Iridex EndoProbe User manual

EndoProbe®and
OtoProbe
Operator Manual
IRIDEX
13103-EN
Revision F
®

Copyright December 2006 of IRIDEX Corporation. All rights reserved.
Published in the USA.
Except with the express written permission of IRIDEX, the contents of this
operator manual may not be copied in whole or in part, or reproduced in,
or transmitted to any other media. Copies IRIDEX does permit, including
those translated into another language, must carry the same proprietary
and copyright notices as were published with the original manual.
This manual is provided for instructional use and while every effort has
been made to ensure that the information is accurate, the text,
illustrations, and specifications are subject to change without notice.
The IRIDEX logo, IRIS Medical, OcuLight, IQ 810, EndoProbe, and
SmartKey are registered trademarks of IRIDEX Corporation. UltraView,
EndoENT, and OtoProbe are trademarks of IRIDEX Corporation.
Grieshaber is a registered trademark of Alcon. Lumenis is a trademark of
Lumenis Corporation. Bausch & Lomb is a registered trademark of
Bausch & Lomb. Alcon is a registered trademark of Alcon Laboratories, Inc.
IRIDEX
CORPORATION
1212Terra BellaAvenue
MountainView,California
94043-1824,USA
800-388-8100(U.S.only)
650-940-4700
FAX:
[phone]
CustomerService:
800-388-4747(U.S.only)
650-962-8100 (Int’l)
www.iridex.com

i
Contents
ABOUT THE ENDOPROBE AND OTOPROBE · 1
SPECIFICATIONS · 2
Probe models · 2
Sterile condition · 2
Illuminating EndoProbe specifications · 2
EndoIlluminator effective aperture · 2
EndoIlluminator numerical aperture · 2
EndoIlluminator light guide materials · 2
Illumination testing · 2
WARRANTY AND SERVICE · 3
Warranty · 3
Service and technical support · 3
OPERATION · 5
ABOUT THE COMPONENTS · 5
EndoProbe Starter Kit components for the OcuLight GL/GLx/TX · 5
EndoProbe Starter Kit components for the OcuLight SL/SLx · 5
Component descriptions · 5
EndoProbe · 5
StandardProbes · 6
Specialty Probes
Illuminating · 7
ActiveAspirating · 8
FlutedAspirating · 8
Stepped 45°Probe · 9
OtoProbe · 10
IRIDEX eye safety filter styles and accessories · 11
Fixed eye safety filter (available for all OcuLight consoles) · 11
SmartKeyemulationplug(availablefortheOcuLightGL/GLx/TX and
OcuLight OR consoles) · 11
Two-position eye safety filter (available only for the OcuLight GL/GLx/TX
and OcuLight OR consoles) · 12
CONNECTING THE COMPONENTS · 13

ii EndoProbe andOtoProbe OperatorManual
13103F-EN
Install the appropriate IRIDEX eye safety filter · 13
Remove the binocular tube from the operating microscope · 13
If you are installing a two-position eye safety filter,configure your Ocu-
Light GL/GLx console · 14
Install the eye safety filter · 15
Remount the binocular tube on the microscope · 15
If using a two-position eye safety filter,insert the SmartKey · 16
IfusinganOcuLightGL/GLx/ORconsoleand a fixedeyesafety filter,
insert the SmartKey emulation plug · 17
Connect the fiber-optic · 18
To IRIDEX lasers · 19
To non-IRIDEX lasers · 19
If applicable,connect the EndoProbe to an
illumination source · 20
CONTROLLING THE SIZE OF THE LASER SPOT · 21
CONTROLLING THE ASPIRATION · 22
Passive · 22
Active · 22
USING THE TWO-POSITION EYE SAFETY FILTER · 23
Closing the filter · 23
Opening the filter · 23
BEFORE TREATING PATIENTS · 24
TREATING APATIENT · 25
CONCLUDING PATIENT TREATMENT · 26
TROUBLESHOOTING · 27
MAINTENANCE · 29
DISPOSING OF THE PROBE · 29
INSPECTING AND CLEANING · 30
Routine care · 30
Inspect the eye safety filter · 30
Clean the eye safety filter · 30
CLINICAL & SAFETY · 31

