AcuPulse User Manual Rev A Nov 2008

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, AcuPulse, SurgiTouch, Pulser, SuperPulse, AcuSpot 712, Digital AcuBlade, OtoLAM and BeamAlign are trademarks or registered trademarks of Lumenis. Caution: US federal law restricts this device to sale by or on the order of a physician.

Copyright © 2008, the Lumenis group of companies. Catalog Part Number: UM-1023360 November, 2008 Revision A

Use of this Manual: The AcuPulse laser system is designed to meet international safety and performance standards. Personnel operating the system must have a thorough understanding of the proper operation of the system. This manual has been prepared to aid medical and technical personnel to understand and operate the system. Do not operate the system before reading this manual and gaining a clear understanding of the operation of the system. 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 AcuPulse CO2 laser system. 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 system, and its location must be known to all personnel operating the system. Additional copies of this manual are available from your Lumenis distributor. System 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 [email protected]

Regulatory European Representative: Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich-Dreieichenhain Germany

Manufactured by Lumenis Ltd. P.O.B. 240 Yokneam 20692 Israel

AcuPulse

Table of Contents

Table of Contents CHAPTER 1

1.1. 1.2. 1.3. 1.4. 1.5. 1.6. 1.7. 1.8. 1.9. 1.10.

Overview

Page

Introduction... 1-1 Characteristics of the CO2 Laser Beam... 1-1 Laser Preparation ... 1-1 Scope of This Manual ... 1-2 Manual Conventions ... 1-3 Physician Responsibility... 1-4 Maintenance... 1-4 Modification of the Device ... 1-4 Resale Inspection ... 1-4 Abbreviations and Acronyms ... 1-4

CHAPTER 2

Laser Safety

Page

2.1. 2.2.

Introduction... 2-1 Training and Institutional Requirements... 2-1 2.2.1. Laser Safety Guidelines ... 2-2 2.2.2. Laser Safety Officer ... 2-2 2.2.3. Laser Treatment/ Operating Area... 2-3 2.3. Understanding and Controlling Laser Impact on Tissue ... 2-4 2.3.1. Laser Classes... 2-5 2.3.2. Wavelength and Tissue Variability... 2-5 2.3.3. Spot Size, Power and Exposure ... 2-6 2.4. Laser Safety Eyewear ... 2-7 2.4.1. Additional Ocular Protection ... 2-7 2.5. Additional Safety Considerations ... 2-8 2.5.1. Skin Hazards ... 2-9 2.5.2. Smoke Evacuation – Laser Plume Pollution Hazards... 2-9 2.5.3. Airway Precautions ... 2-10 2.5.4. Protecting Non-Target Tissues... 2-11 2.6. Fire Hazards ... 2-12 2.7. Electrical Hazards ... 2-13 2.7.1. Grounding the System... 2-14 2.8. Operating Safety Cautions & Warnings ... 2-14 2.8.1. Cautions ... 2-14 2.8.2. Warnings ... 2-15

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2.9.

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System Safety Features ... 2-16 2.9.1. Password Protection... 2-16 2.9.2. Self Testing at Start Up... 2-16 2.9.3. Safety Shutter... 2-16 2.9.4. Door Interlock Connector ... 2-16 2.9.5. Safety Interlocks and Failsafes ... 2-17 2.9.5.1. Dual-Footswitch Microswitch... 2-17 2.9.5.2.

Laser Stop Button... 2-17

2.9.5.3.

Shutter Position Failsafe ... 2-17

2.9.5.4.

Power Measurement Failsafe ... 2-17

2.9.6. Safety Timer... 2-17 2.9.7. Continuous Internal System Monitoring... 2-17 2.9.7.1. System Faults ... 2-17 2.9.7.2.

Internal Power Monitoring... 2-18

2.9.7.3.

Temperature ... 2-18

2.9.8. Laser Beam Emission Indicators... 2-18 2.10. Compliance with International Standards ... 2-18 2.11. Warning, Certification and Identification Labels ... 2-20

CHAPTER 3

System Installation

Page

3.1. 3.2. 3.3.

Introduction... 3-1 Unpacking the System ... 3-1 Facility Requirements ... 3-2 3.3.1. Space and Positioning Requirements ... 3-2 3.3.2. Electrical Requirements ... 3-3 3.3.3. Environmental Requirements... 3-3 3.4. Installation and Setup... 3-3 3.4.1. Articulated Arm Setup ... 3-5 3.4.2. Bacteriological Filter Installation... 3-6 3.4.3. Service Panel Connections... 3-6 3.5. Initial System Testing ... 3-7 3.5.1. System Controls ... 3-7 3.5.2. Main Control Panel ... 3-7 3.5.3. System Start Up ... 3-7 3.5.4. Door Interlock Check... 3-8 3.5.5. Footswitch Connection Check ... 3-8 3.5.6. Emergency Stop Button Check ... 3-9

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3.6.

