QUOTIENT MOSAIQ 125 User manual

USER MANUAL
MosaiQ 125
MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
FCC ID: 2AWE5MOSAIQ125

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MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
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MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
TABLE OF CONTENT
1. ABOUT THIS MANUAL...........................................................................................................................................4
2. INTENDED USE.................................................................................................................................................................12
3. PRIOR TO USE....................................................................................................................................................................16
4. SAFETY INSTRUCTIONS.................................................................................................................................22
5. MOSAIQ 125 PARTS DESCRIPTION AND LOCATION................................. 29
6. GRAPHICAL USER INTERFACE............................................................................................................47
7. OPERATING INSTRUCTIONS..................................................................................................................54
8. SAMPLE LOADING AND TESTING................................................................................................85
9. QUALITY CONTROL.............................................................................................................................................111
10. MOSAIQ 125 SHUTDOWN..................................................................................................................116
11. ADVANCED FUNCTIONS........................................................................................................................118
12. MAINTENANCE.......................................................................................................................................................128
13. TROUBLESHOOTING AND ERROR OVERVIEW .............................................147
14. CYBERSECURITY..................................................................................................................................................157
15. INSTALLATION AND REMOVAL OF THE MOSAIQ 125.....................163
16. WARRANTY ................................................................................................................................................................164
17. CONTACT QUOTIENT.....................................................................................................................................165
18. TECHNICAL DATA..............................................................................................................................................166
19. INDEX.........................................................................................................................................................................................171
20. APPENDIX.......................................................................................................................................................................172
TABLE OF CONTENT 3

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MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
1. ABOUT THIS MANUAL
1.1 PURPOSEഩ...........................................................................................................................................................................................ഩ5
1.2 AUDIENCEഩ.......................................................................................................................................................................................ഩ5
1.3 DISCLAIMERഩ...............................................................................................................................................................................ഩ5
1.4 HOW TO USE THE USER MANUAL ഩ....................................................................................................ഩ5
1.5 GENERAL INFORMATION
ഩ..................................................................................................................................ഩ5
1.6 VERSIONഩ............................................................................................................................................................................................ഩ6
1.6.1 EDITIONഩ.......................................................................................................................................................................ഩ6
1.6.2 SOFTWAREഩ..............................................................................................................................................................ഩ6
1.7 TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY ഩ.......................ഩ6
1.7.1 SPECIAL TYPESഩ..................................................................................................................................................ഩ6
1.7.2 TERMINOLOGYഩ...................................................................................................................................................ഩ7
1.7.3 CONVENTIONSഩ...................................................................................................................................................ഩ7
1.7.4 LIST OF ACRONYMSഩ....................................................................................................................................ഩ7
1.7.5 DISPLAY OF WARNINGS AND NOTESഩ................................................................................ഩ9
1.7.6 SYMBOLSഩ..................................................................................................................................................................ഩ9
1.8 FIGURESഩ...........................................................................................................................................................................................ഩ11
1.9 METRIC SYSTEMഩ................................................................................................................................................................ഩ11

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ABOUT THIS MANUAL / PURPOSE
MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
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. For best
results, please be sure to read the manual carefully.
This User Manual has been designed to assist users in running assays on the MosaiQ125.
It describes both the MosaiQ125 and the Graphical User Interface (GUI) of the software.
There are step-by-step guides and procedures to illustrate how to use the MosaiQ125.
1.2 AUDIENCE
The intended audience for this User Manual is laboratory personnel. MosaiQ 125 allows
any trained person to perform assays.
1.3 DISCLAIMER
Quotient Suisse SA reserves the right to make any necessary changes to this information
during the course of technical development without prior notice.
Copyright © 2019, Quotient Suisse SA. All rights reserved.
1.4 HOW TO USE THE USER MANUAL
This User Manual includes both informational and procedural information about the
MosaiQ 125. The User Manual contains both general information and also specific
procedures regarding MosaiQ 125.
Read all instructions.
The User Manual is accessible via the GUI of the MosaiQ 125.
1.5 GENERAL INFORMATION
The MosaiQ125 is designed and manufactured in accordance with the safety requirements
for electronic equipment and medical devices. It is the user’s responsibility to comply
with local and national laws, regulations, and laboratory procedures for operation of the
MosaiQ125.
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
that enables a safe and a reliable operation.
Under no circumstances can Quotient, its employees, suppliers, or third parties referred
to in this manual be held liable, in respect of any proceedings of any kind whatsoever, for
the safety and effectiveness of the system or for any loss or harm whatsoever, be it direct
or indirect, tangible or intangible, incidental or consequential, or of any kind whatsoever,
or for any damage whatsoever, including but not limited to in the cases listed hereunder:
If the recommendations are not followed or if procedures not described by Quotient
are used.
If reagents (wash buffers, sample diluents, detection reagents, enhancement
reagents) other than those manufactured by Quotient are used.
If sample tubes other than those specifically described in this manual are used,
please see the description in chapter 8.9 of this manual.
If necessary, consumables (SDS Magazines with 50 or 250 microarrays) other
than those manufactured by Quotient and sold by Quotient and/or by its official
distributors are used.
If the standard, regular maintenance and control procedures described in this
manual, required to ensure the constant proper working order and safety of the
system, are not carried out.
If the system has not been decontaminated in accordance with the decontamination
procedures described in this manual.

