LUMENIS UltraPulse Operator's Manual
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LUMENIS UltraPulse Operator's Manual

Carbon dioxide laser for encore and surgitouch models
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UltraPulse
Carbon Dioxide Laser
Operator Manual
for Encore
and SurgiTouch
Models
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Summary of Contents for LUMENIS UltraPulse

  • Page 1 ® UltraPulse Carbon Dioxide Laser Operator Manual for Encore and SurgiTouch Models...
  • 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. Under the law, copying includes translation into another language.

  • Page 3: Table Of Contents

    Connecting the delivery device ........22 UltraPulse Delivery Device Connection Diagram ..... . 23 Balancing the articulated arm .
  • Page 4 Setting the repetition rate or average power ......84 Timed exposure and repeat delay in UltraPulse mode ....86 Setting timed exposure .
  • Page 5 Laser emission indicators ........132 Location of regulatory and system labels ......133 UltraPulse 0637-129-01, Revision G...
  • Page 6 ........169 UltraPulse 0637-129-01, Revision G...

  • Page 7: General

     7 General Operation Overview • Introduction: The UltraPulse Laser Systems 9 • Laser Preparation 11 • UltraPulse Components 12 • Connection Instructions 14 • UltraPulse Delivery Device Connection Diagram 21 • Laser Console Basics 29 • Control Screen Basics 35 •...

  • Page 9: Introduction: The Ultrapulse Laser Systems

    The optional SurgiTouch+ interface offers predetermined application settings that make the UltraPulse Encore even more adaptable and easy-to-use in a variety of specialties, including aesthetics, ENT, gynecology, neurosurgery, and general surgery. Our complete line of delivery systems and accessories, including the optional UltraPulse SurgiTouch Scanner, further extends the versatility of the UltraPulse laser system.

  • Page 10: Characteristics Of The Carbon Dioxide Laser Beam

    Carbon dioxide laser energy is readily absorbed by water in tissue. Since soft tissue is comprised primarily of water, carbon dioxide laser energy can be used effectively for the excision, incision, ablation, vaporization, and coagulation of soft tissue. UltraPulse 0637-129-01, Revision G...

  • Page 11: Laser Preparation

    Laser Preparation  11 Laser Preparation The laser is shipped directly from the factory to your site. Your local Lumenis representative initially uncrates, inspects, sets up, and installs the laser to ensure that it is ready for use. In addition, Lumenis provides in-service training to ensure that your surgical staff is experienced with the operation and safety considerations of the laser.

  • Page 12: Ultrapulse Components

    • Thread adapters for connecting delivery devices • A purge air compressor An UltraScan Encore CPG, an UltraPulse SurgiTouch Scanner, a DeepFX microscanner or additional delivery systems, if ordered, may also be shipped with your laser system. Articulated UltraScan Encore CPG...

  • Page 13: Laser Console

    Delivery Devices Delivery devices for a variety of applications may have been shipped with your UltraPulse laser. Refer to the operator manuals included with those delivery devices for specific descriptions and operating instructions. In addition to the UltraScan Encore CPG and Focused Incisional Handpieces, compatible ™...

  • Page 14: Connection Instructions

    Never look directly into the laser articulated arm while the laser is energized. Accidental laser exposure can cause severe eye damage. CAUTION - Do not touch any optical lens; finger oils may damage the delicate coatings. UltraPulse 0637-129-01, Revision G...
  • Page 15 Connection Instructions  15 Scanner communication cable External door interlock Footswitch To electrical outlet UltraPulse Connections UltraPulse 0637-129-01, Revision G...

  • Page 16: Connecting The Footswitch

    (footswitch) receptacle. If the footswitch is not properly connected when the laser is turned on, "Attach Footswitch" displays in the advisory text bar on the control screen, and the laser cannot be placed in ready mode. Connecting the Footswitch UltraPulse 0637-129-01, Revision G...

  • Page 17: Inserting The External Door Interlock Plug

    “Remote Interlock” displays in the advisory text bar on the control screen. To resume treatment, close the treatment room door or reinsert the interlock plug, and press the button on the advisory text bar. Inserting the External Door Interlock Plug UltraPulse 0637-129-01, Revision G...

  • Page 18: Releasing And Orienting The Articulated Arm

    Turn the latch on the side panel lock to the vertical position, and carefully swing the articulated arm up and out of the storage compartment. Arm pivot lock Arm clip Side panel lock Releasing the Articulated Arm UltraPulse 0637-129-01, Revision G...
  • Page 19 Remove the red protective cap from the distal end of the arm. Store the cap in the holder on the mast. Hold the articulated arm in place until you have connected a delivery system. Orienting the Articulated Arm UltraPulse 0637-129-01, Revision G...

  • Page 20: Connecting The Delivery Device

    UltraPulse Delivery Device Connection Diagram on the following pages for an illustrated overview of delivery device connections. If using the UltraPulse SurgiTouch Scanner, connect the scanner to the articulated arm as shown, then connect the appropriate delivery device to the scanner.

  • Page 21: Ultrapulse Delivery Device Connection Diagram

    Connection Instructions  21 UltraPulse Delivery Device Connection Diagram 0.2mm Focused Incisional Handpiece 1.0mm Focused Incisional Handpiece ClearSpot 160 Micromanipulator (in UltraPulse or CW mode only) ClearSpot 350 Micromanipulator Laser articulated arm UltraScan Encore CPG* (Computer Pattern Generator) Nezhat Laparoscopic Coupler...
  • Page 22 22  General Operation This configuration Laser articulated arm is only suitable for the UltraPulse Blue UltraPulse thread adapter (with lens) SurgiTouch laser model. AcuBlade end joint UltraPulse SurgiTouch Scanner AcuSpot 712 Micromanipulator AcuBlade Microsurgery System Laser articulated arm Blue UltraPulse thread adapter (with lens)
  • Page 23 Connection Instructions  23 Laser articulated arm Silver UltraPulse thread adapter (without lens) FiberLase Probe Coupler Lens Probe holder Quick Connector Nasal or Laryngeal Probes (with "FiberLase" waveguide fiber inserts) Tube from Purge Air Compressor Laser articulated arm Blue UltraPulse thread...

