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Summary of Contents for Iridex OcuLight SL
- Page 1 ® OcuLight SL/SLx Operator Manual...
- Page 2 13099-EN Rev F 2013-05 © 2013 by IRIDEX Corporation. All rights reserved. IRIDEX, the IRIDEX logo, OcuLight, EndoProbe and SmartKey are registered trademarks; BriteLight, CW- Pulse, DioPexy, EasyFit, EasyView, FiberCheck, G-Probe, IQ 532, IQ 577, IQ 810, LongPulse, MicroPulse, MilliPulse, OtoProbe, PowerStep, Symphony, TruFocus, and TruView are trademarks of IRIDEX...
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Page 3: Table Of Contents
Warnings and Cautions ..........5 IRIDEX Corporation Contact Information ....... . . 6 2 Setup . - Page 4 Contents EMC Safety Information ..........28 EMC Requirements for Console and Accessories .
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Page 5: Introduction
IRIDEX does not make recommendations regarding the practice of medicine. References in literature are provided as a guide. Individual treatment should be based on clinical training, clinical observation of laser tissue interaction, and appropriate clinical endpoints. The OcuLight SL/SLx is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. -
Page 6: References
The Treatment of Macular Disease Using a Micropulsed and Continuous Wave 810-nm Diode Laser, Friberg TR, Karatza EC., Ophthalmology 104:2030-2038, 1997. Pulse Types Three pulse types are available: CW-Pulse™, MicroPulse™ (SLx only), and LongPulse™ (optional on SL). ® 2 IRIDEX OcuLight SL/SLx Operator Manual 13099-EN Rev F... - Page 7 CW-Pulse CW-Pulse allows you to select either a single, continuous-wave pulse or repetitive pulses. CW-Pulse is active after each key start. Interval Time (ms) Pulse Duration MicroPulse (SLx Only) MicroPulse (μP) delivers laser energy in a burst of very short pulses and separating intervals. You may adjust MicroPulse duration and MicroPulse interval or select from three preset duty cycle values.
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Page 8: Compatible Delivery Devices
NOTE: Refer to the appropriate delivery device manual for indications for use, contraindications, precautions, and adverse effects information. Contraindications • Any situation where the target tissue cannot be adequately visualized or stabilized. • Do not treat albino patients who have no pigmentation. ® 4 IRIDEX OcuLight SL/SLx Operator Manual 13099-EN Rev F... -
Page 9: Potential Side Effects Or Complications
Potential Side Effects or Complications • Specific to retinal photocoagulation: inadvertent foveal burns; choroidal neovascularization; paracentral scotomata; transient increased endema/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. -
Page 10: Iridex Corporation Contact Information
IRIDEX service personnel. WARNING: Use only IRIDEX delivery devices with the IRIDEX laser system. Use of a non-IRIDEX delivery device may result in unreliable operation or inaccurate delivery of laser power. This Warranty and Service agreement does not cover any damage or defect caused by the use of non-IRIDEX devices. -
Page 11: Setup
Setup Unpacking the System Make sure you have all components that were ordered. Check components for damage before use. NOTE: Contact your local IRIDEX Customer Service representative if there are problems with your order. Laser Keys Fuses Footswitch Remote Wireless Footswitch... -
Page 12: Choosing A Location
NOTE: Refer to the appropriate delivery device manual for specific connection instructions. NOTE: The Auxiliary Output contact supports low-voltage electrical signaling circuits of up to five amperes and 24 volts AC or DC. Ensure all wiring conforms to local electrical codes. OcuLight SL/SLx Rear Panel Connectors Remote Footswitch... -
Page 13: Operation
Operation Front Panel Controls Treat/Standby Laser Status Volume display button control (on rear panel) Counter Reset button MicroPulse 9000 Mode Keyswitch Power Aiming Beam LIO control Fiber SmartKey button control control connector Emergency Stop Duration Interval control control button Powering the Laser On and Off •... -
Page 14: Activating The Pulse Type
Counter Press the button to reset to zero. OUNTER ESET Aiming Beam Adjust the aiming beam intensity. Adjust the LIO illumination intensity. Volume Adjust the volume of audible indicators. ® 10 IRIDEX OcuLight SL/SLx Operator Manual 13099-EN Rev F... -
Page 15: Selecting The Laser Mode
Selecting the Laser Mode Press the T button to select the laser mode: REAT TANDBY • Yellow = Standby mode The footswitch and the treatment beam are disabled. • Green = Treat mode The footswitch is enabled. Press the footswitch to deliver the treatment beam. WARNINGS: Except during actual treatment, the laser must always be in Standby mode. -
Page 16: Selecting User Preferences (Sl)
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. ® 12 IRIDEX OcuLight SL/SLx Operator Manual 13099-EN Rev F... - Page 17 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. O TREAT A PATIENT Turn on the laser. Reset the counter. Set the treatment parameters. Position the patient. If required, select an appropriate contact lens for the treatment.
