LUMENIS Novus Spectra Operator's Manual
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LUMENIS Novus Spectra Operator's Manual

Solid-state 532-nm green laser
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Solid-State 532-nm Green Laser
Operator Manual

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Summary of Contents for LUMENIS Novus Spectra

  • Page 1 Novus Spectra ® ™ Solid-State 532-nm Green Laser Operator Manual...
  • Page 2 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.

  • Page 3: Table Of Contents

    ............7 Operation Introduction: The Novus Spectra Laser ......9 Characteristics of the 532-nm green laser beam .
  • Page 4 External door interlock ......... . 64 Novus Spectra...
  • Page 5 Slit lamps and LaserLinks for slit lamps......100 Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 6 6 Contents Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 7: Overview

    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 •...
  • Page 8 8 General Operation Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 9: Introduction: The Novus Spectra Laser

    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.

  • Page 10: Laser Preparation

    10 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.

  • Page 11: Novus Spectra Components

    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.

  • Page 12: Laser Console

    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.

  • Page 13: Connection Instructions

    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.

  • Page 14: Connecting The Footswitch

    (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 Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 15: Using The 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.

  • Page 16: Plugging In The Main Power Cable

    Insert the mains power plug into the mains receptacle on the rear of the laser console. 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 Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 17: Connecting The Remote Control

    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. Remote control Connecting the remote control Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 18: Connecting The Delivery Device(S)

    If the delivery device is not compatible with the Novus Spectra laser system, an E301 error code will display. Novus Spectra...

  • Page 19: Connecting Eye Safety Filters (Laserlink, Slit Lamp, And Acculite Only)

    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.
  • Page 20 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. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 21 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) Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 22: Laser Console Basics

    In most cases you will not need to restart the laser. If a condition occurs that requires you to restart the laser: Turn the keyswitch to the (off ) position; wait 5 seconds. Turn the keyswitch to the (on) position. The laser begins the routine start-up sequence. Keyswitch Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 23: Turning Off The Laser

    EOFF code will appear in the laser console display, and the system will be in standby. To clear the EOFF, press the emergency stop button. The system will return to standby mode with all of the user settings retained. STOP Red emergency stop button Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 24: Disconnecting The Laser

    Moving the laser console This is a portable laser, so it can be simply picked up and moved from place to place. For transporting long distances, place the laser in the carrying case. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 25: Laser Beam Integrity Check

    fiber may cause accidental laser exposure to the treatment room personnel or patient, and/or fire in the treatment room. Set the laser treatment parameters, as instructed in the Setting Treatment Parameters of this chapter. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 26: Laser Console Display And Remote Control Basics

    Aiming beam display intensity selectors reset selector (For future product enhancement) Standby/ready mode selector Treatment power display Treatment power selectors Pulse repeat Pulse duration Pulse duration Pulse repeat interval interval display display adjustment adjustment Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 27: Remote Control Selectors, Icons, And Displays

    Pulse count reset selector selector Standby icon Standby/ready mode selector Ready icon Laser emission indicator Delivery device icon--LIO Illumination intensity selectors Delivery device icon-- LaserLink or slit lamp Delivery device icon-probe Remote control buttons, icons and displays Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 28: Laser Status And Laser Emission: Ready And Standby Modes

    If the laser is not used for five minutes, the system automatically defaults to standby mode. If the laser cannot be placed in ready mode, the system beeps, and an error message displays in the top display. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 29 Laser Console and Remote Control Basics 29 Standby/ready mode selector Standby icon Standby/ready mode selector and Standby icon on laser console Standby/ready mode selector Standby icon Laser emission icon Ready icon Standby/ready mode selector and icons on remote control Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 30: Setting Treatment Parameters

    If there is no change in display values when you press the selectors on the laser console, or if the laser console or remote control appears otherwise erratic, do not use the laser. Contact your local Lumenis representative. Selecting and verifying the delivery device Connect the desired delivery device, as described in “Connecting the delivery...
  • Page 31 Setting Treatment Parameters 31 Aiming beam intensity selector Aiming beam intensity selector Adjusting the aiming beam Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 32: Setting The Power

    To set the pulse duration, press the up or down pulse duration selectors on either the laser console or remote control until the desired value displays. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 33 Setting Treatment Parameters 33 Pulse duration selectors Setting the pulse duration Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 34: Setting The Treatment Interval

    To set the pulse interval, press the up or down Interval selectors on the laser console display or the remote control until the desired value displays. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 35 Setting Treatment Parameters 35 Pulse interval display and selectors Setting the treatment interval Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 36: Resetting The Pulse Counter

    Resetting the pulse counter The pulse counter displays the total number of treatment pulses delivered since the reset selector was last pressed. The range on the Novus Spectra display is 0-9999 pulses. It can be reset to zero by pressing the Count Reset selector located above the display on the laser console or by pressing the count reset selector underneath the display on the remote control.