  • Page 24: Balancing The Articulated Arm

    Loosen the control knob by rotating it counterclockwise. Adjust the weight bar forward or backward along the articulated arm, as needed. Retighten the knob until the weight bar is secure. Weight bar Control knob Adjusting the Weight Bar UltraPulse 0637-129-01, Revision G...

  • Page 25: Connecting The Scanner Communication Cable

    Connection Instructions  25 Connecting the Scanner Communication Cable (for the UltraPulse SurgiTouch Scanner and the UltraScan Encore CPG) Verify that the laser keyswitch is in the (off) position before connecting the scanner communication cable to the laser. The UltraPulse SurgiTouch Scanner and the UltraScan Encore CPG scanning devices are controlled by laser system software.
  • Page 26 Insert the communication cable plug into the cable receptacle on the scanning device. Small cable Large cable clip clip Securing the Communication Cable to the Articulated Arm UltraPulse 0637-129-01, Revision G...

  • Page 27: Connecting The Main Power Cable

    (off ) position. Unwrap the power cable from the power cable wrap. Insert the UltraPulse main power plug into the wall socket, and ensure that the plug is secure in the socket. UltraPulse 0637-129-01, Revision G...
  • Page 28 28  General Operation Main power cable and plug Power cable wrap Main power circuit breaker Connecting the main Power Cable UltraPulse 0637-129-01, Revision G...

  • Page 29: Laser Console Basics

    Turn the keyswitch to the (off ) position. Wait five seconds before turning the keyswitch to the (start) position. Release the key. The system goes through the standard start-up sequence. UltraPulse 0637-129-01, Revision G...
  • Page 30 30  General Operation Main power on (up) Main power circuit breaker Start Keyswitch Controls for Turning On and Restarting the Laser UltraPulse 0637-129-01, Revision G...

  • Page 31: Laser Beam Alignment Check

    Beam alignment checks are extremely important for the safe operation of your laser equipment. Do not use the laser or delivery system if aiming and treatment beams are not coincident; call your local Lumenis representative. Misalignment of aiming and treatment beams may result in laser exposure to nontarget tissues and possible injury.
  • Page 32 32  General Operation Main power off (down) Main power circuit breaker Red emergency off button Keyswitch Controls for Turning Off the Laser UltraPulse 0637-129-01, Revision G...

  • Page 33: Disconnecting The Laser

    Laser Console Basics  33 Disconnecting the Laser (for UltraPulse systems with a removable wall plug) Turn the keyswitch to the (off ) position. Place the laser main power circuit breaker in the off (down) position. Remove the power plug from the electrical outlet and wrap the power cable around the cable wrap.
  • Page 34 34  General Operation Footswitch storage mounts Wheel locks Moving the Laser Console UltraPulse 0637-129-01, Revision G...

  • Page 35: Control Screen Basics

    Control Screen Tabs The tabs at the top of the control screen allow you to select one of three treatment control screens: SurgiTouch+, UltraPulse, or CW (continuous wave). You can also select the Options screen, from which you can adjust system preferences.

  • Page 36: Overview Of Operating Modes And Treatment Screens

    The UltraPulse laser has three treatment control screens, allowing you to operate using the SurgiTouch+ interface, UltraPulse mode, or CW (continuous wave) mode. For detailed instructions on using the treatment control screens, refer to the SurgiTouch+, UltraPulse, and CW sections of this manual. SurgiTouch+ The SurgiTouch+ interface allows you to select a specialty and application.

  • Page 37: Changing The Control Screen Mode: English Or Icon

    Press the button to select English mode; press the button to English select icon mode. Select Eng- Select icon English lish mode mode SurgiTouch + UltraPulse Options Sleep The error text will Mode Ready Standby be displayed in English. English English...
  • Page 38 Fluence Rate 10 Hz 1.3 W Power Pattern: Size: 2 Density: 5 1-2-5 17.3 J/cm Repeat Delay 0.10 s Memory UltraPulse Treatment Screen—English Mode Ready Standby Options SurgiTouch + UltraPulse Options Active Active Lite Gentle Energy 125 mJ Fluence J/cm 9.4 J/cm...

  • Page 39: Laser Status: Ready Or Standby

    There is a two-second delay before ready. • Laser emission is occurring. • An advisory message appears in the advisory text bar; you must read and acknowledge the message before you can place the laser in ready mode. UltraPulse 0637-129-01, Revision G...
  • Page 40 40  General Operation Standby Select ready mode Select standby mode Two-second delay before SurgiTouch + UltraPulse Options ready Active Active Lite Gentle 125 mJ 9.4 J/cm J/cm Ready 600 Hz 60 W 1-2-5 17.3 J/cm 0.10 s Laser emission...

  • Page 41: Advisory Messages

    Acknowledge Advisory View additional messages message text bar Error messages and advisory text SurgiTouch + UltraPulse Options Sleep The error text will Mode Ready Standby be displayed in English. English...
  • Page 42 The selected language appears in the language display. Language The error text will display be displayed in English. Language English selector SurgiTouch + UltraPulse Options Sleep The error text will Mode Ready Standby be displayed in English. English...

