PULSE 50H and 100H Operators Manual Rev A

Lumenis® PulseTM 50H / 100H Laser Systems 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, Pulse 50 and Pulse 100 are trademarks or registered trademarks of Lumenis. Copyright © Lumenis (Germany) GmbH Catalog Part Number: UM-20006520DE July 2015 Revision A

Manufactured by Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich-Dreieichenhain Germany Tel: +49 (0) 6103.8335.0 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.

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Lumenis® PulseTM 50H / 100H Laser Systems

Table of Contents

Table of Contents Table of Contents ... 3 Chapter 1: Introduction ... 7 Reference to the Lumenis Pulse Systems ... 8 Manual Conventions ... 8 System Description and Main Features ... 9 Laser System Console ... 10 Touch-Screen Control Panel ... 10 User Interface Language... 10 Footswitch ... 10 Optical Fibers ... 11 Component Checklist ... 11 Chapter 2: Theory of Operation ... 12 Laser Power Parameters ...12 Chapter 3: Safety ... 14 Introduction ... 14 Optical Hazards ...14 Laser Safety Eyewear ... 14 Additional Ocular Protection ... 15 Electrical Hazards... 16 Fire Hazards ... 16 Additional Safety Considerations ... 16 Protecting Non-Target Tissues ... 17 Laser Emission Indicators ... 18 Warning, Certification and Identification Labels... 18 Explanation of the symbols used in the labels... 19 Chapter 4: Clinical Guide ... 22 Indications for Use ... 24 Contraindications ... 24

Lumenis® PulseTM 50H / 100H Laser Systems

Table of Contents

Specific Contraindications in Urology ... 24 Specific Contraindications in Gynecology ... 24 Warnings and Precautions ... 24 Complications ... 25 Detailed Indications for Use ... 26 Urology ... 27 Arthroscopy ... 28 General Surgery... 29 ENT Surgery ...30 Gynecological Surgery ... 30 Gastroenterology Surgery ... 31 Pulmonary Surgery ...31 Dermatology and Plastic Surgery ... 32 Chapter 5: Preparing the System for Use ... 33 Moving the Laser System Console ...34 Connecting the Footswitch ... 35 Connecting the External Door Interlock Connector ... 36 Plugging in the Main Power Cable ... 37 Connecting the Optical Fiber ...38 SIS (Secured Identification System) Technology ... 41 Chapter 6: Operating Instructions ... 42 Emergency Stop Switch ... 42 Safety Eyewear ...43 Verification of Connections ... 43 Powering on the System ... 43 Restarting the Laser System ... 43 Treatment Screen Description ... 44 Laser Emission Indicators ... 46 Intra-Operative Instructions ... 47 Post-Operative Instructions ... 49 Moving the Laser Console ... 50 Chapter 7 - Troubleshooting and Maintenance ... 51

Lumenis® PulseTM 50H / 100H Laser Systems

Table of Contents

Handling Error Messages and Notifications... 51 Troubleshooting ... 52 Initialization Error Message Appears ...52 System Does Not Turn On ... 52 Inadequate or No Aiming Beam ... 52 No Laser Energy Emission ... 52 “Popping” or “Tapping” Coming Sound from the Fiber Port ... 53 Fiber Burn Back ...53 Unrecognized Fiber ... 53 A Notification or Error Message Appears on the Control Panel ... 53 System Overheats ... 54 Message Appears: Attach an Authorized Fiber ... 54 Message Appears: Attach fiber ... 54 Message Appears: Attach footswitch ... 54 Message Appears: Check footswitch ... 55 Message Appears: Check interlock ... 55 Message Appears: Insert debris shield ... 55 Message Appears: No lasers ... 55 Message Appears: Energy high ... 55 Message Appears: Energy low...55 Message Appears: Rate high ... 56 Message Appears: Rate low ... 56 Routine Periodic Maintenance ...57 Hospital/Clinic Staff Maintenance ... 58 Visual Inspection ... 58 Routine Exterior Cleaning... 58 Remote Interlock Check ... 58 Emergency Stop Button Check ... 59 Inspect the Debris Shield ... 59 Change the Debris Shield Optic ... 62 Professional Maintenance ... 63 Energy Detectors Calibration 63

