MosaiQ 125 USER MANUAL FCC ID: 2AWE5MOSAIQ125 MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
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TABLE OF CONTENT TABLE OF CONTENT 3 1. ABOUT THIS MANUAL...........................................................................................................................................4 13. TROUBLESHOOTING AND ERROR OVERVIEW ............................................. 147 2. INTENDED USE ................................................................................................................................................................. 12 14. CYBERSECURITY ......................
1. ABOUT THIS MANUAL 1.1 PURPOSEഩ........................................................................................................................................................................................... ഩ5 1.2 AUDIENCEഩ ....................................................................................................................................................................................... ഩ5 1.7 TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY ഩ .......................ഩ6 1.7.
ABOUT THIS MANUAL / PURPOSE 1.1 PURPOSE This User Manual provides key information and recommendations on how to use the MosaiQ 125 safely and effectively. Users must fully understand the MosaiQ 125 and its functions before performing testing. The User Manual is accessible on the MosaiQ 125 software and it can be consulted during the operation of the MosaiQ 125. Users can consult the User Manual table of contents as a reference to identify the location of the information they need quickly and easily.
ABOUT THIS MANUAL / VERSION 1.6 VERSION This section details the User Manual version and hence the MosaiQ 125 system for which this User Manual is prepared. The document version is used to manage multiple versions of a document. Please read the information below to ensure you are using the correct version for your specific MosaiQ 125 system set-up. 1.6.1 EDITION Date: November 2020 Reference no.: MMSURM.0010.02 Rev. 2- 2020-11 1.6.2 SOFTWARE 1.
ABOUT THIS MANUAL / TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY 1.7.2 TERMINOLOGY This section provides information about the meaning of certain words and acronyms used in the user manual. 1.7.4 LIST OF ACRONYMS The table below defines frequently used acronyms, abbreviations and units of measure. Acronyms Definition 1.7.3 CONVENTIONS The terms in the tables below are used consistently throughout the manual with a very specific meaning.
ABOUT THIS MANUAL / TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY Acronyms Definition GS1 128 General Specifications Standard, code 128 GUI Graphical User Interface Hz Hertz (frequency unit) in Inch IEC International Electrotechnical Commission IFU Instructions For Use IH Immunohematology IPA Isopropyl alcohol IQ Installation Qualification ISBT International Society of Blood Transfusion ISO International Organization for Standardization IVD In Vitro Diagnostic kg Kilogram L Liter lb P
ABOUT THIS MANUAL / TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY 1.7.5 DISPLAY OF WARNINGS AND NOTES This section provides information about the various symbols used in the user manual. In this user manual, safety messages and warnings have specific meanings. The symbol and the associated definition for each term is provided below. Symbol Definition DANGER DANGER Indicates a hazardous situation that, if not avoided, will result in serious injury or death.
ABOUT THIS MANUAL / TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY On the MosaiQ 125 components: Other Symbols This section provides information about the informative symbols used on the MosaiQ 125 and its documentation.
ABOUT THIS MANUAL / FIGURES 1.8 FIGURES The equipment may vary slightly from the figures shown in this User Manual. However, unless otherwise noted, the procedures 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 fasteners such as screws and nuts used in the MosaiQ 125 have metric dimensions.
2. INTENDED USE 2.1 INTENDED USE ............................................................................................................................................................................................................................................................................................................ 13 2.2 MOSAIQ SYSTEM COMPOSITION .............................................................................................................................................
INTENDED USE / INTENDED USE 2.1 INTENDED USE The MosaiQ 125 is an automated instrument intended for the qualitative infectious disease screening of human blood using MosaiQ magazines and MosaiQ system reagents. It is intended for professional use within a blood donor environment. 2.3 2.3.1 NOTICE 2.2 Immunohematology testing (IH) is defined by antigen typing and antibody detection. Currently the MosaiQ 125 cannot perform antigen typing (AT) and antibody detection (ABD/ABID).
INTENDED USE / PRINCIPLES OF OPERATION The detail of the microarray processing is described in the following figure and table. The microarray processing is entirely automated. Process Step Microarray transport As shown in the following illustration, the microarray is transported from the magazine to dedicated positions on the incubation ring corresponding to the different analytical processing steps until imaging and final disposal.
INTENDED USE / RESULTING PRINCIPLES 2.4 2.4.3 RESULTING PRINCIPLES Analytical process Imaging Image analysis Interpretation INTERPRETATION Each spot of the panel that has been given one of the 3 possible states is interpreted by group or individually by the software to determine the reportable result. The resulting process begins at the end of the biological reaction. Result The algorithm used for the interpretation is specific to each analyte.
3. PRIOR TO USE 3.1 USER QUALIFICATION 3.1.1 ........................................................................................................................................................................................................................................................... USER QUALIFICATION ...............................................................................................................................................................................................
PRIOR TO USE / USER QUALIFICATION This section provides information that must be taken into consideration before using the MosaiQ 125. 3.1 USER QUALIFICATION The equipment is intended for professional use within a blood establishment. Only trained laboratory personnel are authorized to use the MosaiQ 125. 3.1.1 USER QUALIFICATION The laboratory personnel will be trained to perform tasks such as: 3.1.2 Follow general laboratory procedures and techniques.
PRIOR TO USE / EQUIPMENT OVERVIEW 3.2 EQUIPMENT OVERVIEW This section provides information on the materials that are required to operate the MosaiQ 125. 3.2.1 MOSAIQ MAGAZINES The MosaiQ magazine is used to hold the microarrays. Each magazine has a RFID (Radio Frequency Identification) Tag which contains information necessary for the traceability and the on-board management such as: catalog number, lot number, expiry date, volume and on-board stability.
PRIOR TO USE / EQUIPMENT OVERVIEW 3.2.3 The DDC (Disposable Dispense Cartridge) for MosaiQ detection and MosaiQ enhancement reagents which are loaded in the MosaiQ 125 behind the reagent door. For more information please refer to chapter 5.9.1 of this manual. 5 7 8 MOSAIQ WATER CANISTER Two water canisters.
PRIOR TO USE / EQUIPMENT OVERVIEW 3.2.4 MOSAIQ QUALITY CONTROLS 3.2.6 SAMPLE RACKS Quality Controls (QC) are used to ensure that disease screening is performed as intended. 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 can be inserted into the MosaiQ 125. In total 120 samples can be loaded at any one time.
PRIOR TO USE / EQUIPMENT OVERVIEW 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 waste bags). Liquid waste canisters. (one solid waste container and two liquid waste canisters) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
4. SAFETY INSTRUCTIONS 4.1 GENERAL SAFETY 4.2 ELECTRICAL SAFETY ..................................................................................................................................................................................................................................................................... 24 4.3 BIOLOGICAL SAFETY ...........................................................................................................................................................
SAFETY INSTRUCTIONS / GENERAL SAFETY 4.1 GENERAL SAFETY For the overall safety of laboratory personnel and equipment, please read the following information regarding general safety precautions before operating the MosaiQ 125. Not Following Safety Instructions WARNING Not following safety instructions may result in personal injury and material damage. Follow all safety instructions included in this manual Follow all warnings marked on the MosaiQ 125.
SAFETY INSTRUCTIONS / ELECTRICAL SAFETY Sharp Edges WARNING Improper Connection of Mains Power Supply Sheet metal parts and circuit boards located behind protective covers may have sharp edges. Contact may lead to injuries. Use caution at corners and edges. Unauthorized Changes to the MosaiQ 125 WARNING Any changes to the MosaiQ 125 that are not authorized by the manufacturer will lead to non-conformity with respect to the applicable regulations the manufacturer has declared.
SAFETY INSTRUCTIONS / BIOLOGICAL SAFETY Obstruction of Access to Mains Power Supply DANGER Improper positioning of the MosaiQ 125 can cause accidents, fire or serious damage to the MosaiQ 125 because it cannot be switched off or disconnected from the mains power supply. Ensure that the power supply and mains switch are easily accessible. 4.
