LUMENIS VersaPulse PowerSuite 20 Operator's Manual
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LUMENIS VersaPulse PowerSuite 20 Operator's Manual

20w holmium surgical laser
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Summary of Contents for LUMENIS VersaPulse PowerSuite 20

  • Page 1 VersaPulse PowerSuite 20W Holmium Surgical Laser Operator Manual...
  • Page 2 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.
  • Page 3 Regulatory European Representative: Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich Germany Manufactured by Lumenis Ltd. P.O.Box 240 Yokneam 20692 Israel VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 5: Table Of Contents

    Setting the aiming beam characteristics ......40 VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 6 ........89 Decontamination of Returned Equipment ....89 VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 7 General surgery indications ........128 Gastroenterology surgery indications ......132 VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 9: Operation

    Connection Instructions, • Laser Console Basics, • Control Screen Basics , 30 • Setting Treatment Values, • Viewing the Summary Screen, • Preoperative Instructions , 63 • Intraoperative Instructions, • Postoperative Instructions, VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 10 10 Operation VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 11: Introduction

    The VersaPulse PowerSuite 20 Watt Holmium Laser is compact, compatible with standard wall power, and features a swivel control screen for viewing treatment settings from any vantage point.

  • Page 12: Laser Preparation

    12 Operation Laser Preparation The laser is shipped directly from the factory to your site. Your local Lumenis service representative initially uncrates, inspects, sets up, and installs the laser 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.

  • Page 13: Versapulse Powersuite Components

    VersaPulse PowerSuite Components 13 VersaPulse PowerSuite Components The VersaPulse PowerSuite 20 Watt Holmium Laser comprises: • A laser console with control screen • An optional printer • An external door interlock plug • A footswitch • All electrical cables necessary for proper connection...

  • Page 14: Laser Console

    The footswitch activates the laser treatment beam when depressed. Delivery systems A variety of fiber optic delivery systems are available for use with VersaPulse PowerSuite lasers. Refer to the appropriate delivery system instruction guide for specific operating instructions. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 15: Connection Instructions

    Ensure that the electrical cables are not frayed or split. Contact your local Lumenis service representative if any component appears damaged. Connecting the footswitch Insert the footswitch plug into the (footswitch) receptacle on the rear of the laser.

  • Page 16: Inserting The External Door Interlock Plug

    To resume treatment, close the treatment room door or reinsert the interlock plug, and press ready External door interlock plug Inserting the external door interlock plug VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 17: Plugging In The Main Power Cable

    If necessary, plug the matching end of the main power cable into the main power receptacle on the laser. Insert the main power plug into the wall socket. Main power cable Main power plug Main power receptacle Plugging in the main power cable VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 18: Connecting The Optional Printer

    (printer) port on the laser console. Attach the 36-pin end of the printer cable to the Centronics parallel interface on your printer. Printer port (HP Deskjet printers only) Optional printer Connecting the optional printer VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 19: Connecting The Delivery System

    WARNING – 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 and will void your Lumenis warranty or service contract. WARNING –...
  • Page 20 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. Proper handling of the laser connector VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 21 fiber port on the laser console, and finger tightening until secure. If the laser connector is not properly seated and securely screwed into the fiber port, the following illustration appears on the control screen. Connecting the delivery system VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 22: Laser Console Basics

    Turn the key switch to the (off ) position. Wait 5 seconds, then rotate the key switch to the || (start) position; hold for one full second, and release the key. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 23 Laser Console Basics 23 Key switch Main power circuit breaker Controls for turning on and restarting the laser VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 24: Turning Off The Laser

    (down) position, and turn off the main electrical service (wall circuit breaker). Emergency off (STOP) In an emergency, press the emergency off (STOP) button on the front of the laser to immediately turn off the laser. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 25 Laser Console Basics 25 Key switch Emergency off button Controls for turning off the laser VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 26: Disconnecting The Laser And Delivery System

