1. Manuals
  2. Brands
  3. LUMENIS Manuals
  4. Medical Equipment
  5. PULSE 60H
  6. Operator's manual

LUMENIS PULSE 60H Operator's Manual

Holmium surgical laser
Hide thumbs
Table of Contents

Advertisement

Quick Links

®
Lumenis PULSE
TM
60H
Holmium Surgical Laser
Operator's Manual
TEMPORARY
PLACEHOLDER

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the PULSE 60H and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for LUMENIS PULSE 60H

Summary of Contents for LUMENIS PULSE 60H

  • Page 1 ® Lumenis PULSE Holmium Surgical Laser Operator's Manual TEMPORARY PLACEHOLDER...
  • Page 2 Lumenis, the Lumenis Logo and Pulse 60H are trademarks or registered trademarks of Lumenis. Copyright © Lumenis Ltd.
  • Page 3 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...

  • Page 4: Table Of Contents

    ® Lumenis Pulse 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 .....................
  • Page 5 ® Lumenis Pulse 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 ......................
  • Page 6 ® Lumenis Pulse 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 ................
  • Page 7 ® Lumenis Pulse 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 ......................
  • Page 8 ® Lumenis Pulse 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...
  • Page 9 ® Lumenis Pulse 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 UM-20057180EN, Rev. A...

  • Page 10: Chapter 1: Introduction

    Pulse 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: •...

  • Page 11: Manual Conventions

    ® Lumenis Pulse 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.

  • Page 12: System Description And Main Features

    Lumenis Pulse 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 •...

  • Page 13: Laser System Console

    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.

  • Page 14: Optical Fibers

    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.

  • Page 15: Chapter 2: Theory Of Operation

    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...

  • Page 16: Theory Of Operation - Moses Mode

    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...
  • Page 17 ® Lumenis Pulse 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.

  • Page 18: Chapter 3: Safety

    The following specifications were calculated for this systems: System Maximum Permissible Exposure Nominal Ocular Hazard Distance Lumenis Pulse 60H 1.9 meters 2 mJ/cm All personnel who are within the Nominal Ocular Hazard Distance are considered to be within the controlled area and must wear eye protection...

  • Page 19: Additional Ocular Protection

    ® Lumenis Pulse 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.

  • Page 20: 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 cables are faulty or frayed.

  • Page 21: Additional Safety Considerations

    • Ensure that all optical fibers and any part of the suction system, including both tubes (aspiration and drainage), collection container, the operating room's hazardous waste container (not supplied by Lumenis) and 3rd party accessories are made of non-conductive material. CAUTION: Smoke evacuation may be required if using the laser system in open-air procedures.
  • Page 22 ® Lumenis Pulse 60H Laser System Protecting Non-Target Tissues CAUTION: • To prevent accidental laser discharge, always make sure that the footswitch is not being operated while connecting the optical fiber. • Never place hands or other objects in the path of the laser beam.

  • Page 23: Laser Emission Indicators

    • When lasing, a lasing emission indicator appears on the screen. • The round LED on the front displays the activity mode of the Lumenis Pulse 60H laser console: Color Illumination Activity Mode...

  • Page 24: Warning, Certification And Identification Labels

    ® Lumenis Pulse 60H Laser System Warning, Certification and Identification Labels Warning, Certification and Identification Labels As required by national and international regulatory agencies, appropriate warning labels have been mounted in the specified locations. Figure 4 displays the identification and certification labels affixed to the system.

  • Page 25: Description Of System Labels

    Description of System Labels: The labels located on the system's panels, components and packaging contain the following information (For illustration purposes only): Symbol Description Lumenis, Energy to Healthcare CE Compliance 0483 Authorized Representative in the European Community Manufacturer Date of Manufacture...
  • Page 26 ® Lumenis Pulse 60H Laser System Description of System Labels: Symbol Description FCC Identification Label: This device contains: This device contains: FCC ID: Z97-1149466 FCC ID: Z97-1149466 Non-Ionizing Electromagnetic Radiation Laser Class IV Label: Laser Class 4/IV Holmium:YAG Laser: 2.1µm, 6J max. 1600 µs (FWHM), Pulse...
  • Page 27 ® Lumenis Pulse 60H Laser System Description of System Labels: Symbol Description RoHS Compliance (China) Ethernet Connection Port USB Connection Port Equipotential Earth Connection Pin Unique Device Identifier (UDI) Code, Type GS1 Power Cable Warning: WARNING Grounding reliability can only be...