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ABOUT THIS MANUAL / VERSION
MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
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
MosaiQ Software Version 1.3
1.7 TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY
This section details the typographical conventions and terminology conventions used
in this MosaiQ 125 User Manual. To aid readability, the following conventions are used
throughout the manual.
1.7.1 SPECIAL TYPES
Certain system components of the GUI such as lights, menu items, fields, buttons, keys and
files are indicated in a different typeface or font. Please read the information below for
more special types used in the User Manual.
Feature Typographical Conventions
LEDs and signal lamps
LEDs (Light-Emitting Diode) and signal lamps are printed in
bold type.
Example: Power LED, Error LED
Menu items and fields Menu items and fields are printed in bold.
Example: File Menu
Buttons Buttons are printed in bold.
Example: Open button
Keys Keys are printed in bold.
Example: Tap on Enter
File examples File examples are printed in typewriter font.
Example: DRIVER=C:\SERVICE\DRIVERS

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ABOUT THIS MANUAL / TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY
MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
1.7.2 TERMINOLOGY
This section provides information about the meaning of certain words and acronyms used
in the user manual.
1.7.3 CONVENTIONS
The terms in the tables below are used consistently throughout the manual with a very
specific meaning.
List of verbs
The table below gives the meaning of frequently used verbs.
Modal verb Definition
May This term is understood to grant permission. The user can do the
action that is mentioned.
Shall This term is understood to be mandatory.
Must Users must do what is required.
Should This term is understood to be advisory. It would be a good idea for
the user to do what is described and compliance is recommended.
List of Terms
The table below defines frequently used terms.
Term Definition
User The term “User” refers to any person who uses the MosaiQ125 for its
intended use.
Service personnel The term “Service personnel” refers to service personnel authorized
by Quotient Suisse SA.
1.7.4 LIST OF ACRONYMS
The table below defines frequently used acronyms, abbreviations and units of measure.
Acronyms Definition
A Ampere
AbD Antibody detection or also described as AbID on the GUI
ABO A, B, O and AB blood groups
AH Ampere Hour - unit of electric charge
ANSI American National Standards Institute
ASCII American Standard Code for Information Interchange
AT Antigen Typing
CE / EC Conformité Européenne (European Community)
CFR Code of Federal Regulations
CLSI Clinical And Laboratory Standards Institute
cm Centimeter
CMV Cytomegalovirus
dBA Decibel
DC Docking Cap
DDC Disposable Dispense Cartridge
DS Disease Screening
EMC Electromagnetic Compatibility
EN European Standards
EU European Union
EULA End-User License Agreement
FCC Federal Communications Commission
ft Feet
GB Gigabyte

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ABOUT THIS MANUAL / TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY
MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
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
LLiter
lb Pound
LAN Local Area Network
LED Light-Emitting Diode
LIS Laboratory Information System
Ltd Limited Liability Company
mMeter
min Minute
mL Milliliter
mW Microwave radiation
NaOH Sodium hydroxide
Acronyms Definition
nm Nanometer
OQ Operational qualification
OS Operating System
PC Personal Computer
QC Quality Control
RAM Random Access Memory
RBC Red Blood Cell
RFID Radio Frequency Identification
RS232 Recommended Standard 232
SDS Serological Disease Screening
SRS Software Requirement Specification
SSR Signal to Standard Deviation Ratio
STAT Short Turnaround Time
Syph Syphilis
T - AH Fuse type T: high-breaking capacity
USB Universal Serial Bus
VAC Volt
WWatt
WEEE Waste Electrical & Electronic Equipment
ʅLMicroliter
ʅsMicrosecond
°C Temperature unit in Celcius
°F Temperature unit in Fahrenheit

