® TM Lumenis PULSE 50H/100H Holmium Surgical Lasers Operator's Manual
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.
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 ......................................................
Lumenis® PulseTM 50H / 100H Laser Systems Table of Contents Specific Contraindications in Urology ..........................................................24 Specific Contraindications in Gynecology ...................................................24 Warnings and Precautions ........................................................................................... 24 Complications ..............................................................................................................
Lumenis® PulseTM 50H / 100H Laser Systems Table of Contents Chapter 7 - Troubleshooting and Maintenance ....................................................... 51 Handling Error Messages and Notifications ................................................................. 51 Troubleshooting ........................................................................................................... 52 Initialization Error Message Appears ...........................................................
Lumenis® PulseTM 50H / 100H Laser Systems Table of Contents Energy Detectors Calibration 63 Chapter 8: System Requirements and General Information .................................. 65 Installation .................................................................................................................... 65 Accessories .................................................................................................................. 65 Tools (Optional) .............................................
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.
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.
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 UM-20006520DE, Rev.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Lumenis® PulseTM 50H / 100H Laser Systems Explanation of the symbols used in the LASERCLASS CLASS4/IV 4/IV LASER LB -20001720_A LB -20001720_A Holmium: YAG: μm, J max. Holmium: YAG: 2.12.1 μm, 3.53.5 J max. 600μsμs pulse max. 600 pulse max. LASERCLASS CLASS3R/Illa LASER 3R/Illa DSPP Laser: 532 DSPP nm, Laser: 5 mW 532 max. nm, 5 mW max.
Lumenis® PulseTM 50H / 100H Laser Systems Symbol Explanation of the symbols used in the Description Manufacturer Date of Manufacture Catalog Number Serial Number Series Number Series Model Name System 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 LASER CLASS 3R/Illa DSPP Laser: 532 nm, 5 mW max.
Lumenis® PulseTM 50H / 100H Laser Systems Symbol STOP Explanation of the symbols used in the Description Emergency Laser Stop Fiber Connection Port (Aperture) External Interlock Connection Footswitch Connection Rx ONLY Caution: U.S. federal law restricts this device to sale by or on the order of a physician. CSA Compliance Waste of Electrical and Electronic Equipment (WEEE) compliance RoHS Compliance (China) UM-20006520DE, Rev.
Lumenis® PulseTM 50H / 100H Laser Systems Chapter 4: Clinical Guide Chapter 4: Clinical Guide Lumenis recommends that physicians learn and gather additional knowledge related to the Lumenis Pulse 50H or 100H system. For details on courses available at Lumenis, contact your Lumenis representative. Lumenis does not make recommendations regarding the practice of medicine.
Lumenis® PulseTM 50H / 100H Laser Systems Chapter 4: Clinical Guide power density on vascularized tissue is an important tool in bleeding control. This may be achieved in 3 ways: • Increasing the pulse width/duration. • Reducing the energy per pulse and repetition rate. • Defocusing the beam without changing the system controls by moving the tip of the optical fiber away from the target tissue approximately 2 to 5 millimeters.
Lumenis® PulseTM 50H / 100H Laser Systems Indications for Use Indications for Use The Lumenis Pulse 50H and 100H system with delivery devices and accessories are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; endo-nasal surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology
Lumenis® PulseTM 50H / 100H Laser Systems Complications until familiar with the instrument’s capabilities. Use extreme caution until the biological interaction between the laser energy and tissue is thoroughly understood. • Due to interaction between flammable gases in the operating field and the laser energy a flash fire may occur. Therefore, during laser procedures, measures to minimize this potential hazard should be practiced (e.g.
Lumenis® PulseTM 50H / 100H Laser Systems Detailed Indications for Use encountered in conventional endoscopic surgery. Refer to updated literature for specific procedure related complications. • As with conventional surgery, the possibility of complications and adverse events, such as chills, fever, edema, hemorrhage, inflammation, tissue necrosis, or infection may occur following treatment. In extreme cases, death may occur due to procedural complications, concurrent illness, or laser application.
