SPECTRA™ Dual Mode Nd:YAG Laser AGENDA • • • • • Laser safety Basic laser physics Laser-tissue interaction Introduction to the SPECTRATM SYSTEM Clinical Protocols – Patient assessment and pre-treatment – Treatment – Post-treatment – Expected sequelae and adverse events • Contact information for Lutronic departments • Questions and discussion LASER SAFETY REGULATORY AGENCIES • NATIONAL - ANSI OSHA: Occupational and Safety Health Administration (US) CDRH FDA: Food and Drug Administration – Center for Devices and Radiological Health (U.S.) • STATE LAWS AND REGULATIONS - Scope of practice: who may operate lasers Educational requirements • COUNTY OR CITY LAWS AND REGULATIONS • INTERNATIONAL - MDD: Medical Devices Directive (EUR) EU-OSHA: European Agency for Safety and Health at Work (EUR) IEC: International Electrotechnical Commission ANSI • The American National Standards Institute: a private non- profit organization that facilitates development of standards for products, services, processes, systems in the US. • ANSI accredits standards that are developed by representatives of other standards organizations, government agencies, consumer groups, companies, and others. • Government agencies such as OSHA use the ANSI guidelines to set their individual requirements and standards. • Non-governmental agencies such as The Joint Commission, Association of Perioperative Registered Nurses, American Society for Lasers in Medicine and Surgery and more have referenced this standard as their guideline. • ANSI Z136.3-2011 is the most recently published standard for safe use of lasers in health care, and will be represented in this presentation. ANSI LASER CLASSIFICATIONS Z136.3-2011 ANSI Laser Classification Description Class 1 Any system containing a laser that cannot emit laser radiation at levels that are known to cause eye or skin injury during normal operation. Class 1M Considered incapable of producing hazardous exposure unless viewed with collectionoptics. Class 2 Visible lasers considered incapable of emitting laser radiation at levels that are known to cause skin or eye injury within the time period of the human eye aversion response (0.25s). Class 2 A For FDA/CDRH: visible lasers that are not intended for viewing and cannot produce any known eye or skin injury during operation based on a maximum exposure time of 1000 s. Class 2 M Emits in the visible portions of the spectrum, and is potentially hazardous if viewed with collectingoptics. Class 3 A FDA/CDRH visible lasers less than 5 times the Class 2 limit. Class 3 R A laser that is potentially hazardous under some direct and specular reflection viewing conditions if the eye is appropriately focused and stable. Class 3 B Medium powered lasers that present a potential eye hazard for intra-beam (direct) viewing or for viewing specular (mirror-like) reflections. Class 3B lasers do not present a diffuse (scatter) reflection hazard or significant skin hazard except for higher powered Class 3B lasers operating in certain wavelengths. Class 4 High-powered lasers (visible or invisible) that present acute hazard to the eye and skin for both direct exposure and for diffuse reflections. Class 4 lasers also present a potential hazard for fire (ignition) and by-product emissions from target or process materials. LASER CLASSIFICATION & STANDARDS SPECTRATM classification: • Class IV laser by Center for Devices and Radiological Health (CDRH) • Class 4 laser by European Standard (EN 60825-1) Follow ANSI, OSHA, European standard: • Contact Laser Institute of America (LIA) T: (800) 34LASER for current ANSI and OSHA standards - http://www.laserinstitue.org - i.e., ANSI Z136.3, ANSI Z136.1 and EN 207 • ANSI: American National Standards Institute ANSI CONTROL CATEGORIES • Administrative Controls (facility and Laser Safety Officer ‘LSO’) • Documentation, training programs, etc. • Procedural Controls (facility and LSO) • Policies, safety glasses, signs, etc. • Engineering Controls (the manufacturer) • Safety Interlocks, standby, emission indicators • Emergency stop switch, Key switch • Covered footswitch (where appropriate) LASER SAFETY OFFICER (LSO) • Every facility must appoint an LSO • LSO verifies Documentation • Facility LSO is responsible for the Laser Log, including (but not limited to): – – – – – System and Equipment Audits Laser Maintenance Records Safety Audits Education – Initial and On-going Competency – Skills Check Lists NHZ : NOMINAL HAZARD ZONE • The NHZ is the actual area (boundary) where injury could occur by the laser beam. • The NHZ is determined by the LSO or facility based on manufacturer specifications. • The NHZ is determined primarily by the wavelength of the system, but can also be influenced by factors such as : • • • • Incident power Spot Size and Divergence Angles Exposure Time MPE (maximum permissible exposure) • Most small practices determine the entire treatment room to be the NHZ. VERIFY PROPER EYE PROTECTION • Ensure all persons in treatment room are wearing protective eyewear appropriate for the laser used. • Best Practice: If a patient’s face is to be treated, they should wear opaque or metal eye goggles or shields. • A laser beam can cause severe corneal or retinal injury, depending on the wavelength. • Best Practice: A pair of goggles should be placed outside the NHZ so entering personel can put on goggles before entering the NHZ SAFETY PRECAUTIONS FOR THE EYES • Do not treat within the bony orbit of the eye. • Ocular Hazard Zone: • Laser energy emitted by the SPECTRA™, when focused by the ocular lens onto the retina, will have a very high irradiance (e.g., even the 5 mW 532 nm aiming beam could produce over 250 W/cm² at the macula, the most sensitive part of the retina) Protective Eyewear Required • Operator Glasses for 532 + 1,064 nm • OD ≥6.5 for 190 - 534 nm • OD ≥6.0 for 910 – 1,070 nm • OD ≥5.0 for 850 – 1,070 nm • Operator Glasses for 