Iridex LIO Plus User manual

IRIDEX®LIO Plus
Operator Manual

IRIDEX®LIO Plus Operator Manual
88046-EN Rev A 06.2020
© 2020 by IRIDEX Corporation. All rights reserved.
IRIDEX, the IRIDEX logo, IRIS Medical, OcuLight, EndoProbe, SmartKey, MicroPulse, Cyclo G6 and
MicroPulse P3 are registered trademarks; BriteLight, CW-Pulse, DioPexy, EasyFit, EasyView, FiberCheck,
G-Probe, IQ 532, IQ 577, IQ 810, LongPulse, MilliPulse, OtoProbe, PowerStep, Symphony, TruFocus, and
TruView are trademarks of IRIDEX Corporation. All other trademarks are the property of their respective
holders.

88046-EN Rev A iii
1 Introduction.........................................................................................................1
Indications for Use ........................................................................................................1
Contraindications..........................................................................................................1
Factors Aecting Spot Size...........................................................................................1
Warnings and Cautions ................................................................................................2
IRIDEX Corporation Contact Information ................................................................3
2 Operation .............................................................................................................5
About the Components ................................................................................................5
Connecting the Cables to IRIDEX Lasers...................................................................6
Adjusting for Pupillary Distance ................................................................................6
Instructions to Treat a Patient......................................................................................7
3 Troubleshooting .................................................................................................8
General Problems ..........................................................................................................8
4 Maintenance ........................................................................................................9
Inspecting the LIO.........................................................................................................9
Cleaning the Fiber-Optic Connector...........................................................................9
Cleaning the External Surfaces....................................................................................9
Cleaning the Optical Components..............................................................................9
Changing the Illumination Lamp .............................................................................10
5 Service.................................................................................................................10
6 Safety and Compliance.................................................................................... 11
Protection for the Physician.......................................................................................11
Protection for All Treatment Room Personnel ........................................................11
Safety Compliance.......................................................................................................12
Labels ............................................................................................................................13
Symbols ........................................................................................................................14
IRIDEX® LIO Plus Specications ..............................................................................15
EMC Safety Information ............................................................................................16
Contents

1IRIDEX®LIO Plus Operator Manual 88046-EN Rev A
1
Introduction
The IRIDEX LIO Plus Laser Indirect Ophthalmoscope when connected to an IRIDEX laser, adds
the therapeutic capability of transpupillary retinal photocoagulation to the wide angle diagnostic
capabilities of a binocular indirect ophthalmoscope. It enables delivery of laser energy to the far
periphery of the retina and to treat supine patients. Integrated eye safety lters protect user’s eyes
while providing a clear view of the target area. Fully enclosed optics prevent misalignment and
contamination.
The LIO Plus is sold to medical doctors and intended to be used by trained medical professionals.
Indications for Use
The LIO Plus is indicated for transpupillary retinal photocoagulation.
Contraindications
The IRIDEX®LIO Plus is not indicated for cases involving laser photocoagulation within the arcades.
Do not treat albino patients who have no pigmentation.
Factors Affecting Spot Size
• The refractive index of media in the eye.
• Working distance. The smallest spot is obtained when the laser spot is at its focus point on the
image plane.
• Refractive status of the eye. The laser spot size on the retina is smallest in a myopic eye and
largest in a hyperopic eye.
A x (B/C) = spot size on the retina where:
• A = aerial spot size
• B = diopter power of handheld aspheric lens
• C = power of eye
Using this formula*:
• Emmetropic eye (60D):1100 μm x (20D/60D) = 360 μm spot size on retina
• Myopic eye (70D):1100 μm x (20D/70D) = 315 μm spot size on retina
• Hyperopic eye (50D):1100 μm x (20D/50D) = 440 μm spot size on retina
*Example only, power may vary by patient.
Positioning the 20D aspheric lens 55 mm from an emmetropic eye should produce a magnied aerial
image of the fundus.

