Operator Manual
63 Pages
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IRIS Medical® OcuLight® GLx Console Operator Manual
IRIDEX ®
30818B-EN
IRIDEX CORPORATION
Copyright July 2001 of IRIDEX Corporation. All rights reserved. Published in the USA.
1212 Terra Bella Avenue Mountain View, California 94043-1824, USA (800) 388-4747 (U.S. only) (650) 940-4700
Except with the express written permission of IRIDEX, the contents of this operator manual may not be copied in whole or in part, or reproduced in or transmitted to any other media. Copies IRIDEX does permit, including those translated into another language, must carry the same proprietary and copyright notices as were published with the original manual.
FAX: (650) 962-0486 Technical Support: (650) 962-8100 www.iridex.com
This manual is provided for instructional use and while every effort has been made to ensure that the information is accurate, the text, illustrations, and specifications in this manual are subject to change without notice. The IRIDEX logo, IRIS Medical, OcuLight, EndoProbe, and SmartKey are registered trademarks of IRIDEX Corporation. TrueCW, TruFocus, and EasyFit are trademarks of IRIDEX Corporation. ENZOL and CIDEX are registered trademarks of Advanced Sterilization Products, a division of Johnson & Johnson Medical, Inc.
Contents INTRODUCTION • 1 ABOUT IRIDEX · 1 ABOUT THE OCULIGHT GLX · 2 CONSOLE SPECIFICATIONS · 3 Treatment wavelength · 3 Treatment power · 3 Duration · 3 Interval · 3 Aiming beam · 3 Electrical · 3 Cooling · 3 Temperature range · 3 Relative humidity · 4 Dimensions · 4 Weight · 4 Compatible delivery devices · 4
WARRANTY AND SERVICE · 5 Warranty · 5 Product registration · 5 Repair/service while under warranty · 5 Service and technical support · 5
OPERATION • 7 ABOUT THE COMPONENTS · 7 Console · 8 Power cord · 8 Key · 8 Footswitch · 8 Footswitch jumper cable (optional) · 8 Spare fuses · 8
CHOOSING THE LOCATION AND POSITION FOR THE OCULIGHT GLX · 9 Ensuring proper ventilation, temperature, and relative humidity Ensuring that the electrical requirements can be met · 9
· 9
North American installation · 9 Installation in other locations · 9
Positioning the OcuLight GLx · 9
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CONNECTING THE COMPONENTS · 10 Connect the main power cable · 10 Connect the footswitch · 11 If desired, connect the GLx footswitch jumper cable · 12 If desired, connect a remote interlock switch · 13 If desired, connect an external warning device · 13 Connect the delivery device · 13
USING THE CONTROL PANEL · 14 TURNING ON AND OFF THE OCULIGHT GLX · 16 Turning on the OcuLight GLx · 16 Turning off the OcuLight GLx · 17 Turning off the OcuLight GLx in an emergency · 18 Turning on the OcuLight GLx after an emergency · 18
SELECTING THE TREATMENT SETTINGS · 19 Set the Power · 19 Set the Duration · 19 Set the Interval · 20 Selecting a single fixed treatment pulse · 20 Selecting multiple treatment pulses · 20
Resetting the Counter · 21
SELECTING THE LASER STATUS · 22 About the Standby mode · 22 About the Treat mode · 23
CUSTOMIZING YOUR OCULIGHT GLX · 24 Adjusting the intensity of the red aiming beam · 24 Adjusting the LIO+ illumination · 24 Adjusting the volume of the laser emission audible indicator · 25 Setting User Preferences · 26 Activating the User Preferences mode · 26 Changing the aiming laser settings · 27 Changing the status display language · 32 Activating the external warning device · 33 Displaying system messages · 34
BEFORE TREATING PATIENTS · 35 TREATING A PATIENT · 36 CONCLUDING PATIENT TREATMENT · 37
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OcuLight GLx Console Operator Manual 30818B-EN
TROUBLESHOOTING • 39 MAINTENANCE • 43 INSPECTING AND CLEANING · 43 Inspecting and cleaning the console · 43 Inspecting and cleaning the footswitch · 43
CHANGING THE AC LINE FUSES · 44 CALIBRATING THE POWER · 45 CLINICAL & SAFETY • 49 CLINICAL APPLICATIONS · 49 SAFETY · 50 Preventing unintended exposure of laser energy · 50 Preventing unauthorized use of the system · 50 Ensuring safe operation · 50 Preventing reflection hazards · 50 Preventing fire and explosion hazards · 50 Ensuring ocular protection · 51 Protection for the physician · 51 Protection for all persons in the treatment room - laser safety eyewear requirements · 51