    Disconnect the delivery system from the laser. If the delivery system is single- use, discard it; if multiple-use, prepare the delivery system for reuse as instructed in the appropriate delivery system instruction guide. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 27 Laser Console Basics 27 Cable wrap Footswitch storage mount Cable wrap Laser console cable wrap and footswitch storage mounts VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 28: Locking And Unlocking The Laser Console Wheels

    Locking and unlocking the laser console wheels Step on the wheel brake to alternately lock and unlock the laser console wheels, as shown. Wheel brake Locking and unlocking the laser console wheels VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 29: Moving The Laser Console

    Position the laser console a minimum of 50 centimeters (20 inches) from walls, furniture, or other equipment. Adequate space around the laser console ensures proper air circulation for system cooling. Lock the laser console wheels. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 30: Control Screen Basics

    Options • Select the English or icon viewing options mode • Set the date and time • Set the laser beep volume VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 31 PowerSuite PowerSuite VersaPulse VersaPulse Holmium 20W Holmium 20W English 12/24 12/24 02:15 PM 14:15 03/20/01 20/03/01 mm/dd/yy dd/mm/yy treatment summary options English mode Icon mode Control screen tabs VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 32: Changing The Viewing Mode: English Or Icon

    Press the tab to view the options screen. options Press to select English mode, or press to select icon mode. English Press the tab to return to the treatment screen. treatment VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 33 02:15 PM 03/20/01 mm/dd/yy treatment summary options Changing the viewing mode—English mode Press to select icon mode PowerSuite VersaPulse Holmium 20W English 12/24 14:15 20/03/01 dd/mm/yy Changing the viewing mode—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 34: Setting The Date And Time

    fields, and the colon between the hour and minutes is blinking. Press the tab to return to the treatment screen. treatment VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 35 03/20/01 mm/dd/yy mm/dd/yy treatment summary options Setting the date and time—English mode PowerSuite VersaPulse Holmium 20W 12/24 English 14:15 20/03/01 12/24 14:15 20/03/01 dd/mm/yy dd/mm/yy Setting the date and time—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 36: Changing The System Beep Volume

    Under these circumstances, you may continue operating the laser. If the condition persists, however, contact your local Lumenis service representative. To adjust the beep volume: Press the tab to view the options screen.
  • Page 37 PowerSuite VersaPulse Holmium 20W 12/24 02:15 PM 03/20/01 mm/dd/yy treatment options summary Changing the beep volume—English mode VersaPulse PowerSuite Holmium 20W English 12/24 14:15 20/03/01 dd/mm/yy Changing the beep volume—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 38: Selecting The Laser Status: Ready Or Standby

    Maintaining the laser in standby mode prevents accidental laser exposure if the footswitch is inadvertently depressed. WARNING – Verify that all persons in the treatment room are wearing the appropriate laser safety eyewear before placing the laser in ready mode. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 39 Selecting the laser status—English mode Press to select ready mode Press to select standby mode Laser status display PowerSuite VersaPulse Holmium 20W 10.0 14:15 Selecting the laser status—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 40: Setting The Aiming Beam Characteristics

    1:01 PM display treatment summary options Setting the aiming beam characteristics—English mode PowerSuite VersaPulse Holmium 20W Blinking aiming beam selector 10.0 Aiming beam 14:15 display Setting the aiming beam characteristics—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 41: Verifying The Aiming Beam

    Doing so will not affect visibility at the treatment site, since the camera compensates for the lower level of light. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 42: Control Screen Messages

    Refer to the “Troubleshooting Guide” in the Maintenance section of this manual for a list of advisory messages, their probable causes, and solutions. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 43 RATE POWER 10.0 TIME 1:01 PM treatment summary options Location of advisory messages—English mode Laser Advisory status message display display PowerSuite VersaPulse Holmium 20W 10.0 14:15 Location of advisory messages—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 44: Setting Treatment Values

