AE-10/AE-20 Laser System
Operator’s Manual - CE
Aesculight, LLC
16928 Wood-Red Road NE, Ste B 104
Woodinville, WA 98072
1-866-697-7548
www.aesculight.com
Table of Contents
Chapter 1
Introduction - - - 1
General - - - 1
System Labels - - - 3
Warranty and Compliance Notes - - - 7
Patents and Conformance - - - 7
Chapter 2
Introduction - - - 1
Training - - - 1
Controlling Laser Impact on Tissue - - - 4
Hazards Of Laser Use - - - 6
Aesculight Laser Safety Features - - - 10
Chapter 3
Introduction - - - 1
Product Overview - - - 1
System Features - - - 1
System Console - - - 4
System Specifications - - - 7
Chapter 4
Introduction - - - 1
Installation and Setup - - - 2
Initial System Checkout - - - 10
00327-01 Rev PA
Chapter 5
Introduction - - - 1
Preparation - - - 1
Instructions for Use - - - 4
System Controls - - - 11
Graphic Symbol Chart - - - 19
Chapter 6
Introduction - - - 1
Delivery Systems - - - 1
Mast - - - 2
Turret - - - 2
Handpieces - - - 2
Handpiece Components - - - 4
General Handpiece Use and Care Instructions 5
Handpiece Cleaning Procedures - - - 6
Deciding - Sterilization/High-level Disinfection - 8
Repeated Sterilization/High-level Disinfection - 8
Fibers - - - 10
Tips - - - 11
Chapter 7
Introduction - - - 1
Aesculight Service - - - 1
Routine Inspection - - - 1
Routine Maintenance - - - 1
User Maintenance - - - 2
Power-Related Problems - - - 5
Trouble-shooting - - - 6
Chapter 8
Introduction - - - 1
Electrical Safety Checks - - - 1
Internal Power Meter Check - - - 2
00327-01 Rev PA
CHAPTER 1
Table of Contents
Introduction - - - 1
General - - - 1
Precautions - - - 2
System Labels - - - 3
Warranty and Compliance Notes - - - 7
CHAPTER 1
Introduction
Introduction
The Aesculight Laser System is a CO2 laser designed for use in a variety of veterinarysurgical and dental applications. This chapter provides general information about
Warnings, Cautions and Notes System Label Locations Warranty, Patents and LicensingRead this operator’s manual thoroughly before operating the system. Pay particular atten-tion to signal words such as cauatten-tions and warnings.
General
Aesculight models AE-10 and AE-20 are Veterinary laser systems used primarily for inci-sion and ablation, utilizing a touch-screen control panel and patented flexible fiber beam delivery. The AE-20 system offers up to 40 watts of continuous wave or 20 watts of aver-age superpulse power with a minimum 100 watts of peak superpulse power. The AE-10 system offers up to 20 watts of continuous wave or 10 watts of average superpulse power with a minimum of 50 watts of peak superpulse power.CAUTION - RESTRICTED DEVICE
Federal law restricts this device to Veterinarian Use Only.
1. To avoid injury or damage to the equipment, read this manual before operating the system.
2. Know the location of the Emergency Stop Switch used to stop the system quickly. 3. Use a properly grounded outlet for the system power cord.
4. Always attach installation platform to wheel base of laser system before use.
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CAUTION - HAZARDOUS EXPOSURE
Use of controls or adjustments or performance of procedures other than those speci-fied herein may result in hazardous radiation exposure.
Figure 1-2, Aesculight Laser Systems
NOTE - INSTALLATION PLATFORM
Always attach the installation platform to the wheelbase before use. Some graphic im-ages in this manual show the laser without the platform attached, for ease in identifi-cation of other components. The proper system setup always includes the attachment of the installation platform.
FIBER
HANDPIECE
HANDPIECE ARTICULATED
TURRET
AESCULIGHT SYSTEM WITH ARTICULATED MAST AESCULIGHT SYSTEM WITH TURRET AE-10/AE-20
AE-10/AE20 FIBER
CHAPTER 1
Introduction
Precautions
Pay particular attention to the warnings and precautions found throughout this manual.A warning is a statement that alerts the user to the possibility of injury, death, or seri-ous adverse reactions associated with the use or misuse of the device, as in this ex-ample:
WARNING - EYE PROTECTION
All personnel in the immediate area of use must wear eye protection rated specifically for the CO2 laser.
A caution is a statement that alerts the user to the possibility of a problem with the vice associated with its use or misuse. Such problems include device malfunction, de-vice failure, damage to the dede-vice or other property. The caution statement includes the precaution that should be taken to avoid the hazard, as in the following example:
CAUTION - MAST/TURRET CAP
When the mast or turret is removed, always cover the beam output port on the console with the attached stub mast cap. Dust and debris can damage the optics.
A note is a statement that alerts the user to particularly important use information, as in the following example:
NOTE - SHIPPING CONFIGURATION
Fibers will be shipped separately. Tips and other accessories may also be shipped separately.
System
Labels
The following illustration, Figure 1-3 shows the location of important labels found on the Aesculight articulating mast laser system. Label locations of the Aesculight turret laser system are shown in Figure 1-4. Detailed views of each label are shown in Figure 1-5.
CAUTION - TO AVOID INJURY OR FIRE
Observe all warning and other labels on the equipment. Failure to do so could result in injury or fire.
1-4
Figure 1-3, Label Locations of Aesculight Laser System With Articulating Mast
1
3, 4, 7 - Internal
5
8
12
9
10
2
13
11
14
7, 6
CHAPTER 1
Introduction
Figure 1-4, Label Locations of Aesculight Laser System With Turret
5
8
12
9
10
2
13
11
1
3, 4, 7 - Internal
14
7, 6
1-6
Figure 1-5, System Label Details
3
1
4
9
6
14
5
8
13
12
11
2
FOR VETERINARY
USE ONLY
DANGER
7
10
CHAPTER 1
Introduction
Warranty and
Compliance
Notes
Aesculight, LLC warrants its Surgical Lasers to be free of defects in material and work-manship for a standard period of three years from the date of delivery, when operated in accordance with this operator’s manual (excludes handpieces, fibers, delivery ac-cessories, and tips). Extended warranties are available at additional cost.
Aesculight Limited
Warranty
Aesculight, LLC warrants its handpieces, and fibers to be free of defects in material and workmanship for a period of one year from the date of delivery, when used in ac-cordance with this operator’s manual.
To correct defects in materials and workmanship, Aesculight, LLC will provide the fol-lowing service without charge during the warranty period:
• All parts and labor costs to restore the equipment to the performance specified in this manual.
This warranty shall not apply where service is required due to negligence, misuse, or catastrophe, or failure to maintain the equipment as outlined in this manual; where ser-vice is required due to the performance of unauthorized serser-vice, the use of unautho-rized parts, or connection to unauthounautho-rized accessories; or where the equipment is found to be operating within the specifications published in this manual.
This warranty is extended to the original purchaser of the equipment from Aesculight or an authorized distributor in lieu of all other warranties expressed or implied, includ-ing warranties of fitness for a particular purpose and implied warranties of merchant-ability, and all other obligations or liabilities on the part of Aesculight, and no person, agent, or dealer is authorized to give any other warranties or to assure any other liabil-ity on behalf of Aesculight.
