Novus Spectra Operator Manual Rev G

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. "Carl Zeiss" is a registered trademark of Carl Zeiss, Inc. Keeler is a registered trademark of Keeler Ltd. HEINE is a registered trademark of HEINE Optotechnik.

Manufactured by:

3959 West 1820 South Salt Lake City, UT 84104 United States of America Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 63303 Dreieich, Germany +49.6103.8335.0

© Lumenis, Inc. Published in USA 0642-543-01 Revision G Lumenis ECO: 12047 Effective: 05/06/2011

3

Contents Safety and Regulatory

Introduction...9 Laser Safety Eyewear... 10 Additional Ocular Protection...13 Additional Safety Considerations... 14 Protecting nontarget tissues... 14 Fire hazards... 15 Electrical hazards... 15

Regulatory Compliance... 16 Emergency stop pushbutton... 17 Key lock switch... 17 Location of controls... 17 Protective housing... 17 External door interlock... 17 Safety interlocks... 17 Manual reset... 18 Electronic fault detection circuitry... 18 Safety shutter... 18 Laser emission indicators... 18 Location of regulatory and system labels... 19

General Operation

Introduction: The Novus Spectra Laser... 27 Characteristics of the 532-nm green laser beam... 27

Laser Preparation... 28 Novus Spectra Components... 29 Laser console... 30 Remote control (optional)... 30 External door interlock plug... 30

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Footswitch... 30 Delivery devices... 30

Connection Instructions... 31 Connecting the footswitch... 32 Using the external door interlock... 33 Plugging in the main power cable... 34 Connecting the remote control... 35 Connecting the delivery device(s)... 36 Connecting eye safety filters (LaserLink, slit lamp, and Acculite only)... 37

Laser Console Basics... 40 Turning on the laser... 40 Restarting the laser... 40 Turning off the laser... 41 Emergency stop... 41 Disconnecting the laser... 42 Moving the laser console... 42 Laser beam integrity check... 43

Laser Console and Remote Control Basics... 44 Single port laser selectors, icons, and displays... 44 Dual port laser selectors, icons, and displays... 45 Remote control selectors, icons, and displays... 46 Laser status and laser emission: ready and standby modes... 47

Setting Treatment Parameters... 49 Selecting and verifying the delivery device... 49 Adjusting the aiming beam intensity... 49 Setting the power... 51 Setting the exposure time (pulse duration)... 51 Setting the pulse interval... 53 Resetting the pulse counter... 55

Preoperative Instructions... 56 Intraoperative Instructions... 57 Postoperative Instructions... 58

Maintenance

Troubleshooting Guide... 61 User Maintenance... 65 Annual laser maintenance... 65 Laser repair... 65 Clean the external surfaces of the laser console... 65 Clean the laser display... 65 Water utilities... 65

Electrical Requirements... 66 Replacing the Fuses... 67 Specifications... 68 Calibration Procedure... 70 Calibration instructions... 71

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Contents  5

Warranty Information... 72 Decontamination of Returned Equipment... 72

Indications for Use

General Information... 75 Tissue effects... 77 General warnings and precautions... 80 Laser plume precautions... 81 Irradiance, fluence, and power... 81 Adverse effects... 82 Guidelines for use... 83 Noncontact and free-beam devices... 83 General references... 84

Ophthalmic Applications of the Laser... 85 Posterior Segment Laser Procedures... 86 Indications... 86 Contraindications... 86 Adverse effects and complications... 88 Precautions... 88 Guidelines for use... 89

Anterior Segment Laser Procedures... 92 Indications... 92 Uses... 92 Contraindications... 92 Warnings... 93 Precautions... 93 Adverse effects... 94 Guidelines for use... 94

Ophthalmology References... 96 Otologic Applications of the Laser... 97 Indications... 97 Uses... 97 Contraindications... 97 Warnings... 98 Precautions... 98 Guidelines for use... 98 Otology references... 99

