VersaPulse P20 Operator Manual Rev A Oct 2017

Table of Contents

Table of Contents 1.

SYSTEM OVERVIEW

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1.1. INTRODUCTION 1.2. CHARACTERISTICS OF THE HOLMIUM LASER WAVELENGTH 1.3. LASER PREPARATION 1.4. SCOPE OF THIS MANUAL 1.5. MANUAL CONVENTIONS 1.6. PHYSICIAN RESPONSIBILITY 1.7. MAINTENANCE 1.8. MODIFICATION OF THE DEVICE 1.9. RESALE INSPECTION 1.10. ABBREVIATIONS AND ACRONYMS

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2. SAFETY AND REGULATORY

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2.1. INTRODUCTION 2.2. TRAINING AND INSTITUTIONAL REQUIREMENTS 2.2.1. LASER SAFETY GUIDELINES 2.2.2. LASER SAFETY OFFICER 2.2.3. LASER TREATMENT/ OPERATING AREA 2.3. UNDERSTANDING AND CONTROLLING LASER IMPACT ON TISSUE 2.3.1. WAVELENGTH AND TISSUE VARIABILITY 2.3.2. SPOT SIZE, POWER AND EXPOSURE 2.4. LASER SAFETY EYEWEAR 2.4.1. ADDITIONAL OCULAR PROTECTION 2.5. ADDITIONAL SAFETY CONSIDERATIONS 2.5.1. SKIN HAZARDS 2.5.2. AIRWAY PRECAUTIONS 2.5.3. PROTECTING NON-TARGET TISSUES 2.6. FIRE HAZARDS 2.7. ELECTRICAL HAZARDS 2.7.1. RESIDUAL CURRENT CIRCUIT BREAKER 2.7.2. GROUNDING THE SYSTEM 2.8. OPERATING SAFETY CAUTIONS & WARNINGS 2.8.1. CAUTIONS 2.8.2. WARNINGS 2.9. SYSTEM SAFETY FEATURES 2.9.1. KEYSWITCH PROTECTION 2.9.2. SELF-TESTING AT START UP 2.9.3. SAFETY SHUTTER 2.9.4. REMOTE INTERLOCK PLUG

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2.9.5. DUAL-FOOTSWITCH MICROSWITCH 2.9.6. EMERGENCY STOP BUTTON 2.9.7. SHUTTER POSITION FAILSAFE 2.9.8. POWER MEASUREMENT FAILSAFE 2.9.9. SAFETY TIMER 2.9.10. CONTINUOUS INTERNAL SYSTEM MONITORING 2.9.10.1. System Faults 2.9.10.2. Internal Power Monitoring 2.9.10.3. Temperature 2.9.10.4. Laser Beam Emission Indicators 2.10. COMPLIANCE WITH INTERNATIONAL STANDARDS 2.10.1. EMERGENCY STOP BUTTON 2.10.2. KEYSWITCH 2.10.3. LASER EMISSION INDICATORS 2.10.4. EXTERNAL DOOR INTERLOCK 2.10.5. PROTECTIVE HOUSING 2.10.6. SAFETY SHUTTER 2.10.7. MANUAL RESTART 2.10.8. ELECTRONIC FAULT DETECTION CIRCUITRY 2.10.9. SAFETY INTERLOCKS 2.10.10. PRECISION OF DISPLAYED VALUES 2.11. WARNING, CERTIFICATION AND IDENTIFICATION LABELS 2.11.1. DESCRIPTION OF SYSTEM LABELS

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3. SYSTEM INSTALLATION AND INITIAL SETUP

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3.1. INTRODUCTION 3.2. SYSTEM DESCRIPTION 3.3. UNPACKING THE SYSTEM 3.4. FACILITY REQUIREMENTS 3.4.1. ELECTRICAL REQUIREMENTS 3.4.2. SPACE AND POSITIONING REQUIREMENTS 3.4.3. ENVIRONMENTAL REQUIREMENTS 3.5. INSTALLATION AND SETUP 3.5.1. CONNECT THE FOOTSWITCH 3.5.2. CONNECT THE REMOTE DOOR INTERLOCK PLUG 3.5.3. CONNECT THE MAIN POWER CABLE 3.5.4. FIBER PORT'S PROTECTIVE CAP 3.5.5. CONNECT THE DELIVERY SYSTEM 3.6. INITIAL SYSTEM TESTING 3.6.1. MAIN CONTROLS 3.6.2. SYSTEM START UP 3.6.3. REMOTE INTERLOCK CHECK 3.6.4. FOOTSWITCH CONNECTION CHECK