88046-EN Rev A Introduction 2
Warnings and Cautions
WARNINGS:
Lasers generate a highly concentrated beam of light that may cause injury if improperly used.
To protect the patient and the operating personnel, the entire laser and the appropriate delivery system
operator manuals should be carefully read and comprehended before operation.
Carefully select your treatment room and location. Treatment locations should be free of uncovered
windows and reective surfaces that could inadvertently reect the treatment beam.
Never look directly into the aiming or treatment beam apertures or the ber-optic cables that deliver the
laser beams, with or without laser safety eyewear.
Never look directly into the laser light source or at laser light scattered from bright reective surfaces.
Avoid directing the treatment beam at highly reective surfaces such as metal instruments.
Ensure that all personnel in the treatment room are wearing the appropriate laser safety eyewear.
Never substitute prescription eyewear for laser safety eyewear.
Always inspect the ber-optic cable before connecting it to the laser to ensure that it has not been
damaged. A damaged ber-optic cable could cause accidental laser exposure or injury to yourself, your
patient, or others in the treatment room.
Always verify that the delivery device is properly connected to the laser. An improper connection may
result in an inadvertent secondary laser beam. Severe eye or tissue damage could occur.
Do not use the delivery device with any laser system other than an IRIDEX laser. Such use may void
product warranties and threaten the safety of the patient, yourself, and others in the treatment room.
CAUTIONS:
US federal law restricts this device to sale by or on the order of a healthcare practitioner licensed by the
law of the State in which he/she practices to use or order the use of the device.
Use of controls or adjustments or performing of procedures other than those specied herein may result
in hazardous radiation exposure.
Do not operate the equipment in the presence of ammables or explosives, such as volatile anesthetics,
alcohol, and surgical preparation solutions.
Turn o the laser before inspecting any delivery device components.
Always handle the ber-optic cables with extreme care. Do not coil the cable into a diameter less than
15 cm (6 in).
Do not use the cable retainers on the headset for ber-optic cables.
Keep the protective cap over the ber-optic connector when the delivery device is not in use.
Do not touch the bulb. Remove any ngerprints from the bulb with a cotton-tipped swab moistened
with methanol.

3IRIDEX®LIO Plus Operator Manual 88046-EN Rev A
IRIDEX Corporation Contact Information
IRIDEX Corporation
1212 Terra Bella Avenue
Mountain View, California 94043-1824 U.S.A.
Telephone: [phone]
[phone] (U.S.A. only)
Fax: [phone]
Technical Support: [phone]
[email protected]
Website: iridex.com/lio
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Warranty and Service. This device carries a standard factory warranty. This warranty is void if
service is attempted by anyone other than certied IRIDEX service personnel.
NOTE: This Warranty and Service statement is subject to the Disclaimer of Warranties, Limitation of
Remedy, and Limitation of Liability contained in IRIDEX’s Terms and Conditions.
Should you require assistance, please contact your local IRIDEX Technical Support representative or
our corporate headquarters.
WEEE Guidance.
Dispose of equipment and accessories in compliance with local and regional regulations. Contact
IRIDEX or your distributor for disposal information.

88046-EN Rev A Introduction 4

5IRIDEX®LIO Plus Operator Manual 88046-EN Rev A
2
Operation
About the Components
Verify that you have received all of the components in the IRIDEX®LIO Plus package, and check the
components carefully before use to ensure that no damage occurred during transit. Along with this
manual, you should have the IRIDEX® LIO Plus, zero-diopter lenses, and a spare halogen bulb. If
there is a problem, contact your local IRIDEX Technical Support representative.
Appearance and type of components may vary based on the delivery device ordered.
One pair of zero-diopter lenses is included with the IRIDEX®LIO Plus. If desired, you may
interchange these lenses with the two-diopter lenses that are factory-mounted in the binocular eye
pieces.
Headband height
adjustment knob
Optical unit
adjustment Aiming beam
adjustment
Illumination and aiming
beam adjustment
Laser aperture
Fiber-optic cable
Illumination cable
Zero-diopter
lenses
Halogen
Bulb

88046-EN Rev A Operation 6
Connecting the
Cables to IRIDEX Lasers
Adjusting for Pupillary
Distance
OcuLight Laser
Family
Illumination cable
Fiber-optic cable
Slide to adjust
Headband height
adjustment knob
Color lter
selector
Illumination eld
size adjustment
IQ Laser Family
Fiber-optic cable
Illumination cable

