Nevyas Eye Associates
Delaware Valley Laser Surgery Institute
Two Bala Plaza
333 City Avenue
Bala Cynwyd, PA 19004

The LEI Eye Safety Test was conducted on June 26, 2010.  A Laser Energetics’ Dazer Laser® (ocular distractor and interrupter) utilizing a Class IIIb - diode pumped solid state laser, emitting laser light at a wavelength of 532 nm, with a power equivalent to the GUARDIAN model’s power of 250 mW and creating a fluence level at the test subject at or higher than the calculated ANSI safe level.

The laser was operated in the pulsed mode (modulating) with a frequency of 12 Hz and 50% duty cycle. The tests performed repeated demonstrations of dazing at higher laser radiation levels than would be experienced by the Laser Energetics’ standard Dazer Laser® GUARDIAN and DEFENDER products. The test subject ranges used were seven (7) feet to achieve a level close to the ANSI calculated safe level and six (6) feet to achieve a radiation level much higher than the ANSI safe level.

Due to the pulsed mode of the laser, the ANSI standard requires the MPE and safe range to be calculated in terms of laser energy measured in Joules (J) and radiant exposure (J/cm2) and not laser power (W) and irradiance (W/cm2).  However the equivalent irradiance or power density may be calculated based on the actual test conditions.

In accordance with the ANSI standard for the safe use of lasers, the operating characteristics of the Dazer Laser® requires that the laser MPE:H for a ten (10) second exposure be limited to 5.15 x10-5 J/cm2, which translates to an NOHD of 2.3 m, or 7.4 ft, given the laser’s divergence.  A ten (10) second exposure was used because the resulting MPE:H reflects a worse case condition for multiple exposures.

Three ten (10) second exposure tests were performed using ten (10) test subjects.  The test subjects were first given complete eye exams on June 12, 2010 to establish a baseline and then all ten (10) test subjects were examined again on June 26, 2010, before and after three separate Dazing (dazzling) exposures with Laser Energetics’ Dazer Laser®. The first Dazing of the test subjects was conducted in well lighted conditions at a distance of seven (7) feet for ten (10) seconds.  The second Dazing was conducted in total darkness at a distance of six (6) feet for ten (10) seconds.  Last, the third Dazing was conducted in total darkness at a distance of six (6) feet for ten (10) seconds with all of the test subjects pupils dilated.

**Note: Two of the test subjects have been Dazed twenty (20) and sixty (60) times respectively.

These tests were performed at seven (7) foot and six (6) foot ranges, with the laser parameters described above.  In the case of the seven (7) foot tests, the energy was 5.75 x 10-5 J/cm2 and for the six (6) foot tests the energy was 7.83 x 10-5 J/cm2.  The seven (7) foot tests reflect an increase of 11% over the ANSI safe range MPE:H level of 5.15 x10-5 J/cm2 and the six (6) foot tests reflect an increase of 52% over this ANSI safe range level.  Tests were performed beyond the calculated MPE:H level to ensure meaningful results, and without risk to the test subjects since it is known that the ANSI calculated safe level has a built-in safety margin and several of the subjects have been Dazed safely at this range before.  The calculated irradiance or power density level for the seven (7) feet range test was 0.69 mW/cm² and for the six (6) foot tests, the power density was 0.93 mW/cm².

Conclusively, these three part test results show the Dazer Laser® can be operated SAFELY at any close or far range, at and above the calculated ANSI safe MPE:H level.