  • Page 43: Setting The Aiming Beam Characteristics

    To turn off the aiming beam, press the (off ) button on the (aiming beam on/off ) control. Turn aiming Turn aiming beam on beam off Options SurgiTouch + UltraPulse Sleep The error text will Mode Ready Standby be displayed in English. English English...
  • Page 44 To set the aiming beam to continuous, press the (off ) button on the (blink) control. Set aiming beam Set aiming beam to to blink continuous Options SurgiTouch + UltraPulse Sleep The error text will Mode Ready Standby be displayed in English. English...
  • Page 45 To adjust the aiming beam intensity, press the buttons on the (aiming beam intensity) control. Decrease aiming Increase aiming beam intensity beam intensity Options SurgiTouch + UltraPulse Sleep The error text will Mode Ready Standby be displayed in English. English...

  • Page 46: Adjusting The System Volume

    Press the Option tab to view the Options screen. Press the buttons on the (volume) control. Decrease system Increase system volume volume Options SurgiTouch + UltraPulse Sleep The error text will Mode Ready Standby be displayed in English. English English...

  • Page 47: Adjusting The Exposure On / Off

    (on) button on the (exposure) control. To turn off the exposure tone, press the (off ) button on the (exposure) control. Turn exposure Turn exposure Options SurgiTouch + UltraPulse Sleep The error text will Mode Ready Standby be displayed in English. English English...

  • Page 48: Sleep Mode

    48  General Operation Sleep Mode When Sleep Mode is configured to On , the UltraPulse system will automatically leave Ready mode and set itself to Standby after a 5-minute period of non-use. When configured to Off , the system will switch to Standby after two hours.

  • Page 49: Replacing The Scanner (Scanner Pause)

    To restart the scanner software module after you have connected the new scan- ning accessory to the endjoint, press the (restart) button on the Options screen. Scanner Pause SurgiTouch + UltraPulse Options Sleep The error text will Mode Ready Standby be displayed in English.

  • Page 50: Saving And Retrieving Treatment Settings

    For each treatment screen, the UltraPulse laser has three memory locations: 1, 2, and 3. Treatment settings that you store in these memory locations are saved even when the laser is turned off and restarted.
  • Page 51 Control Screen Basics  51 SurgTouch + UltraPulse Options 400mm AcuBlade Larynx 2.0 mm 10.0 W 10 ms 0.00 s Open memory window SurgiTouch + UltraPulse Options 400mm Larynx AcuBlade 2.0 mm Close memory 30 W window 10 W! Memory...
  • Page 52 52  General Operation To retrieve treatment settings: Select the appropriate treatment screen: SurgiTouch+, UltraPulse, or CW. In SurgiTouch+, you must select the specialty, application, and delivery device for which to retrieve treatment settings. Refer to the SurgiTouch+ section of this manual for detailed instructions on using SurgiTouch+.
  • Page 53 Control Screen Basics  53 SurgiTouch + UltraPulse Options 400mm Larynx AcuBlade 2.0 mm Close memory 30 W window 10 W! Memory locations 10 ms Open Save 0.00 s Retrieve treatment settings Retrieving Treatment Settings UltraPulse 0637-129-01, Revision G...

  • Page 54: Ultrascan Encore Cpg Functions

    PigmentFX mode is used with the UltraScan CPG handpiece to deliver very low sub-ablative energy for use on dyschromia. These low energies induce zero to very-low downtime, but may require multiple treatments. PigmentFX mode is available only when the CPG is connected to the UltraPulse laser Lite Button The CO Lite button displays on the UltraPulse treatment screen when the UltraScan Encore CPG handpiece is attached.

  • Page 55: Beam Offset

    Control Screen Basics  55 Beam Offset The beam offset controls display on the Options screen when the UltraPulse SurgiTouch Scanner is attached to the laser. Beam offset is a fine-tuning adjustment for centering the laser beam in the exit aperture of some narrow- diameter delivery devices that are used with the UltraPulse SurgiTouch Scanner, such as the OtoScan Ear Aeration Delivery System.

  • Page 56: Preoperative Instructions

    If the aiming and treatment beams are not aligned, do not use the laser until alignment is corrected by a Lumenis-certified service technician. Misalignment of aiming and treatment beams may result in laser exposure to nontarget tissues and possible injury.

  • Page 57: Intraoperative Instructions

    Intraoperative Instructions  57 Intraoperative Instructions Set the treatment values, as instructed in the SurgiTouch+, UltraPulse, and CW sections of this manual. If any of the “OtoScan”, “Tympanic Membrane”, “Nasal” or “Nasal Probes” ENT applications have been selected, a message will appear in the advisory text bar requesting you to turn on the external Purge Air Compressor (see below).

  • Page 58: Postoperative Instructions

    Clean the exterior surfaces of the laser, as instructed in the Maintenance section of this manual. Replace the red protective cap on the distal end of the laser articulated arm. Fold and secure the articulated arm, as instructed in “Connection Instructions” in this manual. UltraPulse 0637-129-01, Revision G...

  • Page 59: Surgitouch

     59 SurgiTouch+ Enabling application- specific settings Overview • Introduction: The SurgiTouch+ User Interface 61 • Selecting a Specialty, Application, and Delivery Device 62 • Setting Treatment Values 66 UltraPulse 0637-129-01, Revision G...

  • Page 61: Introduction: The Surgitouch+ User Interface

    AcuSpot 712 Micromanipulator Laryngeal Probes Nasal Multi-Application (Oral Pharyngeal) & Nasal Delivery System AcuSpot 712 Micromanipulator Nasal Probes Laparoscopy Lumenis/Nezhat Laparoscopic Coupler (Gynecology) Variable Spot Laparoscopic Coupler Second Puncture Probe Coupler BeamAlign CVD 200 BeamAlign CVD 300 Colposcopy MicroSlad Micromanipulator...