585 + 650 nm • OD ≥5.0 for 190 - 400 nm , 645 - 670 nm • OD ≥6.0 for 585 - 665 nm • Patient Goggles or Shields • Opaque material e.g., metal SAFETY GUIDELINES • ‘Laser in Use’ warning sign on door • Pair of operator goggles outside of door • Enclosed room with opaque fire resistant window coverings • Allow any flammable liquids used for cleaning the skin to fully evaporate before treatment • Have a fire extinguisher available • Water must be available (e.g., faucet or in bowl) • Avoid the use of instruments with reflective surfaces • Be aware of other reflective surfaces (mirrors, trolleys, etc.) BASIC LASER PHYSICS BASIC LASER PHYSICS The electromagnetic spectrum is comprised of visible colors, infrared, radio, X-rays and gamma rays, which are all forms of light. Wavelengths vary in size as depicted below. Source http://www.alk aon.net/tag/electromagnetic-spectrum BASIC LASER PHYSICS • LASER: Light Amplification by Stimulated Emission of Radiation • Lasers are devices that emit light using a process of optical amplification. • Laser light is very different from other light: White (sunlight, light bulbs, IPL, etc.) Laser Beam Non-collimated Collimated Polychromatic Monochromatic Non-coherent Coherent • There are many types of lasers and many mediums such as gases, dyes, crystalline rods, and diodes, which are used to create various wavelengths. BASIC LASER PHYSICS Lasers used in cosmetic dermatology range from the high 400 nm range to 10,600 nm. LASER TISSUE INTERACTION LASER/LIGHT TISSUE INTERACTION There are five mechanisms of action with lasers or light treatment depending on the system type (laser or non-laser), the wavelength and the incident power density: 1. PhotoTHERMAL 2. PhotoCHEMICAL 3. PhotoMECHANICAL (acoustic) 4. PhotoDISRUPTIVE 5. PhotoBIOACTIVATIVE LASER TISSUE INTERACTION When light is applied to tissue there are four reactions: 1. Reflection (from the surface of the target) 2. Scatter (forward, lateral and back-scattering) 3. Transmission (deep into the target tissue) 4. Absorption - the ultimate desired key reaction in the appropriate targeted chromophore LASER TISSUE ABSORPTION SPECTRUM Source: Department of Medical & Scientific Affairs, Lutronic Corporation Source: Department of Medical & Scientific Affairs, Lutronic Corporation SELECTIVE PHOTOTHERMOLYSIS • Different laser wavelengths are preferentially absorbed by their corresponding chromophores (target). • The main goal of selective photothermolysis is to heat the targeted pigments swiftly with a laser and destroy them without damaging surrounding tissue. • Targeted pigments are selectively damaged through the absorption of light and the subsequent instant photothermal energy transfer, with minimal conducted heat to the surrounding normal tissue. PARAMETER CONSIDERATIONS • To achieve selective photothermolysis, we need three factors. 1. Appropriate wavelength - selective absorption 2. Short pulse width - targeting and heat confinement 3. Very high peak power (irradiance) - desired effect • Ideally, the pulse width should be equal to or shorter than the Thermal Relaxation Time (TRT) of the target (e.g. melanin or tattoo ink) to confine thermal damage selectively to the target. Q-SWITCHED LASERS: SPECTRA • Q-switching is a process in which the quality of the beam is amplified, making it possible to produce ultra-short pulse durations in the nanosecond domain or shorter, delivering a high peak power. • The pulse duration with Q-switched lasers is so short that it creates photo-acoustic and -osmotic shockwaves which fragment the pigment particles. • The tiny fragments of pigment are then engulfed by macrophage cells and carried away by the lymphatic system. SELECTIVE PHOTOTHERMOLYSIS Q-Switched Nd:YAG Laser (SPECTRATM et al.) Laser Beam Chromophores (e.g.melanin or ink particles) Explosion Source: Department of Medical & Scientific Affairs, Lutronic Corporation Fragmented chromophores Macrophage cell Absorption by macrophages and excretion by the lymphatic system INTRODUCTION TO THE SPECTRATM SYSTEM COMPONENTS OF SPECTRA TM Articulated Arm Handpiece Control Panel Handle Key switch Caster Calibration Port Emergency Stop Button System Main Body SPECTRA SYSTEM OVERVIEW – SPEC. • • • • • • • • • • Laser Medium: Nd:YAG Wavelengths: 1064 nm / 532 nm (Option: 585 nm, 650 nm) Operation Modes: Q-switched (5 ns )& Spectra Mode (300 μs) Beam Profile: Top Hat Mode Pulse Energy: Max 1.2 J Pulse Widths: 5 - 10 ns (Q-switched Mode) / 300 μs (Spectra Mode) 3-8 Zoom Collimated Handpiece (Max 8 mm Spot Size) Pulse Rate: Max. 10 Hz Energy Calibration: External, Auto-Calibration & Self-Restoration Auto-Detected Handpiece Spot Size SPECTRA HANDPIECES TM 3-8 mm Zoom Collimated (Standard) Source: Research and Development Center, Lutronic Corporation 585 nm Dye (Optional) 650 nm Dye (Optional) AUTO-DETECTED HANDPIECE AUTO-RECOGNITION • Changing the Handpiece spot size automatically changes the GUI spot size. • Ensures the GUI fluence matches the output delivered, preventing adverse events due to unexpected excessive fluence. ZOOM HANDPIECE Pigmented Lesions • Spot size is different depending on the distance between the tip of handpiece and skin surface. • If the tip of handpiece is pulled slightly from the skin surface, the spot size gets smaller, thus the irradiance (power density) increases accordingly with a correspondingly more powerful laser/tissue interaction. (Power Density = Output power [W]/Spot size [cm2]) • It is recommended to use this handpiece always in contact with the skin surface. Size of the area affected by laser beam = Spot size ✔ ✕ ZOOM COLLIMATED HANDPIECE SoftPeel, SpectraPeel, Laser Toning, Pigmented Lesions • Standard Handpiece, most commonly used • Spot size can be adjusted (e.g., 3-8 mm at 1,064 nm) • Laser beam is collimated (not focused); as a result the spot size remains constant. The operator can work without having the tip