  • Page 28: Chapter 4: Clinical Guide

    Chapter 4: Clinical Guide Lumenis recommends that physicians learn and gather additional knowledge related to the Lumenis Pulse 60H system. For details on courses available at Lumenis, contact your Lumenis representative. Lumenis does not make recommendations regarding the practice of medicine.
  • Page 29 ® Lumenis Pulse 60H Laser System 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 30: Indications For Use

    60H Laser System Indications for Use Indications for Use The Lumenis Pulse 60H system including the delivery devices with 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 31: Warnings And Precautions

    ® Lumenis Pulse 60H Laser System Warnings and Precautions Warnings and Precautions This section contains warnings and precautions that are applicable to surgical procedures specifically related to the use of this system. • Holmium lasers are intended solely for use by physicians trained in the use of the Ho:YAG (2.1 µm) wavelength.

  • Page 32: Complications

    ® Lumenis Pulse 60H Laser System Complications control with the laser system. The risk of bleeding may be higher in patients taking anticoagulants/ platelet aggregates. • Baskets, guide wires, and other surgical accessories may be damaged by direct contact with the laser treatment beam.

  • Page 33: Detailed Indications For Use

    Insufflation pressure should be set to minimum settings for effective insufflation. Detailed Indications for Use The Lumenis Pulse 60H system with delivery devices and accessories is 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 34: Arthroscopy

    ® Lumenis Pulse 60H Laser System 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 35: General Surgery

    ® Lumenis Pulse 60H Laser System 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 36: Ent Surgery

    ® Lumenis Pulse 60H Laser System 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 sinusotomy > Sphenoidotomy >...

  • Page 37: Gastroenterology Surgery

    ® Lumenis Pulse 60H Laser System 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 >...

  • Page 38: Dermatology And Plastic Surgery

    ® Lumenis Pulse 60H Laser System 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 >...

  • Page 39: 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 40: Moving The Laser Console

    2. Move they system to the desired location. Verify that the Lumenis Pulse 60H laser console is a minimum of 50 centimeters (20 inches) from walls, furniture, or other equipment. 3. Lock all wheels by pressing the brake pedals down to the locked position.

  • Page 41: Connecting The Footswitch

    Align the red dot on the footswitch connector on top, then press it in. This Ethernet port is only TEMPORARY for the use of Lumenis service personnel for the purpose of PLACEHOLDER system diagnostics and communications.

  • Page 42: Connecting The External Door Interlock Connector

    5. To resume treatment, close the treatment room door or reinsert the external door interlock connector, and press the Ready button. This Ethernet port is only for the use of Lumenis service personnel for the purpose of system diagnostics and communications.

  • Page 43: Plugging In The Mains Power Cable

    3. Turn on the laser system’s mains power circuit breaker (up position). CAUTION: Ensure that the Lumenis P60H laser system is positioned such that the main power plug will be easily accessible. WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

  • Page 44: Installing The Fiber Arm Support

    (C) into the adapter (already in the arm port). Press it all the way TEMPORARY PLACEHOLDER Figure 9: Installing the Fiber Support Arm 1. Optional purchase equipment, to be installed only by Lumenis-certified service technicians. UM-20057180EN, Rev. A Page 44...

  • Page 45: Connecting The Optical Fiber

    To avoid possible damage to the optical system or jeopardize safe operation, 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. •...
  • Page 46 ® Lumenis Pulse 60H Laser System Connecting the Optical Fiber WARNING: Never inspect the optical fiber while it is connected to the laser system. Accidental laser exposure can cause severe eye damage. 3. The scrub nurse hands off the laser connector to the circulating nurse while securing the distal tip of the fiber in the sterile field.