Regulatory compliance safety features · 53 Emergency off · 53 Protective housing · 53 Safety interlock · 53 Remote interlock · 53 Key switch · 53 Laser emission indicator · 53 Beam attenuator · 54 Viewing optics · 54 Location of controls · 54 Manual restart · 54 Internal power monitor · 54 Footswitch · 54 Location of regulatory compliance and other system labels · 55
Contents 30818B-EN
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OcuLight GLx Console Operator Manual 30818B-EN
Introduction About IRIDEX
Founded in 1989, IRIDEX is the leading worldwide provider of solid-state laser systems. IRIDEX markets its products to the ophthalmology, aesthetic, and research markets. The ophthalmic solid-state laser systems, marketed under the brand name OcuLight, are used to treat a variety of ocular diseases, including the three leading causes of blindness: age-related macular degeneration, diabetic retinopathy and glaucoma. These innovative laser systems provide high value and lasting solutions for ophthalmic photocoagulation needs. Further, the advanced features and benefits of the IRIS Medical OcuLight lasers fulfill the changing needs of ophthalmologists, today and in the future. Unsurpassed in reliability, true portability, and efficient operation, the aesthetic family of lasers are used for hair removal and for treating pigmented and vascular skin lesions. IRIDEX also develops products for the research and scientific communities. Key patents protect highly advanced commercial products as IRIDEX continues to develop lasers that are powerful, reliable, and durable. IRIDEX is a fully integrated manufacturer, FDA-GMP, and ISO 9001/EN46001 compliant.
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About the OcuLight GLx CAUTION Federal law restricts this device to sale by or on the order of a physician.
WARNING Surgical lasers generate a highly concentrated beam of light which may cause injury if improperly used. Be sure to operate the OcuLight GLx in accordance with the procedures described in this manual. Failure to do so may harm yourself, your patient, or others.
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The OcuLight GLx is the most advanced, compact, laser photocoagulator system available. The laser source, power supply, and control panel are combined in a single unit making it portable and easy to stack on existing operating room equipment, a counter, or a cart. The OcuLight GLx console is compatible with a complete line of delivery devices allowing for a wide variety of ophthalmic applications. The OcuLight GLx uses diode-pumped, solid-state technology. It is equipped with a diode to optically pump a solid-state laser that is converted by a frequency doubling crystal to emit green light. Diodepumped, solid-state lasers are highly efficient and consume very little electrical power. Thus, the OcuLight GLx does not require special power outlets or water-pumped cooling. The OcuLight GLx uses a solid-state electronic switching power supply that meets strict EN60601-1 and UL 544 performance and safety standards. A dedicated microprocessor continuously monitors the safe function of all subsystems within the console.
OcuLight GLx Console Operator Manual 30818B-EN
Console Specifications Treatment wavelength Diode-pumped, frequency-doubled, solid-state laser, 532 nm (green) TrueCW™ (continuous wave) power on demand technology
Treatment power Varies by type of delivery device used. The OcuLight GLx automatically recognizes the delivery device attached, simultaneously calibrates, and displays the power delivered to the tissue.
Duration 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200, 250, 300, 350, 400, 450, 500, 600, 700, 800, 900 and 1000 ms One minute continuous duration is only available when using the EndoProbe® (maximum Power must be ≤ to 500 mW).
Interval None, 50, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 ms. You can select a repeat interval equal to or greater than the selected exposure duration (≤ 50% duty cycle). Up to 83% duty cycle is only available when using the SLA (maximum Power ≤ 500 mW and the Duration ≤ 500 ms).