of the handpiece in contact with the skin surface. • It is still recommended to keep the tip as close as possible to the skin. DYE HANDPIECES 585 nm for Sky Blue Tattoos 650 nm for Green Tattoos The Spectra System automatically recognizes the handpiece, and the user simply adjusts the fluence. CONNECTING THE HANDPIECE • Take off the protective cap covering the end of the articulated arm. Hold the end of the articulated arm steady. • Carefully insert the handpiece into the end of the arm. Gently turn the rotating collar at the end of the articulated arm in a counterclockwise direction (as shown by the arrow in the illustration) until the handpiece is firmly connected. • Be sure that the handpiece is securely fastened. CONNECTING THE HANDPIECE • Hold the handpiece cable connector and articulated arm cable connector. • Line up the arrows on the two connectors and connect them to each other as shown in the illustration. CLEANING THE HANDPIECE 1. Remove the tip from the handpiece: hold the handpiece body with one hand and GENTLY pull the handpiece tip with the other hand. 2. Gently clean the handpiece and exterior system components with hospital grade anti-viral, anti-bacterial, anti-fungal solution, EXCEPT the lens at the end of the handpiece body. 3. To eliminate all foreign matter from the lens, use a cotton swab saturated in 90% alcohol to clean it thoroughly. CLEANING THE HANDPIECE 4. In addition, be sure to remove any debris on the inner side of the handpiece tip using the same method. 5. After thoroughly cleaning the handpiece, shine a light onto the window of the handpiece to examine it and check for cleanliness. 6. Reassemble the handpiece in reverse order from disassembly. 7. If the handpiece is not to be used immediately, wipe it with a dry cotton cloth and place it in the handpiece case. CALIBRATION (OPTIONAL) 1. Before starting calibration, check the beam mode. 2. Connect the articulated arm as shown in the figure. 3. After entering the setup mode, press the “Calibration” button at the bottom of the screen. CALIBRATION (OPTIONAL) 3. As shown in the illustration, the device checks that the end of the articulated arm is connected to the calibration port. 4. Once the “Start” button is displayed as shown in the right hand panel, press it to start the calibration process. CALIBRATION (OPTIONAL) 5. Calibration then commences, and the process completes automatically as shown in the illustrations. ERROR STATUS MESSAGES Message Code Possible Cause for Errors Actions to Take CODE 01 Emergency Error Turn off the device and unlock the emergency stop switch. Restart the device. CODE 02 Main Shutter Error Turn off the device, wait 2 minutes before restarting the device. CODE 03 Water Flow Error Refill with cooling water according to the instructions. (Refer to the Operator’s Manual) CODE 04 Door Open Turn off the device, wait 2 minutes before restarting the device. CODE 24 Energy Setup Error It is possible to use the device temporarily, but the device is unstable. Before using the device again, you must contact your local Lutronic distributor for inspection CODE 30 Power Module Error Turn off the device, wait 2 minutes before restarting the device. CODE 32 AC Contactor Error Turn off the device, wait 2 minutes before restarting the device. CODE 33 Water Level Error Refill with cooling water according to the instructions. (Refer to the Operator’s Manual) CODE 34 Interlock Switch Off Turn off the device, wait 2 minutes before restarting the device. CODE 36 Simmer Error Turn off the device, wait 2 minutes before restarting the device. CODE 37 Water Temp. Error Turn off the device and contact your local Lutronic distributor for inspection Note : If the problem persists despite following the recommended action, contact your local Lutronic distributor GRAPHIC USER INTERFACE Fluence Energy density per unit area (J/cm²) Spot Count The total number of laser shots fired. The Reset button sets the shot count back to zero Aiming Beam Visually shows the target of the treatment laser; possible to adjust light intensity. Pulse Rate The number of pulses which are emitted per second Memory Saves parameters into the system Memory, recalls and displays the parameters on the control panel Spot size Shows the spot size of the laser beam, automatically detected depending on the handpiece fitted and spot size selected on the handpiece Wavelength Selects wavelength and mode Toning Saves the basic parameters for laser toning Standby / Ready Standby – Parameters can be set, but laser energy cannot be emitted, even if the footswitch is depressed Ready – laser energy can be emitted Source: Research and Development Center, Lutronic Corporation USING THE MEMORY FUNCTION To save frequently used parameters to memory: 1. Enter Memory mode by pressing the Memory button located at the bottom of the screen as shown in the figure. 2. Activate the parameter setting section by pressing the Modify button located at the bottom of the screen. USING THE MEMORY FUNCTION 3. After setting parameters in the parameter setting section, press one of the memories at left of the screen to save the setting. At this time, a popup window is displayed to make sure users want to save the selected memory. Then press the OK button. USING THE MEMORY FUNCTION 4. Press the Rename button located at the bottom of the screen to set the memory name. The keyboard pop-up appears as below. 5. Using the keyboard, type a memory name into the blank space and press the Accept button. USING THE MEMORY FUNCTION 6. As shown in the figure, saving a memory is complete. It is possible to return to the original name while inputting the new name by pressing the Restore button. USING THE MEMORY FUNCTION To load the saved parameters FROM memory: 1. Enter Memory mode by pressing the Memory button. Press a memory to recall it. The selected memory is highlighted in yellow. 