Iridex TxCell SSLA User manual

TxCell® Scanning Laser
Delivery System
Operator Manual

TxCell® Scanning Laser Delivery System Operator Manual
70375-EN Rev B 12.2021
© 2021 Iridex Corporation. All rights reserved.
Iridex, the Iridex logo, OcuLight, G-Probe, IQ 532, IQ 577, EndoProbe, and MicroPulse are registered trademarks;
TxCell, BriteLight, CW-Pulse, DioPexy, EasyFit, EasyView, FiberCheck, IQ 810, LongPulse, MilliPulse, OtoProbe,
PowerStep, Symphony, TruFocus, and TruView are trademarks of Iridex Corporation. All other trademarks are the
property of their respective holders.

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Contents
1. INTRODUCTION ................................................................................................................................................ 1
PRODUCT DESCRIPTION .................................................................................................................................................. 1
IRIDEX CORPORATION CONTACT INFORMATION ................................................................................................................. 1
WARNINGS AND CAUTIONS ............................................................................................................................................. 2
2. OPERATION ...................................................................................................................................................... 4
ABOUT THE COMPONENTS .............................................................................................................................................. 4
SET UP TXCELL CONTROL BOX ......................................................................................................................................... 5
INSTALL TXCELL SSLA .................................................................................................................................................... 6
TREATMENT SCREEN .................................................................................................................................................... 10
PATTERN SELECTION SCREEN ......................................................................................................................................... 11
AIMING BEAM INTENSITY ADJUSTMENT ........................................................................................................................... 13
AUTOMATED FIBERCHECK™ .......................................................................................................................................... 13
TREATING PATIENTS ..................................................................................................................................................... 14
3. PATIENT TREATMENT AND CLINICAL INFORMATION ....................................................................................... 15
INTENDED USE/INDICATIONS FOR USE ............................................................................................................................. 15
CONTRAINDICATIONS ................................................................................................................................................... 16
POTENTIAL SIDE EFFECTS OR COMPLICATIONS ................................................................................................................... 16
SPECIFIC WARNINGS AND PRECAUTIONS .......................................................................................................................... 16
PROCEDURAL RECOMMENDATIONS ................................................................................................................................. 17
CLINICAL REFERENCES .................................................................................................................................................. 20
4. TROUBLESHOOTING ........................................................................................................................................ 21
GENERAL PROBLEMS .................................................................................................................................................... 21
TXCELL SCANNING LASER DELIVERY SYSTEM ERRORS .......................................................................................................... 22
5. MAINTENANCE ............................................................................................................................................... 24
6. SAFETY AND COMPLIANCE .............................................................................................................................. 26
PROTECTION FOR THE PHYSICIAN .................................................................................................................................... 26
PROTECTION FOR ALL TREATMENT ROOM PERSONNEL ........................................................................................................ 26
SAFETY COMPLIANCE .................................................................................................................................................... 26
LABELS ...................................................................................................................................................................... 27
SYMBOLS (AS APPLICABLE) ............................................................................................................................................ 29
TXCELL SSLA SPECIFICATIONS ........................................................................................................................................ 30
EMC SAFETY INFORMATION .......................................................................................................................................... 31

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70375-EN Rev B 1
1
Introduction
Product Description
The TxCell®Scanning Laser Delivery System adds the use of pattern scanning technology when coupling
with commercially available Iridex laser systems. This offers existing Iridex laser systems the ability to
deliver, in addition to standard single-spot applications, a full spectrum of multi-spot pattern scanning
options through a variety of customer-owned slit lamps. It is intended for use by trained physicians for the
diagnosis and treatment of ocular pathology.
The TxCell Scanning Laser Delivery System consists of the following system components:
• TxCell Scanning Slit Lamp Adapter (SSLA) that may be coupled to Iridex laser workstations, Zeiss or
Haag-Streit styles .
• TxCell Control Box with power supply, scanner controller, drive electronics and electrical connections.
The Control Box is paired with an SSLA.
• Cables to connect the SSLA to the Control Box and the Control Box to the laser console.
Iridex Corporation Contact Information
Iridex Corporation
1212 Terra Bella Avenue
Mountain View, California 94043-1824 USA
Telephone: [phone] (US only)
[phone]
Fax: [phone]
Technical Support: [phone]
[phone] (US only)
[e-mail]
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
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.
Should you require assistance, please contact your local Iridex Technical Support representative or our
corporate headquarters.
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.

