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

13103-EN Rev K Operation 7
Connecting the Components
NOTE: Use the eye safety filter appropriate for the laser in use. If you are using a two-position eye
safety filter, you may need to configure your laser before installing the filter. Follow the
configuration instructions in your laser manual.
WARNINGS:
If you are using a beam splitter on your operating microscope, you must install the fixed eye
safety filter before installing the beam splitter.
If the pouch is open or damaged, do not use the probe.
Always inspect the fiber-optic cable before connecting it to the console. A damaged
fiber-optic cable could cause accidental laser exposure or injury to you, your patient, or
others in the treatment room.
CAUTION: Gentlyfinger-tightentheconnectortotheport.Donotovertighten.
Laser Spot Size
To change the spot size, move the probe farther from or closer to the target.
Treating Patients
Before treating apatient:
• Ensurethattheeyesafetyfilter(asappropriate)isproperlyinstalledandthattheSmartKey®, if
used, is selected.
• Ensurethatthelasercomponentsanddeliverydevice(s)areproperlyconnected.
• Postthelaserwarningsignoutsidethetreatmentroomdoor.
NOTE: Refer to Chapter 5, “Safety and Compliance,” and your delivery device manual(s) for
important information about laser safety eyewear and eye safety filters.
totreat apatient:
1. Turn on the laser.
2. Reset the counter.
3. Set the treatment parameters.
4. Position the patient.
probe tip beam waist

8IRIDEX EndoProbe® Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual 13103-EN Rev K
5. If required, select an appropriate contact lens for the treatment.
6. Ensure that all ancillary personnel in the treatment room are wearing the appropriate laser
safety eyewear.
7. Select Treat mode.
8. Position the aiming beam on the treatment site.
9. Focus or adjust the delivery device as applicable.
10. 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 off 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. Disconnect the SmartKey, if used.
8. If the delivery device is single-use, dispose of it properly. Otherwise, inspect and clean the
delivery device(s) as instructed in your delivery device manual(s).
9. If a contact lens was used, handle the lens according to the manufacturer’s instructions.

13103-EN Rev K Troubleshooting 9
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.
• Inspect the fuses.
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
(LIO only)
• 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
(LIO only)
• 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 patient’s retina
(LIO only)
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.

10 IRIDEX EndoProbe® Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual 13103-EN Rev K
Problem User Action(s)
The treatment lesions are variable
or intermittent (LIO only)
• 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.
Does not t on the mounting plate
(OMA only)
• Inspect and clean the mounting plate.
• Verify that the mounting plate corresponds to your microscope.
Laser and viewing systems are
not focussed at the same point
(OMA* only)
• Verify installation of a 175 mm microscope objective lens on
the microscope.
• Turn on the aiming beam to determine focus position and adjust
as necessary.
View is blocked or partially
blocked by OMA (OMA* only)
Set magnication to 10X or more.
*Operating microscope adapter compatible with IRIDEX IQ 810 and SLx Systems.

13103-EN Rev K Maintenance 11
4
Maintenance
These probes are single-use, disposable delivery devices. The device is intended for use on one
patient during a single procedure. It is not intended to be reprocessed (cleaned, disinfected/
sterilized) and used on another patient. No reuse processes have been validated by the manufacturer.
The reuse of a single-use medical device can compromise the safety and health of patients, users or
third parties. Reuse risks the introduction of contaminants and/or microbes and may lead to patient
injury and/or infection.
Store probe package under normal storage conditions - in a dry, clean, well ventilated area at room
temperature, between 15º-25ºC (59-77ºF).
Cleaning Optical Components
1. Wrap a lens tissue around one end of a cotton-tipped swab.
2. Place several drops of 100% ethanol, 100% methanol, or high-grade acetone on the tissue.
3. Wipe the lens gently with the swab to remove all dust and debris.
4. If the surface is still not clean, put a clean lens tissue around the end of the swab and gently wipe
it again.
Optical components refer to eye safety filters, output prism of DioPexy handpiece, mirrors on slit
lamp adapters, operating microscope adapters, etc.