2. Recall the memory to the operation mode by pressing the Accept button at the top of the screen. The selected memory can be cancelled by pressing the Restorebutton. SPECTRA INDICATIONS • Tattoo (inc. colored) • Melasma • PIH • Skin Rejuvenation • Active Acne* •Post Acne Erythema • Nevus of Ota • Lentigo • Freckles • Seborrheic Keratosis • Large Pores** • Others *Note: No FDA clearance for active acne / inflammatory acne **Note: No FDA clearance for large pores Tattoo Removal THE PHYSICS OF LASER TATTOO REMOVAL • Each pulse of energy penetrates the skin and is absorbed by the tattoo ink. • As the tattoo ink particles absorb the energy, they heat up and then shatter into tiny fragments. • Then, over the weeks following treatment, the body’s immune system flushes the tattoo ink particles away from the location, lightening the appearance of the tattoo. • Each laser treatment breaks down more and more of the tattoo ink until none remains. SelectivePhotothermolysis From 3 Greek rootwords • "photo" = light • "thermo" = heat • "lysis" = destruction Precise targeting of a structure or tissue using a specific wavelength of light with the intention of absorbing lightinto that target area alone. The energy directed into the target area produces sufficient heat to damage the target while allowing the surrounding area to remain relatively untouched. MECHANISM OF ACTION FOR TATTOO REMOVAL • Q-switching is a special type of laser pulse creation. Q-switched lasers produce intensely powerful, brief pulses of energy – for Spectra lasting just 5 nanoseconds (10-9). • Tattoo ink particles are extremely small (typically nanometers in diameter), and so they need to be heated for a very brief period of time to warm up and explode. • The longer the pulse the more time for heat to conduct to surrounding tissue. By using very short nanosecond pulses heat is confined to pigment particles leaving the surrounding tissue intact. Macrophage Q-Switched Nd:YAG Laser Pigment or ink particles Source : Lutronic illustration Explosion Absorption and drainage by human immune system SPEED OF TREATMENT 3-8 MM ZOOM COLLIMATED HANDPIECE • • Large 8 mm spot size enables rapid treatments of tattoo inks o 3-8 mm adjustable on-the-fly spot size change o Set the spot size to the tattoo size Easier on operator o Collimated output eliminates need to maintain specific distance from tissue o Auto-recognition handpiece provides consistent fluences TARGETING TATTOO INK • Tattoos come in every color and different colors absorb and reflect different wavelengths. An apparent color, however, can be a mixture of different pigments. • To breakup the tattoo ink particles the wavelength used must be well-absorbed. • When treating multicolored tattoos, access to a variety of laser wavelengths is important. • The most common wavelengths used for laser tattoo removal are 1064 nm and 532 nm – they can treat 95%+ of tattoos. • The optional 585 nm and 650 nm dye handpieces are useful for treating sky blue or green inks. LETTING THE BODY DO ITS WORK • Tattoo removal is not an instant fix – it’s usually a several month commitment. Most tattoos require between 5 and 10 treatments fspaced at least 6 weeks apart. • The tattoo ink is injected at different depths within the dermis. The shallowest layers of ink absorb the energy and shatter. Once the body flushes away the top layers of ink the deeper layers be treated. • In effect, every successive tattoo removal treatment affects deeper and deeper layers of ink until none remain. • It takes time for the body to flush away the shattered tattoo ink from within the skin. Phagocytic cells gradually moving the ink particles to the lymph nodes, where the pigments remain. Because the body can only flush away the ink at a certain speed, it’s beneficial to wait as long as possible between treatments to see maximum fading from each session. Also, the waiting period allows any scabs or blisters to heal, minimizing the possibility of over-treating the area and causing unwanted side effects. SPECTRA – BEFORE AND AFTER PICTURES Tattoo Removal SPECTRA – TATTOO REMOVAL Before 4 Mo. After 3 Tx 4 Mo. After 9 Tx Courtesy of Medermis Clinic, USA SPECTRA – TATTOO REMOVAL Before After 8 Tx Courtesy of Medermis Clinic, USA SPECTRA – TATTOO REMOVAL After Before Courtesy of Medermis Clinic, USA SPECTRA – TATTOO REMOVAL Before After 12 Tx Courtesy of Medermis Clinic, USA SPECTRA – TATTOO REMOVAL BEFORE AFTER 10 Tx Courtesy of Matthew Werner, M.D. (Rancho Mirage, CA) SPECTRA – TATTOO REMOVAL BEFORE AFTER 10 Tx Courtesy of Matthew Werner, M.D. (Rancho Mirage, CA) SPECTRA – TATTOO REMOVAL BEFORE AFTER 7 Tx Courtesy of Matthew Werner, M.D. (Rancho Mirage, CA) SPECTRA – TATTOO REMOVAL BEFORE AFTER 7 Tx Courtesy of Kevin Duplechain, M.D. (Lafayette,LA) SPECTRA – TATTOO REMOVAL BEFORE AFTER 2 Tx Courtesy of Kevin Duplechain, M.D. (Lafayette,LA) SPECTRA – TATTOO REMOVAL BEFORE AFTER 2 Tx Courtesy of Kevin Duplechain, M.D. (Lafayette,LA) SPECTRA – TATTOO REMOVAL BEFORE AFTER 5 Tx Courtesy of Kevin Duplechain, M.D. (Lafayette,LA) SPECTRA – TATTOO REMOVAL BEFORE AFTER 2 Tx Courtesy of Kevin Duplechain, M.D. (Lafayette,LA) SPECTRA – TATTOO REMOVAL BEFORE Post 2 year 4 months Courtesy of Kevin Duplechain, M.D. (Lafayette,LA) Clinical Protocols: Tattoo Removal PATIENT ASSESSMENT AND PRE-TREATMENT • Obtain complete patient history • Manage patient’s expectations • Discuss number of treatments • Discuss contraindications • Discuss complications & possible side effects • Record clinical indications CONTRAINDICATIONS • Allergic response to topical anesthetics, antibiotics, or other medications • Healing disorders such as those caused by diabetes mellitus, connective tissue disease, radiation therapy, HIV ,hepatitis, or chemotherapy • Seizure disorder caused by bright light • Unrealistic expectations regarding the outcome of the treatment • An inability or unwillingness to follow