  • Page 37: Preoperative Instructions

    fire in the treatment room. CAUTION - Before using the laser, always verify that the displays on both the laser console and the remote control are properly working and are consistent with each other. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 38: Intraoperative Instructions

    Depress the footswitch to deliver the treatment beam to the tissue. (laser emission) icon will illuminate on the remote control, and the system emits a beep. If surgery must be interrupted, place the laser in standby mode to disable the footswitch. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 39: Postoperative Instructions

    Disconnect the external door interlock (if used). Clean the exterior surfaces of the laser, as instructed in the Maintenance sec- tion of this manual. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 40 40 General Operation Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 41: Overview

    • Troubleshooting Guide 43 • User Maintenance 47 • Electrical Requirements 48 • Replacing the Fuses 49 • Specifications 50 • Calibration Procedure 52 • Warranty Information 54 • Decontamination of Returned Equipment 54 Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 42 42 Maintenance Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 43: Troubleshooting Guide

    External door interlock If the external door interlock is used in conjunction with a remote switch, verify that the external door interlock plug is inserted in the external door interlock receptacle. Close the interlocked door. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 44 The fuse is blown. Replace fuses. No treatment beam There is an internal laser system failure. Contact your local Lumenis output although the representative. aiming beam operates properly. The footswitch may be defective. With the laser in ready mode, verify...
  • Page 45 If the condition continues, restart the laser system. If the condition persists, contact your local Lumenis representative. E300 The fiber is not properly connected. Ensure that the fiber is properly connected.
  • Page 46 If the condition persists, contact your local Lumenis representative. The laser detected a lower level of energy Turn off the system for five seconds, E501 than the level selected by the user.

  • Page 47: User Maintenance

    Lumenis-certified service engineer to ensure proper laser performance. Laser repair All laser repairs should be performed by a Lumenis-certified service engineer. For training and information, contact your local Lumenis representative. Clean the external surfaces of the laser console Use a cloth dampened with a noncaustic cleaning solution, such as soap and water, isopropyl alcohol, or a “hospital-grade”...

  • Page 48: Electrical Requirements

    48 Maintenance Electrical Requirements The Novus Spectra laser is designed to meet UL2601-1, IEC 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-22, and 60825-1, and CSA 22.2 No. 601 requirements. The laser is available in one electrical configuration with a universal, 100–240 V, 5.0-A power input.

  • Page 49: Replacing The Fuses

    Replace the fuses as follows: two fuses rated 250 V, 5A, Type T, Slo Blo (5 mm × 20 mm) Reinsert the fuse holder. Fuse holder Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 50: Specifications

    50 Maintenance Specifications Specifications are subject to change without notice. Novus Spectra Laser Treatment beam Type Frequency-doubled Nd:YAG, diode-pumped solid-state Wavelength Green: 532 nm Power output 50–2500 mW 50 mW = power setting ≤ 500 mW: all settings are available Duty cycle 500 mW <...

  • Page 51: Physical Characteristics

    Specifications 51 Novus Spectra Laser Environmental requirements (nonoperating) Maximum altitude Standard commercial shipping altitude Operating temperature -10 °C to 55 °C (14 °F to 131 °F) Maximum humidity 90% at 55 °C (131°F) noncondensing Physical characteristics Height 15.2 cm (6 in.) Width 25.4 cm (10 in.)

  • Page 52: Calibration Procedure

    Disclaimer warning Calibration is a service procedure to be done only by Lumenis-certified Service Engineers or customers who have taken and passed a Lumenis Service Certification Training course. Adjustment by anyone other than a trained Lumenis Service Engineer or a certified customer voids any existing manufacturer’s warranty on the instrument.

  • Page 53: Calibration Instructions

    WARNING - Opening the laser console protective covers will expose the user to the laser resonator and possible laser radiation. Only Lumenis-certified service technicians shall work inside the console. On the CPU board (bottom PCB), slide switches 1 and 2 of SW2 to the open position.

