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Table of Contents
Related Manuals for Iridex OcuLight GL
Summary of Contents for Iridex OcuLight GL
- Page 1 ® OcuLight GL/GLx/TX Operator Manual...
- Page 2 33003-EN Rev B 2013-05 © 2013 by IRIDEX Corporation. All rights reserved. IRIDEX, the IRIDEX logo, IRIS Medical, 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 ..........6 IRIDEX Corporation Contact Information ....... . . 7 2 Setup . - Page 4 Contents 33003-EN Rev B...
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Page 5: Introduction
Individual treatment should be based on clinical training, clinical observation of laser tissue interaction, and appropriate clinical endpoints. The IRIDEX laser and the handpieces, delivery devices, and accessories that are used with it to deliver laser energy in CW-Pulse™ or ®... -
Page 6: References
Otolaryngology. Poe DS. Laser-assisted endoscopic stapedectomy: a prospective study. Laryngoscope 2000 May: 110(5 Pt 2 Suppl 95):1-37. OcuLight GL/GLx The OcuLight GL/GLx is indicated for retinal photocoagulation and laser trabeculoplasty. The following are examples of applications for the OcuLight GL/GLx laser systems. Condition... -
Page 7: Oculight Tx
Ophthalmology. The OcuLight TX is intended to photocoagulate ocular tissue in ophthalmic procedures. Indications for use include: Retinal Photocoagulation, Laser Trabeculoplasty, Iridotomy, Iridoplasty. Compatible Delivery Devices Compatible Delivery Devices OcuLight GL Oculight GLx OcuLight TX Laser Indirect Ophthalmoscope (LIO) ® EndoProbe OtoProbe™... -
Page 8: Potential Side Effects Or Complications
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: •... -
Page 9: Specific Contraindications
• 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. Specific Contraindications •... -
Page 10: Warnings And Cautions
Do not operate the equipment in the presence of flammables or explosives, such as volatile anesthetics, alcohol, and surgical preparation solutions. Laser plume may contain viable tissue particulates. Keep the protective cap over the fiber-optic connector when the delivery device is not in use. ® 6 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B... -
Page 11: 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 12: 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. Remote Control (optional accessory) Laser Wireless Footswitch... -
Page 13: Choosing A Location
Choosing a Location Choose a well-ventilated location within the specified operating range of the console. Place the laser system on a table or on existing operating room equipment. Allow at least 5 cm (2 in.) of clearance on each side. In the US, this equipment must be connected to an electrical supply source at 100-240 VAC with a center tap. - Page 14 OcuLight GL/GLx/TX Rear Panel Connectors Remote Auxiliary Remote Control Output Interlock Footswitch AC Power Inlet ® 10 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B...
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Page 15: Operation
Operation Front Panel Controls Counter Reset Laser Status Treat/Standby button display button 2000 Status message here EndoProbe Aiming Beam SmartKey Volume LIO control Keyswitch Mode control control button Emergency Off Interval Power Fiber Duration control button control connector control Powering the Laser On and Off •... -
Page 16: Setting Treatment Parameters
Verify that all persons in the treatment room are wearing the appropriate laser safety eyewear before placing the laser in Treat mode. Never substitute prescription eyewear for laser safety eyewear. ® 12 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B... -
Page 17: Selecting User Preferences
Selecting User Preferences NOTE: Menu selections are automatically saved when selecting a new menu item or when exiting User Preferences mode. O VIEW OR CHANGE USER PREFERENCE SETTINGS Place the laser in Standby mode. Press and hold M until the laser status display flashes “User Preferences.” The Interval display reads “... -
Page 18: Treating Patients
If a contact lens was used, handle the lens according to the manufacturer’s instructions. 10. Keep the protective cap over the fiber-optic connector when the delivery device is not in use. ® 14 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B... -
Page 19: 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 20 Adjust the laser beam in the illumination field. • 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. ® 16 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B...
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Page 21: Status Panel Messages
Press the button. A description of the fault displays briefly on the 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 22: 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 23: Verifying The Power Calibration
Verifying the Power Calibration To ensure that calibration meets the requirements of the National Institute of Standards and Technology (NIST), the laser treatment power is calibrated at the IRIDEX factory with a power meter and an IRIDEX delivery device with previously measured transmission. - Page 24 IRIDEX delivery device. 14. If the readings are still outside the acceptable levels, contact your local IRIDEX Technical Support Representative. 15. Place a signed copy of the table in your device records to refer to during use and service.
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Page 25: Safety And Compliance
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. - Page 26 Numerical Φ Power Aperture NOHD Delivery Device (W/m (NA) EndoProbe 0.100 2.000 Oto/ENT Probes 0.100 2.500 Laser Indirect Ophthalmoscope (LIO) 0.013 2.000 33.0 Slit Lamp Adapter (SLA) 0.012 1.800 33.9 ® 22 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B...
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Page 27: Safety Compliance
CE-labeled devices comply with all requirements of the European Medical Device Directive MDD 93/ 42/EEC. The IRIDEX GL, GLx, and TX use solid-state electronic switching power supply that meets strict EN60601-1 and UL 60601-1 performance and safety standards. A dedicated microprocessor continuously monitors the safe function of all subsystems within the laser console. -
Page 28: Labels
Labels NOTE: The actual label may vary with laser model. Serial Number (rear panel) Ground (bottom of laser) Footswitch Wireless Receiver Remote Control ® 24 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B... - Page 29 Laser Warning Safety and Compliance 33003-EN Rev B...
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Page 30: 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. ® 26 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B... - Page 31 Protections Against Protections Against Temperature IPX4 IPX8 Splash Water Coming 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 32: Specifications
Specifications NOTE: Unless otherwise noted, laser console specifications are identical for the OcuLight GL, GLx, and TX. Specification Description Treatment Wavelength 532 nm Treatment power Varies by type of delivery device. The laser system displays the power delivered to the tissue. -
Page 33: 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 Footswitch was designed with a battery life expectancy of 3 – 5 years of normal operation and use. -
Page 34: 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 35: Emc Requirements For Console And Accessories
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 36 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. ® 32 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B...
- Page 37 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 38 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. ® 34 IRIDEX OcuLight GL/GLx/TX Operator Manual 33003-EN Rev B...