................................................ 1.7.5 DISPLAY OF WARNINGS AND NOTES ................GENERAL INFORMATION ..........................1.7.6 SYMBOLS .................................. VERSION ......................................FIGURES ......................................1.6.1 EDITION ..................................METRIC SYSTEM ................................1.6.2 SOFTWARE ................................MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
The manufacturer guarantees that the equipment functions safely, both electrically and mechanically. The MosaiQ 125 is tested and supplied by the manufacturer in a condition The intended audience for this User Manual is laboratory personnel. MosaiQ 125 allows that enables a safe and a reliable operation.
Buttons are printed in bold. Buttons Example: Open button Keys are printed in bold. Keys Example: Tap on Enter File examples are printed in typewriter font. File examples Example: DRIVER=C:\SERVICE\DRIVERS MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
European Standards The term “Service personnel” refers to service personnel authorized Service personnel by Quotient Suisse SA. European Union EULA End-User License Agreement Federal Communications Commission Feet Gigabyte MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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Limited Liability Company WEEE Waste Electrical & Electronic Equipment Meter Microliter Minute Microsecond °C Temperature unit in Celcius Milliliter °F Temperature unit in Fahrenheit Microwave radiation NaOH Sodium hydroxide MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
(e.g. messages related to property damage). Not following a safety instruction can result in damage to the MosaiQ 125 or an adverse effect on operation. INFO INFO Complementary information on MosaiQ 125 description and/or operation. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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Date of manufacture (YYYY-MM-DD) Restriction of certain Hazardous Substances (RoHS) in electronic equipment Nemko certification mark for North American market access Disposal of electrical and electronic equipment Fuse MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
MosaiQ 125 have metric dimensions. Users must be sure to have the appropriate tools, such as metric wrenches and screwdrivers. Do not use screws and nuts from a non-metric system. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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MOSAIQ SYSTEM COMPOSITION ......................................PRINCIPLES OF OPERATION ............................................2.3.1 MOSAIQ 125 PROCESS WORKFLOWS ............................... 2.4 RESULTING PRINCIPLES .................................................. 2.4.1 IMAGING ............................................................2.4.2 IMAGE ANALYSIS .................................................... 2.4.3 INTERPRETATION ..................................................MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Centrifuged and decapped blood sample tubes are loaded into the MosaiQ 125. Immunohematology testing (IH) is defined by antigen typing and The MosaiQ 125 is designed for the fully-automated testing of blood donor samples. It antibody detection. Currently the MosaiQ 125 cannot perform...
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Disposal container. For more information on this topic, please refer to the MosaiQ SDS Magazine instructions for use (IFU). MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Mean (Background): Mean value of the grey level of the background surrounding the spot calculated on the area of the background. StD (Background): Standard deviation of the background surrounding the spot, calculated on the area of the background. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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MOSAIQ MAGAZINES ..............................................3.2.2 MOSAIQ SYSTEM REAGENTS ......................................3.2.3 MOSAIQ WATER CANISTER ........................................3.2.4 MOSAIQ QUALITY CONTROLS ....................................3.2.5 SAMPLES ..........................................................3.2.6 SAMPLE RACKS ....................................................3.2.7 SYSTEM WASTE ....................................................MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
3.1.3 USER TRAINING MosaiQ 125. To minimize any potential risk, prior to the use of the MosaiQ 125, the user must be trained USER QUALIFICATION Download the appropriate user manual, the instructions for use and the safety data sheets for every product required to use the MosaiQ 125 from the customer The equipment is intended for professional use within a blood establishment.
The MosaiQ SDS Standard Magazine with a capacity of 50 microarrays. To perform SDS assay only, one bottle of MosaiQ Sample Diluent 1 NOTICE must be loaded in the MosaiQ 125, although this reagent is not used to run this type of assay. (MosaiQ Standard Magazine) For detailed information please refer to the MosaiQ SDS Magazine IFU.
MOSAIQ WATER CANISTER The DDC (Disposable Dispense Cartridge) for MosaiQ detection and MosaiQ Two water canisters. enhancement reagents which are loaded in the MosaiQ 125 behind the reagent door. For more information please refer to of this manual. chapter 5.9.1...
