Iridex PASCAL Synthesis TwinStar User manual

PASCAL® Synthesis™ TwinStar
(SL-PA04 577 nm & 638 nm)
Ophthalmic Scanning Laser System
Operator Manual
European Authorized Representative Iridex Corporation
Obelis 1212 Terra Bella Avenue
Boulevard Général Wahis 53 Mountain View, CA 94043
1030 Brussels USA
Belgium Office: +1.650.940.4700
Phone: [phone] Fax: [phone]
Fax: [phone] www.iridexretina.com
www.obelis.net
PASCAL Synthesis System Software 3.6.1
Caution: “Federal law restricts this device to sale by or on the order of a physician”

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This manual is copyrighted with all rights reserved. Under the copyright laws, this manual
may not be copied in whole or in part or reproduced in any other media without the
express written permission of Iridex Corporation. Permitted copies must carry the same
proprietary and copyright notices as were affixed to the original under the law. Copying
includes translation into another language.
Please note that while every effort has been made to ensure that the data given in this
document is accurate, the information, figures, illustrations, tables, specifications and
schematics contained herein are subject to change without notice.
Iridex Corporation, the Iridex Corporation Logo™ and PASCAL® are trademarks or
registered trademarks of Iridex Corporation.
PASCAL Synthesis; PASCAL Synthesis Ophthalmic Scanning Laser System are
trademarks of Iridex Corporation.
PASCAL Synthesis refers to a family of laser products: single wavelength 532 nm and
single wavelength 577 nm.

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INTRODUCTION
INTENDED USE / INDICATIONS FOR USE
PASCAL® Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to
perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the
anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation
in the non-macular retina of the eye. Single-spot delivery may be performed using a slit
lamp biomicroscope. Pattern delivery may be performed using a slit lamp biomicroscope.

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FEATURES
PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is a laser system
console with an integrated slit lamp. The system connects to the slit lamp to enable laser
energy to be delivered through the slit lamp illumination path. The system may be used for
standard single shot photocoagulation and laser scanning patterns.
PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System enables the physician
to deliver multiple laser spots with a single footswitch depression by automating the
emission of laser light. The aiming beam displays the pattern, allowing the physician to
place it in the appropriate location.
PURPOSE OF THIS MANUAL
This manual outlines PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System,
including operating procedures, troubleshooting, maintenance and cleaning. Please refer
to this operator manual for instructions and guidance on how to appropriately use your
laser.
Before using the system, carefully read “CAUTION & WARNING” and “General Safety
and Regulatory Information” section to familiarize yourself with the operation of the
system.
ATTENTION
Iridex Corporation accepts full responsibility for safety, reliability and performance of the
device only if:
• Service, readjustments, modifications and/or repairs are performed exclusively by
Iridex Corporation-certified personnel.
• The electrical installation of the treatment room complies with the applicable IEC,
CEC and NEC requirements.
The warranty is void if any of these warnings are disregarded.
Iridex Corporation reserves the right to make changes to the device(s) herein. Device(s),
therefore, may not agree in detail with the published design or specifications. All
specifications are subject to change without notice.
For questions regarding your laser, please contact Iridex Corporation or your local Iridex
Corporation representative.