    Contact your local Lumenis service representative. Some energy settings may not be available at higher pulse rate settings. If you attempt to select an energy setting that is unavailable at the existing rate setting, the system will emit a low beep, indicating that the selection is not available.
  • Page 45 POWER ENERGY RATE 10.0 TIME 1:01 PM treatment summary options Setting the energy per pulse—English mode VersaPulse PowerSuite Holmium 20W 10.0 14:15 Setting the energy per pulse—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 46 The grey area represents the maximum energy available for the selected rate. The dark-colored bar represents the current energy setting. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 47 Setting Treatment Values 47 Maximum energy setting for the laser Energy available at current rate setting Current energy setting Icon mode shown; the graph is the same in English mode. Energy bar graph VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 48: Setting The Pulse Rate

    Contact your local Lumenis service representative. Some rate settings may not be available at higher energy settings. If you attempt to select a pulse rate that is unavailable at the existing energy setting, the system will emit a low beep, indicating that the selection is not available.
  • Page 49 POWER ENERGY RATE 10.0 TIME 1:01 PM treatment summary options Setting the pulse rate—English mode VersaPulse PowerSuite Holmium 20W 10.0 14:15 Setting the pulse rate—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 50 (Hz), and the top of the graph indicates the maximum rate for your laser. The grey area represents the maximum rate available for the selected energy. The dark-colored bar represents the current rate setting. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 51 Setting Treatment Values 51 Maximum rate setting for the laser Rate available at current energy setting Current rate setting Icon mode shown; the graph is the same in English mode. Rate bar graph VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 52: Understanding Average Power

    POWER ENERGY RATE 10.0 Average power display TIME 1:01 PM treatment summary options Average power display—English mode PowerSuite VersaPulse Holmium 20W 10.0 Average power display 14:15 Average power display—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 53 16.0 W 20.0 W 2.0 J 2.2 J 11.0 W 13.2 W 17.6 W 2.4 J 12.0 W 14.4 W 19.2 W 12.5 W 15.0 W 20.0 W 2.5 J Average power VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 54: Casesaver™ Mode

    CaseSaver mode lets you complete a surgical procedure with a lower maximum energy, 1.5 joules per pulse, rather than lose use of the laser altogether. When you finish the procedure, contact your local Lumenis service representative. Pulse Rate (pulses/second)
  • Page 55 ENERGY RATE POWER 10.0 TIME 1:01 PM treatment summary options CaseSaver message—English mode CaseSaver ≤ 1.5J message PowerSuite VersaPulse Holmium 20W 10.0 14:15 CaseSaver message—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 56: Viewing The Summary Screen

    Resets the average laser parameters to zero Viewing the current or previous treatment Press current treatment to view the current treatment previous treatment summary. Press to view the previous treatment summary. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 57 13:06 language 13:53 Press to view the current treatment 0.1 kJ 1.0 J @ 10Hz (10W) Press and hold for 3 seconds to start a new treatment Summary screen—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 58: Treatment Summary

    If you want to print an itemized list of each successive energy and rate change made during the current or previous treatment, see “Printing a treatment report” later in this section. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 59 1.0 J @ 10Hz Parameters (10.0 W) print treatment summary options Summary screen—English mode PowerSuite VersaPulse Holmium 20W DANSK 13:06 language 13:53 0.1 kJ 1.0 J @ 10Hz (10W) Summary screen—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 60: Printing A Treatment Report

    If, after printing the report, you intend to start a new treatment, press and hold button for 3 seconds to clear the current treatment summary. Press the tab to return to the treatment screen. treatment VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 61 PowerSuite VersaPulse Holmium 20W DANSK 13:06 Press to select your language 13:53 language 0.1 kJ 1.0 J @ 10Hz (10W) Press to print your treatment report Printing the treatment report—icon mode VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 62 0.2 kJ Average laser parameters: 1.93 J @ 8.48 Hz (16.3 W) LASER PARAMETERS Energy Rate Number of pulses 2.0J 10Hz 2.0J 1.8J 1.5J End of Report May 6, 2001 Treatment report—English VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 63: Preoperative Instructions

    Do not use the laser or delivery system if the aiming beam is not visible. Operating the laser without the aiming beam may result in laser exposure to nontarget tissue and possible injury. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 64: Intraoperative Instructions