  • Page 54: Warranty Information

    Decontamination of Returned Equipment To comply with United States postal and transportation law, equipment shipped to Lumenis U.S. offices for repair or return must be properly decontaminated with a chemical germicide that is commercially available and cleared for use as a “Hospital Disinfectant.” To ensure that all equipment has been properly decontaminated, a signed Decontamination Certificate...
  • Page 55 Safety and Regulatory Overview • Introduction 57 • Laser Safety Eyewear 58 • Additional Ocular Protection 61 • Additional Safety Considerations 62 • Regulatory Compliance 64 Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 56: 56 Safety And Regulatory

    56 Safety and Regulatory Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 57: Introduction

    Additional precautions must be taken to prevent fire, electrical injury, and explosion. Lumenis does not make recommendations regarding the practice of medicine. Laser treatment parameters are provided as a guide. Individual treatment should be based on clinical training, clinical observation of laser-tissue interaction, and appropriate clinical endpoints.

  • Page 58: Laser Safety Eyewear

    ANSI Z136.1-1993, ANSI Z136.3-1996, or European Standard EN 60825: 1992, Appendix A. The following formula was used to calculate the worst case NOHD for Lumenis Novus Spectra lasers and compatible delivery systems. Φ Pf - a NOHD = θ...
  • Page 59 LaserLink HS 0.050 0.00255 0.020 LaserLink Z 0.041 0.00255 0.025 0.022 0.00255 0.102 Acculite 0.140 0.00255 0.020 which results in a worst case NOHD of: NOHD LaserLink HS 7.13 LaserLink Z 8.72 23.15 Acculite 3.57 Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 60 The barrier should be made of material that can withstand the power of the treatment beam for the maximum exposure time, relative to the configuration of the controlled area and the treatment parameters for the specific medical application. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 61: Additional Ocular Protection

    Never look directly into any optical lens, except for therapeutic purposes, nor any optical fiber, probe, or laser system aperture while the laser is energized. Severe eye damage could occur. Turn off the laser before inspecting any delivery system or laser components. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 62: Additional Safety Considerations

    Laser beam integrity checks are extremely important for the safe operation of your laser equipment. Do not use the laser or delivery system if aiming and treatment beams are not coincident; contact your local Lumenis representative. Misalignment of aiming and treatment beams may result in laser exposure to nontarget tissues and possible injury.

  • Page 63: Fire Hazards

    WARNING - Never open the laser console protective covers. Opening the covers will expose personnel to high voltage components and possible laser radiation. Only Lumenis-certified service technicians shall work inside the console. WARNING - To avoid electrical shock, the area around the laser and footswitch should be kept dry.

  • Page 64: Regulatory Compliance

    64 Safety and Regulatory Regulatory Compliance Lumenis lasers and delivery systems comply with 21 CFR Chapter I, Subchapter J, as administered by the Center for Devices and Radiological Health of the US Food and Drug Administration (FDA). CE-labeled devices comply with all appropriate performance standards as specified in Annex II of the European Medical Device Directive MDD...

  • Page 65: Key Lock Switch

    Therefore, the laser does not have, and is not required to have, any safety interlocks within the meaning of US FDA 21 CFR, Section 1040 or European EN 60825-1. However, the protective housing cannot be easily opened without special tools. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 66: Manual Reset

    An audible tone occurs during treatment beam delivery, and the laser emission indicator on the remote control screen illuminates. The indicators continue the duration of treatment beam emission. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 67: Location Of Regulatory And System Labels

    As required by national and international regulatory agencies, appropriate labels have been mounted in specified locations. Laser console front panel Laser console back panel Laser console bottom Laser console top Remote control Locations of regulatory compliance labels Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 68 VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT per IEC 60825-1:2001 CLASS IV LASER PRODUCT per 21 CFR 1040 Regulatory compliance labels–laser console Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 69 Front panel regulatory labels Remote interlock Footswitch Remote control Protected earth plug Ingress protection Attention read manual (Read and comprehend the operator manual before use) Fuse rating label replace fuse as marked Back panel regulatory labels Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 70 70 Safety and Regulatory Treat Power Pulse Duration Aiming beam Pulse interval Count reset Illumination Standby Ready Laser emission indicator Slit lamp icon Probe icon Remote control icons Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 71: Overview

    Ophthalmic Applications of the Laser 83 • Posterior Segment Laser Procedures 84 • Anterior Segment Laser Procedures 90 • Ophthalmology References 93 • Otologic Applications of the Laser 95 • Delivery Devices and Accessories 99 Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 72 72 Indications for Use Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 73: General Information

    I is the intensity at a distance x into the tissue, I is the intensity at the tissue surface, and e is the base of the Napierian log. The term Equation 2 –1 is the wavelength-dependent attenuation coefficient [cm Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 74 β β β β [cm µm [cm 37.4 Human Dermis (In Vitro) 122.3 Blood Thrombus 31.7 Fibrous Plaque Vessel Wall Table 1: Absorption coefficient, scatter coefficient, attenuation coefficient, and depth of penetration for some representative tissue types. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 75 Desired Effect Approximate Required Irradiance Heating > 10 W/cm Coagulation 100-500 W/cm Vaporization > 1000 W/cm Cutting > 1000 W/cm Rapid Cutting > 5000 W/cm Table 2: Approximate irradiance required for specific tissue effects Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 76 Vacuoles are a definite indication of temperatures in excess of 100°C. As temperatures rise above 125°C, complete oxidation of protein and lipids occurs, leaving behind carbon particles. As Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 77: Tissue Effects

