LUMENIS smart532 User manual

Solid-State 532-nm Green Laser
Operator Manual

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.
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, Smart532 and LaserLink, are trademarks or registered trademarks of Lumenis.
"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.
In the US:
Caution: Federal law restricts this device to sale by or on the order of a physician.
Copyright © 2016, Lumenis Ltd.
Catalog Part Number: UM-1151440EN
May 2016
Revision C
Use of this Manual:
The Smart532 laser device is designed to meet international safety and performance standards. Personnel
operating the device must have a thorough understanding of the proper operation of the device.
This manual has been prepared to aid medical and technical personnel to understand and operate the
device. Do not operate the device before reading this manual and gaining a clear understanding of the
operation of the device. If any part of this manual is not clear, please contact your Lumenis representative
for clarification.
The information provided in this manual is not intended to replace physician training or professional
training on the clinical use of the Smart532 laser device. Such training should include a review of
published literature, seminars, workshops and appropriate preceptorships. Please contact your Lumenis
representative for current information on available training.
This manual should always accompany the device, and its location must be known to all personnel
operating the device. Additional copies of this manual are available from your Lumenis distributor.
Device and accessory specifications subject to change without notice.
For further information about Lumenis, visit the Lumenis Website: http://www.Lumenis.com or send
email to [e-mail]

Authorized Representative in the European Community:
Lumenis (Germany) GmbH
Heinrich-Hertz-Str. 3
Dreieich-Dreieichenhain D-63303
Germany
Tel: [phone]
Fax: [phone]
Manufactured by Lumenis Ltd.
Yokneam Industrial Park
6 Hakidma Street
P.O.B. 240
Yokneam 2069204, Israel
Tel: [phone]
Fax: [phone]
www.Lumenis.com
Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE)
In accordance with Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE), any
item which is marked with the crossed-out wheelie bin symbol must not be disposed of as unsorted
municipal waste, but segregated from other waste types for eventual treatment and recovery at an
approved recycling facility.
By returning waste electrical and electronic equipment via the correct segregated disposal channel, users
can ensure the environmentally sound treatment and disposal of the waste equipment, thereby reducing
the potential for any environmental or health risks that could arise as a result of incorrect disposal.
Lumenis provides web-based collection, recycling and reporting arrangements to the business end-user
for equipment marked with the crossed-out wheelie bin. Please visit
www.lumenis.com/Homepage/About2/Recycle to understand what arrangements Lumenis has made in
each EU Member State.

Smart532
™Table of Contents
UM-1151440EN, Rev. C, May 2016 TOC-1
Table of Contents
CHAPTER 1 Overview Page
1.1. Introduction........................................................................................................................................ 1-1
1.2. Scope of This Manual........................................................................................................................ 1-1
1.3. Manual Conventions.......................................................................................................................... 1-2
1.4. Physician Responsibility.................................................................................................................... 1-3
1.5. Maintenance....................................................................................................................................... 1-3
1.6. Modification of the Device................................................................................................................ 1-3
1.7. Resale Inspection............................................................................................................................... 1-3
1.8. Abbreviations and Acronyms ............................................................................................................ 1-4
CHAPTER 2 Laser Safety and Regulatory Page
2.1. Introduction........................................................................................................................................ 2-1
2.2. Training and Institutional Requirements............................................................................................2-1
2.2.1. Laser Safety Officer .................................................................................................................... 2-2
2.2.2. Laser Treatment/ Operating Area................................................................................................2-3
2.3. Laser Safety Eyewear ........................................................................................................................ 2-4
2.3.1. Additional Ocular Protection....................................................................................................... 2-6
2.4. Additional Safety Considerations ...................................................................................................... 2-7
2.5. Fire Hazards....................................................................................................................................... 2-8
2.6. Electrical Hazards.............................................................................................................................. 2-8
2.6.1. Grounding the System................................................................................................................. 2-9
2.7. Operating Safety Cautions & Warnings.............................................................................................2-9
2.7.1. Cautions....................................................................................................................................... 2-9
2.7.2. Warnings ..................................................................................................................................... 2-9
2.8. System Safety Features.................................................................................................................... 2-10
2.8.1. Password Protection.................................................................................................................. 2-10
2.8.2. Self-Testing at Start Up............................................................................................................. 2-10
2.8.3. Safety Shutter............................................................................................................................ 2-10
2.8.4. Door Interlock Connector..........................................................................................................2-10
2.8.5. Location of Controls.................................................................................................................. 2-10
2.8.6. Laser Emergency Stop Button...................................................................................................2-11
2.8.7. Continuous Internal System Monitoring...................................................................................2-11
2.8.7.1. System Faults................................................................................................................ 2-11
2.8.7.2. Internal Power Monitoring............................................................................................2-11
2.8.7.3. Temperature .................................................................................................................. 2-11