    Place the laser in ready mode. Depress the footswitch to deliver the treatment beam. During treatment, TREATMENT appears on the control screen. If surgery is interrupted, place the laser in standby mode to disable the footswitch. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 65: Postoperative Instructions

    Disconnect the external door interlock, if used. Clean the exterior surfaces of the laser, as instructed in the “Maintenance” section of this manual. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 67: Maintenance

    • User Maintenance, • Electrical Utilities , 81 • Specifications , 83 • External Door Interlock Pin Assignments, • Calibration Procedure, • Warranty Information, • Decontamination of Returned Equipment , 89 VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 68 68 Maintenance VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 69: Troubleshooting Guide

    External door interlock – If the external door interlock is used in conjunction with a remote switch, verify that the external door interlock plug is inserted in the external door interlock receptacle. Close the interlocked door. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 70 Note – If your debris shield requires replacement, you should also replace your delivery system optical fiber; the debris shield is typically blown by failed fibers. The aiming beam is malfunctioning. Contact your local Lumenis service representative. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 71 Note – If your debris shield requires replacement, you should also replace your delivery system optical fiber; the debris shield is typically blown by failed fibers. The laser is malfunctioning. Contact your local Lumenis service representative. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 72 The footswitch is not Connect the “Attach footpedal” advisory message appears on the control screen, as shown: properly connected to footswitch as the laser. instructed in the “Connection Instructions” section of this manual. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 73 “Insert debris shield” advisory message appears The debris shield is Insert the debris shield as missing or is not properly instructed in the “User on the control screen, as shown: inserted. Maintenance” section of this manual. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 74 Service Required five seconds, then turn it back on. If the message reappears, record the advisory code from the summary screen and contact your local Lumenis service representative. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 75 If the condition continues, turn off the laser for five seconds, then turn it back on. Energy low If the condition persists, contact your local Lumenis service representative. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 76 If the condition continues, turn off the laser for Rate < 80% five seconds, then turn it back on. If the condition persists, contact your local Lumenis service representative. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 77: User Maintenance

    Lumenis-certified service engineer to ensure proper laser performance. Laser repair All laser repairs should be performed by a Lumenis-certified service engineer. For training and information, contact your local Lumenis representative. Clean the external surfaces of the laser console Use a cloth dampened with a noncaustic cleaning solution, such as soap and water, isopropyl alcohol, or a “hospital-grade”...

  • Page 78: Inspecting The Debris Shield

    To inspect the debris shield: Remove the debris shield panel on the laser console. Debris shield panel Remove the debris shield panel Locate and remove the debris shield panel VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 79 Grasp the debris shield handle, and pull the shield out of the receptacle. Do not touch the debris shield optic; finger oils may damage the delicate coatings. Debris shield handle Remove the debris shield VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 80 Attach a new fiber to the laser and resume treatment. If the abnormal popping sound and decrease in energy persist, contact your local Lumenis service representative. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 81: Electrical Utilities

    Electrical Utilities 81 Electrical Utilities The VersaPulse PowerSuite 20 Watt Holmium Laser is available in several electrical configurations. Electrical power should be set up 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 82: Hard-Wired Configurations

    If the laser is to be hardwired to the electrical service, prior to installation, the customer’s engineer or electrical contractor will be responsible for ensuring that the proper electrical requirements are available at the site. After the Lumenis service representative arrives, the customer’s engineer or electrical contractor will be responsible for connecting the power cable supplied with the system to the service box, in accordance with local codes.

