UltraPulse for Encore and SurgiTouch Models Operator Manual Rev G

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. Please note that while every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. Lumenis, the Lumenis logo, UltraPulse, UltraPulse SurgiTouch, SurgiTouch+, Encore, UltraScan CPG, PigmentFX, ActiveFX, ActiveFX gentle, MaxFX, DeepFX, SCAAR FX, PreciseFX, IncisionFX, BrowFX, CoolScan, CO2 Lite, TrueSpot, ClearSpot, UltraFlex, Lumenis/Nezhat, AcuSpot, OtoScan, OtoLAM, AcuBlade, BeamAlign, MicroSlad, and FiberLase are trademarks or registered trademarks of Lumenis. Retin-A and Renova are registered trademarks of Ortho Pharmaceuticals Corporation, Dermatological Division. Melanex is a registered trademark of Neutrogena Dermatologics. Valtrex is a registered trademark of Glaxo Wellcome, Inc. Famvir is a registered trademark of SmithKline Beecham Pharmaceuticals. Cipro is a registered trademark of Bayer Corporation. Coppertone and Shade are trademarks, distributed by Schering-Plough HealthCare Products, Inc. Vaseline is a registered trademark of Chesebrough-Pond’s USA, Co. Acutane is a registered trademark of Roche Laboratories, Inc.

Copyright© Lumenis Ltd. May 2012 0637-129-01 Revision G

Authorized Representative: Lumenis GmbH Germany Heinrich-Hertz-Strasse 3 D-63303 Dreieich-Dreieichenhain Germany

Manufactured by Lumenis Ltd. P.O.B. 240 Yokneam 20692 Israel Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE) In accordance with Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE), any item which is marked with the crossed-out wheelie bin symbol must not be disposed of as unsorted municipal waste, but segregated from other waste types for eventual treatment and recovery at an approved recycling facility. By returning waste electrical and electronic equipment via the correct segregated disposal channel, users can ensure the environmentally sound treatment and disposal of the waste equipment, thereby reducing the potential for any environmental or health risks that could arise as a result of incorrect disposal. Lumenis provides web-based collection, recycling and reporting arrangements to the business end-user for equipment marked with the crossed-out wheelie bin. Please visit www.lumenis.com/recycling to understand what arrangements Lumenis has made in each EU Member State.

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Contents General Operation

Overview... 9 Introduction: The UltraPulse Laser Systems... 11 Characteristics of the carbon dioxide laser beam... 12

Laser Preparation... 13 UltraPulse Components... 14 Laser console... 15 Footswitch... 15 External door interlock plug... 15 Delivery devices... 15 Purge air compressor... 15

Connection Instructions... 16 Connecting the footswitch... 18 Inserting the external door interlock plug... 19 Releasing and orienting the articulated arm... 20 Connecting the delivery device... 22 UltraPulse Delivery Device Connection Diagram... 23 Balancing the articulated arm... 26 Connecting the scanner communication cable... 27 Connecting the main power cable... 29

Laser Console Basics... 31 Turning on the laser... 31 Restarting the laser... 31 Laser beam alignment check... 33 Turning off the laser... 33 Emergency off... 33 Disconnecting the laser... 35 Moving the laser console... 35 UltraPulse 0637-129-01, Revision G

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Control Screen Basics... 37 Control screen tabs... 37 Overview of operating modes and treatment screens... 38 Changing the control screen mode: English or icon... 39 Laser status: ready or standby... 41 Advisory messages... 43 Setting the aiming beam characteristics... 45 Adjusting the system volume... 48 Adjusting the Exposure On / Off... 49 Sleep Mode... 50 Replacing the Scanner (Scanner Pause)... 51 Saving and retrieving treatment settings... 52 UltraScan Encore CPG functions... 56 Beam offset... 57

Preoperative Instructions... 58 Intraoperative Instructions... 59 Postoperative Instructions... 60

SurgiTouch+

Overview... 61 Introduction: The SurgiTouch+ User Interface... 63 Selecting a Specialty, Application, and Delivery Device... 64 Recalling the last setup... 67

Setting Treatment Values... 68 Selecting the scan mode: Non-scan or Scan... 68 Adjusting the power... 70 Adjusting the UltraPulse SurgiTouch Scanner settings... 72 Timed exposure and repeat delay in SurgiTouch+... 75 Setting timed exposure... 76 Setting repeat delay... 77