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3.6.5. EMERGENCY STOP BUTTON CHECK 3.7. TRANSPORTATION AND STORAGE

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4. OPERATING INSTRUCTIONS

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4.1. INTRODUCTION 4.2. SAFETY CONSIDERATIONS 4.3. BEFORE TURNING ON THE SYSTEM 4.4. AIMING BEAM VERIFICATION 4.5. CONTROL SCREEN BASICS 4.5.1. CONTROL SCREEN TABS 4.5.2. TREATMENT SCREEN ELEMENTS 4.5.3. UNDERSTANDING AVERAGE POWER 4.5.4. CASESAVER MODE 4.5.5. SUMMARY SCREEN ELEMENTS 4.5.6. OPTIONS SCREEN ELEMENTS 4.6. SLEEP MODE 4.7. SYSTEM MESSAGES 4.7.1. ADVISORY MESSAGES 4.7.2. ERROR MESSAGES 4.7.3. FIBER MESSAGES 4.8. SERVICE MODE 4.9. INTRA-OPERATIVE INSTRUCTIONS 4.10. POST-OPERATIVE INSTRUCTIONS

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5. MAINTENANCE

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5.1. SERVICE INFORMATION 5.2. SYSTEM SPECIFICATIONS 5.3. ROUTINE PERIODIC MAINTENANCE 5.4. HOSPITAL/CLINIC STAFF MAINTENANCE 5.4.1. VISUAL INSPECTION 5.4.2. ROUTINE EXTERIOR CLEANING 5.4.3. REMOTE INTERLOCK CHECKS 5.4.4. REMOTE INTERLOCK 5.4.5. EMERGENCY STOP BUTTON CHECK 5.4.6. INSPECT / REPLACE THE DEBRIS SHIELD 5.5. PROFESSIONAL MAINTENANCE 5.5.1. ENERGY DETECTORS CALIBRATION 5.6. MOVING AND TRANSPORTING THE SYSTEM 5.7. CUSTOMER SERVICE INFORMATION 5.7.1. WARRANTY 5.7.2. DECONTAMINATION OF RETURNED EQUIPMENT 5.7.3. RETURNING THE SYSTEM TO LUMENIS

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6. TROUBLESHOOTING

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6.1. 6.2. 6.3. 6.4.

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INTRODUCTION WARRANTY HAZARD PRECAUTIONS TROUBLESHOOTING GUIDES

7. CLINICAL GUIDE

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7.1. INDICATIONS FOR USE 7.2. CONTRAINDICATIONS 7.2.1. SPECIFIC CONTRA-INDICATIONS IN UROLOGY 7.2.2. SPECIFIC CONTRA-INDICATIONS IN GYNECOLOGY 7.3. WARNINGS AND PRECAUTIONS 7.4. COMPLICATIONS 7.5. CLINICAL PARAMETERS FOR TREATMENT 7.5.1. UROLOGY 7.5.2. URINARY LITHOTRIPSY 7.5.3. ENT SURGERY 7.5.4. GENERAL SURGERY 7.5.5. GYNECOLOGY 7.5.6. GASTROENTEROLOGY SURGERY

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8. EMC GUIDANCE AND MANUFACTURER’S DECLARATIONS

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8.1. ELECTRONIC EMISSIONS 8.2. ELECTROMAGNETIC IMMUNITY 8.3. RECOMMENDED SEPARATION DISTANCES

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List of Illustrations Figure 2-1: Laser Treatment Room Warning Sign ... 2-3 Figure 2-2: Warning, Certification and Identification Labels ... 2-18 Figure 3-1: System Description – Front Panel ... 3-2 Figure 3-2: System Description – Rear Panel ... 3-2 Figure 3-3: Physical Dimensions ... 3-4 Figure 3-4: Connecting the Footswitch ... 3-5 Figure 3-5: Remote Interlock Plug Pin Assignments (solder side of plug shown) ... 3-6

