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Summary of Contents for Iridex G-Probe
- Page 1 G-Probe Device ® Operator Manual...
- Page 2 © 2019 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...
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Page 3: Table Of Contents
Indications for Use ......................1 Contraindications ......................1 Clinical Warnings ......................1 Precautions ........................2 Recommended Procedure ....................2 Warnings and Cautions ....................3 IRIDEX Corporation Contact Information ..............4 Operation ..................... 6 About the Components ....................6 Connecting the G-Probe ....................6 Treating Patients ......................7 Troubleshooting ................... 8 General Problems ......................8... - Page 4 Contents 13105-EN Rev E...
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Page 5: Introduction
Introduction Indications for Use The G-Probe Device, used with an IRIDEX laser, is indicated for transscleral photocoagulation ® (TSCPC) of the ciliary processes and is typically used when: • The patient has failed prior filtration surgery and is expected to fail further filtration surgery. • The patient has a secondary glaucoma in which failure is a likely outcome of filtration surgery (e.g., neovascular, inflammatory, postpenetrating keratoplasty, postscleral buckling). • The patient has lost ambulatory level vision and is being treated with cyclophotocoagulation for comfort or to prevent further visual loss. -
Page 6: Precautions
1.0-1.2 mm posterior to the limbus and assures proper spacing between lesions. Each half of the G-Probe covers a 16º sector, with the fiber located in the center. Since the 600 µm fiber optic protrudes from the tip of the G-Probe by 0.75 mm, mating the curved surface of the G-Probe with the sclera ensures that the protruding fiber optic indents the sclera an equal distance at each treatment spot, and assures repeatable scleral indentation and reproducible scleral transmission. Keep the eye moist throughout the entire laser procedure, using ophthalmic saline or methylcellulose as needed. -
Page 7: Warnings And Cautions
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 8: Iridex Corporation Contact Information
Significant scleral burns are not typical and may indicate contamination at the G-Probe tip. Replace immediately. Do not continue to use; a full thickness or near full thickness burn or sclerostomy may result. - Page 9 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. 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.
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Page 10: Operation
Operation About the Components The G-Probe is a single-use, fiber-optic delivery device that consists of a hemispheric probe tip, a handle, and a fiber-optic cable. It delivers laser energy through its fiber-optic tip. The probe tip allows precise placement around the circumference of the limbus. -
Page 11: Treating Patients
Treating Patients efore treating a Patient • 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. NOTE: Refer to Chapter 5, “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. -
Page 12: 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 • Verify that the remote interlock has not been activated. -
Page 13: Maintenance
Maintenance The G-Probe is a single-use, disposable delivery device. The device is intended for use on one patient during a single procedure. It is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient. No reuse processes have been validated by the manufacturer. The reuse of a single-use medical device can compromise the safety and health of patients, users or third parties. -
Page 14: 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. 10 G-Probe Device Operator Manual 13105-EN Rev E... -
Page 15: Safety Compliance
Safety Compliance Complies with FDA performance standards for laser products, except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007. CE-marked devices comply with all requirements of the European Medical Device Directive MDD 93/42/EEC. Feature Function Eye safety filter The eye safety filter ensures that all laser radiation returned to the physician and any co-observers is below Class I limits. Laser emission indicator Illumination of the green Treat light on the laser provides a visible warning that laser radiation may be emitted. -
Page 16: Symbols (As Applicable)
Pulse Count No-ionizing Pulse Count Reset Electromagnetic Read Information Radiation Remote Control Remote Interlock Serial Number Single Use Standby Treat Waste Electrical Type B Equipment and Electronic Pattern is Activated Equipment (WEEE) 12 G-Probe Device Operator Manual 13105-EN Rev E ®... -
Page 17: G-Probe Specifications
Laser Firing Laser Preparing Speaker Screen System Brightness Latex Free Prescription Warning, Replace with fuses as indicated G-Probe Specifications Specification Definition Probes Standard handle: 10.30 cm (4.05 in.) Laser compatibility OcuLight SL OcuLight SLx IQ 810 Treatment wavelength Laser diode, 810 nm Fiber diameter 600 µm...
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