QUOTIENT MOSAIQ 125 User Manual Download Page 162

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CYBERSECURITY

/ IDENTIFICATION OF POSSIBLE INSTALLATION / CONNECTION SCENARIOS

162

TION SCENARIO

MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02

14.10.2 SCENARIO 2 - CONNECTION OF THE MOSAIQ TO A LOCAL NET-

WORK – LIS ON NETWORK OR DIRECTLY CONNECTED

The connection of the MosaiQ to a LIS through the Laboratory local area network
can potentially create vulnerabilities related to local access to the

MosaiQ 125

. The

vulnerabilities that are related to a direct physical access to the

MosaiQ 125

must be

considered.

(MosaiQ 125 network connection)

Summary of Contents for MOSAIQ 125

Page 1: ...USER MANUAL MosaiQ 125 MosaiQ 125 User Manual November 2020 Reference n MMSURM 0010 02 FCC ID 2AWE5MOSAIQ125...

Page 2: ...2 MosaiQ 125 User Manual November 2020 Reference n MMSURM 0010 02 Page intentionally left blank...

Page 3: ...29 6 GRAPHICAL USER INTERFACE 47 7 OPERATING INSTRUCTIONS 54 8 SAMPLE LOADING AND TESTING 85 9 QUALITY CONTROL 111 10 MOSAIQ 125 SHUTDOWN 116 11 ADVANCED FUNCTIONS 118 12 MAINTENANCE 128 13 TROUBLESHO...

Page 4: ...1 4 HOW TO USE THE USER MANUAL 5 1 5 GENERAL INFORMATION 5 1 6 VERSION 6 1 6 1 EDITION 6 1 6 2 SOFTWARE 6 1 7 TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY 6 1 7 1 SPECIAL TYPES 6 1 7 2 TERMINOLOGY 7 1 7...

Page 5: ...MATION The MosaiQ 125 is designed and manufactured in accordance with the safety requirements for electronic equipment and medical devices It is the user s responsibility to comply with local and nati...

Page 6: ...onventions and terminology conventions used in this MosaiQ 125 User Manual To aid readability the following conventions are used throughout the manual 1 7 1 SPECIAL TYPES Certain system components of...

Page 7: ...requently used terms Term De nition User The term User refers to any person who uses the MosaiQ 125 for its intended use Service personnel The term Service personnel refers to service personnel author...

Page 8: ...ork LED Light Emitting Diode LIS Laboratory Information System Ltd Limited Liability Company m Meter min Minute mL Milliliter mW Microwave radiation NaOH Sodium hydroxide Acronyms De nition nm Nanomet...

Page 9: ...t in serious injury or death CAUTION CAUTION Indicates a hazardous situation that if not avoided could result in minor or moderate injury NOTICE NOTICE Indicates information considered important but n...

Page 10: ...gue number Serial number In vitro diagnostic medical device Caution consult accompanying documents Consult instructions for use CE marking Manufacturer Date of manufacture YYYY MM DD Restriction of ce...

Page 11: ...edures are the same 1 9 METRIC SYSTEM The MosaiQ 125 its equipment and accessories have been developed and built using the metric system Units of measurement are given using the metric system All fast...

Page 12: ...e n MMSURM 0010 02 2 INTENDED USE 2 1 INTENDED USE 13 2 2 MOSAIQ SYSTEM COMPOSITION 13 2 3 PRINCIPLES OF OPERATION 13 2 3 1 MOSAIQ 125 PROCESS WORKFLOWS 13 2 4 RESULTING PRINCIPLES 15 2 4 1 IMAGING 15...

Page 13: ...MosaiQ Software driving the Graphical User Interface GUI The MosaiQ Standard Magazines or MosaiQ Quantum Magazines for Serological Disease Screening SDS The associated MosaiQ system reagents sample d...

Page 14: ...emove the excess of the detection reagents needed for the assay if applicable Dispensing Thedispensingsteps ifapplicable areusedfortheadditionoftheassociated detection and enhancement reagents resulti...

Page 15: ...easure the intensity of the microarray panel spots in relation to the background The intensity of each spot is quali ed into one of these three possible states Reactive Non reactive Technical Error if...

Page 16: ...SER QUALIFICATION 17 3 1 2 ADVANCED USER QUALIFICATION LABORATORY ADMINISTRATOR 17 3 1 3 USER TRAINING 17 3 2 EQUIPMENT OVERVIEW 18 3 2 1 MOSAIQ MAGAZINES 18 3 2 2 MOSAIQ SYSTEM REAGENTS 18 3 2 3 MOSA...

Page 17: ...DVANCED USER QUALIFICATION LABORATORY ADMINIS TRATOR The advanced users commonly know as laboratory administrators will be trained to perform additionally tasks that are restricted to their function s...