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ABOUT THIS MANUAL / TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY
MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
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.
WARNING
WARNING
Indicates a hazardous situation that, if not avoided, could result in
serious injury or death.
CAUTION
CAUTION
Indicates a hazardous situation that, if not avoided, could result in
minor or moderate injury.
NOTICE
NOTICE
Indicates information considered important, but not hazard-related
(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.
1.7.6 SYMBOLS
This section provides information about warning symbols used on the MosaiQ125.
Warning Symbols
Symbol Definition
Caution, risk of danger to person or damage to equipment. Consult User
Manual.
Biohazard
Hot surface
Laser hazard radiation / do not stare into the beam / class 2 laser
product
Disconnect mains power connector before servicing.

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ABOUT THIS MANUAL / TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY
MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
Other Symbols
This section provides information about the informative symbols used on the MosaiQ125
and its documentation. On the MosaiQ 125 type label:
Symbol Meaning
Catalogue number
Serial number
In vitro diagnostic medical device
Caution, consult accompanying documents
Consult instructions for use
CE marking
Manufacturer
Date of manufacture (YYYY-MM-DD)
Restriction of certain Hazardous Substances (RoHS) in electronic equipment
Nemko certification mark for North American market access
Disposal of electrical and electronic equipment
Fuse
On the MosaiQ 125 components:
Symbol Meaning
Temperature limit
Humidity limitations
Protective earth
No heavy load
Waste
Purified water

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ABOUT THIS MANUAL / FIGURES
MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
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. 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.

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2. INTENDED USE
2.1 INTENDED USE ............................................................................................................................................................................................................................................................................................................ 13
2.2 MOSAIQ SYSTEM COMPOSITION ......................................................................................................................................................................................... 13
2.3 PRINCIPLES OF OPERATION ........................................................................................................................................................................................................................ 13
2.3.1 MOSAIQ 125 PROCESS WORKFLOWS ............................................................................................................................................... 13
2.4 RESULTING PRINCIPLES .................................................................................................................................................................................................................................................. 15
2.4.1 IMAGING ........................................................................................................................................................................................................................................................................................................ 15
2.4.2 IMAGE ANALYSIS ............................................................................................................................................................................................................................................................ 15
2.4.3 INTERPRETATION .......................................................................................................................................................................................................................................................... 15

INTENDED USE / INTENDED USE
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MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
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.
NOTICE
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). For this
reason, please ignore any reference to IH (AT and ABID) in the GUI.
2.2 MOSAIQ SYSTEM COMPOSITION
The MosaiQ System is made up of the following key components:
The MosaiQ 125 consisting of:
භVarious hardware modules, some of them controlled by firmware running on
various micro-controllers.
භMosaiQSoftware driving the Graphical User Interface (GUI).
The MosaiQ Standard Magazines or MosaiQ Quantum Magazines for Serological
Disease Screening (SDS).
The associated MosaiQ system reagents (sample diluents, wash buffers, detection
reagents and enhancement reagents) needed to run the assay.
System liquid (purified water).
2.3 PRINCIPLES OF OPERATION
This section describes the principles of operation governing the MosaiQ125 test orders
process.
2.3.1 MOSAIQ125 PROCESS WORKFLOWS
Centrifuged and decapped blood sample tubes are loaded into the MosaiQ 125.
The MosaiQ 125 is designed for the fully-automated testing of blood donor samples. It
consists of an analyzer which performs serological disease screening assays based on a
qualitative in vitro detection method.
The analytical process is entirely automated. It is composed of several steps and is assay
dependent. The different steps (sample dilution, shaking, incubation, washing, reagent
dispensing) are performed by hardware or fluidic modules controlled by software.

