User's Manual

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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 st
andard, 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.