Iridex TruFocus LIO+ User manual

Operator Manual
IRIDEX
13102-EN
Revision C
®
TruFocus™ LIO+

Copyright December 2000, 2005, 2006. IRIDEX Corporation. All rights
reserved. Published in the USA.
Except with the express written permission of IRIDEX, the contents of this
operator manual may not be copied in whole or in part, or reproduced in,
or transmitted to any other media. Copies IRIDEX does permit, including
those translated into another language, must carry the same proprietary
and copyright notices as were published with the original manual.
This manual is provided for instructional use and while every effort has
been made to ensure that the information is accurate, the text,
illustrations, and specifications are subject to change without notice.
The IRIDEX logo, IRIS Medical, OcuLight, and SmartKey are registered
trademarks of IRIDEX Corporation. TruFocus and IQ 810 are trademarks of
IRIDEX Corporation.
IRIDEX
CORPORATION
1212 Terra Bella Avenue
Mountain View, California
94043-1824, U.S.A.
800-388-8100 (U.S. only)
650-940-4700 (Int’l)
FAX:
650-962-0486
Customer Service:
800-388-4747 (U.S. only)
650-962-8100 (Int’l)
www.iridex.com

i
Contents
INTRODUCTION · 1
ABOUT THE TRUFOCUS LIO+ · 1
TRUFOCUS LIO+ SPECIFICATIONS · 2
Standard-Spot Dual Wavelength TruFocus LIO+ · 2
Console compatibility · 2
Console firmware compatibility · 2
Treatment wavelength · 2
Laser spot size · 2
Headset styles · 2
Standard-Spot 810 nm Wavelength TruFocus LIO+ · 2
Console compatibility · 2
Treatment wavelength · 3
Laser spot size · 3
Headset styles · 3
Large-Spot 810 nm Wavelength TruFocus LIO+ · 3
Console compatibility · 3
Treatment wavelength · 3
Laser spot size · 3
Headset styles · 3
WARRANTY AND SERVICE · 4
Warranty · 4
Product registration · 4
Service and technical support · 4
OPERATION · 5
ABOUT THE COMPONENTS · 5
TruFocus LIO+ · 6
Cable assembly · 6
Fiber-optic cable · 6
Illumination cable · 6
Zero-diopter lenses · 6
CONNECTING THE COMPONENTS · 7
Using the TruFocus LIO+ as a therapeutic device · 7
Connect the fiber-optic to the console · 7
Connect the illumination connector to the console · 8
Using the TruFocus LIO+ as a diagnostic device · 8

ii TruFocus LIO+ Operator Manual
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ADJUSTING THE FIT · 9
Fitting the headpiece · 9
Adjusting the head size · 9
Adjusting the height · 9
Adjusting the optical unit · 9
Adjusting the eyepieces · 10
ADJUSTING THE ILLUMINATION LIGHT AND AIMING BEAM · 11
Using the TruFocus LIO+ as a therapeutic device · 11
Adjusting the white illumination beam intensity · 11
Adjusting the aiming beam intensity · 11
Positioning the white illumination beam · 12
Positioning the red aiming beam · 12
USING THE SPECIAL FUNCTION CONTROLS · 13
Selecting the illumination filter · 13
Selecting the illumination aperture size · 13
BEFORE TREATING PATIENTS · 14
TREATING APATIENT · 15
CONCLUDING PATIENT TREATMENT · 16
TROUBLESHOOTING · 17
MAINTENANCE · 21
INSPECTING AND CLEANING · 21
Routine care · 21
Inspect the TruFocus LIO+ · 21
Clean the fiber-optic connector · 21
Clean the external surfaces · 21
Clean the hand held aspheric lens · 21
Clean the binocular eyepieces · 21
Clean the dust window · 21
CHANGING THE ILLUMINATION LAMP · 22