SAFETY INSTRUCTIONS / POSITIONS OF SAFETY LABELS AND TYPE LABEL Chemical Waste Chemicals must be disposed of according to the regulations in force in your country. 4.5 POSITIONS OF SAFETY LABELS AND TYPE LABEL This section provides information on the various positions and types of safety labels used on the MosaiQ 125. Infectious Waste WARNING Potentially infectious materials and all parts that may come in contact with potentially infectious materials can cause severe contamination.
SAFETY INSTRUCTIONS / POSITIONS OF SAFETY LABELS AND TYPE LABEL 4.5.2 POSITIONS OF SAFETY LABELS 4.5.3 POSITIONS OF ALL OTHER LABELS This section provides information on where to find safety labels on the MosaiQ 125.
SAFETY INSTRUCTIONS / RADIO INTERFERENCE 4.6 RADIO INTERFERENCE FCC Statements This section provides information about the risks of radio interference and the safe operation of the MosaiQ 125. CAUTION The MosaiQ 125 is a Class A digital device in accordance with CISPR 11 and FCC Rules. The MosaiQ 125 complies with the following standards and rules for information concerning radio interference: IEC 61326-2-6 (Class A for emissions) and IEC 61326-1. 47 CFR Part 15, Subpart B, of the FCC Rules.
5. MOSAIQ 125 PARTS DESCRIPTION AND LOCATION 5.1 EXTERNAL PARTS ...................................................................................................................................................................................................................................................................................... 30 5.2 INTERNAL PARTS 5.3 POWER SWITCH AND MAINS POWER OUTLET ................................................................................................
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / EXTERNAL PARTS This section provides information about the various components (parts) of the MosaiQ 125 and where to find them. 5.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / INTERNAL PARTS 5.2 INTERNAL PARTS Pipettor module Microarray turntable Washer modules 1 and 2 Reagent carriage Microarray turntable Washer modules 1 and 2 Pipettor module Reagent carriage (MosaiQ 125 internal parts localization - Top view / upper panel removed) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / INTERNAL PARTS Magazine station Sample loading station Camera module Incubator module Camera module Magazine station Sampe loading station Incubator module (MosaiQ 125 internal parts localization - Top view / upper panel removed) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / POWER SWITCH AND MAINS AINS POWER OUTLET 5.3 POWER SWITCH AND MAINS POWER OUTLET The power switch is used to turn the MosaiQ 125 on and off. The MosaiQ 125 must be connected to the mains power supply via the mains power connector for the power switch to operate. This section shows where to find the power switch and the mains power connector on the MosaiQ 125. 5.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / TOUCH SCREEN 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. The touch screen can be adjusted by tilting the screen (20° upward and 10° downward). (MosaiQ 125 touch screen adjustement) (MosaiQ 125 touch screen) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / MAGAZINE STATION 5.6 MAGAZINE STATION The magazine station is the place to load the magazines in the MosaiQ 125. There are two MosaiQ magazine sizes offering more operational flexibility. The locking and unlocking of the magazine station door is software controlled. The magazine station can hold up to four MosaiQ magazines. Function: The magazine station holds the MosaiQ magazines and also supplies the MosaiQ 125 with microarrays to process.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / SAMPLE STATION 5.7 SAMPLE STATION The sample station is the area where sample racks are loaded into the MosaiQ 125. The sample station holds up to 10 racks. Each rack has a capacity of 12 sample tubes, allowing a total of 120 samples to be loaded. The sample station module features a barcode scanner to read the sample barcode present on each tube label for sample tube identification.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / WASTE DRAWER 5.8 WASTE DRAWER The waste system has two components located in the waste drawer. One area for liquid waste with two canister and one for solid waste (used microarrays) with one drawer. Function: The waste drawer collects the liquid and the solid waste. Capacity: Two compartments.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / WATER DRAWER 5.9 WATER DRAWER The water drawer is located on the bottom right side of the MosaiQ 125 and houses a maximum of two canisters containing the system liquid required to operate the MosaiQ 125. Users can open and close the water drawer manually. The water drawer can be opened and closed while the MosaiQ 125 is in operation. 5.9.1 WATER CANISTERS There are two canisters with a capacity of 10 L each (provided with your MosaiQ 125).
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / WATER DRAWER 5.9.2 COMPUTER WORKSTATION The MosaiQ Software is installed on the computer workstation which is located on the left side of the water canisters in the water drawer. (computer workstation loclization) (computer workstation power cord) Function: The computer workstation handles all data input and output for the MosaiQ 125 and controls the assay processing. NOTICE The computer workstation power cord is located behind the MosaiQ 125.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / REAGENT DRAWER 5.10 REAGENT DRAWER The reagent drawer holds the bottles of MosaiQ wash buffers and MosaiQ sample diluents. There are eight positions in which to place the reagent bottles. There are dilution chambers to ensure the correct ratios of wash buffer and system liquid. The reagent drawer can be opened and closed while the MosaiQ 125 is in operation.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / PROCESS MODULES 5.11 PROCESS MODULES The reagent door light status. The process modules are housed within the MosaiQ 125 body on the upper right side of the MosaiQ 125 and include the reagent carriage, wash module, incubator module, camera module and pipettor module. Light is off : reagent door CAN be opened To access the process modules compartment, the reagent door must be opened.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / PROCESS MODULES 5.11.1 REAGENT CARRIAGE The reagent carriage in the process modules compartment houses up to eight reagent bottles. The symbols of the MosaiQ system reagents indicate the position where each reagent bottle shall be inserted. Technology: An RFID reader is used to read and write on the RFID tags present on each reagent bottle. One yellow LED is located on the top right side of each slot on the reagent carriage.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / PROCESS MODULES 5.11.2 WASHER MODULES 5.11.3 INCUBATOR MODULE The MosaiQ 125 has two independent washer modules to rinse microarrays at various stages of the process. The incubator module is located on the lower part of the process modules compartment of the MosaiQ 125. Both MosaiQ Wash Buffer 1 and MosaiQ Wash Buffer 2 are loaded in the reagent drawer.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / PROCESS MODULES 5.11.4 CAMERA MODULE 5.11.5 MICROARRAY TURNTABLE The camera module is located on the left-hand side of the process modules compartment of the MosaiQ 125. It generates images that are automatically transmitted to the MosaiQ Software for analysis. The microarray turntable is located behind the magazine station inside the MosaiQ 125. It is a mechanical part that individually rotates the microarrays coming from the magazine towards the incubator.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / PROCESS MODULES 5.11.6 PIPETTOR MODULE The pipettor module comprises two needles: One needle is dedicated to AT assays using a sample of red blood cells and MosaiQ Sample Diluent 1. The second needle is dedicated to the SDS assays using sample of plasma or serum and MosaiQ Sample Diluent 2.
MOSAIQ 125 PARTS DESCRIPTION AND LOCATION / MATERIAL AND ACCESSORIES ORIES 5.12 MATERIAL AND ACCESSORIES The MosaiQ 125 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 10 Sample rack 1/2 2 Waste canister 1/2 2 Water canister 1/2 2 Power cord (country specific) 1/2 1 Set of covers 2/2 5.12.
6. GRAPHICAL USER INTERFACE 6.1 6.2 GUI OVERVIEW ...................................................................................................................................................................................................................................................................................................... 48 6.1.1 MAIN SCREEN 6.1.2 NAVIGATION BAR MOSAIQ MENU 6.2.1 ....................................................................................................
