LumiraDx SARS-CoV-2 Manual Download Page 20

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Document Name:

SARS-CoV-2 Ag Test Strip Product Insert

Document Number:

S-COM-DOUT-00112

Revision:

This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for

the most recent version unless formally issued and stamped by QA. Created with S-QMS-TEM-00001

Symbols glossary:

Symbol

Meaning

Temperature limitation

Manufacturer

In Vitro

Diagnostic Medical Device

Catalogue Number

Batch code/Lot Number

Use by

Consult Instructions for Use

Rx Only

Prescription Use Only

Do Not Re-use

Contains sufficient for 12

48 Tests

Summary of Contents for SARS-CoV-2

Page 1: ... meet the requirements to perform moderate high or waived complexity tests This test is authorized for use at the Point of Care POC i e in patient care settings operating under a CLIA Certificate of Waiver Certificate of Compliance or Certificate of Accreditation The LumiraDx SARS CoV 2 Ag test does not differentiate between SARS CoV and SARS CoV 2 Results are for the identification of SARS CoV 2 ...

Page 2: ...n to person through small droplets from the nose or mouth which are spread when a person with COVID 19 coughs or exhales Most estimates of the incubation period for COVID 19 range from 2 14 days2 The use of a LumiraDx SARS CoV 2 Ag Test will enable the physician to verify infection quickly begin proper treatment and to initiate isolation precautions helping prevent further spread of infection Prin...

Page 3: ...roteins from SARS CoV 2 not for any other viruses or pathogens Do not open the test strip until ready for immediate use Discard and do not use any damaged or dropped Test Strips or other materials Inadequate or inappropriate sample collection storage and transport can result in incorrect results The test cannot be visually interpreted the LumiraDx Instrument must be used to generate results Do not...

Page 4: ...immediately Do not use the Test Strip if there are any visible signs of damage to the foil pouch such as tears or holes Sample material The following samples can be used with the LumiraDx SARS CoV 2 Ag Test Strip Nasal Swab Specimen NS The Test device contains Rabbit and mouse monoclonal antibodies Fluorescent particles Magnetic particles Buffer and stabilising agents Preparing the Instrument to p...

Page 5: ...ed The LumiraDx SARS CoV 2 Ag Test results should be evaluated by a Healthcare Professional in the context of all available clinical and laboratory data Instructions for sample collection When collecting any type of sample follow universal collection precautions and guidelines according to your organization For specimen collection of nasal swabs follow the Centers for Disease Control and Preventio...

Page 6: ...ion Vial as soon as possible Do not place the swab back into the swab packaging sleeve after specimen collection 1 Tilt patient s head back 70 2 A swab sample is needed from both nostrils and this is taken using the same swab While gently rotating the swab insert swab less than one inch into the first nostril until resistance is met at Turbinates Turbinates are the small structures inside the nose...

Page 7: ...op of the Extraction Vial containing the Extraction Buffer Place and soak the Patient Swab in the Extraction Buffer for 10 seconds and then stir well by rotating the swab against the side of the vial 5 times Firmly attach Dropper Lid to the top of the Extraction Vial The extracted sample must be used within 5 hours of preparation when stored at room temperature Extracted nasal specimens may be fro...

Page 8: ...n message will be displayed The touchscreen of the LumiraDx Instrument will request the user to immediately close the door Note you have 10 seconds only to close the door 3 Do not add more than one drop of sample Do not open the door while the test is in progress The touchscreen will indicate test progress 4 The result will appear on the Instrument touchscreen within 12 minutes of applying the sam...

Page 9: ...sage will be displayed on the Instrument touch screen Alert messages include useful information and are highlighted by an orange banner Error messages also include a symbol All messages will contain a description of the Instrument status or error and an instruction Error messages contain an identifying code that may be used for further troubleshooting purposes Refer to the LumiraDx Platform User M...

Page 10: ...atory compliance requirements Quality controls Liquid Controls for SARS CoV 2 Ag are available from LumiraDx Details can be found via the website lumiradx com or at the Customer Services telephone number 1 888 586 4721 Quality Control testing policy is at the discretion of your organization Good laboratory practice recommends the use of control materials Follow the appropriate federal state and lo...

