Operators Manual
140 Pages
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®
TM
Lumenis PULSE 60H Holmium Surgical Laser Operator's Manual
TEMPORARY PLACEHOLDER
Lumenis® PulseTM 60H Laser System 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 and Pulse 60H are trademarks or registered trademarks of Lumenis. Copyright © Lumenis Ltd. Catalog Part Number: UM-20057180EN September 2016 Revision A
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.
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Lumenis® PulseTM 60H Laser System
0483
EC
REP
Authorized Representative in the European Community: Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich-Dreieichenhain Germany Tel: +49 (0) 6103.8335.0 Manufactured by Lumenis Ltd. Yokneam Industrial park 6 Hakidma Street P.O.B. # 240 Yokneam 2069204, Israel Tel: +972 (0) 4.959.9000 Fax: +972 (0) 4.959.9050 www.Lumenis.com
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Lumenis® PulseTM 60H Laser System
Table of Contents
Table of Contents Table of Contents ... 4 Chapter 1: Introduction ... 10 Manual Conventions ... 11 System Description and Main Features ... 12 Laser System Console ... 13 Touch-Screen Control Panel ... 13 User Interface Language ... 13 Footswitch ... 13 Optical Fibers ... 14 Chapter 2: Theory of Operation ... 15 General Theory of Operation ... 15 Laser Power Parameters ... 15 Theory of Operation – Moses Mode ... 16 Chapter 3: Safety ... 18 Introduction ... 18 Optical Hazards ... 18 Laser Safety Eyewear ... 18 Additional Ocular Protection ... 19 Electrical Hazards ... 20 Fire Hazards ... 20 Additional Safety Considerations ... 21 Protecting Non-Target Tissues ... 21 Laser Emission Indicators ... 23 Warning, Certification and Identification Labels ... 24 Description of System Labels: 25 Chapter 4: Clinical Guide ... 28 Indications for Use ... 30 Contraindications ... 30
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Lumenis® PulseTM 60H Laser System
Table of Contents
Specific Contraindications in Urology ... 30 Specific Contraindications in Gynecology ... 30 Warnings and Precautions ... 31 Complications ... 32 Detailed Indications for Use ... 33 Urology ... 33 Arthroscopy ... 34 General Surgery ... 35 ENT Surgery ... 36 Gynecological Surgery ... 36 Gastroenterology Surgery ... 37 Pulmonary Surgery ... 37 Dermatology and Plastic Surgery ... 38 Chapter 5: Preparing the System for Use ... 39 Moving the Laser Console ... 40 Connecting the Footswitch ... 41 Connecting the External Door Interlock Connector ... 42 Plugging in the Mains Power Cable ... 43 Installing the Fiber Arm Support ... 44 Connecting the Optical Fiber ... 45 SIS (Secured Identification System) Technology 47 Connecting the Suction System ... 48 Main System Screens ... 51 Home Screen Description ... 51 Specialties Screen Description ... 54 Treatment Screen Description ... 55 Laser Emission Indication ... 59 Chapter 6: Operating Instructions ... 60 Emergency Stop Switch ... 60 Safety Eyewear ... 61 Verification of Connections ... 61
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Lumenis® PulseTM 60H Laser System
Table of Contents
Powering Up the System ... 61 Restarting the Laser System ... 63 Setting the Treatment Parameters and Controls ... 64 Starting the Laser Treatment ... 67 Operating in Moses Mode with Moses Fibers ... 69 Selecting Moses Mode Treatment ... 69 Intra-Operative Instructions ... 71 Post-Operative Instructions ... 73 Shutting Down the System ... 74 Advanced Operations ... 76 Saving Settings as Presets ... 76 Preset Management ... 78 Introduction ... 78 Choosing Presets ... 80 Creating New Presets ... 82 Editing Presets ... 84 Duplicating Presets ... 86 Deleting Presets ... 88 Exporting Presets ... 89 Favorites ... 91 Changing the Favorite Presets (Add, Remove and Reorder) ... 91 Favorite: Quick Add ... 94 Favorite: Quick Remove ... 95 Reports ... 96 Exporting the Reports ... 97 Changing the Default Specialty ... 100 Other Operations ... 102 Turning Off the Aiming Beam ... 102 Changing Screen Settings ... 103 Adjusting Volume and Sound Indications ... 104 Changing Date and Time ... 107 Changing the Interface Language ... 110