Page 18: ...saiQ SDS Magazine IFU 3 2 2 MOSAIQ SYSTEM REAGENTS Various reagents including MosaiQ wash buffers MosaiQ detection reagents MosaiQ enhancement reagents and MosaiQ sample diluents are necessary to perf...

Page 19: ...osaiQ Enhancement Reagent 1 7 MosaiQ Detection Reagent 2 8 MosaiQ Detection Reagent 1 MosaiQ detection and MosaiQ enhancement reagent bottles For detailed information please refer to the appropriate I...

Page 20: ...s manual illustration of a lled sample tube 3 2 6 SAMPLE RACKS Sample tubes are loaded onto the MosaiQ 125 in MosaiQ sample racks Twelve sample tubes can be loaded onto one rack and in turn ten racks...

Page 21: ...SURM 0010 02 3 2 7 SYSTEM WASTE The following different container and canisters are provided with the MosaiQ 125 Solid waste container that is built into the MosaiQ 125 to be used with biological wast...

Page 22: ...4 2 ELECTRICAL SAFETY 24 4 3 BIOLOGICAL SAFETY 25 4 4 SAFETY AND TIPS ABOUT DISPOSAL AND DECONTAMINATION 25 4 5 POSITIONS OF SAFETY LABELS AND TYPE LABEL 26 4 5 1 MISSING WARNINGS 26 4 5 2 POSITIONS O...

Page 23: ...es caused by improper use or handling of the MosaiQ 125 Missing Improperly Opened Damaged or Opened Protective Covers WARNING To avoid serious injuries with deadly consequences due to electric shock o...

Page 24: ...r Connection of Mains Power Supply DANGER Improper connection of the MosaiQ 125 and peripheral devices to the mains power supply can cause serious personal injury with potential deadly consequences an...

Page 25: ...ents NOTICE Canisters and hoses can be seriously damaged by some organic solvents and become unusable Please follow the cleaning instructions provided in this manual 4 4 SAFETY AND TIPS ABOUT DISPOSAL...

Page 26: ...hazardous Please follow the safety instructions provided on the product packaging and IFU Strictly follow the local and national provisions legislation and laboratory regulations Do not mix bleach or...

Page 27: ...ft side of the front pump panel On the left side of the pipettor sledge On the right side of the pipettor sledge Electrical Hazard Above the power switch Laser Radiation Do not stare into beam Class 2...

Page 28: ...f the MosaiQ 125 FCC Statements CAUTION Changes or modi cations not expressly approved by the party responsible for compliance could void the user s authority to operate the MosaiQ 125 INFO The MosaiQ...

Page 29: ...6 MAGAZINE STATION 35 5 7 SAMPLE STATION 36 5 8 WASTE DRAWER 37 5 9 WATER DRAWER 38 5 9 1 WATER CANISTERS 38 5 9 2 COMPUTER WORKSTATION 39 5 10 REAGENT DRAWER 40 5 11 PROCESS MODULES 41 5 11 1 REAGEN...

Page 30: ...components parts of the MosaiQ 125 and where to nd them 5 1 EXTERNAL PARTS Touch screen Magazine station Sample station Waste drawer Visual alarm alert Reagent door Power switch Reagent drawer Water d...

Page 31: ...November 2020 Reference n MMSURM 0010 02 5 2 INTERNAL PARTS Pipettor module Microarray turntable Washer modules 1 and 2 Reagent carriage MosaiQ 125 internal parts localization Top view upper panel re...

Page 32: ...125 User Manual November 2020 Reference n MMSURM 0010 02 Magazine station Sample loading station Camera module Incubator module Camera module Incubator module Magazine station Sampe loading station M...

Page 33: ...Power switch Mains fuse box Mains power cord MosaiQ 125 power switch and mains power outlet 5 4 VISUAL ALERT ALARM The different status of the visual alert alarm indicate that the MosaiQ 125 is operat...

Page 34: ...02 5 5 TOUCH SCREEN The touch screen is the interface between the user and the MosaiQ 125 Users control and operate the MosaiQ 125 via the MosaiQ Software using the touch screen MosaiQ 125 touch scree...

Page 35: ...250 MosaiQ Quantum Magazine The maximum capacity is 1000 microarrays Function The magazine station holds the MosaiQ magazines and also supplies the MosaiQ 125 with microarrays to process Magazine stat...

Page 36: ...hite lights located above the loading area of the sample station are used to give a permanent status on each of the 10 lanes as described below Light status Lane status Note Off Lane empty Sample rack...

Page 37: ...id waste from MosaiQ system reagents processed samples and system liquid on the left hand side provided with your MosaiQ 125 One compartment with the solid waste container to be used with a biological...