MosaiQ 125. In total 120 samples can be loaded at any one time. Perform regular quality control of the MosaiQ 125 at least once During each run, the MosaiQ 125 associates the barcode of each tube with a corresponding daily and as per laboratory and or regional specific requirement.
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)
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4.5 POSITIONS OF SAFETY LABELS AND TYPE LABEL ................4.5.1 MISSING WARNINGS ..............................................4.5.2 POSITIONS OF SAFETY LABELS ....................................4.5.3 POSITIONS OF ALL OTHER LABELS ................................. 4.6 RADIO INTERFERENCE ..................................................4.7 LABORATORY EQUIPMENT ............................................. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
The handling and maintenance of the MosaiQ 125 shall be performed only by trained and authorized personnel. Do not block or cover ventilation slots. For more information about the maintenance of the MosaiQ 125 please read The air must be able to circulate. chapter 12 of this manual.
Malfunction of the MosaiQ 125 may cause electrical shock, burns, DANGER cuts or contusions. Use the main switch to switch off the MosaiQ 125 or the mains plug to disconnect the MosaiQ 125 from the mains power supply. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
(WEEE) statement is applicable only to European countries. At the information regarding biological safety precautions before operating the MosaiQ 125. end of the life cycle of the MosaiQ 125, do not dispose of the device as unsorted municipal waste, even if it is decontaminated. Please refer to the dismantling Risk of Infection and recycling instructions available at Quotient Suisse SA.
Strictly follow the local and national provisions, legislation and laboratory regulations. Do not mix bleach or decontamination liquid with alcohol. Do not use incompatible decontamination products. Please follow the cleaning instructions provided in this manual. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
On the back, left-hand side of the MosaiQ 125. Laser Radiation Do not stare into beam Next to the barcode scanner of the Sample Class 2 laser product Station Laser Information / Technical Data MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
The MosaiQ 125 complies with the following standards and rules for information concerning radio interference: The MosaiQ 125 has been tested and found to comply with the IEC 61326-2-6 (Class A for emissions) and IEC 61326-1. limits for a Class A digital device, pursuant to part 15 of the FCC 47 CFR Part 15, Subpart B, of the FCC Rules.
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5. 1 2. 1 MATERIAL PROVIDED ......................................................................................................5. 1 2.2 ACCESSORIES AND SPARE PARTS ................................WATER DRAWER ......................................................... 5. 9 . 1 WATER CANISTERS ................................................5. 9 .2 COMPUTER WORKSTATION ........................................ MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Visual alarm/alert Reagent door Power switch Reagent door Reagent drawer Magazine station Water drawer Sample station Power switch Reagent drawer Waste drawer Water drawer (MosaiQ 125 external parts localization) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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.0010.02...
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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.0010.02...
POWER SWITCH AND MAINS POWER OUTLET VISUAL ALERT / ALARM The different status of the visual alert/alarm indicate that the MosaiQ 125 is operating The power switch is used to turn the MosaiQ 125 on and off. The MosaiQ 125 must be properly or that the user needs to perform an action.
The touch screen can be adjusted by tilting the screen (20° upward and 10° downward). operate the MosaiQ 125 via the MosaiQ Software, using the touch screen. (MosaiQ 125 touch screen adjustement) (MosaiQ 125 touch screen) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Function: The magazine station holds the MosaiQ magazines and also supplies the MosaiQ 125 with The magazine station is the place to load the magazines in the MosaiQ 125. There are two microarrays to process. MosaiQ magazine sizes offering more operational flexibility.
To load the samples in the MosaiQ 125 please refer to chapter 8.5 of this manual. To see the types of tubes that can be used please refer to the chapter 8.11 of this manual. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
50 liters) which collects all used microarrays on the right side of the waste drawer. Based on the amount of processed microarrays, the MosaiQ 125 informs the user when the solid waste container needs to be emptied. Drawers NOTICE The pulled-out drawer can support the weight of waste filled...