iii
Contents
13103F-EN
CLINICAL APPLICATIONS · 31
Indications for clinical use · 31
Clinical warnings · 31
Precautions · 31
Recommended procedure for clinical use · 32
Power density and spot size · 32
Power and duration · 32
SAFETY · 33
Preventing unintended exposure of laser energy · 33
Preventing unauthorized use of the system · 33
Ensuring safe operation · 33
Preventing reflection hazards · 33
Preventing fire and explosion hazards · 33
Ensuring ocular protection · 34
Protection for the physician · 34
Protection for all persons in the treatment room — laser safety eyewear
requirements · 34
Regulatory compliance safety features for IRIDEX lasers · 35
Eye safety filter · 35
Laser emission indicator · 35
Safety interlocks · 35
Location of regulatory compliance and other system labels · 35
Sterile Pouch Label · 36

iv EndoProbe andOtoProbe OperatorManual
13103F-EN

1
IntroductionAbouttheEndoProbeandENTProbe
The IRIDEX EndoProbe is used to perform a variety of ophthalmic laser
treatments.
The EndoProbe is offered in straight or angled styles and features a low
cone angle to allow a comfortable working distance from the retina and a
more reproducible endpoint. The aspiration feature removes unwanted eye
fluid that is causing refraction or scattering of the laser beam from the
intended treatment site. The illumination feature illuminates the interior
of the eye.
The ENT Probe is used to perform otolaryngological procedures, and is
offered in short- and long-angled styles. The OtoProbe is a member of the
ENT Probe family.
The EndoProbe handpieces come with a universal SMA connector that
allows them to be used with validated compatible laser systems.
CAUTION
Federal law restricts this
device to sale by or on the
order of a physician.
WARNING
Surgical lasers generate a
highly concentrated beam
of light,which may cause
injuryifimproperlyused.
Be sure to operate
the console and the probe
in accordance with the
procedures described in
your console manual and
this manual.Failure to do
so may harm yourself,your
patient,or others.

2EndoProbe andENT ProbeOperatorManual
13103F-EN
EndoProbeSpecifications
Probemodels
Standard and specialty EndoProbe and ENT probe handpieces are
available.
Sterilecondition
The probes are single-use devices that have been factory pre-sterilized
using Ethylene Oxide (EtO) gas and are shipped in double-pouched, sterile
bags, ready for clinical use.
IlluminatingEndoProbespecifications
In accordance with ISO 15752, Section 6.2 the following information
specific to the illumination capability of this device is provided:
EndoIlluminatoreffectiveaperture
0.6 mm
EndoIlluminatornumericalaperture
0.5
EndoIlluminatorlightguidematerials
PMMA acrylic plastic polymer or fused silica
Illuminationtesting
In accordance with ISO 15752, Section 4.4.2 the following information
specific to the illumination capability of this device is provided:
Measurement of the aphakic weighted irradiance of an illuminating
EndoProbe may be made under sterile conditions by using the means
provided for this purpose by the manufacturer of your EndoIlluminator
light source together with the use of a means to temporarily grip the
EndoProbe during measurement. This may be accomplished by draping
the EndoProbe handpiece with a sterile sleeve or alternatively by gripping
the EndoProbe with a sterile clamp, forceps, or gloves during
measurement. Be careful not to compromise the sterile tip of the
EndoProbe during fixturing or measurement.

3
Introduction
13103F-EN
Warranty
The probes are single-use devices that are warranted against
manufacturing defects.
Serviceandtechnicalsupport
IRIDEX has established an efficient process to support its installations
worldwide. Should you require assistance, please contact your local
IRIDEX Technical Support representative or our corporate headquarters.
NOTE
The probes are intended
forsingle-useonly.
WARNING
Ifthese single-usedevices
arereused,performance,
safety,and efficacy cannot
beguaranteed.
WarrantyandService