GRAPHICAL USER INTERFACE / GUI OVERVIEW The Graphical User Interface (GUI) is displayed on the touch screen. 6.1 Use the touch screen keyboard to type alphanumeric inputs, e.g. A - Z, 0 - 9, etc.). The touch screen keyboard automatically appears each time the user taps inside an editable field on the screen. GUI OVERVIEW This section provides an overview of the main screens, menus, functions, icons, notifications and color codes users will encounter in the GUI.
GRAPHICAL USER INTERFACE / GUI OVERVIEW 6.1.2 NAVIGATION BAR The following section describes all functions available from the navigation bar. 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 chapter 6.1”. Tap to display information about sample loading. Refer to chapter 8. (navigation bar) Tap to access additional functions (e.g.
GRAPHICAL USER INTERFACE / MOSAIQ MENU 6.2 MOSAIQ MENU The following section provides information about the various menus available in the GUI. 6.2.1 Tap to display the notifications menu and the messages. Refer to chapter 6.2.3. BASIC FUNCTIONS The following section provides an overview of the basic functions available from the navigation bar. Tap to access the User Manual. Tap to initialize the MosaiQ 125. Tap to display the lock screen. Refer to chapter 6.3.
GRAPHICAL USER INTERFACE / MOSAIQ MENU 6.2.2 LABORATORY ADMINISTRATIVE FUNCTIONS The administrative functions are available for users with laboratory administrator access rights. 6.2.3 NOTIFICATIONS MENU The following section shows how notifications are displayed. Notifications Notification button (administrative functions) Notification options (notifications menu) INFO Laboratory administrator access rights This menu is not displayed when the user is logged in as User.
GRAPHICAL USER INTERFACE / MOSAIQ MENU Color Code Notification Reminder All messages appear in chronological order (the newest on the top): A notification 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. Icon The number inside the symbol indicates the number of messages. Description Type of Messages Meaning Information messages Indicate information • The MosaiQ 125 is fully functional.
GRAPHICAL USER INTERFACE / LOCK SCREEN 6.3 LOCK SCREEN During the test run, the screen is automatically locked after a configurable time (installation settings). The lock screen shows all information about the status of the system. Login to access any functions. Enables the previous user (or a new user) to log back into the system (lock screen) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
7. OPERATING INSTRUCTIONS 7.1 7.2 BEFORE STARTING TO TEST SAMPLES ......................................................................................................................................................... 55 HOW TO REMOVE AND LOAD EACH RESOURCE ........................................................................................................................................................................................................................................................
OPERATING INSTRUCTIONS / BEFORE STARTING TO TEST SAMPLES This section explains how to operate the MosaiQ 125 safely and effectively. 7.1 7.1.1 BEFORE STARTING TO TEST SAMPLES SAFETY AND TIPS DANGER Emergency Shutdown in case of malfunction Malfunction of the MosaiQ 125 may cause electrical shock, burns, cuts or bruises. In case of malfunction: • Switch off the MosaiQ 125 • Disconnect the MosaiQ 125 from the mains power supply.
OPERATING INSTRUCTIONS / BEFORE STARTING TO TEST SAMPLES 7.1.2 PROCESSING SEQUENCE OVERVIEW Steps Description Load samples and start test run • Load sample tube racks • Assign test order (only if no LIS connected) • Start test run Overview • Switch to the Overview screen (please refer to chapter 18.
OPERATING INSTRUCTIONS / BEFORE STARTING TO TEST SAMPLES (processing sequence overview) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
OPERATING INSTRUCTIONS / GETTING STARTED 7.1.3 PRERUN CHECKS 7.2 GETTING STARTED This section provides a quick summary of the activities required prior to starting the MosaiQ 125: This section explains the operations required for start-up of the MosaiQ 125. 1 - Ensure that all MosaiQ 125 environmental conditions are met (refer to chapter 18.6). 7.2.1 2 - Ensure that all incubation ring insulating covers are securely in place. The following section explains how to start the MosaiQ 125.
OPERATING INSTRUCTIONS / GETTING STARTED 3 - Open the water drawer to access to the computer workstation. 5 - Close the water drawer. 6 - Wait for the MosaiQ 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.
OPERATING INSTRUCTIONS / GETTING STARTED 7.2.2 CHECK AVAILABLE RESOURCES This section provides information about how to check the available resources on the MosaiQ 125. 7.2.3 RESOURCES OVERVIEW The following section explains how to display an overview of all the available resources. When loading samples, MosaiQ 125 checks if conditions are met to run the tests.
OPERATING INSTRUCTIONS / GETTING STARTED 7.2.4 CHECKING INDIVIDUAL RESOURCES The following section provides step-by-step instructions on how to check each resource. - 3 The Magazines screen shows the number of microarrays remaining in each magazine. Magazines To check the quantity of microarrays available in the magazines: - 1 Tap on the Resources icon in the navigation bar. The Resources screen shows the quantity of microarrays available for the SDS test.
OPERATING INSTRUCTIONS / GETTING STARTED Reagents - To check the quantity of reagents available: - 1 Tap on the Resources icon in the navigation bar. The Resources screen shows the remaining volume of each reagent in each bottle. - 2 Tap on the Reagents area to check the reagent details. 3 The following data are displayed for each reagent: The fill level of every bottle and the number of tests remaining, The lot number, The expiry date, The remaining open shelf life.
OPERATING INSTRUCTIONS / GETTING STARTED MosaiQ wash buffers and MosaiQ sample diluents To check the quantity of wash buffers and sample diluents available: - 1 Tap on the Resources icon in the navigation bar. The Resources screen shows the remaining volumes of each buffer and diluent bottle. - 2 Tap on the Wash Buffers & Sample Diluents area to display the details.
OPERATING INSTRUCTIONS / GETTING STARTED Water /System Liquid - 3 Check the remaining volume in each canister. To refill the canister please refer to chapter 7.3.12 of this manual. To check the quantity of water available: 1 Tap on the Resources icon in the navigation bar. - 2 Tap on the System Liquid area to display the overall level.
