Luminex xPONENT 3.1 Rev 2 (IVD) - Manual (Page 13)

Manufacturer In-vitro Diagnostic Device
Conformité
Europeénne
(European Union
Conformity)
General Guidelines
Modifying or deleting Luminex ® xPONENT ® system files may cause degradation to system
performance. You can repair modified or deleted xPONENT system files by uninstalling and
re-installing the xPONENT software.
Use of unauthorized third-party software with xPONENT software may result in corruption or
failure of the xPONENT software. Use third-party software at your own risk.
If using a screen saver on the xPONENT system, be aware that xPONENT will prevent it
from activating. A dialog box will display each time xPONENT is launched, recommending
that the screen saver and any power management settings are turned off.
This system contains electrical, mechanical, and laser components that, if handled
improperly, are potentially harmful. In addition, biological hazards may be present during
system operation. Therefore, we recommend that all system users adhere to standard
laboratory safety practices. The protection provided by the equipment may be impaired or the
warranty voided if the Luminex FLEXMAP 3D is used in a manner not specified by the
instructions or by Luminex Corporation.
Biological Samples
Human and animal samples may contain biohazardous infectious agents. Where exposure to
potentially biohazardous material, including aerosol, exists, follow appropriate biosafety
procedures and use personal protective equipment - gloves, gowns, laboratory coats, face
shields, or mask and eye protection - and ventilation devices. Observe all local, state, and
federal biohazard handling regulations when disposing of biohazardous waste material.
Bead Handling
Avoid excessive agitation of the product to reduce foaming and surface precipitation. The
xMAP beads will settle if left undisturbed. Always ensure that the xMAP beads are
homogeneously resuspended prior to dispensing. The uncoupled xMAP beads are not
monodispersed and tend to aggregate until coated. Multiple pipetting from the original
container may affect bead concentrations. Protect the xMAP beads from light at all times.
Store xMAP beads at 2 to 8°C.
NOTE: Refer to the product information sheet that accompanies your xMAP
beads or assay for additional information.
Limitations
xMAP beads are susceptible to photobleaching; photobleaching effects are cumulative.
Minimize exposure of xMAP beads to light to maintain product integrity.
TABLE 2. Symbols Continued
For In Vitro Diagnostic Use Introduction
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