Page 38: ...all be lled with puri ed water also called system liquid in this manual Both canisters are connected to an intermediate container with a 5 L capacity NOTICE Puri ed water is used in general laboratory...

Page 39: ...nd controls the assay processing NOTICE The computer workstation has its own mains power cord for connection to the mains power supply The computer mains power cord passes through a hole on the back o...

Page 40: ...nt bottles in the MosaiQ 125 please refer to chapter 8 3 6 of this manual Capacity The reagent drawer has a capacity of up to eight bottles Reagents each of these reagents has a speci c position on th...

Page 41: ...e used at speci c steps in the assay procedure such as washing dispensing of reagents and imaging To open the reagent door lift the door until it is looked Some of the process modules are visible from...

Page 42: ...iQ Detection Reagent 1 MosaiQ Detection Reagent 2 MosaiQ Enhancement Reagent 1 MosaiQ Enhancement Reagent 2 Technology An RFID reader is used to read and write on the RFID tags present on each reagent...

Page 43: ...Wash module 2 is connected to the MosaiQ Wash Buffer 1 and the system liquid The reagent drawer has a capacity of loading two bottles of MosaiQ Wash Buffer 1 and two bottles of MosaiQ Wash Buffer 2 5...

Page 44: ...d of the incubator module processing stage The images are stored within the MosaiQ Software and are not accessible to the user NOTICE The images taken are not accessible to the user They can only be a...

Page 45: ...Diluent 2 pipetting pipetting area Function 1 First the dedicated needle aspirates the appropriate diluent depending on the test performed It can access the sample diluents via two wells one for Mosai...

Page 46: ...is provided with detachable components and accessories as described below 5 12 1 MATERIAL PROVIDED Quantity Description Crate 1 MosaiQ 125 1 2 1 Computer Workstation 1 2 1 Display display holder 1 2 1...

Page 47: ...ce n MMSURM 0010 02 6 GRAPHICAL USER INTERFACE 6 1 GUI OVERVIEW 48 6 1 1 MAIN SCREEN 48 6 1 2 NAVIGATION BAR 49 6 2 MOSAIQ MENU 50 6 2 1 BASIC FUNCTIONS 50 6 2 2 LABORATORY ADMINISTRATIVE FUNCTIONS 51...

Page 48: ...n the touch screen are Tap once on the screen with your nger to single click Tap twice on the screen with your nger to double click Swipe up and down to scroll lists for example the results screen INF...

Page 49: ...or to change users Refer to chapter 6 3 It shows the system to status e g Idle Initializing Processing Finishing Maintenance Error To consult the current process and any upcoming tasks Refer to chapt...

Page 50: ...nctions available from the navigation bar basic functions Tap to display the noti cations menu and the messages Refer to chapter 6 2 3 Tap to access the User Manual Tap to initialize the MosaiQ 125 Ta...

Page 51: ...l users role to add edit and delete users Refer to schapter 11 3 Tap to con gure sample loading Refer to chapter 8 6 2 3 NOTIFICATIONS MENU The following section shows how noti cations are displayed N...

Page 52: ...ion symbol in the top right corner reminds the user about currently active and unresolved messages The symbol has the same color as the message severity color The number inside the symbol indicates th...

Page 53: ...0010 02 6 3 LOCK SCREEN Duringthetestrun thescreenisautomaticallylockedafteracon gurabletime installation settings The lock screen shows all information about the status of the system Login to access...

Page 54: ...D EACH RESOURCE 66 7 3 1 REMOVING MAGAZINES 66 7 3 2 LOADING MAGAZINES 67 7 3 3 REMOVING MOSAIQ DETECTION AND MOSAIQ ENHANCEMENT REAGENT BOTTLES 69 7 3 4 LOADING DETECTION AND ENHANCEMENT REAGENT BOTT...

Page 55: ...s can cause serious injuries with deadly consequences or damage to the MosaiQ 125 Follow the steps in the individual instructions closely Check correct data input Check correct application of the load...

Page 56: ...ottles Load reagent bottles Load magazines Waste Empty solid waste container waste bag Empty liquid waste canisters System liquid Fill the water canister with puri ed water Maintenance Execute require...

Page 57: ...OPERATING INSTRUCTIONS BEFORE STARTING TO TEST SAMPLES 57 MosaiQ 125 User Manual November 2020 Reference n MMSURM 0010 02 processing sequence overview...

Page 58: ...us to Health 5 Ensure that the connector on the liquid waste connector is securely locked in position refer to chapter 7 3 10 6 Ensure that the solid waste drawer is empty rmly shut and locked into pl...

Page 59: ...saiQ Software to start 7 Initialization starts automatically and lasts approximately 5 minutes Initialization allows MosaiQ 125 to check that all hardware modules are functioning as expected initializ...