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Table of Contents
INTRODUCTION ................................................................................................................... 5
INTENDED USE / INDICATIONS FOR USE ........................................................... 5
Table of Contents .................................................................................................................. 7
CAUTIONS & WARNINGS ................................................................................................. 10
Disclaimer ........................................................................................................................... 11
Operator Manual Symbol Definitions .................................................................................. 16
General Safety and Regulatory Information ........................................................................ 16
Ocular Protection ................................................................................................................ 17
Laser Safety Eyewear ......................................................................................................... 18
Electrical Hazards ............................................................................................................... 19
Non Homogeneous Pattern Delivery ................................................................................... 19
Fiber Optic Cable Assembly ................................................................................................ 20
Pattern Titration ................................................................................................................... 20
Titration ............................................................................................................................... 21
Fire Hazard ......................................................................................................................... 21
Protecting Non-target Tissues ............................................................................................. 21
Operational Safety .............................................................................................................. 22
Additional Safety Considerations ........................................................................................ 25
Regulatory Compliance Safety Features ............................................................................ 26
Ophthalmic Applications ...................................................................................................... 27
Contraindications ................................................................................................................ 29
Potential Complications or Side Effects .............................................................................. 29
Adverse Effects and Complications .................................................................................... 30
Posterior Segment Laser Procedures .................................................................... 30
Anterior Segment Laser Procedures ...................................................................... 30
System Components ........................................................................................................... 32
Laser Console ........................................................................................................ 32
Touchscreen LCD Control Panel ........................................................................... 32
Slit Lamp (model SL-PA04) .................................................................................... 33
Footswitch .............................................................................................................. 33
Door Interlock Plug ................................................................................................. 33
Micro Manipulator ................................................................................................... 34
Power Knob ............................................................................................................ 34
3D Controller (Purchased Separately) ................................................................... 35
System Installation and Setup ............................................................................................. 37
Connecting the System Components ..................................................................... 38
System Start-up and Shut-down ......................................................................................... 40
Control Screen Description ................................................................................................. 41
Home Screen ......................................................................................................... 41
Posterior Treatment Screen ................................................................................... 42
Anterior Treatment Screen ..................................................................................... 47
Posterior Pattern Descriptions/Pattern Parameters ............................................... 50
Anterior Pattern Descriptions/Pattern Parameters ................................................. 77
Pattern Titration ...................................................................................................... 79
Endpoint Management with Landmark Patterns (optional) .................................... 81

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System Software Setup ....................................................................................................... 83
System Setup Screen ............................................................................................ 83
Contact Lens Selection Screen .............................................................................. 88
Favorites Window ................................................................................................... 89
Treatment Report Window ..................................................................................... 93
Export Treatment Report ........................................................................................ 94
Treatment Reports ................................................................................................. 96
Intraoperative Instructions ................................................................................................. 100
Slit Lamp Treatment Procedure ........................................................................... 100
Between Patient Treatments ................................................................................ 102
System Shut-down ............................................................................................... 102
Maintenance Instructions .................................................................................................. 103
Annual Maintenance ............................................................................................ 103
System Repair ...................................................................................................... 103
User Maintenance ................................................................................................ 103
Cleaning the Console External Surfaces ............................................................. 103
Cleaning the Control Panel Screen ...................................................................... 103
Maintaining Effectiveness of Grounds .................................................................. 103
Replacing the Fuses ............................................................................................ 104
System Specifications ....................................................................................................... 105
Troubleshooting Guide ...................................................................................................... 108
Error Messages ................................................................................................................. 112
Error States .......................................................................................................... 112
Calibration Procedure ....................................................................................................... 122
Disclaimer Warning .............................................................................................. 122
Calibration Instructions ......................................................................................... 122
System Relocation Instructions ......................................................................................... 123
Room Preparation ............................................................................................................. 123
Instructions for Use ........................................................................................................... 124
Intended Use Environment ................................................................................... 124
Patient Environment ............................................................................................. 124
Electromagnetic Compatibility ........................................................................................... 126
Ophthalmology References ............................................................................................... 132
General information on Usage .......................................................................................... 133
Intended Patient Population ................................................................................. 133
Intended User Profile ........................................................................................... 133
Accessories .......................................................................................................... 133
Warranty Information ......................................................................................................... 134
Warranty Shipments, Returns, and Adjustments ................................................. 134
Decontamination of Returned Equipment ......................................................................... 135
US Technical Service Information ..................................................................................... 135
Decontamination Certification ........................................................................................... 136
Disposal ............................................................................................................................ 137
Pattern Scanning Laser Trabeculoplasty (PSLT) (optional) ............................................. 138
Anterior Pattern Descriptions/Pattern Parameters ............................................... 140
Array ..................................................................................................................... 141
PSLT 3 Row ......................................................................................................... 142

