LumiraDx Platform User manual

Platform User Manual

1
Platform User Manual

On the packaging and on the identication 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 specic 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.
Identies the power button to power on or power o the Instrument.
Consult Instructions for Use
2

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.
Notication - 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 conrmation of a completed action.
3

Abbreviations
CDC Centers for Disease Control and Prevention
EHR Electronic Health Record
HCP Health Care Professional
ID Identication
QC Quality Control
RFID Radio-Frequency Identication
UK United Kingdom
USB Universal Serial Bus
WHO World Health Organization
HIS Hospital Information Service
LIS Laboratory Information Service
DOB Date of Birth
4

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 aer use and are capable of
transmitting pathogens between patients and healthcare professionals 4.
The Instrument should be disinfected aer 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
5

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 aer 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 conguration.
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
7

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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4.4 Connected Instrument First Time Setup
4.5 Display and Sound Preferences
4.6 Performing a Patient Test
4.7 Quality Control
4.8 Performing a Quality Control test
4.9 Result History
5 Cleaning and Disinfecting
6 Soware Updates
7 Troubleshooting
8 Maintenance and Disposal
9 Instrument Specications
10 Ancillary Devices
10.1 LumiraDx Barcode Scanner
10.2 LumiraDx USB Memory Stick
10.3 LumiraDx Connect Hub
10.4 LumiraDx Connect App
11 Customer Service
11.1 Warranty
12 References
13 Compliance
13.1 Environmental Practises
13.2 Compliance
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9

Read this LumiraDx Platform User Manual and the LumiraDx Test Strip Product
Inserts carefully and completely before testing for the rst time.
This Platform User Manual provides the information required to operate and care
for the LumiraDx Instrument.
If error messages appear on the Instrument touch-screen, follow the instructions
displayed or refer to the “Troubleshooting” chapter. For questions not answered in
the LumiraDx Platform User Manual or Product Inserts, please contact Customer
Service. Refer to the “Customer Service” chapter of this Platform User Manual for
contact information.
Please note:
Instructions are combined with example screenshots. Some screens may look
dierent 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.
This Platform User Manual highlights cautions and important information:
About this Platform User Manual
10
This symbol indicates a caution. 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.

1 Introduction
1.1 Intended use
The LumiraDx Instrument (hereaer referred to as Instrument) is intended for use
with the LumiraDx family of Test Strips (hereaer referred to as Test Strips) for the in
vitro quantication of various analytes in a range of biological samples (whole
blood, plasma, serum, urine) by trained healthcare professionals.
1.2 Important information
Read this LumiraDx Platform User Manual and the LumiraDx Test Strip Product
Inserts carefully and completely before testing. Pay attention to the “Important
safety information” at the start of this Platform User Manual before operating
the Instrument. In addition, please watch the LumiraDx Platform Training Video
available at www.lumiradx.com.
1.3 Summary of the test procedure
To perform a patient test, the user is required to insert a Test Strip, apply a small
sample volume of one drop, and close the Instrument door. Patient ID can be
entered using the touch-screen keyboard or LumiraDx Barcode Scanner.
When the test process is complete, the result is displayed on the touch-screen
and the user can optionally add a comment. Upon completion of the test, the
Instrument stores the test result.
The Instrument provides visual and audible prompts throughout the test process.
Introduction - 11

1.4 Principles of operation
The LumiraDx platform utilises unitary test strips that contain all of the reagents
necessary to perform a test. The Instrument automatically processes the test strip
including sample movement, reagent mixing, thermal control and uorescent
reading of the reaction product and provides a calibrated, quantitative result.
Each Lot of Test Strips requires a LumiraDx Lot Calibration File, which provides the
instrument with the information required to process the test. The Lot Calibration
File is installed by placing the RFID tag in the Test Strip Carton against the RFID
reader in the Instrument.
Quality assurance
The LumiraDx Instrument ensures the quality of test results obtained through the
following features:
• Automated checks of the correct functioning of the Instrument at power on
and during operation.
• This includes electrical component operation, heater operation,
battery charge state, mechanical actuators and sensors and
optical system performance.
• Monitoring of Test Strip performance and controls during test runtime.
• Ability to perform Quality Control Tests using LumiraDx Quality Control
solutions to meet regulatory compliance requirements.
12 - Introduction

1.5 Storage and operating conditions
LumiraDx Test Strips
For specic information on Test Strip storage and operating conditions, refer to
the relevant LumiraDx Test Strip Product Inserts.
LumiraDx Instrument
The Instrument is portable and can be used across a range of settings, such as
care homes, primary care clinics, hospital wards and departments, pharmacy
and laboratories. The Instrument is not intended for hand-held operation.
The Instrument can be stored or transported at a temperature between -10°C
and 50°C (14°F and 122°F).
To power on and access the Instrument result history, operate the LumiraDx
Instrument at a temperature between 15°C and 30°C (59°F and 86°F), and at
a relative humidity between 10 % and 90 % (non-condensing). Specic test
operating conditions may be more restrictive.
Always place the Instrument on a level, stable surface before starting a test.
Testing should be performed in a location where the air vents located in
the back of the Instrument will not be blocked, i.e. on a table top away from
so surfaces. The Instrument will display an error message if these operating
conditions are not met.
Avoid placing the Instrument in direct sunlight. This may interfere with proper
functioning of the Instrument.
Refer to the “Instrument Specications” chapter of this Platform User Manual
for additional information on operating conditions and complete Instrument
specications.
Introduction - 13

