Luminex 200 System User Manual - Manual (Page 15)

impaired or the warranty voided if the system is used in a manner not specified by the
instructions or by Luminex Corporation.
Fluidics
This system contains fluidics. In the event of a fluid leak, turn off all power to the system and
disconnect all power cords. The on/off switch is not a disconnect means; power cords must
be removed from the outlet. Contact Luminex Corporation for further information.
You must monitor waste levels manually. Do not allow the waste container to overflow! Empty
the waste container each time the sheath fluid container is filled. Do not place the waste
container on top of the instrument. Contact Luminex Technical Support before relocating the
waste container or rerouting the waste line.
WARNING: If biological samples have been tested with the system, use
your standard laboratory safety practices when handling system
waste.
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.
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
code reader. The Luminex 200 complies with IEC 60825-1 and 21 CFR 1040.10 and 1040.11
except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007.
The following label appears on the back of the Luminex 200 instrument.
For In Vitro Diagnostic Use Safety
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