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TOC-2 UM-1151440EN, Rev. C, May 2016
2.9. Laser Beam Emission Indicators .....................................................................................................2-11
2.10. Compliance with International Standards........................................................................................ 2-12
2.11. Warning, Certification and Identification Labels ............................................................................2-14
2.12. Symbol Descriptions........................................................................................................................ 2-16
CHAPTER 3 System Description Page
3.1. Introduction........................................................................................................................................ 3-1
3.1.1. Characteristics of the 532-nm Green Laser Beam.......................................................................3-1
3.1.2. Smart532 Laser System Components..........................................................................................3-2
3.1.2.1. Laser Console.................................................................................................................. 3-3
3.1.2.2. Remote Interlock Connection Plug................................................................................. 3-3
3.1.2.3. Footswitch....................................................................................................................... 3-3
3.1.2.4. Delivery Systems ............................................................................................................3-3
3.1.3. System Description – Front Panel...............................................................................................3-4
3.1.4. Laser Emergency Stop Button..................................................................................................... 3-4
3.1.5. System Description – Rear Panel................................................................................................3-5
3.1.6. Touch-Screen LCD Control Panel .............................................................................................. 3-6
3.1.7. Optical Bench Assembly............................................................................................................. 3-6
3.1.8. System Specifications.................................................................................................................. 3-7
3.1.8.1. Outputs............................................................................................................................ 3-7
3.1.8.2. Operation and Control..................................................................................................... 3-7
3.1.8.3. Compatible Accessories..................................................................................................3-8
3.1.8.4. Electrical Requirements..................................................................................................3-8
3.1.8.5. Physical Specifications ................................................................................................... 3-8
3.1.8.6. Environmental Specifications ......................................................................................... 3-8
3.1.8.7. System Classifications .................................................................................................... 3-9
CHAPTER 4 System Installation and Initial Setup Page
4.1. Introduction........................................................................................................................................ 4-1
4.2. Unpacking the System ....................................................................................................................... 4-1
4.3. Facility Requirements........................................................................................................................ 4-2
4.3.1. Space and Positioning Requirements.......................................................................................... 4-2
4.3.2. Electrical Requirements .............................................................................................................. 4-2
4.3.3. Environmental Requirements...................................................................................................... 4-3
4.4. Installation and Setup......................................................................................................................... 4-4
4.5. Connection Instructions..................................................................................................................... 4-6
4.5.1. Connect the Footswitch............................................................................................................... 4-6
4.5.2. Connect the Remote Interlock..................................................................................................... 4-7

