Operator Manual
150 Pages
Preview
Page 1
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 the Lumenis group of companies. 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 information in this document is accurate, the instructions, photos, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. LightSheer, LightSheer Duet, the LightSheer logo, ChillTip, OptiPulse, AutoPace, Lumenis, and the Lumenis logo are trademarks or registered trademarks of the Lumenis group of companies. Cavicide® is the property of Metrex Research Corporation. Virex™ is the property of S.C. Johnson Commercial Markets, Inc. © Copyright Lumenis Ltd. P/N: UM-1080310 Revision B Effective Date: February, 2011 Manufactured by Lumenis, Ltd. P.O.B. 240 Yokneam 20692, Israel Tel: +972.4.959.9000
0473
Authorized Representative: Lumenis GmbH Germany Heinrich-Hertz-Strasse 3 D-63303 Dreieichenhain Germany
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 Safety and Regulatory
Regulatory Compliance... 9 Ocular hazards... 10 Electrical hazards... 11 Laser plume precautions... 12 Fire hazards... 12 Health hazard during treatment... 13 Chemical hazard... 13 Clean-up procedure... 13
LightSheer Safety Features... 14 Safety interlocks... 14 Audible emission indicator... 14 Electronic shutter... 15 Handpiece enable... 15 Handpiece trigger... 16 Handpiece design... 16 LightSheer Duet safety features... 17
Location of Regulatory and System Labels... 19
Operation
Introduction... 25 HS handpiece... 25 ET handpiece... 25
LightSheer Duet Components... 26 Inspecting the components... 27 Laser console... 27 Touchscreen... 27 External door interlock plug... 27 Handpieces... 28
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
4 Contents
HS and ET handpiece holsters... 31
Installation Instructions... 32 Laser Preparation... 32 Unpacking the LightSheer Duet... 33 Installing the holsters... 35 Attaching the handpieces to the LightSheer Duet... 38 Installing an external door interlock... 40
Connection Instructions... 41 Plugging in the main power cable... 41 External door interlock... 42 USB port... 43 RJ-45 Ethernet Port... 43 Disconnecting and storing the laser components... 44
Laser Console Basics... 45 Operator training... 45 Moving the laser console... 46 Turning on the laser... 48
LightSheer Duet System Operation... 49 Calibrating the handpieces... 50 Turning off the laser... 60 Restarting the laser... 61 Emergency stop... 61 Treatment Screen Basics... 62 HS handpiece Treatment Screen... 66 ET Handpiece Treatment Screen... 67 Physician recommended preset values for the ET handpiece... 71 Physician recommended preset values for the HS handpiece... 73 Save As User Preset screen... 75 Create a user preset... 76
System Messages... 78 “System Cooling”... 78 Recoverable error... 79 Non-recoverable error... 79
Setting System Options... 80 Laser Operation... 84 Preoperative instructions... 84 Intraoperative instructions for the HS handpiece... 85 Intraoperative instructions for the ET handpiece... 86 Postoperative instructions... 89
Patient Treatment... 90 Patient consultation... 90 Pre-treatment procedure... 91 Dosimetry... 92 HS handpiece placement and technique... 93
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
Contents 5
ET handpiece placement and technique... 97 Skin cooling with the ET handpiece... 97 Tip cleaning... 97
Maintenance
Introduction... 101 Cleaning and Disinfecting... 102 Cleaning during treatment... 102 Cleaning and disinfecting the handpiece between patients... 103 Cleaning the energy meter windows... 104 Cleaning the touchscreen... 104 Cleaning the console... 105
HS handpiece Maintenance... 106 Replacing the HS handpiece disposable insert... 106 Understanding the HS handpiece filters... 107
Troubleshooting Guide... 108 Laser will not turn on... 108 Laser fails to operate properly... 108
Information Messages... 110 Error Messages... 111 Errors requiring a system restart... 111 Errors limiting system functionality... 111 Errors requiring user attention and may require a system restart... 112 Errors identifying hardware problems and/or requiring user attention... 113
Calibration Details and Output Monitoring... 115 Automated calibration procedure... 115 General approach... 115 Detailed approach - ET handpiece... 116 Detailed approach - HS handpiece... 117
Electrical Utilities... 118 Electromagnetic Compatibility... 118 Technical Specifications... 119 Warranty Information... 121 Decontamination of Returned Equipment... 121 Returning the Laser to Lumenis... 121
Indications for Use
Introduction... 125 HS handpiece... 125 ET handpiece... 125 Theory of operation... 126
Contraindications... 127 Relative contraindications... 127
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
6 Contents