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CAUTIONS &
WARNINGS

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Disclaimer
Calibration of the PASCAL Synthesis TwinStar (577 nm & 638 nm) is a service procedure
to be performed only by Iridex Corporation-certified personnel or customers who have
taken and passed a Iridex Corporation Bio-Medical Preventative Maintenance Training
course on the appropriate laser system. Adjustment by anyone other than Iridex
Corporation-certified personnel or by customers who have taken and passed a Bio-
Medical Preventative Maintenance Training course voids any existing manufacturer’s
warranty on the instrument and can result in serious personal injury.
Console Labels
Emergency Stop
3. European Representative Label
4. System Information Label
5. Danger Label
6. Laser Radiation Caution Label
7. Component Connections
1. Key Switch Position
2. Emergency Stop Button and Label

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PASCAL Synthesis TwinStar
Laser Radiation Caution Label,
includes:
Laser Emission Warning
PASCAL Synthesis TwinStar
System Information Label,
includes:
Manufacturer
Part Number
Serial Number
Manufacture Date
Follow operating instructions
WEEE Directive
Type B applied part
λ Wavelength (nm)
Rx ONLY Prescription Only
European Representative
Caution, Class 4 Laser Emission
Laser beam may be present in this
area, when opened.

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PASCAL Synthesis TwinStar (577 nm & 638 nm)
Danger label, includes:
• Laser Emission Warning
• Wavelength
• Power
• Laser Class
USB Connections
Wireless USB Caution
Remote Door Interlock Connection
Footswitch Connection
I
ON
O
OFF
Laser Aperture Label
Laser Emission Warning
Warning, Hot Surface Label
Warning, this surface may be
extremely hot.

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General Warning Label
Additional Labels
Footswitch
Ingress Protection
“Hospital Grade” Cord Grounding Instructions

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Operator Manual Symbol Definitions
Please read this manual and follow its instructions carefully. These words WARNING &
CAUTION and NOTE carry special meanings and should be carefully reviewed.
CAUTION
Alert the user to use special care necessary for
the safe and effective use of the device. They
may include actions to be taken to avoid effects
on patients or users that may not be potentially
life threatening or result in serious injury, but
about which the user should be aware. Cautions
are also provided to alert the user to adverse
effects on this device of use or misuse and the
care necessary to avoid such effects.
WARNING
Alert the user to potential serious outcomes
(death, injury, or serious adverse events) to the
patient or the user.
LASER
WARNING
Warning specifically related to hazard from a
laser beam
DANGEROUS
WARNING
Warning specifically related to a hazard from
electricity
NOTE
Provided when additional general information is
applicable.
General Safety and Regulatory Information
Iridex Corporation laser systems are precision medical instruments. The systems have
undergone extensive testing. With proper handling, they are useful and reliable clinical
instruments. To protect operating personnel and patients, this safety section and the
appropriate slit lamp and pattern generator delivery system safety section should be read
thoroughly before operation.
Iridex Corporation lasers are classified as Class IV lasers by the National Center for
Devices and Radiological Health. Class IV represents the highest power lasers; for this
reason, the user must take precautions to prevent exposure of laser energy to the eye and
skin from either direct or diffusely reflected laser beams, except as a therapeutic
application. In addition, precautions must be taken in the surgical environment to prevent
the hazards of fire and electrical injury.
Iridex Corporation does not recommend specific clinical practices. The following
precautions are extensive but may not be complete. Laser users are advised to
supplement this information with technological advances in surgical products and
techniques as they become available to the medical laser user community through
medical literature. See also the American National Standard (ANSI) publications ANSI
Z136.3-2005―American National Standard for the Safe Use of Lasers in Health Care
Facilities, ANSI Z136.1-2000―American National Standard for the Safe Use of Lasers,