Page 11: ...ens and Extraction buffer must be at room temperature before testing Positive test results do not rule out co infection with other pathogens A false negative result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected inappropriately therefore a negative test result does not rule out the possibility of SARS CoV 2 infection The ...

Page 12: ...oduct of which they become aware All operators using your product must be appropriately trained in performing and interpreting the results of your product use appropriate personal protective equipment when handling this kit and use your product in accordance with the authorized labeling You authorized distributors and authorized laboratories using your product will ensure that any records associat...

Page 13: ...uring the 2020 COVID 19 pandemic Specimens were collected from sequentially enrolled subjects who presented with symptoms of COVID 19 159 or key workers 98 at increased risk of infection No positive results were observed from patients without symptoms or beyond 12 days of symptom onset Dual nasal swabs were simultaneously collected and then randomly allocated to testing with the LumiraDx test or a...

Page 14: ...al Sensitivity Limit of Detection LoD studies determined the lowest detectable concentration of SARS CoV 2 at which 100 of all true positive replicates test positive The LoD for the LumiraDx SARS CoV 2 Ag Test was established using limiting dilutions of gamma irradiated SARS CoV 2 BEIResources NR 52287 The NR 52287 is a preparation of SARS Related Coronavirus 2 SARS CoV2 isolate USA WA1 2020 that ...

Page 15: ...tes with concentrations at the tentative Limit of Detection The final LoD of the LumiraDx SARS CoV 2 Ag Test was determined to be the lowest concentration resulting in positive detection of twenty 20 out of twenty 20 replicates Based on this testing the LoD for nasal swab specimens was confirmed as 32 TCID50 mL Starting Material Concentration Estimated LOD No Positive Total Positive 2 8 x 105 TCID...

Page 16: ...trix 1 x 106 CFU mL No 3 3 negative Streptococcus pyogenes Zeptometrix 1 x 106 CFU mL No 3 3 negative Candida albicans Zeptometrix 1 x 106 CFU mL No 3 3 negative Pooled human nasal wash LumiraDx 14 v v No 3 3 negative Bordetella pertussis Zeptometrix 1 x 106 CFU mL No 3 3 negative Mycoplasma pneumoniae ATCC 1 x 106 CFU mL No 3 3 negative Chlamydia pneumoniae ATCC 1 x 106 CFU mL No 3 3 negative Leg...

Page 17: ...n Interference Yes No Human coronavirus 229E Zeptometrix 1 x 105 PFU mL No 3 3 positive Human coronavirus OC43 Zeptometrix 1 x 105 PFU mL No 19 20 positive Human coronavirus NL63 Zeptometrix 9 87 x 103 No 3 3 positive MERS coronavirus Zeptometrix 7930 PFU mL No 3 3 positive Adenovirus e g C1 Ad 71 Zeptometrix 1 x 105 PFU mL No 3 3 positive Human Metapneumovirus Zeptometrix 1 x 105 PFU mL No 3 3 po...

Page 18: ...e Sore Throat Phenol Spray 15 v v No 3 3 Negative 3 3 Positive Tobramycin 3 3 mg dL No 3 3 Negative 3 3 Positive Mupirocin 0 15 mg dL No 3 3 Negative 3 3 Positive Fluticasone 0 000126 mg dL No 5 5 Negative 4 4 Positive Tamiflu Oseltamivir phosphate 500 mg dL No 3 3 Negative 3 3 Positive Budenoside 0 00063 mg dL No 3 3 Negative 3 3 Positive Biotin 0 35 mg dL No 3 3 Negative 3 3 Positive Methanol 15...

Page 19: ... the most recent version unless formally issued and stamped by QA Created with S QMS TEM 00001 1 0 495 2 62 5 26100 6 3 250 63013 8 4 1000 83451 8 5 1 4 x 105 86220 Point of Care Use The LumiraDx SARS CoV 2 Ag Test was used by 8 untrained users in 4 sites across the United States Untrained users tested 132 patients and ran 148 tests References 1 World Health Organisation www who int 2 Centers for ...

Page 20: ...trolled and should not be relied upon for the most recent version unless formally issued and stamped by QA Created with S QMS TEM 00001 Symbols glossary Symbol Meaning Temperature limitation Manufacturer In Vitro Diagnostic Medical Device Catalogue Number Batch code Lot Number Use by Consult Instructions for Use Rx Only Prescription Use Only Do Not Re use Contains sufficient for 12 or 24 or 48 Tes...