  • Page 47: 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 60H laser system will only operate with Lumenis-qualified SIS (Secure Identification System) optical fibers. Attaching any other type of fiber will disable laser emission.

  • Page 48: Connecting The Suction System

    60H Laser System Connecting the Suction System Connecting the Suction System The surgeon may use the Lumenis Pulse 60H laser's built-in suction system to remove tissue, liquids, stones or other debris into the collection container. The Lumenis-supplied disposables required for this are: •...
  • Page 49 ® Lumenis Pulse 60H Laser System Connecting the Suction System 5. Pull open the suction pump. TEMPORARY PLACEHOLDER Figure 12: Pulling open the Suction Pump 6. Insert the drainage tube into the channel in the suction pump. 7. Set the system's suction pump to the correct drainage tube's inner diameter: pull open the suction pump.
  • Page 50 ® Lumenis Pulse 60H Laser System Connecting the Suction System WARNING: Aspiration flows in the direction of the arrow on the pump head. Always verify that the drainage tube is loaded in the required direction. TEMPORARY PLACEHOLDER Figure 14: Directional Arrow for the Aspiration Tube 8.

  • Page 51: Main System Screens

    ® Lumenis Pulse 60H Laser System Main System Screens Main System Screens Home Screen Description Figure 15: Home Screen UM-20057180EN, Rev. A Page 51...
  • Page 52 ® Lumenis Pulse 60H Laser System Home Screen Description The elements of the Home screen are detailed as follows (the numbered arrows in Figure 16 correlate to the numbered steps below): Figure 16: Home Screen Legend 1. Specialty – Identifies the currently-selected surgical specialty. This can be set as a default specialty in the Settings and Utilities screen.
  • Page 53 10. Notification Bar – Notifications and error messages will appear in this bar. 11. Presets – Lumenis Presets are hard-coded into the system software and are marked with the Lumenis logo. Hospital Presets are designed and entered to the system by the hospital's surgeons. Any settings entered or re-entered on the main Treatment screen during a procedure, may be saved and named as a Hospital Preset.

  • Page 54: Specialties Screen Description

    ® Lumenis Pulse 60H Laser System Specialties Screen Description Specialties Screen Description Select the surgical specialty that best meets your needs. Presets are defined for each surgical specialty. Figure 17: Specialties Screen UM-20057180EN, Rev. A Page 54...

  • Page 55: Treatment Screen Description

    ® Lumenis Pulse 60H Laser System Treatment Screen Description Treatment Screen Description Figure 18: Treatment Screen UM-20057180EN, Rev. A Page 55...
  • Page 56 ® Lumenis Pulse 60H Laser System Treatment Screen Description The elements of the Treatment Settings are detailed as follows (the numbered arrows in Figure 19 correlate to the numbered steps below): Figure 19: Treatment Beam Delivery via Right or Left Pedals 1.
  • Page 57 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. 1. Optional purchase equipment; consult with your Lumenis representative. UM-20057180EN, Rev. A Page 57...
  • Page 58 Pulse 60H Laser System Treatment Screen Description 8. Fiber Status Area - Certain Lumenis SIS fiber delivery systems for the Lumenis Pulse 120H are designed to allow several surgical treatments, while others are limited to only one treatment. When a fiber is connected, the system immediately knows: •...

  • Page 59: Laser Emission Indication

    • The total energy indicator should be reset to zero between patients, and: • When switching between preset modes (relevant for both pedals), including both Lumenis and user-generated presets. • The total energy displayed in the reports is not affected when resetting the total energy on the screen (reset dialog shown on left).

  • Page 60: Chapter 6: Operating Instructions

    ® Lumenis Pulse 60H Laser System 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 laser energy emission and operation of...

