Platform User Manual

Contents Symbols Instrument icons and buttons Abbreviations Important safety information Overview of the LumiraDx Platform About this Platform User Manual Getting Started Instrument Operation Intended use Important information Summary of the test procedure Principles of operation Storage and operating conditions Warnings Precautions Help and support 4.1 Home Screen 4.2 Settings Menu 4.3 Standalone Instrument First Time Setup Unpacking Powering the Instrument on and off Instrument self-check User ID Operating mode and first time setup The LumiraDx Instrument Power supply LumiraDx Lot Calibration...

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 4.10 Onboard Quality Control 5.1 Cleaning procedure 5.2 Disinfecting procedure Software Updates 6.1 Check software version 6.2 Performing a software update Instrument Specifications Ancillary Devices LumiraDx Barcode Scanner LumiraDx Printer LumiraDx Connect Hub LumiraDx Connect App LumiraDx Platform Instrument Base Customer Services 13.1 Environmental Practices 13.2 Compliance

Symbols On the packaging and on the identification plate of the Instrument you may encounter the following symbols, shown here with their meaning: 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...

Instrument icons and buttons 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. 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...

Centers for Disease Control and Prevention Electronic Health Record Health Care Professional Radio-Frequency Identification United Kingdom World Health Organization Hospital Information System Laboratory Information System Quality Control

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 after use and are capable of transmitting pathogens between patients and healthcare professionals 4. The Instrument should be disinfected at least once per day when in use or if contamination is suspected, unless recommended otherwise for specific tests 4. The Instrument may only be used for testing multiple patients when standard precautions and the manufacturer’s...

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. The LumiraDx Instrument can be used in Standalone mode, providing...

About this Platform User Manual Read this LumiraDx Platform User Manual and the LumiraDx Test Strip Product Inserts carefully and completely before testing for the first 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 Services. Refer to the “Customer Services” chapter of this Platform User...

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. In addition,...

1.4 Principles of operation The Instrument automatically processes the Test Strip including sample movement, reagent mixing, thermal control and fluorescent reading of the reaction product and provides a calibrated, quantitative or qualitative 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. 1.4.1 Quality Assurance The LumiraDx Instrument ensures the quality of...

1.5 Storage and operating conditions 1.5.1 LumiraDx Test Strips For specific information on Test Strip storage and operating conditions, refer to the relevant LumiraDx Test Strip Product Inserts. 1.5.2 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,...