  • Page 83: Specifications

    Voltage Single Phase 15A, 120± 10% VAC Current 10A, 200± 10% VAC 10A, 230± 10% VAC Internal water-to-air heat exchanger Cooling Minimum 50 cm (20 inches) from walls Cooling air requirements VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 84 The laser is intended for use only with Lumenis-qualified delivery Compatible delivery systems systems. Contact your local Lumenis representative for a list of available products. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 85: Laser Safety Eyewear

    Goggles, Safety, Holmium (2100 nm) and Nd:YAG (1064 nm) Replacement parts Miscellaneous Part Number Product Name 0640-083-01 VersaPulse PowerSuite Holmium 20 Watt debris shield 5107-0190 VersaPulse laser key 2104-1121 External door interlock plug VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 86: External Door Interlock Pin Assignments

    Total length of cable shall not exceed five meters (16 feet). Pin assignments are as follows: External interlock Locking tab, with red dot Jumper Ground shield External interlock RTN External door interlock pin assignments (solder side of plug shown) VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 87: Calibration Procedure

    Lumenis Service Certification Training course. Adjustment by anyone other than a trained Lumenis service engineer or a certified customer voids any existing manufacturer’s warranty on the instrument. A service manual for the laser may be purchased from Lumenis.
  • Page 88 Attach Digital Voltmeter to TP24 and TP20 on the control board. Depress footswitch and adjust potentiometer SGAIN 1 (R17) on control board such that 0.00 ± 0.02 V is measured across TP24 and TP20. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 89: Warranty Information

    Decontamination of Returned Equipment To comply with United States postal and transportation law, equipment shipped to Lumenis US offices for repair or return must be properly decontaminated with a chemical germicide that is commercially available and cleared for use as a “Hospital Disinfectant.” To ensure that all equipment has been properly decontaminated, a signed Decontamination Certificate...

  • Page 91: Safety And

    • Laser Safety Eyewear, 94 • Additional Ocular Protection , 97 • Additional Safety Considerations, • Smoke evacuation, • Protecting nontarget tissues, • Electrical hazards, • Fire hazards, • Regulatory Compliance, VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 92 92 Safety and Regulatory VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 93: Introduction

    Additional precautions must be taken to prevent fire, electrical injury, and explosion. Lumenis does not make recommendations regarding the practice of medicine. Laser treatment parameters are provided as a guide. Individual treatment should be based on clinical training, clinical observation of laser-tissue interaction, and appropriate clinical endpoints.

  • Page 94: Laser Safety Eyewear

    ANSI Z136.1-1993, ANSI Z136.3-1996, or European Standard EN 60825: 1992, Appendix A. The following formula was used to calculate the worst case NOHD for Lumenis VersaPulse PowerSuite Holmium 20 Watt lasers and compatible delivery systems: Φ Pf - a NOHD = θ...
  • Page 95 All personnel who are within the NOHD are considered to be within the controlled area and shall wear eye protection with a minimum optical density (OD) of: FIBER WORST-CASE LASER ENERGY 1.2 cm Ho:YAG (2.1 µm) VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 96 4 x 4’s. For periorbital treatment, the physician must protect the patient with dulled, metal eye shields. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 97: Additional Ocular Protection

    Never look directly into any optical lens, optical fiber, handpiece, probe, laser articulated arm, or laser system aperture while the laser is energized. Severe eye damage could occur. Turn off the laser before inspecting any delivery system or laser components. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 98: Additional Safety Considerations

    US federal law restricts this device to sale by or on the order of a physician. CAUTION – Lumenis medical lasers and laser delivery systems are intended solely for physicians trained in the use of these instruments. CAUTION – Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure.

  • Page 99: Smoke Evacuation-Laser Plume Pollution Hazards

    filter system may eventually clog that system, requiring extensive repair. For minor procedures, wall suction may be used; however, first install an in-line disposable filter. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 100: Protecting Nontarget Tissues

    Never discharge the laser without a target to absorb it and without consideration given to what lies behind the target. Place energy-absorbing material behind the target tissue when aiming the laser at an oblique target. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 101: Electrical Hazards

    WARNING – Never open the laser console protective covers. Opening the covers will expose the user to high voltage components, the laser resonator, and possible laser radiation. Only Lumenis-certified service technicians shall work inside the console. WARNING – The area around the laser and footswitch should be kept dry. Do not operate the laser if any of the cords are faulty or frayed.