4EndoProbe andENT ProbeOperatorManual
13103F-EN

Operation
5
AbouttheComponents
After unpacking the contents of the package, ensure that you have
received all of the components ordered. Check the components carefully
before use to ensure that no damage occurred during transit. If you
ordered an EndoProbe Starter Kit, please refer to the appropriate
section below:
EndoProbeStarterKit componentsfortheOcuLightGL/GLx/TX/OR
Along with this manual, you should have the EndoProbe style(s) you
ordered, an IRIDEX fixed or two-position eye safety filter labeled for use at
the 532 nm wavelength, four pairs of safety glasses, and a SmartKey® , (if
applicable).
EndoProbeStarterKitcomponentsfor theOcuLight SL/SLxor IQ810
Along with this manual, you should have the EndoProbe style(s) you
ordered, an IRIDEX fixed eye safety filter labeled for use at the
810 nm wavelength, and four pairs of safety glasses, (if applicable).
Componentdescriptions
EndoProbe
Each EndoProbe delivers the treatment and aiming laser beams from the
console to the patient’s eye and consists of a blunt intraocular needle that
comes in straight and angled models, a handle, a fiber-optic cable, and, on
some models, an illumination fiber or aspiration tube. The angled
EndoProbe needles allow for more effective treatment of the peripheral
retina.
ENTProbe
Each ENT Probe delivers the treatment and aiming beams from the
console to the tissue and consists of a tapered needle that comes in two
varieties of angulation, a handle, and a fiber-optic cable.
NOTE
Shouldyou notice
problemswithyourorder,
please contact your local
IRIDEX Customer Service
representative
immediately.
800-388-4747(U.S.only)
650-962-8100 (Int’l)

EndoProbe andENT ProbeOperatorManual
13103F-EN
6
Standard
The tapered EndoProbe makes it easier to insert and extract at the
sclerostomy site.
IRIDEX
IRIDEX

Operation
13103F-EN 7
Illuminating
An illuminating EndoProbe permits simultaneous white light illumination
and laser photocoagulation from the same needle. The illumination
connector allows you to use the EndoProbe with a variety of ophthalmic
light sources, such as Bausch & Lomb®and Alcon®. An adapter may be
required for use with some illuminating light sources. Contact IRIDEX
customer service for additional information.
IRIDEX
Handle
Fiber-optic cable
Illumination fiber connector
Straightneedle
Tip
IRIDEX
Angled needle

EndoProbe andENT ProbeOperatorManual
13103F-EN
8
.
FlutedAspirating
The fluted EndoProbe allows for aspiration (ventilation) of unwanted fluid
from the eye. By removing your finger from the opening (finger port) on
the probe handle, you can control the amount of fluid that is aspirated.
Aspiration occurs through the positive pressure within the eye.
IRIDEX
IRIDEX
ActiveAspirating
The active aspirating EndoProbe (available in straight and angled models)
allows for aspiration (ventilation) of unwanted fluid from the eye. The
aspiration is originated from the vitrectomy port on the vitrectomy system
console and is regulated through depression of the vitrectomy system
foot pedal.
Finger
port

Operation
13103F-EN 9
Stepped45°Angled
The stepped EndoProbe handpieces offer a smooth, gently tapered needle
which permits the angled 45°tip to be inserted through straight cannulas
for full coverage of the peripheral retina.

EndoProbe andENT ProbeOperatorManual
13103F-EN
10
ENTProbes
The short-angled OtoProbe offers better visibility when viewing the tissue
around the needle tip.
The long-angled OtoProbe offers a longer, straight needle for easier tissue
applanation.

Operation
13103F-EN 11
IRIDEXeyesafety filter stylesandaccessories
The IRIDEX eye safety filters have optics which protect your eyes from
backscattered laser reflections during laser surgery while using the probe
with an operating microscope.
Two eye safety filter styles for the 532 nm wavelength are available for the
OcuLight GL/GLx/TX and OR consoles: the fixed eye safety filter and the
two-position eye safety filter.
The fixed eye safety filter for the 810 nm wavelength is available for the
OcuLight SL/SLx and IQ 810™ consoles.
Fixedeyesafety filter (availableforallOcuLight consoles)
The fixed eye safety filter is silent and non-moving and has specially
coated lenses that allow for a clear, unobstructed view of the retina.
SmartKeyemulationplug(availableforOcuLightGL/GLx/ORconsoles)
The SmartKey emulation plug, which comes with the fixed eye safety filter
for the 532 nm wavelength, must be inserted into the corresponding port
on the console to place the laser in Treat mode. The OcuLight TX laser
does not require a SmartKey emulation plug.
Fixed eye safety filter
SmartKey emulation plug
(For OcuLight 532 nm consoles,excluding theTX)
WARNING
When using an
IRIDEX probe with a non-
IRIDEXlaserconsole,
ensure that the proper eye
safety filter is installed for
the specific
non-IRIDEX laser console
beingused.Refer to your
laseroperator manual for
specificeyesafety filter
information.
CAUTION
Usethe ENT probes only
withtheOcuLightGLx/TX
orOcuLightORconsole.