Moving, Transporting and Storage ... 3-9 3.6.1. Moving the System within the Facility ... 3-9 3.6.2. Transporting the System ... 3-9

CHAPTER 4

4.1. 4.2. 4.3. 4.4.

Table of Contents

System Description

Page

General Laser Theory ... 4-1 CO2 Laser Theory ... 4-1 AcuPulse Laser System... 4-2 System Description ... 4-2 4.4.1. Control Panel ... 4-5 4.4.2. Optical Bench Assembly... 4-7 4.4.3. Cooling System... 4-7 4.4.4. Service Panel... 4-8 4.4.4.1. External Ground Connection ... 4-8 4.4.4.2.

Footswitch Connection ... 4-8

4.4.4.3.

Door Interlock Connection... 4-8

4.4.4.4.

Smoke Evacuator Connection ... 4-9

4.4.4.5.

Power Circuit Breaker... 4-9

4.4.4.6.

Power Cable Connection... 4-9

4.4.4.7.

USB Connections... 4-9

4.4.4.8.

VGA Monitor Connection ... 4-9

4.4.4.9.

Remote ... 4-9

4.5.

Understanding Laser Delivery ... 4-10 4.5.1. Exposure Types... 4-10 4.6. System Specifications ... 4-14 4.6.1. Outputs... 4-14 4.6.2. Operation and Control... 4-15 4.6.3. Cooling System... 4-15 4.6.4. Electrical Requirements ... 4-16 4.6.5. Physical Specifications ... 4-16 4.6.6. Environmental Specifications ... 4-16

CHAPTER 5

5.1. 5.2. 5.3.

Operating Instructions

Page

Introduction... 5-1 Safety Considerations ... 5-1 Starting the System ... 5-2

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5.3.1. Before Turning On the System ... 5-2 5.4. Operating the System... 5-2 5.5. Surgical Treatment... 5-5 5.5.1. SurgiTouch Treatment ... 5-5 5.5.1.1. SurgiTouch Menu ... 5-6 5.5.1.2.

Treatment Screen: Scanning Mode ... 5-7

5.5.1.3.

Treatment Screen: Non-Scanning Mode ... 5-10

5.5.2. Manual Treatment ... 5-11 5.6. Aesthetic Treatment ... 5-12 5.7. User Presets... 5-14 5.7.1. Programming User Presets... 5-14 5.7.2. My Settings ... 5-15 5.7.3. Fix Settings ... 5-16 5.8. Atlas of Accessories... 5-17 5.9. Preferences... 5-18 5.9.1. General Preferences ... 5-18 5.9.2. Air Flow Preferences ... 5-20 5.9.3. Sound Preferences... 5-21 5.10. Utilities Menu ... 5-22 5.10.1. Beam Offset ... 5-22 5.11. Users List ... 5-24 5.11.1. Add User ... 5-25 5.11.2. Edit User ... 5-26 5.12. System Messages ... 5-27 5.13. System Shut-Down ... 5-27

CHAPTER 6

Delivery Systems

Page

6.1. 6.2.

Introduction... 6-1 125mm Handpiece Set ... 6-1 6.2.1. Handpiece Assembly... 6-1 6.3. SurgiTouch Flashscanner... 6-2 6.3.1. Setting up the Flashscanner... 6-2 6.3.2. Cleaning the Optical Head ... 6-3 6.4. Beam Alignment Check ... 6-4 6.5. Optional Accessories ... 6-5 6.6. Cleaning, Sterilization and High-level Disinfection ... 6-6 6.6.1. General... 6-6 6.6.2. Deciding on Sterilization or High-level Disinfection ... 6-6

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6.6.3. 6.6.4. 6.6.5. 6.6.6.

Repeated Sterilization or High-level Disinfection ... 6-7 Cleaning Procedure ... 6-7 Sterilization Techniques... 6-8 High-level Disinfection Techniques ... 6-8

CHAPTER 7

7.1. 7.2. 7.3. 7.4. 7.5.

