Iridex EndoProbe Series User manual

EndoProbe®Handpiece,
OtoProbe™ Device
and FlexFiber™ Device
Operator Manual

EndoProbe®Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual
13103-EN Rev K 2019 06
© 2019 by IRIDEX Corporation. All rights reserved.
IRIDEX, the IRIDEX logo, IRIS Medical, OcuLight, EndoProbe, FlexFiber, and SmartKey are registered
trademarks; BriteLight, CW-Pulse, DioPexy, DualSense, EasyFit, EasyView, FiberCheck, FlexFiber, G-Probe,
IQ 532, IQ 577, IQ 810, LongPulse, MicroPulse, MilliPulse, OtoProbe, PowerStep, SmartKey, Symphony,
Tri-Mode, TruFocus, and TruView are trademarks of IRIDEX Corporation. All other trademarks are the
property of their respective holders.

1 Introduction......................................................................................... 1
Indications for Use.........................................................................................................1
Precautions .....................................................................................................................1
Recommended Procedure ............................................................................................1
Power and Duration......................................................................................................1
Warnings and Cautions ................................................................................................2
References .......................................................................................................................3
Compatible IRIDEX Lasers...........................................................................................4
IRIDEX Corporation Contact Information.................................................................4
2 Operation ............................................................................................. 5
About the Components.................................................................................................5
EndoProbe Models ........................................................................................................5
OtoProbe Models ...........................................................................................................6
FlexFiber Models ...........................................................................................................6
Eye Safety Filters............................................................................................................6
Connecting the Components .......................................................................................7
Laser Spot Size ...............................................................................................................7
Treating Patients ............................................................................................................7
3 Troubleshooting................................................................................... 9
General Problems...........................................................................................................9
4 Maintenance....................................................................................... 11
Cleaning Optical Components...................................................................................11
5 Safety and Compliance...................................................................... 12
Protection for the Physician .......................................................................................12
Protection for All Treatment Room Personnel.........................................................12
Safety Compliance.......................................................................................................13
Illuminating Probe Specifications .............................................................................13
Illumination Testing ....................................................................................................13
Symbols (As Applicable) ............................................................................................14
Contents
13103-EN Rev K iii

Contents
iv 13103-EN Rev K

13103-EN Rev K Introduction 1
1
Introduction
IRIDEX probes come with a universal SMA connector that allows them to be used with validated
compatible laser systems.
Indications for Use
The EndoProbe®Handpiece is indicated for use in performing ophthalmic laser treatments to deliver
laser energy to the treatment area inside the eye. The EndoProbe is cleared for use for the particular
indications of the compatible laser system to which it is attached.
The OtoProbe™ Device is intended for use in surgical procedures including incision, excision,
coagulation, and vaporization of soft and fibrous tissue (including osseous tissue) in the medical
specialty of Ear, Nose and Throat (ENT) surgery. The OtoProbe is cleared for use for the particular
indications of the compatible laser system to which it is attached. The FlexFiber™ Device is intended
for use in treatment of soft tissue/vascular lesions of the airway and larynx. The FlexFiber is cleared
for use for the particular indications of the compatible laser system to which it is attached.
Precautions
Protect the fiber-optic tip from damage. If damaged, discard the probe.
Recommended Procedure
Qualified physicians should review the available literature presented in clinical papers before using
the probe delivery device.
Power and Duration
If uncertain of tissue response, start with the lower power settings and increase the power until
satisfactory clinical lesions are observed.

2IRIDEX EndoProbe® Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual 13103-EN Rev K
Warnings and Cautions
WARNINGS:
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.
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.
Always handle the fiber-optic cables with extreme care. Do not coil the cable into a diameter
less than 15 cm (6 in).
Turn off the laser before inspecting any delivery device components.
Keep the protective cap over the fiber-optic connector when the delivery device is not in use.
Follow standard facility procedures for the handling of biohazardous material after each use
of the delivery device.
Always verify that the delivery device is properly connected to the console. An improper
connection may result in an inadvertent secondary laser beam. Severe eye or tissue damage
could occur.
When using an IRIDEX probe with a non-IRIDEX laser console, ensure that the proper eye
safety filter is installed. Refer to your laser manual for specific eye safety filter information.
The IRIDEX eye safety filter (ESF) is designed to be used with an IRIDEX laser. Always
ensure that the ESF is properly connected to the laser during use.
The relationship between spot size and resultant power density is not linear. Halving the
spot size quadruples the power density. The physician must understand the relationships
among spot size, laser power, power density, and laser/tissue interaction before using an
Iridex probe.
Ophthalmic Warnings:
• Excessive treatment power may result in a retinal hole and a retinal hemorrhage.
• Excessive power delivered at short pulse durations may result in choroidal hemorrhage.

13103-EN Rev K Introduction 3
ENT Warnings:
• 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;and
• Protecttheendotrachealtubecuffwithwetcottonoids.
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.
References
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).
• 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.

4IRIDEX EndoProbe® Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual 13103-EN Rev K
Compatible IRIDEX Lasers
Laser System EndoProbe OtoProbe FlexFiber
GL 
GLx 
TX 
SL 
SLx 
IQ 810 
IQ 532 
IQ 577 
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]
[email protected]
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
2797
Warranty and Service. This device carries a standard factory warranty. This warranty is void if
service is attempted by anyone other than certified 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.

13103-EN Rev K Operation 5
2
Operation
About the Components
After unpacking the contents of your IRIDEX laser probe, ensure that you have all of the
components ordered. Check the components carefully before use to ensure that no damage occurred
during transit.
Ensure that the appropriate eye safety filter is installed prior to using a probe.
EndoProbe Models
Model Description
Standard (straight or angled) Provides intraocular laser delivery.
Illuminating Provides light illumination and laser delivery.
Stepped 45° angled Provides laser delivery; probe designed for use with a trochar.
Adjustable and Intuitive Provides laser delivery; probe designed for manual adjustment of angle.
laser aperture
ber-optic connector

6IRIDEX EndoProbe® Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual 13103-EN Rev K
OtoProbe Models
Part Number Model Description
14320 Short-angled* Angle at the distal end of the needle
14310 Long-angled* Angle at the proximal end of the needle
* Also available with RFID connector
FlexFiber Models
Part Number Description
15702 200 μm Laser Fiber
15703 300 μm Laser Fiber
15704 400 μm Laser Fiber
15706 600 μm Laser Fiber
Eye Safety Filters
Eye Safety Filter 532 nm 577 nm 810 nm
Fixed   
Two-Position  
Fixed Eye Safety Filter
Eye protection for physician is fixed and always in place.
Two-Position Eye Safety Filter
Filter position is adjusted manually. SmartKey®provides feedback to laser to ensure no laser emission
when filter is out of position.
WARNING: For use with IRIDEX laser systems only.
SmartKey Extension
handle
Lever