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Summary of Contents for Iridex TxCell SSLA
- Page 1 ® TxCell Scanning Laser Delivery System Operator Manual...
- Page 2 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...
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Page 3: Table Of Contents
Contents INTRODUCTION ..............................1 ..............................1 RODUCT ESCRIPTION IRIDEX C ......................... 1 ORPORATION ONTACT NFORMATION ............................. 2 ARNINGS AND AUTIONS OPERATION ..............................4 .............................. 4 BOUT THE OMPONENTS ............................5 ONTROL SSLA ..............................6 NSTALL ..............................10 REATMENT CREEN ............................11... - Page 4 70375-EN Rev B...
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Page 5: Introduction
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. -
Page 6: Warnings And Cautions
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. - Page 7 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.
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Page 8: Operation
Slit Lamp Compatibility Model Spot Size (µm) Slit Lamp Styles Console Compatibility Iridex SL 980, Iridex SL 990, Single-spot: 50 - 500 ® ® TxCell SSLA IQ 532 / IQ 577... -
Page 9: Set Up Txcell Control Box
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. -
Page 10: Install Txcell Ssla
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. - Page 11 5. For Zeiss equivalent: Install Eye Safety Filter (ESF) to the slit lamp oculars per the images below (as applicable). Thumbscrew Slit Lamp Mounting Platform Setscrew for Securing ESF Dovetail Mount ESF Lever 6. Install micromanipulator handle and finger rest (as applicable). Tighten with thumbscrews. Micromanipulator Finger rest handle...
- Page 12 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. 15cm Velcro Strap 8. Connect fiber-optic cable to the laser console. Fiber-optic Cable 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.
- Page 13 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.
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Page 14: Treatment Screen
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. Open Closed Lever... -
Page 15: Pattern Selection Screen
Pattern Selection Screen Displays selected pattern. 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;... - Page 16 Left control knob adjusts the Rotation of the pattern (Grid, Triple Arc only). Examples: 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.
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Page 17: Aiming Beam Intensity Adjustment
Aiming Beam Intensity Adjustment Aiming Beam & Target Grid intensity during pattern scanning mode 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. 70375-EN Rev B... -
Page 18: Treating Patients
Treating Patients EFORE 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,”... -
Page 19: Patient Treatment And Clinical Information
(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 i s intended to be used by a trained ophthalmologist for the treatment of ocular pathology of both the anterior and posterior segments of the eye. -
Page 20: Contraindications
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:... -
Page 21: Procedural Recommendations
Procedural Recommendations MPORTANT ELEMENTS OF EVERY LASER PHOTOCOAGULATION PROCEDURE Ophthalmic laser photocoagulation has a decades-long history of successfully providing durable clinical outcomes that are both meaningful and beneficial to the patient. It is important, however, to consider the various hardware controls and adjustments, their interactions with one another, and each patient’s needs to achieve the best possible clinical results. - Page 22 • MicroPulse Duty Cycle Typical MicroPulse treatment settings deliver 500 MicroPulse applications per second. 500 Hz defines a 2-millisecond (ms) period, which is the sum of Laser ON time + Laser OFF time. MicroPulse duty cycle examples: 5% duty cycle = 0.1 ms ON + 1.9 ms OFF time 10% duty cycle = 0.2 ms ON + 1.8 ms OFF time 15% duty cycle = 0.3 ms ON + 1.7 ms OFF time In contrast, a Continuous Wave (CW) exposure, which is always ON, can be thought of as having a...
- Page 23 YPICAL ASER REATMENT ARAMETERS FOR CULAR HOTOCOAGULATION (Please note that multi-spot pattern mode is available with 100 µm and larger spot sizes.) 577 nm Continuous Wave Treatment Treatment Spot Size at Target (µm) Power (mW) Exposure Duration (ms) Retinal Photocoagulation 50 - 1000 50 - 2000 10 - 1000...