INTENDED USE / PRINCIPLES OF OPERATION
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MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
The detail of the microarray processing is described in the following figure and table.
The microarray processing is entirely automated.
Process Step Description
Microarray
transport
The microarray is extracted from the magazine and transported to the
microarray turntable module.
Pipetting
The pipettor module dispenses sample containing the targeted analyte
into the microarray wells.
The appropriate sample diluent is dispensed in accordance with the type
of assay. The diluents allow for dissolving of the microarray’s preservative
coating and exposure of the printed probes to the analyte.
Shaking The microarray is shaken by the piezoelectric shaking module to reach
the required homogeneity.
Incubation
The incubator module keeps the microarrays at the required temperature
as it moves the microarrays through the different process modules. The
targeted analyte binds the printed probes depending on the specificity.
Washing
Washing 1: The appropriate wash buffer is used to remove the excess of
sample and diluent.
Washing 2: The appropriate wash buffers are used to remove the excess of
the detection reagents needed for the assay (if applicable).
Dispensing
T he dispensing steps, if applicable, are used for the addition of the associated
detection and enhancement reagents resulting in a detectable reaction.
Rinsing
The system liquid is used to remove the excess of the enhancement
reagents needed for the assay (if applicable), to reveal a clean panel
ready for imaging.
Imaging
The camera module takes an image of the processed microarray.
The MosaiQ Software analyzes and interprets this image to provide the
assay result.
Disposal The single use microarray is finally disposed of into the solid waste
container.
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.
(microarray positions during processing)
INFO
Each microarray contained inside the MosaiQ magazines is made
of two plastic chassis enclosing two panels. The panels are made
of functionalized glass onto which samples of various biological
materials are printed. Control spots are also printed to verify
that the MosaiQ 125 has properly dispensed the MosaiQ system
reagent and/or sample on the microarray during the assay.
For more information on this topic, please refer to the MosaiQ SDS
Magazine instructions for use (IFU).

INTENDED USE / RESULTING PRINCIPLES
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2.4 RESULTING PRINCIPLES
The resulting process begins at the end of the biological reaction.
ResultInterpretationImage analysisImagingAnalytical process
It is based on three main phases which are automated on the MosaiQ Software; imaging,
image analysis and interpretation, as described thereafter.
Although the structure of the resulting process is common, certain assay specific
parameters may apply.
2.4.1 IMAGING
Upon completion of the analytical process, the microarray is ready for imaging.
A software controlled high-resolution camera captures a black and white image of the
microarray under assay dependent, controlled illumination conditions. The resulting
image is stored as an image file for subsequent analysis.
2.4.2 IMAGE ANALYSIS
Different metrics are used for image analysis. A parameter called the Signal to Standard
Deviation Ratio (SSR) is used to measure the intensity of the microarray panel spots in
relation to the background. The intensity of each spot is qualified into one of these three
possible states:
Reactive
Non-reactive
Technical Error: if for technical reasons (spot morphology, characteristics of
analyzed spot) the status of the spot cannot be defined as reactive or non-reactive.
The mathematical definition of the SSR is as follows:
With:
Mean (Signal): Mean value of the grey level of the spot signal calculated on the
area of the spot.
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.
SSR = Mean (Signal) - Mean (Background)
StD (Background)
2.4.3 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 algorithm used for the interpretation is specific to each analyte. For detailed
information about the interpretation algorithms, please refer to the instructions for use
for the related assay.

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3. PRIOR TO USE
3.1 USER QUALIFICATION ........................................................................................................................................................................................................................................................... 17
3.1.1 USER QUALIFICATION ................................................................................................................................................................................................................................. 17
3.1.2 ADVANCED USER QUALIFICATION
(LABORATORY ADMINISTRATOR)....................................................................................................................................................................................................... 17
3.1.3 USER TRAINING ................................................................................................................................................................................................................................................................... 17
3.2 EQUIPMENT OVERVIEW ................................................................................................................................................................................................................................................. 18
3.2.1 MOSAIQ MAGAZINES ................................................................................................................................................................................................................................... 18
3.2.2 MOSAIQ SYSTEM REAGENTS ............................................................................................................................................................................................ 18
3.2.3 MOSAIQ WATER CANISTER .................................................................................................................................................................................................... 19
3.2.4 MOSAIQ QUALITY CONTROLS ................................................................................................................................................................................. 20
3.2.5 SAMPLES .................................................................................................................................................................................................................................................................................................. 20
3.2.6 SAMPLE RACKS ................................................................................................................................................................................................................................................................. 20
3.2.7 SYSTEM WASTE .................................................................................................................................................................................................................................................................. 21