  • Page 62: Selecting A Specialty, Application, And Delivery Device

    Press the SurgiTouch+ tab to view the Specialties screen. Press the button for the desired specialty; the available applications for each specialty will appear as shown in the following Aesthetic and ENT example screens. SurgiTouch + UltraPulse Options Select ENT or Aesthetic specialty Aesthetic...
  • Page 63 For example, when you select the Larynx application, the treatment screen displays the default treatment settings for the AcuBlade at a 400 mm working distance, as shown. Specialty: Application: Default Delivery Device: Larynx AcuBlade 400mm SurgiTouch + UltraPulse Options 400mm Larynx AcuBlade 0.7 mm 16.0 W 9 ms 1.00 s...
  • Page 64 The Specialty, Application, or Delivery Device screen appears. Press the button for the desired specialty, application, or delivery device. Select a new specialty Select a new application SurgiTouch + UltraPulse Options Select a new delivery 400mm device AcuBlade Larynx 0.7 mm...

  • Page 65: Recalling The Last Setup

    The SurgiTouch+ treatment screen automatically displays the default treatment settings for the last setup. Verify that the correct delivery device is attached, then press the button in the advisory text bar to continue. SurgiTouch + UltraPulse Options Aesthetic Neuro General Recall the...

  • Page 66: Setting Treatment Values

    Setting Treatment Values All available delivery devices have default treatment settings, including power, timed exposure, repeat delay, scan mode, and UltraPulse SurgiTouch Scanner settings (where applicable). Available treatment settings vary depending on the selected application and delivery device. You can adjust treatment settings from the default values, as needed.
  • Page 67 Setting Treatment Values  67 Select Non-scan Select Scan mode mode SurgiTouch + UltraPulse Options 400mm Larynx AcuBlade 2.0 mm 10.0 W 10 ms 0.00 s SurgiTouch+; Selecting the Scan Mode UltraPulse 0637-129-01, Revision G...

  • Page 68: Adjusting The Power

    Power density is inversely related to spot size; for any constant power setting, power density will decrease as spot size is increased. For this reason, any increase in spot size must be accompanied by a corresponding increase in power if an equivalent power density is desired. UltraPulse 0637-129-01, Revision G...
  • Page 69 Setting Treatment Values  69 Increase power Decrease power 30 W 16.0 W! SurgiTouch + UltraPulse Options 400mm Larynx AcuBlade 0.7 mm 30 W 16.0 W! 146 ms 1.00 s SurgiTouch+; Adjusting the Power When the power is adjusted from the default setting, the default power appears below the selected setting in the power display, as shown, indicating that the power is set outside of recommended parameters.

  • Page 70: Adjusting The Ultrapulse Surgitouch Scanner Settings

    70  Enabling application- specific settings Adjusting the UltraPulse SurgiTouch Scanner Settings When the SurgiTouch Scanner and communication cable are connected to the laser, default scanner settings automatically display on the treatment screen. Scanner settings, including shape, size, and depth, are active when Scan mode is selected.
  • Page 71 The selected scan size displays on the control screen. Selected size 2.0 mm Decrease scan Increase scan size size SurgiTouch + UltraPulse Options 400mm Larynx AcuBlade 2.0 mm 30 W 10 W! 10 ms 0.00 s...
  • Page 72 The scan depth represents the number of times that the selected pattern is scanned. Selected depth Decrease Increase scan scan depth depth SurgiTouch + UltraPulse Options 400mm Larynx AcuBlade 2.0 mm 30 W 10 W! 10 ms 0.00 s...

  • Page 73: Timed Exposure And Repeat Delay In Surgitouch

    When Repeat delay is set to 0 in Scan mode, the duration of the treatment is controlled entirely by the footswitch. UltraPulse 0637-129-01, Revision G...

  • Page 74: Setting Timed Exposure

    To turn off timed exposure, press the timed exposure (off ) button. Decrease exposure time Increase exposure time 10 ms Timed exposure on/off SurgiTouch + UltraPulse Options 400mm Larynx AcuBlade Shape: 2.0 mm 10.0 W 10 ms 0.00 s SurgiTouch+;...

  • Page 75: Setting Repeat Delay

    (off ) button. To turn off all timed exposures, press the timed exposure (off ) button. Decrease delay time Increase delay time 0.00 s Repeat delay on/off SurgiTouch + UltraPulse Options 400mm AcuBlade Larynx Shape: 2.0 mm 10.0 W 10 ms 0.00 s...

  • Page 77: Ultrapulse

    UltraPulse Overview • Setting the Energy or Fluence 79 • Setting the Repetition Rate or Average Power 82 • Timed Exposure and Repeat Delay in UltraPulse Mode 84 • Setting Timed Exposure 85 • Setting Repeat Delay 86 UltraPulse 0637-129-01, Revision G...

  • Page 79: Setting Treatment Values

    In UltraPulse mode, the available treatment settings are energy, rate (or power), timed exposure, and repeat delay. Fluence is adjustable in UltraPulse CPG mode only. To select UltraPulse mode, press the UltraPulse tab at the top of the control screen, or access UltraPulse mode through SurgiTouch+, Aesthetic and one of the mode buttons: ActiveFX/MaxFX or PigmentFX.
  • Page 80 80  UltraPulse Energy Level and Fluence In UltraPulse mode, fluence, or energy density, determines the nature of the laser-tissue interaction. Fluence is defined as energy per unit area and is measured in joules per square centimeter (J/cm Ablation of tissue with minimal thermal artifact requires pulse fluence above...
  • Page 81 As explained fully in the “Energy level and fluence” section of this manual, the shaded area of the above table shows the critical range where the combined spot sizes and energy settings produce a pulse fluence of greater than or equal to 5 J/cm UltraPulse 0637-129-01, Revision G...

  • Page 82: Setting The Repetition Rate Or Average Power

    Power refers to the average output power of the laser, in watts. There is a direct correlation between repetition rate and average power. The UltraPulse laser allows you to select either the repetition rate or the average power. When you adjust the repetition rate, the resultant change in power also displays on the control screen.
  • Page 83 10 Hz Set the 1.3 W power SurgiTouch + UltraPulse Options Active Active Lite Gentle 100 mJ 7.5 J/cm J/cm 10 Hz 1.3 W 10 ms 0.10 s UltraPulse—Setting the Repetition Rate or Average Power UltraPulse 0637-129-01, Revision G...