7IRIDEX®LIO Plus Operator Manual 88046-EN Rev A
Instructions to Treat a Patient
Before treating apatient:
• Inspect the LIO before use to conrm it is in good operating order. Verify aiming beam is present,
uniform, round and not distorted prior to treatment.
• Ensure that the laser components and delivery device(s) are properly connected.
• Post the laser warning sign outside the treatment room door.
• Ensure that all ancillary personnel in the treatment room are wearing the appropriate laser
safety eyewear.
NOTE: Refer to Chapter 6, “Safety and Compliance,” and your delivery device manual(s) for important
information about laser safety eyewear and eye safety lters.
totreat apatient:
1. Turn on the laser.
2. Reset the counter.
3. Set the treatment parameters.
4. Position the patient.
5. Select an appropriate ophthalmoscopic examination lens.
6. Select Treat mode.
7. Position the aiming beam on the treatment site.
8. Focus or adjust the delivery device as applicable.
9. Press the footswitch to deliver the treatment beam.
toConClude patient treatment:
1. Select Standby mode.
2. Record the number of exposures and any other treatment parameters.
3. Turn o the laser and remove the key.
4. Collect the safety eyewear.
5. Remove the warning sign from the treatment room door.
6. Disconnect the delivery device(s).
7. Inspect and clean the LIO as instructed in section 4 Maintenance, below.
8. If an examination lens was used, handle the lens according to the manufacturer’s instructions.
9. Keep the protective cap over the ber-optic connector when the delivery device is not in use.

88046-EN Rev A Troubleshooting 8
3
Troubleshooting
General Problems
Problem User Action(s)
No display • Verify that the keyswitch is on.
• Verify that the components are properly connected.
• Verify that the electrical service is on.
If there is still no display, contact your local IRIDEX Technical Support
representative.
Inadequate or no aiming beam • Verify that the delivery device is properly connected.
• Verify that the console is in Treat mode.
• Turn the aiming beam control fully clockwise.
• Verifythattheber-opticconnectorisnotdamaged.
• If possible, connect another IRIDEX delivery device and place the
console in Treat mode.
If the aiming beam is still not visible, contact your local IRIDEX Technical
Support representative.
No treatment beam • Verify that the remote interlock has not been activated.
• Verify that the aiming beam is visible.
• Verifythattheberswitchisinthecorrectpositionforthelasersystem
and wavelength you are using.
• Verifythattheeyesafetylterisintheclosedposition.
If there is still no treatment beam, contact your local IRIDEX Technical
Support representative.
No illumination light • Verify that the illumination connector is connected to the console.
• Verify that the special function control is not between detents.
• Check the bulb and replace it if necessary.
Illumination light is too dim • Verify that the special function control is not between detents.
• Adjust the console illumination intensity control.
The aiming beam is large or out
of focus on the patients’ retina
Readjust your working distance between the LIO headset and the
examinationlens.Theaimingbeamshouldbesharplydenedandatits
smallest diameter when in focus.
The treatment lesions are variable
or intermittent
• The LIO may be slightly out of focus. This decreases power density.
Readjust your working distance to obtain the smallest spot size.
• A poorly centered laser beam may be clipping on the examination lens
oronthepatient’siris.Adjustthelaserbeamintheilluminationeld.
• The laser treatment parameters may be too close to the tissue response
threshold for consistent response. Increase the laser power and/or
exposure duration, or select a different lens.