iii
Contents
13102C-EN
CLINICAL & SAFETY · 23
CLINICAL APPLICATIONS · 23
Indications for clinical use · 23
Contraindication · 23
Recommended procedure for clinical use · 23
Panretinal photocoagulation (outpatient) · 23
Panretinal photocoagulation (operating room) · 24
Sealing treatment · 24
Treating patients who have a gas-filled eye · 24
Treating patients with recent ocular surgery · 24
Treating patients with a localized vitreous hemorrhage · 25
Treating patients with a scleral buckle · 25
Treating patients with small pupils · 25
Treatment considerations · 25
Positioning · 25
Using the scleral depressor · 26
Moving the spot · 26
Positioning the condensing lens · 26
Power density and spot size · 27
Choosing anesthesia · 27
Power and duration · 28
Repeat interval · 29
Red aiming and treatment beams · 29
SAFETY · 30
Preventing unintended exposure of laser energy · 30
Preventing unauthorized use of the system · 30
Ensuring safe operation · 30
Preventing reflection hazards · 30
Preventing fire and explosion hazards · 30
Ensuring ocular protection · 31
Protection for the physician · 31
Protection for all persons in the treatment room — laser safety eyewear
requirements · 31
Regulatory compliance safety features · 31
Eye safety filter · 31
Laser emission indicator · 31
Safety interlock · 31
Location of regulatory compliance and other system labels · 32

iv TruFocus LIO+ Operator Manual
13102C-EN

1
IntroductionAbout the TruFocus LIO+
The TruFocus™ LIO+, when connected to the OcuLight®console, adds
the therapeutic capability of transpupillary retinal photocoagulation to
the diagnostic indirect ophthalmoscope. It enables you to deliver laser
energy to pathologies in the far periphery of the retina and to treat
supine patients.
The TruFocus LIO+ is ideal for patients who are best examined and
treated in a supine position, including infants in neonatal units, small
children, and disabled patients. The non-moving eye safety filter protects
your eyes while providing a clear view of the developing lesion. The
exclusive TruFocus optical system provides consistent treatment results
by offering the capability of changing working distance and lens position
without changing laser focus adjustments. Its unique controls allow you
to move the laser and the illumination field separately or both together.
Fully enclosed optics prevent misalignment and contamination.
CAUTION
Federal law restricts this
device to sale by or on the
order of a physician.
WARNING
Surgical lasers generate a
highly concentrated beam
of light, which may cause
injury if improperly used.
Be sure to operate
the console and the
TruFocus LIO+ in
accordance with the
procedures described in
your console manual and
this manual. Failure to do
so may harm yourself, your
patient, or others.

2TruFocus LIO+ Operator Manual
13102C-EN
TruFocus LIO+ Specifications
Standard-Spot Dual Wavelength TruFocus LIO+
Console compatibility
OcuLight GL
OcuLight GLx
OcuLight TX
OcuLight SLx
OcuLight OR
IQ 810™
Console firmware compatibility
OcuLight GL version 3.2 and above
OcuLight GLx version 3.3 and above
OcuLight TX version 4.0 and above
OcuLight SLx version 4.1 and above
OcuLight OR version 2.0 and above
IQ 810 version 1.0 and above
Treatment wavelength
Diode-Pumped, Frequency-Doubled Solid State, 532 nm
Laser Diode, 810 nm
Laser spot size
360 µm spot at the retina using a 20 D lens
Headset styles
Cap, strap
Standard-Spot 810 nm Wavelength TruFocus LIO+
Console compatibility
OcuLight SL
OcuLight SLx

3
Introduction
13102C-EN
IQ 810
Treatment wavelength
Laser Diode, 810 nm
Laser spot size
360 µm spot at the retina using a 20 D lens
Headset styles
Cap, strap
Large-Spot 810 nm Wavelength TruFocus LIO+
Console compatibility
OcuLight SL (with optional large-spot upgrade)
OcuLight SLx
IQ 810
Treatment wavelength
Laser Diode, 810 nm
Laser spot size
1.3 mm spot at the retina using a 20 D lens
Headset styles
Cap, strap