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Lumenis® PulseTM 60H Laser System
Table of Contents
Exporting Service Log ... 112 Restoring Default Settings ... 115 Case Saver Mode ... 115 Help ... 116 Chapter 7 - Troubleshooting and Maintenance ... 117 Handling Error Messages and Notifications ... 117 Troubleshooting ... 118 Initialization Error Message Appears ... 118 System Does Not Turn On ... 118 Inadequate or No Aiming Beam ... 118 No Laser Energy Emission ... 118 “Popping” or “Tapping” Coming Sound from the Fiber Port ... 119 Fiber Burn Back ... 119 Unrecognized Fiber ... 119 A Notification or Error Message Appears on the Control Panel ... 119 System Overheats ... 120 Non-Specific Events of Unusual System Behavior ... 120 Message Appears: Attach an Authorized Fiber ... 120 Message Appears: Attach fiber ... 121 Message Appears: Attach footswitch ... 121 Message Appears: Check footswitch ... 121 Message Appears: Check interlock ... 121 Message Appears: Insert debris shield ... 121 Message Appears: No lasers ... 121 Message Appears: Energy high ... 122 Message Appears: Energy low ... 122 Message Appears: Rate high ... 122 Message Appears: Rate low ... 122 Routine Periodic Maintenance ... 123 Hospital/Clinic Staff Maintenance ... 124 Visual Inspection ... 124 Routine Exterior Cleaning ... 124
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Lumenis® PulseTM 60H Laser System
Table of Contents
Remote Interlock Check ... 124 Emergency Stop Button Check ... 125 Inspect the Debris Shield ... 125 Remove the Debris Shield ... 125 Inspect the Optic ... 126 Reinsert the Debris Shield ... 127 Professional Maintenance (to be updated by Yehudit and reviewed by Yoav) ... 128 Energy Detectors Calibration ... 128 Chapter 8: System Requirements and Information ... 130 Installation ... 130 Accessories ... 130 Tools (Optional) ... 131 Electrical Requirements ... 131 Electrical Utilities ... 131 Systems Designed for Use in European Communities Under the MDD ... 132 External Door Interlock Pin Assignments ... 132 Compliance with International Standards ... 133 Emergency Stop Button ... 133 Login Password ... 133 Laser Emission Indicators ... 133 External Door Interlock ... 133 Protective Housing ... 133 Safety Shutter ... 133 Manual Restart ... 134 Electronic Fault Detection Circuitry ... 134 Safety Interlocks ... 134 Precision of Displayed Values ... 134 Space Requirements ... 134 System Specifications ... 135 Laser Safety Eyewear ... 136 Compatible Optical Fibers ... 136 Decontamination of Returned Equipment ... 136
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Lumenis® PulseTM 60H Laser System
Table of Contents
Customer Service and Warranty ... 136 Appendix A: EMC Guidance and Manufacturer's Declaration ... 137 Electromagnetic Emissions ... 137 Electromagnetic Immunity ... 138 Recommended Separation Distances ... 140
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Lumenis® PulseTM 60HLaser System
Chapter 1: Introduction
Chapter 1: Introduction The Lumenis Pulse 60H holmium laser system provides 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 operator’s manual and the appropriate optical fiber instruction guides, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.
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Lumenis medical lasers and laser optical fibers are intended solely for physicians trained in the use of these instruments.
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No modification of this equipment is allowed.