UltraPulse

Overview... 79 Setting Treatment Values... 81 Setting the energy or fluence... 81 Setting the repetition rate or average power... 84 Timed exposure and repeat delay in UltraPulse mode... 86 Setting timed exposure... 87 Setting repeat delay... 88

CW

Overview... 89 Setting Treatment Values... 91 Setting the power... 91 Timed exposure and repeat delay in CW mode... 93 Setting timed exposure... 94 Setting repeat delay... 95

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Contents  5

Maintenance

Overview... 97 Troubleshooting Guide... 99 User Maintenance... 105 Annual laser maintenance... 106 Laser repair... 106 Clean the external surfaces of the laser console... 106 Clean the laser control screen... 106 Water utilities... 106

Electrical Utilities... 107 Systems designed for use outside of Europe... 107 Systems designed for use in the European Community under MDD... 107 Hard-wired configurations... 108 Removable or lockable wall socket and plug configurations... 108

Specifications... 109 External Door Interlock Pin Assignments... 112 Calibration Procedure... 113 Calibration instructions... 114

Warranty Information... 115 Decontamination of Returned Equipment... 115

Safety and Regulatory

Overview... 117 Introduction... 119 Laser Safety Eyewear... 120 Additional Ocular Protection... 123 Additional Safety Considerations... 124 Fire hazards... 125 Airway precautions... 126 Smoke evacuation-laser plume pollution hazards... 127 Protecting nontarget tissues... 128 Electrical Safety... 130

Regulatory Compliance... 131 Emergency off pushbutton... 131 Key lock switch... 131 Location of controls... 131 Protective housing... 131 External door interlock... 131 Safety interlocks... 131 Manual reset... 132 Electronic fault detection circuitry... 132 Safety shutter... 132 Laser emission indicators... 132 Location of regulatory and system labels... 133

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Indications for Use

Overview... 139 General Indications... 141 General laser contraindications... 142 General laser warnings and precautions... 142 General laser recommendations... 143

Aesthetic (Dermatology/Plastic Surgery) Indications... 144 Safety considerations for dermatology and plastic surgery... 146 Safety considerations for laser skin resurfacing... 148

Podiatry Indications... 154 Safety considerations for podiatry... 154

Otolaryngology (ENT) Indications... 155 Safety considerations for ENT... 157 Safety considerations for LAUP... 159 Safety considerations for myringotomy/tympanostomy (tympanic membrane fenestration)... 160

Gynecology and GYN Laparoscopy Indications... 161 Safety considerations for gynecology and GYN laparoscopy... 162

Neurosurgery Indications... 163 Safety considerations for neurosurgery... 163

Orthopedics Indications... 164 Safety considerations for orthopedics... 164

General and Thoracic Surgery Indications... 165 Safety considerations for general and thoracic surgery... 165

Dental and Oral Surgery Indications... 166 Safety considerations for dental and oral surgery... 167

Genitourinary Indications... 168 Safety considerations for genitourinary procedures... 168

Clinical Studies Referenced... 169

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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

•

Preoperative Instructions 56

•

Intraoperative Instructions 57

•

Postoperative Instructions 58

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Introduction: The UltraPulse Laser Systems  9

Introduction: The UltraPulse Laser Systems The Lumenis UltraPulse® SurgiTouch™ and the UltraPulse Encore™ CO2 lasers are the benchmark for speed, reproducibility, and ease of treatment for a wide variety of aesthetic and surgical procedures. Each system incorporates our patented high-energy, short-pulse CO2 technology that has delivered proven results in hospitals and surgery centers for over a decade. Extensive experience with CO2 laser skin resurfacing has broadened not only the merits of the technology, but also its utility for a full range of surgical treatments. With the addition of the SurgiTouch automation system, Lumenis combines state-of-the-art scanning technology with the best in pulsed laser technology. 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. UltraPulse is now available in two models: The SurgiTouch model includes the SurgiTouch scanning system and application-specific SurgiTouch+ user interface. The Encore model is fully upgradeable to SurgiTouch to support the future needs of your practice. And, of course, both models deliver the proven benefits of UltraPulse technology. Lumenis lasers and delivery systems are precision medical instruments. They have undergone extensive testing and with proper handling are useful and reliable clinical instruments. If you have questions regarding your laser or delivery system, contact your local Lumenis representative. WARNING - Lasers generate a highly concentrated beam of light that may cause injury if improperly used. To protect the patient and the operating personnel, the entire laser and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.