Delivery Devices and Accessories...101 Filters... 101 Acculite Endoprobe or fiber optic devices... 101 Fluence... 103 Laser Indirect ophthalmoscope (LIO)... 106 Sit lamps and Laserlinks for slit lamps... 110

Appendix 1

EMC Guidance and Manufacturer’s Declarations... 113 Decontamination Certificate... 117

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6  Contents

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Safety and Regulatory

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8  Safety and Regulatory

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Introduction  9

Introduction The Novus Spectra ophthalmic laser systems are classified as Class IV lasers by the Center for Devices and Radiological Health of the Food and Drug Administration and as Class 4 by the International Standard IEC 60825. Users must take precautions to prevent exposure of laser energy to the eyes and skin from either direct or diffusely reflected laser beams, except as a therapeutic application. 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. See the American National Standard (ANSI) publications Z136.3-2005, ANSI Z136.1-2007, and EN 207 for recommendations on the safe use of lasers in health care facilities. This package conforms to the conditions and limitations specified in US federal regulations, title 49 CFR 173.426 for radioactive material, excepted packagearticles manufactured from natural thorium, UN 2910.

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10  Safety and Regulatory

Laser Safety Eyewear Laser safety eyewear is routinely required with most lasers. When using the laser system, the Laser Safety Officer should determine the need for safety eyewear based on the Maximum Permissible Exposure (MPE), Nominal Hazard Zone (NHZ), the Nominal Ocular Hazard Distance (NOHD), and the optical density (OD) for each of the available laser emissions and the configuration of the treatment room (usually within the controlled area). For additional information, refer to ANSI Z136.1-2007, ANSI Z136.3-2005, or International Standard IEC 60825-1: 2007. The following formula was used to calculate the worst case NOHD for Lumenis Novus Spectra lasers and compatible delivery systems:

NOHD = Z +

1 

4 

 Pf - a2 MPE

where,

Novus Spectra 0642-543-01, Rev G

Z

=

the distance of the beam waist from the laser system;

a

=

the beam waist diameter (1/e2 of axial irradiance for gaussian beam);

θ

=

minimum full angle beam divergence (1/e2 of axial irradiance for gaussian beam);

e

≈

2.7182818285, the base of natural logarithms;

Φ

=

maximum energy of one laser pulse or maximum CW laser power;

Pf

=

the profile correction factor (1 for uniform profile or 2 for gaussian irradiance profile);

MPE

=

Maximum Permissible Exposure, in energy density units (energy per unit area), or power density units (power per unit area);

NOHD

=

the Nominal Ocular Hazard Distance (measured from laser aperture);

=

the distance required to reduce the energy density or power density to the MPE.

Laser Safety Eyewear  11

Z

NOHD = Z +

Laser system

1 

4 

 Pf - a2 MPE

a

Using this approach we derive the following values: θ (rad)

Φ (W)

MPE (W/cm2)

Pf

a (cm)

Z (cm)

LaserLink HS

0.020

2.5

0.00255

1

0.050

5.7

LaserLink Z

0.010

2.5

0.00255

1

0.100

9.8

Novus Spectra

0.041

2.5

0.00255

1

0.025

9.8

LIO Keeler

0.024

2.5

0.00255

2

0.096

36.6

LIO Heine

0.022

2.5

0.00255

2

0.107

37.08

LIO Tri Color

0.022

2.5

0.00255

2

0.107

37.08

Acculite

0.014

2.5

0.00255

2

0.02

0

Lumenis 1000

0.010

2.5

0.00255

1

0.100

9.8

which results in a worst case NOHD of: NOHD (m) LaserLink HS

17.74

LaserLink Z

34.60

Novus Spectra

8.72

LIO Keeler

21.19

LIO Heine

23.08

LIO Tri Color

23.08

Acculite

3.57

Lumenis 1000

34.60

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12  Safety and Regulatory

All personnel who are within the NOHD are considered to be within the controlled area and shall wear eye protection with a minimum optical density (OD) of: OD LaserLink HS

