Iridex OcuLight Symphony, Operator'S Manual

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Clinical & Safety
31144C-EN
Preventing fire and explosion hazards
Do not operate the OcuLight SLx/GLx/TX console and OcuLight
Symphony Adapter in the presence of flammables or explosives such as
volatile anesthetics, alcohol, and surgical preparation solutions.
Ensuring ocular protection
Protection for the physician
An eye safety filter on the OcuLight Symphony Adapter ensures that any
laser radiation returned to your eyes during clinical use is below Class 1/I
limit.
Protection for all persons in the treatment room — laser safety
eyewear requirements
When using the OcuLight SLx/GLx/TX console with the OcuLight
Symphony Adapter, 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 OcuLight Symphony Adapter and the OcuLight
SLx/GLx console used and the configuration of the treatment room.
Regulatory compliance safety features
The OcuLight Symphony Adapter 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 all 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 1/I limits.
Safety interlock
The laser fiber-optic connector attached to the OcuLight Symphony
Adapter cannot be opened without the use of special tools. The OcuLight
Symphony Adapter is also safety interlocked at the fiber-optic port on the
OcuLight SLx/GLx/TX console.
WARNING
Do not operate the
OcuLight SLx/GLx console
and OcuLight Symphony
Adapter in the presence of
flammables or explosives
such as volatile
anesthetics, alcohol, and
surgical preparation
solutions.
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 OcuLight console
manuals for more
information about the
formula used to calculate
the worst case NOHD for
the OcuLight Symphony
Adapter and the
OcuLight console.
REFERENCE
For further information,
you may refer to:
IEC 60825-1 and
ANSI Z136.1.