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.

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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Note: 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 ± 10% (typically).