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FDA Clearance

510(k) K053628, 7 April 2006

Skin Types

Fitzpatrick I-VI, including tanned skin

Primary Procedures

Hair removal, permanent hair reduction

Secondary Procedures

Treatment of benign vascular lesions, leg veins
Treatment of pseudofolliculitis barbae (PFB)
Treatment of benign pigmented lesions

LightSheer Duet: Intended Use

510(k)

(Part Number: PB-1076090_A)

Содержание LightSheer Duet

Страница 1: ...Clinical In Service Training UPDATE v 24 March 2010 PB 1076090_A High Speed...

Страница 2: ...Clinical In Service Training Laser Safety Laser Tissue Interaction Laser Operations Platform Handpieces Clinical Protocols LHR PFB Lumenis You A Partnership for Success Questions Agenda 2...

Страница 3: ...Laser Safety...

Страница 4: ...viewed directly for extended period of time i e checkout scanners Class IIIa Generally pose low hazard risk i e laser pointers Class IIIb Can produce hazard if viewed directly i e low wattage eye lase...

Страница 5: ...ser Safety Officer LSO appointed Administrative Controls Documentation training programs etc Procedural Controls Policies Safety Glasses Signs etc Engineering Controls by Mfg Interlocks standby emissi...

Страница 6: ...ntation Facility LSO is responsible for Laser Log to include not limited to System and Equipment Audits Laser Maintenance Records Safety Audits Education Initial and On going Competency Skills Check L...

Страница 7: ...l area boundary where someone could be injured by the laser beam ANSI Laser Standards state that the entire room is the NHZ NHZ depends on factors such as Wavelength Power Spot Size and Divergence Ang...

Страница 8: ...m If patient s face is treated they must wear opaque or metal eye goggles or shields Laser beam can cause severe retinal injury Do not treat within bony orbit of eye Do not treat eyebrows or eyelashes...

Страница 9: ...Protective Eyewear Required Operator Glasses OD 5 for 800 nm wavelength Patient Goggles or Shields Opaque or metal Laser Safety 9...

Страница 10: ...When new handpiece is attached After 25 000 pulses in one power on session Calibration is recommended prior to the start of each treatment Verify port is clean and handpiece is properly seated prior t...

Страница 11: ...and reinsert into the calibration port Verify hp is perpendicular to port and not seated at an angle improves accuracy avoids damage Touch screen prompts follow each step Press enable button on handp...

Страница 12: ...re any treatments To ensure proper function of vacuum assist technology Vacuum Purge is also recommended as needed between treatments To clear system and prevent build up of debris Laser Safety Upgrad...

Страница 13: ...Select Utility on Main Screen System Operating Tools on Utility Menu Vacuum Purge on System Tools Screen Follow on screen instructions until purge is complete Vacuum Purge Instructions Laser Safety 13...

Страница 14: ...or glasses 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...

Страница 15: ...ical Health CDRH Class 4 laser by European Standard EN 60825 1 Follow ANSI OSHA European standards Contact Laser Institute of America LIA 800 34LASER for current ANSI and OSHA standards http www laser...

Страница 16: ...Laser Tissue Interaction...

Страница 17: ...owth Catagen transition regression Telogen resting Growth cycle Depends on body part Lasts anywhere from 4 to 12 months Hair reduction is considered permanent when a significant amount of hair does no...

Страница 18: ...lysis The target chromophore is melanin Present in the hair shaft Also present in the upper third of the follicular epithelium Heat generated in the hair shaft diffuses to the follicular epithelium to...

Страница 19: ...A normal follicle A damaged follicle Laser Tissue Interaction Goal is to Damage Hair to Kill Point 19...

Страница 20: ...to cause follicular damage while sparing surrounding tissue Depends on melanin content in skin vs surrounding tissue Note maximum tolerated fluence is generally inversely proportional to melanin conte...

Страница 21: ...Laser Operation LightSheer Duet Platform...

Страница 22: ...Main Screen with Two Options LS ET LS HS 22...

Страница 23: ...area 10 100 J cm2 5 400 msec pulse widths ChillTip cooling Full LS ET functionality Field replaceable LightSheer ET 22 X 35 mm treatment area Up to 12 J cm2 30 400 msec pulse widths Vacuum Assist tech...