treatment guidelines • Cancerous or premalignant lesions • Active suntan or sunbed exposure: Patients should have avoided UV exposure for at least four weeks prior to treatment • Use of artificial tan or tanning products • History of keloid scarring • Psoriasis or eczema • Active herpes / herpes simplex • Skin infections on or around in the area to be treated PRE-TREATMENT • If possible, use sunblock and/or bleaching cream to lighten the color of the skin for some weeks prior to treatment. This allows for better laser penetration. • Cleanse the face with alcohol or acetone to remove oil and excess sebum from the skin surface and pores. • Remove residue with cotton pads soaked in warm water. • Pat the face dry with a towel or cotton cloth. • If EMLA or equivalent anesthetics are to be used, follow the directions provided by the manufacturer. TREATMENT: PARAMETERS Wavelength (nm) • The wavelengths can be selected by pressing the “wavelength” button. • There are wavelength modes available, 1064, 532 and Spectra. • With the addition of optional solid dye handpieces, 585 nm and 650 nm wavelengths are also available for other tattoo pigments. Mode on GUI Wavelength 1064 1,064 nm 532 532 nm Description Laser radiation at 1064 nm in Q-switched mode. The pulse width is 5-10 ns and the peak power and energy density are higher than that of Spectra Mode for the same duration Green laser radiation at 532 nm in Q-switched mode. The peak power and energy density are high Laser radiation at 1064 nm with a pulse width of 300 µs. The peak power and energy density are thus much lower than that of Q-switched mode for the same duration Spectra 1,064 nm 585 585 nm 585 nm laser radiation is derived from the Q-switched 532 nm source laser which pumps the 585 nm solid dye handpiece 650 650 nm 650 nm laser radiation is derived from the Q-switched 532 nm source laser which pumps the 650 nm solid dye handpiece TREATMENT: PARAMETERS • Fluence (J/cm2) • Fluence represents the incident energy (J) per 1 cm2 . • It is adjustable using the up and down push buttons on the right side. • The range of values varies automatically according to the “Spot Size” and “Wavelength” set on the control panel. • Spot Size (mm) • Spot size represents the spot size of the laser beam at the end of the handpiece. • The value of the fluence displayed on the GUI depends on the width and energy of the pulse and the beam spot size. TREATMENT: PARAMETERS • Pulse Repetition (Hz) • Pulse Repetition represents the number of pulses delivered per second. • It can be adjusted by pressing the up and down buttons. • It can be set at 1, 2, 4, 5 as well as 10 Hz and single shot (S1). • Shot Count • Shot Count represents the total number of laser shots delivered. • The number can be reset to zero by pressing the ‘Reset’ button on the left side of the screen. • Aiming Beam • The brightness of the aiming beam can be adjusted. TREATMENT: PARAMETERS • PERFORM TEST SPOTS • Performing test shots is very important both for safety and to determine the settings for optimum outcomes. • Adjust the fluence for each session according to the patient’s skin reactions or pain. • Check the skin reaction 10 - 15 minutes after the test shot. Allow longer for darker skin types. • Tattoo test spots: • After 1 or 2 test shots on the edge of a tattoo, check for frosting and if the tattoo color has changed. • Caution: Lip tattoo pigments may include iron oxide which can turn black after laser treatment. Permanent make-up can be problematic to treat, so be sure to obtain appropriate consent in case of adverse reactions. Test shots are recommended to observe the skin reaction. TREATMENT: TECHNIQUES TATTOOS • Tattoos are ink particles located in the dermis or subdermal tissues that have been encapsulated as foreign bodies. In their stable state, they are too big to be removed by macrophages, the skin’s natural scavenger cells, and so remain as colored artificial lesions. • Using ultrashort pulse width, high peak power light at various wavelengths, lasers can fracture and explode the ink particles into microscopic pieces that the macrophages can remove, harnessing the natural energy of light and the natural responses of the body to dispose of the fragmented ink particles. TREATMENT: TECHNIQUES TATTOO REMOVAL • The treatment sessions for tattoo removal may vary depending on the types and depth of tattoo pigment particles. • In rare cases, red-colored tattoos may darken after tattoo removal treatment because red tattoos sometimes contain iron oxide. Therefore, test shots should be carried out prior to the treatment. • As the treatment sessions continue, gradually increase the fluence since there will be less and deeper pigment chromophores than in previous sessions. • Do not overdo the treatment in a single session. Routine treatment requires at least 2 sessions minimum. TREATMENT: BEST PRACTICES TREATMENT: TATTOO REMOVAL PARAMETERS 1064 – BLACK, DARK BLUE, BROWN, ALL COLORS INITIALLY TREATMENT: TATTOO REMOVAL PARAMETERS 532 - RED, PURPLE, ORANGE TREATMENT: TATTOO REMOVAL PARAMETERS TREATMENT: TATTOO REMOVAL PARAMETERS TREATMENT: CLINICAL END POINTS TATTOO REMOVAL The endpoint is determined: • Tattoos: tattoo turns white (frosting of the epidermis) and there is an appearance that suggests pinpoint bleeding might occur. Before Treatment Immediately after Treatment Before Treatment Immediately after Treatment POST TREATMENT TATTOO REMOVAL • If desired, apply antibacterial ointment every morning & night until crust peels off. • Apply dressing on the day of treatment. Dressing provides protection against invasion of microorganisms until crust forms. • Avoid contact with water on the day of treatment: shower or washing can be done the following day. • Complete all patient records noting the full treatment details including laser type, wavelength, pulse width, fluence, spot size and where appropriate