LumiraDx SARS-CoV-2, Manual

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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 after 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 configuration.
LumiraDx EHR Connect can enable the transfer of patient test results to the
Electronic Health Record (EHR).
The LumiraDx Platform comprises:
• LumiraDx Instrument
• LumiraDx Test Strips (Available separately)
• LumiraDx Quality Controls (Available separately)
• LumiraDx Barcode Scanner (Available separately)
• LumiraDx Printer (Available separately)
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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