  • Page 61: Safety Eyewear

    ® Lumenis Pulse 60H Laser System Safety Eyewear Safety Eyewear Verify that all persons in the operating room are equipped with and wearing 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 62 ® Lumenis Pulse 60H Laser System Powering Up the System 3. Press the empty field above the Login button; a virtual keyboard will  appear. Type in the 4-digit password and press the green button on the keyboard. Figure 23: Login Keyboard 4.

  • Page 63: Restarting The Laser System

    (and before you come to turn the system on), you must ensure that the system is turned off. If it turns on by itself when connected discontinue use, disconnect from the wall socket and contact Lumenis Customer Service. •...

  • Page 64: Setting The Treatment Parameters And Controls

    60H Laser System Setting the Treatment Parameters and Controls Setting the Treatment Parameters and Controls The Home screen appears on the control screen after Lumenis Pulse 60H is powered On, the self-test is successfully completed and you complete the Login procedure.
  • Page 65 : use these buttons (E) to switch between Suction On, Suction Off, or Automatic operation while the system is lasing. 7. In order to revert to the original presets, press the Undo button (G). 1. Optional purchase equipment, consult with your Lumenis representative. UM-20057180EN, Rev. A Page 65...
  • Page 66 ® Lumenis Pulse 60H Laser System Setting the Treatment Parameters and Controls Figure 28: How to Change Treatment Settings UM-20057180EN, Rev. A Page 66...

  • Page 67: Starting The Laser Treatment

    ® Lumenis Pulse 60H Laser System Starting the Laser Treatment Starting the Laser Treatment 1. Turn on the aiming beam, and set it 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 fiber tip.
  • Page 68 ® Lumenis Pulse 60H Laser System Starting the Laser Treatment NOTE: A Ready voice signal is generated when the system is transitioned to Ready mode. A standby voice signal is generated when the system is transitioned to Standby mode. The voice signals are generated in the language that was selected in the “Changing Language”...

  • Page 69: Operating In Moses Mode With Moses Fibers

    Operating in Moses Mode with Moses Fibers Lumenis Moses fibers with SIS technology are designed to work with the Lumenis Pulse 60H configured to Moses mode. When a Moses fiber is connected to the system it will be recognized by the system and the Moses mode feature will be available to the user.
  • Page 70 ® Lumenis Pulse 60H Laser System Selecting Moses Mode Treatment • Moses mode is available for use either with the left or right pedal, independently, in short pulse width only. • When the system is started, the default fiber default with is Regular (Moses mode off), using regular pulses.

  • Page 71: Intra-Operative Instructions

    ® Lumenis Pulse 60H Laser System 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 non- reflective surface in front of the side opening at the fiber tip.
  • Page 72 ® Lumenis Pulse 60H Laser System 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 73: Post-Operative Instructions

    ® Lumenis Pulse 60H Laser System Post-Operative Instructions Post-Operative Instructions 1. Set the system to Standby mode. 2. 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 fiber’s instruction guide.

  • Page 74: Shutting Down The System

    ® Lumenis Pulse 60H Laser System Shutting Down the System Shutting Down the System 1. Press the main On/Off button and wait until the system powers down. • Normal System Shut-Down: Press the main On/Off button for one second (short press).
  • Page 75 • If you want to hang the footswitch on the laser console, wrap the power cable around the footswitch and hang it on the rear of the Lumenis Pulse 120H laser console. Figure 33: Power Cable on the Cable Rack 7.

  • Page 76: Advanced Operations

    ® Lumenis Pulse 60H Laser System Advanced Operations Advanced Operations Saving Settings as Presets Saving presets is performed from the Main Treatment screen. When changes are made to an existing preset from that screen, the preset will be in edited mode (fonts change and an asterisk appears). Then you can save these settings as a new preset.
  • Page 77 ® Lumenis Pulse 60H Laser System Saving Settings as Presets 2. Press inside the Preset Name field and type in the new name using the virtual keyboard. When you are done, press the green check mark key on the keyboard.