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CAN/CSA-S386-2008―Laser Safety in Health Care Facilities and other national
standards as may be applicable for the country in which the laser system is used.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
Ocular Protection
WARNING: LASER HAZARD
Never look directly into the laser aperture or scattered laser light from reflective surfaces
when the treatment beam is activated. Severe eye damage could occur.
Never look into the path of a laser beam. Laser safety eyewear only offers protection
against stray or diffuse laser beam energy for a maximum exposure of 10 seconds.
Never substitute glass prescription eyewear for the appropriate laser safety eyewear, as
severe eye damage could occur. The glass in prescription eyewear can concentrate the
laser light onto the retina. A high power-density beam can also shatter glass prescription
eyewear, resulting in possible severe eye damage.
Do not use eyewear that is broken or damaged.
The (laser emission) indicator is displayed on the Treatment screen to warn the user
that the system is capable of emitting laser energy. Appropriate precautions, such as
wearing appropriate eyewear in the room, should be taken.
As a precaution against accidental exposure to the output beam or its reflection, anyone
checking or adjusting calibration should wear appropriate laser safety eyewear.
Because prolonged intense light exposure can damage the retina, the use of the device
for ocular examination should not be unnecessarily prolonged and the brightness setting
should not exceed what is needed to provide clear visualization of the target structures.
The retinal exposure dose for a photochemical hazard is a product of the radiance and the
exposure time. If the value of radiance were reduced in half, twice the time would be
needed to reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for slit lamps, it is
recommended that the intensity of light directed into the patient’s eye be limited to the
minimum level that is necessary for diagnosis. Infants, aphakes and persons with
diseased eyes will be at greater risk. The risk may also increase if the person being
examined has had any exposure with the same instrument or any other ophthalmic
instrument using a visible light source during the previous 24 hours. This will apply
particularly if the eye has been exposed to retinal photography.
The red diode laser aiming beam has an average power varying from barely visible to 1
mW maximum. The safe (Class II) exposure duration limit at a maximum power level of 1

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mW is 3.9 seconds. To protect the patient from possible retinal damage during treatment,
use the lowest practical aiming beam intensity and the minimal required time duration.
Using any of the larger patterns while the slit lamp magnification is set to 32X, may result
in the pattern overfilling the visual field. Reduce the slit lamp magnification or adjust the
pattern size. Do not attempt treatment unless the entire pattern is visible.
Laser Safety Eyewear
WARNING: LASER HAZARD
Laser safety eyewear is routinely required with most lasers. When using the system, the
laser safety officer should determine the need for safety eyewear based on the Maximum
Permissible Exposure (MPE), Nominal Hazard Zone (NHZ) and the Nominal Ocular
Hazard Distance (NOHD) for each of the available laser wavelengths, as well as the
wavelength itself and the configuration of the treatment room (usually within the controlled
area).
ANSI Standard Z136.1-2007 defines MPE as “the level of radiation to which a person may
be exposed without hazardous effect or adverse biological changes in the eye or skin”; the
NHZ as “the space within which the level of direct, reflected or scattered radiation during
normal operation is not expected to exceed the applicable MPE”; and the NOHD as “the
distance along the axis of the unobstructed beam from the laser to the human eye beyond
which the irradiance or radiant exposure during operation is not expected to exceed the
appropriate MPE.”
The NOHD is measured from the slit lamp and pattern generator delivery system laser
aperture. ANSI defines the controlled areas as “an area where the occupancy and activity
of those within is subject to control and supervision for the purpose of protection from
radiation hazards.”
All personnel who are within the NOHD are considered to be in the controlled area
and shall wear eye protection with the appropriate optical density. Eyewear must be
resistant to physical damage and photo-bleaching. The minimum optical density
(OD) is 4 at 577 nm; 3 at 638 nm; for countries inside Europe and that comply with
EN 207, the eyewear must have a protection class of L4 at 577 nm; L3 at 638 nm.
Delivery Device
NOHD (577 nm)
NOHD (638 nm)
Slit Lamp
5.4 m (17.7’)
3 m (10’)
NOTE
These ratings only apply to laser exposure greater than 200 mm (7.9 in) away from the
laser exit aperture of the SLA.
The type of eye protection recommended for the physician, the patient, and/or treatment
room personnel within the NHZ depends on the planned procedure and the equipment
required to perform that procedure.