  • Page 84: Timed Exposure And Repeat Delay In Ultrapulse Mode

    84  UltraPulse Timed Exposure and Repeat Delay in UltraPulse Mode In UltraPulse mode, timed exposure is adjustable only when the UltraScan Encore CPG is not connected to the laser. When the CPG is attached and turned on, timed exposure is on but is not adjustable; in this case, exposure time is determined by the CPG settings.

  • Page 85: Setting Timed Exposure

    Set the exposure time by pressing the buttons on the timed expo- sure bar. In UltraPulse mode, exposure time increments are dependent upon the rate setting; the higher the rate, the smaller the increments, and hence, the more control you have over exposure time.

  • Page 86: Setting Repeat Delay

    86  UltraPulse Setting Repeat Delay Turn on and set timed exposure, as instructed in the previous section. Press the (on) button on the (repeat delay) bar. The button high- lights to indicate that repeat delay is active. The delay time, in seconds, displays on the control screen. Available repeat delay intervals are 0.1–5.0 seconds.

  • Page 87: Overview

     87 Overview • Setting the Power 89 • Timed Exposure and Repeat Delay in CW Mode 91 • Setting Timed Exposure 92 • Setting Repeat Delay 93 UltraPulse 0637-129-01, Revision G...

  • Page 89: Setting Treatment Values

    Consult your delivery system operator manual to determine if the delivery system introduces a transmission loss to the final output power. Decrease power Increase power 60 W SurgiTouch + UltraPulse Options 60 W 10 ms 0.10 s CW—Setting the Power UltraPulse...
  • Page 90 Power (W) 2.25 31850 1270 63690 2550 1510 95540 3820 2260 127390 5100 3120 1270 1010 159240 6370 3770 1590 1260 1020 191080 7640 4520 1920 1510 1220 Power Density at Various Power Settings and Spot Sizes UltraPulse 0637-129-01, Revision G...

  • Page 91: Timed Exposure And Repeat Delay In Cw Mode

    Repeat delay is available only when timed exposure is turned on. Combined, the repeat delay and timed exposure functions allow you to control the pace at which you operate. UltraPulse 0637-129-01, Revision G...

  • Page 92: Setting Timed Exposure

    To turn off timed exposures, press the timed exposure (off ) button. Decrease exposure time Increase exposure time 10 ms Timed exposure on/off SurgiTouch + UltraPulse Options 60 W 10 ms 0.10 s CW—Setting Timed Exposure UltraPulse 0637-129-01, Revision G...

  • Page 93: Setting Repeat Delay

    (off ) button. To turn off all timed exposures, press the timed exposure (off ) button. Decrease delay time Increase delay time 0.10 s Repeat delay on/off SurgiTouch + UltraPulse Options 60 W 10 ms 0.10 s CW—Setting Repeat Delay UltraPulse 0637-129-01, Revision G...

  • Page 95: Maintenance

    • Troubleshooting Guide 97 • User Maintenance 104 • Electrical Utilities 105 • Specifications 107 • External Door Interlock Pin Assignments 110 • Calibration Procedure 111 • Warranty Information 113 • Decontamination of Returned Equipment 113 UltraPulse 0637-129-01, Revision G...

  • Page 97: Troubleshooting Guide

    Place the laser main power circuit in the off (down) position. breaker in the on (up) position.  The electrical outlet is defective. Use another outlet or have the outlet professionally tested and, if appropriate, repaired. UltraPulse 0637-129-01, Revision G...
  • Page 98 98  Maintenance Problem Probable Cause Solution No treatment beam  There is an internal laser system failure. Contact your local Lumenis output although the representative. aiming beam operates properly.  The footswitch is defective. With the laser in ready mode, verify...
  • Page 99 Verify that your message appears. with the laser system. CPG has a blue label before attempting to use it with UltraPulse laser. If the condition persists, contact your local Lumenis representative. UltraPulse 0637-129-01, Revision G...
  • Page 100  You have attached the UltraScan Encore Select the Resurfacing CPG application. CPG with a non-CPG application selected. “SurgiTouch Scanner  The UltraPulse SurgiTouch Scanner has Press the button to acknowledge detached” advisory been intentionally disconnected. the message. message appears.
  • Page 101 The communication cable is not Verify that the communication cable is properly attached to the laser console or securely plugged into the cable UltraPulse SurgiTouch Scanner, or the receptacles on the laser console and communication cable is defective. UltraPulse SurgiTouch Scanner and that the cable is not damaged.
  • Page 102 If the condition continues, turn off the system for five seconds, then restart. If the condition persists, contact your local Lumenis representative. “Energy Low” advisory  The laser detected a lower level of energy...
  • Page 103 - Resume scanner operation - Press the desired tab again.  Alternately, restart the system.  If all of the above fails, refer to Lumenis' service department. Microscanner is  The CPG’s body feels warmer than Shut down the laser system, disconnect...

  • Page 104: 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 service 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 105: Electrical Utilities

    In order to comply with the European Community Medical Devices Directive 93/42/EEC and harmonized standard EN 60601-2-22, the 200/230 VAC configured UltraPulse laser must either be permanently connected to a 16A, 230 VAC, 50 Hz supply mains in accordance with national wiring regulations, or connected by means of a dedicated single phase, 16A, 250V wall socket and lockable plug combination designed to ensure the connection is “mechanically...

  • Page 106: Hard-Wired Configurations

    EEC, the 16A, 250V wall socket and lockable plug combination must comply with EN 60309 (=IEC 309). An installation kit can be ordered via your local Lumenis representative or, alternately, may be sourced locally. The wall socket and plug combination...