Aiming beam Red laser diode User-adjustable intensity; 1 mW maximum; coaxial with treatment beam
Electrical 100-240 VAC, 50/60 Hz, 3.5 A
Cooling Air cooled No water cooling required
Temperature range 10º C to 35º C (50º F to 95º F)
Introduction 30818B-EN
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Relative humidity 20% to 75%
Dimensions 30 cm x 30 cm x 15 cm (12 in. W x 12 in. D x 6 in. H)
Weight 6.8 kg (15 lbs)
Compatible delivery devices Slit Lamp Adapter TruFocus™ LIO+ EndoProbe EasyFit™ Adapter IRIS Medical Integrated Slit Lamp Workstation SL130 Integrated Slit Lamp Workstation Dermatology Handpieces
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OcuLight GLx Console Operator Manual 30818B-EN
Warranty and Service Warranty The OcuLight GLx console carries a standard factory warranty. The warranty covers all parts and labor required to correct problems with materials or workmanship; however, should the OcuLight GLx console cover be removed by anyone other than trained and certified IRIDEX service personnel, the warranty will be void.
Product registration Please complete and forward to us the enclosed product registration card.
Repair/service while under warranty Should the OcuLight GLx require repair or service while under warranty, IRIDEX may provide a loaner unit upon request at no charge. For consoles shipped outside of the USA, please contact your local IRIDEX Technical Support representative for further information about the loaner policy in your area.
WARNING Only IRIS Medical delivery devices can be used with the OcuLight GLx console. Each delivery device has a proprietary connector that identifies its transmission characteristics. Substitution of a non-IRIS Medical delivery device may result in unreliable operation or inaccurate delivery of laser power. Any attempt to use fiber-optic devices manufactured by another company will void the warranty covering the OcuLight GLx console.
Service and technical support IRIDEX has established an efficient process to support its installations worldwide. Should you require assistance, please contact your local IRIDEX Technical Support representative or our corporate headquarters.
Introduction 30818B-EN
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OcuLight GLx Console Operator Manual 30818B-EN
Operation About the Components
After unpacking the contents of the OcuLight GLx package, ensure that you have all of the components ordered. Check the components carefully before use to ensure that no damage occurred during transit. Along with this manual, you should have the console, a power cord, keys, the footswitch and cable, spare fuses, the Laser in Use warning sign, and any other accessories that you may have ordered.
IRIS Medical OcuLight GLx POWER
DURATION
mW
INTERVAL
ms
NOTE Should you notice problems with your order please contact your local IRIDEX Customer Service representative immediately.
COUNTER
Σn
ms
Treat Standby
Laser Aperture At End Of Fiber Optic
Mode !
Counter Reset Σn = Ø
Off On
STOP
!
Aiming Beam
Volume
SmartKey
Auxiliary Output
Console
Spare fuses
Keys
Power cord Footswitch
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Console The console houses the main power key switch, the emergency off button, the laser source for the treatment and aiming beams, the power supply, the control electronics, and the control panel. The console is the central unit to which all of the other laser components attach.
Power cord The power cord connects the console to the power source.
Key The key fits into the main power switch and is used to turn the console on and off.
Footswitch The footswitch controls laser delivery by activating the treatment beam when pressed.
Footswitch jumper cable (optional) The footswitch jumper cable is an optional component if you have both an OcuLight GLx and an OcuLight SL or OcuLight SLx console. The cable allows you to operate either console with one footswitch.
Spare fuses AC line fuses protect the OcuLight GLx from overcurrent conditions.
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OcuLight GLx Console Operator Manual 30818B-EN
Choosing the Location and Position for the OcuLight GLx Ensuring proper ventilation, temperature, and relative humidity Choose a well-ventilated location such as an operating room or office with a temperature between 10° C (50° F) and 35° C (95° F) and a relative humidity between 20 and 75 percent.
Ensuring that the electrical requirements can be met North American installation The OcuLight GLx is equipped with a hospital grade (green dot) three-wire grounding plug. When choosing the location, ensure that a grounding-type AC port is available, as it is required for safe operation.
Installation in other locations The power cord included in the packaging is appropriate for your location. You may order replacement cords locally to match the IEC320 standard power inlet. Always use a three-wire grounding cord set. Do not alter the power inlet, as it contains protective fusing. Follow local electrical codes before installing the OcuLight GLx to ensure proper grounding.