4TruFocus LIO+ Operator Manual
13102C-EN
Warranty and Service
NOTE
Your console may not be
configured for Large-Spot
delivery device
compatibility.
Warranty
The TruFocus LIO+ carries a standard factory warranty.
Product registration
Please complete and forward to us the enclosed product registration card.
Service and technical support
IRIDEX has established an efficient process to support its installations
worldwide. Should you require assistance, please contact your local
IRIDEX Technical Support representative or our corporate headquarters.

5
Operation
About the Components
After unpacking the contents of the TruFocus LIO+ package, ensure that
you have received all of the components ordered. Check the components
carefully before use to ensure that no damage occurred during transit.
Along with this manual, you should have the TruFocus LIO+, zero-diopter
lenses, and a spare halogen bulb.
NOTE
Should you notice
problems with your order,
please contact your local
IRIDEX Technical Support
representative
immediately.
Mad e i n
8 1 0
TruFocus LIO+
(Standard-Spot 810 nm wavelength shown)
Halogen bulb
Zero-diopter
lenses
Fiber-optic cable
Illumination cable
Cable assembly

6TruFocus LIO+ Operator Manual
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TruFocus LIO+
The TruFocus LIO+ delivers the treatment and aiming beam from the
console to the patient’s eye. It consists of:
• Optical assembly
• Controls for adjusting the headpiece
• Controls for adjusting the position of the optical assembly
• Controls for adjusting the eyepieces
• Controls for selecting the illumination light filter
• Controls for adjusting the aperture size of the white illumination beam
• Controls for moving the treatment and aiming beams vertically
• Controls for moving the entire illuminated field and treatment/aiming
beam simultaneously
• Identification of wavelength engraved on fiber adapter cap
Cable assembly
Fiber-optic cable
The fiber-optic cable and connector is part of the cable assembly attached
to the TruFocus LIO+. The fiber-optic cable transmits the laser light from
the console to the TruFocus LIO+ optics.
Illumination cable
The illumination cable and connector is also part of the cable assembly.
The illumination power supply is built into the console. The connection of
the illumination connector to the console allows you to adjust the intensity
of the illuminated field using the console controls.
Zero-diopter lenses
One pair of zero-diopter lenses is included with the TruFocus LIO+. If
desired, you may interchange these lenses with the two-diopter lenses that
are factory-mounted in the binocular eye pieces.

7
Operation
13102C-EN
Connecting the Components
Using the TruFocus LIO+ as a therapeutic device
Connect the fiber-optic to the console
Remove the protective caps from the console fiber-optic port and from the
TruFocus LIO+ fiber-optic connector.
WARNING
Always inspect the
fiber-optic cable before
connecting it to the
console to ensure that it
has not been damaged.A
damaged fiber-optic cable
could cause accidental
laser exposure or injury to
yourself, your patient, or
others in the treatment
room.
WARNING
Do not use the
TruFocus LIO+ with any
laser system other than an
IRIDEX console.Such use
may void any product
warranties and jeopardize
the safety of the patient,
yourself,and others in the
treatment room.
ms
LIO
Counter Reset
Σ n=0
Σ n
LIO
Laser Aperture
At End Of
Fiber Optic
SmartKey
!
Carefully insert and finger-
tighten the connector into
the console fiber-optic port
until secure.
If the TruFocus LIO+ is
properly connected, when
you turn on the console, LIO+
or LS-LIO+ displays on the
console status panel.
Fiber-optic port
Fiber-optic connector
Protective cap
Protective cap
ms
LIO
Counter Reset
Σ n=0
Σ n
LIO
Laser Aperture
At End Of
Fiber Optic
SmartKey
!

