2AV6APOCLumiraDx POC Instrument

For product and connectivity support please contact LumiraDx Customer Services at [email protected] SPEC-32180 Rev1 ART-00410 Rev1 Rev Date 2020/05 LumiraDx UK Ltd Dumyat Business Park Alloa FK10 2PB, UK LumiraDx Group Limited, 2020 - © All rights reserved, worldwide. S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 1S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 111/05/2020 18:1111/05/2020 18:11 Platform User Manual For Investigational Use Only Unapproved S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 3S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 311/05/2020 18:1111/05/2020 18:11 S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 1S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 111/05/2020 18:1111/05/2020 18:11 1 Platform User Manual S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 1S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 111/05/2020 18:1111/05/2020 18:11 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 off 2.3 Instrument self-check 2.4 User ID 2.5 Operating mode and first 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 Capillary sample collection and application 3.4 Sample application using other sample types 3.5 Quality Control solution application 4 Instrument Operation 4.1 Home Screen 4.2 Settings Menu 4.3 Standalone Instrument First Time Setup 4 6 8 9 10 14 13 13 13 13 13 14 15 17 18 19 19 19 19 20 20 21 22 23 24 26 26 27 28 30 30 31 31 32 33 2 S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 2S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 211/05/2020 18:1111/05/2020 18:11 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 Cleaning and Disinfecting 6 Software Updates 7 Troubleshooting 8 Maintenance and Disposal 9 Instrument Specifications 10 Ancillary Devices 10.1 LumiraDx Barcode Scanner 10.2 LumiraDx Printer 10.3 LumiraDx USB Memory Stick 10.4 LumiraDx Connect Hub 10.5 LumiraDx Connect App 11 Customer Services 11.1 Warranty 12 References 13 Compliance 13.1 Environmental Practices 13.2 Compliance 34 38 39 49 50 62 64 67 69 71 77 78 79 79 82 84 84 85 85 85 87 88 88 88 3 S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 3S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 311/05/2020 18:1111/05/2020 18:11 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 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. Identifies the power button to power on or power off the Instrument. Consult Instructions for Use 4 S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 4S-COM-ART-00410 R1 Platform User Manual V5E 1.4.3 US EUA - FOR APPROVAL.indd 411/05/2020 18:1111/05/2020 18:11 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 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 field of all data. …

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FCC ID: 2AV6APOC

LumiraDx UK Ltd Dumyat Business Park Alloa FK10 2PB, UK Made in Austria FCC ID: 2AV6APOC Contains FCC ID: 2AI9JRFM Wireless ID: Power Supply: 12V3A SPEC-30874 Rev3 LumiraDx AB, Västra Vägen 5A, 16961 Solna, Sweden 272717 CUS This instrument complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This instrument may not cause harmful interference, and (2) this instrument must accept any interference received, including interference that may cause undesired operation. XXXX-XXXXX-XXXXX XXXXX-XX-XX-XXXXX 34.60mm 58.60mm R1.30mm 17.00mm 58.60mm R1.30mm Label Location Label will be placed here on bottom of device

