Operator Manual
110 Pages
Preview
Page 1
This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not be copied in whole or in part or reproduced in any other media without the express written permission of Lumenis, Inc. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original. Under the law, copying includes translation into another language. Please note that while every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. Lumenis, the Lumenis logo, and Novus are registered trademarks of Lumenis, Inc. Spectra, LaserLink, and Acculite are trademarks of Lumenis, Inc. Keeler is a registered trademark of Keeler Ltd.
Writer: Editor: Illustrator: Translator:
Loretta Orgill Sandra Abbott Steven C. Wyness, staff IDEM Translation Center, Inc. Palo Alto, California, USA
© Lumenis, Inc. December 2002 Published in USA 0642-543-01 Revision A
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C on ten t s General Operation
Overview... 7 Introduction: The Novus Spectra Laser... 9 Characteristics of the 532-nm green laser beam... 9
Laser Preparation... 10 Novus Spectra Components... 11 Laser console... 12 Remote control (optional)... 12 External door interlock plug... 12 Footswitch... 12 Delivery devices... 12
Connection Instructions... 13 Connecting the footswitch... 14 Using the external door interlock... 15 Plugging in the main power cable... 16 Connecting the remote control... 17 Connecting the delivery device(s)... 18 Connecting eye safety filters (LaserLink, slit lamp, and Acculite only)... 19
Laser Console Basics... 22 Turning on the laser... 22 Restarting the laser... 22 Turning off the laser... 23 Emergency off... 23 Disconnecting the laser... 24 Moving the laser console... 24 Laser beam integrity check... 25
Laser Console Display and Remote Control Basics... 26 Laser console display selectors, icons, and displays... 26 Novus Spectra 0642-543-01, Rev A, 12/02
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Contents
Remote control selectors, icons, and displays... 27 Laser status and laser emission: ready and standby modes... 28
Setting Treatment Parameters... 30 Selecting and verifying the delivery device... 30 Adjusting the aiming beam intensity... 30 Setting the power... 32 Setting the exposure time (pulse duration)... 32 Setting the treatment interval... 34 Resetting the pulse counter... 36
Preoperative Instructions... 37 Intraoperative Instructions... 38 Postoperative Instructions... 39
Maintenance
Overview... 41 Troubleshooting Guide... 43 User Maintenance... 47 Annual laser maintenance... 47 Laser repair... 47 Clean the external surfaces of the laser console... 47 Clean the laser control screen... 47 Water utilities... 47
Electrical Requirements... 48 Replacing the Fuses... 49 Specifications... 49 Calibration Procedure... 51 Calibration instructions... 52
Warranty Information... 53 Decontamination of Returned Equipment... 53
Safety and Regulatory
Overview... 54 Introduction... 56 Laser Safety Eyewear... 57 Additional Ocular Protection... 60 Additional Safety Considerations... 61 Protecting nontarget tissues... 61 Fire hazards... 62 Electrical hazards... 62
Regulatory Compliance... 64 Emergency off pushbutton... 64 Key lock switch... 64 Location of controls... 64 Protective housing... 64 External door interlock... 64 Novus Spectra 0642-543-01, Rev A, 12/02
Contents 5
Safety interlocks... 64 Manual reset... 65 Electronic fault detection circuitry... 65 Safety shutter... 65 Laser emission indicators... 65 Location of regulatory and system labels... 66
Indications for Use
Overview... 71 General Information... 73 Tissue effects... 73 General warnings and precautions... 76 Laser plume precautions... 76 Irradiance, fluence, and power... 77 Adverse effects... 77 Guidelines for use... 78 Noncontact and free-beam devices... 78 General references... 78
Ophthalmic Applications of the Laser... 79 Adverse effects and complications... 80 Precautions... 81 Guidelines for use... 81
Anterior Segment Laser Procedures... 84 Indications... 84 Uses... 84 Contraindications... 84 Warnings... 85 Precautions... 85 Adverse effects... 86 Guidelines for use... 86
Ophthalmology References... 88 Otologic Applications of the Laser... 89 Indications... 89 Uses... 89 Contraindications... 89 Warnings... 90 Precautions... 90 Guidelines for use... 90 Otology references... 90
Delivery Devices and Accessories... 93 Filters... 93 Acculite Endoprobe or fiber optic devices... 93 Fluence... 95 Laser indirect ophthalmoscope (LIO)... 96 Slit lamps and LaserLinks for slit lamps... 100
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Contents
Novus Spectra 0642-543-01, Rev A, 12/02
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General Operation Overview • • • • • • • • • •
Introduction: The Novus Spectra Laser 9 Laser Preparation 10 Novus Spectra Components 11 Connection Instructions 13 Laser Console Basics 22 Laser Console and Remote Control Basics 26 Setting Treatment Parameters 30 Preoperative Instructions 37 Intraoperative Instructions 38 Postoperative Instructions 39
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General Operation
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Introduction: The Novus Spectra Laser 9
Introduction: The Novus Spectra Laser The Novus® Spectra™ 532-nm green laser is the benchmark for ease, speed, and intricate treatment in ophthalmic surgery, integrating the reliability of 532-nm green light with the convenience of a small, portable laser package. The adaptability of the Novus Spectra is ideal for ophthalmic procedures such as angle-closure glaucoma, open-angle glaucoma, diabetic retinopathy, retinal detachments, and age-related macular degeneration. It also is ideal for otologic procedures such as stapedotomy, stapedectomy, tympanoplasty, myringotomy, bleeding control, lysis of adhesions, and treatment of soft tissue adhessions. Our complete line of delivery systems and accessories further extends the versatility of the Novus Spectra laser. Lumenis lasers and delivery systems are precision medical instruments. They have undergone extensive testing and with proper handling are useful and reliable clinical instruments. If you have questions regarding your laser or delivery system, contact your local Lumenis representative. WARNING - Lasers generate a highly concentrated beam of light that may cause injury if improperly used. To protect the patient and the operating personnel, the entire laser and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.