Page 60: ...ution message and it will prevent the execution of the run the Add to Process button will not be available 1 To control available resources tap on the Resources icon in the navigation bar 2 The Resour...

Page 61: ...has only SDS magazines loaded the screen will display only the SDS magazine level bar MosaiQ 125 will always use the magazine which has a shorter period of validity rst To return to the main Resource...

Page 62: ...en shows the remaining volume of each reagent in each bottle 2 Tap on the Reagents area to check the reagent details 2 1 reagents resources area 3 The following data are displayed for each reagent The...

Page 63: ...yed for each type of bottle The reagent position The lot number The expiry date Bottle is full Bottle is low level Bottle validity is expired 3 Bottle is empty buffers and diluents resources details I...

Page 64: ...2 1 system liquid resources area 3 Check the remaining volume in each canister To re ll the canister please refer to chapter 7 3 12 of this manual 3 Connected Not connected system liquid resources det...

Page 65: ...eir maximum capacity a message will appear on the touch screen to inform you that both liquid waste canisters are full Solid waste when the maximum calculated threshold is reached a message will appea...

Page 66: ...operations 1 1 Open the magazine station door and rotate the magazine carousel until the empty magazine is facing you 2 Remove the magazine from the magazine station 2 Pull the upper part of the magaz...

Page 67: ...same time To load magazines 1 Tap on the Resources icon 2 Tap on the Magazine area 2 1 magazine resources area 3 The detailed Magazines screen is displayed Information contained in the magazine RFID t...

Page 68: ...e is securely in place 1 Insert the bottom of the magazine rst 2 Push the upper part of the magazine against the drum until a click is heard 1 2 loading the magazine in the magazine station 8 To load...

Page 69: ...remove reagent bottle from the reagent carriage on the MosaiQ 125 The system software controls the reagent door locking and unlocking 1 Tap on Resources icon in the navigation bar 2 Tap on the Reagen...

Page 70: ...off reagent door CAN be opened reagent door light status 4 Open the reagent door by lifting the door panel up opening the reagent door 5 Press the lock mechanism of the empty reagent bottle together...

Page 71: ...ction reagents and MosaiQ enhancement reagents into the MosaiQ 125 The system software controls reagent door locking and unlocking operations 1 Tap on the Resources icon in the navigation bar 2 Tap on...

Page 72: ...reagent door 5 Insert the reagent bottle at an angle into the corresponding reagent carriage position insertion of the reagent bottle The reagent carriage can support two bottles of each reagent 5 8 7...

Page 73: ...lock mechanism 7 Release the lock and make sure that it snaps into place 8 If necessary load another reagent bottle 9 Close the reagent door 10 Wait until the system initializes the reagent carriage...

Page 74: ...bottles are located in the reagent drawer The reagent drawer can be opened and closed manually when the MosaiQ 125 is in operation 1 Tap on the Resources icon in the navigation bar 2 Tap on the Wash B...

Page 75: ...pening the reagent drawer 5 Draw the empty bottles out removing of the buffer or diluent bottle 6 Dispose of the empty bottles follow the disposal information on the product IFU INFO Bottles can be re...

Page 76: ...ocated in the reagent drawer The reagent drawer can be opened or closed when the MosaiQ 125 is in operation 1 Open the drawer opening the reagent drawer 2 Insert the MosaiQ wash buffer and MosaiQ samp...

Page 77: ...a waste buffer with a capacity of 10 microarrays allowing up to 4 minutes to replace the bag during operation 1 Tap on the Resources icon in the navigation bar 2 Tap on the Liquid Waste Solid Waste a...

Page 78: ...d waste container The solid waste drawer can be opened and closed manually when the MosaiQ 125 is in operation 1 Open the waste drawer 2 Pull out the solid waste container 3 Insert one side of the emp...

Page 79: ...ble and can hold up to 10 L The liquid waste canister must be cleaned monthly please see chapter 12 7 1 of this manual CAUTION The liquid waste canister should be lled in accordance with the laborator...

Page 80: ...4 Open the waste drawer opening of the waste drawer 5 Remove the canister which is not in use signal LED off 6 Pull up the level sensor connectors only by holding the white plastic support Avoid pulli...

Page 81: ...gently 12 Close the screw caps WARNING Risk of injury While emptying the liquid waste canister wear protective glasses and gloves 7 3 10 LOADING LIQUID WASTE CANISTER This section explains how to loa...

Page 82: ...the liquid waste level sensor 7 3 11 REMOVING THE WATER CANISTER This section explains how to remove the water canister from the MosaiQ 125 The water canisters are located in the water drawer The wate...

Page 83: ...etailed information for each water canister is displayed water canisters detailed information 3 Open the water drawer opening the water drawer 4 Remove the canister straightforward to prevent damaging...