FCC ID: 2AV6APOC

Bureau Veritas Consumer Products Serv ices, Inc.is accredited by the American Association f or Laboratory Accreditation f or the specif ic scope of accreditation under Certif icate Number 1627-01. This report may contain data which is not cov ered by the A2LA accreditation. ____________________________________________________________ Bureau Veritas Consumer Products Services, Inc. One Distribution Center Circle, #1  Littleton, MA  TEL (978) 486-8880  FAX (978) 486-8828 page 1 of 22 Test Report Bureau Veritas Consumer Products Services, Inc. Report No EU0806-1 Client LumiraDx Address 221 Crescent ST, Suite 502 Waltham, MA 02453 Phone 978-479-7459 Items tested LumiraDx POC Instrument FCC ID 2AV6APOC FRN 0029449600 Equipment Type Equipment Code Part 15 Low Power Communication Device Transmitter DXX FCC/IC Rule Parts CFR Title 47 FCC Part 15.225, ISED Canada RSS-210 Issue 9 Annex B.6 Test Dates April 14 – April 15, 2020 Results As detailed within this report Prepared by Anna Vancheva – EMC Engineer Authorized by Arik Zwirner- Senior EMC Engineer Issue Date 4/15/2020 Conditions of Issue This Test Report is issued subject to the conditions stated in the ‘Conditions of Testing’ section on page 23 of this report. Report for LumiraDx • Report No. EU0806-1 April 15, 2020 _________________________________________________________________________________________ ____________________________________________________________ Bureau Veritas Consumer Products Services, Inc. One Distribution Center Circle, #1  Littleton, MA  TEL (978) 486-8880  FAX (978) 486-8828 page 2 of 22 Contents Contents .......................................................................................................................................2 Summary and Test Methodology .................................................................................................3 Product Tested - Configuration Documentation ..........................................................................4 Compliance Statement .................................................................................................................5 Modifications Required for Compliance .......................................................................................5 Test Results .................................................................................................................................6 Fundamental Reading ..............................................................................................................6 99% Occupied Bandwidth ........................................................................................................7 Emission Mask..........................................................................................................................9 Radiated Spurious Emissions ................................................................................................10 Temperature Stability..............................................................................................................15 AC Line Conducted Emissions ...............................................................................................17 Measurement Uncertainty ..........................................................................................................20 Conditions of Testing .................................................................................................................21 Form Final Report REV 12-07-15 Report for LumiraDx  Report No. EU0806-1 April 15, 2020 ______________________________________________________________________ _____________________________________________________________ Bureau Veritas Consumer Products Services, Inc. One Distribution Center Circle, #1  Littleton, MA  TEL (978) 486-8880  FAX (978) 486-8828 page 3 of 22 Summary and Test Methodology On April 14 and April 15, 2020 we tested the LumiraDx POC Instrument, which contains the iDTRONIC Embedded HF RFID Reader M9000 series (Model: SPEC 30199 Rev1) for compliance with the following requirements: CFR Title 47 FCC Part 15.225, ISED Canada RSS-210 Issue 9 Annex B.6 EUT transmits at 13.56MHz. Emissions were measured with the EUT in its intended upright installation orientation. EUT includes a certified Bluetooth module (FCC ID: 2AI9JRFM). Radiated emission testing was performed according to the procedures specified in ANSI C63.10-2013 and RSS-Gen Issue 5. AC mains conducted emission testing was performed for 12VDC configuration. Following bandwidths were used during radiated and conducted spurious emissions testing. Frequency RBW VBW 9kHz-150kHz 200Hz 1kHz 150kHz-30MHz 9kHz 30kHz 30MHz-1GHz 120kHz 1MHz The test sample was received in good condition on April 13 th 2020. Report for LumiraDx  Report No. EU0806-1 April 15, 2020 ______________________________________________________________________ _____________________________________________________________ Bureau Veritas Consumer Products Services, Inc. One Distribution Center Circle, #1  Littleton, MA  TEL (978) 486-8880  FAX (978) 486-8828 page 4 of 22 Product Tested - Configuration Documentation EUT Conf iguration Work Order: U0806 Company: LumiraDx Company Address: 221 Crescent Street Waltham, MA 02453 Contact: Dave Goodall P roduct Marketing Name Model Number SN EUT: LumiraDx P OC Instrument SP EC 30199 Rev1 EUT Description: P OC Instrument, contains the iDTRONIC Embedded HF RFID Reader M9000 series EUT Tx Frequency: 13.56MHz (HF RFID) Port Label Port Type # ports # populated cable type shielded f errites length (m) in/out under test comment Ethernet Door Ethernet 2 2 Ethernet No No 2.5 in no P ower DC P ower DC 1 1 P ower DC No Yes 1.4 in yes Sof tware Operating Mode Description: NFC transmits continuously. Commands provided by client.. Report for LumiraDx  Report No. EU0806-1 April 15, 2020 ______________________________________________________________________ _____________________________________________________________ Bureau Verit…

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FCC ID: 2AV6APOC 9kHz-30MHz FCC ID: 2AV6APOC 30MHz-1GHz FCC ID: 2AV6APOC CEMI