Page 21: ...shall either repair or replace at LumiraDx s discretion the Test Strips Except for the limited warranty stated in this section LumiraDx disclaims any and all warranties express or implied including but not limited to any warranty of merchantability fitness for a particular purpose and non infringement regarding the product LumiraDx s maximum liability with any customer claim shall not exceed the n...

Page 22: ...t for Specimen Collection Warning and Precautions and Limitations Warning and Precautions All kit components can be discarded as Biohazard waste according to local guidelines Refer to the product safety data sheet for risk and safety phrases and disposal information The product safety data sheet is available at https lumiradx com us en what we do diagnostics test technology antigen test Exercise t...

Page 23: ...8 Results are displayed within 12 minutes of applying the sample The left hand image here shows a positive result for SARS CoV 2 Ag and the right hand image shows a negative result for SARS CoV 2 Ag Tap Finish to complete testing or tap Comment to leave a comment or to reject the Test then follow prompts to return to the Home Screen All test results must be read using the Lumiradx Instrument 1 Sel...

Page 24: ...in patient care settings operating under a CLIA Certificate of Waiver Certificate of Compliance or Certificate of Accreditation This test has been authorized only for the detection of proteins from SARS CoV 2 not for any other viruses or pathogens In the USA this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in...

Page 25: ...ct Insert and this entire pack insert In addition please watch the LumiraDx Platform Training video available at lumiradx com The Quality Controls are intended for healthcare professional use only Intended Use The LumiraDx SARS CoV 2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS CoV 2 Ag Test Strip The Quality...

Page 26: ...you are performing tests Recap and store the Control Vials in their original container at 2 C and 8 C 36 and 46 F after use Carton Contents 2 x 0 5ml vial SARS CoV 2 Ag Positive Control 2 x 0 5ml vial SARS CoV 2 Ag Negative Control 24 Transfer pipettes 20µl LumiraDx SARS CoV 2 Ag Quality Control Pack Insert Materials required but not provided with the Control Carton LumiraDx Instrument LumiraDx SA...

Page 27: ...e door while the test is in progress The touch screen will indicate test progress 4 The Result will appear on the touch screen within 12 minutes of applying the Quality Control solution and starting the test The results will be displayed as a PASS or FAIL QC result for SARS CoV 2 Ag on the instrument screen 5 NOTE If you need to repeat a test use a new Test Strip Expected results The Instrument di...

Page 28: ...rization number from LumiraDx Customer Services This return authorization number must be on the shipping carton for return For ordinary returns following purchase please contact LumiraDx Customer Services for terms and conditions Limited warranty LumiraDx SARS CoV 2 Ag Quality Controls Pack As per shelf life For the applicable warranty period LumiraDx warrants that each product shall be i of good ...

Page 29: ...gents provided under license right from TriLink BioTechnologies LLC Legal notices Copyright 2020 LumiraDx UK and affiliates All rights reserved LumiraDx and Flame logo are protected trademarks of LumiraDx International LTD Full details of these and other registrations of LumiraDx can be found at lumiradx com IP All other trademarks are the property of their respective owners Manufacturer informati...

Page 30: ...s by email customerservices US lumiradx com telephone 1 617 621 9775 or at lumiradx com SPEC 32180 Rev1 ART 00410 Rev1 Rev Date 2020 06 LumiraDx UK Ltd Dumyat Business Park Alloa FK10 2PB UK For Emergency Use Authorization Only LumiraDx Group Limited 2020 All rights reserved worldwide ...

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Page 34: ...ser Manual The LumiraDx Platform is for use with SARS Cov 2 Ab Test Strips and SARS Cov 2 Ag Test Strips under the Food and Drug Administration s Emergency Use Authorization only For In Vitro Diagnostic Use Rx Only ...

Page 35: ...strument 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...

Page 36: ...cting 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...

Page 37: ...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...

Page 38: ...ord 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 Qua...

Page 39: ...c Health Record HCP Health Care Professional ID Identification QC Quality Control RFID Radio Frequency Identification UK United Kingdom USB Universal Serial Bus WHO World Health Organization HIS Hospital Information System LIS Laboratory Information System DOB Date of Birth 6 ...

Page 40: ...opyright of LumiraDx Group Limited 2020 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 Lu...