Page 84: ...0 L of puri ed water a canister can weigh up to 11 2 kg NOTICE The MosaiQ 125 requires puri ed water i e deionized water For more information on the water quality required please contact your local te...

Page 85: ...5 8 6 1 AUTOMATIC TEST ASSIGNMENT 95 8 6 2 MANUAL TEST ASSIGNMENT 95 8 7 INDIVIDUAL TEST ORDER ASSIGNMENT 97 8 8 BARCODE READING ERRORS 98 8 8 1 CHECK BARCODE LABELS 98 8 8 2 EDIT SAMPLE ID S 99 8 9 B...

Page 86: ...review criteria de ned in the application is met Rejected The order may be placed in the Rejected status from the Review status by user request In the Rejected status the result will not be transmitte...

Page 87: ...ocess the corresponding behavior user interaction capability and display method These status de nition and properties are described in the following chapters The 7 possible process order status are St...

Page 88: ...ation status For SDS displayed DS test order after the sample processing the results will be checked against con rmation criteria an initial reactive result on Syphilis T Pallidum triggers a con rmati...

Page 89: ...ther in the Finished Review Rejected or Completed status Order status Finished The order is placed in the Finished status from the Processing or Con rmation status when the nal result is available aft...

Page 90: ...me type may be used to avoid problems during the aspiration of liquids NOTICE The sample racks provided with the MosaiQ 125 are used for standard sample tubes as referred in chapter 8 11 If you need a...

Page 91: ...l supply INFO Never load more than one sample rack at the same time For proper barcode identi cation the sample racks must be loaded one after the other as indicated by the white light Ensure that you...

Page 92: ...Empty No rack loaded Processable collapsed The lane is waiting for a rack to be loaded Reading MosaiQ 125 is adjusting the focus of the barcode reader Processable expanded Ready to be processed as di...

Page 93: ...y Reading Loadable Loaded Querying Test Orders Processable collapsed Processable expanded Scheduled collapsed Scheduled expanded In Use Finished collapsed rack Finished expanded rack Loaded warning ex...

Page 94: ...ding the sample rack information Removing of the sample rack is possible Checking for LIS test order All test on this rack are nished Waiting for test orders An error e g missing sample ID has occurre...

Page 95: ...ube symbols as white circles automatic test assignment INFO Problems with automatic test assignment If the MosaiQ 125 is connected to a LIS system but the samples could not be automatically assigned t...

Page 96: ...list with all selectable test pro les 3 Select the test for each lane and each sample tube if the tests are different 4 4 Select the desired test pro le from the list 5 The chosen test pro le is shown...

Page 97: ...perform a different test order on each of the samples in a sample rack select the given sample number on the rack 2 Tick the appropriate box under the Test Orders list to apply the relevant test indi...

Page 98: ...the pipettor module 8 8 BARCODE READING ERRORS In some cases the barcode on a sample tube cannot be read A warning message is displayed The following screen is displayed if there is a barcode reading...

Page 99: ...mation strip beside the Sample ID 8 9 BARCODE SPECIFICATIONS 8 9 1 LABEL The barcodes used on the tubes must satisfy the CLSI AUTO2 A2 requirements The barcodes must also satisfy at least quality leve...

Page 100: ...rry out and monitor a test run using the graphical user interface It also provides information on end of run procedures and test results 8 11 1 OVERVIEW The diagram below provides an overview of test...

Page 101: ...eadily 3 Once a rack has been loaded and samples have been pipetted the rack can be replaced by a new rack in the same lane Navigate back to the Sample Loading icon When the upward facing arrow below...

Page 102: ...same sample ID may have several test results with different status The colors indicate the status of these test results as described below Test results status Test results are available Test has faile...

Page 103: ...reactive CMV and non reactive Syph reported result details 1 Tap on an overview line to show the complete details Reported Results reactive results The Reported Result screen shows the details of the...

Page 104: ...le loading screen the sample will automatically be assigned for testing 2 Select the appropriate test and tap on the Add to Process to run the retesting as described in chapter 8 6 The sample has been...

Page 105: ...must have an appriopriate reaction for the test to be interpreted by the MosaiQ Software The failure of one or more of these control probes during the image analysis will provide a Data Reduction Err...

Page 106: ...retesting verify the level of the MosaiQ system reagents as this might have been the cause of this error 5 con rm the test repeat 8 14 TEST RESULTS FLAGS This section explains how to nd test results a...

Page 107: ...reen displays the results details and the ag name 3 test result details with the result ag Flags de nitions for SDS tests Flags Type 1 Data Reduction Error There is no data returned 2 Processing Error...

Page 108: ...iew a result To do this start a two stage review process 1 Tap on the Results icon in the navigation bar 2 If necessary tap on the Finished button or another result menu entry 3 Tap on the desired tes...