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Warnings and Cautions
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.
Always keep the Iridex laser in Standby mode when you are not treating a patient. Maintaining the Iridex
laser in Standby mode prevents accidental laser exposure if the footswitch is inadvertently pressed.
If you are using a beam splitter, you must install the fixed ESF for the appropriate wavelength before
installing the beam splitter.
Avoid over-treatment of targeted tissue by using the lowest power density. Please refer to “Treating
Patients” in Chapter 2.
Ensure pattern covers only the desired treatment area prior to footswitch actuation.
Reaction time can exceed rate of treatment spot delivery in either single-spot repeat or multi-spot pattern
mode. This can result in delivery of laser applications after intended release of the footswitch prior to
completion of a pattern.
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 relationship among spot size, laser power,
power density, and laser/tissue interaction before using the TxCell Scanning Slit Lamp Adapter.
Always inspect the fiber-optic cable before connecting it to the laser to ensure that it has not been damaged.
A damaged fiber-optic cable could cause accidental laser exposure or injury to yourself, your patient, or
others in the treatment room.
Always verify that the delivery device is properly connected to the laser. An improper connection may result
in an inadvertent secondary laser beam. Severe eye or tissue damage could occur.
Do not use the delivery device with any laser system other than an Iridex laser. Such use may void product
warranties and jeopardize the safety of the patient, yourself, and others in the treatment room.
Tissue absorption is directly dependent upon presence of pigmentation; therefore, dark pigmented eyes will
require lower energies to obtain equivalent results as compared to light pigmented eyes.
Observation equipment such as a beam splitter or co-observation tube must be installed between the ESF and
the oculars.
To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective
earth. EN60601-1:2006/AC; 2010 16-2 (C)

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CAUTIONS:
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.
Turn off the laser before inspecting any delivery device components.
Always handle the fiber-optic cables with extreme care. Do not coil the cable into a diameter less than 15 cm
(6 in).
Keep the protective cap over the fiber-optic connector when the delivery device is not in use.
Do not touch the end of the fiber-optic connector, as finger oils can impair light transmission through the
fiber-optic and reduce power.
Do not handle any illumination lamp by its glass bulb.

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2
Operation
About the Components
After unpacking the contents of your TxCell®Scanning Laser Delivery System, ensure that you have all of
the components ordered.
In addition to the TxCell Scanning Slit Lamp Adapter (SSLA), control box, and control box cable, you may
have an Eye Safety Filter (ESF), a split-mirror illumination prism, a finger rest, a micromanipulator,
mounting bracket, and installation tools, depending on the slit lamp model. Check the components
carefully before use to ensure that no damage occurred during transit.
Slit Lamp Compatibility
Model
Spot Size (µm)
Slit Lamp Styles
Console Compatibility
TxCell SSLA
Single-spot: 50 - 500
Multi-spot: 100 - 500
Iridex SL 980, Iridex SL 990,
Zeiss 30 SL, Zeiss SL 130,
Haag-Streit BM/BQ 900
and equivalents
IQ 532® / IQ 577®
Typical Slit Lamp Adapter and Components (Depending on Model)
Eye Safety
Filter
Micromanipulator Handle
Fiber-optic Cable
Split-mirror Illumination
Prism
SSLA Control Cable
Delivery
Mirror
Finger Rest