PRIOR TO USE / USER QUALIFICATION
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MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
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:
Follow general laboratory procedures and techniques.
Understand and follow all relevant safety rules and safety regulations.
Understand and follow the chemical manufacturer’s safety data sheets.
Operate the MosaiQ 125.
Perform MosaiQ 125 maintenance.
3.1.2 ADVANCED USER QUALIFICATION (LABORATORY ADMINIS-
TRATOR)
The advanced users, commonly know as laboratory administrators, will be trained to
perform additionally tasks that are restricted to their function such as:
Manage user profiles on the MosaiQ 125.
Select the type of assays to run on the MosaiQ 125.
Access to different sub-menus.
For more details about roles and access rights, please refer to the Appendix of this manual.
3.1.3 USER TRAINING
To minimize any potential risk, prior to the use of the MosaiQ 125, the user must be trained
to:
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
portal.
Use the MosaiQ 125 properly.
Prevent injury related to electrical hazards.
Prevent bio contamination and biohazards.
Prevent any injury related to sharp edges.
Perform maintenance tasks on the MosaiQ 125 and the accessories.

PRIOR TO USE / EQUIPMENT OVERVIEW
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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.
The MosaiQ SDS magazines are available in two sizes.
The MosaiQ SDS Quantum Magazine with a capacity of 250 microarrays.
(MosaiQ SDS Quantum Magazine)
The MosaiQ SDS Standard Magazine with a capacity of 50 microarrays.
(MosaiQ Standard Magazine)
For detailed information please refer to the MosaiQ SDS Magazine IFU.
3.2.2 MOSAIQ SYSTEM REAGENTS
Various reagents, including MosaiQ wash buffers, MosaiQ detection reagents, MosaiQ
enhancement reagents and MosaiQ sample diluents are necessary to perform assays.
Each bottle 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.
There are two types of bottles:
The DC (Docking Cap) bottles for MosaiQ wash buffers and MosaiQ sample
diluents which are loaded in the reagent drawer. For more information please refer
to chapter 5.8 of this manual.
1
MosaiQ Wash Buffer 1
2MosaiQ Wash Buffer 2
3
3
MosaiQ Sample Diluent 1
4
MosaiQ Sample Diluent 2
(MosaiQ wash buffers and MosaiQ sample diluents bottles)
For detailed information please refer to the appropriate IFU.
NOTICE
T
o perform SDS assay only, one bottle of MosaiQ Sample Diluent 1
must be loaded in the MosaiQ 125, although this reagent is not used
to run this type of assay.

PRIOR TO USE / EQUIPMENT OVERVIEW
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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.
5MosaiQ Enhancement Reagent 2
MosaiQ Enhancement Reagent 1
7MosaiQ Detection Reagent 2
8MosaiQ Detection Reagent 1
(MosaiQ detection and MosaiQ enhancement reagent bottles)
For detailed information please refer to the appropriate IFU.
NOTICE T
o perform SDS assay, MosaiQ Detection Reagent 1 is NOT required.
3.2.3 MOSAIQ WATER CANISTER
Two water canisters.
(two water canisters)
Water canisters
(reusable) Purpose
System liquid (purified water)
• Used to clean the pipettor needles,
• Mixed with wash buffer according to the required
concentration,
• Used to perform rinsing and cleaning operation

PRIOR TO USE / EQUIPMENT OVERVIEW
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3.2.4 MOSAIQ QUALITY CONTROLS
Quality Controls (QC) are used to ensure that disease screening is performed as intended.
NOTICE
Perform regular quality control of the MosaiQ 125 at least once
daily and as per laboratory and or regional specific requirement.
Laboratories must validate their own quality control method for
the assays performed by MosaiQ.
Please, refer to chapter 9 of this manual.
3.2.5 SAMPLES
NOTICE
For detailed information about sample preparation please follow
the instructions for use for MosaiQ SDS magazines.
To load samples please refer to chapter 8.3 of this manual.
(illustration of a filled sample tube)
3.2.6 SAMPLE RACKS
Sample tubes are loaded onto the MosaiQ125 in MosaiQ sample racks. Twelve sample
tubes can be loaded onto one rack, and in turn, ten racks can be inserted into the
MosaiQ125. In total 120 samples can be loaded at any one time.
During each run, the MosaiQ 125 associates the barcode of each tube with a corresponding
barcode on the rack.
To identify the sample rack, the MosaiQ125 needs to read the code label (near the handle)
of the rack.
(sample rack with sample tubes)
“% A” stands for standard rack
Table 1
The MosaiQ125 accepts uncapped tubes.
Please refer to the list of appropriate sample tubes at chapter 8.11. The minimum fill volume
for routine samples shall be ≥ 500 µl.
NOTICE
Please consult our catalog for tube size adapters and contact
your local technical representative for the appropriate MosaiQ125
configuration.