Smart 532 Operator Manual Rev C

Authorized Representative in the European Community: Lumenis (Germany) GmbH Heinrich-Hertz-Str. 3 Dreieich-Dreieichenhain D-63303 Germany Tel: +49 (0) 6103-8335-0 Fax: +49 (0) 6103-8335-300 Manufactured by Lumenis Ltd. Yokneam Industrial Park 6 Hakidma Street P.O.B. 240 Yokneam 2069204, Israel Tel: +972-4-959-9000 Fax: +972-4-959-9050 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

Table of Contents CHAPTER 1

1.1. 1.2. 1.3. 1.4. 1.5. 1.6. 1.7. 1.8.

Overview

Page

Introduction ... 1-1 Scope of This Manual ... 1-1 Manual Conventions ... 1-2 Physician Responsibility ... 1-3 Maintenance ... 1-3 Modification of the Device ... 1-3 Resale Inspection ... 1-3 Abbreviations and Acronyms ... 1-4

CHAPTER 2

Laser Safety and Regulatory

Page

2.1. 2.2.

Introduction ... 2-1 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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Table of Contents

2.9. 2.10. 2.11. 2.12.

Laser Beam Emission Indicators ... 2-11 Compliance with International Standards ... 2-12 Warning, Certification and Identification Labels ... 2-14 Symbol Descriptions ... 2-16

CHAPTER 3

3.1.

Smart532™

System Description

Page

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. 4.2. 4.3.

Introduction ... 4-1 Unpacking the System ... 4-1 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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Smart532™

Table of Contents

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. 5.2. 5.3.

Safety Considerations ... 5-1 Starting the System ... 5-1 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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CHAPTER 6

Maintenance and Troubleshooting

Smart532™

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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Smart532™

Table of Contents

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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Smart532™

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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Smart532™

Table of Contents

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

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Smart532™

UM-1151440EN, Rev. C, May 2016

Chapter 1 Overview

1.1. Introduction

The Smart532-nm green laser system is indicated for ophthalmic applications; ear, nose and throat applications; dentistry and dermatologic applications. Complete and detailed lists of the system's clinical indications appear in Appendix A of this manual – Clinical Guide. The Smart532 laser system is shipped directly from the factory to your site. A Lumenis-certified field engineer will initially uncrate, inspect, set up and install the laser to ensure that it is ready for use. In addition, Lumenis provides in-service training to ensure that your staff is experienced with the operation and safety considerations of the laser. Thereafter, you or the staff at your facility will perform the daily maintenance routines associated with the laser and with any delivery systems and/or accessories used during surgery, including inspecting and 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 systems and accessories. Most nursing staff prefer to inspect the laser and delivery systems daily, usually prior to scheduled cases and before patients are admitted and prepped. Doing so will ensure adequate time to troubleshoot a problem or seek professional service with the least disruption to patient care.

1.2. Scope of This Manual

This manual is intended to provide the surgeon, private practitioner and 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 in the use and care of the equipment, it does not serve as a substitute for proper training in the clinical applications of medical laser devices. This operator's manual incorporates the following chapters:

UM-1151140EN, Rev. C, May 2016

Chapter 1:

Overview

Contains a general introduction to the system.

Chapter 2:

Laser Safety and Contains explanations and directions concerning safety measures for Regulatory operating the system. This chapter also includes regulatory information and requirements.

1-1

Smart532™

Overview

Chapter 3:

System Description

Contains a detailed overview of the system and its various components, controls, displays and connections. Includes detailed specifications of all facets of the system.

Chapter 4:

System Installation and initial setup

Lists electrical, space and environmental requirements for installation of the system and basic installation & setup instructions.

Chapter 5:

Operating Instructions

Explains how to operate the system.

Chapter 6:

Maintenance and Troubleshooting

● Provides a detailed review of how to maintain the system. ● Lists the system's error messages that might occur during operation, their probable causes and what actions to take.

Appendix A: Clinical Guide

1.3. Manual Conventions

Offers information about staff training, indications and contraindications for use, recommended setup parameters and suggested professional reference literature.

Throughout this manual, notes, cautions and warnings and are used to provide critical information needed before the device is used. Examples: Note A Note is a statement that alerts the operator to particularly important information. Caution A Caution is a statement that alerts the operator to the possibility of a problem with the device associated with its use or misuse. Such problems include device malfunction, device failure, and damage to the device or other property. The caution statement includes the precaution that should be taken to avoid the hazard.

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Smart532™

Overview

Warning A Warning is a statement that alerts the operator to the possibility of injury, death, or serious adverse reactions associated with the use or misuse of the device.

1.4. Physician Responsibility

Federal (USA) law restricts prescription medical devices to sale by or on the order of a physician, or properly licensed practitioner. The properly licensed practitioner will be responsible for the use and operation of the device and for all user qualifications. Lumenis makes no representations regarding federal, state or local laws or regulations that might apply to the use and operation of any medical device. The physician is responsible for contacting his or her local licensing agencies to determine any credentials required by law for clinical use and operation of the device.

1.5. Maintenance

The Smart532 laser system is a precision, technical medical device that requires routine service. All service must be performed by a Lumenis technician and all parts must be purchased from Lumenis. Failure to obtain service and parts through Lumenis voids all warranties, expressed and implied. Please call Lumenis or your local representative for details.

1.6. Modification of the Device

Unauthorized modification of the hardware, software or specifications of the Smart532 voids all warranties, expressed and implied. Lumenis takes no responsibility for the use or operation of such a device. Caution Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment.

1.7. Resale Inspection

If any Lumenis device is resold by anyone other than an authorized sales representative, Lumenis offers a resale inspection by a Lumenis technician to assure that the device is working in accordance with manufacturer’s specifications. Using the device after it has been resold and before it has been inspected is a misuse of the device, which may result in injuries and voids all warranties, express and implied. Lumenis also offers service contracts and extended warranties for its devices. For more information about the services or about the costs of inspections or service calls, please call Lumenis or your local representative.

