Iridex OcuLight GL, OcuLight GLx, OcuLight TX Operator's Manual

OcuLight® GL/GLx/TX

Operator Manual

OcuLight® GL/GLx/TX Operator Manual
33003-EN Rev B 2013-05

© 2013 by IRIDEX Corporation. All rights reserved.

IRIDEX, the IRIDEX logo, IRIS Medical, OcuLight, EndoProbe and SmartKey are registered trademarks;
BriteLight, CW-Pulse, DioPexy, EasyFit, EasyView, FiberCheck, G-Probe, IQ 532, IQ 577, IQ 810, LongPulse,
MicroPulse, MilliPulse, OtoProbe, PowerStep, Symphony, TruFocus, and TruView are trademarks of IRIDEX
Corporation. All other trademarks are the property of their respective holders.

Contents

1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

OcuLight GL/GLx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

OcuLight TX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Compatible Delivery Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Procedural Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Specific Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Potential Side Effects or Complications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Specific Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Laser Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

IRIDEX Corporation Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Unpacking the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Choosing a Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Connecting the Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Front Panel Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Powering the Laser On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Setting Treatment Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Selecting the Laser Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Selecting User Preferences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Treating Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

General Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Status Panel Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Inspecting and Cleaning the Laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Inspecting and Cleaning the Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Verifying the Power Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

6 Safety and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Protection for the Physician. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Protection for All Treatment Room Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Safety Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Symbols (As Applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

7 Wireless Footswitch and EMC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Setting Up the Wireless Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Testing the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

EMC Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

EMC Requirements for Console and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 31

33003-EN Rev B iii

Contents

iv 33003-EN Rev B

1

Introduction

The OcuLight® GL, GLx, and TX are solid state lasers that deliver true continuous wave green laser
(532 nm) light for ophthalmic applications. The OcuLight TX and GLx are also indicated for
otolaryngological applications. Improper use of the laser system can result in adverse effects. Follow
the instructions for use described in this operator manual.

Indications for Use

This section provides information on the use of the laser in clinical specialties. Information is provided
by specialty and includes procedural recommendations along with specific indications and
contraindications. This information is not intended to be all-inclusive and is not intended to replace
surgeon training or experience. The regulatory information provided is applicable only in the United
States. If you use the laser for indications not included herein, you will be subject to 21 CFR Part 812,
the Food and Drug Administration’s Investigational Device Exemption (IDE) regulations. For
information regarding the regulatory status of indications other than those listed in this manual,
contact IRIDEX Regulatory Affairs.

IRIDEX does not make recommendations regarding the practice of medicine. References in literature
are provided as a guide. Individual treatment should be based on clinical training, clinical observation
of laser tissue interaction, and appropriate clinical endpoints. The IRIDEX laser and the handpieces,
delivery devices, and accessories that are used with it to deliver laser energy in CW-Pulse™ or

MicroPulse™ mode in the medical specialty of Ophthalmology. The OcuLight
intended for use in ophthalmic and otolaryngological applications for therapeutic purposes only by
trained medical practitioners. IRIDEX does not make recommendations regarding the practice of
medicine. References in literature are provided as a guide. Individual treatment should be based on
clinical training, clinical observation of laser-tissue interaction, and appropriate clinical endpoints.

OcuLight GL OcuLight GLx OcuLight TX

Ophthalmology

Retinal photocoagulation 333

Laser trabeculoplasty 333

Iridotomy 333

Iridoplasty 333

Otolaryngology

Stapedectomy 33

Stapedotomy 33

®

GL, GLx, and TX are

33003-EN Rev B Introduction 1

References

Ophthalmology. Ludwig K, Lasser TH, Sakowski H, Abramowski H, Wörz G. Continuous wave laser
photocoagulation at different wavelengths: equivalent power settings in edematous and non-edematous retina.
Lasers and Light in Ophthalmology 1994 Vol. 6 No. 3 159-167.
Gnanaraj L, Brennan R, Cottrell DG. Retinopathy of Prematurity in Practice. II: Longterm Results Following
Treatment for Threshold Disease. Eye 2003;(17); 189-193.
HC Agarwal, S Poovali, R Sihota and T Dada. Comparative evaluation of diode laser trabeculoplasty vs.
frequency-doubled Nd: YAG laser trabeculoplasty in primary open angle glaucoma. Eye (2006) 20, 1352-1356.
Abreu MM, Sierra RA, Netland PA. Diode laser-pumped, frequency-doubled neodymium: YAG laser peripheral
iridotomy. Ophthalmic Surg Lasers 1997;28:305-310.

Otolaryngology. Poe DS. Laser-assisted endoscopic stapedectomy: a prospective study. Laryngoscope 2000 May:
110(5 Pt 2 Suppl 95):1-37.

OcuLight GL/GLx

The OcuLight GL/GLx is indicated for retinal photocoagulation and laser trabeculoplasty. The
following are examples of applications for the OcuLight GL/GLx laser systems.