  • Page 102: Fire Hazards

    A UL-approved fire extinguisher and water should be readily available. WARNING – When performing procedures in the perianal area, the flammability of methane gas must be considered. Moistened sponges should be inserted into the rectum. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 103: Regulatory Compliance

    The laser has a protective housing that prevents unintended human access to laser radiation. 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. Location of controls The controls are located on the control screen so the user need not be exposed to the treatment beam.

  • Page 104: Safety Shutter

    Location of regulatory and other system labels As required by national and international regulatory agencies, appropriate warning labels have been mounted in specified locations. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 105 Regulatory Compliance 105 STOP Laser aperture at distal end of fiber Emergency stop Location of regulatory compliance labels VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 106 106 Safety and Regulatory Regulatory compliance labels IP 28 Ingress protection Location of regulatory compliance labels VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 107 AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION manufacturing date CLASS 4 LASER PRODUCT per EN 60825-1/1994 CLASS IV LASER PRODUCT per 21 CFR 1040 0635-365-01 Rev. B Danger label Regulatory compliance labels VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 108 IP 20 oxygen, or nitrous oxide.) Flammable anesthetics and gases warning Ingress protection (Read and comprehend the operator manual before use.) Attention, read manual Regulatory compliance labels VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 109: Indications

    Use Overview • General warnings, 112 • Arthroscopy indications, • Urology indications, • Urinary lithotripsy indications, • E.N.T. surgery indications, • Gynecology indications, • General surgery indications, • Gastroenterology surgery indications, VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 110 110 Indications for Use VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 111: Indications For Use Specific To The Ho:yag Wavelength

    CAUTION – Lumenis VersaPulse PowerSuite Holmium lasers are intended solely for use by physicians trained in the use of the Ho:YAG (2.1 µm) wavelength. The use of a laser instrument for an application is at the physician’s discretion except in cases where the indication has been contraindicated.

  • Page 112: General Warnings, Precautions, And Complications To Consider When Using The Holmium Wavelength

    WARNING – There is an increased risk of back scatter (reflection) and forward scatter (penetration) when using the laser if the laser is in non-contact mode. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 113 Discontinue laser treatment immediately if the patient develops any cardiopulmonary problems. CAUTION – Lumenis has no clinical information concerning the safety of laser treatment on pregnant or nursing women. CAUTION – Refer to the appropriate delivery system instruction guide for use instructions.
  • Page 114 Sepsis can result from performing any surgical procedure. If a question of sepsis exists, appropriate evaluations should be made. • Perforation may occur as a result of laser treatment. To diagnose perforations, patients must be carefully followed post-operatively with appropriate tests. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 115: Arthroscopy Indications

    • Chondroplasty in the knee • Chondromalacia ablation Arthroscopy warnings, precautions, and complications Read “General laser warnings”, “General laser precautions”, and “General laser complications” earlier in this chapter for further information. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 116: Urology Indications

    Read “General laser precautions” earlier in this chapter for a list of additional precautions. Urology complications Read “General laser complications” earlier in this chapter for a list of complications. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 117 1. Energy delivered endoscopically in a fluid medium. Note–Laser settings are guidelines only; always start with low settings and increase to achieve the desired tissue effect. Urology—recommended treatment parameters, holmium wavelength VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 118: Urinary Lithotripsy Indications

    Use of excessive power may result in inadvertent perforation of the ureter or damage to other urologic structures. Read “General laser warnings” earlier in this chapter for a list of additional warnings. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 119 The rate of irrigation should be carefully adjusted to avoid flux of calculi into the kidney. Read “General laser precautions” earlier in this chapter for a list of additional precautions. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 120 Although rare, loss of a kidney may occur as a result of the procedure or because of the stone, itself. Read “General laser complications” earlier in this chapter for a list of additional complications. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 121 1. Energy delivered endoscopically in a fluid medium. Note–Laser settings are guidelines only; always start with low settings and increase to achieve the desired tissue effect. Urinary lithotripsy—recommended treatment parameters, holmium wavelength VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 122: E.n.t. Surgery Indications

