LUMENIS PULSE 100H Operator's Manual
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LUMENIS PULSE 100H Operator's Manual

Holmium surgical lasers
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Lumenis PULSE
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50H/100H
Holmium Surgical Lasers
Operator's Manual

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  • Page 1 ® Lumenis PULSE 50H/100H Holmium Surgical Lasers Operator's Manual...
  • Page 2 Lumenis, the Lumenis Logo, Pulse 50 and Pulse 100 are trademarks or registered trademarks of Lumenis. Copyright © Lumenis (Germany) GmbH...

  • Page 3: Table Of Contents

    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...
  • Page 4 ® Lumenis Pulse 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...
  • Page 5 ® Lumenis Pulse 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 ............52 System Does Not Turn On ................52 Inadequate or No Aiming Beam ..............52...
  • Page 6 ® Lumenis Pulse 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) ......................66 Electrical Requirements ....................66 Electrical Utilities ......................66 Systems Designed For Use Outside of Europe ...........66...

  • Page 7: Chapter 1: Introduction

    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.

  • Page 8: Reference To The Lumenis Pulse 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...

  • Page 9: System Description And Main Features

    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 •...

  • Page 10: Laser System Console

    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.

  • Page 11: Optical Fibers

    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.

  • Page 12: Chapter 2: Theory Of Operation

    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.
  • Page 13 ® Lumenis Pulse 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”.

  • Page 14: Chapter 3: Safety

    Optical Hazards Laser Safety Eyewear The following specifications were calculated for this systems: System Maximum Permissible Exposure Nominal Ocular Hazard Distance Lumenis Pulse 50H 1.9 meters 2 mJ/cm 1.9 meters Lumenis Pulse 100H 2 mJ/cm All personnel who are within the Nominal Ocular Hazard Distance are...

  • Page 15: Additional Ocular Protection

    ® Lumenis Pulse 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.

  • Page 16: Electrical Hazards

    • 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.

  • Page 17: Protecting Non-Target Tissues

    ® Lumenis Pulse 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.

  • Page 18: Laser Emission Indicators

    ® Lumenis Pulse 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.

  • Page 19: Explanation Of The Symbols Used In The Labels

    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 UM-20006520DE, Rev. A Page 19...
  • Page 20 ® Lumenis Pulse 50H / 100H Laser Systems Explanation of the symbols used in the Symbol Description Manufacturer Date of Manufacture Catalog Number Serial Number Series Number Series System Model Name Follow Instruction for Use Electrical Requirements Type BF Equipment...
  • Page 21 ® Lumenis Pulse 50H / 100H Laser Systems Explanation of the symbols used in the Symbol Description STOP Emergency Laser Stop Fiber Connection Port (Aperture) External Interlock Connection Footswitch Connection Caution: U.S. federal law restricts this device to sale by or on the Rx ONLY order of a physician.

  • Page 22: 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.
  • Page 23 ® Lumenis Pulse 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.

  • Page 24: Indications For Use

    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;...

  • Page 25: Complications

    ® Lumenis Pulse 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.

  • Page 26: Detailed Indications For Use

    Insufflation pressure should be set to minimum settings for effective insufflation. Detailed 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;...

  • Page 27: Urology

    50H / 100H Laser Systems Urology gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and general surgery. The Lumenis Pulse 50H or 100H system with delivery devices and accessories are indicated for use in the performance of specific surgical applications as follows: Urology •...

  • Page 28: Arthroscopy

    ® Lumenis Pulse 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 >...

  • Page 29: General Surgery

    ® Lumenis Pulse 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.

  • Page 30: Ent Surgery

    ® Lumenis Pulse 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 >...

  • Page 31: Gastroenterology Surgery

    ® Lumenis Pulse 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 >...

  • Page 32: Dermatology And Plastic Surgery

    ® Lumenis Pulse 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: >...

  • Page 33: Chapter 5: Preparing The System For Use

    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.

  • Page 34: Moving The Laser System Console

    ® Lumenis Pulse 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.

  • Page 35: Connecting The Footswitch

    ® Lumenis Pulse 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.

  • Page 36: Connecting The External Door Interlock Connector

    ® Lumenis Pulse 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.

  • Page 37: Plugging In The Main Power Cable

    ® Lumenis Pulse 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.

  • Page 38: Connecting The Optical Fiber

    ® Lumenis Pulse 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.
  • Page 39 NOTE: SIS (Secure Identification System) enabled Lumenis Pulse 50H and Lumenis Pulse 100H laser systems will only operate with Lumenis- qualified SIS optical fibers. Attaching any other type of fiber will disable laser emission.
  • Page 40 ® Lumenis Pulse 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.

  • Page 41: Sis (Secured Identification System) Technology

    Removing the protective cap in the sterile field may compromise sterility. SIS (Secured Identification System) Technology SIS enabled Lumenis Pulse 50H and Lumenis Pulse 100H laser systems will only operate with Lumenis-qualified SIS (Secure Identification System) optical fibers. Attaching any other type of fiber will disable laser emission.

  • Page 42: Chapter 6: Operating Instructions

    ® Lumenis Pulse 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.).

  • Page 43: Safety Eyewear

    ® Lumenis Pulse 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.

  • Page 44: Treatment Screen Description

    ® Lumenis Pulse 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...
  • Page 45 ® Lumenis Pulse 50H / 100H Laser Systems Treatment Screen Description Clear kJ Fault XXX 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.