    500 W/cm is required for the adequate photocoagulation of tissues. Incisional and excisional vaporization (debulking) occurs with irradiance greater than 1000 W/cm . Irradiance greater than 5,000 W/cm results in rapid incision. (See Table 2). Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 78: General Warnings And Precautions

    78 Indications for Use General warnings and precautions WARNING - Lumenis and/or related entities assume no responsibility for parameters, techniques, methods or results. Physicians must use their own clinical judgement and professionalism in determining all aspects of treatment, i.e. technique, proper power settings, intervals, durations, etc.

  • Page 79: Laser Plume Precautions

    Refer to “Delivery Devices and Accessories” in this section, as well as to the appropriate delivery device operator manual for additional details regarding power and duration settings to achieve the desired irradiance or fluence. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 80: Adverse Effects

    Laser interaction with tissue sterilizes only the treated area. Bleeding Coagulation is the primary tissue effect of the Novus Spectra laser. The possibility of postoperative bleeding must be considered following the sloughing of tissue. Observation for bleeding by postoperative hematocrit evaluation and dressing evaluations should be considered.

  • Page 81: Guidelines For Use

    Laser applications done with noncontact devices are indicated throughout this manual by the following icon: Laser applications using free-beam devices, such as slit lamps, are indicated by the following icon: 1. Reference 2, “General references” 2. Reference 3, “General references” Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 82: General References

    2. American National Standards Institute. “Safe Use of Lasers in Health Care Facilities” ANSI Standard Z-136.3. New York: ANSI, 1430 Broadway, 1996. 3. American National Standards Institute. “Safe Use of Lasers” ANSI Stan- dard Z-136.1. New York: ANSI, 1430 Broadway, 1993. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 83: Ophthalmic Applications Of The Laser

    The laser may be used for procedures done in the hospital or in a physician's office, and for in-patient or out-patient procedures. The use of the laser is not a contributing factor in deciding whether a procedure is done on an in- or an out-patient basis. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 84 In these cases, photocoagulation can shrink the closely adherent vitreous strands, causing an increase in the vitreo-retinal tractional and possibly a detachment of the retina. However, laser endophotocoagulation at the time of 1. Reference 7, “Ophthalmology References” Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 85 In clinical experience, photocoagulation has not helped posterior polar edema and exudation where the underlying problem has been advanced hypertension. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 86: Adverse Effects And Complications

    CAUTION - Immediately following treatment, patients should avoid altitudes over 8000 ft. (Commercial aircraft cabins are pressurized below this altitude.) 1. Reference 8, “Ophthalmology References” Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 87: Guidelines For Use

    The following is a list of some of the retinal conditions that can be treated with the laser, and a method of laser treatment. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 88 Complications can occur because of traction caused by the shrinkage or shortening of the vitreous strands. This traction can cause the detachment to spread. Also, as in any retinal laser treatment, if too much power is used a vitreal hemorrhage can result. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 89 This result can usually be obtained with about 200 to 500 mW of power, depending on the size of the laser spot. The procedures done with endoprobes include photocoagulation of retinal detachments and pan-retinal photocoagulation. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 90: Anterior Segment Laser Procedures

    flat anterior chamber. Laser applications should be timed sufficiently apart so that heat generated in the aqueous can dissipate without heating the corneal endothelium. When the anterior chamber is extremely shallow, the Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 91: Warnings

    CAUTION - Transient comeal epithelial bums have reportedly resolved within 1 week without scarring. Endothelial bums are rarely encountered when careful focusing is employed. 1. Reference 11, “Ophthalmology References” 2. Reference 9, “Ophthalmology References” Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 92: Adverse Effects

    After the laser has burned through the 1. Reference 10, “Ophthalmology References” Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 93 After this time, the pressure usually remains constant for several years. However, if the pressure begins to rise again, repeated trabeculoplasty appears to be much less successful in controlling the pressure ride than the first time the procedure is performed. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 94: Ophthalmology References

    Primary Open-angle Glaucoma Ophthalmology 89:338, 1980. 10. Thomas JV, Simmons Ri, and Belcher CD III. Complications of Krypton Laser Trabeculoplasty Glaucoma 4:50,1982. 11. Wise JB. Errors in Laser Spot Size in Laser Trabeculoplasty Ophthalmol- ogy, 91:186, 1984. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 95: Otologic Applications Of The Laser