9IRIDEX®LIO Plus Operator Manual 88046-EN Rev A
4
Maintenance
toprovide routine Care:
• Do not kink or bend the ber-optic cable.
• When the ber-optic cable is connected to the console, ensure that the cable is located
away from high trac areas.
• Do not strike the ber-optic connector against hard surfaces.
• Keep the optical components free of ngerprints.
• When not in use, cover the LIO to keep it free of dust, and store all accessories
in suitable storage boxes.
Inspecting the LIO
Inspect the LIO for dirt, debris, and damage prior to each use.
Cleaning the Fiber-Optic Connector
Always inspect the ber-optic connector for cleanliness prior to use; if needed, clean the connector
using a cotton swab moistened with acetone. Inspect the ber-optic connector using a minimum of
100X magnication to verify cleanliness. Inspect the lanyard for contamination before re-installing it
onto the ber-optic connector.
Cleaning the External Surfaces
Wipe the external surfaces of the LIO (except the optics) with a soft lint-free cloth dampened with a
70/30 Isopropyl Alcohol (IPA) solution.
Cleaning the Optical Components
toClean the optiCal Components:
1. Place 2-3 drops of high-grade acetone onto a cotton swab.
2. Wipe the optics gently in one direction with the swab to remove all dust and debris.
3. Repeat as needed with a fresh swab until all dust and debris have been removed
from the optical surfaces.

88046-EN Rev A Service 10
5
Service
The LIO contains no user serviceable items. LIO service must be performed by IRIDEX trained
service personnel. Contact IRIDEX or your distributor for service information.
Changing the Illumination Lamp
1. Unscrew the retaining cap.
2. Remove the burned-out illumination lamp.
3. Insert an identical replacement lamp, aligning the key on the lamp base with the slot in
the LIO Plus so that it points to the observer’s right.
4. Screw on the retaining cap.

11 IRIDEX®LIO Plus Operator Manual 88046-EN Rev A
6
Safety and Compliance
To ensure safe operation and prevent hazards and unintended exposure to the laser beams, read and
follow these instructions:
• Always review and observe the safety precautions outlined in the operator manuals before using
the device to prevent exposure to laser energy, except as a therapeutic application from either
direct or diusely reected laser beams.
• This device is intended for use only by a qualied physician or other medical professional.
The suitability of the equipment and treatment techniques selected for clinical use is your sole
responsibility.
• Do not use any device if you think it is not functioning properly.
• Laser beams reected from specular surfaces can harm your eyes, the patient’s eyes, or others’
eyes. Any mirror or metal object that reects the laser beam can constitute a reection hazard.
Be sure to remove all reection hazards near the laser. Use non-reecting instruments whenever
possible. Be careful not to direct the laser beam at unintended objects.
CAUTION: Changes or modications not expressly approved by the party responsible for compliance could
void the user’s authority to operate the equipment.
Protection for the Physician
Eye safety lters protect the physician from backscattered treatment laser light. Integral eye safety
lters are permanently installed in every compatible Slit Lamp Adapter (SLA) and Laser Indirect
Ophthalmoscope (LIO). For endophotocoagulation or for Operating Microscope Adapter (OMA) use,
a separate discrete eye safety lter assembly must be installed into each viewing path of the operating
microscope. All eye safety lters have an optical density (OD) at the laser wavelength sucient to
permit long-term viewing of diuse laser light at Class I levels.
Always wear appropriate laser safety eye wear when performing or observing laser treatments with
the unaided eye. Refer to laser console Operator Manual for laser safety eye wear minimum OD; it is
specic per each laser console wavelength and maximum power output.
Protection for All Treatment Room Personnel
The Laser Safety Ocer should determine the need for safety eyewear based on the Maximum
Permissible Exposure (MPE), Nominal Ocular Hazard Area (NOHA), and Nominal Ocular Hazard
Distance (NOHD) for each of the delivery devices used with the laser system, as well as the
conguration of the treatment room. Eyewear safety parameters are tabulated for each compatible
IRIDEX laser console in the appropriate laser console operator manual. For additional information,
refer to ANSI Z136.1, ANSI Z136.3, or IEC 60825-1.

88046-EN Rev A Safety and Compliance 12
Safety Compliance
Complies with FDA performance standards for laser products, except for deviations pursuant to
Laser Notice No. 50, dated June 24, 2007.
The IRIDEX®LIO Plus is compliant with EC directive 93/42/EEC and subsequent amendments.
Feature Function
Eyesafetylter Theeyesafetylter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 laser provides a visible warning that
laser radiation may be emitted.
Safety interlock Thedeliverydevice’sprotectivehousingandthelaserberconnector
cannot be opened without the use of special tools. The delivery device is
alsosafety-interlockedattheber-opticportonthelaser.
The IRIDEX LIO Plus is classied as a Group 1 instrument according to EN ISO 15004-2:2007.
This classication was determined using a 20D ophthalmoscopy lens.
The IRIDEX LIO Plus is classied as a Group 1 instrument according to ANSI Z80.36-2016.
This classication was determined using a 20D ophthalmoscopy lens.