Warnings... 128 Precautions... 129 Complications and Side Effects... 129 Clinical Studies... 131 Hair removal and permanent hair reduction... 131 Pseudofolliculitis barbae treatment using the ET handpiece... 133
Bibliography... 134 Hair removal with LightSheer... 134 Other applications with LightSheer... 136
Customer Support, Sales, and Service... 137
Appendix 1
EMC Guidance and Manufacturer’s Declarations... 141
Appendix 2
Accessory Kit Components... 147
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
7
Safety and Regulatory
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
8 Safety and Regulatory
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LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
Regulatory Compliance 9
Regulatory Compliance The LightSheer Duet system complies with 21 CFR, Chapter I, Subchapter J, as administered by the Center for Devices and Radiological Health (CDRH) of the 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 ammended by 2007/47/EC. The LightSheer system is classified as a Class IV laser by the CDRH and as a Class 4 laser by the European Standard EN 60825-1. WARNING - Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure.
The following precautions are extensive but may not be complete. Laser users are advised to supplement these precautions with information regarding technological advances in surgical products and techniques as they become available to the medical laser user community through medical literature. For more information refer to ANSI Z136.3, ANSI Z136.1, and EN 207 for recommendations on the safe use of lasers in health care facilities. Please follow the recommendations of the latest edition of these standards. In particular, the use of safety eyewear with an adequate optical density rating for the LightSheer wavelength must be used for all persons with the potential for laser exposure. All persons operating the LightSheer Duet laser system or in the vicinity of the laser must be aware of the potential hazards. Be certain all personnel carefully review the following safety information. Only authorized individuals with appropriate laser training and knowledge should operate, assist in the operation of, or provide maintenance to the LightSheer system. For information on training, contact Lumenis Customer Support. In Canada this device must be installed and operated according to CAN/CSA-Z386-92: Laser Safety in Health Care Facilities. There are no user-serviceable parts in the LightSheer system, and all service and repair must be performed only by the factory or authorized field service technicians. See the Maintenance and Troubleshooting section of this manual for troubleshooting and routine maintenance instructions.
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
10 Safety and Regulatory
Ocular hazards WARNING - The light emitted by the LightSheer laser is capable of causing serious eye damage or blindness.
The LightSheer system is to be operated only in an enclosed room with protective eyewear for all persons. Direct eye exposure is not safe at any distance within the room. All windows in the laser room must be covered with opaque material, and measures should be taken to prevent unauthorized access to the room. A remote interlock is provided, which can be connected to the treatment room doors disabling laser output if the door is opened during a procedure. In addition, compliance with ANSI Z136.3 and EN 60825-1 requires that laser safety signs be posted at all entrances whenever the laser is in use. An approved sign is provided with each system along with protective eyewear. Additional eyewear or safety signs may be obtained from Customer Support. WARNING - All persons in the treatment room, including the patient, must wear appropriate eye protection whenever the main power and keyswitch are on. The protective eyewear must have an optical density (OD) of 5 or greater at the wavelength of 790 – 830 nanometers. For users outside the U.S., the appropriate standard may be EN 207, in which case the safety eyewear must have a protection class of L5. WARNING - While operating the LightSheer system, never look directly into the laser aperture at the distal end of the handpiece, even if you are wearing laser safety glasses. Serious eye injury or blindness could result. WARNING - Avoid directing the laser beam anywhere other than within the holster or at the intended treatment area. Stray laser light and reflection is always a potential hazard and may cause serious injury. WARNING - Do not treat eyebrows, eyelashes, or other areas within the bony area surrounding the orbit. The light emitted by the LightSheer laser is capable of causing serious eye damage or blindness. For maximum safety, metal eye goggles must be worn by the patient for all facial treatments.