5.9.1 WATER CANISTERS There are two canisters with a capacity of 10 L each (provided with your MosaiQ 125). They 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.
The computer mains power cord passes through a hole on NOTICE the back of the MosaiQ 125. The computer workstation has an USB port in the front panel to allow specific support operation, please refer to chapter 14.6. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
To remove and load the MosaiQ wash buffer and MosaiQ sample diluent bottles, please refer to chapter 7.3.5 chapter 7.3.6 of this manual. To clean the reagent drawer (monthly task), please refer to chapter 12.7.1 of this manual. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
The reagent door can be opened and closed manually only when WARNING the MosaiQ 125 is not in operation. Locking and unlocking of the reagent door is software controlled. (visible process modules with the opened reagent door) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
To remove and load the MosaiQ detection and MosaiQ enhancement reagent bottles, please refer to chapter 7.3.3 chapter 7.3.4 of this manual. To clean the reagent carriage (weekly task), please refer to chapter 12.6.1 of this manual. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
The reagent drawer has a capacity of loading two bottles of MosaiQ Wash Buffer 1 and two bottles of MosaiQ Wash Buffer 2. Capacity: There is one incubation ring (with inner and outer positions) offering 80 positions for microarrays. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
MosaiQ Software and are not accessible to the user. The images taken are not accessible to the user. They can only be NOTICE analyzed by the MosaiQ Software. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
For SDS assay, samples can be plasma or serum of blood NOTICE specimens. To clean pipettor module (weekly task), please refer to chapter INFO 12.6.2 of this manual. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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 MosaiQ 125 Computer Workstation Display + display holder...
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MAIN SCREEN ......................................................6.1.2 NAVIGATION BAR ..................................................6.2 MOSAIQ MENU ..........................................................6.2.1 BASIC FUNCTIONS ................................................6.2.2 LABORATORY ADMINISTRATIVE FUNCTIONS ....................6.2.3 NOTIFICATIONS MENU ............................................6.3 LOCK SCREEN ............................................................... MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Tap twice on the screen with your finger to double click. Swipe up and down to scroll lists (for example the results screen). INFO The touch screen can also be used while wearing gloves. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Tap to display all quality controls. Tap to log off or to change users. Refer to chapter Refer to chapter 6.3. Tap to display any upcoming maintenance tasks. Refer to chapter MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Software and switch off the MosaiQ 125, as described in chapter Tap to display information about the system software. • MosaiQ Software version • Device serial number • Manufacturer (basic functions) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Tap to export and save all messages into a file. users. Refer to schapter 11.3. Tap to print out selected messages. Tap to configure sample loading. Refer to chapter MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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2 - Tap on the Speaker symbol. The audible warning signal stops and a “X” on the Speaker symbol appears. 3 - Respect the shown warning or error message (see above). MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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.0010.02...
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LOADING THE SOLID WASTE BAG ................................7.3.9 REMOVING LIQUID WASTE CANISTER ............................7.3.10 LOADING LIQUID WASTE CANISTER ..............................7.3.11 REMOVING THE WATER CANISTER ................................. 7.3.12 LOADING THE WATER CANISTER ..................................MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
WARNING • Wear suitable protective clothing. • Clean, disinfect or decontaminate and dry the MosaiQ 125 according to the applicable local and national provisions, legislation and laboratory procedures. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
• System liquid Fill the water canister with purified water Maintenance • Execute required maintenance tasks • Run quality controls. Quality control • Please refer to the appropriate IFU. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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OPERATING INSTRUCTIONS / BEFORE STARTING TO TEST SAMPLES (processing sequence overview) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
MosaiQ 125: 7.2.1 SWITCH ON 1 - Ensure that all MosaiQ 125 environmental conditions are met (refer to chapter 18.6 2 - Ensure that all incubation ring insulating covers are securely in place. The following section explains how to start the MosaiQ 125.
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Login button or tap on the Shutdown button to cancel and shut down the MosaiQ Software. (login pop-up window) (computer workstation power button localization) When not used during a 30 Min MosaiQ 125 goes automatically in NOTICE standby mode. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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. If all conditions are not met, MosaiQ 125 will display a caution message and it will prevent the execution of the run (the “Add to Process” button will not be available).