Patents and
Conformance
The Aesculight waveguide fiber technology is U.S. patent pending. The Aesculight laser system technology is U.S. patent pending.
The Aesculight smoke evacuating handpiece technology is U.S. patent pending.
Performance
Standards
This laser system conforms to laser performance standards established by the Center of Devices and Radiological Health (CDRH) under the provision of US CFR 21, part 1040.10 for Class IV laser products. This laser is in compliance with IEC 60825 re-quirements for laser safety.
Conformance
This device conforms to CE requirements under the Electromagnetic Compatibility Directive 89/336/EC amended by 2004/108/EC; and the Low Voltage Directive 2006/95/EC.00327-01 Rev PA
CHAPTER 2
Table of Contents
Introduction - - - 1
Training - - - 1
Laser Safety Guidelines - - - 1
Laser Safety Officer - - - 2
Laser Treatment Area - - - 2
Laser Use Documentation - - - 3
Controlling Laser Impact on Tissue - - - 4
Laser Classes - - - 5
Wavelength and Tissue Variability - - - 5
Spot Size, Power, and Exposure - - - 6
Hazards Of Laser Use - - - 6
Eye Hazards - - - 7
Skin Hazards - - - 8
Smoke Plume Hazards - - - 8
Fire Hazards - - - 9
Gas Embolism - - - 10
Electrical and Facility Hazards - - - 10
Aesculight Laser Safety Features - - - 10
Keyswitch - - - 10
Emergency Stop Switch - - - 11
Self Testing at Power-Up - - - 11
Shutters - - - 11
Remote Interlock Connector - - - 11
Safety Interlocks and Failsafes - - - 11
Safety Timer - - - 12
Continuous Internal System Monitoring - - - 12
Bibliography and References - - - 12
CHAPTER 2
Laser Safety
Introduction
Patient safety should always be the clinician's first concern. This chapter of the Aesculight Laser System Operator’s Manual includes the minimum information needed to operate the system safely. In addition to the guidelines presented here, follow all applicable insti-tutional procedures. Read this chapter completely before attempting a procedure with the Aesculight laser system. Chapter 2 includes basic institutional requirements, including responsibilities of the Laser Safety Officer. How and why the laser impacts tissue, and how this is controlled Hazards associated with unsafe laser use Safety features of the Aesculight Warnings, cautions, and notes associated with the Aesculight laser system Bibliography and references for further reading and informationTraining
Both user and safety training is available from Aesculight. Call Aesculight sales at 1-866-697-7548 to inquire about seminars in your area.CAUTION - TRAINING
No one should use the Aesculight laser system, or any other medical laser, without spe-cific training in both surgical laser use and laser safety.
In addition, The Laser Institute of America conducts training courses on laser safety. Their their address may be found at the end of this chapter.
The Library Of Clinical Cases is a software feature developed by Aesculight to enable vet-erinarians to view videos and photographs of specific procedures and case studies. The Library should never be used as a training tool and is not a replacement for specific train-ing in surgical laser use. It is intended solely as a reference tool and visual aid.
WARNING - LIBRARY
The Library Of Clinical Cases should not be used as a training tool for specific proce-dures. Avoid possible injury or damage to equipment by obtaining proper training in sur-gical laser use.
Laser Safety
Guidelines
American National Standards Institute specification ANSI Z136.3−1988 and Z136.1-1993 include a very thorough discussion of laser safety and guidelines for medical laser use. These standards were developed in the earliest days of lasers and are routinely revised to keep up with growing technology. ANSI Z136.3 is written specifically for the use of lasers in medicine. While non-binding, the guidelines are excellent guides for an office or
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institution seeking to set up a formal safety program. We strongly recommend that the user read these two ANSI standards before using a laser in clinical practice.
Aesculight also provides training in laser use and safety principles to purchasers of its medical laser equipment. In addition, Aesculight strongly recommends that the new laser user obtain, read, and follow the ANSI standards.
Laser Safety
Officer
Large institutions are following the prescriptions of ANSI 136.3 by setting up Laser Safety Committees and appointing Laser Safety Officers to manage laser use. Even the smallest office should have one person to act in the capacity of Laser Safety Officer. ANSI 136.3-1988 requires the Laser Safety Officer to fulfill the following responsibilities:
Classify, or verify classification of, lasers and laser systems Evaluate hazards of laser treatment areas Assure that the prescribed control measures are in effect and recommend or approve alternates when the primary ones are not feasible Approve operational procedures, including any procedural checklists Recommend or approve protective equipment, and assure that it is periodical-ly inspected to ensure proper working order Approve wording on signs and equipment labels Approve installation and equipment prior to use, and modifications to existing equipment and facilities Assure adequate safety education and training is provided for all personnel The Laser Safety Officer may also assume other responsibilities, such as keeping laser use and maintenance logs. The Laser Safety Officer should become familiar with the periodic maintenance requirements in Chapter 7 of this manual.Laser
Treatment
Area
According to ANSI Z 136.3, the Laser Safety Officer is responsible for the area in which laser treatments are carried out. In meeting this requirement, the Laser Safety Officer should ensure that:
The surroundings are safe for both the patient and the user. The floor is uncluttered and clear access is maintained to the footswitch. Ca-bles are secure, and cords are not crimped. The operating area is occupied only by authorized personnel. Appropriate warning signs are posted in the operating area and just outside of it. The Aesculight laser system is a Class IV laser. The warning sign for Class IV lasers is shown below.CHAPTER 2
Laser Safety
Figure 2-1, Danger - Laser In Use Sign
Laser Use
Documentation
To maintain a history of laser operation, ANSI Z136.1 recommends that even the smallest office keep a formal record of:
Laser procedure and time Anesthesia Power settings used Accessories used Problems, and their resolutionsIn addition, use a laser safety checklist incorporating the sample shown below. The sample is not meant to be all-inclusive but the intention is to stimulate thinking about procedures and safety. Because the Aesculight laser system is used in a wide variety of environments, each user should develop a safety checklist appropriate to the set-ting.
Sample laser checklist:
Personnel trained in the use of the Aesculight laser system Name of person to contact in case of an emergency situation Aesculight contact number readily available Appropriate type of safety goggles ready for use Safety goggles in good condition Danger - Laser In Use sign posted Laser area secure2-4
Pre-treatment safety check Patient protection available Flammable substances check Water or saline available in the event of fire Operator Manual read and readily available Preventive maintenance performed as needed Smoke evacuation available and working Emergency shutdown protocol understood Laser room free of unauthorized personsControlling
Laser Impact
on Tissue
Many different types of lasers have been developed for multitudes of different uses. Each type of laser has a certain potential for harm if misused. Even lasers designed for medical use must be handled carefully in order to avoid:
Hazards to the patient or clinical personnel Hazards to the physical surroundingsWARNING - CO
2LASER
The Aesculight laser system contains a Class IV, CO2 laser which produces an invisi-ble beam of high energy infrared radiation. Improper use could result in serious per-sonal injury. Observe all safety precautions for Class IV devices.
For this reason, it is important to understand the basics of how laser energy effects human tissue and how to control this energy to avoid misapplication.