Maintenance

Page

Introduction... 7-1 Service Information ... 7-1 Routine Periodic Maintenance... 7-2 Lumenis Service... 7-3 Clinic Staff Maintenance ... 7-3 7.5.1. Visual Inspection ... 7-3 7.5.2. Routine Exterior Cleaning ... 7-3 7.5.3. Safety Interlock Checks ... 7-3 7.5.3.1. Door Interlock ... 7-4 7.5.3.2.

Emergency Stop Button Check ... 7-4

7.5.4. Purge Air Flow Check... 7-4 7.6. Professional Maintenance ... 7-5 7.6.1. Power Meter Calibration... 7-5 7.6.1.1. Internal Power Meter Check ... 7-5 7.7. 7.8.

Software Upgrade ... 7-7 Moving and Transporting the System... 7-7 7.8.1. Moving the Assembled System... 7-7 7.8.2. Transporting the System ... 7-8

CHAPTER 8

8.1. 8.2. 8.3. 8.4.

Troubleshooting

Page

Introduction... 8-1 Warranty ... 8-1 Hazard Precautions ... 8-1 Troubleshooting Guides... 8-1

APPENDIX A

Clinical Guide: Surgical Applications

Page

A.1. Introduction... A-1 A.2. Indications for Use ... A-1 A.2.1. General Laser Contraindications... A-2 A.2.2. General Laser Recommendations... A-2

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A.3. Podiatry Indications ... A-3 A.3.1. Safety Considerations and Complications for Podiatry ... A-3 A.4. Otolaryngology (ENT) Indications ... A-3 A.4.1. Safety Considerations for ENT ... A-5 A.4.1.1. Complications and Expected Sequelae ... A-5 A.4.2. Safety Considerations for LAUP ... A-6 A.4.2.1. Contraindications ... A-6 A.4.2.2. Complications ... A-6 A.4.3.

Safety Considerations for Myringotomy/Tympanostomy (Tympanic Membrane Fenestration) ... A-7 A.4.3.1. Precautions and Recommendations... A-7 A.4.3.2. Complications ... A-7

A.5. Gynecology and GYN Laparoscopy Indications ... A-7 A.5.1. Safety Considerations for Gynecology and GYN Laparoscopy ... A-8 A.5.1.1. Contraindications ... A-8 A.5.1.2. Complications ... A-9 A.6. Neurosurgery Indications... A-9 A.6.1. Safety Considerations for Neurosurgery... A-10 A.6.1.1. Contraindications ... A-10 A.6.1.2. Complications ... A-10 A.7. Orthopedics Indications ... A-10 A.7.1. Safety Considerations for Orthopedics ... A-11 A.7.2. Complications ... A-11 A.8. General and Thoracic Surgery Indications... A-11 A.8.1. Safety Considerations for General and Thoracic Surgery... A-12 A.8.1.1. Contraindications ... A-12 A.8.1.2. Complications ... A-12 A.9. Dental and Oral Surgery Indications... A-12 A.9.1. Safety Considerations for Dental and Oral Surgery... A-13 A.9.1.1. Contraindications ... A-13 A.9.1.2. Complications ... A-13 A.10. Genitourinary Indications ... A-13 A.10.1. Safety Considerations and Complications for Genitourinary Procedures... A-13 A.11. References... A-14

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APPENDIX B

Table of Contents

Clinical Guide: Aesthetic Applications

Page

B.1. Introduction ... B-1 B.2. Indications for Use ... B-1 B.2.1. General Laser Contraindications... B-2 B.2.2. General Laser Recommendations... B-2 B.3. Aesthetic (Dermatology/ Plastic Surgery) Indications ... B-3 B.3.1. Safety Considerations for Dermatology and Plastic Surgery... B-5 B.3.1.1. Contraindications ... B-5 B.3.1.2. Complications and Expected Sequelae... B-5 B.3.2. Safety Considerations for Laser Skin Resurfacing ... B-6 B.3.2.1. Contraindications ... B-7 B.3.2.2. Complications and Expected Sequelae... B-7 B.3.2.3. Patient Care and Treatment Recommendations ... B-8 B.3.2.4. Postoperative Care... B-8 B.4. References ... B-9