3.41

LaserLink Z

3.41

Novus Spectra

3.41

LIO Keeler

3.41

LIO Heine

3.41

LIO Tri Color

3.41

Acculite

3.57

Lumenis 1000

3.41

Laser safety eyewear must also be resistant to physical damage or photobleaching resulting from laser exposure as per ANSI Z136.1-2007, section 4.6.2 and Appendix C. For users who must comply with EN 207, the safety eyewear must have a protection class of L5. Depending on the procedure, the physician must protect the patient’s eyes with either laser safety eyewear or one of the following items moistened with a nonflammable solution: thick cloth, eye pads, or gauze 4 x 4’s. For periorbital treatment, the physician must protect the patient with dulled, metal eye shields. In addition to providing the required laser safety eyewear, take the following steps to secure the treatment room, or the controlled area:

1 To alert personnel before they enter the controlled area, place a warning sign on the outside of the treatment room door when the laser is in use.

2 Close the treatment room door during operation of the laser. 3 External door interlocks that automatically disable the laser when the treatment room door is opened may be installed. A blocking barrier, screen, or curtain capable of blocking or filtering the laser beam could be placed to create a controlled area inside a large treatment room. 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.

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Additional Ocular Protection  13

Additional Ocular Protection WARNING - Always verify that the delivery device is properly connected to the laser. An improper connection may result in an inadvertent secondary laser beam. Severe eye or tissue damage could occur. WARNING - Never substitute prescription eyewear for the appropriate laser safety eyewear, as severe eye damage could occur. Prescription eyewear can concentrate the laser light to the eye and/or can be shattered by a high power density beam, possibly causing severe eye damage. WARNING - Severe and irreversible eye damage and scarring may occur from direct or indirect exposure to the treatment beam. The predominant ocular structures at risk are dependent on the laser wavelength in use. In general, visible and near-infrared wavelengths are most damaging to the retina, while ultraviolet or infrared wavelengths are most damaging to the cornea and sclera. Severity of injury depends on how concentrated or diffused the treatment beam is and the length of exposure. A thorough understanding of the specific ocular risks and safety precautions for each laser wavelength is necessary to ensure the safety of the patient and operating personnel. WARNING - 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.

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14  Safety and Regulatory

Additional Safety Considerations Protecting nontarget tissues 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 - Never deliver the treatment beam to the target tissue if the aiming beam is not visible; the fiber optic cable or the delivery device may be damaged. A damaged cable or device may cause accidental laser exposure to the treatment room personnel or patient, and/or fire in the treatment room. WARNING - Except during actual treatment, the laser must always be in standby mode. Maintaining the laser in standby mode prevents accidental laser exposure if the footswitch is inadvertently depressed. WARNING - -Unintended tissue damage can occur due to incorrect energy, repetition rate, exposure duration, or power application. The lowest energy, repetition rate, exposure duration, and power settings that are effective for the intended application should be used until familiar with the instrument’s capabilities. Extreme caution should be employed until you understand the biological interaction between the laser energy and tissue. WARNING - 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. WARNING - To prevent accidental laser discharge, always place the laser in standby mode before connecting the delivery system. WARNING - Never place hands or other objects in the path of the laser beam. Severe burns could occur. WARNING - Activate the laser only when the aiming beam is directed at the targeted lesion or structure and there is a clear view of the treatment site. CAUTION - Only the person directing the aim of the laser beam should have access to the laser footswitch. Use caution depressing the laser footswitch when it is in proximity to footswitches for other equipment. Make sure the footswitch depressed is the correct one to avoid accidental laser exposure. CAUTION - Laser equipment not in use should be protected against unqualified use by removal of key from keyswitch.

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Additional Safety Considerations  15

Fire hazards WARNING - Do not use this device in the presence of flammables or explosives, such as volatile anesthetics, alcohol, volatile surgical preparation solutions, and similar substances. An explosion or fire could occur. WARNING - The treatment beam can ignite most nonmetallic materials. Use fire retardant drapes and gowns. The area around the treatment site can be protected with towels or gauze sponges moistened with sterile saline solution or sterile water. If allowed to dry, protective towels and sponges can increase the potential fire hazard. A UL-approved fire extinguisher and water should be readily available.