  • Page 78: Preset Management

    Figure 36: Saving the Preset Preset Management Introduction The Lumenis Pulse 60H offers the use of predefined presets to select treatment parameters. Presets are divided into two groups: System Presets (hard-coded into Lumenis Pulse 60H). Hospital Presets (defined by the hospital staff).
  • Page 79 ® Lumenis Pulse 60H Laser System Introduction You can save any settings defined on the Treatment screen during a procedure as a Hospital Preset. Figure 37: Manage Presets Screen UM-20057180EN, Rev. A Page 79...

  • Page 80: Choosing Presets

    ® Lumenis Pulse 60H Laser System Choosing Presets Choosing Presets On the Home screen, press the View All… button to display all of the available presets, not only those defined as Favorites. The presets are organized in two groups: System Presets and Hospital Presets.
  • Page 81 ® Lumenis Pulse 60H Laser System Choosing Presets To open the list of a preset group, press the + sign. If all of the presets do not fit into the screen, a scroll bar appears to the right of the preset group.

  • Page 82: Creating New Presets

    ® Lumenis Pulse 60H Laser System Creating New Presets Creating New Presets 1. From the Home screen, press Manage Presets. 2. Press the New button. Figure 40: Creating a New Preset UM-20057180EN, Rev. A Page 82...
  • Page 83 ® Lumenis Pulse 60H Laser System Creating New Presets 3. In the New Preset screen, create the names and settings that you want. Figure 41: New Preset Screen 4. Edit the Preset Name and the names of operations performed by each footswitch pedal.When you press inside a text field, a virtual keyboard...

  • Page 84: Editing Presets

    ® Lumenis Pulse 60H Laser System Editing Presets Editing Presets You can only edit hospital presets. To create a new preset based on an system preset, first duplicate the preset, then edit it. 1. From the Home screen, press Manage Presets.
  • Page 85 ® Lumenis Pulse 60H Laser System Editing Presets 5. In the Edit Preset screen, create the names and settings that you want. When you press inside a text field, a virtual keyboard pops up. Figure 43: Edit Preset Screen (With Keyboard Visible) 6.

  • Page 86: Duplicating Presets

    ® Lumenis Pulse 60H Laser System Duplicating Presets Duplicating Presets 1. From the Home screen, press Manage Presets. 2. Select anywhere on the row for the preset that you want to duplicate. If you don’t see the preset, press Hospital Presets button.
  • Page 87 ® Lumenis Pulse 60H Laser System Duplicating Presets 4. The duplicated preset automatically appears with the Copy_ prefix under Hospital Presets. Figure 45: Preset Screen (With a Duplicated Preset) UM-20057180EN, Rev. A Page 87...

  • Page 88: Deleting Presets

    ® Lumenis Pulse 60H Laser System Deleting Presets Deleting Presets You can only delete hospital presets. You cannot delete system presets. 1. From the Home screen, press Manage Presets. 2. Press the Hospital Presets button. 3. Select anywhere on the row for the preset that you want to delete.

  • Page 89: Exporting Presets

    Exporting Presets 1. Insert a USB storage device into the USB port at the rear of the Lumenis Pulse 60H. 2. From the Home screen, press Manage Presets. 3. Select anywhere on the row for the preset that you want to export. If you don’t see the preset, press Hospital Presets button.
  • Page 90 ® Lumenis Pulse 60H Laser System Exporting Presets 5. In the Export data to USB menu, press OK. 6. Wait until the export operation is completed successfully. Figure 49: Export Operation Completed UM-20057180EN, Rev. A Page 90...

  • Page 91: Favorites

    ® Lumenis Pulse 60H Laser System Favorites Favorites Every specialty has its own favorite presets that you can select directly from the Home screen. Changing the Favorite Presets (Add, Remove and Reorder) The Home screen has positions for nine favorite presets. You can place any preset in each of the 9 positions.
  • Page 92 ® Lumenis Pulse 60H Laser System Changing the Favorite Presets (Add, Remove and 3. To add an existing, non-favorite preset to your list of favorites, press the Add a favorite button. Figure 51: Select Favorites > Manage 4. Press a non-favorite preset to select it. Press the Add button to add it to the favorites.
  • Page 93 ® Lumenis Pulse 60H Laser System Changing the Favorite Presets (Add, Remove and 5. Press the Move Up or Move Down button to position the new favorite in the desired spot (number) in the list. Figure 53: New Preset Added to Favorites 6.