the number of shots. Patient records should be signed and dated. Schedule follow ups as necessary. • Advise patients to avoid picking at or damaging any crust that may occur and to let the scab fall off naturally to avoid scarring. • If tattoos are treated below the knee or below the elbow, advise elevation for 24- 48 hours. EXPECTED SEQUALAE & ADVERSE EVENTS • EXPECTED SEQUELAE • Tattoo Removal • Immediate frosting of the epidermis over the tattoo • Slight edema and erythema • Mild pinpoint bleeding • Blisters can form EXPECTED SEQUALAE & ADVERSE EVENTS EXPECTED SEQUELAE • Persistent tattoos or pigmentation: Although positive results can be achieved in most cases, some tattoo particles located deep in the dermis may not be totally removed, even with repeated treatments. Some cosmetic tattoo inks contain metallic ink particles that do not respond well to laser treatment while other tattoo inks may change in color. These tattoos cannot normally be treated with a laser, or many repeated treatments may be needed to remove them. EXPECTED SEQUELAE & ADVERSE EVENTS • Transient Hypopigmentation The increased melanin absorption seen with shorter wavelength lasers can increase the risk for hypopigmentation. In most patients the treated area loses pigmentation and becomes lighter in color. This is temporary and may last up to 4 weeks. • Allergic Reaction Local allergic responses to many tattoo pigments have been reported, and allergic reactions to tattoo pigments after Q-switched laser treatment are also possible. Q-switched lasers mobilize the tattoo ink fracturing the particles into the intercellular space possibly generating a systemic allergic response. If an allergic reaction to ink is noted, future Q-switched laser treatment is not advised. EXPECTED SEQUELAE & ADVERSE EVENTS • Hyperpigmentation This is a very rare reaction with Nd:YAG lasers. However, if it does occur, it may last 3 - 6 months. Hyperpigmentation is related to the patient’s skin type, and darker skin is more likely to become hyperpigmented no matter which wavelength is used. The melanocytes of dark-skinned patients tend to respond to stimuli such as lasers. Hence, the pre- and postoperative use of lightening agents such as hydroquinone is important. Treatment with hydroquinones and broad spectrum sunblocks will usually resolve the hyperpigmentation. • Textural Changes Transient textural changes should be noted and monitored but usually resolve within 1 - 2 months and are rarely permanent. If a patient is prone to pigmentary or textural changes, longer treatment intervals are recommended. EXPECTED SEQUELAE & ADVERSE EVENTS ADVERSE EVENTS • Burns and blisters • Infection at the treatment site • As with the use of any laser system, scarring is a possibility, but rare. In the occurrence of adverse events please CONTACT LUTRONIC @ 888-588-7644 FDA 510(k) & CE Clearances CONTACT INFORMATION • Caution is advised when treating patients with any of the listed contraindications. • In the event of adverse events, contact Lutronic immediately. • You may reach any of our departments by calling the main office at: 888-588-7644 Questions? Dyschromia Reduction and Laser Toning REMOVAL OF UNWANTED PIGMENT • Basic mechanisms – Theory of selective photothermolysis – Damage melanosome or melanocyte? • What and where is the pigment? PHYSICS PRINCIPLES • SELECTIVE ABSORPTION – Melanin the target chromophore has a broad spectrum of absorption • TISSUE SCATTER - Larger spot size has deeper effect • WAVELENGTHPENETRATION – Shorter wavelengths have higher absorption and greater scatter so they don’t penetrate as deep as longer wavelengths REMOVAL OF BENIGN PIGMENTED LESIONS • The nanopulse Nd: YAG laser is the gold standard in treating moderate and deep pigment disorders and more recently melasma. – <750 ns pulses disrupt melanosomes through a photoacoustic disruption longer pulse durations (eg, 400 microseconds) do not – This is consistent with the theory of selective photothermolysis, which states that the pulse duration of an emitted laser wavelength must be less than the thermal relaxation time of the targeted object. – A typical 1-µm melanosome has a thermal relaxation time of 0.5-1 μs. • Long-pulse, broad-band approaches such as IPL can be effective – Create sufficient bulk heating to cause sloughing of epidermis which removes the pigment containing keratinocytes – For PIH and melasma bulk heating approaches are not recommended because bulk heating and inflammation can further stimulate melanocytes SPECTRA LOW FLUENCE Q-SWITCHED YAG 1064 ηm* MELASMA TREATMENT 1st pass 1.6 – 1.8 J/cm2 With carbon lotion 2nd 1.0 J/cm2 to mild erythema pass to mild erythema 1.0 J/cm2 without carbon lotion 1-2 week interval A 1st pass with carbon lotion is optional 1.6 – 1.8 J/cm2 Repeat for 7 – 12 treatments *Q-Switch 1064nm 5 ns fixed pulse width setting WHAT IS IMPORTANT WHEN TREATING MELASMA 240 Other 1064 nm Q-S Lasers Lower Peak Power Max. Peak Energy : 240 Mega Watt SPECTRA High Power Short PW QSw 1064 nm 100 50 Longer PW Less melanin breakdown Thermal damage can stimulate melanocytes High recurrence of melasma * Lutronic Illustration Melanin breakdown No Thermal damage to stimulate melanocytes No recurrence after treatment ULTRASTRUCTURAL FINDINGS: 3D RECONSTRUCTION (All images courtesy JY Mun) Dendritic processes Two melanocytes are seen in 3D, reconstructed from the data from 500 x 50 nm slices and computer rendered: color is for illustrative purposes only. Image is of skin from a melasma patient before skin toning Journal of Electron Microscopy, 2011; 60: 11–18 A melanocyte from the same patient after laser toning. The cell is still alive, but appears to have undergone a ‘dendrectomy’ SPECTRA – BEFORE AND AFTER Pigmentation, Melasma, PIH and Vascular SPECTRA – SKIN REJUVENATION & PIGMENT Before After 13 Tx Courtesy of Melanie D. Palm, M.D. (Solana Beach, CA) SPECTRA - PIGMENT BEFORE Courtesy of I.H. Kim, M.D. (Korea) AFTER 8 Tx SPECTRA - PIGMENT BEFORE Courtesy of I.H. Kim, M.D. (Korea) AFTER 8 Tx SPECTRA - PIGMENT BEFORE Courtesy of I.H. Kim, M.D. (Korea) AFTER 8 Tx SPECTRA – MELASMA & PIGMENT Courtesy of Kevin Duplechain, M.D. (Bethlehem, PA) SPECTRA – MELASMA & PIGMENT Before Courtesy of Melanie D. Palm, M.D. (Solana Beach, CA) After 8 Tx SPECTRA – MELASMA AND PIGMENT Before After 10 Tx Courtesy of John Shieh, M.D. (South Pasadena, CA) SPECTRA - MELASMA Before After 12 Tx Courtesy of Melanie D. Palm, M.D. (Solana Beach, CA) SPECTRA - MELASMA Before After 6 Tx Courtesy of Melanie D. Palm, M.D. (Solana Beach, CA) SPECTRA - MELASMA Before After 13 Tx Courtesy of Melanie D. Palm, M.D. (Solana Beach, CA) SPECTRA - MELASMA Before After 12 Tx Courtesy of John Shieh, M.D. (South Pasadena, CA) SPECTRA – MELASMA, SPLIT FACE Treated Untreated BEFORE Courtesy of I.H. Kim, M.D. (Korea) Treated Untreated AFTER 7 Tx SPECTRA - MELASMA BEFORE Courtesy of B. S. Chandrashekar, M.D. (India) AFTER 10 Tx SPECTRA - PIH BEFORE AFTER 12 Tx Courtesy of W. S. Kim, M.D. (Korea) SPECTRA - LENTIGO BEFORE AFTER Courtesy of Matthew Werner, MD, USA SPECTRA – EPIDERMAL NEVUS BEFORE AFTER 8 Tx Courtesy of B. S. Chandrashekar, M.D. (India) Clinical Protocols: Dyschromia Reduction and Laser Toning PATIENT ASSESSMENT AND PRE-TREATMENT • Obtain complete patient history • Manage patient’s expectations • Discuss number of treatments • Discuss contraindications • Discuss complications & possible side effects • Record clinical indications CONTRAINDICATIONS • Allergic response to topical anesthetics, antibiotics, or other medications • Healing disorders such as those caused by diabetes mellitus, connective tissue disease, radiation therapy, HIV ,hepatitis, or chemotherapy • Seizure disorder caused by bright light • Unrealistic expectations regarding the outcome of the treatment • An inability or unwillingness to follow treatment guidelines • Cancerous or premalignant lesions • Active suntan or sunbed exposure: Patients should have avoided UV exposure for at least four weeks prior to treatment • Use of artificial tan or tanning products • History of keloid scarring • Psoriasis or eczema • Active herpes / herpes simplex • Skin infections on or around in the area to be treated PRE-TREATMENT • If possible, use sunblock and/or bleaching cream to lighten the color of the skin for some weeks prior to treatment. This allows for better laser penetration. • Cleanse the face with alcohol or acetone to remove oil and excess sebum from the skin surface and pores. • Remove residue with cotton pads soaked in warm water. • Pat the face dry with a towel or cotton cloth. • If EMLA or equivalent anesthetics are to be used, follow the directions provided by the manufacturer. TREATMENT: PARAMETERS Wavelength (nm) • The wavelengths can be selected by pressing the “wavelength” button. • There are wavelength modes available, 1064, 532 and Spectra. • With the addition of optional solid dye handpieces, 585 nm and 650 nm wavelengths are also available for other tattoo pigments. Mode on GUI Wavelength 1064 1,064 nm 532 532 nm Description Laser radiation at 1064 nm in Q-switched mode. The pulse width is 5-10 ns and the peak power and energy density are higher than that of Spectra Mode for the same duration Green laser radiation at 532 nm in Q-switched mode. The peak power and energy density are high Laser radiation at 1064 nm with a pulse width of 300 µs. The peak power and energy density are thus much lower than that of Q-switched mode for the same duration Spectra 1,064 nm 585 585 nm 585 nm laser radiation is derived from the Q-switched 532 nm source laser which pumps the 585 nm solid dye handpiece 650 650 nm 650 nm laser radiation is derived from the Q-switched 532 nm source laser which pumps the 650 nm solid dye handpiece TREATMENT: PARAMETERS • Fluence (J/cm2) • Fluence represents the incident energy (J) per 1 cm2 . • It is adjustable using the up and down push buttons on the right side. • The range of values varies automatically according to the “Spot Size” and “Wavelength” set on the control panel. • Spot Size (mm) • Spot size represents the spot size of the laser beam at the end of the handpiece. • The value of the fluence displayed on the GUI depends on the width and energy of the pulse and the beam spot size. TREATMENT: PARAMETERS • Pulse Repetition (Hz) • Pulse Repetition represents the number of pulses delivered per second. • It can be adjusted by pressing the up and down buttons. • It can be set at 1, 2, 4, 5 as well as 10 Hz and single shot (S1). • Shot Count • Shot Count represents the total number of laser shots delivered. • The number can be reset to zero by pressing the ‘Reset’ button on the left side of the screen. • Aiming Beam • The brightness of the aiming beam can be adjusted. TREATMENT: DERMATOLOGIC PARAMETERS TREATMENT: BEST PRACTICES TREATMENT: TECHNIQUES LASER TONING • • • • Treat with under 50% spot overlap and 2-3 passes until mild erythema appears. Over 80-90% overlapping might cause side effects such as PIH. During treatment around the eye and over the cheek bone, decrease the number of passes and watch the skin reaction. These areas are sensitive with very thin skin and redness can easily occur. Keep the end of the handpiece within 3 cm from the skin during the treatment. Using a bright light, make a final check for untreated areas. Mild erythema Before treatment Immediately after treatment TREATMENT: TECHNIQUES LASER TONING is a treatment method using the Q-switched 1064 nm wavelength without spectra lotion. Laser Toning not only treats melasma but also yields additional benefits in terms of improved skin tone and texture, with minimal risk of adverse effects and virtually no downtime. Low-fluence Q-switched 1064 nm Nd:YAG Source: Medical & Scientific Affairs, Lutronic Corporation POST TREATMENT