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Smart532™

Overview

1.8. Abbreviations and Acronyms

µm °C cm2 °F ANSI CE CFR cm FCC FDA ESF EU GUI J/cm2 Kg Lbs. LCD LIO m mm ms mW NHZ NOHD nm OD PRP RoHS Sec UL USB VAC VDC W WEEE W/cm2

1-4

Microns Degrees Celsius Centimeters squared Degrees Fahrenheit American National Standards Institute European Directives Compliance Marking Code of Federal Regulations Centimeters Federal Communications Commission (USA) Food & Drug Administration (USA) Eye Safety Filter European Union Graphic User Interface Joules per square centimeter Kilogram(s) Pounds Liquid Crystal Display Laser Indirect Ophthalmoscope Meters Millimeters Milliseconds MilliWatts Nominal Hazard Zone Nominal Ocular Hazard Distance Nanometers Optical Density Pan-Retinal Photocoagulation Restriction of Hazardous Substances Directive (RoHS) Compliance Marking Seconds Underwriters Laboratories Universal Serial Bus Volts, Alternating Current Volts, Direct Current Watts Waste Electrical and Electronic Equipment Watts per square centimeter

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Chapter 2 Laser Safety and Regulatory

2.1. Introduction

Operators 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. Patient safety should always be the clinician's first concern. This chapter of the manual includes the minimum information required to operate the system safely. In addition to the guidelines presented here, follow all applicable institutional procedures. Read this chapter completely before attempting a procedure with the Smart532 laser system. This chapter includes:

● Basic institutional requirements, including responsibilities of the Laser Safety Officer.

● Detailed information concerning the safety eyewear required when using the Smart532 laser system and its associated delivery systems.

● Hazards associated with unsafe laser use. ● Safety features of the Smart532 laser system. ● Compliance with regulatory standards and regulatory labels adhered to the Smart532 laser system.

2.2. Training and Institutional Requirements

Caution No one should use the Smart532, or any other medical laser, without specific training in both medical laser use and laser safety.

Both operator and safety training is available from Lumenis. Contact your Lumenis representative to inquire about seminars in your area.

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Smart532™

Laser Safety and Regulatory

2.2.1. Laser Safety Officer

Large institutions are following the prescriptions of ANSI 136.3 and EN 207 by setting up Laser Safety Committees and appointing Laser Safety Officers to manage laser use. Even the smallest office should have one person to act in the capacity of Laser Safety Officer. ANSI Z136.3 and EN 207 require the Laser Safety Officer to fulfill the 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 are not feasible. 4. Approve operational procedures, including any procedural checklists. 5. Recommend or approve protective equipment, and assure that it is periodically inspected to ensure proper working order. 6. Approve wording on signs and equipment labels. 7. Approve installation and equipment prior to use, and modifications to existing equipment and facilities. 8. Assure adequate safety education and training is provided for all personnel. The Laser Safety Officer may also assume other responsibilities, such as keeping laser use and maintenance logs. The Laser Safety Officer should become familiar with the periodic maintenance requirements in the Maintenance chapter of this manual. For detailed information refer to Section 2.10. - Compliance with International Standards.

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Smart532™

2.2.2. Laser Treatment/ Operating Area

Laser Safety and Regulatory

According to ANSI Z136.3, the Laser Safety Officer is responsible for the area in which laser treatments are carried out. In meeting this requirement, the Laser Safety Officer should ensure that: 1. The surroundings are safe for both the patient and the operator. 2. The floor is uncluttered and clear access is maintained to the 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 and just outside of it. The Smart532 is a Class IV laser; the door warning sign for the Smart532 is shown in Figure 2-1.

Figure 2-1: Laser Treatment Room Warning Sign

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Smart532™

Laser Safety and Regulatory

2.3. 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 Z136.1-2014, ANSI Z136.3-2011, or International Standard IEC 60825-1: 2014. The following formula was used to calculate the worst case NOHD for Lumenis Smart532 lasers and compatible delivery systems:

Where: 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;

Ф=

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);

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. Z

NOHD = Z +

1

4

MPE

Laser System

Pf - a 2

a

θ

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Smart532™

Laser Safety and Regulatory

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

0.00137

1

0.050

5.7

LaserLink Z

0.010

2.5

0.00137

1

0.100

9.8

LIO Keeler

0.024

2.5

0.00137

2

0.096

37

LIO Heine

0.022

2.5

0.00137

2

0.107

36

Endoprobe

0.140

2.5

0.00137

2

0.02

0

Lumenis 1000

0.010

2.5

0.00137

1

0.100

9.8

Insight

0.010

2.5

0.00137

1

0.100

9.8

Array LaserLink

0.010

2.5

0.00137

1

0.100

9.8

Which results in a worst case NOHD of: NOHD [m] LaserLink HS

24.2

LaserLink Z

48.3

LIO Keeler

28.8

LIO Heine

31.3

Endoprobe

4.87

Lumenis 1000

48.3

Insight

48.3

Array LaserLink

48.3

Calculated OD value is OD=3.7 for all delivery types. 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:

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LaserLink HS

OD 4+

LaserLink Z

OD 4+

LIO Keeler

OD 4+

LIO Heine

OD 4+

Endoprobe

OD 4+

Lumenis 1000

OD 4+

Insight

OD 4+

Array LaserLink

OD 4+

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Smart532™

Laser Safety and Regulatory

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 operators who must comply with EN 207, the safety eyewear must have a protection class of LB6. 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. Note 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.

2.3.1. 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.

● 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.

● 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.

● 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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