Solta Medical Fraxel 1550, Operator'S Manual

Page: 49 / 92

Fraxel
®
1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 49 of 92
3.3 Optical Safety
3.3.1 The designated Facility Laser Safety Officer (F-LSO) and physician
shall control and enforce the safety aspects of the laser in the health
care facility.
3.3.2 The F-LSO and physician are responsible for determining the
appropriate Nominal Ocular Hazard Distance (NOHD), Nominal
Hazard Zone (NHZ) and Maximum Permissible Exposure (MPE) per
ANSI Standard Z136.1-2000, Z136.3-2005 and/or IEC 60825-1.
3.3.3 The F-LSO and physician are responsible for providing appropriate
laser safety items including, but not limited to, the correct laser
safety eyewear, and enforcing the use of these items through laser
safety protocols and Standard Operating Procedures.
3.3.4 A laser-trained physician, nurse, or technician shall be responsible
for enforcing safety guidelines during operation.
3.3.5 All operators shall attend the appropriate laser training course and
shall receive certification and/or credentialing prior to patient
treatment.
3.3.6 Laser safety eyewear is routinely required with most lasers. Failure
to use appropriate eyewear with the Fraxel Laser Systems
increases the risk of injury to the cornea, sclera and soft tissue of
the eye.
3.3.7 The following formula, taken from ANSI Standard Z136.1, was used
to calculate the Worst Case NOHD for the Fraxel Laser Systems.






 
a
MPE
NOHD

 
4 1
Where:
NOHD = the Nominal Ocular Hazard Distance, defined as the distance from the
source required to reduce the energy density incident on a 7 mm aperture
to less than the Maximum Permissible Exposure,
θ (theta) = the full angle beam divergence, is measured in radians,
Φ (phi), the energy or power of the laser is measured over one aversion response
time (Watts or Joules),
MPE, the Maximum Permissible Exposure, as defined per ANSI 136.1 and ANSI
136.3, is in Watts per unit area.
a = the beam waist diameter at the e point in units of length, and the beam waist is
at the exit window.
Note:
Length units for “a” and MPE must be the same.