OPERATING INSTRUCTIONS / GETTING STARTED Waste - To check the quantity of waste present in the waste container and waste canisters: 1 Tap on the Resources icon in the navigation bar. - 2 Tap on the Liquid Waste / Solid Waste area to display the details. - 3 On the liquid and solid wastes details screen: When both liquid waste canisters have reached their maximum capacity, a message will appear on the touch screen to inform you that both liquid waste canisters are full.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3 HOW TO REMOVE AND LOAD EACH RESOURCE The following section provides step-by-step instructions on how to remove and load each resource. 7.3.1 You cannot open the magazine station door when the MosaiQ 125 is operating or performing initialization. Wait until the light is off to open the magazin station door.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3.2 LOADING MAGAZINES Up to four magazines (equal or different sizes) can be loaded onto the MosaiQ 125 at the same time. To load magazines: - 1 Tap on the Resources icon. - - 3 The detailed Magazines screen is displayed. Remaining microarrays 3 2 Tap on the Magazine area.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 6 - Load the magazine at an angle as shown on the picture, engaging the two pins at the bottom of the microarrays carousel. 8 - To load another magazine, rotate the carousel manually until reaching an empty position and repeat the steps from point 5 to 8. 9 - Once the magazines have been loaded, close the magazine station door.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3.3 REMOVING MOSAIQ DETECTION AND MOSAIQ ENHANCEMENT REAGENT BOTTLES - 3 Wait until the MosaiQ 125 status is Idle. This section provides a step-by-step instruction on how to 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 Reagents area to access the Reagents screen.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E Note: A light indicates when you can open the reagent door. Light is off : reagent door CAN be opened Light is on : reagent door CANNOT be opened (reagent bottles lock mechanism) 6 - Pull the empty reagent bottle backward at a 45° angle. (reagent door light status) 4 - Open the reagent door by lifting the door panel up.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3.4 LOADING DETECTION AND ENHANCEMENT REAGENT BOTTLES - 3 Wait until the MosaiQ 125 status is Idle. This section provides step-by-step instructions on how to load reagent bottles (MosaiQ detection 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.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 4 - Open the reagent door. The reagent carriage can support two bottles of each reagent. 5 7 8 (opening the reagent door) 5 - Insert the reagent bottle at an angle into the corresponding reagent carriage position. (2 slots for each MosaiQ detection and MosaiQ enhancement reagent bottles) NOTICE The correct reagents positions on the reagent carriage following the colored symbols.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 6 - Press the lock mechanism of the reagent bottle cap together. (reagent bottles 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. 11 - Check the MosaiQ system reagent conditions (volume available, expiry date) on the Resources screen.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3.5 REMOVING THE MOSAIQ WASH BUFFER AND MOSAIQ SAMPLE DILUENT BOTTLES This section explains how to remove the bottles from the MosaiQ 125. The bottles are located in the reagent drawer. The reagent drawer can be opened and closed manually when the MosaiQ 125 is in operation. - 3 Empty and low-level bottles are displayed in red and orange on the screen respectively. 3 1 Tap on the Resources icon in the navigation bar.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 4 - Open the reagent drawer. NOTICE The upright symbol on the reagent bottles packaging is meant for transport and storage purposes only. (opening 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 removed even when they are low level and not empty.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3.6 LOADING THE MOSAIQ WASH BUFFER AND MOSAIQ SAMPLE DILUENT BOTTLES This section explains how to load the bottles into the MosaiQ 125. The bottles are located in the reagent drawer. The reagent drawer can be opened or closed when the MosaiQ 125 is in operation. 1 - Open the drawer. 4 - Bottles can be loaded in duplicate for higher throughput if required.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3.7 REMOVING THE SOLID WASTE BAG This section explains how to empty the solid waste container of the MosaiQ 125. The solid waste container is located in waste drawer. Since this waste is of a biological nature (blood samples), a biohazard waste bag is used to line the waste container. The solid waste drawer can be opened and closed manually when the MosaiQ 125 is in operation.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3.8 LOADING THE SOLID WASTE BAG This section explains how to load the solid waste container in the MosaiQ 125. The solid waste canister is located in the waste drawer. Since this waste is of a biological nature (blood samples), a biological waste bag is used to line the solid waste container. 7 - Close the waste drawer. The solid waste drawer can be opened and closed manually when the MosaiQ 125 is in operation.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3.9 REMOVING LIQUID WASTE CANISTER This section explains how to remove the liquid waste canister from the MosaiQ 125. The liquid waste canister is located in the waste drawer. Even when the MosaiQ 125 is in 1 Tap on the Resources icon in the navigation bar. - 2 Tap on the Liquid Waste / Solid Waste area to check the level. - operation, it is possible to remove one of the cannisters even if its not completely full.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 3 - Detailed information for each waste canister and waste container is displayed. 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 pulling or bending the black parts and the electric wire because these are fragile, and they may be damaged. (solid and liquid waste capacity details) 4 - Open the waste drawer.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 8 - Remove the canister. 7.3.10 9 - Leave the connectors in the canisters drawer. This section explains how to load the liquid waste canister into the MosaiQ 125. The liquid waste canister is located in the waste drawer. The liquid waste drawer can be opened and closed manually when the MosaiQ 125 is in operation. LOADING LIQUID WASTE CANISTER 1 - Open the drawer.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 3 - Remove the stopper from the canister level sensor hole. 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 water drawer can be opened and closed manually. The users can open and close this compartment when the MosaiQ 125 is in operation if a canister needs to be replaced or refilled.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E Detailed information for each water canister is displayed. 3 - Open the water drawer. (opening the water drawer) 4 - Remove the canister straightforward, to prevent damaging the connection between the canister and the reservoir. (water canisters detailed information) (removing of the water canister, mind the water canister / reservoir connection) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE E 7.3.12 LOADING THE WATER CANISTER This section explains how to load the water canister into the MosaiQ 125. The water canisters are located in the water drawer. To load the water canister: The water drawer can be opened and closed manually when the MosaiQ 125 is in operation if a canister needs to be replaced or refilled. 2 - Close the screw cap. 1 - Open the water canister screw cap and fill it with 10 L of purified water.
8. SAMPLE LOADING AND TESTING 8.1 SAMPLE PROCESS FLOW OVERVIEW 8.2 GLOBAL SAMPLE PROCESS FLOW ................................................................................................................................................................................ 87 8.2.1 SAMPLE ORDERING- PHASE 1 ..................................................................................................................................................................................... 8.2.
SAMPLE LOADING AND TESTING / SAMPLE PROCESS FLOW OVERVIEW 8.1 SAMPLE PROCESS FLOW OVERVIEW The following table shows the different possible scenarios for each test together with the associated process status. There are 7 different possible process order status. IH, AT, ABID and DS results, when no confirmation is required Order Standby : The sample is loaded in a rack, the order has been placed and is waiting to be put in process.
SAMPLE LOADING AND TESTING / GLOBAL SAMPLE PROCESS FLOW 8.2 GLOBAL SAMPLE PROCESS FLOW This section provides information on how the sample is processed from the sample loading until the results. The sample processing workflow is composed of four key phases. 8.2.1 SAMPLE ORDERING- PHASE 1 After the sample has been loaded into the MosaiQ 125 test orders can be placed for each sample. After placing the orders, they are in Standby status and are waiting to be added to the process (see chapter 8.5).
SAMPLE LOADING AND TESTING / GLOBAL SAMPLE PROCESS FLOW 8.2.2 SAMPLE PROCESSING - PHASE 2 Once the rack has been added to process, all corresponding orders will be set to the Processing status. The orders for each sample will be frozen (no longer possible to add or cancel an order) until it has been processed. The samples will be processed in the chronological order. The resulting phase will proceed to the analyse of the data to calculate the order results. 8.2.
SAMPLE LOADING AND TESTING / GLOBAL SAMPLE PROCESS FLOW 8.2.4 SAMPLE REVIEW - PHASE 4 Order status: Rejected: When the order is in the Finished status it will be checked against the review criteria. If they are met the status will be set to Review. The order may be placed in the Rejected status from the Review status by user request. Otherwise the order will be set to the Completed status.
SAMPLE LOADING AND TESTING / PREPARING SAMPLE RACKS AND TUBES 8.3 PREPARING SAMPLE RACKS AND TUBES The following sections explain how to load and test samples into the MosaiQ 125. WARNING Please consult our catalog for tube size adapters and contact your local technical representative for appropriate MosaiQ 125 configuration. 8.4 SELECTING LOADING LANE Select the sample rack type corresponding to the run to be processed by MosaiQ 125.
SAMPLE LOADING AND TESTING / INSERTING SAMPLE RACKS 8.5 INSERTING SAMPLE RACKS 1- Tap on the Sample Loading icon in the navigation bar. Tubes status symbols This section provides step-by-step instructions on how to load sample racks into the MosaiQ 125. Lane status symbols Environmental conditions WARNING If the operating temperature in the laboratory is ≤ 16 °C (60.8 °F), MosaiQ 125 must be switched on for a minimum of 2 hours before processing any assay.
SAMPLE LOADING AND TESTING / INSERTING SAMPLE RACKS 5 - Press the sample rack briefly against the pressure of the spring, until you hear a click. 6 - The barcodes of the sample tubes are read automatically as the sample rack is inserted into the MosaiQ 125. Definition of the terms used to describe racks and tube appearances Message Explanation Message Processable INFO 7- No rack loaded Reading: MosaiQ 125 is adjusting the focus of the barcode reader. Loadable Lane is ready to be loaded with a rack.
SAMPLE LOADING AND TESTING / INSERTING SAMPLE RACKS Lanes racks and tubes appearances on the screen: Empty Reading Loadable Loaded Processable Processable Scheduled Scheduled (collapsed) (expanded) (collapsed) (expanded) Querying Test Orders Finished (collapsed rack) Finished (expanded rack) Loaded warning (example missing resources) Warning (example Sample ID) Error In Use NOTICE The collapsed views only show the racks status. The expanded view show both the tubes and the racks status.