The tissue damage that a misused laser may do depends on six factors: • Class of the laser
• Wavelength of the laser
• Tissue variability of the area in contact with a beam • Spot size or beam diameter
• Power
CHAPTER 2
Laser Safety
Laser Classes
Lasers are divided into classes by power according to the degree of safety hazardsthey present to humans. See Table 2-1. The Aesculight laser system is a Class IV laser and is therefore potentially hazardous to both patient and user.
Table 2-1⎯Laser Classification
Wavelength
and Tissue
Variability
Different types of lasers generate different wavelengths of light. When laser energy strikes tissue, the laser wavelength and the target tissue type determine the basic nature of the impact.
Lasers of different wavelengths may demonstrate assorted results on a given type of tissue. However, a laser of a specific wavelength affects different tissue types in vari-ous ways. The primary factor is the efficiency with which the tissue absorbs light of the given wavelength.
An example that illustrates this concept is the use of the Argon laser for retinal surgery. The Argon laser is used for retinal surgery because the tissues and fluids in front of the retina do not absorb the Argon laser wavelength, whereas the retina itself does. By comparison, the CO2 laser wavelength would be totally absorbed by the lens and would damage it before reaching the retina.
The Aesculight laser is a CO2 laser. The CO2 emits a concentrated beam of light at a wavelength of 10.6 microns, which is in the invisible infrared portion of the electromag-netic spectrum. The effects, and therefore the risks, of the CO2 laser are primarily ther-mal.
Laser Class
Example Characteristics
Class I Grocery store scanner Class I lasers do not emit levels of optical radia-tion above the exposure limits for the eye under any circumstances as they are no more harmful than an electric light bulb
Class II Laser pointer Momentary viewing of Class II lasers is not con-sidered dangerous
Class III Laser light show Class III lasers may be hazardous for direct view-ing
Class IV Most surgical lasers Class IV includes all lasers that exceed over 0.5 watt average power over 0.25 seconds or those that exceed 0.125 J. They can cause serious eye and skin injuries and set fire to many materials. Both the direct and reflected beams are hazard-ous to the eye.
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Light at the CO2 laser wavelength is efficiently absorbed by water, the primary compo-nent of soft tissue. When the laser beam strikes soft tissue, its energy is absorbed by water in the tissue. The water heats up, boils, and vaporizes, taking the surrounding tissue with it. CO2 laser energy is effectively absorbed by all soft tissue, regardless of the pigmentation.
Note
The CO2 laser beam may also damage bone or teeth, causing pitting, glazing and ex-plosive separation.
Spot Size,
Power, and
Exposure
Assuming that the laser wavelength and target tissue are given, the spot size, power, and exposure (including exposure duration) determine the laser's degree of impact.
Spot size is the diameter of the aperture containing 86% of the total power of the laser beam. Rated tip size and tip distance from the tissue target determine the exact spot size on the target, which is typically on the order of 1 mm.
The user sets the power in watts with the laser controls. Note the relationship of spot size and power: at a given power setting, a larger spot size spreads the power out over a larger area. This yields a larger area of impact, but a lesser tissue effect.
The user controls the exposure with the laser controls. The exposure determines the duration of the applied laser beam. Obviously, the longer the exposure, the greater the tissue impact. The primary exposure control is the footswitch. Three front panel control options for exposure timing during footswitch activation are available: continuous, sin-gle and repeat. For single and repeat, the user further selects the duration of exposure and repeat frequency.
The clinician uses spot size, power, and exposure to control the interaction of the Aesculight laser beam, and its attendant thermal effects, on the patient’s tissue. There is no one formula for performing a procedure. Safe and effective use of the laser in clin-ical procedures comes with a mix of clinclin-ical training, mentoring, and experience.
Hazards Of
Laser Use
The laser beam can cause serious injury to the clinician, patient, and bystanders if used improperly. The reflections of the beam may be dangerous, as well. The specific hazards from CO2 laser energy fall into the following broad categories:
Eye hazards Skin hazards Smoke plume hazards Fire hazards Gas embolismsCHAPTER 2
Laser Safety
Eye Hazards
The laser beam and its associated reflections represent a potential for serious injury toseveral structures of the eye. Light from some lasers may cause severe corneal and retinal damage without any accompanying pain, because all of the focused beam energy is directed on an extremely small spot. At present, there is no course of therapy for retinal damage.
The Aesculight laser beam, because it radiates in the far infrared portion of the spec-trum, affects the cornea, or surface of the eye. The light from the CO2 laser beam is
absorbed by the epithelium of the cornea, causing burning, scarring and opification. Viewing CO2 laser light with the eyes unprotected may contribute to the development of cataracts. Far infrared laser light does not penetrate the eye or cause retinal dam-age.
Eye Protection
CO2 wavelength-specific eye protection must be worn by everyone in the room, spec-tators and patient included, when the laser is in use. Sunglasses and contact lenses do not provide adequate protection during laser procedures. While ordinary everyday glass or plastic lenses do afford some protection against the CO2 laser, they are inad-equate because they have no side shields. Goggles are recommended for their increased coverage. Use eye protection even when lasing is contained within the abdomen.
WARNING - EYE PROTECTION
All personnel in the immediate area of use must wear eye protection rated specifically for the CO2 laser. Eyewear with an ANSI rating Z87, with lens specifications for optical density of 5@10,600nM are recommended.
Make sure goggles fit each person properly. Goggles should fit over everyday glasses and seal off reflected or diffused laser light. Goggles should be vented, especially if they are to be used in the operating room. Even when wearing goggles, never point laser beam directly toward your eyes.
The goggles should have "O.D.5" and "CO2" or “10.6 micron” written on them. Aescu-light recommends that the Laser Safety Officer, along with other equipment responsi-bilities, make sure that goggles are correct, that they fit, and that extra protective measures such as eye shields for the patient are used when necessary. Goggles should be washed regularly in soap and warm water and checked for cracks and dis-coloration. A busy office may want to have spare goggles available for visitors.
Additional Eye Protection for the Patient
Avoid eye shields made from stainless steel or aluminum foil, which may reflect the laser beam.
Because the laser beam is absorbed in water, a double layer of saline moistened gauze or eye pads afford excellent patient protection, especially when used with wave-length specific goggles.
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During laser treatment of the eyelid or near the eye, use lead shields that can be inserted into an anesthetized and lubricated eye to provide protection.
Skin Hazards
The skin is the second most vulnerable organ of the body. The damage from eitherdirect or reflected laser light is thermal and shows as an erythematous reaction (red-dening). The skin may also become dry and itch, or even char.
Drapes. Use wet packs or wet drapes and cotton pads thoroughly moistened with ster-ile saline to protect the patient from adjacent tissue burns.
Gloves and gowns. The clinician should wear gloves and gowns for added protection from chronic skin exposure.
Hair. Wetting the hair during procedures on the face and scalp will not guarantee it will not burn. Surgically drape hair to the maximum extent possible.
Tips. The tip may become hot during lasing and may cause tissue damage to either the clinician or patient on contact. After lasing has stopped, allow the tip to cool for 10 seconds before touching it.
Diffuse reflections. In some cases, the patient may be burned by diffuse reflections from instruments and other surfaces. When procedures are done in the clinic or office, neither doctor nor patient should wear reflective jewelry, such as gold watchbands, rings, or pendants.