Page 109: ...n the most important results 1 2 3 ltering test results 4 The following screen appears Combination of the conditions All shows only results that ful ll all conditions Delete the condition line To add...

Page 110: ...ns how to print test results using the graphical user interface To print the test results 1 Select and tap on the test to be printed 2 Tap on Print 1 2 printing test results NOTICE There are 2 possibl...

Page 111: ...ser Manual November 2020 Reference n MMSURM 0010 02 9 QUALITY CONTROL 9 1 QUALITY CONTROL METHOD 112 9 2 QUALITY CONTROLS PREPARATION 112 9 3 QUALITY CONTROLS LOADING AND RUNNING 113 9 4 QUALITY CONTR...

Page 112: ...TY CONTROLS PREPARATION Before loading any QC material into the MosaiQ 125 Follow the instructions for use of the QC material Let the QC material reach the room temperature if required Transfer the QC...

Page 113: ...until the light on the chosen lane blinks slowly 5 Insert the rack carefully into the selected lane and slide it in Follow the instruction on how to insert the rack into the MosaiQ 125 as described i...

Page 114: ...le tube if the tests are different 7 4 Select the desired test pro le from the list 8 The chosen test pro le is shown in the grey box 9 Tap on the grey box with the test pro le to assign it to the mar...

Page 115: ...n the Results icon in the navigation bar 2 If necessary tap on the Finished button 3 Tap on the QC test result to show the details 3 1 2 viewing the result of the sample with QC material NOTICE The in...

Page 116: ...racks from the MosaiQ 125 removing the sample rack 2 Remove all samples from the racks removing the sample tubes 3 Empty the liquid canister and solid waste container if necessary Discard the waste f...

Page 117: ...the Menu icon 2 Tap on the Shut Down button 2 1 shut down the MosaiQ Software 3 Con rm to shut down and wait until the PC has shut down touch screen is black 3 shut down con rmation 4 Switch off the M...

Page 118: ...N MODE 120 11 1 2 INACTIVITY TIME OUT 120 11 1 3 PASSWORD POLICY ENFORCEMENT 121 11 1 4 ALARM ALERT MODE 121 11 2 USERS ROLES 122 11 3 USER ADMINISTRATION 123 11 3 1 ADD A NEW USER ACCOUNT 124 11 3 2...

Page 119: ...cess certain software system con gurations 11 1 GENERAL SETTINGS On this screen you can modify several functionalities on the dedicated scroll button The kind of operational mode SDS only available Sa...

Page 120: ...rom this scroll button you can select the type of assays the MosaiQ 125 can run IH only not available IH and DS operation mode selection 11 1 2 INACTIVITY TIME OUT This function allows you to set the...

Page 121: ...sword characteristics password length and special characters enforcing password policy selection 11 1 4 ALARM ALERT MODE By taping on this scroll button you can select the Alarm Alert mode when the Mo...

Page 122: ...l of access rights Tasks Operator Laboratory Administrator Local technical representative Normal operation Load remove samples Load remove resources Start sample tests Show sample test results Start Q...

Page 123: ...ciated access rights The diagram below explains how to View a list of all user accounts Create a new user account Print out the list of users View the details of a selected user account Special access...

Page 124: ...Menu button 2 Tap on the Users button 3 Tap on the Add button to create a new user account 1 2 3 adding a new user 4 Fill in the appropriate elds Choose the appropriate role of the user All changes wi...

Page 125: ...sers button 3 Select the appropriate user account from the list 4 Tap on the Active button to deactivate the user account 1 2 3 4 deactivating a user account 11 3 3 DELETE A USER ACCOUNT This section...

Page 126: ...on the Menu button screen to access to the administration sub menu 2 Tap on the Users button 3 Select the appropriate user account from the list 4 Tap on the Reset button 1 2 3 4 resetting a user pass...

Page 127: ...sample pro le DS available only will be available on the Sample Loading dialog screen sample pro le in the sample loading dialog window To set a sample pro le 1 Tap on the Menu button screen to access...

Page 128: ...DILUENT 1 135 12 5 9 PRIME SAMPLE DILUENT 2 136 12 5 10SHIFT START 136 12 6 WEEKLY MAINTENANCE 137 12 6 1 WEEKLY MAINTENANCE TASKS OVERVIEW 138 12 6 2 CLEANING OF THE PIPETTOR NEEDLES 140 12 6 3 CLEA...

Page 129: ...echanical injury if the MosaiQ125isnotdisconnectedfromthemainspowersupplybefore performing some maintenance Please read the maintenance instructions carefully Additionally there is the danger that the...

Page 130: ...ONTAMINATION This section provides information on how to clean disinfect and decontaminate the MosaiQ 125 It also provides information on the recommended cleaning products NOTICE Comply with the follo...