MosaiQ 125.such as: • Magazine positions without information are empty. The remaining quantity of microarrays available, • If MosaiQ 125 has only SDS magazines loaded, the screen will The catalog number, display only the SDS magazine level bar. NOTICE The unique magazine number, •...
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The remaining open shelf life. Tap on the Reagents area to check the reagent details. Remaining dispensing available Information contained in the reagent RFID tag (reagents resources area) (reagents resources details) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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• MosaiQ 125 will always use the reagent which has a shorter period of validity first. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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: A red dot with a “X” shows that the canister is not present or not properly inserted/connected. Re-usable canister INFO The water canister is re-usable and can contain up to 10 L purified water. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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If you remove the locked canister (yellow signal LEDs are on) and no other waste canister is connected the MosaiQ 125 will stop. • Remove only the unlocked canister (yellow signal LEDs are off). MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
OPERATING INSTRUCTIONS / HOW TO REMOVE AND LOAD EACH RESOURCE HOW TO REMOVE AND LOAD EACH RESOURCE You cannot open the magazine station door when the MosaiQ 125 is operating or performing initialization. The following section provides step-by-step instructions on how to remove and load each Wait until the light is off to open the magazin station door.
4 - Open the magazine station door. 5 - Rotate the carousel manually until you reach an available position. NOTICE The carousel is divided into 4 numbered sections. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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10 - The system runs a 360° rotation of the carousel to read all magazines information. heard. 11 - Check magazine conditions (such as quantity of test available, expiry date) on the Magazines screen. (loading the magazine in the magazine station) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
MENT REAGENT BOTTLES 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. Tap on Resources icon in the navigation bar.
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7 - Remove the empty reagent bottle. 8 - Dispose of the empty reagent bottle (follow the disposal information on the product 5- Press the lock mechanism of the empty reagent bottle together. IFU). MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
(reagents resources detais screen) To know the remaining time before MosaiQ 125 goes to Idle, go to NOTICE the Results menu and tap on the Processing button. (reagents resources area) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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(2 slots for each MosaiQ detection and MosaiQ enhancement reagent bottles) The correct reagents positions on the reagent carriage following NOTICE the colored symbols. (insertion of the reagent bottle) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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11 - Check the MosaiQ system reagent conditions (volume available, expiry date) on the Resources screen. NOTICE The upright symbol on the reagent bottles packaging is meant for transport and storage purposes only. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Tap on the Wash Buffers & Sample Diluents area. Bottle Bottle is Bottle is Bottle is validity is empty low level full expired (buffers and diluents resource details) (buffers and diluents resource area) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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6 - Dispose of the empty bottles (follow the disposal information on the product IFU). Bottles can be removed even when they are low level and not INFO empty. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
2 - Insert the MosaiQ wash buffer and MosaiQ sample diluent bottles upside down in the appropriate location. 3 - Press the bottle down slightly. (inserting the buffer and diluent bottles) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
7 - Dispose of the full bag according to your laboratory biohazard waste procedure. Wast drawer Remaining quantity of door is open waste (microarrays) (removing of the solid waste bag) (solid waste drawer status and back up bin capacity) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
5 - Place other side of the waste bag over the holding clamp. 6 - Gently release the holding clamps. (confirmation message) (placing of the solid waste bag) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
When filled with 10 L of liquid waste, a canister can weight up to 11,2 kg. Shows the overall fill level of the liquid waste containers as a percentage. Shows the quantity of the solid waste (microarrays) (waste capacity area) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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(removing of the liquid waste level sensor) 7 - Fit the stopper onto the canister level sensor hole. (fitting the stopper of the canister level sensor hole) (opening of the waste drawer) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
12 - Close the screw caps. Risk of injury WARNING While emptying the liquid waste canister wear protective glasses and gloves. (inserting of the empty liquid waste canister) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
4 - Plug in the level sensor connector and insert the liquid waste connector into the canister, until a click is heard. Click ! (plugging in the liquid waste level sensor) (system liquid resources area) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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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.0010.02...
