Luminex® Card Reader System
The Luminex® Card Reader System is designed to
permit realistic sham treatments and double blinding for sponsor-investigators
interested in doing clinical studies with Laser Therapy.
The system operates by swiping a specially coded card through
the card reader. If the card used is a "sham" card, the system appears
to operate normally, the emission indicators will be lit and the laser probe begins
to chirp, but no laser light is emitted. When a "real" card is used,
the system operates identically, but laser light is emitted. In both cases, the
system is configured so that the patient is unaware of whether or not a "real"
or "sham" laser treatment is being administered.
Blinding of the clinical investigator is also achieved by
using coded cards that differentiate "real" from "sham". The
clinical study is double blinded when only trial administrators know whether an
individual card is "real" or "sham".
Technical Specifications for 500mW Laser Probe
This is a Class IIIb laser system. The table shown below
shows the ON time of the laser light (the time that laser light is being emitted)
as well as the time that laser light is NOT being emitted because of the interruption
pulses. In addition, the power density (at 1.04cm2) and energy density (for 2
seconds) is also shown for the Luminex® at 500mW.
||Power Density W/cm2
Although the total OFF time increases as the Pulse Rate
increases, the net effect on the Power Density and the Energy Density is very
small. The deviation from the mean values is on the order of 3%.
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The NCDRH procedure for measuring laser output is the energy detectable
within a circular aperture stop having a 7mm diameter at a distance
of 20cm from the probe tip or laser diodes. LUMINEX's High Power
Laser Probe beam divergence is a 35° X 8° (typical]. Because
of the divergence of the beam, the distance, and the aperture used,
the energy detectable falls within the Class IIIb laser product
standard. The typical average power for the 500mW probe shown on
the warning logotype in our brochures and user's guide is 5 mW as
measured in accordance with the procedure described above. A typical
"Danger" label is shown above. Each High Power Laser Probe
is tested individually and the actual measured values in accordance
with NCDRH procedures is shown on the logotype label attached to
the unit. If the power is measured directly at the output of the
laser probe, the average power is approximately 500 milliwatts ±