Electrical 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. Do not operate the laser if any of the cords are faulty or frayed. The laser should undergo routine inspection and maintenance per Lumenis manufacturer’s recommendations and institutional standards.

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16  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 93/42/EEC. CAUTION - US law restricts this device to sale by or on the order of a physician. CAUTION - Lumenis medical lasers and laser delivery systems are intended solely for physicians trained in the use of these instruments. CAUTION - Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure.

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Regulatory Compliance  17

Emergency stop button The laser has an emergency stop button that immediately turns off the laser. The emergency stop button turns off all power to the laser off, but does not turn off the CPU board or the laser console display. When the button is pressed, an EOFF code will appear in the laser console display, and the system will be in standby. To clear the EOFF, release the emergency stop button. The system will return to standby mode with all of the user settings retained.

Key lock switch To prevent unauthorized use, the laser can only be turned on with the master key, the key can only be removed when the laser is turned off, and the laser only operates when the key is inserted into the keyswitch. When the keyswitch is turned to the on position , the laser power-up sequence is initiated.

I

Location of controls Operation and adjustment controls are located so that the user need not be exposed to laser radiation during laser operation or adjustment.

Protective housing The laser has a protective housing that prevents unintended human access to laser radiation above Class I limits. The housing must only be opened by a Lumenis-certified technician.

External door interlock An external door interlock receptacle and plug are provided to disable the laser if the treatment room doors are opened while the laser is in ready mode. Refer to the Laser Safety Eyewear section of this manual for additional information.

Safety interlocks The protective housing is not designed to be removed by the user during operation or maintenance. 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.

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18  Safety and Regulatory

Manual reset If laser emission is externally interrupted during treatment by remote interlock activation, the laser will automatically go into standby and the safety shutter will revert to a closed position. To resume treatment, reset the laser by placing the laser in ready mode. If laser emission is interrupted during treatment by main electrical power loss, the laser system will automatically turn off. To resume treatment after an electrical power loss, the system must be manually restarted by rotating the keyswitch to OFF then ON .

I

Electronic fault detection circuitry If the electronic system detects a fault condition, laser exposure cannot occur. The laser power supply is turned off, the safety shutter is closed, and the footswitch is disabled. Some fault conditions may be cleared by the operator. Refer to the Troubleshooting Guide in this manual for additional information.

Safety shutter The laser includes an electronic safety shutter that prevents unintentional laser emission. The safety shutter opens only when the laser is in ready mode. The safety shutter remains closed when the system is turned off, during self-test at system turn on, when the system is placed in standby mode, or when the safety monitor detects a fault.

Laser emission indicators The Ready mode illuminates on the laser console and the Ready icon illuminates on the remote control screen when the system is in ready mode. These indicators alert the user that the system is able to emit laser radiation. Before treatment beam delivery, the system emits a low-pitched tone to indicate the beginning of a two-second delay until laser radiation is accessible. 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.

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Regulatory Compliance  19

Location of regulatory and system labels As required by national and international regulatory agencies, appropriate labels have been mounted in specified locations.

STOP

Emergency stop

Laser console front panel (Dual Port models)

Laser aperture label (Laser aperture at end of fiber optic)

STOP

Emergency stop

Laser console front panel (Single Port models)

Locations of regulatory compliance labels

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20  Safety and Regulatory

Attention, read manual

Laser console rear panel

Fuse rating label (replace fuse as marked)

www.lumenis.com/weee LB-1070550_A WEEE label

(Instructions for proper disposal of the system, as required by the Waste in Electrical and Electronic Equipment Directive 2002/96/EC, are provided by Lumenis at the following website: http://www.lumenis.com/weee)

Locations of regulatory compliance labels

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