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10  General Operation

Characteristics of the Carbon Dioxide Laser Beam The carbon dioxide laser wavelength falls in the mid-infrared region of the electromagnetic spectrum. This wavelength is invisible to the human eye; therefore, a low-power, visible aiming beam that is coaxial with the invisible treatment beam is used to target tissue. 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.

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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. Thereafter, you or the nursing staff at your facility will perform the daily maintenance routines associated with the laser and with any delivery systems used during surgery, including inspecting and cleaning the laser and delivery systems; sterilizing, connecting, and disconnecting the delivery systems; and performing laser beam alignment safety checks. These procedures are detailed in this manual and in your delivery system operator manuals. Most nursing staff prefer to inspect delivery systems and perform a laser beam alignment check daily, usually prior to scheduled cases and before patients are premedicated. Doing so will ensure adequate time to troubleshoot a problem or seek professional service with the least disruption to patient care. These routine surgical tasks may be performed outside of the sterile field; in this case, ensure enough time to sterilize any components, as necessary, before scheduled cases.

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12  General Operation

UltraPulse Components The UltraPulse laser system comprises: • • • • • •

A laser console with articulated arm and control screen A footswitch An external door interlock plug All electrical cables necessary for operation 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 arm

UltraScan Encore CPG (optional) Communication cable and clips (for UltraScan Encore CPG or UltraPulse SurgiTouch Scanner)

Control screen

Blue UltraPulse thread adapter (with lens, for non-fiber accessories)

Silver UltraPulse thread adapter (without lens, for fiber accessories)

UltraPulse SurgiTouch Scanner (optional)

DeepFX microscanner (optional)

Laser console

Footswitch External door interlock plug

Purge air compressor (optional)

UltraPulse Laser Console and Components UltraPulse 0637-129-01, Revision G

UltraPulse Focused Incisional Handpieces

UltraPulse Components  13

Laser Console The laser console houses the control screen, articulated arm, main power keyswitch, emergency off button, control electronics, laser source and associated optics, and power supply.

Footswitch The footswitch activates the laser treatment beam.

External Door Interlock Plug The external door interlock plug must be inserted into the proper receptacle on the back of the laser console in order for the laser to operate. It can be wired to an external switch to disable the laser if the treatment room doors are opened during treatment.

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 delivery devices include the UltraPulse SurgiTouch Scanner; the AcuBlade™ Micromanipulator; the DeepFX™ Microscanner; the OtoScan™ Ear Aeration Delivery System; and a wide range of other handpieces. For a complete list of compatible delivery devices, refer to the UltraPulse Delivery Device Connection Diagram in this chapter. Refer to the operator manuals of the above delivery devices for complete operating instructions.

Purge Air Compressor An optional external purge air compressor should be connected to and used with delivery devices that require internal air-cooling and smoke evacuation. These include: • The nasal and laryngeal probes • Multi-Application (Oral Pharyngeal) and Nasal Handpiece • AcuSpot 712 Micromanipulator • AcuBlade Micromanipulator • DeepFX Microscanner (with connected disposable tip) • OtoScan Ear Aeration Delivery System

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14  General Operation

Connection Instructions Before connecting the system components, inspect the individual components, cables, and electrical connections for dirt, debris, or damage. Check all electrical cables to ensure that they are not frayed or split. Inspect all delivery systems, as instructed in the appropriate delivery system operator manual. WARNING - Always disconnect delivery system components from the laser articulated arm before inspection. Never look directly into a delivery system while it is connected to the laser articulated arm. 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.