5 - Press down on the front of the canister. 6 - Ensure that the water canister is fitted correctly to the intermediate reservoir to avoid any leakage of purified water. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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INDIVIDUAL TEST ORDER ASSIGNMENT ............................8.16 FILTERING OF TEST RESULTS ........................................... 8.8 BARCODE READING ERRORS ..........................................8.17 PRINTING TEST RESULTS ..............................................8.8.1 CHECK BARCODE LABELS ........................................8.8.2 EDIT SAMPLE ID(S) ................................................MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
In the Completed status, the result is validated, displayed and transmitted to the LIS (if connected). 1 st 2 nd Processing Review New order Standby Finished Confirmation Confirmation MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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. This section provides information on how the sample is processed from the sample loading until the results.
The order is placed in the Finished status from the Processing or Confirmation status when the final result is available after the processing or confirmation(s) is (are) completed. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Order status: Review: The order may be placed in the Review status from the Finished status if one the Review criteria defined in the application is met. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Do not touch any optical surfaces. NOTICE • Only clean the optical surfaces with a soft and lint-free wipe. • Do not use any harsh detergents or solutions (e.g. acetone). (rack contact pin) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
≤ If the operating temperature in the laboratory is 16 °C (60.8 °F), WARNING MosaiQ 125 must be switched on for a minimum of 2 hours before processing any assay. Improper loading or removing of sample racks WARNING Improperly loaded or removed sample racks can produce erroneous results due to incorrect pipetting activities and may damage the pipettor.
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Lane has been Rack information could loaded with a rack Error Error message not be read. but all sample tube information are missing. (starting of the assay process) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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Scheduled Scheduled In Use (collapsed) (expanded) (collapsed) (expanded) The collapsed views only show the racks status. NOTICE The expanded view show both the tubes and the racks status. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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The affected sample Waiting for test orders. tubes on the screen are also marked. All sample test tubes assigned to Error with the sample rack. test order. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Check if the test request was sent from the LIS-system to the MosaiQ 125. • Check the barcodes of the sample tubes. • Check the connection to the LIS-system. (all sample ID on the sample rack on lane 1) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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8 - If necessary, repeat the procedure for the other sample tubes. 9 - To close the rack details view, tap on the dimmed background or a main navigation item when you have finished. (assay profile selection) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
To perform a different test order on each of the samples in a sample rack, select the given sample number on the rack. Tick the appropriate box under the Test Orders list to apply the relevant test (starting of the assay process) (individual test assignment) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Ensure that the barcode labels face outwards (open side of the sample rack). 4 - Check the barcodes of the affected sample tubes. 5 - Insert the sample rack again. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
(American Standard Code for Information Interchange). GS1 (General Specifications Standard) requires that barcodes shall have a quality of ANSI If the sample ID has been successfully identified by the MosaiQ 125. INFO “Grade C. The measurements are based on a scale of 0-4 and expressed as a letter grade (A, B, C, D or The Sample ID cannot be modified manually.
8.11 SAMPLE TESTING MONITORING Only the sample tube references listed below have been tested for use in the MosaiQ 125. 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.
Once a run has started, different messages such as Maintenance (during maintenance operation), Processing (while MosaiQ 125 is performing assays) and Finishing (while MosaiQ 125 is finishing the assays) appear transiently. When the run is completed, the initial Idle message is displayed (selecting test result) steadily.
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For detailed explanations on the interpretation of the results, please refer to the MosaiQ SDS Magazine IFU. (detailed result report) Tap on an overview line to show the complete details. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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(reactive CMV and non-reactive Syph reported result details) (confirmation screen) Tap on an overview line to show the complete details. 2 - On the list select the result you want to retest. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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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 removed and is no longer in the MosaiQ 125. 1 - Load the Sample into the MosaiQ 125, the sample will automatically be assigned for testing (as described in chapter 8.6).