  • Page 94: Favorite: Quick Add

    ® Lumenis Pulse 60H Laser System Favorite: Quick Add Favorite: Quick Add The Home screen has positions for 9 favorite presets. You can place any preset in each of the 9 positions. 1. From the Home screen, press Manage Presets.

  • Page 95: Favorite: Quick Remove

    ® Lumenis Pulse 60H Laser System Favorite: Quick Remove Favorite: Quick Remove The Home screen has positions for 9 favorite presets. You can place any preset in each of the 9 positions. 1. From the Home screen, press Manage Presets.

  • Page 96: Reports

    60H Laser System Reports Reports Lumenis Pulse 60H automatically generates a report of each treatment. 1. To view a summary of the reports listed in chronological order with the most recent treatment on top; from the Home screen, press the Reports button.

  • Page 97: Exporting The Reports

    Exporting the Reports Exporting the Reports 1. Insert a USB storage device into the USB port at the rear of the Lumenis Pulse 60H. 2. From the Home screen, press the Reports button. 3. Press the Export reports to USB button.
  • Page 98 ® Lumenis Pulse 60H Laser System Exporting the Reports 5. Wait until the export operation is completed successfully and press the OK button. Figure 58: Reports Export Operation Completed UM-20057180EN, Rev. A Page 98...
  • Page 99 ® Lumenis Pulse 60H Laser System Exporting the Reports Figure 59: Sample of Reports Export (for illustration only) UM-20057180EN, Rev. A Page 99...

  • Page 100: Changing The Default Specialty

    60H Laser System Changing the Default Specialty Changing the Default Specialty When you start up Lumenis Pulse 60H, the Home screen automatically displays the default specialty. You can change this in the Settings & Utilities screen. 1. From the Home screen, press the Settings & Utilities button.
  • Page 101 ® Lumenis Pulse 60H Laser System Changing the Default Specialty 3. From the Change Specialty pop-up, press the specialty that you want to become the default specialty. Figure 61: Default Specialty Button 4. In the Change Specialty pop-up, press OK.

  • Page 102: Other Operations

    ® Lumenis Pulse 60H Laser System Other Operations Other Operations Turning Off the Aiming Beam 1. To turn off the aiming beam press the < (decrease intensity) until the minimum aiming beam intensity is reached. Then press the < for several seconds.

  • Page 103: Changing Screen Settings

    ® Lumenis Pulse 60H Laser System Changing Screen Settings Changing Screen Settings 1. Press the cogwheel in the upper-right corner and select Quick Settings. Figure 62: Select Quick Settings 2. In the Quick Settings screen that opens, slide the lower slider to the right to increase screen brightness or to the left to decrease screen brightness.

  • Page 104: Adjusting Volume And Sound Indications

    ® Lumenis Pulse 60H Laser System Adjusting Volume and Sound Indications 3. Press OK. NOTE: You can also edit the screen settings in the Settings & Utilities screen. Figure 64: Settings & Utilities > Display Adjustment Adjusting Volume and Sound Indications 1.
  • Page 105 ® Lumenis Pulse 60H Laser System Adjusting Volume and Sound Indications 2. Sound Indications: • In the Quick Settings screen that opens, slide the upper slider to the right to increase volume or to the left to decrease the volume of the voice indications, or: •...
  • Page 106 ® Lumenis Pulse 60H Laser System Adjusting Volume and Sound Indications 4. Press OK. NOTE: You can also edit the screen settings in the Settings & Utilities screen. Figure 67: Settings & Utilities > Sound Indications Level Adjustments UM-20057180EN, Rev. A...