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Page 42: ...h 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 Sca...

Page 43: ...Services Refer to the Customer Services chapter of this Platform User Manual for contact information Please note Instructions are combined with example screenshots Some screens may look different 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 ca...

Page 44: ...n at the start of this Platform User Manual before operating the Instrument In addition please watch the LumiraDx Platform Training Video available at kc 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 o...

Page 45: ...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 opt...

Page 46: ...ondensing Specific test operating conditions may be more restrictive Allow time for the Instrument to acclimatize to operating temperatures if it has been stored in a cold environment Allow time for the Instrument to acclimatise to operating temperatures if it has been stored in a cold environment Always place the Instrument on a level stable surface when powering up or starting a test Testing sho...

Page 47: ... prompt Do NOT apply more than one drop of sample Close the Instrument door after applying the sample and the Instrument prompt Do NOT touch the Test Strip until the test has finished and the result is displayed Do NOT open the door or move the Instrument during the test or an error will occur and the test result will not be saved Dispose of all Test Strips used for patient testing safely in accor...

Page 48: ...cal 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 Lumir...

Page 49: ... maintain compliance follow the instructions below The transmitter must not be co located or operating in conjunction with any other antenna or transmitter Avoid direct contact to the antenna or keep contact to a minimum while using the Instrument 16 Introduction Instrument disposal Do NOT attempt to replace or reinstate the battery ...

Page 50: ...ual protection provided by the equipment will be impaired The LumiraDx Instrument including power supply unit is designed to operate within the manufacturer specifications Do not exceed the manufacturer specifications when in use Avoidance of electrical shock fire and explosions Use only the power supply unit that is provided with the Instrument Use the appropriate power blade for the region The c...

Page 51: ...terference will not occur in a particular installation If this Instrument does cause harmful interference to radio or television reception which can be determined by turning the Instrument off and on the user is encouraged to try to correct the interference by one of the following measures a Reorient or relocate the receiving antenna b Increase the separation between the Instrument and receiver c ...

Page 52: ...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 kc 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 Services Refer to the Custom...

Page 53: ...Instrument powering on and the display will be blank for several seconds When prompted enter user ID and or password to login The Instrument touch screen will dim after 2 minutes of inactivity Tap the touch screen to restore the touch screen brightness To power the Instrument off after use press the power button at the rear of the Instrument for 2 seconds and tap the screen message to confirm powe...

Page 54: ...ing operated in standalone mode If the Instrument is being managed in a connected mode then these settings will be downloaded from Connect Manager 2 5 Operating mode and first time setup The language and current date and time will need to be set by the administrator prior to performing a patient test Other sound and display preferences can be set by any user Settings will automatically be download...

Page 55: ...used in conjunction with the LumiraDx family of Test Strips for the in vitro quantification of various analytes in a range of biological samples 2 6 The LumiraDx Instrument Test Strip slot 22 Getting Started Power connection USB port x2 Power button ...

Page 56: ... operation the Instrument touch screen always displays the battery power level and provides an alert when the battery level is low To save power when battery operated the Instrument will automatically power off after 55 minutes unless the touch screen is tapped When the Instrument powers off all result records will remain in the Instrument memory and any Instrument settings will be maintained Refe...

Page 57: ...installation is performed manually Locate the RFID reader by looking for the symbol on the side of the Instrument To install a new Lot Calibration File touch the back of the Test Strip Carton to the symbol to install When the Lot Calibration File is installed the Instrument will sound and a confirmation message will be displayed The Instrument will prompt to install the Lot Calibration File when i...

Page 58: ...ials Manage compliance and governance functions LumiraDx Connect Manager LumiraDx Connect Manager Electronic Health Record LumiraDx Instrument LumiraDx Connect Hub or LumiraDx Connect App LumiraDx Instrument 2 9 Extended functionality and operating modes The LumiraDx Instrument can be used in Standalone mode or two Connected modes Managed and EHR Connected meaning connected to the organization s e...

Page 59: ...p Product Insert for further information on handling and stability 3 2 Inserting and removing Test Strips Hold the Test Strip by gripping the blue label end with the label facing upward Line up the black alignment rib on the Test Strip with the black line on the Instrument Insert the Test Strip gently as far as it will go The Instrument will sound when the Test Strip is detected if sounds are turn...