List of Illustrations Figure 2-1: Laser Treatment Room Warning Sign ... 2-3 Figure 2-2: Location of System Labels... 2-21 Figure 3-1: Physical Dimensions ... 3-2 Figure 3-2: Assembled AcuPulse Laser System ... 3-4 Figure 3-3: Release the Articulated Arm ... 3-5 Figure 3-4: Service Panel... 3-6 Figure 3-5: Control Panel... 3-8 Figure 4-1: AcuPulse Laser System... 4-4 Figure 4-2: Laser Optical System Diagram ... 4-5 Figure 4-3: Control Panel... 4-6 Figure 4-4: AcuPulse Treatment Screen (sample) ... 4-7 Figure 4-5: Service Panel... 4-8 Figure 4-6: CW Exposure Types ... 4-11 Figure 4-7: Pulser Exposure Types... 4-12 Figure 4-8: SuperPulse Exposure Types... 4-13 Figure 5-1: Login Screen ... 5-3 Figure 5-2: Home Screen ... 5-3

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Figure 5-3: Select Specialty Screen ... 5-5 Figure 5-4: SurgiTouch Menu Screen – Surgical (ENT) ... 5-6 Figure 5-5: Treatment Screen – Scanning Mode ... 5-7 Figure 5-6: Treatment Screen – Non-Scanning Mode ... 5-10 Figure 5-7: Treatment Screen – Manual Settings ... 5-11 Figure 5-8: Select Specialty Screen (Aesthetics) ... 5-12 Figure 5-9: SurgiTouch Menu Screen – Aesthetics ... 5-12 Figure 5-10: Treatment Screen (Aesthetics) ... 5-13 Figure 5-11: Add Settings Screen ... 5-14 Figure 5-12: My Settings Screen ... 5-15 Figure 5-13: SurgiTouch Presets Screen... 5-16 Figure 5-14: Atlas of Accessories Screen ... 5-17 Figure 5-15: General Preferences Screen... 5-18 Figure 5-16: Air Flow Preferences Screen... 5-20 Figure 5-17: Sound Preferences Screen ... 5-21 Figure 5-18: Utilities Menu Screen... 5-22 Figure 5-19: Beam Offset Screen... 5-23 Figure 5-20: Users List Screen... 5-24 Figure 5-21: Add User Screen ... 5-25 Figure 5-22: Edit User Screen... 5-26 Figure 6-1: 125mm Handpiece ... 6-1 Figure 6-2: Setting Up the SurgiTouch Flashscanner... 6-3 Figure 6-3: Beam Alignment Check Results ... 6-5 Figure 7-1: System Software Upgrade Utility Screen... 7-7

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Chapter 1 Overview

1.1. Introduction

AcuPulse encompasses a family of four DC-excited, CO2 laser system models for use in a variety of aesthetic, surgical and dental applications: 1. AcuPulse 30 2. AcuPulse 40 3. AcuPulse 30ST – this system includes software operating modules for the Lumenis SurgiTouch Flashscanner accessories. 4. AcuPulse 40ST – this system includes software operating modules for the Lumenis SurgiTouch Flashscanner accessories. The AcuPulse systems deliver maximal power of:

1.2. Characteristics of the CO2 Laser Beam

1.3. Laser Preparation

System Power: Î

30 Watt System

40 Watt System

Continuous Wave Mode

30 Watts

40 Watts

Pulser Mode

25 Watts

35 Watts

SuperPulse Mode

10 Watts

15 watts

The CO2 laser wavelength falls in the mid-infrared region of the electromagnetic spectrum. This wavelength is invisible to the human eye. Carbon dioxide laser energy is readily absorbed by water in tissue. Since soft tissue is comprised primarily of water, CO2 laser energy can be used effectively for the excision, incision, ablation, vaporization, and coagulation of soft tissue.

The laser is shipped directly from the factory to your site. Your local Lumenis representative initially uncrates, inspects, sets up and installs the laser to ensure that it is ready for use. In addition, Lumenis provides inservice 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.

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Overview

AcuPulse

Most nursing staff prefer to inspect the laser and delivery systems daily, usually prior to scheduled cases and before patients are premedicated. Doing so will ensure adequate time to troubleshoot a problem or seek professional service with the least disruption to patient care. These routine tasks may be performed outside of the sterile field; in this case, ensure enough time to sterilize any components, as necessary, before scheduled cases.

1.4. Scope of This Manual

This manual is intended to provide the surgeon 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 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:

1-2

Chapter 1:

Overview

Contains a general introduction to the system.

Chapter 2:

Laser Safety

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

Chapter 3:

System Installation

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

Chapter 4:

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 5:

Operating Instructions

Explains how to operate the system.

Chapter 6:

Delivery Systems

Describes the various delivery systems used with the AcuPulse.

Chapter 7:

Maintenance

Provides a detailed review of how to maintain the system.

Chapter 8:

Troubleshooting Lists the system's error messages that

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System

might occur during operation, their probable causes and what actions to take.