Positioning the OcuLight GLx Place the OcuLight GLx on a table or existing operating room equipment. Do not block the OcuLight GLx side vents. Allow at least 5 cm (2 in.) of clearance on each side.
WARNING Do not defeat the purpose of the grounding pin. This equipment is intended to be electrically grounded. Contact a licensed electrician if your outlet prevents you from inserting the plug.
CAUTION Do not position or use the OcuLight GLx near open flames.
Operation 30818B-EN
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Connecting the Components Connect the main power cable
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Insert this end of the main power cable into the AC power inlet.
Plug this end of the main power cable into a properly grounded electrical outlet. (North American outlet shown)
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OcuLight GLx Console Operator Manual 30818B-EN
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When the OcuLight GLx console is connected to an SL130 Integrated Slit Lamp Workstation, the footswitch is connected to the IRIDEX Interface Box rather than directly to the OcuLight GLx console.
-22
REFERENCE Plug the footswitch into the footswitch port.
See the SL130 Integrated Slit Lamp Workstation Operator manual for footswitch connection instructions.
Operation 30818B-EN
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NOTE The OcuLight SL/SLx must be in the Standby mode for the OcuLight GL/GLx to be in the Treat mode.
If desired, connect the GLx footswitch jumper cable If you have an OcuLight GLx and either an OcuLight SL or OcuLight SLx and want to use one footswitch to control both lasers: 1. Either position both lasers side by side or stack them. 2. Plug the OcuLight GLx footswitch into the Footswitch In port. 3. Plug the five pin end of the GLx footswitch jumper cable into the OcuLight GLx Footswitch Out port. 4. Plug the four pin end of the GLx footswitch jumper cable into the OcuLight SL/SLx Footswitch port.
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OcuLight GLx Console Operator Manual 30818B-EN
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If desired, connect a remote interlock switch As a safety feature a remote interlock switch may be installed, for example a switch that disables the laser whenever a treatment room door opens while the console is in the Treat mode. If you will not be using a remote interlock, no modifications to the OcuLight GLx are necessary. If you will be using a remote interlock switch, remove the factory installed wire and in its place attach the two wires leading to your own switch. If the remote interlock switch is not properly connected, when you turn on the console, No Remote Interlock displays on the console status panel.
If desired, connect an external warning device As an additional safety measure you may connect an external warning device such as a warning light or small rotating beacon to the Auxiliary Output contact. If an external warning device is used, the system activates the device when you are in the Treat mode. You also have the option of programming the system to activate the warning device when you turn on the keyswitch or when you press the footswitch. Auxiliary Output contact Factory-installed remote interlock wire
4
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REFERENCE See the Setting User Preferences section of this manual for procedures on changing the Auxiliary Indicator contact options.
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The No Remote Interlock message also displays if you are using a remote interlock switch and the door is opened during treatment. In this scenario, the remote interlock switch disables the laser; once the door is closed the console goes into the Standby mode and the Power resets to zero, but all other treatment parameters remain at your previous settings.
The Auxiliary Output contact supports low voltage electrical signalling circuits of up to five amps and 24 volts AC or DC. Ensure all wiring conforms to local electrical codes.
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Connect the delivery device Before using the OcuLight GLx, connect your delivery device.
See the appropriate delivery device manual for connection instructions.
Operation 30818B-EN
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Using the Control Panel
Power Use to select the energy to be delivered to the tissue from the delivery device.
Laser Status Display Displays spot size, pulse duration, and status and error messages.
IRIS Medical OcuLight GLx POWER
Treat/Standby Use to select the desired laser status. Also use in the User Preferences mode to scroll through menu options.
mW
Treat Standby
Mode Use to display and clear Call Service messages. Also use to activate User Preferences settings.
Mode !
Key Switch Use to turn the system on and off.
Emergency Off Use to disable the console and all laser-related circuitry in an emergency.
Aiming Beam Use to adjust the intensity of the aiming beam.
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OcuLight GLx Console Operator Manual 30818B-EN
Off On
STOP
Aiming Beam