LumiraDx Platform - Introduction; Intended Use; Important Information; Summary of the Test Procedure

12 - Introduction
1 Introduction
1.1 Intended Use
The LumiraDx Instrument (hereafter referred to as Instrument) is intended for use
with the LumiraDx family of Test Strips (hereafter referred to as Test Strips) for the
in vitro measurement of various analytes in a range of biological samples 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.
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.