(test results report in collapsed view) Tap on the test result message or on Review button to decide if you want to repeat the test. (review screen) (test results review) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Tap Results on the navigation bar Select the result that has a flag you want to check and tap on its line. (confirm the test repeat) (selecting a test result with result flag) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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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.0010.02...
If necessary, tap on the Finished button or another result menu entry. Tap on the desired test result to show the details. (to view test results details) (reviewing test results) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
• Equals: The specified value is identical to Apply: to apply the the value of the result (e.g. 456231 => only filter to the results. 456231). (filtering test results) (filter criteria) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
1- Print all finished results: NOTICE On Finished screen, tap on Print. 2- Print individual result: On Finished screen, tap on the selected result and tap on Print. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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9. QUALITY CONTROL QUALITY CONTROL METHOD ........................................QUALITY CONTROLS PREPARATION ................................. QUALITY CONTROLS LOADING AND RUNNING ..................QUALITY CONTROLS RESULTS ......................................MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
QC material and apply it on the prepared tube. This will allow The laboratories must validate their own quality control method and quality control the MosaiQ 125 to process the QC material as a normal sample (as described in material for the assays performed by MosaiQ 125.
Before loading the QC into the MosaiQ 125: Tap one of the lanes (Lanes 1-10) to view tube details Make sure that the MosaiQ 125 is ready for running tests (check for required maintenance tasks, resources, waste capacity). chapter 8.3...
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10 - The corresponding lane is displayed with the selected profile. 11 - To close the rack details view, tap on the dimmed background or a main navigation item when you have finished. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
CMV and Syph reactive results Using QC material, initial reactive result on syphilis does not need to be retested. (viewing the result of the sample with QC material) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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(removing the sample rack) Remove all samples from the racks. (removing the remaining magazines) 5 - Remove any empty reagents bottles. (removing the sample tubes) (removing the remaining reagent bottles) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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Please refer to chapter 12 of this manual . Confirm to shut down and wait until the PC has shut down (touch screen is black). (shut down confirmation) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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11.3.2 DEACTIVATE A USER ACCOUNT ..................................11.1.4 ALARM / ALERT MODE ............................................11.3.3 DELETE A USER ACCOUNT ........................................11.3.4 RESET A USER’S PASSWORD ......................................11.3.5 SAMPLE PROFILE SETTING ........................................MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
OPERATION MODE 11.1.2 INACTIVITY TIME - OUT From this scroll button you can select the type of assays the MosaiQ 125 can run: 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.
11.1.4 ALARM / ALERT MODE To enforce the password security this function allows the laboratory administrator By taping on this scroll button you can select the Alarm/Alert mode, when the MosaiQ 125 to determine the required password characteristics (password length and special displays a notification:...
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.
Special access rights In most cases, special access rights are INFO required for the described functions. To reset user To delete user password account (users list and profile) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Tap here to activate / deactivate the Fill new user new user account information (adding a new user) Scroll down menu to select the new user note (creating a new user profile) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Tap on the Active button to deactivate the user account. Select the appropriate user account from the list. Tap on the Delete button. (deactivating a user account) (deleting a user profile) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
A temporary password can be entered in a dialogue box. NOTICE The user must enter and confirm a new password at the next login. (resetting a user password) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Tap on the Menu button screen to access to the administration sub-menu. Tap on the Sample Loading button, 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.
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12.5.7 PRIME WASH BUFFERS AND SAMPLE DILUENTS ................. 12.8 GUI MAINTENANCE TASKS OVERVIEW 12.5.8 PRIME SAMPLE DILUENT 1 ..................................................................12.5.9 PRIME SAMPLE DILUENT 2 ........................................ 12.5.10 SHIFT START ......................................................MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
All service and maintenance operations that are not described in this instruction manual will be performed by the local technical representative. Any changes made to the MosaiQ 125 that are not authorized by the manufacturer will void the manufacturer warranty. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Strictly follow the local and national provisions, legislation and laboratory Dispose of used batteries according to the local and national provisions or regulations. legislation. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
2 - Tap on the Next Due button to make sure that all tasks have been performed correctly. Do not use improper decontamination products. 3 - Some maintenance tasks (that are not performed by the MosaiQ 125) need to be Only use 70% alcohol (i.e. Isopropanol) to decontaminate the external parts of the confirmed by the user by taping on the Task Finished button, on the top right corner...
