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Luminex MAGPIX Installation and Hardware User (IVD) User Manual

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Table of Contents

Chapter 1: About This Manual ............................................................................................. 1

Overview ......................................................................................................................... 1
Warnings and Notes........................................................................................................ 1
Symbols .......................................................................................................................... 2

Chapter 2: Safety and Regulatory Considerations............................................................... 3

Intended Use .................................................................................................................. 3
Regulatory Labels and Warnings .................................................................................... 4
Testing and Certifications................................................................................................ 6
Safety Practices .............................................................................................................. 7

General...................................................................................................................... 7
Mechanical ................................................................................................................ 7
Electrical .................................................................................................................... 7
Electromagnetic Compatibility ................................................................................... 7
Bar Code Reader Laser............................................................................................. 8
Heat ........................................................................................................................... 8
Fluids ......................................................................................................................... 8
Biohazard .................................................................................................................. 8
Indicator Light ............................................................................................................ 9

Decontamination Procedure............................................................................................ 9
Disposal of Instrument .................................................................................................... 9

Chapter 3: Installation Procedure ...................................................................................... 11

Unpacking and Assembling the PC............................................................................... 12
Unpacking and Assembling MAGPIX............................................................................ 13
Connecting the Components......................................................................................... 15
Preparing MAGPIX........................................................................................................ 17

Removing the Shipping Plug ................................................................................... 17
Installing the Sample Probe..................................................................................... 20
Installing the Drive Fluid .......................................................................................... 22

Powering Up MAGPIX................................................................................................... 25
Performing an Initial Startup.......................................................................................... 27
Installation Diagrams..................................................................................................... 28
Shipping Checklist......................................................................................................... 29

Chapter 4: Technical Overview.......................................................................................... 31

How MAGPIX Operates ................................................................................................ 31
System Components..................................................................................................... 34

Software .................................................................................................................. 34
Hardware ................................................................................................................. 34
Reagents ................................................................................................................. 35

Subsystems .................................................................................................................. 36

Electronic Subsystem .............................................................................................. 36
Fluidics Subsystem.................................................................................................. 37