Page 60: ...ib Line up black line on Test Strip with black line on Instrument Test type Sample Application Area Apply sample or Quality Control solution AFTER inserting Test Strip Preparation for Testing 27 Note Test Strip may appear differently ...

Page 61: ... tip on the side which faces down Before lancing ask the patient to rinse their hands in warm water and dry them This is good practice to remove any residue and to increase the blood flow in the finger Holding their arm straight down at their side or massaging the finger from its base also increases blood flow to produce a sufficiently large hanging blood drop Applying a finger stick sample to the...

Page 62: ...ple into the tube Do NOT squeeze the bulb of the transfer tube before or during sample collection Do NOT allow the transfer tube to touch the finger Ensure the transfer tube is filled to the black fill line or to the end of the collection tube depending on what type of transfer tube is being used If air bubbles are seen discard the transfer tube and start again Preparation for Testing 29 Touch the...

Page 63: ...ed Applying a transfer tube sample to the Test Strip Hold the filled transfer tube vertically over the Sample Application Area and gently squeeze the bulb or depress the plunger to move the sample to the tip of the transfer tube Allow the blood drop to touch the sample application area without releasing the pressure on the bulb to apply the sample When the sample is detected the Instrument will so...

Page 64: ... time setup set preferences perform patient and Quality Control tests and view result history Extended functionality for Connected Instruments is also described Please note Instructions are combined with example screenshots Some screens may appear differently depending on the test or mode of operation All screens test names and results displayed in this Platform User Manual are intended only as ex...

Page 65: ... set date and time Refer to the Instrument Operation chapter in this Platform User Manual for instructions The About screen provides information on Instrument software and hardware versions and serial number For Connected Instruments the screen will also display the Organization Instrument and WorkGroup names Factory Reset can be used to delete all data currently stored on the Instrument including...

Page 66: ...ce Guide 1 Power on Power on the Instrument by pressing the power button at the rear of the Instrument You will hear the Instrument powering on and the display will be a blank black screen for several seconds before starting up If the screen is just dimmed tap the touch screen to wake up the Instrument 2 Enter Password Tap the password field to display the keyboard Enter password using administrat...

Page 67: ...nter Tap Done then check the date and time are correct and tap Confirm to save Return to the home screen and tap Logout 3 Set language The language is set to English by default To set a different language go to Settings and tap Language Choose a language from the list for the text appearing on the display The currently set language is ticked Tap Done to save and return to the Settings menu 34 Inst...

Page 68: ...teps for Standalone first time setup to set the language Instrument Operation 35 To download other Instrument settings ensure the Instrument is within range of a LumiraDx Connect Hub or a device running the LumiraDx Connect App within approximately 10 metres If appears at the top of the screen the Instrument is connected to Connect Manager and the Instrument settings will download and install auto...

Page 69: ...Electronic Health Record Downloading settings for first time setup will take up to 4 minutes A will appear at the top of the screen for EHR Connected Instruments This integrates the LumiraDx Instrument with the existing Electronic Health Record for transfer of patient test results Patient test results can then be viewed within the LIS or HIS 36 Instrument Operation ...

Page 70: ... or to set the volume using the slider Tap Done to save and return to the Settings menu All users can set display and sound preferences in the Settings menu Display In the Display menu the brightness of the display can be set Go to Settings and tap Display Use the slider to adjust the brightness Tap Done to save and return to the Settings menu Instrument Operation 37 ...

Page 71: ...tant Notes To view test information during a patient test or on the test result screen tap the at the top of the touch screen To cancel a patient test tap Cancel at the top of the touch screen and follow the Instrument prompts ALWAYS Place the Instrument on a level stable surface before starting a test Apply sample AFTER inserting the Test Strip and the Instrument prompt Follow the test operating ...

Page 72: ...g a Standalone Instrument with just a password field tap the password field to display the keyboard Enter password and tap Login to complete the login If using a Connected Instrument tap the User ID field to use the keyboard to enter User ID Alternatively scan User ID using the Barcode Scanner Refer to the Ancillary devices chapter in this Platform User Manual for scanning instructions Tap the pas...