Characteristics of the 532-nm green laser beam The 532-nm wavelength falls in the green region of the electromagnetic spectrum. Laser light visible or invisible can cause tissue damage; therefore, eye safety precautions must be taken by the physician, patient, and any observers in the room. A low-power, visible aiming beam that is coaxial with the treatment beam is used to target tissue. Green light energy is readily absorbed by melanin, hemoglobin, and oxyhemoglobin in the eye, but avoids macular xanthophyll. These characteristics allow for effective laser photocoagulation of ocular tissue.
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General Operation
Laser Preparation The laser is shipped directly from the factory to your site. Your local Lumenis representative initially unpacks, inspects, sets up, and installs the laser to ensure that it is ready for use. In addition, Lumenis provides in-service training to ensure that your surgical staff is experienced with the operation and safety considerations of the laser. Thereafter, you, or the nursing staff at your facility, will perform the daily maintenance routines associated with the laser and delivery devices, including inspecting and cleaning the laser and delivery devices; sterilizing; connecting, and disconnecting the delivery devices; and performing a laser beam integrity check. These procedures are detailed in this manual and in the delivery device operator manuals.
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Novus Spectra Components 11
Novus Spectra Components The Novus Spectra laser system comprises: • • • •
a laser console with display an optional remote control a footswitch all electrical cables necessary for proper connection
Delivery devices, including integrated slit lamps and slit lamp tables, if ordered, may also be shipped with your laser system.
Display
Footswitch
Laser console 800
.05
mW
s
.05 s
0 n=0
Power Cord Remote control
Novus Spectra laser console and components
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General Operation
Laser console The laser console houses the control screen, main power keyswitch, emergency off button, control electronics, laser source and associated optics, and power supply. The laser console is the central unit to which the laser components and delivery devices attach.
Remote control (optional) The optional remote control provides all of the necessary controls for setting treatment parameters. It can be used in place of, or in addition to, the laser console controls.
External door interlock plug The external door interlock plug must be inserted into the external interlock receptacle on the rear of the laser console for the laser to operate. The plug comes pre-installed from the factory. The plug may be wired to an external switch to disable the laser if the treatment room doors are opened during treatment.
Footswitch The footswitch activates the laser treatment beam when you depress it while the laser is in ready mode. If you are using the Smart footswitch, the footswitch engages the automatic eye safety filter when you place your foot inside of the footswitch housing while the laser is in ready mode. If you are using the PowerEase footswitch, you can adjust the laser power by pressing the switches on the inside left (decrease power) and right (increase power) of the footswitch housing.
Delivery devices Delivery devices for a variety of applications may have been shipped with your Novus Spectra laser. Refer to the operator manuals included with those delivery devices for specific descriptions and operating instructions. Compatible delivery devices include Acculite endoprobes, fibers, laser integrated ophthalmoscopes (LIO), LaserLink Z and HS and integrated slit lamps.
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Connection Instructions 13
Connection Instructions CAUTION - Do not touch any optical lens; finger oils may damage the delicate coatings.
Before connecting the laser components, inspect the individual components, cables, and electrical connections for dirt, debris, or damage. Ensure that the electrical cables are not frayed or split. Inspect all delivery devices, as instructed in the appropriate delivery device operator manual. Contact you local Lumenis representative if any component appears damaged.
Footswitch
External door interlock (Pre-installed from factory) 800
.05
mW
s
.05
0
s
Remote control n=0
To electrical outlet
Novus Spectra Connections
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General Operation
Connecting the footswitch Insert the footswitch plug into the (footswitch) receptacle on the rear of the laser console. If the footswitch is not properly connected when the laser is turned on, “E200” displays on the laser console until the footswitch is properly connected.