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Component
Description
Illumination prism
Projects white light from slit lamp without interference with laser delivery.
Micromanipulator handle
Allows independent beam steering capabilities.
Eye Safety Filter
Protects against laser wavelength reflected back to oculars.
Finger rest
For use when using the micromanipulator.
Spacer
As necessary, depending on TxCell SSLA model.
Mounting bracket
As necessary, depending on TxCell SSLA model.
Slit lamp table
Diagnostic system to which TxCell SSLA attaches (workstation component).
Fiber-optic cable
Transmits laser light.
SSLA Control cable
Communicates spot size, filter information, and scanning information to the control box.
Control box
Houses the power supply, scanner controller, and electrical components
Control box cable
Connects the control box to the laser console
Set Up TxCell Control Box
1. Place the laser console on top of the Control Box (preferred, or as space permits). If brought in from the
cold, wait for the temperature of the system to warm up to room temperature.
2. Connect Control Box to laser console using the provided Control Box Cable.
3. Connect Control Box to electrical outlet.
Control Box Cable

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Install TxCell SSLA
1. Lock slit lamp in place.
2. Move illumination tower out of the way.
3. For Haag-Streit equivalent: Install mounting bracket or spacer as necessary.
4. For Haag-Streit equivalent: Unlatch ESF from storage position. Place SLA on the post of the slit lamp
microscope. Tighten with thumbscrew.
Haag-Streit ESF
Slit Lamp
Mounting Platform
Thumbscrew

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5. For Zeiss equivalent: Install Eye Safety Filter (ESF) to the slit lamp oculars per the images below
(as applicable).
6. Install micromanipulator handle and finger rest (as applicable). Tighten with thumbscrews.
ESF Lever
Slit Lamp
Mounting Platform
Setscrew for
Securing ESF
Thumbscrew
Dovetail Mount
Micromanipulator
handle
Finger rest

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7. Secure fiber-optic cable to the slit lamp using the supplied Velcro straps, while maintaining a minimum
loop diameter of 15cm in the fiber-optic cable.
8. Connect fiber-optic cable to the laser console.
9. Plug SSLA Control cable into TxCell Control Box. The connector will align in a specific orientation.
Push in and rotate clockwise until fully seated.
SSLA Control Cable
15cm
Fiber-optic Cable
Velcro Strap

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Verify Alignment of Aiming Beams
1. Turn the TxCell Control Box on using the service power switch on the back of the Control Box. The
service power switch can remain on.
2. Turn the laser console key to On. Wait about 40 seconds for the Pattern button to appear.
3. Select 500-micron spot size on SSLA.
4. Install the focus post of the slit lamp or a card from the forehead rest. Press the Pattern button and look
through the slit lamp to confirm that the aiming beams are aligned. For this purpose, visually inspect
that the projected circle is centered within the square. Both the circle and the square will appear to
flash. If the observed circle is outside of the square, please contact your local Iridex Technical Support
representative.
5. If aligned, press OK.
Verify the Focus
1. Adjust slit lamp oculars to appropriate diopter setting.
2. Turn on Iridex laser to see aiming beam.
3. In single-spot mode, use X and Y adjustments to center aiming beam in illumination slit.
4. In single-spot mode, use Z adjustment knob for fine focus.
5. Activate a pattern from the Pattern Selection Screen and ensure Target Grid is also in focus. (If Target
Grid is not in focus or appears to be only a partial Target Grid, please refer to Chapter 4,
“Troubleshooting.”)
Laser Console Treatment Aiming Beam
Grid Aiming Beam
Z Adjustment
Knob

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Set the Two-Position ESF
1. Move lever to closed position to view through the laser Eye Safety Filter and enable laser treatment.
2. Move to open position to obtain a clear view unimpeded by a laser Eye Safety Filter.
NOTE: As a safety precaution, the laser is unable to enter Treat mode while the Eye Safety Filter is open.
Treatment Screen
A
Button to access Pattern Selection Screen for multi-spot applications.
A
Closed
Open
Lever