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4.5.3. Connect the Main Power Cable................................................................................................... 4-8
4.5.4. Connect a Delivery System......................................................................................................... 4-9
4.5.5. Eye Safety Filters ...................................................................................................................... 4-10
4.5.5.1. Installing the Eye Safety Filter(s) .................................................................................4-10
4.5.5.2. Connecting an Automatic Eye Safety Filter to the Laser..............................................4-10
4.5.5.3. Connecting a Fixed Eye Safety Filter to the Laser........................................................4-10
4.5.6. Connecting an LIO Illumination Power Connector...................................................................4-12
4.5.7. Connecting an Auxiliary Monitor ............................................................................................. 4-12
4.6. Transporting and Storage................................................................................................................. 4-12
CHAPTER 5 Operating Instructions Page
5.1. Safety Considerations ........................................................................................................................ 5-1
5.2. Starting the System............................................................................................................................ 5-1
5.3. Main Treatment Screen Elements...................................................................................................... 5-2
5.3.1. Delivery System Selection .......................................................................................................... 5-3
5.3.2. Power Setting .............................................................................................................................. 5-3
5.3.3. Exposure Time Setting................................................................................................................ 5-4
5.3.4. Pulse Interval Selection............................................................................................................... 5-4
5.3.5. Aiming Beam Intensity Adjustment............................................................................................ 5-4
5.3.6. SmartPulse Mode ........................................................................................................................ 5-5
5.3.7. Pulse Counter .............................................................................................................................. 5-6
5.3.8. Standby/Ready Mode Selection .................................................................................................. 5-6
5.3.9. Preset Name................................................................................................................................. 5-7
5.3.10. Save a New Preset................................................................................................................... 5-7
5.3.11. Edit, Delete or Select an Existing Preset.................................................................................5-7
5.3.12. Open Options Screen ..............................................................................................................5-8
5.3.12.1. LIO Illumination Setting Screen..................................................................................... 5-9
5.3.12.2. Language Setting Screen................................................................................................. 5-9
5.3.12.3. Volume Setting Screen.................................................................................................. 5-10
5.3.12.4. Backlight Setting Screen............................................................................................... 5-11
5.3.12.5. Eye Safety Filter (ESF) Mode Selection Screen...........................................................5-12
5.4. Pre-Operative Instructions ............................................................................................................... 5-13
5.4.1. Aiming Beam Integrity Test......................................................................................................5-14
5.5. Intra-Operative Instructions............................................................................................................. 5-15
5.6. Post-Operative Instructions.............................................................................................................. 5-15
5.7. Extended Term Disconnection......................................................................................................... 5-15

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TOC-4 UM-1151440EN, Rev. C, May 2016
CHAPTER 6 Maintenance and Troubleshooting Page
6.1. User Maintenance .............................................................................................................................. 6-1
6.1.1. Annual Laser Maintenance..........................................................................................................6-1
6.1.2. Laser System Repair.................................................................................................................... 6-1
6.1.3. Clean the External Surfaces of the Laser Console ......................................................................6-1
6.1.4. Clean the LCD Panel................................................................................................................... 6-1
6.1.5. Fuse Replacement........................................................................................................................ 6-2
6.2. Professional Maintenance.................................................................................................................. 6-3
6.2.1. Power Meter Calibration ............................................................................................................. 6-3
6.2.2. Internal Power Meter Test...........................................................................................................6-3
6.3. Warranty Information ........................................................................................................................ 6-4
6.4. Decontamination of Returned Equipment..........................................................................................6-4
6.5. Lumenis Customer Support ............................................................................................................... 6-4
6.6. Troubleshooting Guide ...................................................................................................................... 6-5
APPENDIX A Clinical Guide Page
A.1. General Information............................................................................................................................... A-1
A.1.1. Tissue effects ......................................................................................................................... A-1
A.1.2. General Warnings and Precautions........................................................................................ A-2
A.1.3. Adverse Effects (AEs) ........................................................................................................... A-2
A.1.3.1. Pain ..................................................................................................................................... A-2
A.1.3.2. Infection.............................................................................................................................. A-3
A.1.3.3. Bleeding.............................................................................................................................. A-3
A.1.3.4. Visual Function................................................................................................................... A-3
A.1.4. Non-Contact and Free-Beam Devices.................................................................................... A-3
A.2. Indications for Use................................................................................................................................. A-4
A.2.1. Ophthalmology....................................................................................................................... A-4
A.2.2. Ear, Nose and Throat (ENT).................................................................................................. A-4
A.2.3. Dermatologic Applications .................................................................................................... A-4
A.2.4. Dentistry Applications.................................................................................................................. A-5
A.3. Ophthalmic Photocoagulation................................................................................................................ A-6
A.3.1. Ophthalmology Indications for Use....................................................................................... A-6
A.3.2. Contraindications in Ophthalmology..................................................................................... A-6
A.3.3. Slit Lamp................................................................................................................................ A-6
A.3.4. Laser Indirect Ophthalmoscope (LIO)................................................................................... A-6
A.3.5. Endoprobe.............................................................................................................................. A-7
A.3.6. Ophthalmology Precautions................................................................................................... A-7
A.3.7. Ophthalmology Warnings...................................................................................................... A-8