Smoke Plume
Hazards
In the early days of lasers it was thought that the laser beam evaporated tissue to the molecular level, giving off water and CO2. We now know that the interaction of laser light with tissue produces a plume of smoke that may contain toxic and carcinogenic chemicals such as benzene, formaldehyde, phenol, and toluene, as well as viruses and bacteria. In some cases, the levels of toxic chemicals may exceed OSHA limits. The particulates are minuscule, with diameters of 0.1 to 0.3 microns. In addition, the plume often has a very noxious smell.
The possible presence of the HIV virus in many of our operating environments dictates that the user proceed with caution. Intact HIV proviral DNA has been collected from laser smoke, although there are no known cases of AIDS resulting from smoke plume inhalation. A thorough review of the clinical literature leads to the conclusion that all of the risks from plume inhalation are unknown at this point.
Smoke evacuation. To evacuate the smoke plume from the laser operating area, the nozzle placement of the smoke evacuator must be within 1 to 2 inches of the origin of the smoke. Let the smoke evacuation system run for 30 seconds after lasing stops. To aid in plume evacuation, Aesculight sells smoke evacuating handpieces.
Masks. Both the user and the patient should wear laser filter masks rated for laser use that filter 0.2 micron and larger particles. A standard surgical mask does not stop par-ticles of this size. Do not use older-type filters, which are only 95 percent efficient for particles 0.5 µm and larger.
CHAPTER 2
Laser Safety
Fire Hazards
Inspect the operating area for flammable material which may come into contact withthe laser beam during laser procedures. Dampen all flammable materials in the target area (including all sponges, pads, and swabs) with saline or sterile water.
Be aware of other flammable agents including drying agents, ointments, plastic resins and anesthetics. Keep them out of the path of the laser beam. Always avoid lasing sur-faces and substances where burning could give off toxic substances.
NOTE - Fire Precautions
Keep a bottle of sterile saline and a fire extinguisher in the same room where a laser procedure is being performed.
Drapes.Some of the most common fires during laser procedures involve surgical drapes. Unless the drapes in the operating area are nonflammable, wet them down with saline.
Endotracheal Tube Fires.Some lasers have caused fires and burns in the trachea, pharynx and oral cavity when oxygen leaks past the barrier cuff in the tracheal tube. Fill the barrier with a liquid, preferably with a blue dye in it, so leaks can be detected. Protect the inflated cuff with wet packs. Avoid the use of plastic (PVC) endotracheal tubes. Use tubes specially designed for use with lasers. Do not use tape-wrapped tubes; they may abrade the airway.
Avoid beam-heating of the wall of any tube used in tube-delivery systems such as bronchoscopes, laparoscopes, and endoscopes. In extreme instances the tube may rupture or catch fire.
Oxygen Fire.Where oxygen is present, there is always a danger from fire. Be very alert when administering oxygen, particularly when a laser procedure is being per-formed on the head or neck.
Anesthesia.Always use non-flammable anesthetics. The oxygen mix of the anesthet-ic should be regulated so that there is no danger from an oxygen fire. The oxygen con-centration in the anesthetic mix should not exceed 25-30 percent. The use of
intravenous anesthetic techniques is recommended.
Flatus. If methane is present in the lower digestive tract, it may be ignited by carbon particles. Some physicians purge the atmosphere all the way to the caecum.
Alcohol and Iodine Preps. Because the laser beam can cause fires in the work area, keep alcohol preps away from the laser beam. Iodine preps, if ignited, may irritate the mucous membranes.
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Gas Embolism
WARNING - RISK OF EMBOLISM
During intrauterine laser surgery, the use of air for purging may cause a life-threatening air embolism.
To help avoid gas embolisms, for procedures on highly vascular sites (such as during laparoscopic surgery), use CO2 rather than air to purge the fiber.
Be alert to the risk of gas or air embolisms when gas such as air or CO2 is used during therapeutic intrauterine procedures. The emboli are presumably caused when the pressurized gas is forced into the vascular system. The Aesculight laser provides air purge through the fiber. This air purge must be disconnected and replaced with CO2 before intrauterine procedures.
Electrical and
Facility
Hazards
Because the Aesculight laser contains high-voltage components, there is a danger of severe shock if its covers are taken off by other than trained personnel. In addition, the system must be properly grounded during operation. Always use proper cords and do not attempt to use three-prong adapter plugs to defeat the grounding system. The use of extension cords is not recommended.
WARNING - RISK OF INJURY
The interior of the Aesculight laser contains exposed high voltages and exposed invis-ible laser radiation. Internal maintenance must be performed only by biomedical tech-nicians trained in electrical and laser safety.
Aesculight
Laser Safety
Features
The Aesculight laser is equipped with many built-in safety features to provide maxi-mum protection for both clinician and patient. Before using the Aesculight laser for the first time, become familiar with these features and how they operate.
Keyswitch
The keyswitch helps to ensure that unauthorized persons do not use the laser system.When set to 1 (or ON) the system is energized. When set to 0 (or OFF) the system is de-energized. After use, remove the key and put it in a secure place.
CHAPTER 2
Laser Safety
Emergency
Stop Switch
The emergency stop switch, a red button surrounded by a yellow warning label, will automatically stop the system from operating when pressed down. To restart the sys-tem, pull the stop switch up and cycle the keyswitch off, and then on.
Self Testing at
Power-Up
When the system is turned ON with the keyswitch, the Aesculight system microproces-sor automatically executes system self-testing. Self-testing checks the following:
Ability of the system to generate lasing power Functionality of the computer systems Safety monitoring circuitsIf the test is successfully completed, the system enters STANDBY status. If a fault is detected, the fault message will display until the keyswitch is turned off.
Shutters
Automatic ShutterThe automatic shutter is opened when the footswitch is depressed. When the foot-switch is released, the shutter closes. Lasing typically stops within 1/10th of a second.
Remote
Interlock
Connector
The remote interlock connector provides a means to connect an external switch to dis-able lasing. For instance, it may be connected to an operating room door to control access during lasing. Once lasing is disabled, the keyswitch must be turned OFF and back to ON to restart the system.
Safety
Interlocks and
Failsafes
Fiber Interlock
The Fiber Interlock prevents unintentional lasing when the fiber is removed from the system. When the fiber is not installed on the system, primary and secondary brass pins block the laser aperture at the connection point.
Footswitch Interlock
The Footswitch Interlock prevents lasing when footswitch is improperly connected. If the footswitch is not properly connected, the system will not convert to READY status when it is selected.
Emergency Stop Switch
The emergency stop switch, a red button surrounded by a yellow warning label, will automatically stop the system from operating when pressed down. To restart the sys-tem, pull the stop switch up and cycle the keyswitch off, and then on.
Shutter Position Failsafe
The Aesculight laser contains optical detectors which monitor the opening and closing of the automatic safety shutter. This monitoring helps ensure that shutter failure is rec-ognized. If the shutter does not close within 1/2 second after releasing the footswitch, lasing is disabled and Fault 82 is displayed. If the shutter does not open when the foot-switch is depressed, Fault 81 is displayed.
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Power Measurement Failsafe
The Aesculight laser system compares lasing power as read by the internal power meter to an internal table of anticipated electrical input power. If there is a significant discrepancy, Fault 92 is displayed.
Safety Timer
The timer resets the system from READY to STANDBY if the system is idle past apre-determined time period. The time period is adjustable from 3 to 15 minutes. The timer is used to prevent unintentional activation of the laser with the footswitch.