CLEANING SOLUTIONS TO BE USED Check that the minimum volumes for the resources for the MosaiQ 125 have been met, The MosaiQ 125 is designed such that the majority of cleaning activities can be performed before performing the maintenance tasks.
For more information to check resources levels please refer to chapter 7.2.2 5 - Once the task is finished, the term Idle will reappear. (maintenance screen) NOTICE Processing is blocked during priming operations. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
3 - Tap on Execute Task on the right side of the screen to start the maintenance. 2 - Tap on Initial Washer Prime. 3 - Tap on Execute Task on the right side of the screen to start the maintenance. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
1 - Tap on Maintenance on the navigation bar. 2 - Tap on Shift Start. 3 - Tap on Execute Task on the right side of the screen to start the maintenance. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
(IPA). Take a new clean wipe when necessary. For application of solutions for cleaning of internal surfaces (i.e. loading bay, turntable) users MUST avoid spraying reagents directly onto MosaiQ 125 surfaces to reduce the risk Improper cleaning of the optical surfaces (e.g. scanners, sensors, of aerosols coming into contact with electrical components.
Maintenance tasks that can be performed when MosaiQ 125 is connected to the mains electrical supply or not. Maintenance tasks that must be performed when MosaiQ 125 is disconnected from the mains electrical supply. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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MAINTENANCE / WEEKLY MAINTENANCE these cleaning disinfection WARNING operations must be carried out with the power supply cord disconnected from the power source. WARNING Never mix cleaning products. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
1 on a MosaiQ rack. Tube (position 1) filled with 0.5 M NaOH (Sodium Hydroxide) (executing a maitenance task) (sample tube in position one on the sample rack) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
The reagent door is controlled by software and cannot be opened when the MosaiQ 125 The external surfaces (covers and drawers) can be cleaned when the MosaiQ 125 is not is operating, but it can be opened when the MosaiQ 125 is in Idle mode. For safety reasons operating.
The magazine station door is controlled by software and cannot be opened when the External part MosaiQ 125 is operating, but it can be opened when the MosaiQ 125 is in Idle mode. For The external part of the sample station is equipped with a laser barcode scanner and safety reasons DO NOT clean the magazine station door when the MosaiQ 125 is connected...
These maintenance tasks can be performed when MosaiQ 125 is connected to the mains Please be aware of the maintenance tasks safety and precautions. power supply or not. WARNING Never mix cleaning products. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
1 - Remove all tubes from the racks. 2 - Let the racks in bleach or Virkon® soak a minimum of two hours. 3 - Rinse the racks and let them dry before use. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
1 Prime Wash Buffer 1 in the reconstitution drawer. Only if a instructions on the if a reagent bottle is installed. MosaiQ 125 reagent bottle is installed. MosaiQ 125 MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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Primes all the liquid lines at wash module 2. As needed, follow the Prime Wash Module 2 indications on the Solutions used: MosaiQ 125 • MosaiQ Wash Buffer 1 • System liquid MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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......................... 13.2.5 SAMPLE ADDITION ..........................13.2.6 PIPETTOR ................................13.2.7 REAGENT CARRIAGE ........................... 13.2.8 WASHING MODULES .......................... 13.2.9 REAGENT DOOR ............................13.2.10 REAGENT DRAWER ..........................13.2.11 WATER DRAWER ............................MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
These warning events give indication to the user to perform something (e.g. fill level), it can An event is classified as a fatal error when an error may cause the MosaiQ 125 to crash and also indicate that a problem has been solved, or that a state has been changed.