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Pattern Selection Screen
A
Displays selected pattern.
B
Right control knob selects Radius in microns (Triple Arc, Circle only). The radius is the distance
from the origin to the inner edge of nearest treatment spot. There will be a different minimum and
maximum Radius range based on the selected treatment spot diameter; for example, a pattern
with a 100-micron spot will have a minimum Radius of 500 microns. Examples:
C
Right control knob selects Spacing between spots (Grid, Triple Arc, Circle only). The spacing is
the distance between the inner edges of a pair of spots. Spacing is displayed as increments of
spot size diameters, and is adjustable from 0.0 to 3.0 in 0.25 spot size increments; for example, a
pattern with a 100-micron spot with 1.00 spacing will have a 100-micron spacing between spots.
Examples:
D
Confirms pattern scanning selection and returns to Treatment Screen.
E
Middle control knob selects pattern type: Grid 2x2, Grid 3x3, Grid 4x4, Grid 5x5, Grid 6x6,
Grid 7x7, Triple Arc, Circle.
F
Displays total number of laser spots for selected pattern.
B
A
C
D
E
H
G
F

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G
Left control knob adjusts the Rotation of the pattern (Grid, Triple Arc only). Examples:
H
Left control knob increases or decreases the Arc angle of the pattern.
(min. 45° to max. 360°, in increments of 45°). Examples:
NOTE: Patterns that exceed a maximum retinal dimension or number of spots are not selectable. For example,
with a 7x7 Grid and a 500-micron spot size, spacings over 2.25 are not selectable.
Examples of Visualized Target Grid
Each pattern will produce a laser Target Grid that is visualized through the slit lamp. The projected Target
Grid will have a spot centered within one of the cells. This spot identifies the size of the associated
treatment beam and the cell in which the multi-spot pattern will initiate. This spot is continuously
illuminated in CW-mode, and it flashes to indicate when MicroPulse mode has been activated.
In CW-mode, the Target Grid is displayed before, and then after each treatment pattern is completed, i.e.
when the footswitch is pressed, the Target Grid will disappear, the treatment pattern will begin, and then
reappear when the pattern is completed.
In MicroPulse-mode, the Target Grid is continuously displayed during treatment.

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Aiming Beam Intensity Adjustment
A
Aiming Beam & Target Grid intensity during pattern scanning mode
B
Aiming Beam intensity during single-spot mode
Automated FiberCheck™
FiberCheck is an automated test to determine fiber integrity. If the fiber needs replacement, the following
prompt will appear: “Fiber Check: Fail. Call Service." Prompt does not prevent continued use of device.
A
B

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Treating Patients
BEFORE TREATING A PATIENT:
• Ensure that the eye safety filter is properly installed.
• 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 6, “Safety and Compliance,” and your delivery device manual(s) for important information about
laser safety eyewear and eye safety filters.
TO TREAT A PATIENT:
1. Turn the TxCell Control Box on using the service power switch on the back of the Control Box.
2. Turn on the laser.
3. Reset the counter.
4. Position the patient.
5. Select a laser contact lens appropriate for the treatment. Use caution when operating with a multiple
mirror laser contact lens in multi-spot mode. Do not overfill the mirror with the pattern and ensure that
you have visualization of the complete pattern and the area to be treated prior to laser treatment.
6. Ensure that all ancillary personnel in the treatment room are wearing the appropriate laser safety
eyewear.
7. Select Treat mode.
8. Ensure use of lowest aiming beam intensity possible.
9. Position the aiming beam or Target Grid on the treatment site.
10. Confirm focus and adjust the delivery device as applicable.
11. To titrate laser power, perform single-spot test exposure prior to initiating treatment. If uncertain of
expected clinical response, always start with conservative settings and increase laser power and/or
duration setting in small steps.
a. Please ensure repeat mode is off when titrating.
12. Select final laser treatment parameters, including multi-spot pattern or repeat mode if desired.
a. Please note that repeat mode is available only with single-spot mode. There is a 10 ms minimum
time interval with single-spot repeat mode.
b. Please note that multi-spot pattern mode is available with 100 µm and larger spot sizes. There is a 2
ms minimum time interval between successive spots with multi-spot pattern mode.
13. Press the footswitch to initiate treatment delivery. Release the footswitch at any time to immediately
terminate treatment laser emission, including any incomplete patterns.
a. Please note that one actuation of the footswitch will deliver one multi-spot pattern when held for
the duration of the pattern.
TO CONCLUDE PATIENT TREATMENT:
1. Select Standby mode.
2. Record the number of exposures and any other treatment parameters.
3. Turn off the laser system and remove the key. The TxCell Control Box service power switch can remain
on.
4. Collect the safety eyewear.
5. Remove the warning sign from the treatment room door, if appropriate.
6. Disconnect the delivery device(s).
7. If a contact lens was used, handle the lens according to the manufacturer’s instructions.