Continuous
Internal
System
Monitoring
The system microprocessor continually monitors internal system status. The following are among the items monitored.
System Faults
If it detects a fault, the screen displays a fault number. Lasing is disabled until the fault is corrected. The complete table of system faults is shown in Chapter 7, Service.
Internal Power Meter
To prevent accidental delivery of excessive energy to tissue, laser energy output is monitored continuously. If the laser power output deviates to twice the power selected by the user, the laser is disabled, the shutter is closed and the system cannot be used. A Fault 80 is displayed on the control panel.
The internal power meter is calibrated to a standard. Aesculight recommends that the power meter calibration be checked annually and adjusted if necessary. Call Aescu-light Service at 1-866-697-7548 to arrange for this checkup.
Temperature
If the system begins to overheat a Fault 85 will occur. A Fault 85 shifts the system into Standby and prohibits lasing until the system reaches a temperature below 190 degrees. See Chapter 7, Fault Codes for additional information.
Bibliography
and
References
The Laser Institute of America has an excellent laser safety program available on slides. In addition, it has many booklets and article reprints available on the general subject of laser safety.
Laser Institute of America
13501 Ingenuity Drive, Suite 128 Orlando, FL 32826
407/380-1553
Laser Safety
Bibliography
Below is a selection of books, journals and pamphlets with information on laser safety. These may assist clinicians and other concerned individuals, particularly those new to laser surgery or setting up a safety program.
• Apfelberg, D. B., Evaluation and Installation of Surgical Laser Systems. Springer-Verlag, New York, 1987.
CHAPTER 2
Laser Safety
• Carruth J. A. S. & McKenzie, Medical Lasers: Science and Clinical Practice.Adam Hilger, Bristol, 1986.
• Sliney, D. H. and Wolbarsht, M. L., Safety with Lasers and Other Optical Sources. Plenum Pub. Corp. New York, 1980.
• Sliney, D. H. and Trokel, S. K., Medical Lasers and Their Safe Use, Springer-Verlag, New York, 1992.
• American National Standards Institute. Safe Use of Lasers, ANSI Standard Z136.1 1430 Broadway, New York, NY
• Laser Institute of America. Guide for the Selection of Laser Eye Protection.
Third Ed.
• Laser Institute of America. Laser Safety Guide. Ninth Ed.
• Laser Institute of America. Laser Safety Reference Guide. 1992.
• Lasers in Medicine and Surgery. A.R Liss. New York. (Quarterly journal) • Clinical Laser Monthly. American Health Consultants, Inc. Atlanta.
OSHA Standards
OSHA often uses ANSI Z136.1 for judging compliance with laser standards. Users of lasers are encouraged to obtain and follow the prescriptions of that standard.European
Laser Safety
Obligations
Clinicians or Laser Safety Officers are strongly encouraged to contact local authorities directly regarding any requirements for registration of laser systems or facilities within the European Union.
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CHAPTER 3
Table of Contents
Introduction - - - 1
Product Overview - - - 1
The Aesculight Laser - - - 1
System Features - - - 1
System Console - - - 4
System Controls - - - 5
Delivery Systems - - - 6
System Specifications - - - 7
Laser Output - - - 7
Physical Specifications - - - 8
Electrical Specifications - - - 9
Environmental Specifications - - - 9
Laser Safety Specifications - - - 10
Operation and Control Specifications - - - 11
CHAPTER 3
System Description
Introduction
This chapter of the Aesculight Laser System Operator’s Manual summarizes the functionsand features of the Aesculight CO2 laser. Included are the following:
A brief explanation of CO2 lasers in general, and the Aesculight laser system in particular Descriptions of the major system components and safety features System specificationsWARNING - LASER SAFETY TRAINING
The Aesculight laser produces an invisible beam of high-energy infrared laser radiation. When used improperly, the laser beam can cause severe personal injury. Only personnel trained in the safe use of laser equipment should operate or service the Aesculight system equipment.
Product
Overview
The CO2 surgical laser is used primarily to create surgical incisions, to excise after inci-sion, or to ablate small surface anomalies.
CO2 laser energy is highly absorbed by water. Since most biological tissues have high wa-ter content, the lasing energy is absorbed very close to the surface, regardless of the coloration of the target tissue. The combination of surface absorption with small spot size results in precise cutting and ablation abilities, minimized bleeding, and minimal risk to un-derlying healthy tissue.
CO2 laser light is absorbed by standard optical fibers. For this reason CO2 lasers were originally developed with an "articulated arm"⎯a laser beam delivery system consisting of a chain of rotating mirrors (knuckles) linked together with large hollow, rigid tubes. Ar-ticulated arms are costly and have a heavy, unnatural "feel." An aiming beam is required, because the laser beam comes to a focus beyond the end of the handpiece.
The
Aesculight
Laser
Rather than an articulated arm, the Aesculight CO2 laser system uses its proprietary flex-ible fiber to deliver the beam. A fiber is a small diameter hollow tube with a highly reflec-tive coating on the inside wall. The laser light enters at one end, reflects down it through the pencil-like handpiece, and exits at the attached tip. Tips of various sizes and shapes are available. The highest power density is within 1 mm of the end of the tip. The tip is held close to tissue, and no aiming beam is required.
System
Features
The design of the Aesculight Laser System incorporates many features which make the system lightweight, portable, reliable, and easy to operate. A discussion of some of the main features follows. For reference, the Aesculight laser system and the dimensions of the Aesculight Laser are shown in the following illustrations.
3-2
Figure 3-1, Aesculight Laser System Identification
FIBER
HANDPIECE
HANDPIECE
AESCULIGHT SYSTEM WITH ARTICULATED MAST AESCULIGHT SYSTEM WITH TURRET FIBER CONTROL PANEL TOUCH SCREEN CONTROL PANEL TOUCH SCREEN CONSOLE EMERGENCY STOP SWITCH EMERGENCY STOP SWITCH FIBER SUPPORT ARM FIBER SUPPORT ARM INSTALLATION PLATFORM USED WITH AE-10 AND AE-20
CHAPTER 3
System Description
Figure 3-2, Aesculight Laser System Dimensions
56.75” (144 CM) 46.25” (117 CM) HEIGHT FROM FLOOR TO TURRET TOP HEIGHT FROM FLOOR TO MAST TOP 40.50” (103 CM) HEIGHT FROM FLOOR TO SUPPORT HOLDER 19.75” 19.75” 19.75” 19.75” (50 CM) (50 CM) (50 CM) (50 CM) INCLUDING INSTALLATION PLATFORM INCLUDING INSTALLATION PLATFORM INCLUDING INSTALLATION PLATFORM
3-4
System
Console
The console provides protection and containment for the functional components of the Aesculight laser. The console has a small footprint and is lightweight and por-table. The system console is shown in Figure 3-3. Cool-ing is by forced air convection.Four subsystems are totally contained within the Aescu-light console.
Power supplies provide modulated power for laser generation and low voltage DC to other subsystems.
RF and laser tube systems create the laser beam. The laser is a sealed-off CO2 laser excited by an internal RF (radio frequency) driver. The system generates a narrow, concentrated beam of invisible infrared light of 10.6 micron wavelength.
Figure 3-3, Aesculight System Console
The optical system transmits the laser energy from the output of the laser tube to the target. Inside the console, the beam is directed past an automatic shutter. The beam delivery assembly and its components are mounted on top of the console.