    Functional endoscopic sinus surgery (FESS) E.N.T. surgery contraindications The Ho:YAG wavelength should not be used in patients with any of the following conditions: • Inappropriate candidates for endoscopic treatment • Endonasal malignant neoplasm VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 123 WARNING – Perforation of dura may result in leakage of cerebral spinal fluid with meningitis. Read “General laser warnings” earlier in this chapter for a list of additional warnings. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 124 0.5–1.0 5–15 2.5–15 Coagulation of Soft Tissue Note–Laser settings are guidelines only; always start with low settings and increase to achieve the desired tissue effect. E.N.T. surgery—recommended treatment parameters, holmium wavelength VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 125: Gynecology Indications

    Insufflation pressure should be set to minimum settings for effective insufflation. (The maximum safe intra-abdominal pressure setting is 15 to 20 mm Hg.) Read “General laser warnings” earlier in this chapter for a list of additional warnings. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 126 2 to 5 millimeters. Third, if the beam is defocused at a distance greater than 5 millimeters, the surgeon may increase the treatment energy and, optionally, the repetition rate to effectively ablate and coagulate. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 127 Bowel Bladder 0.5–1.5 5–20 10–15 0.5–1.5 5–20 10–15 Note–Laser settings are guidelines only; always start with low settings and increase to achieve the desired tissue effect. Gynecology—recommended treatment parameters, holmium wavelength VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 128: General Surgery Indications

    Parathyroidectomy • Herniorrhaphy • Tonsillectomy • Lymphadenectomy • Partial nephrectomy • Pilonidal cystectomy • Resection of lipoma • Debridement of decubitus ulcer • Hemorrhoids • Debridement of statis ulcer • Biopsy VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 129 15 to 20 mm Hg. Read “General laser warnings” earlier in this chapter for a list of additional warnings. General surgery precautions Read “General laser precautions” earlier in this chapter for a list of precautions. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 130 Second, the physician may elect to defocus the beam without changing the system controls by moving the tip of the handpiece away from the target tissue approximately 2 to 5 millimeters. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 131 Coagulation of Soft Tissue 0.5–1.0 5–15 2.5–15 Note–Laser settings are guidelines only; always start with low settings and increase to achieve the desired tissue effect. General surgery—recommended treatment parameters, holmium wavelength VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

  • Page 132: Gastroenterology Surgery Indications

    Gastric ulcer • Duodenal ulcer • Non-bleeding ulcer • Gastric erosions • Colorectal cancer • Gastritis • Bleeding tumors • Pancreatitis • Vascular malformations • Telangiectasias • Telangiectasias of the Osler-Weber-Renu disease VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 133 CAUTION – Use caution when treating patients who have had previous esophageal-tracheal fistulae or episodes of aspiration. Read “General laser precautions” earlier in this chapter for a list of additional precautions. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 134 Second, the physician may elect to defocus the beam without changing the system controls by moving the tip of the handpiece away from the target tissue approximately 2 to 5 millimeters. VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 135 Coagulation of Soft Tissue 0.5–1.0 5–15 2.5–15 Note–Laser settings are guidelines only; always start with low settings and increase to achieve the desired tissue effect. Gastroenterology surgery—recommended treatment parameters, holmium wavelength VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 137 The undersigned also agrees to reimburse Lumenis for any costs incurred in cleaning the en- closed equipment, in the event said item(s) is/are received by Lumenis in a contaminated con- dition.
  • Page 139 Overview 139 Index VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 140 140 Index VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 141 Warning do not use if aiming beam is weak, Warning – storage mount handling the connector, Warning specifications See your delivery system instruction guide – gastroenterology surgery indications sterilization VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 142 – main power circuit breaker safety maintenance, annual laser – electrical hazards moving the laser console fire hazards moving the laser console, Caution – regulatory compliance smoke evacuation VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...
  • Page 143 Insert Debris Shield advisory message laser does not turn on no power from end of optical fiber Overheating advisory message – popping sound during treatment VersaPulse PowerSuite 20 Watt Holmium 0640-041-01, Rev. B, 09/04...

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