The
range
of
worst
case
NOHD
values
calculated
for
all
IRIS
Medical
delivery
devices
is
included
in
the
following
table:
Delivery
Device
MPE
(W/m
2
)
Numerical
Aperture
(N.A.)
Maximum
Power
(W)
NOHD
(m)
G
‐
Probe
16.8
0.25
3.0
1.6
EndoProbe
16.8
0.10
2.0
3.3
SLA
(500
micron
spot)
16.8
0.04
2.0
8.3
DioPexy
Probe
16.8
0.03
2.0
11.0
Large
Spot
SLA
16.8
0.03
2.0
11.0
LIO
16.8
0.02
2.0
16.6
Large
Spot
LIO
Large
Spot
Symphony
16.8
0.02
2.0
16.6
Symphony
810
Fiber
16.8
0.01
2.0
33.1
Operating
Microscope
Adapter
(OMA)
(2.0
mm
spot)
16.8
0.01
2.0
33.1
Safety Features
The
SL/SLx
complies
with
FDA
Laser
Safety
Requirements
21
CFR
1040.10
and
1040.11
except
for
deviations
pursuant
to
Laser
Notice
No.
50,
dated
7/26/01.
CE
‐
labeled
devices
comply
with
appropriate
performance
standards
as
specified
in
Annex
II
of
the
Medical
Device
Directive
MDD
93/42/EEC.
Emergency Off
Pushing
the
emergency
off
button
immediately
disables
the
laser
and
electronic
circuits.
Protective Housing
The
external
enclosure
prevents
unintended
access
to
laser
radiation
above
CDRH
Class
I
limits.
Safety Interlock
An
electronic
interlock
at
the
fiber
port
prevents
the
SL/SLx
from
emitting
laser
energy
if
a
delivery
device
is
not
properly
connected.
OcuLight SL/SLx Operator Manual
PN 13099D-EN
33