Страница 24: ...LightSheer ET LightSheer HS User Friendly Interface ET Treatment Screen HS Treatment Screen LS ET LS HS 24...

Страница 25: ...Laser Operation LightSheer ET Handpiece...

Страница 26: ...How to Operate the Handpiece Press enable button Depress pulse trigger to begin treatment Position tip on patient s skin apply light pressure LightSheer ET 26...

Страница 27: ...Cooling with ChillTip reduces temperature Compression Reduces competing chromophore oxyhemoglobin Blanches vessels eliminates energy lost into this target Rotates follicle closer to surface so laser...

Страница 28: ...Clinical Indications Starting Presets Lumenis Presets User Presets LightSheer ET 28...

Страница 29: ...Clinical Indications Saving Presets LightSheer ET User pre sets Save user pre set Sample of Saved User Preset 29...

Страница 30: ...ameters GUI Settings LightSheer ET Select Rate Hz OptiPulse ms Fluence J cm2 Reset Pulse Counter Verify ChillTip Blue is ON Verify in Ready Mode NOTE CHILLTIP MUST REMAIN ON DURING LASER HAIR REMOVAL...

Страница 31: ...ate is 3 Hz Fluence J cm2 AUTO 30 ms and 100 ms will allow up to 60 J cm 400 ms pulse duration will allow up to 100 J cm The highest tolerable fluence will provide the greatest efficacy Higher fluence...

Страница 32: ...dense hair Treatment Parameters What to Select LightSheer ET Tip Counter Counts total pulses on handpiece and per treatment During treatment the system operator must visually check tip every 50 100 pu...

Страница 33: ...or to treatment Apply gel if desired Avoid contact between laser tip and any areas of blood from shaving Press enable button Position tip on patient s skin apply moderate pressure Depress pulse trigge...

Страница 34: ...e next treatment area and lowered against the skin Bounce Glide Technique Place on skin hold trigger in ON position the tip is kept continuously in contact with the skin and bounced along skin tissue...

Страница 35: ...Singed hair can collect on tip causing excessive heating Can occur after several pulses or up to one full run depending on the amount of hair extrusion Visually check the tip for any debris every 50...

Страница 36: ...ned with distilled water or a mild alcohol solution Caution While operating the LightSheer system never look directly into the laser aperture at the distal end of the handpiece even if you are wearing...

Страница 37: ...Laser Operation LightSheer HS High Speed Handpiece...

Страница 38: ...Assist technology Enhances light absorption Improves treatment comfort LightSheer HS Disposable tip insert protects VA technology Replace disposable insert between patients Also replace during treatme...

Страница 39: ...ment Press ENABLE button Position HS opening on patient s skin Obtain vacuum contact Press and hold trigger for desired pulses Move to next treatment spot Note A fine mist of mineral spring water may...

Страница 40: ...air is pulled closer to energy source Density of melanocytes in skin is reduced Less energy will be absorbed by the epidermis Vacuum pressure temporarily compresses tissue and surrounding vessels Bloo...

Страница 41: ...Clinical Indications Starting Presets Lumenis Presets User Presets LightSheer HS 41...

Страница 42: ...Clinical Indications Saving Presets LightSheer HS User pre sets Save user pre set Sample of Saved User Preset 42...

Страница 43: ...Treatment Parameters GUI Settings Select No of Pulses Vacuum OptiPulse ms Fluence J cm2 Verify Vacuum Green is ON Verify in Ready Mode Reset Pulse Counter LightSheer HS 43...

Страница 44: ...lses will emit additional energies and should only be increased with caution If desired clinical endpoints are not reached using single pulse at max fluence move to pulse stacking and repeat test spot...

Страница 45: ...Pulse Duration Fluence max 6 J Custom Most common setting automatic PD selection 30 70 ms based on fluence level selected Actual will be indicated at column bottom 100 ms Darker skin types and tans 40...

Страница 46: ...ect LightSheer HS Tip Counter Counts total pulses on handpiece and per treatment During treatment the system operator must visually check insert frequently e g every 5 10 pulses and keep clean at all...

Страница 47: ...rface clean skin Press ENABLE button Position handpiece on patient s skin Depress pulse trigger to begin treatment Perform test spot Observe laser tissue interaction Wait and observe tissue response S...