Electronic and software systems
control, display, and monitor the system. The built-in microcomputer:
• Monitors and regulates laser output power
• Verifies fiber integrity and calibrates system to match delivery system transmission
• Automatically tests the system, monitors its performance, and indicates specific malfunctions
• Automatically shuts off the laser during unsafe operating conditions
• Acts on commands from the control panel and updates the display
Figure 3-4, Aesculight System Optical Path
COOLING FANS OPTICAL SYSTEM SHUTTER BOX LASER TUBE RF SYSTEM POWER SUPPLY
CHAPTER 3
System Description
The Aesculight laser console contains a built-in air pump which provides purge air flow through the fiber to blow away smoke and keep the tip free of debris. The air flow is automatic during lasing.The "fiber verification" port on the side of the console measures actual power from the tip while calibrating for fiber efficiency.
System
Controls
Control Panels
The upper control panel is located at the top of the con-sole. It contains the on/off power keyswitch and the emergency stop switch.
Figure 3-5, Upper Control Panel
The touch screen control panel is located at the top front of the console. It is the main control panel and is used for controlling output power, setting exposure timing, and determining system status. In addition, software features al-low customers to access the Library Of Clinical Cases and gain assistance through Help.
Figure 3-6, Touch Screen Control Panel
Power
When the user selects the desired power level, the Aesculight laser system directly measures the generated power inside the console. The internal microprocessor ad-justs the generated power to match the displayed power, using the calibration factor from the fiber verification procedure. This ensures that tip power is within +/- 20% of the displayed power.UPPER CONTROL PANEL KEYSWITCH
EMERGENCY STOP SWITCH
3-6
Exposure Mode
Three modes of exposure timing are available:• Continuous exposure⎯laser power is continuous while the footswitch is de-pressed
• Single exposure⎯one timed exposure is delivered for each depression of the footswitch
• Repeat exposure⎯timed exposures are repeated while the footswitch is de-pressed
Preset modes provide different combinations of pulse exposure time and pulse repe-tition rate at the selected power. These are detailed in Chapter 5.
Delivery
Systems
The beam delivery assembly conducts the laser beam from the console to the target tissue. It consists of the mast or turret, fiber, handpiece, and tip.
Mast
The laser beam travels through the mast, a rigid arm that mounts to the top of the console, which is a sys-tem accessory. The fiber focus assembly, mounted at the distal end of the mast, rotates horizontally and ver-tically for superior maneuverability.
Figure 3-7, Mast
Turret
If the laser system has a turret configuration, the laser beam travels through the turret, which is a system ac-cessory. A fiber focus assembly is attached to the dis-tal end of the turret.
Figure 3-8, Turret MAST FIBER FOCUS TURRET FIBER FOCUS
CHAPTER 3
System Description
Fibers
After exiting the mast, the beam enters the fiber. The fiber is a small diameter hollowtube with a highly reflective coating on the inside wall. The laser light enters the fiber at one end and reflects down the hollow core to the tip. Fibers are available in 1.5 meter lengths for use on a mast or turret.
Figure 3-9, Fiber
There are minimal transmission efficiency variations between fibers. Fiber verification is an internal system self-calibration which allows the Aesculight laser system to com-pensate for fiber efficiency variations.
Handpieces and
Tips
Aesculight offers a variety of handpieces and unique, disposable tips which provide the ability to perform a wide variety of procedures in many medical areas.
The handpiece fits over the end of the fiber and holds the tip. The handpiece is used to direct the laser beam to the clinical site.
Handpieces can be used much like a scalpel, but allow greater access to restricted ar-eas and precise control within the area of interest. The small spot size of the laser beam and variety of tip sizes and shapes make it easy to target the area of interest.
System
Specifications
Laser Output
LaserType: Sealed-off, CO2, RF-excited Class: FCC, CDRH
Requirements Met: FCC, CDRH
Wavelength: 10.6 microns (invisible infrared) Excitation Frequency: 45 Megahertz
Beam Diameter: 3.2 mm
Energy Delivery - (General)
Delivery method: Flexible hollow waveguide (fiber) Mode structure: Multi-mode
Type: Non-contact
Minimum spot size: .25mm to 3mm, depending on tip
Display accuracy: +/-20% of actual power for all delivery system positions, with properly calibrated fiber Power adjustability: One-watt increments, up or down
3-8
Energy Delivery - (CW)
Power to Tissue: (with new fiber, handpiece, straight nozzle, ceramic tip): Adjustable 2-20 watts (AE-10) or 2-40 watts (AE-20) Gated Pulse Widths: 5 to 500 milliseconds (0.005 to 0.5 seconds)
Gated Repetition Rates: One single pulse or 2 to 20 pulses per second
Energy Delivery (Superpulse)
Power to Tissue: (with new fiber, handpiece, straight nozzle, ceramic tip): Adjustable 2-10 watts (AE-10) or 2-20 watts (AE-20) Gated Pulse Widths: 10 to 500 milliseconds (0.010 to 0.5 seconds) Superpulse Pulse Rates: 160-375 pulses per second
Gated Repetition Rate: One single pulse or 2 to 30 pulses per second Peak Power: > 50 Watts (AE-10) or > 100 watts (AE-20) Super Pulse Widths: 100-800 microseconds
Delivery System
Mast: Counterbalanced, fully rotating, removable with electrical interlock.
Turret: Removable, with electrical interlock Waveguide (Fiber): 1.5 meter flexible hollow waveguide
Handpieces: Removable, sterilizable, aluminum and stainless Tip Material: Sterilizable, disposable, ceramic
Fiber Purge Gas
Internal: A small internal pump automatically delivers a nominal 2.0 liters per minute of air down the fiber while lasing to purge smoke from the fiber and tip.
Physical
Specifications
Size
Height of Console: 40.25 inches (103 cm) Height with Mast: 56.75 inches (144 cm) Height with Turret: 46.25 inches (117 cm) Width: 19.75 inches (50 cm) Depth: 19.75 inches (50 cm)
Weight AE-10: 61 lbs (28 kg) with platform, 58 lbs (26 kg) without platform Weight AE-20: 74 lbs (34 kg) with platform, 70 lbs (32 kg) without platform
Portability
Portability: When removed from installation platform, large wheels and a conveniently positioned handle provide easy portability.
Cooling
Cooling: Forced air with automatic over-temperature protection. No water pumps required.
CHAPTER 3
System Description
Fiber Support Arm
Support: At maximum extension of the fiber support arm mechanism with a one-pound static loading (maximum weight of handpiece, sheath and smoke evacuation tube) the distal end of the arm should not move more than one inch over a one-hour period.
Electrical
Specifications
Input Power
Electrical Safety
Current Leakage: Less than 500 uA (per EN 61010) Ground Impedance: Less than 0.1 ohms (per EN 61010)
High Potential: Input can withstand 2,500 VDC for 1 minute
Environmental
Specifications
Ambient Temperature
Operating: 50 to 86° F (10 to 30° C) Storage: 32 to 185° F (0 to 85° C)
Duty Cycle: 3 minutes of lasing in a 45 minute cycle under these conditions: Power: 40 watt maximum delivered
Fiber: 1.5 m
Duty cycle is reduced at higher temperatures or higher power settings
Moisture Resistance
Operating: 15% to 95% relative humidity, non-condensing Storage: 0% to 95% relative humidity, non-condensing
EU Value EU Value US Value Units Input Voltage: 100-120 200-240 115 VAC, +/- 10% Input
Current: 15 7.5 15 Amps, maximum Fuses: 15 7.5 15 Amps, Fast blow Cycles: 50-60 50-60 50-60 Hz, single phase
3-10
Laser Safety
Specifications
Safety Key Switch
Key Switch: System operates only with the key switch in the ON (1) position The key is removable only in the OFF (0) position.
