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Summary of Contents for Iridex EndoProbe
- Page 1 ® EndoProbe OtoProbe Operator Manual IRIDEX 13103-EN ® Revision F...
- Page 2 Copyright December 2006 of IRIDEX Corporation. All rights reserved. IRIDEX Published in the USA. CORPORATION Except with the express written permission of IRIDEX, the contents of this 1212 Terra Bella Avenue operator manual may not be copied in whole or in part, or reproduced in, Mountain View, California or transmitted to any other media.
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Page 3: Table Of Contents
Service and technical support · 3 OPERATION · 5 · 5 BOUT THE OMPONENTS EndoProbe Starter Kit components for the OcuLight GL/GLx/TX · 5 EndoProbe Starter Kit components for the OcuLight SL/SLx · 5 Component descriptions · 5 EndoProbe · 5 Standard Probes ·... - Page 4 Install the appropriate IRIDEX eye safety filter · 13 Remove the binocular tube from the operating microscope · 13 If you are installing a two-position eye safety filter, configure your Ocu- Light GL/GLx console · 14 Install the eye safety filter · 15 Remount the binocular tube on the microscope ·...
- Page 5 Protection for the physician · 34 Protection for all persons in the treatment room — laser safety eyewear requirements · 34 Regulatory compliance safety features for IRIDEX lasers · 35 Eye safety filter · 35 Laser emission indicator · 35 Safety interlocks ·...
- Page 6 EndoProbe and OtoProbe Operator Manual 13103F-EN...
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Page 7: Probe
Federal law restricts this device to sale by or on the The EndoProbe is offered in straight or angled styles and features a low order of a physician. cone angle to allow a comfortable working distance from the retina and a more reproducible endpoint. -
Page 8: Specifications
Measurement of the aphakic weighted irradiance of an illuminating EndoProbe may be made under sterile conditions by using the means provided for this purpose by the manufacturer of your EndoIlluminator light source together with the use of a means to temporarily grip the EndoProbe during measurement. -
Page 9: Warranty And Service
WARNING Service and technical support If these single-use devices IRIDEX has established an efficient process to support its installations are reused, performance, worldwide. Should you require assistance, please contact your local safety, and efficacy cannot IRIDEX Technical Support representative or our corporate headquarters. - Page 10 EndoProbe and ENT Probe Operator Manual 13103F-EN...
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Page 11: Operation
Along with this manual, you should have the EndoProbe style(s) you 800-388-4747 (U.S. only) ordered, an IRIDEX fixed or two-position eye safety filter labeled for use at 650-962-8100 (Int’l) ® the 532 nm wavelength, four pairs of safety glasses, and a SmartKey , (if applicable). - Page 12 Standard The tapered EndoProbe makes it easier to insert and extract at the sclerostomy site. EndoProbe and ENT Probe Operator Manual 13103F-EN...
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Page 13: Illuminating
Illuminating An illuminating EndoProbe permits simultaneous white light illumination and laser photocoagulation from the same needle. The illumination connector allows you to use the EndoProbe with a variety of ophthalmic ® ® light sources, such as Bausch & Lomb and Alcon . -
Page 14: Active Aspirating
Active Aspirating The active aspirating EndoProbe (available in straight and angled models) allows for aspiration (ventilation) of unwanted fluid from the eye. The aspiration is originated from the vitrectomy port on the vitrectomy system console and is regulated through depression of the vitrectomy system foot pedal. -
Page 15: Stepped 45° Probe
Stepped 45° Angled The stepped EndoProbe handpieces offer a smooth, gently tapered needle which permits the angled 45° tip to be inserted through straight cannulas for full coverage of the peripheral retina. Operation 13103F-EN... -
Page 16: Otoprobe
ENT Probes The short-angled OtoProbe offers better visibility when viewing the tissue around the needle tip. The long-angled OtoProbe offers a longer, straight needle for easier tissue applanation. EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 17: Iridex Eye Safety Filter Styles And Accessories
IRIDEX eye safety filter styles and accessories The IRIDEX eye safety filters have optics which protect your eyes from backscattered laser reflections during laser surgery while using the probe WARNING with an operating microscope. When using an Two eye safety filter styles for the 532 nm wavelength are available for the... - Page 18 (such as binoculars, a beamsplitter, etc.) other 532 nm lasers. Two-position eye safety filter Lever Extension handle Integral SmartKey For IRIS Medical 532 nm consoles only) EndoProbe and ENT Probe Operator Manual 13103F-EN...