Lumenis® PulseTM 50H / 100H Laser Systems

Table of Contents

Chapter 8: System Requirements and General Information... 65 Installation ... 65 Accessories ... 65 Tools (Optional) ... 66 Electrical Requirements ... 66 Electrical Utilities... 66 Systems Designed For Use Outside of Europe ... 66 Systems Designed For Use in European Communities Under the MDD ... 66 External Door Interlock Pin Assignments ... 67 Compliance With International Standards ... 68 Emergency Stop Button ...68 Keyswitch ... 68 Laser Emission Indicators ... 68 External Door Interlock... 68 Protective Housing ... 68 Safety Shutter ... 68 Manual Reset ... 69 Electronic Fault Detection Circuitry ... 69 Safety Interlocks... 69 Precision of Displayed Values ... 69 Space Requirements ... 69 System Specifications... 70 Laser Safety Eyewear ... 71 Replacement Parts Part Numbers ... 71 Compatible Optical Fibers ... 71 Decontamination of Returned Equipment ... 72 Customer Service and Warranty ... 72 Appendix A: EMC Guidance and Manufacturer's Declaration ... 73 Electromagnetic Emissions ... 73 Electromagnetic Immunity ... 74 Recommended Separation Distances ... 76

Lumenis® PulseTM 50H / 100H Laser Systems

Chapter 1: Introduction

Chapter 1: Introduction The Lumenis Pulse 50H and Lumenis Pulse 100H holmium laser systems provide utility in urology, orthopedics, ENT, gynecology and general surgery applications. Fiber delivery of holmium laser energy is ideal for minimally invasive surgery. 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 system and the appropriate optical fiber operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.

•

Lumenis medical lasers and laser optical fibers are intended solely for physicians trained in the use of these instruments.

In the USA: CAUTION: US federal law restricts this device to sale by or on the order of a physician.

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 system or optical fiber, contact Lumenis Customer Service.

NOTE: All of the screen captures shown in this manual are for illustration only and may differ depending on the specific version of your system and the language selected.

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Lumenis® PulseTM 50H / 100H Laser Systems Reference to the Lumenis Pulse Systems

Reference to the Lumenis Pulse Systems This operator's manual discusses two laser systems: the Lumenis Pulse 50H system and the Lumenis Pulse 100H system. • In many places the instructions in this manual are identical for both systems. In these instances the manual refers generically to the System. • In instances where the instructions are explicit to one or the other system, the manual refers specifically to the Pulse 50H system or to the Pulse 100H system.

Manual Conventions 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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Lumenis® PulseTM 50H / 100H Laser Systems

System Description and Main Features

System Description and Main Features The Lumenis Pulse 50H or Pulse 100H laser system comprises the following main components and features: • Laser system console • Rotatable control panel with touch-screen technology • Dual-pedal footswitch • Security Identification System (SIS) technology • Green aiming beam

Figure 1: Lumenis Pulse 50H / Pulse 100H Laser System Console

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Lumenis® PulseTM 50H / 100H Laser Systems

Laser System Console

Laser System Console The laser system console houses the control screen, the laser control keyswitch, emergency stop knob, main On/Off switch, control electronics, laser source and associated optics, and power supply. An optical fiber attaches to the fiber connection port on the front of the console, enabling laser energy to be delivered to the treatment site. Touch-Screen Control Panel The control panel is an LCD monitor with touch-screen technology that allows the operator to select treatment settings outside of the sterile field. User Interface Language To change the language displayed in the user interface screens consult with Lumenis Customer Service. Footswitch The dual-pedal footswitch activates the laser treatment beam when pressed, and offers the ability to select treatment from two sets of parameters by using the left or the right foot-pedal. It also incorporates a Standby/Ready foot-operated button.