Page 131: ...oducts Only use 70 alcohol i e Isopropanol to decontaminate the external parts of the MosaiQ 125 Only use decontamination liquid in accordance with the User Manual 12 3 PREVENTIVE MAINTENANCE TO BE PE...

Page 132: ...n on the external surfaces where it is safe to do so away from all ports outlets and connections Another option is to spray cleaning solution onto a lint free wipe which can then be used to clean the...

Page 133: ...lable capacity in the waste canister For more information to check resources levels please refer to chapter 7 2 2 The daily maintenance tasks must be executed to ensure each module is primed and ready...

Page 134: ...MAINTENANCE DAILY MAINTENANCE TASKS 134 MosaiQ 125 User Manual November 2020 Reference n MMSURM 0010 02 12 5 1 DAILY MAINTENANCE TASKS OVERVIEW...

Page 135: ...saiQ sample diluents are plugged in On the touch screen 1 Tap on Maintenance on the navigation bar 2 Tap on Initial Washer Prime 3 Tap on Execute Task on the right side of the screen to start the main...

Page 136: ...three times consecutively On the touch screen 1 Tap on Maintenance on the navigation bar 2 Tap on Prime Diluent 2 3 Tap on Execute Task on the right side of the screen to start the maintenance 12 5 10...

Page 137: ...isk of aerosols coming into contact with electrical components Safety and precautions WARNING Unless speci ed any cleaning disinfection operation performed on the MosaiQ 125 by the user must be carrie...

Page 138: ...se read the details for each maintenance task in the corresponding chapter The table is split in three sections Maintenance tasks that must be performed when MosaiQ 125 is connected to the mains elect...

Page 139: ...MosaiQ 125 User Manual November 2020 Reference n MMSURM 0010 02 WARNING All of these cleaning disinfection operations must be carried out with the power supply cord disconnected from the power source...

Page 140: ...connected to the mains power supply For example on the external parts and inside the drawers solid and liquid waste system liquid and reagent drawer NOTICE On completion of the cleaning the remaining...

Page 141: ...an the reagent carriage 1 Be sure that the MosaiQ 125 is not connected to the mains power supply 2 Open the reagent door 3 Remove all detection and enhancement reagent bottles from the reagent carriag...

Page 142: ...wer supply 2 Open the water drawer 3 Wipe the surface of the computer workstation and the ON OFF button with a lint free wipe and 70 alcohol 4 Close the water drawer More information about the compute...

Page 143: ...hly basis Please be aware of the maintenance tasks safety and precautions 12 7 1 MONTHLY MAINTENANCE TASKS OVERVIEW This table provides an overview of the monthly maintenance tasks with a short descri...

Page 144: ...er needs to be performed to reduce the risk of microbial build up over time Users should perform as per local guidelines and procedures used for similar instrumentation taking care to ensure all resid...

Page 145: ...er 2 pumps in the reconstitution drawer Only if a reagent bottle is installed As needed follow the indications on the MosaiQ 125 Shift start Starts the archiving of results quality control results and...

Page 146: ...tions on the MosaiQ 125 Prime Wash Buffers and Sample Diluents Primes MosaiQ Wash Buffer 1 and 2 pumps in the reconstitution drawer and MosaiQ Sample Diluent 1 and 2 sample diluent pumps in the interm...

Page 147: ...ATION 149 13 2 2 SAMPLE STATION 149 13 2 4 MICROARRAY LOADING 149 13 2 5 SAMPLE ADDITION 149 13 2 6 PIPETTOR 149 13 2 7 REAGENT CARRIAGE 150 13 2 8 WASHING MODULES 150 13 2 9 REAGENT DOOR 150 13 2 10R...

Page 148: ...ired Critical errors will provide information they are displayed on the screen when they are detected by the MosaiQ 125 Errors messages and descriptions can be reviewed by tapping on the Noti cations...

Page 149: ...age s Severity Recovery Possible cause s Target position not reached FATAL ERROR Reinitialize the MosaiQ 125 Mechanism that pushes the microarrays out of the Magazine Magazine Red Cap on top of the mi...

Page 150: ...he interlock is not detecting that the reagent door is closed Processing error CRITICAL ERROR Power off restart the system and reinitialize the MosaiQ 125 Not updated RFID information due to interlock...

Page 151: ...ialization not possible Cancel initialization 1 Is Status Disconnected 2 If not reboot computer workstation 3 Check MosaiQ 125 is on Blinking blue LED 4 Check if the blue LED is ashing this can be vie...

Page 152: ...ng system liq uid level indication 1 Ensure water canisters are tted properly as shown Not correct The connector is not fully plugged on the canister Correct The connector is correctly plugged on the...

Page 153: ...At least one Liquid Waste canister must to be connected when MosaiQ 125 is processing EventID Message Severity Event Recovery 209 000 00080 Internal error memory nearly full Please collect data with...

