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Safety, Intended use, Warnings and notes – Luminex 200 System User Manual User Manual

Page 13: Chapter 1 safety, Intended use warnings and notes, Chapter 1: safety

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Please become familiar with the information in this chapter before using the equipment. Do
not perform procedures on your Luminex

®

200

system that are not specifically contained in

this manual, unless you are directed to do so by Luminex Technical Support.

Intended Use

The Luminex 200 Instrument is a clinical multiplex test system intended to measure and sort
multiple signals generated in an In Vitro Diagnostic assay from a clinical sample. This
instrumentation is used with a specific assay to measure multiple similar analytes that
establish a single indicator to aid in diagnosis. The device includes a signal reader unit, raw
data storage mechanisms, data acquisition software and software to process detected
signals.

Warnings and Notes

The following informational notes and warnings appear as necessary in this manual.

NOTE: This message is used to provide general helpful information. No

safety or performance issues are involved.

CAUTION:

This message is used in cases where the hazard is minor or only
a potential hazard is present. Failure to comply with the caution
may result in hazardous conditions.

WARNING:

This message is used in cases where danger to the operator or
to the performance of the instrument is present. Failure to
comply with the warning may result in incorrect performance,
instrument failure, invalid results, or hazard to the operator.

DANGER:

This message is used in cases where significant risk of serious
injury or death is present.

Chapter 1: Safety

1