Condition Treatment

Diabetic Retinopathy

• Nonproliferative Retinopathy

• Macular Edema

• Proliferative Retinopathy

Glaucoma

• Primary Open Angle

• Closed Angle

Retinal Tears and Detachments RPC; Focal and Grid Laser Treatments

Lattice Degeneration RPC; Focal and Grid Laser Treatments

Age-Related Macular Degeneration (AMD) RPC; Focal and Grid Laser Treatments

Intra-Ocular Tumors

• Choroidal Hemangioma

• Choroidal Melanoma

• Retinoblastoma

Retinopathy of Prematurity RPC; Focal and Grid Laser Treatments

Sub-Retinal (choroidal) Neovascularization RPC; Focal and Grid Laser Treatments

Central and Branch Retinal Vein Occlusion RPC; Focal and Grid Laser Treatments

Ear, Nose and Throat*

• Otosclerotic Hearing Loss

*GLx only

Retinal Photocoagulation (RPC); Focal and Grid
Laser Treatments

Laser Trabeculoplasty; Iridotomy; Iridoplasty

RPC; Focal and Grid Laser Treatments

Stapedotomy

2 IRIDEX OcuLight® GL/GLx/TX Operator Manual 33003-EN Rev B

OcuLight TX

Otolaryngology. The OcuLight TX is intended to be used in ENT surgery for tissue incision, excision,
coagulation, vaporization, ablation and vessel hemostasis. Indications for use include, but are not
limited to Stapedectomy, Stapedotomy, Myringotomy, Lysis of adhesions, control of bleeding, removal
of Acoustic Neuromas, Soft Tissue Adhesion in Micro/Macro Otologic procedures.

Ophthalmology. The OcuLight TX is intended to photocoagulate ocular tissue in ophthalmic
procedures. Indications for use include: Retinal Photocoagulation, Laser Trabeculoplasty, Iridotomy,
Iridoplasty.

Compatible Delivery Devices

Compatible Delivery Devices OcuLight GL Oculight GLx OcuLight TX

Laser Indirect Ophthalmoscope (LIO) 333

EndoProbe

OtoProbe™ 33

Slit Lamp Adapter (SLA) 333

EasyFit

EasyView™ SLA 333

IRIDEX Integrated Slit Lamp
Workstation

Symphony™ SLA / Symphony 2 333

®

™

Adapter

333

333

333

NOTE: Refer to the appropriate delivery device manual for indications for use, contraindications, precautions,

and adverse effects information.

Procedural Recommendations

The user is directed to review the operating instructions for the compatible delivery devices prior to
treatment.

Specific Warnings and Precautions

It is essential that the surgeon and attending staff be trained in all aspects of these procedures. No
surgeon should use these laser products for ophthalmic and ENT surgical procedures without first
obtaining detailed instructions in laser use. Refer to “Warnings and Cautions” for more information.

Proper eye protection for 532 nm light must be utilized. Follow the Eye Protection Policy at your
facility.

33003-EN Rev B Introduction 3

Potential Side Effects or Complications

Ophthalmic

• Specific to retinal photocoagulation: inadvertent foveal burns; choroidal neovascularization;
paracentral scotomata; transient increased edema/decreased vision; subretinal fibrosis;
photocoagulation scar expansion; Bruch’s membrane rupture; choroidal detachment; exudative
retinal detachment; pupillary abnormalities from damage to the ciliary nerves; and, optic neuritis
from treatment directly or adjacent to the disc.

• Specific to laser iridotomy or iridoplasty: inadvertent corneal or lens burns/opacities; iritis; iris
atrophy; bleeding; visual symptoms; IOP spike; and, rarely, retinal detachment.

• Specific to laser trabeculoplasty: IOP spike, and, disruption of the corneal epithelium.

ENT

Excessive treatment may cause swelling (edema) in the area treated by the laser.

Anesthesia Considerations

One of the main concerns during otolaryngeal and bronchial procedures is the substantial risk of
endotracheal fires. The following sections provide information and safety guidelines, which can
greatly decrease the risks associated with these procedures. Information is also provided on what to
do if such a fire does occur.

IRIDEX Corp. recommends the safety guidelines of American National Standards ANSI Z136.3-2007
as follows:

• Care must be taken to protect endotracheal tubes from laser radiation. Ignition or perforation of
endotracheal tubes by the laser beam could result in serious or fatal patient complications.

• Use the lowest possible oxygen concentration to support the patient.

• Use the venturi ventilation technique when possible.

• Use intravenous anesthetic agents rather than inhalation techniques.

• Use non-flammable laser-safe endotracheal tubes.

• Protect the endotracheal tube cuff with wet cottonoids.

Reference material and additional information regarding laser safety and the prevention of
endotracheal fires may be obtained from the following U.S. sources:

• ANSI Z136.3, The Safe Use of Lasers in Health Care Facilities, American National Standards

2007.

• Recommended Practices: Laser Safety in the Practice Setting. AORN Journal, March 1993, Vol. 57
No. 3, Pg. 720-727.

• Safety Considerations for the Use of Medical Lasers, The Nursing Spectrum of Lasers, Pfister,
Kneedler, Purcell, Education Design, 1988, Pg. 70-72.

• Prevention of Fires and Protection of Non-Target Tissues, Airway Precautions, Plan for Success:
A Practical Guide for Your Carbon Dioxide Laser Surgery Program, Lewis, Coherent 1989, Pg. 16-17.