  • Page 107: Specifications

    Specifications  107 Specifications Specifications are subject to change without notice. UltraPulse Laser Treatment beam Type Sealed carbon dioxide, radio frequency (RF) excited Active medium Low-pressure mixture of carbon dioxide, nitrogen, helium, and xenon gases Repetition rate 1 to 1,000 Hz...

  • Page 108: Electrical Requirements

    108  Maintenance UltraPulse Laser Aiming beam Type Diode Power 5.0 mW maximum CDRH classification Class IIIa European MDD laser classification Principal output 635 nm Cooling Internal, closed-cycle, liquid-to-air heat exchanger Electrical requirements 100–120 VAC input power Voltage 100, 110, 115, or 120 VAC ±10%...
  • Page 109 Refer to “Laser Safety Eyewear” in the Safety and Regulatory section of this manual for detailed laser safety eyewear information. Compatible delivery systems The laser is intended for use only with Lumenis-qualified delivery systems. Refer to the UltraPulse Delivery Device Connection Diagram in the General Operation section of this manual for a list of compatible delivery systems.

  • Page 110: 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) UltraPulse 0637-129-01, Revision G...

  • Page 111: Calibration Procedure

    Disclaimer Warning Calibration is a service procedure to be done only by Lumenis-certified Service Engineers or customers who have taken and passed a 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.

  • Page 112: Calibration Instructions

    ±20% of maximum power for your laser, discon- tinue this procedure and contact your local Lumenis service representative. Calibrate Laser Power Place the system in UltraPulse mode. Set energy to 100 millijoules, and rate to 300 hertz. Observing the power meter reading, adjust the E1 GAIN potentiometer (R40) on the main PCB until the laser power coming out of the end of the arm reaches 30 watts.

  • Page 113: 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...

  • Page 115: Safety And

     115 Safety and Regulatory Overview • Introduction 117 • Laser Safety Eyewear 118 • Additional Ocular Protection 121 • Additional Safety Considerations 122 • Regulatory Compliance 129 UltraPulse 0637-129-01, Revision G...

  • Page 117: 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 118: Laser Safety Eyewear

    (usually within the controlled area). For additional information, refer to ANSI Z136.1-2000, ANSI Z136.3-2005, or European Standard EN 60825. The following formula was used to calculate the worst case NOHD for Lumenis UltraPulse lasers and compatible delivery systems: Φ Pf - a NOHD = θ...
  • Page 119 NOHD = θ π θ Using this approach we derive the following values:   Laser System UltraPulse Encore and 0.00224 0.6 cm 1.0 cm 0.1 W/cm SurgiTouch models which results in a worst case NOHD of: Laser System NOHD...
  • Page 120 C. For users who must comply with EN 207, the safety eyewear must have a protection class of: Laser System EN 207 Class UltraPulse Encore and SurgiTouch models Depending on the procedure, the physician must protect the patient’s eyes with either laser safety eyewear or one of the following items moistened with a nonflammable solution: thick cloth, eye pads, or gauze 4 x 4’s.

  • Page 121: Additional Ocular Protection

    Severe eye damage could occur. Turn off the laser and disconnect the delivery system before inspecting any delivery system or laser components. UltraPulse 0637-129-01, Revision G...

  • Page 122: Additional Safety Considerations

    Carbon dioxide light can be reflected off of smooth metallic surfaces, even though they may be blackened. CAUTION - Lumenis medical lasers and laser delivery systems are intended solely for physicians trained in the use of these instruments. CAUTION - When using carbon dioxide as a purge gas, the treatment room must be adequately ventilated.

  • Page 123: Fire Hazards

    WARNING - Laser treatment of adipose tissue may cause cellular fat to liquefy and accumulate into lipid pools. Pooled lipids are flammable and can be ignited by laser radiation, resulting in fire and potential patient injury. UltraPulse 0637-129-01, Revision G...

  • Page 124: Airway Precautions

    The endotracheal tube can be further protected by strategic placement of wet sponges to absorb accidental or stray laser energy. Ensure that the sponges do not dry, as this increases potential fire hazard. UltraPulse 0637-129-01, Revision G...

  • Page 125: Smoke Evacuation-Laser Plume Pollution Hazards

    Repeated suctions of the laser plume into standard hospital wall suction systems without the use of an in-line 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. UltraPulse 0637-129-01, Revision G...

  • Page 126: Protecting Nontarget Tissues

    Beam alignment checks are extremely important for the safe operation of your laser equipment. Do not use the laser or delivery system if aiming and treatment beams are not coincident; contact your local Lumenis representative. Misalignment of aiming and treatment beams may result in laser exposure to nontarget tissues and possible injury.
  • Page 127 • When anesthesia or pain medication is not used, the comfort and pain tolerance of the patient must be assessed. Unexpected movement by the patient could result in unintended laser exposure to nontarget tissue. UltraPulse 0637-129-01, Revision G...

  • Page 128: Electrical Safety

    Lumenis manufacturer’s recommendations and institutional standards. Residual Current Circuit Breaker Lumenis strongly recommends the installation of a residual current circuit breaker (RCCB), also referred to as a ground fault circuit interrupter (GFCI). This is an electrical wiring device that disconnects a circuit whenever it detects that the electric current is not balanced between the phase ("hot"...

  • Page 129: Regulatory Compliance

    Regulatory Compliance  129 Regulatory Compliance Lumenis lasers and delivery systems comply with 21 CFR Chapter 1, Subchapter J, as administered by the Center for Devices and Radiological Health of the US Food and Drug Administration (FDA). CE-labeled devices comply with all appropriate performance standards as specified in Annex II of the Medical Device Directive MDD 93/42/EEC as amended by 2007/47/EC.

