PULSE 120H Operators Manual Rev F

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, Lumenis Pulse 120H, SlimLine, Xpeeda and Moses are trademarks or registered trademarks of Lumenis. CAUTION: In the USA: Federal law restricts this device to sale by or on the order of a physician. Copyright © Lumenis Ltd. Catalog Part Number: UM-10012510 March 2017 Revision F

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 http://www.lumenis.com/Service-Support/Recycle to understand what arrangements Lumenis has made in each EU Member State.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 2

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: +972.4.959.9000 Fax: +972.4.959.9050 www.Lumenis.com

Lumenis Pulse 120H UM-10012510 Rev. F

Page 3

Introduction ... 7 Manual Conventions ... 8 System Description and Main Features ... 9 Component Checklist ... 11 Holmium Laser Theory of Operation ... 12 Laser Power Parameters ... 12 Moses Capability ... 13 Safety ... 15 Introduction ... 15 Optical Hazards ... 15 Electrical Hazards ... 17 Fire Hazards ... 18 Additional Safety Considerations ... 18 Protecting Non-Target Tissues ... 19 Safety Indicators ... 20 Warning, Certification and Identification Labels ... 21 Clinical Guide ... 25 Effect on Soft Tissue ... 25 Effects on Stones ... 26 Indications for Use ... 27 Contraindications ... 27 Warnings and Precautions ... 28 Complications ... 29 Detailed Indications for Use ... 30 Preparing the System for Use ... 37 Moving the System ... 38 Adjusting the Fiber Support Arm ... 39 Adjusting the Screen ... 40 Connecting the Footswitch ... 41 Inserting the External Door Interlock Connector ... 42 Plugging in the Main Power Cable ... 43

Lumenis Pulse 120H UM-10012510 Rev. F

Page 4

Connecting the Delivery System ... 44 Connecting the Suction System ... 46 Main System Screens ... 49 Home Screen Description ... 49 Specialties Screen Description ... 52 Treatment Screen Description ... 53 Normal Operation ... 59 Emergency Stop Button ... 59 Verification of Connections ... 59 Powering on the System ... 60 Selecting the Treatment ... 60 Starting Laser Treatment ... 63 Shutting Down the System ... 65 Moving the Laser Console ... 66 Advanced Operations ... 69 Moses Capability ... 69 Saving Settings as Presets ... 71 Preset Management ... 73 Favorites ... 87 Reports ... 92 Changing the Default Specialty ... 95 Other Operations ... 97 Help ... 111 Troubleshooting and Maintenance ... 112 Handling Error Messages and Notifications ... 112 Troubleshooting ... 114 Routine Periodic Maintenance ... 117 Hospital/Clinic Staff Maintenance ... 118 Professional Maintenance ... 122 System Requirements and General Information ... 124

Lumenis Pulse 120H UM-10012510 Rev. F

Page 5

Installation ... 124 Accessories ... 125 Electrical Requirements ... 125 Compliance With International Standards ... 126 Space Requirements ... 128 Specifications ... 128 Customer Service ... 133 Warranty ... 133 Returning Equipment ... 133 Customer Feedback ... 133 Appendix A: EMC Compliance ... 134 Electromagnetic Emissions ... 134 Electromagnetic Immunity ... 135 Recommended Separation Distances ... 137

Lumenis Pulse 120H UM-10012510 Rev. F

Page 6

Introduction

Introduction The Lumenis Pulse 120H holmium laser 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 and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.

•

Lumenis medical lasers and laser delivery systems 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 or delivery system, contact your local Lumenis representative. 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.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 7

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.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 8

System Description and Main Features

System Description and Main Features The Lumenis Pulse 120H laser comprises the following main components and features: • Laser console • Rotatable control screen • Dual-pedal footswitch • Integrated suction pump1 • Fiber support arm • Security Identification System (SIS) technology • Green aiming beam

Figure 1: Lumenis Pulse 120H Laser Console

1. Optional purchase equipment

Lumenis Pulse 120H UM-10012510 Rev. F

Page 9

Laser Console Laser Console The laser console houses the control screen, integrated suction pump (optional), the laser control keyswitch, emergency stop knob, main On/ Off switch, control electronics, laser source and associated optics, and power supply. Fiber optic delivery systems attach to the fiber receptacle on the front of the console, enabling laser energy to be delivered to the treatment site. Control Screen The control screen is an LCD monitor that allows you to select treatment settings outside of the sterile field. Integrated Suction Pump1 An integrated suction pump and suction control that determines the suction flow rate. The suction pump can be used in conjunction with the laser. Footswitch The dual-pedal footswitch activates the laser treatment beam when pressed, offers the ability to select treatment from two sets of parameters by using the left or the right foot-pedal, and incorporates a STANDBY/ READY foot-operated button.