EndoProbe andENT ProbeOperatorManual
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12
Two-positioneyesafetyfilter (availableonlyforthe 532 nmconsoles)
The two-position eye safety filter has specially coated UltraView™lenses
which enable you to see objects in their true colors and in heightened
detail.
A manual lever allows you to open or close the filter when you are not
performing photocoagulation. During photocoagulation, the filter must
be in the viewing path to enable laser activation.
The integral SmartKey that is attached to the two-position eye safety filter
provides electronic communication from the eye safety filter to the
console, indicating when the filter is in the viewing path and when it is not.
The extension handle provides easier access to the eye safety filter lever in
the event that access to the lever is obstructed by microscope accessories
(such as binoculars, a beamsplitter, etc.)
Two-position
eye safety filter
Lever
IntegralSmartKey
(ForIRISMedical 532 nmconsolesonly)
Extension
handle
WARNING
TheIRIDEX
two-position eye safety
filter protects from
backscatteredlaser light in
the closed filter positions
only when used with the
IRIDEX
532nm lasers.The
two-position eye safety
filtershould notbe
used with any other
laser photocoagulator
consoles,including
other532 nmlasers.

Operation
13103F-EN 13
InstalltheappropriateIRIDEXeyesafetyfilter
When using the OcuLight SL/SLx or IQ 810 console, install the IRIDEX
810 nm eye safety filter into your microscope. When using the
OcuLight GL/GLx/TX or OcuLight OR console, install the 532 nm eye
safety filter into your microscope. For simultaneous protection from 810
nm and 532 nm laser light, install both IRIDEX eye safety filters into your
microscope.
Removethebinoculartubefromthe operating microscope
Loosen the thumbscrew that holds the binocular tube onto the operating
microscope.
Carefully lift the binocular tube off of the microscope.
16
6
16
6
ConnectingtheComponents
NOTE
Fixed eye safety filters for
both 810 nm and 532 nm
IRIDEXlaser systemsare
available for the Leica
M84X surgical
microscope.Please
contact your local IRIDEX
representative forfurther
information.

EndoProbe andENT ProbeOperatorManual
13103F-EN
14
Installingatwo-positioneyesafetyfilter
OcuLightGL/GLxconsole
The two-position eye safety filter is compatible with firmware versions
1.05, 1.1, and higher. When installing this type of filter, first configure your
console:
1. Activate the diagnostic mode to determine which firmware version you
have by pressing the Counter Reset and Treat/Standby buttons
simultaneously for three seconds or until you hear a beep. The Treat
and Standby lights illuminate.
2. Simultaneously press and hold the Counter Reset button while rotating
the Repeat Interval control clockwise until you see #7 in the Counter
display. Release the Counter Reset button. Your version of firmware is
shown in the status display.
3. If you have a compatible version of firmware, turn the Repeat Interval
control until #8 is shown in the Counter display. Press the Treat/
Standby button to scroll to Movable.
4. Press the Mode button to activate your selection and exit diagnostic
mode.
OcuLightOR
1. Refer to “Setting Up for an Endo Procedure” in the OcuLight OR
Operator Manual.
OcuLightTX
1. Simply connect the SmartKey to the laser.. No changes to laser
preference setting required. The OcuLight TX is designed to recognize
a twp-position filter.
WARNING
Thetwo-position eye
safety filter is not
compatible with
OcuLight GL/GLx firmware
versions 1.02,1.03,1.04,or
1.06.