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An eye safety filter is provided with the Slit Lamp and is required for safe use. Laser safety
eyewear is not required by the physician who views the procedure through the slit lamp
eyepieces. All other personnel within the NHZ must wear laser safety eyewear with the
recommended optical density.
Along with providing the appropriate safety eyewear, the following steps should be taken
to secure the controlled area:
1. Treatment should be conducted in a dedicated, enclosed room.
2. A warning sign should be placed on the outside of the treatment room door when the
laser is in use. The sign is intended to alert personnel before they enter the controlled
area.
3. The treatment room door should be kept closed during treatment.
Electrical Hazards
WARNING: DANGEROUS VOLTAGE
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth. Hospital Grade Cord grounding reliability can only be
achieved when equipment is connected to an equivalent receptacle marked “Hospital
Grade” or “Hospital only”.
To avoid the risk of electric shock, do not touch any external connector and the patient
simultaneously.
Do not use power cables other than the power cable provided with the system. Do not use
extension cables with the system.
Disconnect the laser system from the electrical outlet when inspecting the fuses.
Never open the laser console protective covers. Opening the covers will expose you to
high voltage components, the laser resonator and possible laser radiation. Only certified
personnel shall work inside the console.
The area around the laser and footswitch shall be kept dry. Do not operate the laser if any
of the cords are faulty or frayed. The laser should undergo routine inspection and
maintenance per the Iridex Corporation manufacturer's recommendation and institutional
standards.
Non Homogeneous Pattern Delivery
WARNING
The optical system in this unit has been designed to provide uniform laser energy
deposition over the entire area of a focused spot. If proper focus of the laser spot on its
intended target is not achieved, or if damage, contamination, or deterioration of the optical
components has occurred, it is also possible to degrade this uniformity. Observation of

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aiming laser spots should provide suitable indication of the level of uniformity attainable in
any given system configuration, and treatment should proceed only when the user is
satisfied as to the level of laser deposition uniformity by observation of properly focused
aiming laser spots. Service personnel should be contacted for any concerns in this regard.
Treatment with laser deposition that is highly non-uniform can result in localized over-
and/or under-treatment of the affected areas.
The larger the pattern, the more likely that spots within the pattern would be non-uniformly
delivered. Smaller pattern sizes may be less likely to produce non-homogeneous lesions
than larger patterns.
There are other variables which may contribute to non-uniform pattern laser application,
including, but not limited to the following: media opacities (i.e. cataract) and heterogeneity
within a particular opacity; ischemic retinal changes; other situations where there is no
visible retinal/media non-homogeneity.
Fiber Optic Cable Assembly
WARNING: LASER HAZARD
Use extreme care with the cable assembly to/from the console and slit lamp. The cable
assembly consists of wiring and fiber optic cables.
Do not pull or stress any cables. Do not exceed bend radius of 15cm
Do not set items on or under the cable assembly.
Damage to the fiber optic cables may cause unintended laser exposure.
Pattern Titration
WARNING
The Physician is expected to show discretion in the dosage and location of the laser
delivery when using the Pattern Titration feature. It is the responsibility of the physician to
select the appropriate power and treatment location.
Please note that when retrieving a favorite that has been saved in titration mode, the
values of the pattern parameters that are not allowed to be changed in titration will be
restored to the defaults.