Lumenis® PulseTM 50H / 100H Laser Systems Urology gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and general surgery.
Lumenis® PulseTM 50H / 100H Laser Systems Arthroscopy Arthroscopy • Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including: > Meniscectomy > Plica removal > Ligament and tendon release > Contouring and sculpting of articular surfaces > Debridement of inflamed synovial tissue (synovectomy) > Loose body debridement > Chondromalacia and tears > Lateral retinecular release > Capsulectomy in the knee > Chon
Lumenis® PulseTM 50H / 100H Laser Systems General Surgery General Surgery • Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: > Cholecystectomy > Lysis of adhesions > Appendectomy > Biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon. > Skin incision > Tissue dissection > Excision of external tumors and lesions > Complete or partial resection of internal organs, tumors and lesions.
Lumenis® PulseTM 50H / 100H Laser Systems ENT Surgery ENT Surgery • Endoscopic endonasal/sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including: > Partial turbinectomy > Ethmoidectomy > Polypectomy > Maxillary antrostomy > Fronta1 smusotomy > Sphenoidotomy > Dacryocystorhinostomy (DCR) > Functional endoscopic sinus surgery (FESS) • Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: > Lesions or tumors
Lumenis® PulseTM 50H / 100H Laser Systems Gastroenterology Surgery Gastroenterology Surgery • Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including: > Gall bladder calculi > Biliary /bile duct calculi > Benign and malignant neoplasm > Polyps > Colitis > Ulcers > Angiodysplasia > Hemorrhoids > Varices > Esophagitis > Esophageal ulcer > Mallory-Weiss tear > Gastric ulcer > Duodenal ulcer > Non-bleeding ulcer > Gastric erosi
Lumenis® PulseTM 50H / 100H Laser Systems Dermatology and Plastic Surgery Dermatology and Plastic Surgery • Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dennatologic and aesthetic surgical procedures, including: > Scars > Vascular lesions > Port wine stains > Hemangioma > Telangiectasia of the face and leg > Rosacea > Corns > Papillomas > Basal cell carcinomas > Lesions of skin and subcutaneous
Lumenis® PulseTM 50H / 100H Laser Systems Chapter 5: Preparing the System for Use Chapter 5: Preparing the System for Use The laser system is shipped directly from the factory to your site. Your Lumenis service representative initially uncrates, inspects, sets up, and installs the laser system to ensure that it is working properly. In addition, Lumenis provides in-service training to ensure that your surgical staff is experienced with the performance and safety considerations of the laser system.
Lumenis® PulseTM 50H / 100H Laser Systems Moving the Laser System Console Moving the Laser System Console 1. Ensure that the laser system’s power cable is properly disconnected. 2. Unlock the laser console wheels. 3. Using the laser console handle, move the laser system to the desired site. CAUTION: As with any heavy equipment, use caution when tilting the laser console or moving it up or down an incline. For optimum safety, use a second person when moving up or down a steep incline.
Lumenis® PulseTM 50H / 100H Laser Systems Connecting the Footswitch Connecting the Footswitch Insert the footswitch connector into the footswitch receptacle on the rear of the laser system console. Align the red dot on the footswitch connector on top, then press it in. Figure 4: Connecting the Dual-Pedal Footswitch NOTE: If the footswitch is not properly connected when the laser system is turned on, the message Attach Footswitch appears in the notification bar until the footswitch is properly connected.
Lumenis® PulseTM 50H / 100H Laser Systems Connecting the External Door Interlock Connecting the External Door Interlock Connector The external door interlock is a safety feature that disables the laser system if the treatment room doors are opened or the external door interlock connector is removed while the laser system is in Ready mode. The laser system remains inoperative until the connector is inserted. 1.