    Uninflamed mastoid cases, such as endolymphatic sac surgery and cochlear implants do not benefit from the laser. 1. Reference 18, “Otology references” 2. Reference16, “Otology references” 3. References 16 and 18, “Otology references” 4. Reference 4, “Otology references” Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 96: Warnings

    The operator should be aware of the irradiances required for specific tissue effects as are outlined throughout this manual, as well as detailed in the appropriate delivery device operator manual. 1. Reference 17, “Otology References” Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 97: Otology References

    15. Glasscock ME, et al. The Argon Laser in Acoustic Tumor Surgery Laryn- goscope 91(9):Part 1. 16. DiBartolomeo JR, Ellis M. The Argon Laser in Otology Laryngoscope 90:1980. 17. DiBartolomeo JR. The Argon and CO Lasers in Otolaryngology: Which One and Why? Laryngoscope 91(9):Suppl 26:1-16, 1981. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 98 22. Carruth JA. The Role of Lasers in Otolaryngology World JSurg 7(6):719- 724,1983. 23. Apfelberg DB, Mittelman H, Chadi B. Carcinogenic Potential of in vitro Carbon Dioxide Laser Exposure to Fibroblast Obstet Gynecol 61:493,1983. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 99: Delivery Devices And Accessories

    Delivery Devices and Accessories 99 Delivery Devices and Accessories Filters Lumenis offers fixed and moving physician’s filters for integrated slit lamps, indirect ophthalmoscope attachments, and microscopes. These filters shield the physician's or observer's eyes from laser light and allow a normal field of view when the laser is in the Ready mode.
  • Page 100 Ensure that the probe tip does not come into direct contact with tissue when treating; if it does, the optical efficiency of the fiber will be compromised. • Use a suction tip in the treatment area to evacuate the laser plume. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 101: Fluence

    (mm) (cm2) cm2) cm2) cm2) .000707 1415 1415 (0.3 mm or.03 cm) .0707 .00283 (0.6 mm or.06 cm) .0707 Table 4: Irradiance and Fluence at 1 W and 0.5 s and 1.0 s Delivered Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 102 Figure 2 illustrates the relationship between irradiance and the distance from the fiber tip. Figure 1. Spot size as a function of distance from fiber tip Figure 2: Irradiance as a function of distance from fiber tip Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 103 200 µm 0.45 0.69 0.94 1.18 1.43 0.30 1415 300 µm 0.55 0.79 1.04 1.20 1.53 0.60 600 µm 0.85 1.09 1.34 1.58 1.83 Table 5: Spot Size and Irradiance at 1 W Delivered Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 104: Laser Indirect Ophthalmoscope (Lio)

    The instabilities inherent in the aiming of the LIO preclude its use in these areas. • The doctor should always hold the viewing lens so that his view of the target is free of aberrations when the laser is fired. Aberrations Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 105 WARNING - The LIO should be carefully inspected before each use to be sure that it is not damaged. Novus Spectra 0642-543-01, Rev A, 12/02...
  • Page 106 106 Indications for Use Guidelines for use • The LIO can be configured at the factory for use with a Lumenis argon laser, krypton laser, or diode-green (Novus Spectra) laser. Only the filter material and electrical characteristics differ. • The LIO consists of an indirect ophthalmoscope that has been modified with an automatic laser safety shutter and a lens system to...
  • Page 107 Detachments Using a Binocular Indirect Ophthalmoscope Laser Delivery System Ophthalmology 95:187-193, 1988. 4. Campochario P, Gaskin H, Vinores S. Retinal cryopexy Stimulates Trac- tion Retinal Detachments in the Presence of an Ocular Wound Archives of Ophthalmology 105:1567-1570, 1987. Novus Spectra 0642-543-01, Rev A, 12/02...

  • Page 108: Slit Lamps And Laserlinks For Slit Lamps

    Slit lamp delivery systems and LaserLinks are indicated for the delivery of laser energy to the eye. They can be used in conjunction with contact lenses designed for the delivery of laser energy. Lumenis slit lamp attachments and integrated slit lamps are indicated for the delivery of laser energy in posterior chamber procedures involving the retina.
  • Page 109 fluids or components thereof. The undersigned also agrees to reimburse Lumenis for any costs incurred in cleaning the enclosed equipment, in the event said item(s) is/are received by Lumenis in a contaminated condition.
  • Page 110 110 Indications for Use Novus Spectra 0642-543-01, Rev A, 12/02...

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