Hardware User (IVD) Instruction 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