Lumenis® PulseTM 50H / 100H Laser Systems Plugging in the Main Power Cable Plugging in the Main Power Cable 1. Turn off the main electrical service (wall circuit breaker). 2. Ensure that the laser system’s main power circuit breaker is in the off (down) position. 3. Insert the laser system’s main power plug into the wall socket. If the laser system has a locking plug and socket, connect the plug collar to the socket so that the plug is secure from loosening. 4.
Lumenis® PulseTM 50H / 100H Laser Systems Connecting the Optical Fiber Main Power Circuit Breaker Main Power Plug Figure 6: Main On/Off switch and Main Power Plug Connecting the Optical Fiber Before connecting the optical fiber to the laser system, refer to the appropriate optical fiber instruction guide for specific instructions, such as optical fiber inspection, sterilization, and assembly.
Lumenis® PulseTM 50H / 100H Laser Systems Connecting the Optical Fiber fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room. • To avoid possible damage to the optical system, use only qualified Lumenis delivery systems. Using other than Lumenis delivery systems may jeopardize safe operation or damage the laser system and will void your Lumenis warranty or service contract.
Lumenis® PulseTM 50H / 100H Laser Systems Connecting the Optical Fiber 4. The circulating nurse secures the laser connector to the laser system by screwing the connector into the optical fiber receptacle on the front of the laser system. If the laser connector is not properly seated and securely screwed into the optical fiber connection port, the attach fiber message appears in the notification area on the control screen. R R Figure 7: Connecting the Optical Fiber UM-20006520DE, Rev.
Lumenis® PulseTM 50H / 100H Laser Systems SIS (Secured Identification System) Tech- WARNING: When removing the protective cap, hold the laser connector, not the strain relief or optical fiber. Pulling on the strain relief or optical fiber may damage the optical fiber and result in unintended laser exposure. CAUTION: Do not remove the protective cap from the laser connector in the sterile field. Removing the protective cap in the sterile field may compromise sterility.
Lumenis® PulseTM 50H / 100H Laser Systems Chapter 6: Operating Instructions Chapter 6: Operating Instructions Emergency Stop Switch In an emergency, press the laser emergency stop switch on the system’s front panel, to immediately disable emission of the laser energy (Refer to figure 8.). NOTE: When the main power cable is connected to the electrical source, some internal circuits remain energized.
Lumenis® PulseTM 50H / 100H Laser Systems Safety Eyewear Safety Eyewear Verify that all persons in the operating room are equipped with appropriate laser safety eyewear. Verification of Connections 1. Verify that the footswitch is properly connected. 2. Verify that the remote interlock connector is connected. Powering on the System 1. Set the laser system’s main power circuit breaker to the On (up) position. 2. Insert the key into the keyswitch (Refer to figure 8.
Lumenis® PulseTM 50H / 100H Laser Systems Treatment Screen Description Treatment Screen Description Once the laser self-test and warm-up have successfully completed, the main Treatment screen displays on the control panel. The elements of the Treatment screen are detailed as follows (the numbered arrows in figure 9 correlate to the numbered steps below): 1. Left Pedal Designation – displays which footswitch pedal should be used for the group of output parameters in the box beneath the designator. 2.
Lumenis® PulseTM 50H / 100H Laser Systems Treatment Screen Description 2 1 4 3 4 5 Clear kJ 6 Fault XXX 9 7 8 Figure 9: Treatment Beam Delivery via Right or Left Pedals 6. Notification bar - errors and notifications appear in the notification bar at the bottom of the screen, to alert you of a necessary action or a laser malfunction. Refer to Handling Error Messages and Notifications for a list of advisory indications, their probable causes, and solutions. 7.
Lumenis® PulseTM 50H / 100H Laser Systems Laser Emission Indicators Laser Emission Indicators • The Energy, Frequency and Pulse Width parameter areas are highlighted by a yellow margin surrounding the applicable pedal on the screen (see figure 10) when the appropriate pedal is pressed, to alert the operator that laser energy is being emitted. • An audible signal sounds during laser energy emission. The audible signal is different for the right and left pedals.