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 60HLaser System
Manual Conventions
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 60HLaser System
System Description and Main Features
System Description and Main Features The Lumenis Pulse 60H laser system comprises the following main components and features: • Laser system console • Control panel with touch-screen technology • Dual-pedal footswitch • Security Identification System (SIS) technology • Green aiming beam
TEMPORARY PLACEHOLDER
Figure 1: Lumenis Pulse 60H Laser System Console
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Lumenis® PulseTM 60HLaser System
Laser System Console
Laser System Console The laser system console houses the control screen, emergency stop knob, main On/Off switch, remote interlock, 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 The user interface language is configured by the Lumenis service engineer during system installation. The user may change the language as desired from the list of available languages. 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 60HLaser System
Optical Fibers
Optical Fibers A variety of optical fibers are available for use with the Lumenis Pulse 60H laser system. Lumenis fibers incorporate Security Identification System (SIS) technology. Refer to the appropriate optical fiber’s instruction guide for specific operating instructions.
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Lumenis® PulseTM 60H Laser System
Chapter 2: Theory of Operation
Chapter 2: Theory of Operation General 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 60H 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 60H can deliver a maximum average power of 60W, i.e., by delivery of 4 Joules x 15 Hz.
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Lumenis® PulseTM 60H Laser System
Theory of Operation – Moses Mode
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 it into particles versus disintegrating it 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.
Theory of Operation – Moses Mode The Lumenis Pulse 60H holmium laser emits a laser beam at a wavelength of 2100nm. This wavelength is strongly absorbed by water. 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. Holmium laser energy is also very effective in lithotripsy of calculi. In a liquid environment when laser is emitted from the holmium fiber tip, the water surrounding the tip heats to above the boiling temperature and a vapor bubble is created. The vapor bubble expands from the fiber tip towards the target tissue or stone. As only a portion of the pulse is sufficient to create the vapor bubble, the remaining pulse energy travels through the void contained in the bubble, and is less attenuated compared to travel through liquid water.
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Lumenis® PulseTM 60H Laser System
Theory of Operation – Moses Mode
When the distance between the fiber tip and the target is very small, this phenomenon is not observed, as most of the energy reaches the target tissue. In contact, the laser is therefore the most efficient. However, when distance is increased, the relative energy that reaches the target is greatly decreased, leading to reduced ablation efficiency of the laser energy. The laser efficiency is therefore much dependent on the distance between the fiber tip and the target. This is defined as the regular mode currently available for all system applications. The Moses mode introduces a modulation to the energy pulse that enables emission of a controlled portion of energy to create the vapor bubble, while leaving a larger portion as the effective energy portion that travels through the vapor bubble to reach the target tissue. Laser efficiency is therefore less dependent on the distance between the fiber tip and the target, and laser energy is delivered with higher precision. The Ho:YAG wavelength provides effective hemostasis without damaging the surrounding or non-target tissues. Decreasing the laser power density on vascularized tissue is an important tool in bleeding control. Defocusing (increasing the fiber distance from the tissue) is a common method for decreasing power density on tissue. When using the Moses feature, due to its higher precision and reduced dependence on fiber tip distance from the target, this technique will be less effective.
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Lumenis® PulseTM 60H Laser System
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 60H
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 60H
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. Laser safety eyewear must meet the requirements as per EN207 and ANSI Z136.1.
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Lumenis® PulseTM 60H Laser System
Additional Ocular Protection
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. Install an external door remote interlock that automatically disables the laser when the treatment room door is opened. 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.
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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.
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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.
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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.
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Lumenis® PulseTM 60H Laser System
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.
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Do not operate the laser system if any of the cables are faulty or frayed. The laser system should undergo routine inspection and maintenance per Lumenis manufacturer’s recommendations and institutional standards.
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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.
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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.
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When performing procedures in the perianal area, the flammability of methane gas must be considered. Moistened sponges should be inserted into the rectum.
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