Ocular safety considerations: • Identify the laser room clearly by posting approved laser safety signs in prominent locations. • Cover all windows to prevent laser light from escaping the laser room. • Restrict entry to the laser room when the laser is in use. Allow access only to those personnel both essential to the procedure and well trained in laser safety. LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
Regulatory Compliance 11
• Never direct the laser beam at anything other than within the holster or at the intended treatment site. • Never look directly into the laser aperture at the distal end of the handpiece. • All persons in the treatment room must wear approved laser safety eyewear with an optical density of 5 or greater at the LightSheer wavelength of 790 - 830 nanometers. For users outside the U.S., the appropriate standard may be EN 207, in which case the safety eyewear must have a protection class of L5. This includes the operator, patient, nurses, and any other persons in the room. • Do not attempt to remove the protective covers on the handpiece, which could allow exposure to high-intensity laser light.
Electrical hazards The LightSheer Duet laser system uses high-voltage internal components, which have the potential to cause serious injury or fatal electrical shock. It is possible for the high voltage components to retain a charge for some period of time even after the laser has been turned off. No part of the exterior housing, except the holsters, should be removed except by trained and authorized LightSheer laser technicians. Do not soak or spray the laser console, handpieces or touchscreen in fluids because this can result in damage to the equipment and electrical shock. Do not operate the system if the power cord is frayed or otherwise damaged. Clean the touchscreen only when the LightSheer system is turned off. WARNING - Opening the exterior housings may cause exposure to hazardous optical radiation and electrical voltage even after the laser has been turned off. No portion of the exterior housing, except the holsters, should be removed by anyone other than a trained and authorized technicians. Do not operate the system if the power cord is frayed or otherwise damaged.
WARNING - Do not operate the laser system if any coolant leakage or spillage is observed, as this may lead to electric shock or death. Turn off the laser and contact your Lumenis representative.
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
12 Safety and Regulatory
Laser plume precautions CAUTION - The user should be aware that laser plumes do present a potential hazard. Plumes may be potentially hazardous, both in terms of particulate matter and infectivity. Special care must be taken to limit the exposure of both patient and user to any laser plume smoke or vapor. CAUTION - Laser plume may contain viable tissue particulates. CAUTION - The user should wear surgical masks that remove particles as small as 0.3 µm. Surgical gloves should also be worn.
Fire hazards The potential for fire hazards exists because the absorption of laser energy may raise the temperature of any material. While this principle is the basis of many useful medical and surgical applications, it requires that precautions be taken against igniting combustible materials. For the LightSheer Duet laser system, the following precautions should be taken: • Allow any flammable liquids used for cleaning the skin or handpiece insert, such as alcohol, to fully evaporate before treatment. • Anesthetics administered topically or by inhalation must be approved as nonflammable. • Exercise particular care in the use of oxygen, which can accelerate the combustion of any flammable material. • Avoid using combustible materials, such as gauze and drapes, in the treatment area. When required, these materials may be made more fire resistant by keeping them moist with water. Clothing should be kept well away from the area of treatment. • Do not operate the laser with any cover or drape over the laser. WARNING - Do not operate the LightSheer system in the presence of flammable liquids (such as alcohol or acetone) or flammable gases (such as ether).
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
Regulatory Compliance 13
Health hazard during treatment High power laser light targets the melanin in the hair and the hair shaft. The heat absorbed by the melanin is transferred to the cells in the follicle, resulting in effective hair removal and permanent reduction. The heated hairs will sometimes vaporize, leading to the “burning hair smell” which often accompanies laser hair removal. While generally safe, this laser plume can condense on the cold ChillTip of the LightSheer. Condensed on the ChillTip, the hair material may harden and will absorb subsequent pulses of laser light. While most of the ChillTip will remain very cold, the burned hair material will become very hot and can lead to burns as the insert is moved across the epidermis. Lumenis has received reports of injuries to patients including superficial burns, 1st degree burns, 2nd degree burns and hyperpigmentation that are directly attributed to the failure of the user to keep the ChillTip clean during hair removal procedures.