Page 73: ...n 4 Enter patient details Tap any field to use the keyboard to enter patient details or scan the patient ID using the Barcode Scanner Refer to the Ancillary devices chapter in this Platform User Manual for scanning instructions Use the Enter button on the keyboard to move from field to field or tap a field to enter additional details Complete all available patient details then tap Next to continue...

Page 74: ... adding any details To search for a patient either the full Patient ID or Last Name must be entered EHR Connect patient search If only one patient matches the details entered the Instrument will show the Confirm Patient Details screen If between 2 and 5 patients match the search details entered the list of matches will be shown Select the correct patient from the search list Note Tap Skip to proce...

Page 75: ... 5 patients matches are found a message will display Tap proceed to proceed with the test without verifying the patient details or tap cancel to go back and try a new search 6 Confirm patient details Check patient details are correct and tap Confirm to proceed 42 Instrument Operation ...

Page 76: ...t will sound when the Test Strip is detected Do NOT touch Test Strip Sample Application Area Do NOT touch Test Strip contacts Do NOT apply sample until prompted 8 Select sample type Select the intended sample type from the list displayed Sample type is test type dependent refer to the LumiraDx Test Strip Product Insert for more information Note The Instrument will prompt to install the Lot Calibra...

Page 77: ... Test Strip The sample must cover the entire Sample Application Area Refer to the Handling Test Strips chapter in this Platform User Manual for sample application instructions The Test Strip draws up the sample by capillary action Note Pay attention to the countdown for sample application to avoid test errors This will be displayed as a countdown bar and the Instrument will sound with 10 seconds r...

Page 78: ...ished and the result is displayed 11 Immediately close door to continue The Instrument display will prompt to close the door Note The countdown bar is only displayed for a few seconds It is important to close the door quickly when prompted to avoid test errors If the door is not closed by the end of the countdown the Instrument will sound and display an error message Instrument Operation 45 ...

Page 79: ...ess bar will be displayed whilst the test is processing Note Each test type has a different processing time Do NOT open the door or move the Instrument during the test or an error will occur and the test result will not be saved 46 Instrument Operation ...

Page 80: ...p Finish or tap Comment to add a comment if required A comment may be up to 50 characters in length To reject a test result go to Comment and tap Reject result A comment must be added if a test result is rejected Once the desired comment s are entered tap Done to return the result screen Tap Finish to save the test result to Result History and complete the test Note If operating the Instrument in ...

Page 81: ... Control policy set to Mandatory by in the Connect Manager settings This means that users and administrators are not able to perform a patient test when a Quality Control test for that particular test is due The timing and frequency of mandatory Quality Control tests are configurable in Connect Manager 48 Instrument Operation 14 Remove and dispose of Test Strip The Instrument will prompt to remove...

Page 82: ...ent on a level stable surface before starting a test Use only LumiraDx Quality Controls Apply Quality Control AFTER inserting the Test Strip and the Instrument prompt 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 To view test information during a QC test or on the te...

Page 83: ...strator Refer to First time setup in this chapter for more information 3 Prepare Quality Control Prepare the Quality Control according to the LumiraDx Quality Control Pack Insert 4 Tap Quality Control Tap the Quality Control button on the home screen 5 Select Quality Control Test Tap Quality Control Test from the Quality Control menu 50 Instrument Operation ...

Page 84: ... line on the Instrument Insert the Test Strip gently as far as it will go The Instrument will sound when the Test Strip is detected 7 Confirm test type Check the test type is correct and tap Confirm to proceed Note The Instrument will prompt to install the Lot Calibration File when inserting a new Test Strip Lot Do NOT touch Test Strip Sample Application Area Do NOT touch Test Strip contacts Do NO...

Page 85: ...Quality Control Lot number Tap the input field to use the keyboard to enter the 16 digit Quality Control Lot number and tap Next to continue Alternatively scan the Quality Control barcode using the Barcode Scanner Refer to the Ancillary devices chapter in this Platform User Manual for scanning instructions Note If the barcode from a different QC level or test from the one selected on the previous ...

Page 86: ...ng with LumiraDx Quality Controls Note Pay attention to the countdown for sample application to avoid test errors This will be displayed as a countdown bar If the sample is not applied by the end of the countdown the Instrument will sound and display an error message When the Quality Control sample is detected the Instrument will sound and a confirmation message will be displayed Do NOT apply more...

