their respective owners.
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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.
Dispose of all Test Strips used for patient or Quality Control testing safely
inaccordance with local regulations and procedures.
The LumiraDx Instrument contains 2 USB ports that are for use with approved
& supported USB devices only. DO NOT connect any unsupported devices into
the USB ports.