13 IRIDEX®LIO Plus Operator Manual 88046-EN Rev A
Labels
IRIDEX Corporation
1212 Terra Bella Ave.
Mountain View, CA
94043 USA
www.iridex.com
Tel: [phone]
[phone]
015619(11)20
0409(21)1234
567
30903-H500
Rev F
LASER APERTURE
OUVERTURE LASER
Product Labels
CE Labels
Laser Aperture Label

88046-EN Rev A Safety and Compliance 14
Symbols
These symbols apply to the LIO Plus. Refer to the operator manual of your IRIDEX laser console for
additional symbols.
Caution CE Mark
Authorized
Representative
in the European
Community
Serial Number Manufacturer Part Number
Waste Electrical
and Electronic
Equipment (WEEE)
CSA Group Mark
Health Canada Laser Aperture
Illumination Field
Size Selector Filter Selector ELT Mark
LASER APERTURE
OUVERTURE LASER

15 IRIDEX®LIO Plus Operator Manual 88046-EN Rev A
IRIDEX® LIO Plus Specications
Specication Standard Spot Large Spot
Laser compatibility OcuLight GL
OcuLight GLx
OcuLight TX
OcuLight SLx
OcuLight OR
OcuLight SL
IQ 532
IQ 577
IQ 810
OcuLight SLx
IQ 810
Laserrmwarecompatibility
(if applicable)
OcuLight GL version 3.2 and above
OcuLight GLx version 3.3 and above
OcuLight SLx version 4.1 and above
Laser spot size on retina with
20D lens 360 µm* 1400μm
LIO Plus models 532 nm and 810 nm
532 nm
810 nm
577 nm
810 nm
*May vary with refractive power.
Operational and Storage Environmental Conditions
Operational Environment
Temperature Limits: 10° C (50° F) to 35° C (95° F)
Humidity Limits 20-80% Relative Humidity, Non-condensing
Storage Environment
Temperature Limits: -20° C (-4° F) to 60° C (140° F)
Humidity Limits 20 - 80% Relative Humidity, Non-condensing

88046-EN Rev A Safety and Compliance 16
EMC Safety Information
The laser system (console and accessories) needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in this section. Portable
and mobile RF communications equipment can aect this system.
This laser system has been tested and found to comply with the limits for medical devices in
IEC 60601-1-2 according to the tables in this section. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation.
CAUTION: Changes or modications to this laser system not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment and may result in increased
emissions or decreased immunity of the laser system.
EMC Requirements for Console and Accessories
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
Thislasersystem(consoleandaccessories)isintendedforuseintheelectromagneticenvironmentspecied
below. The customer or the user of the laser system should assure that it is used in such an environment.
Emissions Test Compliance
RF emissions
CISPR 11
Group 1 The laser system uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltageuctuations/
Flicker emissions
Complies
The laser system is suitable for use in all establishments, other than domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

17 IRIDEX®LIO Plus Operator Manual 88046-EN Rev A
Guidance and Manufacturer’s Declaration - Immunity
Thislasersystem(consoleandaccessories)isintendedforuseintheelectromagneticenvironmentspecied
below. The customer or the user of the laser system should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic
Environment —
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete, or ceramic tile.
Ifoorsarecoveredwith
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
Not Applicable
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 cycles
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 cycles
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
or the laser system
requires continued
operation during power
mains interruptions, it is
recommended that the
laser system be powered
from an uninterruptible
power supply or
a battery.
(50/60 Hz)
magneticeld
IEC 61000-4-8
3 A/m 3 A/m Power frequency
magneticeldsshould
be at levels characteristic
of a typical location in
a typical commercial or
hospital environment.
NOTE: UTis the AC mains voltage prior to application of the test level.