Chemical hazard WARNING - Always wear gloves during treatment and it is recommended to wear long sleeves. This prevents skin contamination with the cooling solution if there is a break in the cooling lines.
The LightSheer laser is cooled by a closed loop cooling system. The system is used to maintain the operating temperature of the lasers in the handpiece and the ChillTip for the ET handpiece. Prevention
Always inspect the system and handpiece before powering up. Do not move the system around with the handpiece or umbilical, this will stress the umbilical and also cause the system to fall over if the wheels are locked on the system or cart.
Clean-up procedure Turn off the system and unplug from the AC outlet. Use paper towels to wipe up all of the spill. Use any household cleaning agent to wipe down the area affected to prevent skin contact and to remove the slipping hazard if it spills on the floor. If in contact with skin, immediately wash with soap and water and remove affected clothing. If there are skin irritations, seek medical attention. If in contact with eyes, flush for 15 minutes and seek medical attention. The cooling solution to be used is an Ethylene Glycol mixture. It has a light green color and feels silky to the touch. It is diluted to 80% water and 20% Ethylene Glycol. LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
14 Safety and Regulatory
LightSheer Safety Features The LightSheer laser system is designed to be safe and convenient for both the operator and patient. The most important safety-related features for all systems are described below. See the Operation section of this manual for descriptions and operating instructions for these and all other system features. Safety features unique to the laser system or handpiece are in the following sections. New devices and applications will be added as an appendix in the manual.
Safety interlocks The LightSheer system contains a comprehensive monitoring system that allows operation only when numerous safety conditions have been met. A fault must be corrected and the system reset before laser operation is reenabled. The monitoring system includes the following: • Remote interlock: An external door interlock receptacle and plug are provided to disable the laser if the treatment room doors are opened. • System time out which disables the laser if it has not been used for 15 minutes. This feature is designed to help prevent unintended exposure and reduce mechanical wear. • Energy monitoring to verify that the laser output is within specific energy tolerances for every laser pulse. If abnormally low or high laser current (indicative of optical energy) is detected, a system fault is triggered and the user is notified. • Temperature monitoring which disables system operation if the diode temperature or ChillTip (on the ET handpiece only) is outside the operating range.
Audible emission indicator For operator feedback and safety, each laser pulse is accompanied by an audible beep. No attempt should be made to disable or impair this emission indicator, and in the unlikely event that emission occurs without an audible beep, use of the system should be discontinued until proper performance is established.
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
LightSheer Safety Features 15
Electronic shutter As a safety feature and in compliance with U.S. and international regulations, the LightSheer Duet system contains an electronic shutter to help prevent inadvertent laser emission. Located in the console, the shutter is an electronic switch that is independent of, and in addition to, the normal energy circuit for the laser pulse. The shutter is directly controlled by the handpiece enable and system mode; laser emission is prohibited by the shutter if the system handpiece enable is active and the laser is not in ready mode. This is unlike conventional lasers, which rely upon shutters to block the beam during warmup, alignment, and other times.
Handpiece enable To help prevent unintended emission, laser output occurs only if the handpiece enable is active, the laser is in ready mode, and the handpiece trigger is pressed. ET handpiece
With the laser in ready mode, the operator must first press the handpiece enable button, which opens the safety shutter, and then press the handpiece trigger to delivery the treatment pulses to the patient. The enable button is unlit when disabled and lit when enabled. The enable button becomes disabled after being idle for more than 30 seconds. HS handpiece
With the laser in ready mode, the operator must first press the handpiece enable button, which opens the shutter, and then press the handpiece trigger to initiate the vacuum function. Once the target vacuum is reached, the treatment pulses are delivered to the patient. The enable button is unlit when disabled and lit when enabled. The enable button becomes disabled after being idle for more than 30 seconds.