  • Page 46: Laser Emission Indicators

    ® Lumenis Pulse 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.

  • Page 47: Intra-Operative Instructions

    ® Lumenis Pulse 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.
  • Page 48 ® Lumenis Pulse 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 left- side or right-side parameter settings on the screen.

  • Page 49: Post-Operative Instructions

    ® Lumenis Pulse 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.

  • Page 50: Moving The Laser Console

    ® Lumenis Pulse 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.

  • Page 51: Chapter 7 - Troubleshooting And Maintenance

    4. Several types of errors will only appear with a number (“Fault XXX”); press the Standby button to clear the error and try to resume normal operation. If this does not resolve the problem restart the system. 5. If the problem does not resolve, contact Lumenis Customer Service. Clear kJ Fault XXX Figure 12: Notification Bar UM-20006520DE, Rev.

  • Page 52: Troubleshooting

    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.

  • Page 53: Popping" Or "Tapping" Coming Sound From The Fiber Port

    • Renew the optical fiber tip by stripping and cleaving the fiber. Unrecognized Fiber 1. Replace the optical fiber with a Lumenis compatible one and resume normal operation. 2. If problem persists, contact Lumenis Service.

  • Page 54: System Overheats

    Allow the system to cool for several minutes and resume normal operation. Message Appears: Attach an Authorized Fiber SIS enabled Lumenis Pulse 50H and Lumenis Pulse 100H laser systems will only operate with Lumenis-qualified SIS (Secure Identification System) optical fibers. Attaching any other type of fiber will disable laser emission.

  • Page 55: Message Appears: Check Footswitch

    If the condition continues, turn off the laser system for five seconds, then turn it back on. If the condition persists, contact Lumenis Customer Service. Message Appears: Energy low The energy delivered is less than 50% of the selected level.

  • Page 56: Message Appears: Rate High

    The pulse rate delivered is less than 80% of the selected level. • Press the Ready button to clear the message. If the condition continues, turn off the laser system for five seconds, then turn it back on. If the condition persists, contact Lumenis Customer Service. UM-20006520DE, Rev. A...

  • Page 57: Routine Periodic Maintenance

    Routine exterior As required by hospital/ Hospital/Clinic None cleaning. clinic protocol. Staff Inspect cables and all Hospital/Clinic If damage is found, call Lumenis external surfaces for Weekly Staff Customer Service. damage. Inspect electrical Hospital/Clinic If damage is found, call Lumenis Weekly connections.

  • Page 58: Hospital/Clinic Staff Maintenance

    3. Open the connected door; the system should display the following message in the notification bar: Check Interlock. 4. If the system does not display the message and remains in Ready mode, discontinue use and contact Lumenis Service. UM-20006520DE, Rev. A Page 58...

  • Page 59: Emergency Stop Button Check

    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. Inspect the Debris Shield The debris shield protects the internal optical components of the laser system from damage by a faulty or misused optical fiber.
  • Page 60 ® Lumenis Pulse 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.
  • Page 61 ® Lumenis Pulse 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.

  • Page 62: Change The Debris Shield Optic

    ® Lumenis Pulse 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.

  • Page 63: 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.
  • Page 64 8. Release the footswitch and record the external power meter's reading. 9. If the external power meter reading falls above or below ±20% of the requested energy on your laser system, discontinue this procedure and contact Lumenis Customer Service. UM-20006520DE, Rev. A Page 64...

  • Page 65: Chapter 8: System Requirements And General Information

    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.

  • Page 66: Tools (Optional)

    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. The line wires in the power cable shall be connected to the building power, and the green/yellow wire must be connected to the building ground.

  • Page 67: External Door Interlock Pin Assignments

    ® Lumenis Pulse 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.

  • Page 68: Compliance With International Standards

    No sections of the protective housing can be easily opened without special tools. This housing is to be opened only by a Lumenis-certified technician. Safety Shutter The laser system features a safety shutter that prevents the treatment beam from exiting the laser system.

  • Page 69: Manual Reset

    ® Lumenis Pulse 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.

  • Page 70: System Specifications

    Laser wavelength 2.1 µm Laser Classifications FDA classification Class IV medical device EN 60825 classification Class 4 laser Power Lumenis Pulse 50H: 1.0 to 50W Lumenis Pulse 100H: 1.0 to 100W Energy 0.2 - 3.5 Joules Repetition rate Lumenis Pulse 50H:...

  • Page 71: Laser Safety Eyewear

    SPSA-10090190 Debris optic (glass only) SPOP-10025270 Laser system key 5107-0146 Compatible Optical Fibers The laser system is intended for use only with Lumenis-qualified optical fibers. Contact Lumenis Customer Service for a list of available products. UM-20006520DE, Rev. A Page 71...

  • Page 72: Decontamination Of Returned Equipment

    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. Failure to enclose the Decontamination Certificate will cause the supplier to assume the product is contaminated. The supplier will assess the customer with cleaning costs.

  • Page 73: Appendix A: Emc Guidance And Manufacturer's Declaration

    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.

  • Page 74: 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.
  • Page 75 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Lumenis Pulse 50H or 100H is used exceeds the applicable RF compliance level above, the Lumenis Pulse 50H or 100H systems should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [MEDICAL EQUIPMENT or MEDICAL SYSTEM].

  • Page 76: Recommended Separation Distances

    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. The customer or the user of the Lumenis Pulse 50H or 100H systems can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Lumenis Pulse 50H &...

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