Emergency Stop Switch: System shuts down immediately when stop switch is depressed. When the stop switch is pulled up, and cycled off and then on, the system restarts.
Laser Safety Shutters
Automatic Shutter: Controlled by the internal computer, prevents laser emissions from the tip when closed, opened only when the user activates the footswitch while in the ready state.
Fiber Port: Dual spring-loaded safety shutters always close the focusing assembly laser aperture whenever the fiber is removed. Mast or Turret Port: Removing the mast or turret opens an electrical interlock and
the control system disables external lasing until the interlock is reconnected.
Shutter Monitoring: The automatic shutter and the mast interlock are monitored continuously by the internal control computer.
Power Display
Display Accuracy: After proper fiber calibration, the actual power delivered will be within +/- 20% of the power displayed.
Fiber Calibration and Verification
Fiber Verification: The user is instructed to allow the computerized control system to perform a 20-second fiber calibration and verification at power up and whenever the fiber is changed. This allows the control system to deliver accurately calibrated power to the tip.
Power Monitoring Safety
Power Seek: Whenever the user selects a new power value or enters the READY state, the control system performs a “Power Seek” by lasing into the internal power monitor (with the automatic shutter closed) and adjusting the laser power (while compensating for losses through the fiber) until computations indicate that the requested power will be delivered out the tip.
While Lasing: During actual lasing, the control system continuously monitors the RF current being fed to the laser tube. This current is directly proportional to the output power of the laser. If this current changes by more than 20%, the lase indicator starts flashing to warn the user. If this current increases to twice what it should be, a fault will be generated, lasing will stop, and the automatic shutter will close.
CHAPTER 3
System Description
Control System Safety
Footswitch: Monitored continuously by the computer control system. If the foot switch is unplugged or shorted, external lasing is disabled. Electrical circuitry prevents the automatic shutter from opening unless the footswitch is activated.
Over-temperature: When the control computer first detects that the RF driver is starting to overheat (approximately 140° F or 60° C), the active cooling fans will stay on when the system goes into standby, until such point that the RF driver temperature drops below 140° F (60° C). If the RF drivers heat to approximately 190 °F (90° C), the control system will indicate a potential overheat situation on the control screen. If the system continues lasing for a period of 30 seconds after signaling, the control system will prohibit the system from lasing until the internal RF driver temperature drops below approximately 140° F (60° C).
Computer Watchdog: The control computer must address an external timer circuit at very specific intervals. If this ‘watchdog timer’ receives pulses either too quickly or too slowly, it may indicate a malfunction and external lasing is disabled.
Computer System: Self-diagnostics are performed by the control computer both at power up and while running. If a monitored component fails in a detectable manner, a fault code is displayed, the automatic shutter is closed, and external lasing is disabled.
Operation and
Control
Specifications
Controls
Left Up/Down Arrows: Increase/decrease the laser power.
Mode: Sequence through continuous, single pulse, and repeat pulse delivery modes.
Superpulse: Toggle between Superpulse and CW modes.
Right Up/Down Arrows: Scrolls up or down through the pre-programmed selections for single pulse or repeat pulse modes.
Standby: Close the automatic shutter and disable external lasing. Ready: Arm the laser and prepare to deliver laser energy when the
user activates the footswitch.
Custom: Allows custom settings for system controls Help: User help screen
Footswitch: Activation required for the automatic shutter to open and for external lasing of any kind.
Library: Case study screens containing information from the Aesculight Veterinarian Compendium.
3-12
Operations
Laser Selection -
Superpulse / CW Mode: Superpulse or CW mode selection involves using the control to select Superpulse or Continious wave lasing delivery.
When switching to a different mode, the settings of power, and exposure last used in that mode will be displayed.
Exposure Mode
Selection: Touching the button runs through continuous, repeat pulse, and single pulse exposure modes. While in repeat or single pulse mode, the right side up and down arrows scroll through pre-programmed selections of pulse width and repetition rate. Power Adjustment: The laser power level is displayed in the watt window. It can be
adjusted simply by touching the up or down arrow keys in either the ready or the standby state. The system will immediately perform a 4-second power seek to the new power level.
Ready / Standby: A transition from standby to ready state involves a delay while the system performs an internal power seek. Transition to the standby state involves no time delay. If the laser receives no input for the time input by user, while in the ready state, it will transition automatically to the standby state.
Fiber Verification: A fiber verification and calibration is initiated by inserting the handpiece into the calibration port and lasing in continuous exposure at 6 watts. The procedure takes about 20 seconds and ends with a tone and a displayed result.
Control Panel Display Windows
Figure 3-10, Control Panel Display Windows
CHAPTER 3
System Description
Left Display: Displays the power (in watts) the laser will deliver out the tip whenthe footswitch is activated. In repeat and single exposure modes, the display indicates a power value that is equivalent to the average power being delIvered during an “ON” cycle.
Center Display: Displays the name of the selected mode; continuous, single, repeat or custom.
Right Display: 1. Displays the pulse width when the system is in a single exposure mode.
2. Blanked when the system is in continuous mode.
3. Displays the pulse width, repetition rate, and duty cycle of the repeat mode.
Control Panel Indicators
Gold STANDBY: Indicates the laser is in a ‘safe’ condition with the laser off and the automatic shutter closed.
Green READY: Indicates the laser is ready to lase. Stepping on the footswitch will deliver laser energy out the tip.
Red LASING: Lasing symbol indicates that the laser is lasing with the automatic shutter open.
00327-01 Rev PA
CHAPTER 4
Table of Contents
Introduction - - - 1
Unpacking and Repacking - - - 1
Unpacking - - - 1
Repacking - - - 1
Installation and Setup - - - 2
Initial System Checkout - - - 10
System Controls - - - 10
Self-Testing - - - 11
Fiber Verification Procedure- - - 11
Power Adjustment Check - - - 14
Tongue Depressor Test - - - 14
Footswitch Interlock Check - - - 14
Emergency Stop Switch Check - - - 14
Moving, Transporting, and Storage - - - 15
Disassembling and Transporting the System - - - 15
Shipping the System - - - 16
Storage - - - 17
CHAPTER 4
System Setup
Introduction
Follow the instructions in this chapter for proper installation and handling of the Aesculightlaser, which includes:
Unpacking/Repacking Installation/Setup Initial system checkout Moving and transporting StorageUnpacking
and
Repacking
Shipping Configuration
The Aesculight laser system is shipped in a container. Contents may vary according to model ordered, but the parts and accessories generally shipped in the container are:
Accessories
Aesculight Laser System Operator’s Manual Fiber support arm Mast and counterbalance or Turret Footswitch CO2 safety goggles MasksNOTE - SHIPPING CONFIGURATION
Fibers will be shipped separately. Tips and other accessories may also be shipped sepa-rately.