SAMPLE LOADING AND TESTING / INSERTING SAMPLE RACKS Rack status symbols Loading of a sample rack is possible. Samples tubes appearance on the screen in operation Samples are pipetted into microarrays. It shows an indication of the time remaining until end of the pipetting sequence. Reading the sample rack information. Removing of the sample rack is possible Checking for LIS test order. All test on this rack are finished Waiting for test orders. An error (e.g. missing sample ID) has occurred.
SAMPLE LOADING AND TESTING / TEST ORDERS 8.6 8.6.2 TEST ORDERS Test orders can be assigned automatically by LIS or manually on the GUI. - 8.6.1 AUTOMATIC TEST ASSIGNMENT MANUAL TEST ASSIGNMENT This section provides step-by-step instructions on how to assign test order manually. - 1 2 Tap on the Sample Loading icon Tap one of the lanes (Lanes 1-10) to view sample tube details. This section provides step-by-step instructions on how to assign test orders automatically.
SAMPLE LOADING AND TESTING / TEST ORDERS To select all sample tubes, tap the tick box next to the Lane headline. 7 - All lanes are displayed with the selected profile. 1 - All tick boxes of the sample tubes are marked with a tick mark. To select one or more sample tubes, tap the tick box next to the sample tube number and ID. 2 - Tap on the arrow next to Apply Profile to open the list with all selectable test profiles. 3 - Select the test for each lane and each sample tube if the tests are different.
SAMPLE LOADING AND TESTING / INDIVIDUAL TEST ORDER ASSIGNMENT 8.7 INDIVIDUAL TEST ORDER ASSIGNMENT This section provides step-by-step instructions on how to assign a specific test order for an individual sample tube. 12- To perform a different test order on each of the samples in a sample rack, select the given sample number on the rack.
SAMPLE LOADING AND TESTING / BARCODE READING ERRORS Once sampling has started, navigate to the Notifications screen. 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 error. (notifications list) 6 - Select the Menu icon in the navigation bar to monitor MosaiQ 125 progress. 7 - Do not remove or add any sample racks that are being pipetted by the MosaiQ 125.
SAMPLE LOADING AND TESTING / BARCODE SPECIFICATIONS An error message stating Missing Sample ID will come into view above the sample barcode number. The barcode can then be entered manually, as described in the next section. 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 level C. (barcode label dimensions) Max.
SAMPLE LOADING AND TESTING / SAMPLE TUBE REQUIREMENTS 8.10 SAMPLE TUBE REQUIREMENTS Only the sample tube references listed below have been tested for use in the MosaiQ 125. 8.11 SAMPLE TESTING MONITORING This section explains how to carry out and monitor a test run using the graphical user interface. It also provides information on end-of-run procedures and test results.
SAMPLE LOADING AND TESTING / SDS TEST RESULTS 8.11.2 END OF A RUN 8.12 The SDS assay processing time is 34 minutes. A successful test run will generate test results. The following section provides step-by-step instructions on how to read the test results of each sample. 1- Before starting a run, the Idle message is displayed on the touch screen below the user name. SDS TEST RESULTS The user can read the test results of each sample. - 1 2 3 Tap on the Results icon in the navigation bar.
SAMPLE LOADING AND TESTING / SDS TEST RESULTS On the finished test results screen the operator can see at a glance which test results are available or failed as well as the tests that require retesting or confirmation. The same sample ID may have several test results with different status. Report (non-reactive results) The Report screen shows a detailed overview for a non-reactive result.
SAMPLE LOADING AND TESTING / SDS TEST RESULTS Reported Results (non-reactive results) Reported Results (reactive results) The Reported Result screen shows the details of the disease screening profile with non-reactive results for both CMV and Syph. The Reported Result screen shows the details of the disease screening profile with reactive result for CMV (non-reactive result for Syph).
SAMPLE LOADING AND TESTING / SDS TEST RESULTS Confirmed result after retesting On the Report sub menu of the Finished screen you can see details of the tests that require retesting. 1 - Tap on the lines to view more details (retesting a sample) Repeating testing Repeating testing is required for Syphilis initial reactive result only. For detailed information, please refer to the MosaiQ SDS Magazine IFU.
SAMPLE LOADING AND TESTING / REPEATING TESTING BY “DATA REDUCTION N ERROR” 8.13 REPEATING TESTING BY “DATA REDUCTION ERROR” When a result is marked as “Data Reduction Error”, the test has been failed and no results can be generated. On each microarray there are several control probes showing that the assay is reacting as expected. All control probes must have an appriopriate reaction for the test to be interpreted by the MosaiQ Software.
SAMPLE LOADING AND TESTING / TEST RESULTS FLAGS - 5 On the review pop up window, tap on the Accept button to repeat the test. Before retesting verify the level of the MosaiQ system reagents as this might have been the cause of this error. 8.14 TEST RESULTS FLAGS This section explains how to find test results flags and their definition. On the Results screen. - 1 2 Tap Results on the navigation bar Select the result that has a flag you want to check and tap on its line.
SAMPLE LOADING AND TESTING / TEST RESULTS FLAGS - 3 The following screen displays the results details and the flag name. 3 Flags definitions for SDS tests # Flags Type 1 Data Reduction Error There is no data returned. 2 Processing Error Issue during sample aspiration and/or dispensing For detailed information about SDS flags, please refer to the MosaiQ SDS Magazine IFU. (test result details with the result flag) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
SAMPLE LOADING AND TESTING / REVIEWING RESULTS 8.15 REVIEWING RESULTS In some cases, it is necessary to review a result. To do this, start a two-stage review process. - 1 2 3 Tap on the Results icon in the navigation bar. - If necessary, tap on the Finished button or another result menu entry. - 4 5 Tap on the Review icon in the menu. Tap on a text area to display the message. Tap on the desired test result to show the details.
SAMPLE LOADING AND TESTING / FILTERING OF TEST RESULTS 8.16 FILTERING OF TEST RESULTS - 4 The following screen appears: This section provides step-by-step instructions on how to filter the test results using different criteria. - 1 2 3 Tap on the Results icon in the navigation bar. Tap on the Finished button or another result menu entry. Combination of the conditions : • All: shows only results that fulfill all conditions. Use the Filter function to focus on the most important results. Category e.g.
SAMPLE LOADING AND TESTING / PRINTING TEST RESULTS 8.17 PRINTING TEST RESULTS This section explains how to print test results using the graphical user interface. To print the test results: - 1 2 Select and tap on the test to be printed. Tap on Print. 1 2 (printing test results) There are 2 possible print options: 1- Print all finished results: NOTICE භ On Finished screen, tap on Print. 2- Print individual result: භ On Finished screen, tap on the selected result and tap on Print.
9. QUALITY CONTROL 9.1 QUALITY CONTROL METHOD ..................................................................................................................................................................................................... 112 9.2 QUALITY CONTROLS PREPARATION ......................................................................................................................................................... 112 9.3 QUALITY CONTROLS LOADING AND RUNNING ..........................
QUALITY CONTROL / QUALITY CONTROL METHOD This section provides information on MosaiQ 125 quality controls (QC). 9.2 QC are used to ensure that MosaiQ 125 performance is acceptable. Before loading any QC material into the MosaiQ 125: QUALITY CONTROLS PREPARATION Follow the instructions for use of the QC material. Let the QC material reach the room temperature (if required). Transfer the QC material into a standard 5 ml test tube that is compatible with the MosaiQ 125 rack.