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Page 24: Clinical References
Clinical References 1. [No authors listed.] Photocoagulation Treatment of Proliferative Diabetic Retinopathy: The Second Report of Diabetic Retinopathy Study Findings. Ophthalmology 1978;85(1):82-106. 2. Early Treatment of Diabetic Retinopathy Study Research Group. Photocoagulation for Diabetic Macular Edema. Early Treatment Diabetic Retinopathy Study Report Number 1. Arch Ophthalmol 1985;103(12):1796-806. -
Page 25: Troubleshooting
Verify that the fiber-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 •... -
Page 26: Txcell Scanning Laser Delivery System Errors
TxCell Scanning Laser Delivery System Errors Please record the Error Code and contact your local Iridex Technical Support representative. Display Error Type Description E09001 Call Service Scanner software checksum error. Scanner checksum error E09002 Call Service The IQ laser is incompatible with the scanner. - Page 27 Display Error Type Description E09022 No Error Displayed Laser console version too old to support the scanner. on Screen Three (3) audible beeps generated by the scanner indicate Laser console version too old the error. No Error Displayed Laser console is not found (i.e., not attached to the E09023 on Screen scanner).
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Page 28: Maintenance
Maintenance O PROVIDE ROUTINE CARE • Do not kink or bend the fiber-optic cable. • When connected to the laser, the fiber-optic cable must be located away from high traffic areas. • Keep the optical components free of fingerprints. • Keep the SSLA attached to the slit lamp, unless you need to transport it or attach a different delivery device. - Page 29 O CHECK AND CHANGE SLIT LAMP FUSES 70375-EN Rev B...
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Page 30: Safety And Compliance
Eye safety filters protect the physician from backscattered treatment laser light. Integral eye safety filters are permanently installed in the Slit Lamp Adapter, LIO, EasyFit Adapter, Iridex Integrated Slit Lamp Workstation, SL130 Integrated Slit Lamp Workstation, and TxCell Scanning Slit Lamp Adapter. 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. -
Page 31: Labels
Labels NOTE: The actual label may vary with laser model. Serial Number and CE Label Wavelength Label ESF Wavelength Label Haag-Streit ESF laser wavelength label 70375-EN Rev B... - Page 32 Laser Aperture, Laser Emission Labels Laser Aperture, Laser Emission Labels Control Box Back Label 70375-EN Rev B...
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Page 33: Symbols (As Applicable)
Read Information Radiation Remote Control Remote Interlock Serial Number Single Use Standby Treat WEE Guidance. Contact Type B Equipment Iridex or your distributor Pattern is Activated for disposal information. Protections Against Temperature Protections Against IPX4 Splash Water Coming IPX8 Limitations... -
Page 34: Txcell Ssla Specifications
Weight Control Box: 3.0 kg (6.6 lb.) Compatible lasers IQ 532 & IQ 577 ® ® Iridex SL 980, Iridex SL 990, Zeiss 30 SL, Zeiss SL 130 Compatible slit lamp styles Haag-Streit BM/BQ 900 and equivalents 70375-EN Rev B... -
Page 35: Emc Safety Information
Connect the laser console into an outlet on a circuit different from that to which the receiver is connected. • Consult Iridex Customer Service for help. This Class B digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations. - Page 36 EMC Requirements for Console and Accessories Guidance and Manufacturer’s Declaration - Electromagnetic Emissions This laser system (console and accessories) is intended for use in the electromagnetic environment specified below. The customer or the user of the laser system should assure that it is used in such an environment. Emissions Test Compliance RF emissions...
- Page 37 (50/60 Hz) magnetic 3 A/m 3 A/m Power frequency field magnetic fields should be IEC 61000-4-8 at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: U is the AC mains voltage prior to application of the test level. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The wireless footswitch is intended for use in the electromagnetic environment specified below.
- Page 38 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Wireless Footswitch The wireless footswitch is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the wireless footswitch can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the wireless footswitch as recommended below, according to the maximum output power of the communications equipment.
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