Lumenis® PulseTM 50H / 100H Laser Systems Intra-Operative Instructions Intra-Operative Instructions 1. Set the aiming beam to high intensity. 2. Test the integrity of the aiming beam. Hold a non-reflective surface, such as a tongue depressor, in front of the optical fiber tip. For side-emission delivery systems, hold the nonreflective surface in front of the side opening at the fiber tip. A green spot, the aiming beam, should appear on the surface.
Lumenis® PulseTM 50H / 100H Laser Systems Intra-Operative Instructions 5. Press the Ready button to switch to Ready mode. WARNING: Always check your parameter settings on the screen before setting the system to Ready mode. 6. Verify that your foot is on the appropriate footswitch pedal for the leftside or right-side parameter settings on the screen. 7. Press the footswitch that corresponds to the desired set of parameters to deliver the treatment beam.
Lumenis® PulseTM 50H / 100H Laser Systems Post-Operative Instructions Post-Operative Instructions 1. Set the system to Standby mode. 2. Turn the keyswitch to the (off) position. 3. Disconnect the optical fiber from the laser system. If the optical fiber is single-use, discard it. If it is multiple-use, prepare the optical fiber for reuse as instructed in the appropriate optical fiber instruction guide. 4. Set the laser system’s main power circuit breaker to the Off (down) position 5.
Lumenis® PulseTM 50H / 100H Laser Systems Moving the Laser Console Moving the Laser Console Using the laser console’s front and rear handles, move the laser system to the desired site. CAUTION: • As with any heavy equipment, use caution when tilting the laser console or moving it up or down an incline. For optimum safety, use a second person when moving up or down a steep incline. • Do not move the laser console rapidly over uneven surfaces; doing so may damage the equipment. UM-20006520DE, Rev.
Lumenis® PulseTM 50H / 100H Laser Systems Chapter 7 - Troubleshooting and Mainte- Chapter 7 - Troubleshooting and Maintenance Handling Error Messages and Notifications Notifications and error messages appear in the Notification bar at the bottom of the screen. 1. Follow the instructions in the notification bar if any are given. 2. If instructions appear, perform the required task as detailed in the message. If the error is resolved, the message will fade and normal operation may be resumed. 3.
Lumenis® PulseTM 50H / 100H Laser Systems Troubleshooting Troubleshooting If the system fails to operate properly, this troubleshooting guide will help you to locate and correct the malfunction. Initialization Error Message Appears 1. Write down the error number. 2. Restart the system via the keyswitch. 3. If the problem re-occurs, contact Lumenis Customer Service. System Does Not Turn On The control screen does not illuminate. 1. Plug in the laser system. 2.
Lumenis® PulseTM 50H / 100H Laser Systems “Popping” or “Tapping” Coming Sound “Popping” or “Tapping” Coming Sound from the Fiber Port This is probably due to a malfunction of the optical fiber connector. • Replace both the optical fiber and the debris shield. Fiber Burn Back Optical fiber burn back may occur during prolonged procedures, especially when using higher power. • Renew the optical fiber tip by stripping and cleaving the fiber. Unrecognized Fiber 1.
Lumenis® PulseTM 50H / 100H Laser Systems System Overheats System Overheats The laser system may overheat if it is used at a high power for an extended amount of time. • Verify that the treatment room temperature is between 10 and 30°C (50 and 86°F). • Verify that the laser system is at least 50 centimeters (20 inches) from walls, furniture, or other equipment. NOTE: If the laser system overheats, do not turn it off.
Lumenis® PulseTM 50H / 100H Laser Systems Message Appears: Check footswitch Message Appears: Check footswitch You are pressing either one both footswitch pedals in Standby mode. • Release the footswitch, switch to Ready and press one of the footswitch pedals. Message Appears: Check interlock The interlock door is open, or the interlock plug is not properly inserted. • Close the interlock door, or insert the interlock plug.
Lumenis® PulseTM 50H / 100H Laser Systems Message Appears: Rate high Message Appears: Rate high The pulse rate delivered is at least 20% more than the selected level. • Press the Standby button to clear the message, then press the Ready button and resume normal operation. If the condition continues, turn off the laser system for five seconds, then turn it back on. If the condition persists, contact your Lumenis Customer Service.
