Luminex FLEXMAP 3D Hardware User Manual - Manual (Page 12)

Become familiar with the information in this chapter before using the equipment. Do not
perform procedures on your system that are not specifically contained in this manual, unless
you are directed to do so by Luminex Technical Support.
Intended Use
The Luminex ® FLEXMAP 3D ® system is a multiplex test system intended to measure and sort
multiple signals generated in an assay from a sample. The system includes a signal reader
unit, raw data storage mechanisms, data acquisition software and software to process
detected signals.
The FLEXMAP 3D system is for research use only and is not for use in diagnostic procedures
within the United States. The system has not been cleared or approved for clinical use by the
US Food and Drug Administration (FDA). The FLEXMAP 3D system is CE marked for in vitro
diagnostic use within the European Union (EU).
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