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A.4. Treatment Parameters in Ophthalmology .............................................................................................. A-8
A.4.1. Parameters in continuous waveform (CW)............................................................................ A-9
A.4.2. Parameters in SmartPulse..................................................................................................... A-10
A.5. Posterior Segment Laser Procedures.................................................................................................... A-11
A.5.1. Adverse Effects and Complications..................................................................................... A-11
A.5.2. Patient Warnings.................................................................................................................. A-12
A.5.3. Guidelines for Use ............................................................................................................... A-12
A.6. Anterior Segment Laser Procedures..................................................................................................... A-13
A.6.1. Uses...................................................................................................................................... A-13
A.6.2. Warnings.............................................................................................................................. A-14
A.6.3. Adverse Effects.................................................................................................................... A-14
A.6.4. Guidelines for Use ............................................................................................................... A-15
A.6.4.1. Iridotomy........................................................................................................................... A-15
A.6.4.2. Trabeculoplasty................................................................................................................. A-16
A.7. Ophthalmology Bibliography............................................................................................................... A-16
A.8. Ear, Nose and Throat (ENT) Laser Applications................................................................................. A-19
A.8.1. Indications............................................................................................................................ A-19
A.8.2. Contraindications................................................................................................................. A-19
A.8.3. Uses...................................................................................................................................... A-19
A.8.4. Warnings.............................................................................................................................. A-20
A.8.5. Precautions........................................................................................................................... A-20
A.8.6. Guidelines for Use ............................................................................................................... A-20
A.9. Otology References.............................................................................................................................. A-20
A.10. Delivery Devices and Accessories..................................................................................................... A-22
A.10.1. Filters ................................................................................................................................... A-22
A.10.2. Acculite Endoprobe.............................................................................................................. A-22
A.10.3. Fluence of laser energy delivered by endoprobe.................................................................. A-23
A.10.4. Laser Indirect Ophthalmoscope (LIO)................................................................................. A-26
A.10.5. Uses...................................................................................................................................... A-26
A.10.6. Warnings.............................................................................................................................. A-26
A.10.7. Guidelines for Use ............................................................................................................... A-26
A.10.8. Slit Lamps and LaserLinks for Slit Lamps .......................................................................... A-28
A.10.9. Description........................................................................................................................... A-28
A.10.10. Guidelines for use ............................................................................................................ A-28
A.11. Indirect Ophthalmoscope Bibliography............................................................................................. A-28

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TOC-6 UM-1151440EN, Rev. C, May 2016
List of Illustrations
Figure 2-1: Laser Treatment Room Warning Sign ......................................................................................... 2-3
Figure 2-2: System Regulatory Labels.......................................................................................................... 2-15
Figure 3-1: Smart532 Laser System Components ..........................................................................................3-2
Figure 3-2: Smart532 Laser System – Front Panel......................................................................................... 3-4
Figure 3-3: Smart532 Laser System – Rear Panel.......................................................................................... 3-5
Figure 3-4: Touch-Screen LCD Control Panel ...............................................................................................3-6
Figure 4-1: Physical Dimensions.................................................................................................................... 4-2
Figure 4-2: Smart532 Laser System – Front Panel......................................................................................... 4-4
Figure 4-3: Smart532 Laser System – Rear Panel.......................................................................................... 4-5
Figure 4-4: Connecting the Footswitch........................................................................................................... 4-6
Figure 4-5: Remote Interlock Plug Connection..............................................................................................4-7
Figure 4-6: Connecting the Main Power Cable ..............................................................................................4-8
Figure 4-7: Connecting a Delivery System (for illustration purposes only).................................................4-11
Figure 4-8: LIO Illumination and DVI Connections.....................................................................................4-12
Figure 5-1: Login Screen ................................................................................................................................ 5-1
Figure 5-2: Main Treatment Screen................................................................................................................ 5-2
Figure 5-3: SmartPulse Parameter Selection Pop-Up.....................................................................................5-5
Figure 5-4: Preset Screen................................................................................................................................ 5-7
Figure 5-5: Options Screen............................................................................................................................. 5-8
Figure 5-6: Option Screen: Adjust LIO Illumination......................................................................................5-9
Figure 5-7: Option Screen: Language Setting.................................................................................................5-9
Figure 5-8: Option Screen: Volume Setting ................................................................................................. 5-10
Figure 5-9: Option Screen: Backlight Setting............................................................................................... 5-11
Figure 6-1: Fuses Replacement....................................................................................................................... 6-2
Figure 5-10: Option Screen: Eye Safety Filter (ESF) Selection...................................................................5-12
Figure A-1: Spot Size versus Distance of fiber tip from Tissue .................................................................. A-24
Figure A-2: Irradiance versus Distance of Fiber Tip from Tissue............................................................... A-24