1.6 Warnings
14 - Introduction
Important safety information
• 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 used Test Strips according to your organization’s infection
control policy.
Inserting Test Strips
• Do NOT touch Test Strip Sample Application Area.
• Do NOT bend or fold the Test Strip.
• Do NOT touch Test Strip contacts.
• Do NOT apply sample until prompted.
Performing a patient test
• Wear a clean pair of gloves before performing a patient test.
• Place the Instrument on a level, stable surface before starting a test.
• Do NOT use any substance other than the sample types indicated in the
LumiraDx Test Strip Product Insert on the Test Strip.
• Apply sample AFTER inserting the Test Strip and the Instrument prompt.
• Do NOT apply more than one drop of sample.
• Do NOT touch the Test Strip until the test has nished and the result is
displayed.
• Do NOT open the door or move the Instrument during the test or an error
will result and the information will not be saved.
• Dispose of all Test Strips used for patient testing safely in accordance
with local regulations and procedures.
• Follow the test operating conditions in the LumiraDx Test Strip Product
Insert.
• Follow the information on correct handling of Test Strips in the LumiraDx
Test Strip Product Insert.

Performing a Quality Control test
• Place the Instrument on a level, stable surface before starting a test.
• Use only LumiraDx Quality Control solutions.
• Apply Quality Control solution AFTER inserting the Test Strip and the
Instrument prompt.
• Do NOT apply more than one drop of Quality Control solution.
• Do NOT touch the Test Strip until the test has nished and the result is
displayed.
• Do NOT open the door or move the Instrument during the test or an error
will result and the information will not be saved.
• Dispose of all Test Strips used for Quality Control testing safely in
accordance with local regulations and procedures.
• Follow the test operating conditions in the LumiraDx Test Strip Product
Insert.
• Follow the information on correct handling of Test Strips in the LumiraDx
Test Strip Product Insert.
Cleaning and disinfecting
• Do NOT attempt to put any objects or cleaning materials inside the Test
Strip slot.
• Always wear gloves whilst cleaning and disinfecting the Instrument.
• Only use LumiraDx recommended cleaning and disinfecting materials
on the Instrument surfaces.
• Only use a damp and not wet swab or cloth for cleaning. Excess liquid
may damage the Instrument.
• Always use TECcare® Control textured wipes to disinfect the Instrument.
• Do NOT spray or pour solution directly onto the Instrument.
• Following cleaning and disinfection, and before performing a patient
test, change gloves and wash hands.
Introduction - 15

1.7 Precautions
Only operate the LumiraDx Instrument for its intended purpose and in
accordance with this Platform User Manual and warnings. If the Instrument is
used in a manner not specied in the Platform User Manual, protection provided
by the equipment will be impaired. The LumiraDx Instrument (including power
supply unit) is designed to operate within the manufacturer specications. Do
not exceed the manufacturer specications when in use.
Avoidance of electrical shock, re and explosions
• Use only the power supply unit that is provided with the Instrument. Use
the appropriate power blade for the region. The correct power supply
unit and adapter is required to maintain the safety and electromagnetic
compatibility of the system.
• Always operate this Instrument on a clean, level and stable surface. Do
not drop the Instrument. Ensure that air ow to the ventilation openings
located on the back of the Instrument are not restricted.
• Risk of electrical shock. Do not operate the Instrument or the power
supply unit if it has been opened, damaged or exposed to moisture,
condensation or rain.
• Overheating can cause the battery pack to catch re or explode.
16 - Introduction
Instrument disposal
• Do NOT attempt to replace or reinstate the battery.

Electromagnetic interference
• Do not use the Instrument near strong electromagnetic elds, which
could interfere with the proper operation of the Instrument.
1.8 Help and support
Information about using the LumiraDx Instrument can be found in this Platform
User Manual. Information about the Test Strips and test performance can be
found in the LumiraDx Test Strip Product Inserts and Quality Control Pack Inserts.
Information about LumiraDx Connect Manager and LumiraDx EHR Connect can
be found in the LumiraDx Connect User Manual.
The documents can also be found at www.lumiradx.com.
If error messages appear on the screen, refer to the “Troubleshooting” chapter
in this Platform User Manual. For questions not answered in the LumiraDx User
Manuals or Product Inserts, please contact Customer Service. Refer to the
“Customer Service” chapter of this Platform User Manual for contact information.
Safe Disposal
• Follow proper infection control guidelines for handling all specimens and
related items. Properly dispose of all contaminated waste according to
local regulations.
• The LumiraDx Instrument and its components must be treated as
potentially biohazardous waste. Decontamination (i.e. a combination of
processes including cleaning, disinfection and/or sterilization) is required
before reuse, recycling, or disposal.
• Dispose of the system or its components according to the appropriate
local regulations.
Introduction - 17

2.1 Unpacking
The LumiraDx Instrument package includes the following contents:
1. LumiraDx Instrument
2. LumiraDx Power Supply Unit
3. Platform User Manual
4. Platform Quick Reference Guide (including passwords for Standalone
operation)
Inspect the Instrument and packaging for damage before use. Report any
damage to Customer Service. Refer to the “Customer Service” chapter of this
Platform User Manual for contact information.
2.2 Powering the Instrument on and o
The Instrument must be fully charged before rst use. It will take approximately 2
hours to fully charge the battery using the power supply unit provided.
Place the Instrument on a level, stable surface. Power on by briey pressing the
power button at the rear of the Instrument. Enter User ID and/or password to
login.
The Instrument touch-screen will dim aer 2 minutes of inactivity. Tap the touch-
screen to restore the touch-screen brightness.
To power the Instrument o aer use, press the power button at the rear of the
Instrument for 2 seconds, and tap the screen message to conrm power o. The
Instrument should be powered o for transportation and when not in use.
2.3 Instrument self-check
The Instrument will perform a self-check when starting up. If the Instrument door
is open, the Instrument will prompt to close the door before performing the self-
check. The self-check will not proceed until the door is closed.
2 Getting Started
18 - Getting Started