Lumenis® PulseTM 50H / 100H Laser Systems Routine Periodic Maintenance Routine Periodic Maintenance Regular cleaning, inspection, testing, and repair are the basis of any effective preventive maintenance program. Such a program helps keep the system in top working order and ensures the reliability of safety interlocks and fail-safe mechanisms. A recommended routine inspection and maintenance schedule is provided below. Inspection/Service Frequency Performed By Remarks Routine exterior cleaning.
Lumenis® PulseTM 50H / 100H Laser Systems Hospital/Clinic Staff Maintenance Hospital/Clinic Staff Maintenance Visual Inspection The exterior of the system should be inspected once a week to ensure that there are no loose cable connections and that there is no damage to the system. Routine Exterior Cleaning The external surfaces of the system (console, LCD panel) and the footswitch should be cleaned when the system is received, and thereafter as required by clinic protocol.
Lumenis® PulseTM 50H / 100H Laser Systems Emergency Stop Button Check Emergency Stop Button Check The Emergency Stop Button is designed to disable the laser system when pressed. To check this interlock: 1. With the system On, press down on the emergency stop button; the system will turn itself off. 2. Restart the laser system by turning the keyswitch. 3. Press the Ready button on the LCD or footswitch to enable lasing. If this is not the situation, discontinue use and contact Lumenis Service.
Lumenis® PulseTM 50H / 100H Laser Systems Inspect the Debris Shield 4. Grasp the debris shield handle, and pull the shield out of the receptacle. Debris shield handle Figure 14: Remove the debris shield Inspect the Optic Inspect the debris shield optic to verify that it is free of any burn marks, scratches, dust, or fingerprints. If the optic is damaged or dirty, replace it as instructed in Change the Debris Shield Optic in this section.
Lumenis® PulseTM 50H / 100H Laser Systems Inspect the Debris Shield Reinsert the Debris Shield 1. Holding the debris shield handle, position the shield so that the pin is aligned with the pin groove. 2. Insert the debris shield into the debris shield receptacle. 3. Replace the panel covering. 4. Restart the laser system. Handle Pin Groove Pin Figure 16: Reinsert the Debris Shield UM-20006520DE, Rev.
Lumenis® PulseTM 50H / 100H Laser Systems Change the Debris Shield Optic Change the Debris Shield Optic 1. Use snap ring pliers to remove the snap ring that secures the debris shield optic to the body of the shield. 2. Carefully turn over the debris shield holder, and allow the debris shield optic and spring washer to drop onto a lens cleaning tissue. 3. Open the vial containing the new debris shield optic.
Lumenis® PulseTM 50H / 100H Laser Systems Professional Maintenance Professional Maintenance This section covers checks, calibrations and maintenance that require internal access to the laser system’s console and special skills. CAUTION: The Lumenis Pulse 50H or 100H laser system may only be serviced by Lumenis certified field service engineer using an approved service manual.
Lumenis® PulseTM 50H / 100H Laser Systems Energy Detectors Calibration WARNING: All personnel in the immediate area must wear eye protection rated specifically for the Holmium laser system. NOTE: Optical components must be clean before the energy detectors check is performed. 1. Verify that all personnel are wearing appropriate laser safety eyewear. 2. Position a calibrated, external power meter 15 cm (6 inches) from the output end of the optical fiber. 3.
Lumenis® PulseTM 50H / 100H Laser Systems Chapter 8: System Requirements and Chapter 8: System Requirements and General Information Installation The laser system is shipped directly from the factory to your site. Your Lumenis service representative initially uncrates, inspects, sets up, and installs the laser system to ensure that it is working properly.
