Luminex 200 Installation Guide - Manual (Page 23)

FIGURE 5. FCC Label
Electromagnetic Compatibility
The Luminex 200 system complies with the emission and immunity requirements described in
EN 61326-1 and EN 61236-2-6. The electromagnetic environment should be evaluated prior
to operation.
WARNING: Do not use this device in close proximity to sources of strong
electromagnetic radiation, for example, unshielded intentional
RF sources, as these may interfere with proper operation.
WARNING: Always handle the Luminex 200 system according to Luminex
instructions to avoid any possible interference from its
electromagnetic fields.
Fluidics
In the event of a fluid leak, turn off all power to the system and disconnect all power cords.
Monitor waste levels manually. Do not allow the waste container to overflow! Empty the
waste container each time you fill the sheath fluid container. Do not place the waste container
on top of the instrument.
WARNING: If biological samples are tested with the system, use standard
laboratory safety practices when handling system waste.
Luminex 200 Analyzer Laser
The Luminex 200 instrument is classified under FDA 21 CFR 1040.10 and 1040.11 as a
Class I laser product consisting of two Class IIIb lasers within the instrument. The accessory
bar code reader is classified as Class II. In accordance with IEC 60825-1, the instrument is
classified as Class 1, containing two Class 3b lasers, and including an accessory Class 2 bar
Luminex ® 200 ™ Installation Manual
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In Vitro Diagnostic Use