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Connection Instructions  15

Scanner communication cable

External door interlock

Footswitch

To electrical outlet

UltraPulse Connections UltraPulse 0637-129-01, Revision G

16  General Operation

Connecting the Footswitch Plug the footswitch cable into the (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

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Connection Instructions  17

Inserting the External Door Interlock Plug The external door interlock is a safety feature that disables the laser if the treatment room doors are opened or the interlock plug is removed while the laser is in ready mode. Use of an external door interlock is optional; however, you must insert the interlock plug into the (external interlock) receptacle whether or not you are using an external door interlock. The laser remains inoperative until the plug is inserted into the receptacle. When an external door interlock is in use, the laser is automatically disabled and returns to standby mode if the treatment door is opened or the interlock plug is removed; “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

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18  General Operation

Releasing and Orienting the Articulated Arm CAUTION - The articulated arm is a precision component; carefully handle and position the arm. An improperly oriented articulated arm can reduce the quality or intensity of the laser beam and may result in unintended tissue effect.

When the laser is not in use, the articulated arm should be stored in the articulated arm storage compartment, with the red protective cap in place. Two latches secure the arm in the compartment.

1 Slide the arm pivot lock to the

(unlocked) position.

2 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

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Connection Instructions  19

3 Release the lower part of the articulated arm from the arm clip, and unfold the arm toward you. As you unfold, ensure that the arm point toward the ceiling.

labels on the articulated

The arrows must point up in order to ensure proper arm orientation. An improperly oriented articulated arm can reduce the quality or intensity of the laser beam.

4 Remove the red protective cap from the distal end of the arm. Store the cap in the holder on the mast.

5 Hold the articulated arm in place until you have connected a delivery system.

Orienting the Articulated Arm

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20  General Operation

Connecting the Delivery Device After unfolding the articulated arm, connect the appropriate delivery device as instructed in your delivery device operator manual. Some devices attach directly to the articulated arm, while some require adapters or couplers. Refer to the 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. If using a delivery device with a smoke evacuation tip, connect the smoke evacuator as instructed in your delivery device operator manual. If using the Nasal or Laryngeal Probes, connect the external Purge Air Compressor to the FiberLase Probe Coupler as follows:

1 Situate the compressor on a stable surface, in close proximity to the base of the articulated arm.

2 Connect one end of the power cable to the compressor’s power cable receptacle and the other end to a normal electrical outlet.

3 Unpack the air tube with the bacteriological filter and connect one end of the tube to the spigot on the compressor labeled Air Outlet.

4 Ensure that the Silver UltraPulse Thread Adapter and the FiberLase Probe Coupler are attached to the articulated arm’s endjoint.

5 Attach the bacteriological filter’s clamp to the silver thread adapter. 6 Connect the free end of the air tube to the FiberLase Probe Coupler’s intake nipple. If using the Multi-Application (Oral Pharyngeal), OtoScan, AcuBlade or 712 Acuspot delivery devices, connect the free end of the air tube to the appropriate purge air port on the delivery device. WARNING - To avoid possible damage to the optical system, use only qualified, compatible Lumenis delivery systems with this laser. Use of incompatible delivery systems may result in unpredictable or unsafe laser operation and will nullify your Lumenis warranty or service contract.

Bacteriological Filter

Silver Adapter

WARNING - Carefully inspect any delivery system sterile packaging to ensure that it has not been torn or punctured. If there is any damage to the sterile packaging, do not use the delivery system. FiberLase Probe Coupler

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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) Laser articulated arm

ClearSpot 350 Micromanipulator UltraScan Encore CPG* (Computer Pattern Generator) Nezhat Laparoscopic Coupler Second Puncture Laparoscopic Coupler Variable Spot Laparoscopic Coupler TrueSpot 2.0mm Collimated Handpiece UltraFlex Waveguide

Laser articulated arm

Blue UltraPulse thread adapter (with lens)

Bronchoscope 781 MicroSlad 715, 717, 718, 719 Micromanipulators AcuSpot 712 Micromanipulator Multi-Application (Oral Pharyngeal) Variable Spot Handpiece BeamAlign Laparoscopic Direct Coupler Single Puncture Laparoscopic Coupler Second Puncture Laparoscopic Coupler

Laser articulated arm

This configuration is only suitable for the UltraPulse SurgiTouch laser model.

Blue UltraPulse thread adapter (with lens)

UltraPulse SurgiTouch Scanner

OtoScan Ear Aeration Delivery System 15300 Bronchoscope 781 MicroSlad 715, 717, 718, 719 Micromanipulators AcuSpot 712 Micromanipulator Multi-Application (Oral Pharyngeal) Variable Spot Handpiece Single Puncture Laparoscopic Coupler Second Puncture Laparoscopic Coupler

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