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Page 19: Connecting The Components
OcuLight GL/GLx/TX or OcuLight OR console, install the 532 nm eye available for the Leica safety filter into your microscope. For simultaneous protection from 810 M84X surgical nm and 532 nm laser light, install both IRIDEX eye safety filters into your microscope. Please microscope. contact your local IRIDEX... -
Page 20: Light Gl/Glx Console
1. Refer to “Setting Up for an Endo Procedure” in the OcuLight OR Operator Manual. OcuLight TX 1. Simply connect the SmartKey to the laser.. No changes to laser preference setting required. The OcuLight TX is designed to recognize a twp-position filter. EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 21: Install The Eye Safety Filter
Install the eye safety filter WARNING If you are using a beam Install the eye safety filter on the microscope and tighten the thumbscrew splitter on your operating to secure. microscope, you must install the fixed eye safety filter before installing the beam splitter. -
Page 22: If Using A Two-Position Eye Safety Filter, Insert The Smartkey
If using a two-position eye safety filter, insert the SmartKey Insert the SmartKey into the SmartKey port on the OcuLight GL/GLx/TX or OR console. Counter Reset Laser Aperture n = Ø At End Of Fiber Optic mination SmartKey EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 23: Insert The Smartkey Emulation Plug
If using an OcuLight GL/GLx or OcuLight OR console and a fixed eye safety filter, insert the SmartKey emulation plug Insert the SmartKey emulation plug into the laser console SmartKey port. Ø At End Of Fiber Optic y Output SmartKey Operation 13103F-EN... -
Page 24: Connect The Fiber-Optic
Fiber-optic port Counter Reset Laser Aperture n = Ø At End Of Fiber Optic Fiber-optic connector Protective tput SmartKey (OcuLight GLx console shown) Protective cap EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 25: To Iridex Lasers
If the probe is properly connected, when you turn on the console, EndoProbe displays on the console status panel. Counter Reset Laser Aperture n = Ø... -
Page 26: If Applicable, Connect The Endoprobe To An Illumination Source
If applicable, connect the EndoProbe to an illumination source If using the illuminating EndoProbe, insert the illumination fiber connector into the appropriate light source port. An illumination source adapter accessory is available for use with certain light sources, such as Grieshaber ®... -
Page 27: Controlling The Size Of The Laser Spot
Controlling the Size of the Laser Spot Laser spot size is controlled by positioning the probe tip near the tissue to WARNING be treated. The probe has a spot size of 200 µm 3 mm from the probe tip. The relationship between To change the spot size, move the probe farther from or closer to the spot size and resultant target. -
Page 28: Controlling The Aspiration
During normal operation, cover the hole on the handle with your finger. To aspirate, lift your finger off of the hole. Finger port covered Finger port uncovered Active Regulate the aspiration by depressing the vitrectomy system foot pedal. EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 29: Using The Two-Position Eye Safety Filter
Before beginning treatment, close the filter using the lever on the two-position eye safety filter. EndoProbe displays on the OcuLight GL/GLx console status panel when the filter is closed; ENT Probe displays on the OcuLight OR. -
Page 30: Before Treating Patients
REFERENCE See the Using the Control Panel section of your console manual for instructions on using the treatment controls and displays. WARNING Do not use a probe whose pouch arrived opened or damaged. EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 31: Treating A Patient
Treating a Patient 1. Set the treatment parameters. REFERENCE See Using the Two- 2. Position the patient. Position Eye Safety Filter 3. If used, close the two-position eye safety filter. in this manual for 4. Ensure that all ancillary personnel in the treatment room are wearing instructions on closing the the appropriate laser safety eyewear. -
Page 32: Concluding Patient Treatment
7. Disconnect the eye safety filter from the operating microscope and store it. 8. If desired, clean and store the console. 9. If desired, remove the laser warning sign from the treatment room door. EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 33: Troubleshooting
Should you experience problems with your probe when using it with an problems with your probe IRIDEX laser, refer to the suggestions in this section. If you continue to when using it with a non- experience problems, write down the error message, product name, serial... - Page 34 • Close the eye safety filter to Green Safety Filter? permit laser delivery. 532nm Safety Filter? • Close the eye safety filter to permit laser delivery. Two-Position Safety Filter? • Close the eye safety filter to permit laser delivery. EndoProbe and ENT Probe Operator Manual 13103F-EN...
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Page 35: Maintenance
Maintenance Disposing of the Probe The probe is a single-use, disposable delivery device. When finished with a CAUTION procedure, dispose of the probe; do not reuse or resterilize it. Follow standard facility procedures for the handling of biohazardous material after each probe use. -
Page 36: Inspecting And Cleaning
3. Wipe the lens gently with the swab to remove all dust and debris. 4. If the surface is still not clean, put a clean lens tissue around the end of the swab and gently wipe it again. EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 37: Clinical & Safety
The EndoProbe is indicated for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye. The EndoProbe is cleared for use for the particular indications of the laser system to which it is attached. -
Page 38: Precautions
Shorter pulse durations require higher power densities to create a burn; however, very short pulse durations can be potentially dangerous. Longer pulse durations may be safer to use with the probe. EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 39: Safety
Safety Preventing unintended exposure of laser energy CAUTION Use of controls or To prevent exposure to laser energy, except as a therapeutic application, adjustments or performing from either direct or diffusely reflected laser beams, always review and of procedures other than observe the safety precautions outlined in this manual and the console those specified herein may operator manual before using the probe. -
Page 40: Ensuring Ocular Protection
NOHD for the console in use. REFERENCE For further information, you may refer to: IEC 60825-1 and ANSI Z136.1. EndoProbe and ENT Probe Operator Manual 13103F-EN... -
Page 41: Regulatory Compliance Safety Features For Iridex Lasers
Regulatory compliance safety features for IRIS Medical lasers REFERENCE Refer to your laser The laser probes, and IRIDEX eye safety filters comply with 21 CFR operator manual for subchapter J as administered by the Center for Devices and Radiological regulatory compliance Health of the Food and Drug Administration (FDA). -
Page 42: Sterile Pouch Label
Sample of an EndoProbe sterile pouch label Sterile pouch label WARNING Do not use if package is damaged. EndoProbe and ENT Probe Operator Manual 13103F-EN... - Page 43 Sample of an ENT sterile pouch label Clinical & Safety 13103F-EN...
- Page 44 EndoProbe and ENT Probe Operator Manual 13103F-EN...
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