QUALITY CONTROL / QUALITY CONTROLS LOADING AND RUNNING 9.3 QUALITY CONTROLS LOADING AND RUNNING Before loading the QC into the MosaiQ 125: Make sure that the MosaiQ 125 is ready for running tests (check for required maintenance tasks, resources, waste capacity). Proceed to a manual test assignment 12- 1 Tap on the Sample Loading icon. 2 Tap one of the lanes (Lanes 1-10) to view tube details 1 - Place the uncapped QC tube in a standard rack, as described in chapter 8.3 of this manual.
QUALITY CONTROL / QUALITY CONTROLS LOADING AND RUNNING 12 - Tap on the Add to Process icon to run the QC. 4 - The tube is marked with a tick mark. 5 - Tap on the arrow next to Apply Profile to open the list with all selectable test profiles. 6 - Select the test for each lane and each sample tube if the tests are different 7- 4 Select the desired test profile from the list. 8 - The chosen test profile is shown in the grey box. 9 - Tap on the grey box with the test profile to assign it to the marked QC tube.
QUALITY CONTROL / QUALITY CONTROLS RESULTS 9.4 QUALITY CONTROLS RESULTS The quality controls are successful when the expected QC results are aligned with the QC given characteristics. Please read carefully the instructions for use provided with your QC material. To review the QC results: 1 Tap on 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.
10. MOSAIQ 125 SHUTDOWN To shut down the MosaiQ 125 safely, please follow this procedure. 3- Empty the liquid canister and solid waste container, if necessary. Discard the waste following the procedure. 10.1. REMOVAL OF REMAINING MATERIAL AND WASTE 1- Remove all racks from the MosaiQ 125. (removing the liquid and solid wast) 4- Remove any empty magazines from the carousel. (removing the sample rack) 2- Remove all samples from the racks.
MOSAIQ 125 SHUTDOWN / SHUTING DOWN THE MOSAIQ 125 10.2. SHUTING DOWN THE MOSAIQ 125 - 1 2 - 4 Switch off the MosaiQ 125. Tap on the Menu icon. Tap on the Shut Down button. 1 4 2 (switching off the MosaiQ 125) (shut down the MosaiQ Software) - 3 NOTICE Perform the cleaning maintenance tasks of the MosaiQ 125 as required. Please refer to chapter 12 of this manual . Confirm to shut down and wait until the PC has shut down (touch screen is black).
11. ADVANCED FUNCTIONS 11.1 GENERAL SETTINGS ..................................................................................................................................................................................................................................................................... 119 11.1.1 OPERATION MODE .................................................................................................................................................................................
ADVANCED FUNCTIONS / GENERAL SETTINGS This section provides information about the advanced functions accessible with laboratory administrator rights available on the MosaiQ 125. Only the laboratory administrator is authorized to access certain software/system configurations. 11.
ADVANCED FUNCTIONS / GENERAL SETTINGS 11.1.1 OPERATION MODE From 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 time-out delay. After a selected period of time, the MosaiQ 125 will automatically log the user out. (inactivity timeout selection) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
ADVANCED FUNCTIONS / GENERAL SETTINGS 11.1.3 PASSWORD POLICY ENFORCEMENT 11.1.4 ALARM / ALERT MODE To enforce the password security this function allows the laboratory administrator to determine the required password characteristics (password length and special characters).
ADVANCED FUNCTIONS / USERS ROLES 11.2 USERS ROLES The access rights determine who can perform certain operations. The MosaiQ 125 provides for three roles with different levels of access rights: Operator, Laboratory administrator, Local technical representative. The table below provides a breakdown of who can perform specific operations according to their level of access rights.
ADVANCED FUNCTIONS / USER ADMINISTRATION 11.3 USER ADMINISTRATION User administration makes it possible to add, edit and deactivate user accounts. Each user must be assigned to one role, which defines the associated 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.
ADVANCED FUNCTIONS / USER ADMINISTRATION 11.3.1 ADD A NEW USER ACCOUNT This section provides step-by-step instructions on how to add a new user account. - 1 Tap on the Menu button 2 Tap on the Users button 3 Tap on the + Add button to create a new user account. - 4 Fill in the appropriate fields. Choose the appropriate role of the user. All changes will be saved automatically. Tap on the Add button to apply the new user account.
ADVANCED FUNCTIONS / USER ADMINISTRATION 11.3.2 DEACTIVATE A USER ACCOUNT 11.3.3 DELETE A USER ACCOUNT This section provides step-by-step instructions on how to deactivate a user account. This section provides step-by-step instructions on how to delete a user account. 1 - 2 - 3 - 4 To delete the selected user account, - Tap on the Menu button screen to access to the administration sub-menu. 1 2 - 3 - 4 Tap on the Users button, Select the appropriate user account from the list.
ADVANCED FUNCTIONS / USER ADMINISTRATION 11.3.4 RESET A USER’S PASSWORD This section provides step-by-step instructions on how to reset a user password. 1 - 2 - 3 - 4 - Tap on the Menu button screen to access to the administration sub-menu. Tap on the Users button, Select the appropriate user account from the list. - 5 A pop up window appears to tap a new temporary password. 5 Tap on the Reset button.
ADVANCED FUNCTIONS / USER ADMINISTRATION 11.3.5 SAMPLE PROFILE SETTING With this setting, the laboratory administrator can select and edit the type of test to be used on the MosaiQ 125.. To set a sample profile: - 1 Tap on the Menu button screen to access to the administration sub-menu. By setting the profile, each time a sample is loaded on the MosaiQ 125, only this selected sample profile (DS available only) will be available on the Sample Loading dialog screen.
12. MAINTENANCE 12.1 SAFETY AND TIPS ABOUT MAINTENANCE AND CLEANING ..... 129 12.1.1 ELECTRIC SHOCK OR MECHANICAL INJURY BY MAINS POWER SUPPLY ...................................................................................................................................................................................................................................................... 129 12.1.2 DEFECTS IN THE LIQUID SYSTEM ..................................................................................
MAINTENANCE / SAFETY AND TIPS ABOUT MAINTENANCE AND CLEANING This section provides information on how to maintain the MosaiQ 125. 12.1.1 ELECTRIC SHOCK OR MECHANICAL INJURY BY MAINS POWER SUPPLY The MosaiQ 125 requires periodic maintenance tasks that must be performed at different stages of the MosaiQ 125 use. Tasks are required on a daily, weekly and monthly basis. The maintenance tasks can also be performed as needed.
MAINTENANCE / SAFETY AND TIPS ABOUT DISPOSAL AND DECONTAMINATION TION 12.2 SAFETY AND TIPS ABOUT DISPOSAL AND DECONTAMINATION This section provides information on cleaning (disinfection/decontamination), disposal of non-contaminated parts and handling of decontamination products. Please read this information carefully before carrying out any cleaning or disposal operations.
MAINTENANCE / PREVENTIVE MAINTENANCE TO BE PERFORMED BY THE USER SER 12.2.3 HANDLING OF DECONTAMINATION SOLUTIONS This section explains how to handle decontamination products. Pay careful attention when handling decontamination products. These products are hazardous, please read the product label and/or instructions for use. Strictly follow the local and national provisions, legislation and laboratory regulations. Do not mix bleach or decontamination liquid with alcohol.
MAINTENANCE / CLEANING SOLUTIONS TO BE USED 12.3.1 BEFORE PERFORMING MAINTENANCE TASKS 12.4 CLEANING SOLUTIONS TO BE USED Check that the minimum volumes for the resources for the MosaiQ 125 have been met, before performing the maintenance tasks. The MosaiQ 125 is designed such that the majority of cleaning activities can be performed following local guidelines and common laboratory cleaning agents. Reagents and system liquid, Available capacity in the waste canister.
MAINTENANCE / DAILY MAINTENANCE TASKS 12.5 DAILY MAINTENANCE TASKS This section provides information on maintenance tasks that must be performed on a daily basis. System priming is an essential step to ensure that each module is ready to operate correctly. Failure to carry out priming may result in inaccurate results. Please read this information carefully before you begin. Check that all resources conditions of the MosaiQ 125 are met before performing maintenance tasks.
