31
Clinical & Safety
13102C-EN
Ensuring ocular protection
Protection for the physician
An integral eye safety filter on the TruFocus LIO+ ensures that any laser
radiation returned to your eyes during clinical use is below Class 1 limit.
Protection for all persons in the treatment room — laser safety
eyewear requirements
When using the console with the TruFocus LIO+, a Laser Safety Officer
should determine the need for safety eyewear for others in the treatment
room based on the MPE, Nominal Ocular Hazard Area (NOHA), and
Nominal Ocular Hazard Distance (NOHD) for the TruFocus LIO+ and the
console used and the configuration of the treatment room.
Regulatory compliance safety features
The TruFocus LIO+ complies with 21 CFR subchapter J as administered
by the Center for Devices and Radiological Health of the Food and Drug
Administration (FDA).
CE-labeled devices comply with appropriate performance standards as
specified in Annex II of the Medical Device Directive MDD 93/42/EEC.
Eye safety filter
The eye safety filter ensures that all laser radiation returned to the
physician and any co-observers is below Class I limits.
Laser emission indicator
Illumination of the green Treat light on the console provides a visible
warning that laser radiation may be emitted from the
TruFocus LIO+.
Safety interlock
The TruFocus LIO+’s protective housing and the laser fiber connector
attached to the TruFocus LIO+ cannot be opened without the use of
special tools. The TruFocus LIO+ is also safety interlocked at the
fiber-optic port on the console.
WARNING
Ensure that all persons in
the treatment room are
wearing the appropriate
laser safety eyewear. Never
substitute prescription
eyewear for appropriate
laser safety eyewear.
REFERENCE
See your console manual
for more information
about the formula used to
calculate the worst case
NOHD for the
TruFocus LIO+ and the
console in use.
REFERENCE
For further information,
you may refer to:
IEC 60825-1 and
ANSI Z136.1.