Connecting the footswitch
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Connection Instructions 15
Using the external door interlock The external door interlock is a safety feature that disables the laser if the treatment room doors are opened or the interlock plug is removed. Use of an external door interlock is optional; however, an interlock plug must be inserted into the external door interlock receptacle whether or not you are using an external door interlock. The laser will be inoperative unless a plug is inserted into the receptacle. For your convience, the Novus Spectra comes from the factory with an interlock plug pre-installed. An external door interlock rated at 12 VDC is required for this system. When using an external door interlock, the laser automatically disables and returns to standby mode if the treatment door is opened or the interlock plug is removed. The code “ILOC” will appear on the laser console display. To resume treatment, close the treatment room door or reinsert the interlock plug, and press the Mode selector to return the system to ready mode. External door interlock receptacle (Plug is factory pre-installed)
Inserting the external door interlock plug
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General Operation
Plugging in the main power cable 1 Ensure that the keyswitch is in the
(off ) position.
2 Insert the mains power plug into the mains receptacle on the rear of the laser console.
3 Insert the other end of the main power plug into the wall socket and ensure that the plug is secure.
Mains receptacle
To electrical outlet
Plugging in the main power cable
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Connection Instructions 17
Connecting the remote control If desired, connect the remote control at any time by inserting the remote control plug into the (remote control) receptacle on the rear of the laser console.
800
.05
mW
s
.05 s
0
Remote control n=0
Connecting the remote control
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General Operation
Connecting the delivery device(s) WARNING - To avoid possible damage to the laser, use only qualified, compatible Lumenis delivery devices. Using other than Lumenis delivery devices may jeopardize safe operation or damage the laser and will void your Lumenis warranty or service contract. WARNING - When using a fiber optic delivery device, always inspect the fiber optic cable to ensure that it has not been kinked, punctured, fractured, or otherwise damaged. The fiber optic cable may be damaged if stepped on, pulled, left lying in a vulnerable position, kinked, or tightly coiled. Do not clamp the cable with a hemostat or other instruments. If sterile tape is used, always remove the tape before lifting the cable. A damaged fiber optic cable may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room. WARNING - Carefully inspect any delivery system sterile packaging to ensure that it has not been torn or punctured. If there is any damage to the sterile packaging, do not use the delivery system WARNING - If an emulation plug is used, the operator shall assume all responsibility for ensuring that the proper eye safety filters are used.
A variety of delivery devices are compatible with this laser. To connect a delivery device, attach the delivery device laser connector to the fiber port and delivery device receptacle (ACC), as appropriate, on the front of the laser console. Refer to the appropriate delivery device operator manual for detailed connection and operating instructions. When a delivery device is properly connected, the corresponding icon displays on the remote control. represents a LaserLink™ or slit lamp represents a probe or handpiece represents an LIO™ If the delivery device is not properly connected, an E300 error code will display on the laser console, and the delivery device icon willnot illuminate on the remote control.Verify that the device is properly connected to the appropriate receptacles before turning the laser on. If the delivery device is not compatible with the Novus Spectra laser system, an E301 error code will display.
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Connection Instructions 19
Connecting eye safety filters (LaserLink, slit lamp, and Acculite only) Installing the eye safety filter(s)
When using a LaserLink, a Lumenis slit lamp, or Acculite delivery devices, you must install a compatible automatic eye safety filter or fixed filter onto the slit lamp or operating microscope. The eye safety filter protects the physician’s eyes from exposure to laser light while looking through the slit lamp or operating microscope. If the eye safety filter is not properly connected to the laser, an E400 error code will display on the laser console. If the eye safety filter is not compatible, an E401 error code will display. Refer to the appropriate delivery device operator manual for detailed eye safety filter installation instructions. CAUTION - During treatment, the eye safety filter must be attached to the slit lamp or operating microscope. Failure to use an eye safety filter could result in ocular injury. In addition, some slit lamps and microscopes require an auxiliary eye safety filter to protect persons observing the procedure through an observation tube. To determine if an auxiliary eye safety filter is required, review your slit lamp or microscope operator manual or contact the manufacturer.
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General Operation
Connecting an automatic eye safety filter to the laser
When using an automatic eye safety filter, you must connect the eye safety filter to the laser console using the extension cable that was provided with your eye safety filter. To connect the eye safety filter to the laser:
1 Insert the eye safety filter plug into the eye safety filter extension cable, as instructed in the appropriate delivery device operator manual.
2 Insert the extension cable plug into the ACC receptacle on the front of the laser console. Connecting a fixed eye safety filter to the laser
If you are using a fixed eye safety filter, then you must insert an emulation plug into the ACC receptacle. The LIO (laser indirect ophthalmoscope) delivery device has an integrated eye safety filter. If you are using an LIO, you do not need to insert an emulation plug into the ACC receptacle.
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Connection Instructions 21
Fiber
To fiber port
To slit lamp power supply
Example of delivery device and eye safety filter connections (slit lamp and LaserLink shown)
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