MAINTENANCE / DAILY MAINTENANCE TASKS 12.5.1 DAILY MAINTENANCE TASKS OVERVIEW MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
MAINTENANCE / DAILY MAINTENANCE TASKS 12.5.2 INITIALIZE SYSTEM 12.5.5 PRIME WASH MODULE 1 This maintenance task is required prior to any sample processing. It takes up to 5 minutes to initialize all components. Initialization of the MosaiQ 125 happens automatically after switching it on. This task is mandatory. This maintenance task primes the wash module 1, to remove any air bubbles. To be performed as needed. On the touch screen: 1 - Tap on Maintenance on the navigation bar.
MAINTENANCE / DAILY MAINTENANCE TASKS 12.5.9 PRIME SAMPLE DILUENT 2 This maintenance task primes the MosaiQ Sample Diluent 2, to avoid or remove any bubbles from the lines. To be performed as needed. For an optimal result please perform this task 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.
MAINTENANCE / WEEKLY MAINTENANCE 12.6 WEEKLY MAINTENANCE This section provides information on maintenance tasks that must be performed on a weekly basis. Please be aware of the maintenance tasks safety and precautions below. Safety and precautions WARNING Unless specified, any cleaning/disinfection operation performed on the MosaiQ 125 by the user must be carried out with the power supply cord disconnected from the power source.
MAINTENANCE / WEEKLY MAINTENANCE 12.6.1 WEEKLY MAINTENANCE TASKS OVERVIEW This table provides an overview of the weekly maintenance tasks with a short description. Please 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 electrical supply and on. Maintenance tasks that can be performed when MosaiQ 125 is connected to the mains electrical supply or not.
MAINTENANCE / WEEKLY MAINTENANCE WARNING WARNING All of these cleaning / disinfection operations must be carried out with the power supply cord disconnected from the power source. Never mix cleaning products. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
MAINTENANCE / WEEKLY MAINTENANCE 12.6.2 CLEANING OF THE PIPETTOR NEEDLES The inner and outer surface cleaning of the sample pipettor is aimed at preventing sample build-up and thus carryover over time. Subsequent washing with system liquid should remove all residual cleaning fluid so that future test orders are not compromised. WARNING Bleach MUST NOT be used as replacement solution due to the high risk of residue remaining in the pipettor needle prior to test processing.
MAINTENANCE / WEEKLY MAINTENANCE 12.6.3 CLEANING OF THE REAGENT DRAWER BLACK INSERT AND REAGENT BOTTLE DOCKING STATION WARNING Disconnect the Mosaiq 125 power cord from the mains power supply before carrying out this cleaning/disinfection operation.. To clean the inside of the reagent drawer: 1 - Open the reagent drawer. 2 - Remove any reagent bottle from the drawer. 3 - Wipe the surface of the black insert of the reagent drawer with a lint free wipe and 70% alcohol.
MAINTENANCE / WEEKLY MAINTENANCE 12.6.8 CLEANING OF THE MAGAZINE STATION The magazine station door is controlled by software and cannot be opened when the MosaiQ 125 is operating, but it can be opened when the MosaiQ 125 is in Idle mode. For safety reasons DO NOT clean the magazine station door when the MosaiQ 125 is connected to the mains power supply. WARNING Disconnect the Mosaiq 125 power cord from the mains power supply before carrying out this cleaning/disinfection operation.
MAINTENANCE / MONTHLY MAINTENANCE TASKS 12.7 MONTHLY MAINTENANCE TASKS 12.7.1 MONTHLY MAINTENANCE TASKS OVERVIEW This section provides information on maintenance tasks that must be performed on a monthly basis. This table provides an overview of the monthly maintenance tasks with a short description. Please read the details for each maintenance task in the corresponding chapter. Please be aware of the maintenance tasks safety and precautions.
MAINTENANCE / MONTHLY MAINTENANCE TASKS 12.7.2 CLEANING OF THE LIQUID WASTE AND WATER SPILL TRAYS The spill trays of both the water and the liquid waste containers need to be cleaned once a month. To clean the spill trays: 1 - Open the water drawer and the waste drawer. 2 - Remove all water canisters and all liquid waste canisters. 3 - Wipe the surface with bleach, or 70% alcohol or Virkon® or Decon®. 12.7.
MAINTENANCE / GUI MAINTENANCE TASKS OVERVIEW 12.8 GUI MAINTENANCE TASKS OVERVIEW This section describes the maintenance tasks provided by the GUI. Procedure 1234- Task Prime Wash Buffer 2 Tap on the Maintenance icon in the navigation bar. Tap on a task to show details. Tap on the Execute Task button to execute the maintenance task. Follow the instructions. Shift start Tasks Task Initialize System Description Initializes the MosaiQ 125.
MAINTENANCE / GUI MAINTENANCE TASKS OVERVIEW Task Description Frequency Primes MosaiQ Enhancement Reagent 2 As needed, follow the Prime Enhancement Reagent 2 dispensers on the reagent carriage. Only indications on the if a reagent bottle is installed. MosaiQ 125 Wash the outside and the inside of both pipettor needles with system liquid.
13. TROUBLESHOOTING AND ERROR OVERVIEW 13.1 INTRODUCTIONഩ.............................................................................................................................................................ഩ148 13.3 FREQUENT OPERATIONAL WARNING MESSAGESഩ ....................................... ഩ151 13.1.1 MESSAGE EVENTSഩ ....................................................................................................................................ഩ148 13.3.1 MOSAIQ 125 FAILS TO INITIALIZEഩ .
TROUBLESHOOTING AND ERROR OVERVIEW / INTRODUCTION This section provides information on how to troubleshoot common errors that may arise when using the MosaiQ 125. 13.1.3 13.1 Critical error INTRODUCTION The MosaiQ 125 presents four events classes from the lowest severity up to the highest. භ භ භ භ Message Events Warning Events Critical Events Fatal Events 13.1.
TROUBLESHOOTING AND ERROR OVERVIEW / ERRORS RELATED TO PROCESS SS MODULES 13.2 ERRORS RELATED TO PROCESS MODULES Each process module has its own related possible errors and troubleshooting instructions. Please carefully follow the instructions provided. 13.2.4 MICROARRAY LOADING Error message(s) Severity Recovery Possible cause(s) Target position not FATAL - Mechanism that pushes the reached ERROR Reinitialize the MosaiQ 125. 13.2.
TROUBLESHOOTING AND ERROR OVERVIEW / ERRORS RELATED TO PROCESS SS MODULES 13.2.7 REAGENT CARRIAGE Error message(s) Data Reduction Error (DRE) Severity Recovery CRITICAL ERROR 13.2.11 Possible cause(s) REAGENT DRAWER Error message(s) Severity Recovery - Check detection and en- There might be a leakage due to a Empty reservoir and prime; hancement reagents bottles. reagent bottle (DDC) failure. always empty the reservoir - Replace the bottles. - Prime the dispenser. from the side.
TROUBLESHOOTING AND ERROR OVERVIEW / FREQUENT OPERATIONAL WARNING ARNING MESSAGES 13.3 FREQUENT OPERATIONAL WARNING MESSAGES During processing, warning messages will disply on the screen. Each of these messages requires an action to continue operating the MosaiQ 125. 13.3.1 MOSAIQ 125 FAILS TO INITIALIZE Messages on the screen “Please check doors” 13.3.2 UNABLE TO ADD TO PROCESS DUE TO WASTE LEVEL Messages on the screen “Warning not enough waste resource” ĐƟŽŶƐ ĐƟŽŶƐ 1.