  • Page 130: Manual Reset

    After two seconds, the system emits a high-pitched tone to indicate that laser radiation is accessible. During treatment beam delivery, (laser emission indicator) appears in the laser status display on the treatment screen to indicate that laser emission is occurring. UltraPulse 0637-129-01, Revision G...

  • Page 131: Location Of Regulatory And System Labels

    Regulatory Compliance  131 Location of Regulatory and System Labels As required by national and international regulatory agencies, appropriate warning labels have been mounted in specified locations. Location of regulatory compliance labels Location of Regulatory Compliance Labels UltraPulse 0637-129-01, Revision G...
  • Page 132 132  Safety and Regulatory Laser Aperture Laser aperture label Location of Regulatory Compliance Labels UltraPulse 0637-129-01, Revision G...
  • Page 133 Regulatory Compliance  133 Heinrich-Hertz-Strasse 3 D-63303 Dreich-Dreieichenhain Germany Lumenis contact information LASER CLASS 4/IV : 10,600 nm, 225 mJ, 2 ms pulse Max, 60W Max LASER CLASS 3A/IIIa Diode Laser: 635 nm, 5 mW Max CW VISIBLE AND INVISIBLE LASER RADIATION...
  • Page 134 PATENTS PENDING DHHS Certification Patents pending (for FDA-compliant systems) 100 Ð 120V~ 200 Ð 240V~ 50/60 Hz 50/60 Hz 20A, 1 φ 16A, 1 φ Part number, serial number, Electrical specification and manufacturing date Regulatory Compliance Labels UltraPulse 0637-129-01, Revision G...
  • Page 135 (Danger. Possible explosion hazard if used in the presence of flammable anesthetics, oxygen, or nitrous oxide.) Emergency stop Flammable anesthetics and gases warning Class I equipment Mains switch Footswitch Communication cable Remote interlock receptacle receptacle receptacle Regulatory Compliance and System Labels UltraPulse 0637-129-01, Revision G...

  • Page 137: Indications

    Gynecology and GYN Laparoscopy Indications 159 • Neurosurgery Indications 161 • Orthopedics Indications 162 • General and Thoracic Surgery Indications 163 • Dental and Oral Surgery Indications 164 • Genitourinary Indications 166 • Clinical Studies Referenced 167 UltraPulse 0637-129-01, Revision G...

  • Page 139: General Indications

    General Indications  139 General Indications The UltraPulse CO laser is intended for use in surgical and aesthetic procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue in medical specialties including: • Aesthetic (Dermatology and plastic surgery) •...

  • Page 140: General Laser Contraindications

    140  Indications for Use General Laser Contraindications • Do not use the UltraPulse CO laser on hard tissues, such as bone or teeth. • Do not use the CO laser for cutting or ablating dense, healthy bone or bone marrow (for example, hard palate and mandible).

  • Page 141: General Laser Recommendations

    Select the appropriate delivery device for the intended application after consulting with surgical experts, reviewing the published literature, and attending procedure-specific training programs. See the UltraPulse Delivery Device Connection Diagram in the General Operation section of this manual for a list of compatible delivery devices.

  • Page 142: Aesthetic (Dermatology/Plastic Surgery) Indications

    142  Indications for Use Aesthetic (Dermatology/Plastic Surgery) Indications The UltraPulse laser is indicated for use in dermatology and plastic surgery for the following applications: • Ablation, vaporization, excision, incision, and coagulation of soft tissue in the performance of: – laser skin resurfacing –...
  • Page 143 Clinical studies demonstrate that using the UltraPulse CO laser for the creation of recipient sites for hair transplantation, when compared to cold steel, results in faster operative times, reduced bleeding, no compression of laser created sites, and greater hair density due to vaporization of scalp tissue from laser created sites.

  • Page 144: Safety Considerations For Dermatology And Plastic Surgery

    – swelling/edema that resolves over time In addition to these general complications and sequelae, note the following procedure-specific complications and sequelae: Rhinophyma Complications include: – transient pustule formation – alar lift Laser Matrixectomy Complications include: – sterile inflammatory condition UltraPulse 0637-129-01, Revision G...
  • Page 145 – delayed healing of laser-created recipient sites, as compared to recipient sites created using cold steel – removal of hair in laser-created slits in areas bearing hair UltraPulse 0637-129-01, Revision G...

  • Page 146: Safety Considerations For Laser Skin Resurfacing

    2) selection of the pattern density variable of the CPG control. • For superficial ablation of tissue, UltraPulse mode of operation with the UltraScan Encore CPG or TrueSpot 2.0mm handpiece is recommended to limit depth of thermal injury or char.
  • Page 147 (Class I) when treated more aggressively (with more than one laser pass). Less aggressive laser treatment may be associated with increased postoperative burning sensation, while more aggressive laser treatment may be associated with decreased postoperative burning sensation. UltraPulse 0637-129-01, Revision G...
  • Page 148 Laser test patching should be considered prior to treatment, especially for subjects identified as having skin types III, IV, V and VI. 1. Study 12 in “Clinical studies referenced” at the end of this chapter 2. Study 12 UltraPulse 0637-129-01, Revision G...
  • Page 149 (Bayer Corporation, West Haven, CT, USA); though its potential overgrowth of other noncovered bacteria or candida should be considered. 1. Studies 12 and 13 in “Clinical studies referenced” at the end of this chapter 2. Study 12 3. Studies 12 and 13 UltraPulse 0637-129-01, Revision G...
  • Page 150 150  Indications for Use Suggested Delivery Devices Laser skin resurfacing with the UltraPulse laser is usually performed with either the TrueSpot 2.0mm collimated handpiece or the UltraScan Encore CPG handpiece. The TrueSpot 2.0mm handpiece is used for freehand manual resurfacing.
  • Page 151 Types III-VI skin may also resume use of ® topical hydroquinones , such as Melanex , or an equivalent depigmenting agent (twice daily). 1. Study 12 in “Clinical studies referenced” at the end of this chapter UltraPulse 0637-129-01, Revision G...