Figure 2: Dual-Pedal Footswitch

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Lumenis® PulseTM 50H / 100H Laser Systems

Optical Fibers

Optical Fibers A variety of optical fibers are available for use with the Lumenis Pulse 50H and Lumenis Pulse 100H laser systems. Lumenis fibers incorporate Security Identification System (SIS) technology. Refer to the appropriate optical fiber’s instruction guide for specific operating instructions.

Component Checklist • Lumenis Pulse 50H or Pulse 100H laser system console. • Detachable dual-pedal footswitch. • External door interlock connector. • Keys • Operator’s manual.

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Lumenis® PulseTM 50H / 100H Laser Systems

Chapter 2: Theory of Operation

Chapter 2: Theory of Operation A laser, an acronym for Light Amplification of Stimulated Emission of Radiation, produces a highly concentrated beam of light of a given wavelength. Laser energy is generated by converting electrical energy to light energy using a flashlamp. The flashlamp energy is then used to excite the lasing medium, in this case a holmium YAG crystal rod. The laser energy is amplified in the laser resonator cavity and a small portion of the energy is allowed to leak out as the laser working beam. The Pulse 50H or 100H holmium laser system emits a laser beam at a wavelength of 2100nm. This wavelength is strongly absorbed by water in tissue. Since soft tissue is comprised primarily of water, holmium laser energy can be used effectively for excision, incision, ablation, and vaporization when in direct contact with soft tissue and for coagulation when in near contact with soft tissue. Calculi (stones) also contain a sufficient amount of water that absorbs the laser energy leading to lithotripsy. When working in liquid environment the holmium laser energy provides additional safety, since laser energy will be absorbed by the surrounding liquid, limiting its reach to non-target tissue. The holmium laser wavelength falls in the near-infrared region of the electromagnetic spectrum. This wavelength is invisible to the human eye. Therefore, a low-power, visible aiming beam is used to verify the laser’s target tissue.

Laser Power Parameters Tissue laser interaction is primarily governed by the laser wavelength and the target tissue absorption coefficient at that wavelength, defining the effectiveness of the laser energy absorption in the target tissue. However additional characteristics of the specific laser system affect the laser tissue interaction. Pulsed lasers (such as the holmium laser) deliver an average power (measured in Watts) that is achieved by multiplying the laser energy emitted during each pulse (measured in Joules) and the frequency at which these pulses are delivered (measured in Hertz). The Lumenis Pulse 50H or Pulse 100H can deliver a maximum average power of 50W or 100W respectively obtained, i.e., by delivery of 2 x 25 Hz.

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Lumenis® PulseTM 50H / 100H Laser Systems

Laser Power Parameters

Holmium laser systems can deliver the same average power at different settings to achieve different laser tissue effect. Changing the energy of each pulse can be described as the “bite size” of the laser effect, whereas the frequency as the “bite rate”. For example, setting the system at 50W can be performed using the following sets of parameters: 2.5J at 20Hz or 2.0J at 25Hz. When working with calculi, for example, these different settings may affect the stone by breaking the stone into particles versus disintegrating the stone into fine dust. The selection of the appropriate energy and frequency settings is dependent on the procedure and specific target tissue. Each pulse is delivered at a specific time frame, leading to fast heating rise in temperature of the target tissue. By increasing the pulse duration, the time frame of energy delivery to the tissue changes and thereby changing the temperature profile of the tissue. A different temperature profile may lead to a heating rather than a vaporizing effect and is useful for example when blood vessel coagulation is desired. The selection of appropriate power parameters and optical fiber is dependent on the procedure and the specific patient condition. It is recommended that you become familiar with laser characteristics and techniques by attending courses and consulting with colleagues in order to utilize the lasers capabilities in a safe manner.