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3
Patient Treatment and Clinical
Information
This chapter provides information on the use of the TxCell®Scanning Laser Delivery System for the
treatment of ocular pathologies, including specific indications and contraindications, procedural
recommendations, and a list of clinical references. The information in this chapter is not intended to be all-
inclusive, nor is it intended to replace surgeon training or experience.
Intended Use/Indications for Use
When the TxCell Scanning Laser Delivery System is connected to the IQ 532®(532 nm) or the IQ 577®(577
nm) Laser Console, from the Iridex Family of IQ Laser Systems and used to deliver laser energy in CW-
Pulse, MicroPulse®or LongPulse mode, it is intended to be used by a trained ophthalmologist for
the treatment of ocular pathology of both the anterior and posterior segments of the eye.
532 nm
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:
Retinal photocoagulation (RPC) for the treatment of:
Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
Retinal tears and detachments
Lattice degeneration
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
Sub-retinal (choroidal) neovascularization
Central and branch retinal vein occlusion
Laser trabeculoplasty for the treatment of:
Primary open angle glaucoma
Laser iridotomy, iridoplasty for the treatment of:
Angle closure glaucoma

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577 nm
Indicated for use in photocoagulation of both anterior and posterior segments including:
Retinal photocoagulation, panretinal photocoagulation of vascular and structural abnormalities of the
retina and choroid including:
Proliferative and nonproliferative diabetic retinopathy
Choroidal neovascularization
Branch retinal vein occlusion
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
Retinal tears and detachments
Laser trabeculoplasty for the treatment of:
Primary open angle glaucoma
Laser iridotomy, iridoplasty for the treatment of:
Angle closure glaucoma
Contraindications
• Any situation where the target tissue cannot be adequately visualized or stabilized.
• Do not treat albino patients that have no pigmentation.
Potential Side Effects or Complications
• 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.
Specific Warnings and Precautions
It is essential that the surgeon and attending staff be trained in all aspects of the use of this equipment.
Surgeons should obtain detailed instructions for proper use of this laser system before using it to perform
any surgical procedures.
For additional Warnings and Cautions, refer to Chapter 1, “Introduction.” For more clinical information,
see “Clinical References” at the end of this chapter.
Proper eye protection must be utilized for the specific treatment laser wavelength in use (532 nm or
577 nm).
Multi-spot mode is intended for retinal photocoagulation only.
For patients with wide variations in retinal pigmentation as evaluated by ophthalmoscopic observation,
select multi-spot patterns which cover a homogenously pigmented smaller area to avoid unpredictable
tissue damage.
Exercise caution while setting multi-spot parameters (pulse duration and the number of spots per pattern)
when CW laser burns are to be delivered in the macula; with longer grid completion times, the possibility
of patient movement increases the risk of treatment of unintended targets.