  • Page 107: Changing Date And Time

    ® Lumenis Pulse 60H Laser System Changing Date and Time Changing Date and Time 1. From the Home screen, press the Settings & Utilities button. 2. Press the Set button. Figure 68: Set Date & Time Button UM-20057180EN, Rev. A...
  • Page 108 ® Lumenis Pulse 60H Laser System Changing Date and Time 3. In the Set screen that opens, press the up and down arrows to set the date and time. Figure 69: Settings & Utilities > Set Date & Time UM-20057180EN, Rev. A...
  • Page 109 ® Lumenis Pulse 60H Laser System Changing Date and Time If you prefer a 12 hour clock, clear the 24H check box. Figure 70: Settings & Utilities > Set Date & Time With 12 Hour Clock 4. In the Set menu, press OK.

  • Page 110: Changing The Interface Language

    ® Lumenis Pulse 60H Laser System Changing the Interface Language Changing the Interface Language 1. From the Home screen, press the Settings & Utilities button. 2. Press the Language button. Figure 71: Language Button 3. In the Change Language screen that opens, select the language that you want to change to.
  • Page 111 ® Lumenis Pulse 60H Laser System Changing the Interface Language 4. The available languages are: English, French, German, Italian, Spanish, Portuguese, Chinese, Japanese, Dutch and Russian. 5. On the Change Language menu press the OK button (see Figure 72). 6. On the Settings screen press the OK button (see Figure 73).

  • Page 112: Exporting Service Log

    Exporting Service Log The option to export the service log enables you to send data about the system to a Lumenis service person that can help that person understand a problem that you encountered. 1. Insert a USB storage device into the USB port at the rear of the Lumenis Pulse 60H.
  • Page 113 ® Lumenis Pulse 60H Laser System Exporting Service Log 4. Insert a USB device. 5. Press the Export data to USB button. Figure 75: Export Data to USB Button 6. In the Export data to USB pop-up menu press one of the following backup period options: •...
  • Page 114 ® Lumenis Pulse 60H Laser System Exporting Service Log 8. Wait until the export operation is completed successfully. 9. Press OK to close the pop-up. Figure 76: Export Operation Completed UM-20057180EN, Rev. A Page 114...

  • Page 115: Restoring Default Settings

    ® Lumenis Pulse 60H Laser System Restoring Default Settings Restoring Default Settings You can set all of the settings that are shown in the Settings & Utilities menu to their default settings. 1. From the Home screen, press the Settings & Utilities button.

  • Page 116: Help

    ® Lumenis Pulse 60H Laser System Help Help 1. Press the Help button. Figure 78: Select Help 2. In the left pane, select the topic that you want. Press the + sign to expand each group of topics. 3. The topic that you are interested in appears in the main pane on the right.

  • Page 117: 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 80: Notification Bar UM-20057180EN, Rev.

  • Page 118: Troubleshooting

    1. Write down the error number. ARE TEMPORARY PLACEHOLDERS. 2. Restart the system. THIS CHAPTER WILL BE UPDATED 3. If the problem re-occurs, contact Lumenis Customer Service. WHEN THE ERROR LIST IS COMPLETE. System Does Not Turn On The control screen does not illuminate.

  • Page 119: 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 120: System Overheats

    2. If problem persists, contact Lumenis Service. Message Appears: Attach an Authorized Fiber SIS enabled Lumenis Pulse 60H laser system will only operate with Lumenis-qualified SIS (Secure Identification System) optical fibers. Attaching any other type of fiber will disable laser emission.

  • Page 121: Message Appears: Attach Fiber

    Message Appears: Insert debris shield The debris shield is missing or is not properly inserted. • Insert the debris shield. Message Appears: No lasers The system is experiencing a laser malfunction. • Contact Lumenis Customer Service. UM-20057180EN, Rev. A Page 121...

  • Page 122: Message Appears: Energy 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-20057180EN, Rev. A...

  • Page 123: Routine Periodic Maintenance

    WARNING: No modification of this equipment is allowed. NOTE: Lumenis will provide upon request circuit diagrams, component part lists, descriptions, calibration instructions, or other information to assist service personnel to repair system components. UM-20057180EN, Rev. A...