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UM-1151440EN, Rev. C, May 2016 TOC-7
List of Tables
Table 6-1: Troubleshooting Guide: Error Messages with Corrective Actions................................................6-5
Table 6-2: Troubleshooting Guide: Error Messages Requiring Contact with Lumenis Service.....................6-7
Table 6-3: Undisplayed System Malfunctions Troubleshooting Guide..........................................................6-8
Table A-1: Typical Treatment Parameters for Ophthalmic Applications...................................................... A-9
Table A-2: Several Examples of Repetitive Waveform Parameters............................................................ A-10
Table A-3: Irradiance and Fluence at 1 W and 0.5 Sec and 1.0 Sec Delivered ........................................... A-23
Table A-4: Spot Size and Irradiance at 1 W Delivered................................................................................ A-25

Table of Contents Smart532
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TOC-8 UM-1151440EN, Rev. C, May 2016

UM-1151140EN, Rev. C, May 2016
1-1
Chapter 1
Overview
1.1. Introduction
1.2. Scope of This
Manual
The Smart532-nm green laser system is indicated for ophthalmic
applications; ear, nose and throat applications; dentistry anddermatologic
applications. Complete and detailed lists of the system's clinical
indications appear in Appendix A of this manual – ClinicalGuide.
The Smart532 laser system is shipped directly from the factory toyour
site. A Lumenis-certified field engineer will initially uncrate, inspect,set
up and install the laser to ensure that it is ready for use. Inaddition,
Lumenis provides in-service training to ensure that your staff is
experienced with the operation and safety considerations of thelaser.
Thereafter, you or the staff at your facility will perform the daily
maintenance routines associated with the laser and with anydelivery
systems and/or accessories used during surgery, including inspectingand
cleaning the laser and delivery systems; sterilizing and connecting/
disconnecting the accessories. These procedures are detailed in this manual
or in the appropriate operator manuals of the delivery systemsand
accessories.
Most nursing staff prefer to inspect the laser and delivery systemsdaily,
usually prior to scheduled cases and before patients are admittedand
prepped. Doing so will ensure adequate time to troubleshoot a problemor
seek professional service with the least disruption to patientcare.
This manual is intended to provide the surgeon, private practitionerand
other personnel who operate or maintain the system with information
regarding the operating principles, controls, safety precautions,installation
and maintenance of the system. While this manual is intended to aid inthe
use and care of the equipment, it does not serve as a substitute forproper
training in the clinical applications of medical laserdevices.
This operator's manual incorporates the followingchapters:
Chapter 1: Overview Contains a general introduction to the
system.
Chapter 2: Laser Safety and
Regulatory Contains explanations and directions
concerning safety measures for
operating the system. This chapteralso
includes regulatory information and
requirements.

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UM-1151140EN, Rev. C, May 2016
Smart532
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Overview
Chapter 3: System
Description
Chapter 4: System
Installation and
initial setup
Contains a detailed overview of the
system and its various components,
controls, displays and connections.
Includes detailed specifications ofall
facets of the system.
Lists electrical, space andenvironmental
requirements for installation of the
system and basic installation & setup
instructions.
Chapter 5: Operating
Instructions Explains how to operate thesystem.
Chapter 6: Maintenance and
Troubleshooting
● Provides a detailed review of how
to maintain the system.
● Lists the system's error messages
that might occur duringoperation,
their probable causes and what
actions to take.
Appendix A: Clinical Guide Offers information about stafftraining,
indications and contraindications for
use, recommended setup parametersand
suggested professional reference
literature.
1.3. Manual
Conventions Throughout this manual, notes, cautions and warnings and are usedto
provide critical information needed before the device isused.
Examples:
A Note is a statement that alerts the operator toparticularly
important information.
A Caution is a statement that alerts the operator to thepossibility
of a problem with the device associated with its use ormisuse.
Such problems include device malfunction, device failure,and
damage to the device or other property. The cautionstatement
includes the precaution that should be taken to avoid thehazard.
Caution
Note