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Page 18: 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 19 Problem User Action(s) The treatment lesions are variable • The LIO may be slightly out of focus. This decreases power density. or intermittent (LIO only) 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.
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Page 20: Status Panel Messages
A description of the fault displays briefly on the Call Service status panel. The console restarts and performs a self-test. If the message displays again, contact your local IRIDEX Technical Support representative. Connect an appropriate delivery device. Connect Fiber •... -
Page 21: Maintenance
WARNING: Do not remove covers! Removing covers and shields may result in exposure to dangerous optical radiation levels and electrical voltages. Only IRIDEX-trained personnel may access the interior of the laser. The laser has no user serviceable parts. -
Page 22: Changing The Ac Line Fuses
O RESET THE CIRCUIT BREAKER Correct any power input conditions or allow the laser to cool down. Press the circuit-breaker reset button. If the button pops out after you have pressed it, contact your local IRIDEX Technical Support representative. Verifying the Power Calibration... - Page 23 IRIDEX delivery device. 16. If the readings are still outside the acceptable levels, contact your local IRIDEX Technical Support Representative. 17. Place a signed copy of the table in your device records to refer to during use and service.
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Page 24: Safety And Compliance
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. ® 20 IRIDEX OcuLight SL/SLx Operator Manual 13099-EN Rev F... - Page 25 The following formula was used to calculate the most conservative NOHD values: NOHD = (1.7/NA)(Φ/πMPE) where: NOHD = the distance, in meters, at which the beam irradiance equals the appropriate corneal MPE NA = the numerical aperture of the beam emerging from the optical fiber Φ...
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Page 26: Safety Compliance
CE-labeled devices comply with all requirements of the European Medical Device Directive MDD 93/ 42/EEC. The OcuLight SL and SLx use a solid-state electronic switching power supply that meets strict EN60601-1 performance and safety standards. A dedicated microprocessor continuously monitors the safe function of all subsystems within the laser console. -
Page 27: Labels
Labels NOTE: The actual label may vary with laser model. Serial Number (rear panel) Ground (bottom of laser) Footswitch Laser Warning 13099-EN Rev F Safety and Compliance... -
Page 28: Symbols (As Applicable)
Electromagnetic Read Information Radiation Remote Control Remote Interlock Serial Number Single Use Standby Treat WEEE Guidance. Contact IRIDEX or Type B Equipment Pattern is Activated your distributor for disposal information. ® 24 IRIDEX OcuLight SL/SLx Operator Manual 13099-EN Rev F... - Page 29 Protections Against Protections Against Temperature IPX4 Splash Water Coming IPX8 Continuous Limitations from all Directions Immersion Refer to Instruction Initial Power Interval between Manual/Booklet (in (PowerStep) Groups blue) Number of Pulses Number of Steps Power (MicroPulse) (Group) (PowerStep) Power Increment Power Increment Parameter is Locked (PowerStep)
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Page 30: Specifications
Specifications NOTE: Unless otherwise noted, laser console specifications are identical for the OcuLight SL and SLx. Specification Description Treatment wavelength 810 nm Treatment power Varies by type of delivery device. The laser system displays the power delivered to the tissue. -
Page 31: Wireless Footswitch And Emc
NOTE: The footswitch is designed to operate within 15 feet of the laser. Testing the Batteries NOTE: When batteries need to be replaced, contact your sales representative or IRIDEX Customer Service. The Wireless Power Adjust Footswitch was designed with a battery life expectancy of 3 – 5 years of normal operation and use. - Page 32 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 33 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 34 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. ® 30 IRIDEX OcuLight SL/SLx Operator Manual 13099-EN Rev F...
- Page 35 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The wireless footswitch is intended for use in the electromagnetic environment specified below. The customer or the user of the wireless footswitch should assure that it is used in such an environment. IEC 60601 Test Compliance Immunity Test Level...
- Page 36 NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. ® 32 IRIDEX OcuLight SL/SLx Operator Manual 13099-EN Rev F...
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