LASER TONING • Thoroughly clean the skin surface using a neutral cleansing lotion and cotton pads dipped in cool water. This will help reduce erythema. • Complete patient records, recording full treatment details including: laser type, wavelength, pulse width, fluence, spot size and, where appropriate, the number of shots. Patient records should be signed and dated. Schedule follow-ups as necessary. • Advise patients that sunscreen with a Sun Protection Factor (SPF) of at least 30 should be applied one hour before going outdoors for at least two weeks after treatment. • Advise patients not to use any harsh products such as glycolic acid, retinol or alcohol based toner for at least 48 hrs after treatment. TREATMENT: CLINICAL END POINTS PIGMENTED LESIONS & TATTOO REMOVAL The endpoint is determined: • Pigmented Lesions: pigment darkens, frosting of the epidermis occurs, or the skin appears slightly erythematous POST TREATMENT PIGMENTATION • If desired, apply antibacterial ointment every morning & night until crust peels off. • Apply dressing on the day of treatment. Dressing provides protection against invasion of microorganisms until crust forms. • Avoid contact with water on the day of treatment: shower or washing can be done the following day. • Complete all patient records noting the full treatment details including laser type, wavelength, pulse width, fluence, spot size and where appropriate the number of shots. Patient records should be signed and dated. Schedule follow ups as necessary. • Advise patients to avoid picking at or damaging any crust that may occur and to let the scab fall off naturally to avoid scarring. EXPECTED SEQUALAE & ADVERSE EVENTS • EXPECTED SEQUELAE • Laser Toning • Mild erythema • Pigmented Lesion Treatment, Soft Peel, 532 Peel • Slight darkening of pigment • Slight edema • Frosting of epidermis over the lesion EXPECTED SEQUALAE & ADVERSE EVENTS EXPECTED SEQUELAE • Persistent tattoos or pigmentation: Although positive results can be achieved in most cases, some tattoo particles located deep in the dermis may not be totally removed, even with repeated treatments. Some cosmetic tattoo inks contain metallic ink particles that do not respond well to laser treatment while other tattoo inks may change in color. These tattoos cannot normally be treated with a laser, or many repeated treatments may be needed to remove them. • Some pigmented lesions, such as melasma, may also return after treatment. Repeated treatments may or may not result in further improvement. EXPECTED SEQUELAE & ADVERSE EVENTS • Transient Hypopigmentation The increased melanin absorption seen with shorter wavelength lasers can increase the risk for hypopigmentation. In most patients the treated area loses pigmentation and becomes lighter in color. This is temporary and may last up to 4 weeks. • Allergic Reaction Local allergic responses to many tattoo pigments have been reported, and allergic reactions to tattoo pigments after Q-switched laser treatment are also possible. Q-switched lasers mobilize the tattoo ink fracturing the particles into the intercellular space possibly generating a systemic allergic response. If an allergic reaction to ink is noted, future Q-switched laser treatment is not advised. EXPECTED SEQUELAE & ADVERSE EVENTS ADVERSE EVENTS • Burns and blisters • Infection at the treatment site • As with the use of any laser system, scarring is a possibility, but rare. In the occurrence of adverse events please CONTACT LUTRONIC @ 888-588-7644 FDA 510(k) & CE Clearances Hollywood Laser Peel aka Spectra Peel NOT TO BE CONFUSED WITH SPECTRA 532 LASER PEEL! DUAL PULSE MODES COMBINATION THERAPY ENABLED Q-Switched Mode 5-10 nsec – short pulse 5nsec Shorter pulse width → High peak power • Break down & removechromophore • Tattoo Removal • Melasma • Laser Peel Explosion of Particle 300μsec SPECTRA Mode 300 µsec – quasi-long pulse Longer pulse width → Thermal effect • Skin Rejuvenation Thermal Diffusion from Particle Source : LutronicIllustration COMBINATION THERAPY: SPECTRA PEEL Carbon Lotion seeps into pores Carbon Lotion is gently heated * Lutronic has a Method Patent to target pigmented lotions Carbon Particles explodes PATENTED SPECTRA PEEL TREATMENT IMMEDIATE AND LONG TERM EFFECTS Changes within 1st and 2nd Tx • • • • • Dyschromia is Improved Clearer, Younger Looking Skin Exfolliates the Stratum Corneum Stimulates Collagen Regeneration Reduces Sebum Production Changes after the 3rd Treatment • • • • • • Gentle Heating Removing the Carbon Softens Skin Tone Improves Skin Texture Continues to Regenerate Collagen Reduces Inflamed Acne and Improves Acne Scar s Reduces Pore Size Improves Fine Lines and Wrinkles Source: Dr. Melanie Palm, MD, MBA SPECTRA – BEFORE AND AFTER Skin Rejuvenation & Other CLINICAL PHOTOS Large Pores* Before Courtesy of T. Fujimoto, MD, Japan *Note: No FDA clearance for large pores 1 Month After tx CLINICAL PHOTO – ACNE & POSTACNE REDNESS For Internal Use Only Before Courtesy of J.H. Kim, Dermatologist, South Korea After CLINICAL PHOTO – ACNE & POSTACNE REDNESS For Internal Use Only Before Courtesy of J.H. Kim, Dermatologist, South Korea After SPECTRA – ACNE SCARS & SKIN REJUVENATION BEFORE AFTER 4 Tx Courtesy of Lori Robertson MSN, FNP (Rancho Cucamonga , CA ) SPECTRA – ACNE SCARS & SKIN REJUVENATION BEFORE AFTER 10 Tx Courtesy of Lori Robertson MSN, FNP (Rancho Cucamonga , CA ) SPECTRA - ROSACEA BEFORE Courtesy of Lori Robertson MSN, FNP (Rancho Cucamonga, CA ) AFTER KEY POINTS SPECTRA: Key Points • Superior tattoo removal • Spectra Mode : for active acne* and better skin rejuvenation • Melasma: Only laser with FDA Clearance • Unique Patented Procedure: Spectra PeelTM • Beam quality stability at 1064 & 532 nm, especially at lower fluence at 532 nm: minimize or less PIH!! • Many Peer reviewed papers and KOL endorsement * No FDA clearance for active acne / inflammatory acne Questions?