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
16 Safety and Regulatory
Handpiece trigger ET handpiece
With the handpiece enable active and the system in ready mode, the laser can be fired repetitively by (1) either pressing and releasing the trigger for each pulse, or (2) keeping the trigger continuously pressed, in which case the laser will fire repetitively for as long as the handpiece trigger is pressed. HS handpiece
With the handpiece enable active and the system in ready mode, the laser can be fired by pressing and releasing the handpiece trigger for each treatment of 1-3 pulses. The trigger must be pressed each time to perform multiple treatments.
Handpiece design Several aspects of the ET and HS handpiece design also contribute to the safety of the LightSheer Duet system. Since the laser emission originates in the handpiece itself and not in the console as in conventional lasers, there is no need for an articulated arm or other beam delivery system with inherent beam quality and alignment concerns. The laser emission is confined to the handpiece, so there is no hazardous optical radiation in the console or umbilical. ET Handpiece
The sapphire tip is placed against the patient’s skin during system use, reducing stray light while increasing the therapeutic effectiveness. The ET handpiece console connector is keyed to connect to the left side of the system (when facing the system). HS handpiece
The handpiece is placed against the patient’s skin during use; a vacuum pump creates suction and draws the skin into the treatment handpiece, thus reducing stray light while increasing the therapeutic effectiveness. The HS handpiece console connector is keyed to connect to the right side of the system (when facing the unit).
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
LightSheer Safety Features 17
LightSheer Duet safety features Keyswitch
To prevent unauthorized use, the laser can only be turned on with the master key, the key can only be removed when the laser is turned off, and the laser only operates when the key is inserted into the keyswitch. When the keyswitch is turned to the (on) position, the laser power-up sequence is initiated.
Emergency stop switch
Releasing the handpiece trigger will stop all laser emission. In the event of an emergency, the laser can be shut down immediately by pushing the emergency stop button located near the keyswitch on the console. To restore operation, rotate the button in the clockwise direction until it pops out again. Then follow the standard startup sequence. Since the emergency stop switch is not intended for routine use, follow the procedure in the Operation section of this manual for normal shutdown.
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
18 Safety and Regulatory
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LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
Location of Regulatory and System Labels 19
Location of Regulatory and System Labels As required by national and international regulatory agencies, appropriate warning labels have been mounted in specified locations.
STOP Emergency stop label
Regulatory compliance labels ON/OFF Keyswitch
Location of regulatory compliance labels
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
20 Safety and Regulatory
HS handpiece
Laser aperture label Handpiece danger label and handpiece manufacturing label
ET handpiece
Laser aperture label
Location of regulatory compliance labels on handpieces
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B
Location of Regulatory and System Labels 21
55ºC (131ºF) -5ºC (23ºF)
HUMIDITY 90% @ 35ºC 32% @ 55ºC
TEMPERATURE -5ºC – 55ºC 23ºF – 131ºF
Nonoperating environmental specifications (on shipping box)
Manufactured by
MONTH/YEAR P/N, REV
P.O.B. 240 Yokneam 20692, Israel +972.4.959.9000
S/N
Lumenis contact information
U.S. AND INTERNATIONAL PATENTS PENDING
Patents pending
EC
CSA compliance
Model name, serial number, and manufacturing date
This equipment conforms to provision U.S. 21.CFR 1040.10 and 1040.11 as applicable
Caution: U.S. federal law restricts this device to sale by or on the order of a physician
(for FDA-compliant systems)
FDA sales restriction
DHHS certification
REP
Lumenis (Germany) GmbH Heinrich-Hertz-Str. 3 D-63303 Dreieich-Dreieichenhain Germany Phone: +49 (0)6103-8335-0
Authorized Representative
100 - 240 V~ 0473
CE Mark
Electrical specification
Regulatory compliance labels
LightSheer® Duet™ Laser System Operator Manual UM-1080310, Rev. B