• Laser Resistant Stainless Steel Endotracheal Tube: Experimental and Clinical Evaluation, Lasers
in Surgery and Medicine, Fried, Marvin P., MD, 11:301-306 (1991).

4 IRIDEX OcuLight® GL/GLx/TX Operator Manual 33003-EN Rev B

• Evaluation & Discussion: Issues in Using and Selecting Laser Resistant Endotracheal Tubes

(LRETTs) and Wraps, ECRI, Health Devices, July-August 1991, Vol. 20 Nos. 7-8.

• Diffuse Reflections, Endoscopic Surgery: Is Laser Safety Eyewear Really Needed?, Radiant

Resources Newsletter, Winter 1992, Rockwell Laser Industries.

Specific Contraindications

• None known specific to ENT use at this time.

•Ophthalmic:

– Any situation where the target tissue cannot be adequately visualized or stabilized.

– Do not treat albino patients who have no pigmentation.

Laser Settings

Beginning at low power with short duration exposures, the surgeon should note the surgical effect
and increase power, power density, or exposure duration until the desired surgical effect is obtained.
The information in the following tables is intended to provide guidance only for treatment settings,
which are not prescriptive for any condition. The operative needs of each patient should be
individually evaluated based on the indication, treatment location, and on the patient’s medical and
wound healing history. If uncertain of expected clinical response, always start with a conservative
setting and increase the setting in small steps.

Ophthalmic Treatment Parameters

Treatment Delivery Devices Power (W) Exposure

Duration (ms)

Trabeculoplasty SLA 1.5–2.0 100–500 100–500

Retina Grid/Focal SLA, LIO,

EndoProbe

Trabeculoplasty SLA 0.5–2.0 100–500 50–200

Iridotomy SLA, LIO 0.2–2.0 100–300 50–200

Retina Grid/Focal SLA, LIO,

EndoProbe

ENT Treatment Parameters

Treatment Delivery Device Power (W) Exposure

Stapedectomy Otoprobe

Stapedotomy

Myringotomies

Lysis of Adhesions

Control of Bleeding Otoprobe

Removal of Acoustic Neuromas

Soft Tissue Adhesion in Micro/Macro
Otologic Procedures

FlexFiber

FlexFiber

1.0–2.0 100–1000 50–100

0.1–2.0 100–1000 100–1000

Duration (ms)

0.8–2.3 100–1000 N/A

0.2–0.6 800–2000 N/A

Spot Size (μm)

Spot Size

(μm)

33003-EN Rev B Introduction 5

Warnings and Cautions

DANGER:

Do not remove covers. Shock hazard and accessible laser radiation. Refer servicing to qualified laser
personnel. Risk of explosion if used in the presence of flammable anesthetics.

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.

Never look directly into the aiming or treatment beam apertures or the fiber-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 reflective surfaces.
Avoid directing the treatment beam at highly reflective 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.

To avoid the risk of electric shock, this equipment must be connected to a supply mains with protective
earth.

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 specified herein may result
in hazardous radiation exposure.

Do not operate the equipment in the presence of flammables or explosives, such as volatile anesthetics,
alcohol, and surgical preparation solutions.

Laser plume may contain viable tissue particulates.

Keep the protective cap over the fiber-optic connector when the delivery device is not in use.

6 IRIDEX OcuLight® GL/GLx/TX Operator Manual 33003-EN Rev B

IRIDEX Corporation Contact Information

IRIDEX Corporation
1212 Terra Bella Avenue
Mountain View, California 94043-1824 USA

Telephone: [phone]

[phone] (US only)

Fax: [phone]

Technical Support: [phone]

[phone] (US only)
[e-mail]

Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Tel: (31) (0) 70 345-8570
Fax: (31) (0) 70 346-7299

0086

Warranty and Service. Each laser system carries a standard factory warranty. The warranty covers all
parts and labor required to correct problems with materials or workmanship. This warranty is void if
service is attempted by anyone other than certified IRIDEX service personnel.

WARNING: Use only IRIDEX delivery devices with the IRIDEX laser system. Use of a non-IRIDEX delivery

device may result in unreliable operation or inaccurate delivery of laser power. This Warranty
and Service agreement does not cover any damage or defect caused by the use of non-IRIDEX
devices.

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.

WEEE Guidance. Contact IRIDEX or your distributor for disposal information.

33003-EN Rev B Introduction 7

2

Setup

Unpacking the System

Make sure you have all components that were ordered. Check components for damage before use.

NOTE: Contact your local IRIDEX Customer Service representative if there are problems with your order.

Remote

Control

(optional accessory)

Laser

Wireless Footswitch
(optional accessory)

Keys

Footswitch

Power cord

Appearance and type of components may vary based on the system ordered.

• Laser (also “Console”) • Operator Manual (not shown)

• Power cord (U.S. configuration shown) • Laser warning sign (not shown)

• Keys • Optional accessories (not all shown)

• Standard footswitch

8 IRIDEX OcuLight® GL/GLx/TX Operator Manual 33003-EN Rev B