Page 154: ...sh system con guration and then restart the system immediately 257 000 00000 General database error Fatal Please contact technical support 257 000 00001 Failed to connect to the database Fatal Please...

Page 155: ...000 00003 The system liquid canister is running low Warning Please replenish the system liquid canisters soon EventID Message Severity Event Recovery 263 000 00004 The system liquid canister is empty...

Page 156: ...n MMSURM 0010 02 EventID Message Severity Event Recovery 279 000 00020 Login failed user 0 has no roles Warning Please contact laboratory administrator or technical support 279 000 00021 Login failed...

Page 157: ...14 4 PASSWORD 159 14 5 EXTERNAL MEDIA AND DEVICES 159 14 7 INCIDENT RESPONSE 159 14 8 DEFINITION 160 14 9 RECOMMENDATION 160 14 10 IDENTIFICATION OF POSSIBLE INSTALLATION CONNECTION SCENARIOS 161 14...

Page 158: ...FICATION OF THREATS AND HAZARDS This section identi es the different threats and hazards that impact the cybersecurity Type of threat Source Description ADVERSE Individual Group Organizational Nation...

Page 159: ...he intended purpose of Quotient The use of the system for other purposes can make the system vulnerable to software viruses The utilization of the USB port is strictly reserved to the Quotient Suisse...

Page 160: ...the information stored in it when a cybersecurity incident occurs Incident Response Team A team of appropriately skilled and trusted members of the organization that handles incidents during their lif...

Page 161: ...osaiQ Software Update MosaiQ data update Assay Con guration 3 Local Barcode scanner Sample QC barcodes 4 Remote LIS via RS232 Direct LIS connection via serial point to point 5 Remote LIS via TCP IP LI...

Page 162: ...CONNECTION OF THE MOSAIQ TO A LOCAL NET WORK LIS ON NETWORK OR DIRECTLY CONNECTED The connection of the MosaiQ to a LIS through the Laboratory local area network can potentially create vulnerabilitie...

Page 163: ...rformed after meeting each protocol of IQ OQ s purpose is to determine that the MosaiQ 125 performance is consistent with the user requirement speci cation within the manufacturer speci ed operating r...

Page 164: ...ember 2020 Reference n MMSURM 0010 02 16 WARRANTY For further information about the warranty refer to the sales contract Read the type label on the back side of the MosaiQ 125 to determine its serial...

Page 165: ...ilton bridge Penicuik EH26 0BF Tel 44 0131 658 5700 UNITED SATES OF AMERICA QUOTIENT 301 South State Street Suite S 204 Newtown Pennsylvania 18940 USA Tel 00 1 215 4978820 SWITZERLAND QUOTIENT SUISSE...

Page 166: ...7 18 3 COMPUTER WORKSTATION AND CONNECTIONS 167 18 4 INSTALLATION DIMENSIONS AND WEIGHT 168 18 5 SPACE REQUIREMENT 168 18 6 ENVIRONMENTAL CONDITIONS 169 18 7 NOISE 169 18 8 PACKAGING 169 18 9 MOSAIQ 1...

Page 167: ...0 V Frequency 50 60 Hz Input current 6 2 5 A Power consumption Mean 400 W 600 W max Fuses Primary T6 3 AH 250 VAC 18 2 LASER OF THE BARCODE SCANNER This section provides technical speci cations for th...

Page 168: ...iQ 125 Please read this information carefully before installing the MosaiQ 125 Width Closed 174 cm 68 51 in Opened only for servicing 354 cm 139 38 in Depth Closed 90 cm 35 44 in Opened 165 cm 64 97 i...

Page 169: ...rmance Altitude Up to 2000 m 6562 ft above mean sea level Dust No excessive dust 18 7 NOISE This section provides information about noise generated by the MosaiQ 125 47 dBA is the maximum noise level...

Page 170: ...memory user memory is structured in 28 blocks of 4 Bytes each Write cycles min 100 000 per lifetime Data retention 50 years MosaiQ magazines RFID Chip Protocol ISO IEC 15693 ISO IEC 18000 3 mode 1 Ty...

Page 171: ...aterial provided p 46 Messages troubleshooting p 147 Metric system p 11 Microarray p 13 p 18 MosaiQ 125 description p 29 N Noise p 169 Notes p 9 Noti cations p 51 O Overview processing sequence p 57 O...

Page 172: ...172 MosaiQ 125 User Manual November 2020 Reference n MMSURM 0010 02 20 APPENDIX roles and responsibilities 21 APPENDIX Operator Laboratory administrator Local technical representative...

Page 173: ...his manual is the property of Quotient Suisse SA It may not be reproduced or transmitted in any way without prior written approval from Quotient Suisse SA For customer service information please refer...

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