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Figure 3-6: Connecting the Main Power Cable ... 3-7 Figure 3-7: Fiber Port's Protective Cap ... 3-7 Figure 3-8: Proper Handling of the Fiber Connector ... 3-8 Figure 3-9: Connecting the Delivery System ... 3-9 Figure 4-1: Treatment Screen ... 4-4 Figure 4-2: Summary Screen ... 4-8 Figure 4-3: Options Screen... 4-9 Figure 4-4: Sleep Mode Display ... 4-11 Figure 4-5: Advisory Message Sample ... 4-12 Figure 4-6: Samples of Fiber Pop-Up Messages ... 4-13 Figure 4-7: Service Mode Screen ... 4-14 Figure 5-1: Debris Shield Removal ... 5-6 Figure 5-2: Inspect the Debris Shield Lens ... 5-7

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1.1. Introduction

The Lumenis VersaPulse P20 Holmium Laser is a multispecialty laser, providing utility in urology, arthroscopy, ENT, gastroenterology, gynecology, and general surgery applications. Fiber delivery of holmium laser energy is ideal for minimally invasive surgery, offering broad treatment options combining precise cutting, ablation, and coagulation. The VersaPulse P20 Holmium Laser is compact, compatible system with standard wall power featuring standard treatment controls. The laser offers a summary screen for case analysis, research, or record keeping. Lumenis lasers and delivery systems are precision medical instruments. They have undergone extensive testing and with proper handling are useful and reliable clinical instruments. If you have questions regarding your laser or delivery system, contact your local Lumenis representative. Warning Lasers generate a highly concentrated beam of light which may cause injury if improperly used. To protect the patient and operating personnel, the entire laser and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.

1.2. Characteristics of the Holmium Laser Wavelength

The holmium laser wavelength is strongly absorbed by water in tissue. Because soft tissue is comprised primarily of water, holmium laser energy is effective for excision, incision, ablation, and vaporization when in direct contact with soft tissue, and for coagulation when a few millimeters from soft tissue. The holmium laser wavelength falls in the near-infrared region of the electromagnetic spectrum. These wavelengths are invisible to the human eye; therefore, a low-powered, visible aiming beam is used to target tissue.

1.3. Laser Preparation

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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.

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System Overview

Thereafter, you or the nursing staff at your facility will perform the daily maintenance routines associated with the laser and any delivery systems used during surgery, including inspecting and cleaning the laser and delivery systems; connecting, disconnecting, and sterilizing the delivery systems; and verifying the aiming beam integrity. These procedures are detailed in this manual and in the delivery system instruction guide. 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. If your scheduled surgical procedure requires disposable delivery devices or accessories, it is helpful to have extra items ready and available in the treatment room should they be needed to complete a procedure.

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 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:

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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:

Installation and Initial Setup

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

Chapter 4:

Operating Instructions

Explains how to operate the system.

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System Overview

1.5. Manual Conventions

Provides a detailed review of how to maintain the system.

Chapter 5:

Maintenance

Chapter 6:

Troubleshooting Lists the system's error messages that might occur during operation, their probable causes and what actions to take.

Chapter 7:

Clinical Guide

Offers information about staff training, indications and contraindications for use, and recommended setup parameters for various Holmium laser applications.

Chapter 8

EMC Guidance

Describes the electromagnetic environment in which the system may be operated.

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 gives the operator particular important, not-safety related, supplemental information regarding the system's operation.

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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System Overview

1.6. 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.

1.7. Maintenance

The VersaPulse P20 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 VersaPulse P20 voids all warranties, express and implied. Lumenis takes no responsibility for the use or operation of such a device.

1.9. Resale Inspection

The VersaPulse P20 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

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"

Inches

°C

Degrees Celsius

CW

Continuous Wave

°F

Degrees Fahrenheit

ANSI

American National Standards Institute

CE

European Directives Compliance Marking

cm

Centimeters

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System Overview

DC

Direct Current

ENT

Ear, Nose and Throat

FDA

Food & Drug Administration (USA)

GUI

Graphic User Interface

GYN

Gynecology

Hz

Hertz International Electrotechnical Commission

IEC J/cm

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2

Joules per square centimeter

kg

Kilogram

lbs.