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1-3
Smart532
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Overview
A Warning is a statement that alerts the operator to thepossibility
of injury, death, or serious adverse reactions associated withthe
use or misuse of thedevice.
1.4. Physician
Responsibility
1.5. Maintenance
1.6. Modification of the
Device
Federal (USA) law restricts prescription medical devices to sale by oron
the order of a physician, or properly licensedpractitioner.
The properly licensed practitioner will be responsible for the useand
operation of the device and for all user qualifications. Lumenis makesno
representations regarding federal, state or local laws or regulationsthat
might apply to the use and operation of any medical device. Thephysician
is responsible for contacting his or her local licensing agenciesto
determine any credentials required by law for clinical use and operationof
the device.
The Smart532 laser system is a precision, technical medical devicethat
requires routine service. All service must be performed by a Lumenis
technician and all parts must be purchased from Lumenis. Failure toobtain
service and parts through Lumenis voids all warranties, expressedand
implied. Please call Lumenis or your local representative fordetails.
Unauthorized modification of the hardware, software or specificationsof
the Smart532 voids all warranties, expressed and implied. Lumenistakes
no responsibility for the use or operation of such adevice.
Changes or modifications not expressly approved bythe
manufacturer could void the user’s authority to operatethe
equipment.
1.7. Resale Inspection If any Lumenis device is resold by anyone other than an authorizedsales
representative, Lumenis offers a resale inspection by a Lumenistechnician
to assure that the device is working in accordance withmanufacturer’s
specifications. Using the device after it has been resold and before ithas
been inspected is a misuse of the device, which may result in injuriesand
voids all warranties, express andimplied.
Lumenis also offers service contracts and extended warranties forits
devices. For more information about the services or about the costsof
inspections or service calls, please call Lumenis or yourlocal
representative.
Caution
Warning

Smart532
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Overview
1-4
UM-1151140EN, Rev. C, May 2016
1.8. Abbreviations and
Acronyms
µm
°C
Microns
Degrees Celsius
cm
2
Centimeters squared
°F
Degrees Fahrenheit
ANSI
American National Standards Institute
CE
European Directives Compliance Marking
CFR
Code of Federal Regulations
cm
Centimeters
FCC
Federal Communications Commission(USA)
FDA
Food & Drug Administration (USA)
ESF
Eye Safety Filter
EU
European Union
GUI
Graphic User Interface
J/cm2
Joules per squarecentimeter
Kg
Kilogram(s)
Lbs.
Pounds
LCD
Liquid Crystal Display
LIO
Laser Indirect Ophthalmoscope
m
Meters
mm
Millimeters
ms
Milliseconds
mW
MilliWatts
NHZ
Nominal Hazard Zone
NOHD
Nominal Ocular HazardDistance
nm
Nanometers
OD
Optical Density
PRP
Pan-Retinal Photocoagulation
RoHS
Restriction of Hazardous Substances Directive(RoHS)
Compliance Marking
Sec
Seconds
UL
Underwriters Laboratories
USB
Universal Serial Bus
VAC
Volts, Alternating Current
VDC
Volts, Direct Current
W
Watts
WEEE
Waste Electrical and ElectronicEquipment
W/cm
2
Watts per square centimeter