Page 87: ...ll be displayed as a countdown bar for only a few seconds If the door is not closed by the end of the countdown the Instrument will sound and display an error message 12 QC test processing The QC test will start and a progress bar will be displayed whilst the test is processing Note Each test type has a different processing time Do NOT open the door or move the Instrument during the test or an err...

Page 88: ...up to 50 characters in length Once the desired comment s are entered tap Done to return the result screen Tap Finish to save the test result to Result History and complete the test 14 Remove and dispose of Test Strip The Instrument will prompt to remove the Test Strip Gently pull the blue label end of the Test Strip to remove and dispose Close the Instrument door Dispose of all Test Strips used fo...

Page 89: ...trol Pack Insert for more information on QC levels Repeat steps in Performing a Quality Control test to test any additional QC levels 16 Mandatory Quality Control Policy Connected Instruments with the Quality Control policy set to mandatory will have an additional menu item of Quality Control Status 56 Instrument Operation ...

Page 90: ...patient test or QC test performed for more than 90 days Note QC statuses can also be filtered by test type The Quality Control level selection screen will also show the status of each QC level as well as the date of any recently performed QC tests After completing a QC test level the Instrument will return to the QC level selection page until all QC levels have been completed Instrument Operation ...

Page 91: ...mpts to perform a patient test using a lot for which a mandatory Quality Control test is due the Instrument will display an alert message and prompt the user to perform a Quality Control test 58 Instrument Operation ...

Page 92: ...y selecting Patient Tests QC Tests Rejected Tests or Invalid Tests Test results are marked as Invalid if a system error occurs during test processing Refer to the Troubleshooting chapter of this Platform User Manual for information on errors Scroll through the list and tap any entry to view the test result in full Search for a patient test result by entering the Patient ID First Name or Last Name ...

Page 93: ...t when a LumiraDx Printer is connected to an Instrument USB port EHR Connected Instruments will indicate whether a test result has been sent to the electronic health record A symbol on the home screen indicates that one or more test results have not yet been sent to the EHR 60 Instrument Operation ...

Page 94: ...The Result History list will indicate whether test results have been sent to the EHR or not with sent and not sent Instrument Operation 61 ...

Page 95: ...OBC test has passed the test result will be displayed as normal Tapping on the on the result screen at the end of the test or from the Result History view shows additional details about the test including Control Valid which confirms that the OBC has passed If the OBC fails then an error message will be displayed and no test result will be returned Follow the on screen instructions to dispose of t...

Page 96: ...Instrument Operation 63 A test which fails the OBC will appear in the Invalid filter of the Results History ...

Page 97: ...is visibly dirty The Instrument should be disinfected after each patient use and anytime you believe the Instrument may be contaminated with a patient sample or Quality Control solution What should be cleaned and disinfected The following parts of the Instrument can be cleaned and or disinfected The area around the Test Strip slot The entire Instrument housing The Instrument touch screen All surfa...

Page 98: ...t for 5 minutes Let air dry Dispose of the wipes in accordance with local procedures The Instrument is now ready to perform another test For technical assistance or questions and information about LumiraDx approved wipes go to lumiradx com Only use LumiraDx recommended cleaning and disinfecting materials on the Instrument surfaces Details of LumiraDx approved wipes can be found at lumiradx com Alw...

Page 99: ...e that the Instrument is connected to a power supply before performing a software update 6 Software Updates 2 Power on Power on the Instrument by pressing the power button at the rear of the Instrument A progress bar on the Instrument display will indicate installation Once installation is completed the Instrument will power on as usual Remove the USB memory stick from the Instrument once complete...

Page 100: ...he Instrument status or error and an instruction Error messages contain an identifying code that may be used for further troubleshooting purposes Follow the instruction to resolve the issue If the issue is resolved continue using the Instrument as required If errors occur frequently or the error persists please note the error code and contact Customer Services If the Instrument has been dropped do...

Page 101: ...t and follow the instructions on the display Example error message Error 002 Description and instruction The Instrument door has been opened while running a test so the test cannot be completed Dispose of Test Strip start a new test and follow the instructions on the display Example error message Error 006 Description and instruction When a test is performed the Instrument must be level and statio...

Page 102: ...a new test and follow the instructions on the display Example error message Error 038 Description and instruction Insufficient sample volume or Instrument has experienced a problem and cannot complete a test Dispose of the Test Strip start a new test and follow the instructions on the application of samples in this User Manual If the problem persists contact Customer Services Example error message...