Lumenis® PulseTM 50H / 100H Laser Systems

Chapter 3: Safety

Chapter 3: Safety Introduction This chapter contains important safety information related to the use of the laser system. All operating personnel should familiarize themselves with the contents of this chapter before operating the laser system. Users must take precautions to prevent exposure of laser energy to the eyes and skin from either direct or diffusely reflected laser beams, except as a therapeutic application. Additional precautions must be taken to prevent fire, electrical injury, and explosion. CAUTION: Read this operator’s manual carefully. Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure.

Optical Hazards Laser Safety Eyewear The following specifications were calculated for this systems: System

Maximum Permissible Exposure

Nominal Ocular Hazard Distance

Lumenis Pulse 50H

2 mJ/cm2

1.9 meters

Lumenis Pulse 100H

2 mJ/cm2

1.9 meters

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 (OD)

Protection Level

Lumenis Pulse 50H

Ho:YAG (2.1 µm)

3.0

DI LB3

Lumenis Pulse 100H

Ho:YAG (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.

Lumenis® PulseTM 50H / 100H Laser Systems

Additional Ocular Protection

Laser safety eyewear must meet the requirements as per EN207 and ANSI Z136.1. 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. 4. Depending on the procedure, the physician must protect the patient’s eyes with either laser safety eyewear or one of the following items moistened with a nonflammable solution: thick cloth, eye pads, or gauze 4 x 4s. For periorbital treatment, the physician must protect the patient with dulled, metal eye shields. Additional Ocular Protection WARNING: •

Always verify that the optical fiber is properly connected to the laser system. 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 fiber, handpiece, probe or laser system aperture while the laser system is energized. Severe eye damage could occur. Turn off the laser system before inspecting any optical fiber or laser components.

Lumenis® PulseTM 50H / 100H Laser Systems

Electrical Hazards

Electrical Hazards WARNING: •

Never open the laser system console protective covers. Opening the covers will expose the user to high voltage components, the laser resonator, and possible laser radiation. Only Lumenis-certified service technicians are qualified to work inside the console.

•

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

•

To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

Fire Hazards WARNING: •

Do not use this device in the presence of flammables or explosives, such as volatile anesthetics, alcohol, certain surgical preparation solutions, and similar substances. An explosion and/or fire could occur.

•

The treatment beam can ignite most non-metallic materials. Use fire retardant drapes and gowns. The area around the treatment site can be protected with towels or gauze sponges moistened with sterile saline solution or sterile water. If allowed to dry, protective towels and sponges can increase the potential fire hazard. A UL-approved fire extinguisher and water should be readily available.

•

When performing procedures in the perianal area, the flammability of methane gas must be considered. Moistened sponges should be inserted into the rectum.

Additional Safety Considerations CAUTION: Smoke evacuation may be required if using the laser system in open-air procedures.

Lumenis® PulseTM 50H / 100H Laser Systems

Protecting Non-Target Tissues

Protecting Non-Target Tissues WARNING: •

When using an optical fiber, always inspect it to ensure that it has not been kinked, punctured, fractured, or otherwise damaged. The optical fiber may be damaged if stepped on, pulled, left lying in a vulnerable position, kinked, or tightly coiled. Do not clamp the optical fiber with a hemostat or other instruments. If sterile tape is used, always remove the tape before lifting the optical fiber. A damaged optical fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.

•

Never deliver the treatment beam to the target tissue if the aiming beam integrity has not been verified; the optical fiber may be damaged. A damaged optical fiber may cause accidental laser exposure to the treatment room personnel or patient, and/or fire in the treatment room.

•

Except during actual treatment, the laser system must always be in Standby mode. Maintaining the laser system in Standby mode prevents accidental laser exposure if the footswitch is inadvertently pressed.

•

CAUTION: To prevent accidental laser discharge, always make sure that the footswitch is not being operated while connecting the optical fiber.

•

Never place hands or other objects in the path of the laser beam. Severe burns could occur.

•

Only the person directing the aim of the laser beam should have access to the laser system footswitch. Use caution pressing the laser system footswitch when it is in proximity to footswitches for other equipment. Verify the footswitch pressed is the correct one in order to avoid accidental laser exposure.