  • Page 152: Podiatry Indications

    152  Indications for Use Podiatry Indications The UltraPulse laser is indicated for use in podiatry for the following applications: • Laser ablation, vaporization and/or excision of soft tissue for the reduction, removal, and/or treatment of: – verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts –...

  • Page 153: Otolaryngology (Ent) Indications

    Otolaryngology (ENT) Indications  153 Otolaryngology (ENT) Indications The UltraPulse laser is indicated for laser incision, excision, ablation, and/or vaporization of soft tissue in otolaryngology for the treatment of: – choanal atresia – leukoplakia, including oral, larynx, uvula, paletal, and upper lateral pharyngeal tissue –...
  • Page 154 154  Indications for Use – partial glossectomy – tumor resection of oral, subfacial and neck tissues – rhinophyma – verrucae vulgares (warts) – gingivoplasty/gingivectomy UltraPulse 0637-129-01, Revision G...

  • Page 155: Safety Considerations For Ent

    – unintended thermal injury from combustion of anesthesia or other volatile surgical preparation solutions – excessive bleeding – infection – edema – hearing loss Zenker’s Diverticulum – transient soft tissue emphysema – mediastinitis Tonsil Ablation/Tonsillotomy – transient dysphagia – mucosa lesions UltraPulse 0637-129-01, Revision G...
  • Page 156 156  Indications for Use Cordotomy – formation of granuloma Turbinate Reduction/Ablation – transient nasal obstruction associated with postoperative edema and limited nasal crusts UltraPulse 0637-129-01, Revision G...

  • Page 157: Safety Considerations For Laup

    The physician should take appropriate precautions when evaluating and selecting patients presenting with chronic palatal snoring and other significant symptoms of sleep apnea. Complications LAUP complications include: – excessive bleeding – infection – edema – rhinophonia – nasopharyngeal stenosis – velopharyngeal incompetence UltraPulse 0637-129-01, Revision G...

  • Page 158: Safety Considerations For Myringotomy/Tympanostomy

    Refer to the current published literature on myringotomy/ tympanostomy for clinical parameters and techniques. Complications Myringotomy/tympanostomy complications include: – scarring – transient otorrea – infection – recurrence of otitis media 1. Studies 20–22 in “Clinical studies referenced” at the end of this chapter UltraPulse 0637-129-01, Revision G...

  • Page 159: Gynecology And Gyn Laparoscopy Indications

    Gynecology and GYN Laparoscopy Indications  159 Gynecology and GYN Laparoscopy Indications The UltraPulse laser is indicated for use in gynecology for the following applications: • Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of: –...

  • Page 160: Safety Considerations For Gynecology And Gyn Laparoscopy

    CAUTION - Avoid placing the tip of the waveguide in direct contact with tissue to prevent reduction of purge flow and to reduce the risk of systemic gas embolism. UltraPulse 0637-129-01, Revision G...

  • Page 161: Neurosurgery Indications

    Neurosurgery Indications  161 Neurosurgery Indications The UltraPulse laser is indicated for laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of: • Cranial – posterior fossa tumors – peripheral neurectomy – benign and malignant tumors and cysts, for example, gliomas,...

  • Page 162: Orthopedics Indications

    162  Indications for Use Orthopedics Indications The UltraPulse laser is indicated for incision, excision, and vaporization of soft tissue in orthopedic surgery, including the following applications: • Arthroscopy – meniscectomy – chondromalacia – chondroplasty – ligament release (lateral and other) –...

  • Page 163: General And Thoracic Surgery Indications

    General and Thoracic Surgery Indications  163 General and Thoracic Surgery Indications The UltraPulse laser is indicated for incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures. Applications include: – debridement of decubitus ulcers, stasis, diabetic, and other ulcers –...

  • Page 164: Dental And Oral Surgery Indications

    164  Indications for Use Dental and Oral Surgery Indications The UltraPulse laser is indicated for incision, excision, and vaporization of soft tissue in dentistry and oral surgery. Applications include: – gingivectomy/removal of hyperplasias – gingivoplasty – incisional and excisional biopsy –...

  • Page 165: Safety Considerations For Dental And Oral Surgery

    Complications Dental and oral surgery complications include: – laser damage to teeth through inappropriate use – infection UltraPulse 0637-129-01, Revision G...

  • Page 166: Genitourinary Indications

    166  Indications for Use Genitourinary Indications The UltraPulse laser is indicated for incision, excision, and vaporization of soft tissue in genitourinary procedures. Applications include: – benign and malignant lesions of external genitalia – condyloma – phimosis – erythroplasia Safety Considerations for Genitourinary Procedures...

  • Page 167: Clinical Studies Referenced

    Parameters.” Dermatol Surg 1995; 21:1042–1046. 10. Ho C; Nguyen Q; Lask G; Lowe N. “Mini-Slit Graft Hair Transplantation Using the Ultrapulse Carbon Dioxide Laser Handpiece.” Dermatol Surg 1995; 21:1056–1059. 11. Unger W; David L. “Laser Hair Transplantation.” J Dermatol Surg Oncol 1994;...
  • Page 168 16. Adrian R. “Comparative Studies of Superficial and Deep Resurfacing Using the UltraPulse CO Laser and Erbium:YAG Laser in Photodamaged Skin.” Unpublished clinical data on file at Lumenis, Inc. 1999. 17. Chernoff W G. “Histological Perspective of Laser Resurfacing.” Operative Techniques in Otolaryngology—Head and Neck Surgery 1997; 8(1):2–8.
  • Page 169 The undersigned also agrees to reimburse Lumenis for any costs incurred in cleaning the enclosed equipment, in the event said item(s) is/are received by Lumenis in a contaminated condition.

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