Pounds

LCD

Liquid Crystal Display

m

Meters

mJ

MilliJoules

mm

Millimeters

Mrad

Millirad (Radian)

mW

MilliWatts

nm

Nanometers

OD

Optical Density

PS

Power Supply

SIS

Security Identification System

µm

Micrometer

UL

Underwriters Laboratories

USB

Universal Serial Bus

VAC

Volts, Alternating Current

W

Watts

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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 VersaPulse P20 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 VersaPulse P20 system. ● Notes, precautions, cautions and warnings associated with the VersaPulse P20 system

2.2. Training and Institutional Requirements

Caution No one should use the VersaPulse P20, 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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2.2.1. Laser Safety Guidelines

American National Standards Institute specification ANSI Z136.3-2011 and Z136.1-2007 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

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 clinician. 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 VersaPulse P20 is a Class IV laser; the door warning sign for the VersaPulse P20 is shown in Figure 2-1.

Figure 2-1: Laser Treatment Room Warning Sign

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Safety and Regulatory

2.3. Understanding and Controlling Laser Impact on Tissue

Warning The VersaPulse P20 system contains a Class IV, holmium laser which produces an invisible beam of high energy 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.

2.3.1. Wavelengt h and Tissue Variability

Different types of lasers generate different wavelengths of light. When laser energy strikes tissue, the laser wavelength and the target tissue type determine the basic nature of the impact. Lasers of different wavelengths show different effects on a given type of tissue. Conversely, a laser of a given wavelength affects different types of tissue in different ways. The primary factor is the efficiency with which the tissue absorbs light of the given wavelength. An example that illustrates this concept is the use of the Argon laser for retinal surgery. The Argon laser is used for retinal surgery because the tissues and fluids in front of the retina do not absorb the Argon laser wavelength, whereas the retina itself does. By comparison, the holmium laser wavelength would be totally absorbed by the lens and would damage it before reaching the retina.

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Safety and Regulatory

The VersaPulse P20 is a holmium laser. The holmium emits a concentrated beam of light at a wavelength of 2.1 m, which is in the invisible infrared portion of the electromagnetic spectrum. The effects, and therefore the risks, of the holmium laser are primarily thermal. Light at the holmium laser wavelength is efficiently absorbed by water, the primary component of soft tissue. When the laser beam strikes soft tissue, its energy is absorbed by water in the tissue. The water heats up, boils, and vaporizes, taking the surrounding tissue with it. The effect of the holmium laser on tissue is further discussed in the Clinical Guide chapter of this manual. Note that the holmium laser beam can also damage bone or teeth, causing pitting, glazing and explosive separation.

2.3.2. Spot Size, Power and Exposure

Assuming that the laser wavelength and target tissue are given, the spot size, power, and exposure (including exposure duration) determine the laser's degree of impact. The operator sets the laser energy in Joules and pulse repetition rate in Hertz. The system calculates the laser power that will be delivered according to these parameters. Note the relationship of spot size and energy: at a given power setting, a larger spot size spreads the energy out over a larger area. This yields a larger area of impact, but a lesser tissue effect. The operator controls the exposure with the laser controls. The exposure determines the duration of the applied laser beam. Obviously, the longer the exposure is, the greater the tissue impact will be. The primary exposure control is the footswitch. The clinician uses spot size and exposure mode to control the interaction of the VersaPulse P20's laser beam, and its attendant thermal effects, on the patient’s tissue. Safe and effective use of the laser in clinical procedures comes with a mix of clinical training, mentoring and experience. A more complete discussion may be found in the Clinical Guide chapters of this manual.

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2.4. Laser Safety Eyewear

The following specifications were calculated for this system: System

Wavelength Used

Maximum Permissible Exposure

Nominal Ocular Hazard Distance [NOHD]

VersaPulse P20

2.1 µm

66.7 J/cm2

0.9 M

All personnel who are within the Nominal Ocular Hazard Distance are considered to be within the controlled area and must wear eye protection according to the following specifications: System

Wavelength Used

Minimum Optical Density

Protection Level

VersaPulse P20

2.1 µm

3.0

DI LB3

Warning

● Select the appropriate laser safety eyewear for the specific laser in use, by verifying that the above specifications are indicated on the laser safety eyewear that is at your disposal.

● Always provide eye protection for the patient. Wet thick cloths or wet gauze 4 x 4's can be used together with the patient's protective eyewear to reduce patient inconvenience. Never use them to replace protective goggles.