1.5. Manual Conventions

Appendix A: Clinical Guide: Surgical Applications

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

Appendix A: Clinical Guide: Aesthetic Applications

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.

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.

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Overview

1.6. Physician Responsibility

AcuPulse

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.

1.7. Maintenance

The AcuPulse 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, express and implied. Please call Lumenis or your local representative for details.

1.8. Modification of the Device

Unauthorized modification of the hardware, software or specifications of the AcuPulse voids all warranties, express and implied. Lumenis takes no responsibility for the use or operation of such a device.

1.9. Resale Inspection

The AcuPulse is a precision, technical medical device. 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.

1.10. Abbreviations and Acronyms

1-4

"

Inches

°C

Degrees Celsius

°F

Degrees Fahrenheit

ANSI

American National Standards Institute

CE

European Directives Compliance Marking

cm

Centimeters

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CO2

Carbon Dioxide

CW

Continuous Wave

DC

Direct Current

ENT

Ear, Nose and Throat

FDA

Food & Drug Administration (USA)

GUI

Graphic User Interface

GYN

Gynecology

Hz

Hertz

IEC

International Electrotechnical Commission

ISO

International Standards Organization

J/cm2

Joules per square centimeter

kg

Kilogram

lbs

Pounds

LAM

Laser-Assisted Myringotomy

LAN

Local Area Network

LAUP

Laser-Assisted Uvulopalatoplasty

LCD

Liquid Crystal Display

LED

Light Emitting Diode

m

Meters

mJ

MilliJoules

mm

Millimeters

mW

MilliWatts

nm

Nanometers

OD

Optical Density

PS

Power Supply

SP

SuperPulse

UL

Underwriters Laboratories

USB

Universal Serial Bus

VAC

Volts, Alternating Current

W

Watts

1-5

2.

Chapter 2 Laser Safety

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 AcuPulse laser system. This chapter includes:

• Basic institutional requirements, including responsibilities of the Laser Safety Officer

• How and why the laser impacts tissue, and how this is controlled • Hazards associated with unsafe laser use • Safety features of the AcuPulse • Notes, precautions, cautions and warnings associated with the AcuPulse

2.2. Training and Institutional Requirements

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

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

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Laser Safety

2.2.1. Laser Safety Guidelines

AcuPulse

American National Standards Institute specification ANSI Z136.3-2005 and Z136.1-2000 include a very thorough discussion of laser safety and guidelines for medical laser use. These standards were developed in the earliest days of lasers and are routinely revised to keep up with growing technology. ANSI Z136.3 is written specifically for the use of lasers in medicine. While non-binding, the guidelines are excellent guides for an office or institution seeking to set up a formal safety program. Lumenis strongly recommends that the operators read these two ANSI standards before using a laser in clinical practice.

2.2.2. Laser Safety Officer

Large institutions are following the prescriptions of ANSI 136.3 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 requires 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 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.

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2.2.3. Laser Treatment/ Operating Area

Laser Safety

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 AcuPulse is a Class IV laser; the door warning sign for the AcuPulse is shown in Figure 2-1.

VISIBLE AND INVISIBLE LASER RADIATION Avoid eye or skin exposure To direct or scattered radiation.

LASER SURGERY IN PROGRESS SAFETY EYEWEAR REQUIRED CO 2 LASER/10600nm

40 Watts Continuous

Diode LASER/635nm

CLASS 4/IV LASER 5 mWatts Continuous CLASS 3A/IIIa LASER

Figure 2-1: Laser Treatment Room Warning Sign

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Laser Safety

2.3. Understanding and Controlling Laser Impact on Tissue

AcuPulse

Warning The AcuPulse system contains a Class IV, CO2 laser which produces an invisible beam of high energy infrared radiation. Improper use could result in serious personal injury. Observe all safety precautions for Class IV lasers.

Many different types of lasers have been developed for multitudes of different uses. Each type of laser has a certain potential for harm if misused. Even lasers designed for use on living tissue must be used and applied carefully in order to avoid:

• Hazards to the patient or clinical personnel • Hazards to the physical surroundings For this reason, it is important to understand the basics of how laser energy affects living tissue and how to control this energy so as to avoid misapplication. The tissue damage that a misused laser may do depends on the following factors:

• Class of the laser • Wavelength of the laser • Tissue variability of the area in contact with a laser beam • Spot size or beam diameter • Power • Exposure, or time duration of beam contact The following sections describe these factors in more detail.

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