TROUBLESHOOTING AND ERROR OVERVIEW / FREQUENT OPERATIONAL WARNING ARNING MESSAGES 13.3.3 SYSTEM LIQUID LEVEL SHOWN IN RESOURCES DOES NOT APPEAR CORRECT Messages on the screen Wrong system liquid level indication INFO ĐƟŽŶƐ All error messages and their recommended actions are described in the user software. 1. Ensure water canisters are fitted properly (as shown) Not correct Correct The connector is not fully plugged on the canister. The connector is correctly plugged on the cannister. 2.
TROUBLESHOOTING AND ERROR OVERVIEW / MOSAIQ 125 ERROR CODES 13.4 MOSAIQ 125 ERROR CODES If for any reason the MosaiQ 125 displays an error message with its event ID (digital number) it can be identified in this table. EventID Message Severity Event Recovery 209.000.00080 Internal error memory nearly full. Please collect data with SSW and erase error memory. Warning Please contact technical support. 210.000.
TROUBLESHOOTING AND ERROR OVERVIEW / MOSAIQ 125 ERROR CODES EventID Message Severity Event Recovery EventID Message Severity Event Recovery 213.000.00072 Solid waste container is full. MosaiQ 125 will stop soon. Critical Please load an empty solid waste container now. 257.000.00003 No database available or connection not possible. Fatal Please contact technical support 257.000.00004 Please contact technical support Both bottles of WB1 or WB2 are either empty or no bottles are plugged in.
TROUBLESHOOTING AND ERROR OVERVIEW / MOSAIQ 125 ERROR CODES EventID Message Severity Event Recovery EventID Message Severity Event Recovery 258.000.00013 Error loading rack on lane {0}. Critical Please re-load rack. If the problem reoccurs, please contact technical support. 263.000.00004 The system liquid canister is empty. Critical Please replenish the system liquid canisters now. 258.005.00001 {0} magazine in slot {1} expires soon. Warning Please replace the magazine. 263.000.
TROUBLESHOOTING AND ERROR OVERVIEW / MOSAIQ 125 ERROR CODES 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, user {0} has no rights to break the lock. Warning Please contact laboratory administrator or technical support. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
14. CYBERSECURITY 14.1 DEFINITION 14.2 USER TRAINING AND EDUCATION .............................................................................................................................................................. 158 14.3 IDENTIFICATION OF THREATS AND HAZARDS .................................................................................. 158 14.4 PASSWORD ..................................................................................................................................
CYBERSECURITY / DEFINITION 14.1 DEFINITION Cybersecurity is variously defined but can be thought of as the protection of information systems, computers and other hardware, and the software and data that runs on these devices. 14.3 IDENTIFICATION OF THREATS AND HAZARDS This section identifies the different threats and hazards that impact the cybersecurity.
CYBERSECURITY / PASSWORD 14.4 PASSWORD Only allow legitimate and trained employees to access to the MosaiQ 125 system with a password. Implement an account management process. Limit the number of privileged accounts to those who have a legitimate activity requirement. Establish a process for revoking system access by disabling accounts immediately upon termination of an employee or contractor.
CYBERSECURITY / DEFINITION 14.8 DEFINITION The definitions below are based on the International Standard for Information Security Incident Management. Cybersecurity Event An identified occurrence of a system, service, or network state, indicating a possible breach of information security, failure of controls, or a previously unknown situation that may be security relevant.
CYBERSECURITY / IDENTIFICATION OF POSSIBLE INSTALLATION / CONNECTION TION SCENARIOS 14.10 IDENTIFICATION OF POSSIBLE INSTALLATION / CONNECTION SCENARIOS This section describes the different possible environments of the MosaiQ 125, how it is connected to the outside and the various paths that could be taken by data in the system. # 1 Type Interface Description Local GUI Touch screen 14.10.
CYBERSECURITY / IDENTIFICATION OF POSSIBLE INSTALLATION / CONNECTION TION SCENARIOS 14.10.2 SCENARIO 2 - CONNECTION OF THE MOSAIQ TO A LOCAL NETWORK – 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.
15. INSTALLATION AND REMOVAL OF THE MOSAIQ 125 15.1 MOSAIQ 125 INSTALLATION CAUTION The installation of the MosaiQ 125 and its connection to external devices (e.g. printer) must be executed by Quotient Suisse SA authorized service personnel only. Improper installation can cause damage or malfunctions. After the installation is completed, the user receives the qualification documentation (IQ, OQ) attesting the installation of the MosaiQ 125 has been performed properly. 15.
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 number. (type label localization) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
17. CONTACT QUOTIENT To contact Quotient, please write to: GREAT BRITAIN QUOTIENT 5 James Hamilton Way Milton bridge Penicuik EH26 0BF Tel: + 44 0131 658 5700 UNITED SATES OF QUOTIENT AMERICA 301 South State Street Suite S-204 Newtown Pennsylvania 18940 USA Tel: + 00 1 215 4978820 SWITZERLAND QUOTIENT SUISSE SA Business Park Terre Bonne Route de Crassier 13 1262 Eysins, Switzerland Tel: + 41 22 716 98 00 For customer service information please refer to : https://quotientbd.
18. TECHNICAL DATA 18.1 POWER REQUIREMENTS 18.2 LASER OF THE BARCODE SCANNER ......................................................................................................................................................... 167 18.3 COMPUTER WORKSTATION AND CONNECTIONS .................................................................... 167 ...........................................................................................................................................................
TECHNICAL DATA / POWER REQUIREMENTS This section provides all technical specifications for the MosaiQ 125. INFO 18.1 Specifications Values are achieved under optimal conditions and can vary depending on environmental conditions, MosaiQ 125 status and processing conditions. Specifications are subject to change without notice. COMPUTER WORKSTATION AND CONNECTIONS This section provides the technical specifications for the computer and the associated connections.
TECHNICAL DATA / INSTALLATION DIMENSIONS AND WEIGHT 18.4 INSTALLATION DIMENSIONS AND WEIGHT This section provides the technical specifications for the dimensions and weight of the MosaiQ 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 in) Height: 166 cm (65.36 in) Weight 285 kg (628.3 lb) 18.
TECHNICAL DATA / ENVIRONMENTAL CONDITIONS 18.6 ENVIRONMENTAL CONDITIONS The following table shows the range of environmental conditions required to operate the system safely. 18.8 PACKAGING This section provides information about how the MosaiQ 125 is packaged as well as the dimensions and weight of each crate. Number of crates: 2 Environmental Conditions The system is made for Indoor use only. Temperature Operating: 16°C to 32°C (60.8°F to 89.
TECHNICAL DATA / RFID TAG AND READER SPECIFICATIONS 18.10 RFID TAG AND READER SPECIFICATIONS The MosaiQ magazines and the MosaiQ system reagents have RFID tags that are embedded in the label for traceability, on board management. Radio Frequency Identification (RFID) system refers to a wireless system comprised of two components: tags and readers. The RFID reader is a device that has one or more antennas that emit radio waves and receive signals back from the RFID tag.
19.INDEX A G N Administrative functions: p.51 General information: p.5 Noise: p.169 Advanced functions: p.118 General safety: p.22 Notes: p.9 Appendix: p.172 Audible warning signal: p.52 B Barcode error: p.92, p.98 Barcode: p.98, p.99, p.100 I O Installation dimensions: p.169 Overview (processing sequence): p.57 Intended use: p.12 Overview (resources): p.60 L Basic functions: p.50 Label (sample rack): p.20 Overview (testing sample): p.86 Electrical safety: p.24 C Label (safety): p.
20. APPENDIX 21. APPENDIX Operator Laboratory administrator Local technical representative (roles and responsibilities) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
For customer service information please refer to : https://quotientbd.com/login This manual is the property of Quotient Suisse SA. It may not be reproduced or QUOTIENT SUISSE SA Business Park Terre Bonne, Route de Crassier 13, CH-1262 Eysins - Switzerland transmitted in any way without prior written approval from Quotient Suisse SA. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.