- Check the tubing / re-adjust it if required (blue coil around the Target position not FATAL Pipettor tubing getting caught on tubing) and reinitialize the the rail. reached ERROR MosaiQ 125. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
Power off, restart the system Not updated RFID information due to intermediate canister. Processing error is not damaged. interlock blocking. FATAL ERROR and reinitialize the MosaiQ 125 . ERROR MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
6. If it still disconnected, shutdown the computer workstation. 7. Turn off MosaiQ 125. 8. Wait 30 secs. 9. Turn on the computer workstation. 10. If error repeats, contact local technical representative. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
2. Re-seat sensor connector Correct when the connector is correctly plugged on the canister. 3. If error repeats, contact your local technical representative. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
MOSAIQ 125 ERROR CODES EventID Message Severity Event Recovery If for any reason the MosaiQ 125 displays an error message with its event ID (digital 209.000.00080 Internal error memory Warning Please contact technical support. number) it can be identified in this table.
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Locked rack '{1}' removed Critical Please review corresponding canceled 257.000.00002 Microsoft SQL Server is Fatal Please contact technical support from lane {0}. results. not ready to accept new client connections. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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Warning Please replenish the system liquid canisters 279.000.00019 Login failed user account Warning Please contact laboratory administrator or is running low. soon. {0} has been disabled. technical support. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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Please contact laboratory administrator or no roles. technical support. 279.000.00021 Login failed, user {0} has Warning Please contact laboratory administrator or no rights to break the technical support. lock. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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14.10.2 SCENARIO 2 - CONNECTION OF THE MOSAIQ TO A LOCAL NETWORK 14.5 EXTERNAL MEDIA AND DEVICES – LIS ON NETWORK OR DIRECTLY CONNECTED ........................................................14.7 INCIDENT RESPONSE ................................................14.8 DEFINITION ............................................................. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
ACCIDENTAL • Deletion: The file is deleted or moved to another location. The risks can be limited by regularly educating MosaiQ 125 users on cybersecurity best • User • Data manipulation: Data inside a file are changed or deleted in such practices.
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 SA authorized service personnel only. Users cannot access to any data of the MosaiQ 125 computer using INFO the USB port.
Incident Response Team A team of appropriately skilled and trusted members of the organization that handles incidents during their lifecycle. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
MOSAIQ TO A LIS VIA RS232 CONNECTION SCENARIOS A stand-alone MosaiQ 125 or the connection of the MosaiQ to a LIS using a RS232 serial link limits the vulnerabilities to those that are related to a direct local access to the MosaiQ 125.
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.
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Operational qualification (OQ) is performed after meeting each INFO protocol of IQ. OQ’s purpose is to determine that the MosaiQ 125 performance is consistent with the user requirement specification within the manufacturer specified operating ranges. In action, this means identifying and inspecting equipment features that can impact final product quality.
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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.0010.02...
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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.com/login MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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18.10.2 RFID READER SPECIFICATIONS ..................................18.4 INSTALLATION DIMENSIONS AND WEIGHT ..................... 18.11 OUTPUT ..................................................................18.5 SPACE REQUIREMENT ................................................18.6 ENVIRONMENTAL CONDITIONS ....................................18.7 NOISE ....................................................................18.8 PACKAGING ............................................................. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
To guarantee a safe use please follow this space clearance around of the MosaiQ 125. Width: 374 cm (147,25 in) Depth: 200 cm (78,74 in) (MosaiQ 125 space clearance) (MosaiQ 125 dimensions) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
47 dBA is the maximum noise level measured at 1 m (39.4 in) around the device 59 dBA is the maximum noise level in the user’s working area at 25 cm (9.8 in) from the device. MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
RFID system frequency range: 13.553 - 13.567 MHz Number of channels: 1 Product Class: Class 1 (inductive loop coil transmitter) Antenna: PCB, integral or external, not changeable Power supply: DC 24V MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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Fill water: p.81 Removal of solid waste: p.77 Weight: p.168 Microarray: p.13, p.18 Removal of water canister: p.84 MosaiQ 125 description: p.29 Removal of the MosaiQ 125: p.163 MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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20. APPENDIX 21. APPENDIX Laboratory Local technical Operator administrator representative (roles and responsibilities) MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02...
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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 transmitted in any way without prior written approval from Quotient Suisse SA. Business Park Terre Bonne, Route de Crassier 13, CH-1262 Eysins - Switzerland...