illumina MiSeqDx User manual

FOR IN VITRO DIAGNOSTIC USE
ILLUMINA PROPRIETARY
Document # 15038353 v04
March 2018
MiSeqDx®Instrument
Reference Guide

ii Document # 15038353 v04
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Revision History
Document# Date Description of Change
Document # 15038353
v04
March
2018
Added information about the Illumina Proactive monitoring
service in the Run Options Screen section.
Document # 15038353
v03
September
2017
Updated regulatory markings.
Document # 15038353
v02
March
2017
Corrected the Intended Use Statement. Removed, "The
MiSeqDx is intended to be used with Illumina supplied
IVDassays and reagent kits."
Document # 15038353
v01
December
2016
Changed the name of the guide from the MiSeqDx Reference
Guide to the MiSeqDx Instrument Reference Guide.
Added a section on the Illumina Worklist Manager application.
Changed the formamide warning to a general warning for
potentially hazardous chemicals, with a recommendation to
wear protective equipment.
Changed the type of water required for washing the
instrument from DNase-free, Rnase-free water to laboratory-
grade water. Listed acceptable examples of laboratory-grade
water, including Illumina PW1.
Removed the Measuring Expected Wash Volumes section.
Changed the Welcome screen to the Home screen.
Changed the Intended Use Statement to make it the same as
the statement in the MiSeqDx Instrument Package Insert
(document # 15050260).
Added storage and handling information.
Marking and formatting changes.
Part # 15038353 Rev. B February
2015
Updated the formamide warning with a web address for
access to safety data sheet (SDS) information.
Added inspecting reagent cartridge positions 2 and 4 to the
instructions in the Inspect the Reagent Cartridge section
because the cartridge positions are the same size as position 1.
Updated the Resolving RFID Read Failure directions to include
obtaining a temporary RFID bypass code from Illumina
Technical Support.
Marking and formatting changes.
Part # 15038353 Rev. A February
2014
Initial release.
MiSeqDx Instrument Reference Guide iii

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Table of Contents
Revision History iii
Table of Contents v
Chapter 1 Getting Started 1
Intended Use 2
Components 3
Start the MiSeqDx 6
Required Consumables 7
Storage and Handling 7
Anti-Virus Software 8
Chapter 2 MiSeqDx Software 9
Introduction 10
Illumina User Management Software 11
Illumina Worklist Manager Software 15
MiSeq Operating Software (MOS) 16
Real-Time Analysis (RTA) 34
MiSeq Reporter 35
Chapter 3 Performing a Run 37
Introduction 38
MiSeqDx Workflow 39
Prepare the Reagent Cartridge 40
Log In and Select Run Type 42
Clean the Flow Cell 43
Load the Flow Cell 45
Loading Reagents 47
Starting the Run 49
Monitoring the Run 50
Chapter 4 Maintenance Procedures 51
Introduction 52
Perform a Post-Run Wash 53
Perform a Maintenance Wash 55
Perform a Standby Wash 58
Shut Down the Instrument 60
Chapter 5 Troubleshooting 61
Introduction 62
Resolve Run Setup Errors 63
Resolve RFID Read Failure 64
Prevent Reboots During a Run 66
Troubleshoot Flow Rate Error 67
Perform a Volume Test 68
Resolve MiSeq Reporter Analysis Errors 70
Index 71
Technical Assistance 73
MiSeqDx Instrument Reference Guide v