8TruFocus LIO+ Operator Manual
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Connect the illumination connector to the console
Insert the illumination connector into the console TruFocus LIO+
receptacle. Press firmly to seat the connector.
Using the TruFocus LIO+ as a diagnostic device
Connect the illumination connector to the console.
LIO
Counter Reset
Σ n=0
Σ n
LIO
Laser Aperture
At End Of
Fiber Optic
SmartKey
!
LIO
Counter Reset
Σ n=0
Σ n
LIO
Laser Aperture
At End Of
Fiber Optic
SmartKey
!

9
Operation
13102C-EN
Adjusting the Fit
Fitting the headpiece
Adjusting the head size
Turn the knob on the strap at the back of the headpiece counter-clockwise
to enlarge the circumference of the strap enough to easily fit over your
head. Place the TruFocus LIO+ on your head. Turn the knob clockwise
until the TruFocus LIO+ fits securely.
Adjusting the height
Turn the knob at the top of the
headpiece until the headband is
comfortably positioned.
Adjusting the optical unit
While holding the optical unit, loosen the adjustment knob. This enables
you to move the optical unit up and down,
in and out, and tilt it forward and
backward. Make the necessary
adjustments to obtain a comfortable
view and tighten the knob to
secure the optical unit.
Example of cap style
headpiece

10 TruFocus LIO+ Operator Manual
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Adjusting the eyepieces
Slide each eye piece to the correct position by pushing the finger tabs
under each eyepiece (interpupillary distance adjustment). Place a viewing
target 36 cm (14 inches) away for the TruFocus LIO+. Close one eye.
Adjust the separation until you see the entire target. Do the same with the
other eye. The eyepieces are properly adjusted when each eye sees the
entire target.

11
Operation
13102C-EN
Adjusting the Illumination Light and Aiming Beam
Using the TruFocus LIO+ as a therapeutic device
Adjusting the illumination light and aiming beam ensures that the
treatment beam will be in the field of view when the TruFocus LIO+ is
used for therapeutic laser treatment.
Adjusting the white illumination beam intensity
Use the illumination brightness
control on the console to adjust
the intensity of the white
illumination beam.
formation
ms ms
Pilot-
Aiming LIO
Σ n
Laser Aperture
At End Of
Fiber Optic
T
Adjusting the aiming beam intensity
Use the Pilot-Aiming adjustment control
on the console to adjust the intensity of
the red aiming beam. Use the lowest
setting that still allows you to clearly
see the aiming spot on the patient’s
retina.
Information
mW ms
Pilot-
Aiming
TT

12 TruFocus LIO+ Operator Manual
13102C-EN
Positioning the white illumination beam
Use the vertical adjustment control to
center the white light within the field
of view. If the illumination beam
appears to be displaced to one side,
move both interpupillary distance
adjustment finger tabs in the same
direction until the light is
centered.
Positioning the red aiming beam
Use the aiming beam/treatment beam
adjustment control to position the red
aiming beam within the field of view. The
console delivers the treatment beam to
the site illuminated.
Mad e i n
IRIS
Medical
Made in USA

13
Operation
13102C-EN
Using the Special Function Controls
Mad e i n
8 1 0
Selecting the illumination filter
Use the illumination filter controls to
select red-free, cobalt or white light
illumination. White light is most
frequently used during laser
treatment.
Selecting the illumination aperture size
Use the illumination aperture control to
select a small, medium, or large
illumination aperture. The large
aperture is most frequently used
during laser treatment.
IRIS
Medical
810 nm
Made in USA

14 TruFocus LIO+ Operator Manual
13102C-EN
1. Ensure that the console and TruFocus LIO+ are properly connected
and set up.
2. Post the laser warning sign outside the treatment room door.
Before Treating Patients
REFERENCE
Read the Clinical and
Safety sections of your
console manual and this
manual before using the
TruFocus LIO+.
REFERENCE
See the Connecting the
Components sections of
your console manual and
this manual for
connection instructions.