UM-1151140EN, Rev. C, May 2016
2-1
Caution
Chapter 2
Laser Safety and Regulatory
2.1. Introduction
2.2. Training and
Institutional
Requirements
Operators must take precautions to prevent exposure of laser energy tothe
eyes and skin from either direct or diffusely reflected laser beams,except
as a therapeutic application. Additional precautions must be takento
prevent fire, electrical injury, andexplosion.
Lumenis does not make recommendations regarding the practiceof
medicine. Laser treatment parameters are provided as a guide.Individual
treatment should be based on clinical training, clinical observationof
laser-tissue interaction, and appropriate clinicalendpoints.
Patient safety should always be the clinician's first concern. Thischapter
of the manual includes the minimum information required to operatethe
system safely. In addition to the guidelines presented here, followall
applicable institutional procedures. Read this chapter completelybefore
attempting a procedure with the Smart532 lasersystem.
This chapter includes:
●Basic institutional requirements, including responsibilities of theLaser
Safety Officer.
●Detailed information concerning the safety eyewear requiredwhen
using the Smart532 laser system and its associated deliverysystems.
●Hazards associated with unsafe laser use.
●Safety features of the Smart532 laser system.
●Compliance with regulatory standards and regulatory labels adheredto
the Smart532 laser system.
No one should use the Smart532, or any other medicallaser,
without specific training in both medical laser use and lasersafety.
Both operator and safety training is available from Lumenis. Contactyour
Lumenis representative to inquire about seminars in yourarea.

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Smart532
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Laser Safety and Regulatory
2.2.1. Laser Safety
Officer Large institutions are following the prescriptions of ANSI 136.3and
EN 207 by setting up Laser Safety Committees and appointingLaser
Safety Officers to manage laser use. Even the smallest office shouldhave
one person to act in the capacity of Laser SafetyOfficer.
ANSI Z136.3 and EN 207 require the Laser Safety Officer to fulfillthe
following responsibilities:
1. Classify, or verify classification of, lasers and laser systems.
2. Evaluate hazards of laser treatment areas.
3. Assure that the prescribed control measures are in effect and
recommend or approve alternates when the primary ones arenot
feasible.
4. Approve operational procedures, including any proceduralchecklists.
5. Recommend or approve protective equipment, and assure that itis
periodically inspected to ensure proper working order.
6. Approve wording on signs and equipment labels.
7. Approve installation and equipment prior to use, and modificationsto
existing equipment and facilities.
8. Assure adequate safety education and training is provided forall
personnel.
The Laser Safety Officer may also assume other responsibilities, suchas
keeping laser use and maintenance logs. The Laser Safety Officershould
become familiar with the periodic maintenance requirements inthe
Maintenance chapter of thismanual.
For detailed information refer to Section 2.10. - Compliancewith
International Standards.

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Smart532
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Laser Safety and Regulatory
2.2.2. Laser Treatment/
Operating Area According to ANSI Z136.3, the Laser Safety Officer is responsible forthe
area in which laser treatments are carried out. In meeting thisrequirement,
the Laser Safety Officer should ensurethat:
1. The surroundings are safe for both the patient and theoperator.
2. The floor is uncluttered and clear access is maintained tothe
footswitch. Cables are secure and not crimped.
3. The operating area is occupied only by authorized personnel.
4. Appropriate warning signs are posted in the operating area andjust
outside of it. The Smart532 is a Class IV laser; the door warningsign
for the Smart532 is shown in Figure 2-1.
Figure 2-1: Laser Treatment Room WarningSign

2-4
UM-1151140EN, Rev. C, May 2016
Smart532
™
Laser Safety and Regulatory
2.3. Laser Safety
Eyewear Laser safety eyewear is routinely required with most lasers. Whenusing
the laser system, the Laser Safety Officer should determine the needfor
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 availablelaser
emissions and the configuration of the treatment room (usually withinthe
controlled area). For additional information, refer to ANSIZ136.1-2014,
ANSI Z136.3-2011, or International Standard IEC 60825-1:2014.
The following formula was used to calculate the worst case NOHDfor
Lumenis Smart532 lasers and compatible deliverysystems:
Where:
Z = the distance of the beam waist from the lasersystem;
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 naturallogarithms;
Ф= maximum energy of one laser pulse or maximum CW laserpower;
Pf = the profile correction factor (1 for uniform profile or 2for
Gaussian irradiance);
MPE = Maximum Permissible Exposure, in energy density units (energy
per unit area), or power density units (power per unitarea);
NOHD = the Nominal Ocular Hazard Distance (measuredfrom
laser aperture;
= the distance required to reduce the energy density orpower
density to the MPE.
Z
a
θ
NOHD = Z + Pf
- a2
1 4
MPE
Laser System