● For periorbital treatment, always protect the patient with dulled metal eye shields, as severe and irreversible eye damage and scarring may occur from direct or indirect exposure to the treatment beam.

Laser safety eyewear must meet all additional requirements as per ANSI Z136.1 and EN 207. 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 operating room. The barrier should be made of material that can withstand the power of the treatment beam for the maximum exposure time, relative to the configuration of the controlled area and the treatment parameters for the specific medical application.

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Safety and Regulatory

2.4.1. 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.

● Use caution when performing procedures around the eyes. 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, scanner, handpiece, probe, optical fiber or laser system aperture while the laser is energized. Severe eye or skin damage could occur. Turn off the laser before inspecting any delivery system or laser components.

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2.5. Additional Safety Considerations

Warning

● Spot size and laser energy are independently controlled. If the user changes to a delivery system with a smaller spot size during a procedure, the operator must remember that the energy or power density will increase.

● Incision/excision ideally should be performed with small laser spot sizes and appropriate power/energy densities. At the highest power densities, avoid prolonged exposure to limit depth of incision.

● Plastic instruments such as speculums or eye shields can melt when impacted by the laser beam, possibly resulting in chemical burns or noxious gases. Therefore, use only stainless steel surgical instruments designed specifically for laser use.

● Holmium laser light can be reflected off of smooth metallic surfaces, even though they may be blackened.

Caution

● US federal law restricts this device to sale by or on the order of a physician.

● Lumenis medical lasers and laser delivery systems are intended solely for physicians trained in the use of these instruments.

2.5.1. Skin Hazards

The skin is the second most vulnerable organ of the body. The damage from either direct or reflected laser light is thermal and shows as an erythematous reaction (reddening). The skin may also become dry and itch, or even char.

● Drapes – use wet packs or wet drapes and cotton pads thoroughly moistened with sterile saline to protect the patient from adjacent tissue burns.

● Gloves and Gowns – the clinician should wear gloves and gowns for added protection from chronic skin exposure.

● Hair – wetting the hair during procedures on the face and scalp will not guarantee it will not burn. Surgically drape hair to the maximum extent possible.

● Accessory Tips – the tip of the accessory may become hot during lasing and may cause tissue damage to either the clinician or patient on contact. After lasing has stopped, allow the tip to cool before touching it.

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● Diffuse reflections – in some cases the patient may be burned by diffuse reflections from instruments and other surfaces. Neither operator nor should patient wear reflective jewelry, such as gold watchbands, rings, or pendants.

2.5.2. Airway Precautions

Use of the laser in the presence of oxygen increases potential fire hazard. When performing a laser procedure, the surgeon and anesthesiologist should carefully consider airway management. Oxygen concentrations should be as low as clinically permissible during airway laser procedures. Anesthetic gases should be least-supportive of combustion. When choosing endotracheal tubes consider the complications that may result from by-products of tube combustion. Use endotracheal tubes that are least hazardous to the patient. Laser-resistant, cuffed, and flexible stainless steel endotracheal tubes are commercially available. Red rubber or silicone endotracheal tubes with FDA-approved, laser-resistant wrapping can also be used. The endotracheal tube cuff can be inflated with saline to protect it from inadvertent penetration. The saline can be dyed with methylene blue so that evidence of cuff-penetration by the laser will readily appear on surrounding gauze sponges. The endotracheal tube can be further protected by strategic placement of wet sponges to absorb accidental or stray laser energy. Ensure that the sponges do not dry, as this increases potential fire hazard.

2.5.3. Protecting Non-Target Tissues

Non-target tissues may be protected in the following ways:

● Saline soaked gauze sponges, moistened cotton-tipped applicators, or titanium rods may be used as backstops for the laser beam.

● Saline may be used in the abdomen to absorb stray laser energy. ● Specialized instrumentation such as laparoscopes with laser beam backstops and retractors designed to protect non-target tissues may be used.

● Patients' lips can be protected by moist gauze. When operating in the oral cavity, care should be taken to protect teeth and bone by using wet gauze or other nonflammable, heat-absorbing protective material.

● When anesthesia or pain medication is not used, the comfort and pain tolerance of the patient must be assessed. Unexpected movement by the patient could result in unintended laser exposure to non-target tissue. Caution To prevent unintended laser discharge, always turn off the laser before connecting a delivery system .

0644-002-01DE-E, Rev. A

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