Lumenis® PulseTM 50H / 100H Laser Systems Tools (Optional) Tools (Optional) • Scissors • Optical fiber stripper • Cleaving tool • Optical fiber inspection scope • SlimLine steam sterilization tray Electrical Requirements Refer to the System Specifications section in this manual. Electrical Utilities Lumenis Pulse 50H or 100H laser systems are available in several electrical configurations. Electrical power should be setup according to the model ordered.
Lumenis® PulseTM 50H / 100H Laser Systems External Door Interlock Pin Assignments External Door Interlock Pin Assignments The external door interlock is a safety feature that disables the laser system if the treatment room doors are opened or the interlock plug is removed while the laser system is in Ready mode. The interlock can be set up with a remote switch, or an external switch can be wired to the interlock plug. Plug wiring shall only be performed by a qualified electrical professional.
Lumenis® PulseTM 50H / 100H Laser Systems Compliance With International Standards Compliance With International Standards In compliance with international standards for laser medical equipment, the system is equipped with the following: Emergency Stop Button The laser system has an emergency stop button knob that, when pushed, immediately disables the laser system in emergency situations. Keyswitch Laser energy can be emitted only when the keyswitch is turned to the Open position.
Lumenis® PulseTM 50H / 100H Laser Systems Manual Reset Manual Reset If laser emission is interrupted during treatment (e.g., main electrical power loss), the laser system automatically turns Off. To resume treatment, you must manually restart the laser system using the main On/ Off button. Electronic Fault Detection Circuitry If any of the electronic system monitors detect a fault condition, laser emission is disabled.
Lumenis® PulseTM 50H / 100H Laser Systems System Specifications System Specifications Output parameters Treatment laser beam Laser type Laser wavelength Holmium:YAG (Ho:YAG), pulsed 2.1 µm Laser Classifications FDA classification EN 60825 classification Class IV medical device Class 4 laser Power Lumenis Pulse 50H: 1.0 to 50W Lumenis Pulse 100H: 1.0 to 100W 0.2 - 3.5 Joules Energy Repetition rate Lumenis Pulse 50H: 5 to 25 Hz Lumenis Pulse 100H: 5 to 53 Hz 0.15 to 0.
Lumenis® PulseTM 50H / 100H Laser Systems Pressure Laser Safety Eyewear 77 – 106 kPa Max. altitude 3,050 m (10,000 ft.) Environmental requirements (non-operating conditions) Temperature 10 to 40°C (50 to 104°F) Humidity 30 to 75% at 30°C/86°F Laser Safety Eyewear Refer to Laser Safety Eyewear in the Safety and Regulatory section of this manual for detailed laser safety eyewear information.
Lumenis® PulseTM 50H / 100H Laser Systems Decontamination of Returned Equipment Decontamination of Returned Equipment In order to comply with postal and transportation laws, equipment shipped to the supplier’s offices for return or repair must first be decontaminated. To communicate that the returned equipment has been properly decontaminated, a signed Decontamination Certificate (obtained from Lumenis Customer Service) must be enclosed in the shipping package.
Lumenis® PulseTM 50H / 100H Laser Systems Appendix A: EMC Guidance and Manu- Appendix A: EMC Guidance and Manufacturer's Declaration Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Lumenis Pulse 50H & 100H systems are intended for use in the electromagnetic environment specified below. The customer or the user of the Lumenis Pulse 50H & 100H systems should assure that it is used in such an environment.
Lumenis® PulseTM 50H / 100H Laser Systems Electromagnetic Immunity Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Lumenis Pulse 50H & 100H systems are intended for use in the electromagnetic environment specified below. The customer or the user of the Lumenis Pulse 50H & 100H systems should assure that it is used in such an environment.
Lumenis® PulseTM 50H / 100H Laser Systems Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Lumenis Pulse 50H & 100H systems are is intended for use in the electromagnetic environment specified below. The customer or the user of the Lumenis Pulse 50H & 100H systems should assure that it is used in such an environment.
Lumenis® PulseTM 50H / 100H Laser Systems Recommended Separation Distances Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Lumenis Pulse 50H or 100H laser system The Lumenis Pulse 50H & 100H systems are is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