Page 103: ...uctions on how to install the Lot Calibration File 2 Ensure that the back of the Test Strip Carton is touching the symbol on the side of the Instrument continually until the Instrument sounds and a confirmation message is displayed Cannot login Do not have or know where to find the correct password 1 Check tear out sheet in the Platform Quick Reference Guide for the login password or contact the a...

Page 104: ... to the First time setup section of this Platform User Manual for instructions on setting date and time Patient test result is red If the patient test result is displayed in red Test results that are above or below the analytic range are displayed in red and indicated by the symbols above or below QC test failure If the Quality Control test fails unexpectedly 1 Check the Quality Control solution t...

Page 105: ...rts No attempt should be made to open the Instrument Changes or modifications not expressly approved by LumiraDx UK Ltd could void the user s authority to operate the Instrument In case of Instrument failure or damage or to arrange collection disposal contact LumiraDx Customer Services 8 Maintenance and Disposal ...

Page 106: ... storage 1000 test results with date time and comments Lot calibration files Communications 2 x USB ports RFID Reader 13 56MHz 0 dBi EIRP Bluetooth Low Energy 2 4GHz ISM band 2400MHz to 2483 5 MHz 0 5dBm ERP Power supply unit Input 100 240V 50 60 Hz 1 0 0 5A Output 12V 3A Battery Lithium Ion Polymer 7 4V 5000 mAh Approx 20 tests per charge cycle Dimensions 210 x 97 x 73 mm Weight 1 100 g Instrumen...

Page 107: ...canner can be used to scan User ID for login Note The same User ID must be assigned to the user in Connect Manager 10 Ancillary Devices 74 Ancillary Devices Scanning distance Hold scanner approximately 15 cm from barcode Scanner lights Scan button Press button to scan A successful scan will be indicated by a beep sound and green light Barcode symbol on screen indicates that you can scan for data e...

Page 108: ...y Devices 75 LumiraDx Barcode Scanner Cradle Attaching LumiraDx Barcode Scanner cradle to Instrument Detaching LumiraDx Barcode Scanner cradle from Instrument Note Correct orientation of Barcode Scanner cradle ...

Page 109: ...76 Ancillary Devices LumiraDx Desktop Stand ...

Page 110: ...led Open the paper cup lid and then close ensuring that the paper passes through the paper exit slot Replacement label rolls can be purchased from LumiraDx Insert the rechargeable batteries into the Printer followed by the USB cable and power cable Fully charge the batteries for 16 hours before first use by connecting the Printer to a power source To use the Printer insert the USB connector into o...

Page 111: ...Printer Off Paper Out Fit new paper Thermal head too hot Allow head to cool Battery cut out no charge remaining Recharge batteries Battery low approx 20 charge remaining Recharge batteries 78 Ancillary Devices Printer status light Connecting the printer ...

Page 112: ...3 LumiraDx USB Memory Stick LumiraDx USB Memory Stick used for Instrument software updates Note Right side USB port nearest the power button at the rear of the Instrument must be used Ancillary Devices 79 ...

Page 113: ...10 5 LumiraDx Connect App Refer to LumiraDx Connect User Manual and Connect Hub Pack Insert for information and setup instructions Refer to LumiraDx Connect User Manual for information and setup instructions 80 Ancillary Devices ...

Page 114: ...ess or implied including but not limited to any warranty of merchantability fitness for a particular purpose and non infringement regarding the product LumiraDx s maximum liability with any customer claim shall not exceed the net product price paid by customer Neither party shall be liable to the other party for special incidental or consequential damages including without limitation loss of busin...

Page 115: ...acute healthcare facility level http who int gpsc ipc components guidelines en 3 CDC Guideline for Isolation Precautions Preventing Transmission of infectious Agents in Healthcare Settings 2007 https cdc gov infectioncontrol guidelines isolation index html 4 CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens https cdc gov injec...

Page 116: ...fety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements CAN CSA C22 2 No 61010 2 101 15 Safety requirements for electrical equipment for measurement control and laboratory use Part 2 101 Particular requirements for in vitro diagnostic IVD medical equipment UL 61010 1 Third Edition Safety requirements for electrical equipment for measurement...

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