Figure 2: Dual-Pedal Footswitch 1. Optional purchase equipment

Lumenis Pulse 120H UM-10012510 Rev. F

Page 10

Fiber Support Arm Fiber Support Arm The fiber support arm can be used for routing the fiber and suction tube in an ordered and controlled manner. Delivery Systems A variety of fiber optic delivery systems are available for use with Lumenis Pulse 120H laser. Refer to the appropriate delivery system instruction guide for specific operating instructions. CAUTION: Use only Lumenis-approved accessories. Third party accessories are not authorized for use.

Component Checklist • Lumenis Pulse 120H laser console. • Detachable dual-pedal footswitch. • External door interlock connector. • Keys • Operator’s manual. • Fiber support arm.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 11

Holmium Laser Theory of Operation

Holmium Laser 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 flash lamp. The flash lamp energy is then used to excite the lasing medium, in this case a holmium YAG laser 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 Lumenis Pulse 120H holmium laser emits a laser beam at a wavelength of 2100 nm. 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. Holmium laser energy is also very effective in lithotripsy of calculi. 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 mid-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 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). For example the Lumenis Pulse 120H can deliver a maximum average power of 120W obtained by delivery of 2 Joules per pulse at a frequency of 60 Hz.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 12

Moses Capability 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 30W can be performed using the following sets of parameters: 1.5J at 20 Hz or 0.5J at 60 Hz. 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 a rapid 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 delivery system 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.

Moses Capability 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. 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.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 13

Moses Capability The Moses capability introduces a modulation to the energy pulse that combined with a Moses fiber - 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 efficiency. NOTE: Moses capability requires the use of dedicated Lumenis Moses fibers and it is available only for systems that incorporate Moses capability which has been activated. A complete discussion of Moses capability and fibers may be found in the Advanced Operations chapter in the section named Moses Capability. 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 capability, due to its reduced dependence on fiber tip distance from the target, this technique may be less effective.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 14

Safety

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 system: System

Wavelength Used

Maximum Permissible Exposure

Nominal Ocular Hazard Distance

Lumenis Pulse 120H

2.1 μm

50 J/m2

1.6 M

All personnel who are within the Nominal Ocular Hazard Distance (NOHD) 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

Lumenis Pulse 120H

2.1 μm

3.0

DI LB3

Lumenis Pulse 120H UM-10012510 Rev. F

Page 15

Laser Safety Eyewear

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 4s can be use together with the patient 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. Install an external door remote interlock that automatically disables the laser when the treatment room door is opened.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 16

Additional Ocular Protection 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 fiber, handpiece, probe or laser system aperture while the laser is energized. Severe eye damage could occur. Turn off the laser before inspecting any delivery system or laser components.

Electrical Hazards WARNING: •

Never open the laser 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 if any of the cords are faulty or frayed. The laser 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.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 17

Fire Hazards

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 in open-air procedures.

•

Do not connect any USB flash drives or network cable to the system during operation.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 18

Protecting Non-Target Tissues

Protecting Non-Target Tissues WARNING: •

When using a fiber-optic delivery device, always inspect the fiberoptic cable to ensure that it has not been kinked, punctured, fractured, or otherwise damaged. The fiber-optic cable may be damaged if stepped on, pulled, left lying in a vulnerable position, kinked, or tightly coiled. Do not clamp the cable with a hemostat or other instruments. If sterile tape is used, always remove the tape before lifting the cable. A damaged fiber-optic cable 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 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 must always be in standby mode. Maintaining the laser 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 delivery system.

•

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 footswitch. Use caution pressing the laser 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 without a target to absorb it and without consideration given to what lies behind the target. Place energyabsorbing material behind the target tissue when aiming the laser at an oblique target.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 19

Safety Indicators

Safety Indicators • The round LED on the front displays the activity state of the Lumenis Pulse 120H laser console. Color

Illumination

Activity state

Blue

Steady

Power On/Standby

Orange

Steady

READY Mode

Orange

Blink

Lasing

Figure 3: System State LED • An audible signal is emitted during lasing. A different audible sound is used for the left and right pedals. • A warning tone or audible voice message is emitted if the system is transitioned to READY mode while there is no fiber connected to the system. • When lasing, the lasing emission indicator appears on the screen.

Lumenis Pulse 120H UM-10012510 Rev. F

Page 20