System
Aesculight laser console Installation platformFollow packing and repacking instructions printed directly on the shipping container.
Unpacking
To unpack the Aesculight laser system, carefully remove all components from theship-ping container. Set the console down on its wheel base. Save all packaging materials in case repacking and shipping is necessary.
4-2
Repacking
To repack the Aesculight system, disassemble the system. Repack it using onlyAes-culight packaging materials.
NOTE - CONSOLE HANDLING
The Aesculight laser console, which weighs approximately 47 pounds (AE-10) or 65 pounds (AE-20), may be lifted using the handle and a leg of the base at the same time. Use proper lifting techniques. When resting on its wheel base, it may be rolled using the handle on top of the console.
CAUTION - FACTORY PACKAGING MATERIALS
Do not ship an Aesculight laser system without the factory packaging materials. Doing so may result in damage to the components during shipping and void the warranty. Contact Aesculight if packaging materials or repacking instructions are needed.
Installation
and Setup
If this is your first Aesculight laser system setup, Aesculight strongly recommends that an Aesculight sales representative be present for setup assistance.
Move the laser system, installation platform and accessories to the desired operating location. Locate and position the laser system near a power outlet, so that the system may be disconnected quickly by pulling the power cord from the outlet in case of an emergency situation.
Assemble the Aesculight laser system as follows:
Installation Platform
1. Place the installation platform flat on the floor with the anchor straps facing up. The front of the platform is marked and will align with the front of the laser base.
Figure 4-1, Installation Platform
ANCHOR STRAP WHEELS
CHAPTER 4
System Setup
2. Roll the laser system onto the platform and position the wheels into the wheelslots on the platform.
Figure 4-2, Wheel Alignment
3. Secure the base of the laser system to the platform by anchoring with the straps across each wheel as shown below.
Figure 4-3, Secure Wheel With Straps
4. The installation platform must be attached to the system to prevent accidental tipping during use. The assembled platform and base are shown below.
4-4
Mast or Turret Insertion
1. With the console on its wheel base, unscrew the stub mast/turret cap counter-clockwise from the beam output port located on top of the console. The stub mast/turret cap protects the beam output port from contaminants.
CAUTION - STUB MAST OR TURRET CAP
When the mast or turret is removed, always cover the beam output port on the console with the attached stub mast/turret cap. Dust and debris can damage the optics.
2. Check the collimating lens by looking down into the beam output port. The collimating lens is recessed approximately 2 inches from the top of the stub on the beam output port. If dust or debris is visible on the lens, clean it as de-scribed in Chapter 7.
The mast is keyed for correct insertion and pre-cision alignment. Carefully insert the mast or turret into the keyed position of the beam output port. Hand-tighten the threaded collar on the mast or turret until it is snug.
Figure 4-5, Mast or Turret Insertion
CAUTION - MAST OR TURRET POSITIONING
The mast and turret are a precision optical instruments. To avoid damage, position carefully. Do not use force, overtighten the collar, or use tools.
CHAPTER 4
System Setup
3. Connect the air purge hose on the mast or turret to the hose barb on top of theAesculight laser console. The hose should fit snugly over the hose barb.
Figure 4-6, Connect Air Purge Hose
4. Check the mast or turret at the base to make certain it’s properly seated and tightened down. A loose attachment can affect power output and laser system performance.
5. For Mast Only:
Hand-screw the counterbalance weight into the top of the mast. Screw it in all the way, but do not tighten it.
Figure 4-7, Mast Counterbalance Assembly
6. Insert the aluminum fiber support arm into one of the two holders on the top of the Aesculight laser console. Secure it by hand tightening the holder until snug. CONNECT AIR HOSE TO BARB CONNECT AIR HOSE TO BARB
AESCULIGHT LASER WITH MAST AESCULIGHT LASER WITH TURRET
4-6
Figure 4-8, Fiber Support Arm
7. Remove the plastic tube containing the fiber from its shipping tube. Remove the fiber from the plastic tube. The fiber will have an end protector attached; use the end protector whenever the handpiece is not attached to the fiber. Save the plastic tube for future fiber storage.
NOTE - FIBER HANDLING
Always handle the fiber carefully. Prevent kinking. Do not bend sharply. Distortion of the fiber reduces efficiency. See Chapter 6 for fiber handling instructions.
8. Remove the protective caps from the fiber ends.
9. Insert the fiber connector into the fiber focus connector in the laser aperture at the top of the mast. Secure the fiber by rotating the fiber connector one-quarter turn.
Figure 4-9, Fiber Assembly
FIBER SUPPORT ARM FIBER SUPPORT HOLDER FIBER SUPPORT ARM
CHAPTER 4
System Setup
10. For the Mast Only: To adjust the counter balance for a 1.5 meter fiber, use the standard counterbalance. To make the adjustment, start with the counterbal-ance screwed all the way in. With the fiber attached, hold the handpiece level with the proximal end of the fiber. Gradually unscrew the counterbalance until the fiber feels balanced. Adjustment of the counterbalance with fiber attached may vary, as the touch is an individual preference..
Figure 4-10, Counterbalance and Ring Grip
11. Insert the fiber clip into the ring grip in the distal end of the fiber support arm. 12. Plug the footswitch into the footswitch receptacle on the power panel. Pull the
cable lightly to verify that it is securely connected and does not disengage.
Figure 4-11, Power Panel
13. When system is not in use, place footswitch on footswitch hanger located on the rear panel.
COUNTERBALANCE RING GRIP FOOTSWITCH FOOTSWITCH JACK POWER PANEL AC INLET
4-8
Figure 4-12, Footswitch Hanger
14. Connect the Smoke Evacuator Cable to the rear panel as shown in the follow-ing illustration. Hold the outer housfollow-ing of the connector near the arrows and push straight in, making sure not to twist the connector. When removing the connector, pull straight out without twisting.
FOOTSWITCH
FOOTSWITCH HANGER
CHAPTER 4
System Setup
Figure 4-13, Smoke Evacuator Cable Installation
CAUTION - SMOKE EVACUATION CONNECTION
The smoke evacuator cable connector must be inserted by pushing straight in or re-moved by pulling straight out. To avoid damage, do not use a twisting action.
15. Plug the Aesculight power cord into the AC inlet. Plug the other end into a hos-pital grade wall outlet.
CAUTION - GROUNDING
The Aesculight laser system requires a properly grounded, hospital-grade outlet.
The system is now ready for checkout.
SMOKE EVACUATOR CONNECTOR CABLE INSERT BY PUSHING CABLE CONNECTOR IN REMOVE BY PULLING CABLE CONNECTOR OUT
DO NOT TWIST
4-10
Initial System
Checkout
Prior to clinical use, check out the Aesculight system to demonstrate that the system, including its built-in safety features, is operational.
Read the entire operating manual before turning on the system. Of particular impor-tance is Chapter 2, Laser Safety.
Before beginning system checkout, make sure that the laser operating area is safe and secure. As when performing any laser procedure, flammable materials should be moistened or beyond contact of the laser beam. All personnel should wear protective goggles or glasses.
The required checkout includes the following procedures, which should be performed in the order indicated:
1. Self-testing 2. Fiber verification
3. Power adjustment check 4. Tongue depressor test 5. Footswitc