•

Never discharge the laser system without a target to absorb it and without consideration given to what lies behind the target. Place energy-absorbing material behind the target tissue when aiming the laser at an oblique target.

Lumenis® PulseTM 50H / 100H Laser Systems

Laser Emission Indicators

Laser Emission Indicators • An audible signal is emitted during lasing. A different audible sound is used for the left and right pedals. • When lasing, a lasing emission indicator appears on the screen.

Warning, Certification and Identification Labels As required by national and international regulatory agencies, appropriate warning labels have been mounted in the specified locations. Figure 3 displays the identification and certification labels affixed to the system and the symbols displayed in the labels:

Explanation of the symbols used in the

VISIBLE AVOID

LASER CLASS 4/IV Ho mi um : Ho lml ui :mYA 606000μsμpsuplsuelsme YGA :2.12.1μ m3,.53.5J mx.ax. :G mμ, mJa amx.ax. LASER CLASS 3R/Illa DS PP DS PP LaLsasere: r5:3523n2mn,m5,m5 WmWmamx.aCLASER x.WCW RADIATION AND INVISIBLE EYE OR SKIN EX POSUR E TO DIRECT

OR SCATTERED RADIATION CLCLAASSSS44LALASSEERRPRPO DUDC pereIEC/ N 082 RO UTCT prIECE/E N660825-1-5/210/200707 CLA CLASSSSIVIVLALASSEERRPPRROODUDCUT pere2C1 FCRFR101400.4100.1A0NADN1 .4101.11 CT pr12 D01400 except for deviations pursuant to Notice 50, dated June 24, 2007

LB 20001720_ A

Lumenis® PulseTM 50H / 100H Laser Systems

LB-20001260DE_A

STOP

SYSTEM SERIES

LASER CLASS 4/IV Holmium: YAG: 2.1 μm, 3.5 J max. 600 μs pulse max.

LASER CLASS 3R/Illa LB -20001720_A

DSPP Laser: 532 nm, 5 mW max. CW

VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION

CLASS 4 LASER PRODUCT per IEC/EN 60825-1/2007 CLASS IV LASER PRODUCT per 21 CFR 1040.10 AND 1040.11 except for deviations pursuant to Notice 50, dated June 24, 2007

LB-20001260DE_A

Figure 3: Location of Regulatory Compliance Labels Explanation of the symbols used in the labels The labels located on the system's front and rear panels contain the following information: Symbol

Description Lumenis, Energy to Healthcare

CE Compliance

Lumenis® PulseTM 50H / 100H Laser Systems Symbol

Explanation of the symbols used in the Description

Manufacturer

Date of Manufacture

Catalog Number

Serial Number

Series

Series Number

System

Model Name Follow Instruction for Use

Electrical Requirements

Type BF Equipment

This device contains: FCC ID: Z97-1149466

This device contains: FCC ID: Z97-1149466

LASER CLASS 4/IV Holmium: YAG: 2.1 μm, 3.5 J max. 600 μs pulse max.

LASER CLASS 3R/Illa LB -20001720_A

DSPP Laser: 532 nm, 5 mW max. CW

VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT per IEC/EN 60825-1/2007 CLASS IV LASER PRODUCT per 21 CFR 1040.10 AND 1040.11

Laser Class 4/IV Holmium:YAG Laser: 2.1µm, 3.5J max. 600 µs pulse max. Laser Class 4/IV DSSP Laser: 532nm, 5mW max. CW Visible and Invisible Laser Radiation Avoid eye or Skin Exposure to Direct or Scattered Radiation Class 4 laser product per IEC 60825-1:2007 CLASS IV LASER PRODUCT per 21 CFR 1040.10 & 1040.11 except for deviations pursuant to Notice 50, Dated June 24, 2007

except for deviations pursuant to Notice 50, dated June 24, 2007

Non-Ionizing Electromagnetic Radiation