12 IRIDEX EndoProbe® Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual 13103-EN Rev K
5
Safety and Compliance
To ensure safe operation and prevent hazards and unintended exposure to the laser beams, read and
follow these instructions:
• Topreventexposuretolaserenergy,exceptasatherapeuticapplicationfromeitherdirector
diffusely reflected laser beams, always review and observe the safety precautions outlined in the
operator manuals before using the device.
• Thisdeviceisintendedforuseonlybyaqualifiedphysician.Theapplicabilityoftheequipment
and treatment techniques selected is your sole responsibility.
• Donotuseanydeviceifyouthinkitisnotfunctioningproperly.
• Laserbeamsreflectedfromspecularsurfacescanharmyoureyes,thepatient’seyes,orothers’
eyes. Any mirror or metal object that reflects the laser beam can constitute a reflection hazard.
Be sure to remove all reflection hazards near the laser. Use non-reflecting instruments whenever
possible. Be careful not to direct the laser beam at unintended objects.
CAUTION: Changes or modifications 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 filters protect the physician from backscattered treatment laser light. Integral eye safety
filters 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 filter assembly must be installed into each viewing path of the operating
microscope. All eye safety filters have an optical density (OD) at the laser wavelength sufficient to
permit long-term viewing of diffuse laser light at Class I levels. When using the handpieces, always
wear the appropriate laser safety eyewear.
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
specific per each laser console wavelength and maximum power output.
Protection for All Treatment Room Personnel
The Laser Safety Officer 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
configuration of the treatment room. For additional information, refer to ANSI Z136.1, ANSI Z136.3,
or European Standard IEC 60825-1.

13103-EN Rev K Safety and Compliance 13
Safety Compliance
Complies with FDA performance standards for laser products except for deviations pursuant to Laser
Notice No. 50, dated June 24, 2007.
CE-marked devices comply with all requirements of the European Medical Device Directive
MDD 93/42/EEC.
Illuminating Probe Specications
The following information on the illumination capabilities of this device is provided in accordance
with ISO 15752, Section 6.2.
Feature Specication
Effective Aperture 0.5 mm
Numerical Aperture 0.5 - 0.8
Light Guide Materials PMMA or Silica
Illumination Testing
The following information on the illumination capabilities of this device is provided in accordance
with ISO 15752, Section 4.4.2.
Measurement of the aphakic weighted irradiance of an illuminating EndoProbe may be made under
sterile conditions. Follow the instructions provided by the manufacturer of your EndoIlluminator
light source. Drape the EndoProbe handpiece with a sterile sleeve, or grip the EndoProbe with a
sterile clamp, forceps, or gloves. Do not compromise the sterile tip.

14 IRIDEX EndoProbe® Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual 13103-EN Rev K
Symbols (As Applicable)
Aiming Beam Angle Aspirating Probe
Caution Audible Signal
2797
CE Mark
Connector Type
Do Not Use
if Package is
Damaged
Duration
Duration with
MicroPulse Emergency Stop ETL Mark
EtO Sterile EU Authorized
Representative Expiration Date
Footswitch Footswitch In Footswitch Out
Fuse Gauge Protective Earth
(Ground)
Illuminating Probe Decrease/Increase Interval
Interval with
MicroPulse
Laser Aperture at
End of Fiber Laser Warning
Illumination LOT Manufacturer
Date of manufacture Off On
Part Number Power Pulse Count
Pulse Count Reset
No-ionizing
Electromagnetic
Radiation
Read Information
Remote Control Remote Interlock Serial Number
Single Use Standby Treat
Type B Equipment
Waste Electrical
and Electronic
Equipment (WEEE)
Pattern is Activated

13103-EN Rev K Safety and Compliance 15
Temperature
Limitations IPX4
Protections Against
Splash Water
Coming from all
Directions
IPX8
Protections Against
Continuous
Immersion
Refer to Instruction
Manual/Booklet
(in blue)
Initial Power
(PowerStep)
Interval between
Groups
Number of Pulses
(Group)
Number of Steps
(PowerStep) Power (MicroPulse)
Power Increment Power Increment
(PowerStep)
Parameter
is Locked
USB Port Indicators Laser Firing
Laser Preparing Speaker Screen
System Brightness Latex Free Prescription
Warning, Replace
with fuses as
indicated