  • Page 124: 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-20057180EN, Rev. A Page 124...

  • Page 125: Emergency Stop Button Check

    4. Press the Ready button on the LCD or footswitch; verify that the system has transitioned to Ready mode. 5. Power down the system. 6. 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 126: Inspect The Optic

    ® Lumenis Pulse 60H Laser System Inspect the Debris Shield 4. Grasp the debris shield handle, and pull the shield out of the receptacle. TEMPORARY Debris shield handle PLACEHOLDER Figure 82: 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 127: Reinsert The Debris Shield

    ® Lumenis Pulse 60H Laser System 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 128: Professional Maintenance (To Be Updated By Yehudit And Reviewed By Yoav)

    This section covers checks, calibrations and maintenance that require internal access to the laser system’s console and special skills. CAUTION: The Lumenis Pulse 60H laser system may only be serviced by Lumenis certified field service engineer using an approved service manual. WARNING: These procedures assume specific knowledge, training and use of tools not available to repair personnel outside of Lumenis.
  • Page 129 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-20057180EN, Rev. A Page 129...

  • Page 130: Chapter 8: System Requirements And 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 131: Tools (Optional)

    Electrical Requirements Refer to the System Specifications section in this manual. Electrical Utilities The Lumenis Pulse 60H laser system is available in the following electrical configurations: • 200/208/220/230/240V~, 50Hz (factory set), 25A max, single- phase. • 200/208/220/230V~, 60Hz (factory set), 27A max, single-phase.

  • Page 132: Systems Designed For Use In European Communities Under The Mdd

    ® Lumenis Pulse 60H Laser System Systems Designed for Use in European Commu- Systems Designed for Use in European Communities Under the MDD To comply with the European Communities Medical Device Directive 93/ 42/EEC, and harmonized standards EN 60601-1 and EN 60601-2-22, the 230 ±10%VAC configured laser must be connected by means of a...

  • Page 133: Compliance With International Standards

    No sections of the protective housing can be 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 134: Manual Restart

    ® Lumenis Pulse 60H Laser System Manual Restart Manual Restart In the event of the system behaving in an unusual manner or being non- responsive, it should be manually restarted; normal operation may be resumed. Electronic Fault Detection Circuitry The fault detection circuitry constantly monitors the system for fault situations and, if required, will disable laser energy emission and suction until the fault situation is resolved.

  • Page 135: System Specifications

    ® Lumenis Pulse 60H Laser System System Specifications System Specifications Output parameters Treatment laser beam Laser type Holmium:YAG (Ho:YAG), pulsed Laser wavelength 2.1 µm Laser classifications FDA classification Class IV medical device EN 60825 classification Class 4 laser Power 1.0 to 60W...

  • Page 136: Laser Safety Eyewear

    Safety and Regulatory section of this manual for detailed laser safety eyewear information. Compatible Optical Fibers The laser system is intended for use only with Lumenis-authorized accessories. Contact Lumenis Customer Service for a list of available products. 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.

  • Page 137: Appendix A: Emc Guidance And Manufacturer's Declaration

    Guidance and manufacturer’s declaration – electromagnetic emissions The Lumenis Pulse 60H system is intended for use in the electromagnetic environment specified below. The customer or the user of the Lumenis Pulse 60H system should assure that it is used in such an environment.

  • Page 138: Electromagnetic Immunity

    Guidance and manufacturer’s declaration – electromagnetic immunity The Lumenis Pulse 60H system is intended for use in the electromagnetic environment specified below. The customer or the user of the Lumenis Pulse 60H system should assure that it is used in such an environ- ment.
  • Page 139 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Lumenis Pulse 60H is used exceeds the applicable RF compliance level above, the Lumenis Pulse 60H system 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 140: Recommended Separation Distances

    The Lumenis Pulse 60H system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Lumenis Pulse 60H system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Lumenis Pulse 60H as recommended below, according to the maximum output power of the communications equipment.

Table of Contents