Страница 48: ...Handpiece Coverage How to Move LightSheer HS 48...

Страница 49: ...ll times during treatment Whenever you see any contamination on the window surface using lint free gauze pad moistened with alcohol clean the HS handpiece window and then clean with dry gauze pad Freq...

Страница 50: ...Laser Operation HS Handpiece Disposable Insert Care Guidelines...

Страница 51: ...per treatment Released in March 2010 available NOW FORMER disposable insert with all plastic design No longer sold replaced with NEW insert above NEW Disposable Insert with glass window available FORM...

Страница 52: ...could lead to absorption of light and overheating and or burning of the disposable insert HS Handpiece Disposable Insert Care Caution FORMER Disposable w all plastic NEW Disposable w glass window Sam...

Страница 53: ...Duet with a damaged disposable insert can damage your HS handpiece and compromise treatment quality Damaged sample of former disposable w all plastic no longer sold obsolete HS Handpiece Disposable I...

Страница 54: ...ughly shave and clean the treatment area to remove any pieces of hair or other debris While the system is OFF inspect the handpiece The diode window should be clean and free of debris HS Handpiece Dio...

Страница 55: ...after firing the laser DO NOT TOUCH the backside that faces diode window insert bottom backside will get very HOT after firing the laser Clean the diode window with lint free gauze moistened with alc...

Страница 56: ...t with a gloved hand note use powder less gloves Avoid creating fingerprints or having debris contaminate the insert How to Insert Note Disposable tip in photo same as disposable insert HS Handpiece D...

Страница 57: ...uze does not clean the insert clean with alcohol moistened gauze If any discoloration or debris is observed on the disposable insert clean with alcohol and then wipe with dry gauze HS Handpiece Dispos...

Страница 58: ...ssary If the disposable insert cannot be completely cleaned with alcohol discard and insert a new one Caution when removing the disposable insert with glass window after firing the laser use outer edg...

Страница 59: ...mediately Caution when removing the disposable insert with glass window after firing the laser use outer edge lip DO NOT TOUCH the backside that faces diode window as this will get very HOT after firi...

Страница 60: ...AN C Burned Insert REPLACE D Burned Insert REPLACE disposable all plastic former obsolete Note C D above are damaged samples of no longer sold and replaced with new disposable insert w glass window HS...

Страница 61: ...A Diode Window is CLEAN Ready to Use B Diode Window is DIRTY Clean prior to Use C Clean Diode Window with alcohol moistened cotton HS Handpiece Diode Window Care Overview 61...

Страница 62: ...IF Diode Window Can NOT Be Cleaned DO NOT USE CALL Customer Service In the US 1 877 LUMENIS Outside the US contact your local service representative HS Handpiece Diode Window Care Contact Service 62...

Страница 63: ...fter firing the laser use outer edge lip DO NOT TOUCH the backside that faces diode window as this will get very HOT after firing the laser Apply a new and clean insert into headpiece and place in sys...

Страница 64: ...Clinical Protocols Laser Hair Removal...

Страница 65: ...define permanent hair reduction Describe need for multiple treatments Multiple treatments are required e g avg 5 7 For darker skin types IV VI more treatments may be needed e g can be as many as 12 D...

Страница 66: ...en wipe skin w alcohol solution to remove tackiness Perform test spot wait 15 30 minutes for skin types I IV allow AT LEAST 48 hours for skin types V VI to observe skin response before conducting trea...

Страница 67: ...plete patient history Manage patient s expectations Discuss number of treatments Discuss contraindications Discuss complications possible side effects Record clinical indications Skin type Hair color...

Страница 68: ...ed treatment parameters e g presets Use added caution with darker skin types Avoid treating patients with recent or lengthy exposure to sun or artificial UV light DO NOT TREAT patients with artificial...

Страница 69: ...eyes Usually burns tans with difficulty III Cream white fair with any eye or hair color very common Sometimes mild burn gradually tans IV Brown typical Mediterranean Caucasian skin Rarely burns tans...

Страница 70: ...V Brown typical Mediterranean Caucasian skin moderately pigmented and may include Asian Middle Eastern Indian Hispanic Rarely burns tans with ease tan stays for months V Darker Brown Middle Eastern sk...

Страница 71: ...erience temporary loss for up to 3 months Recommend electrolysis as a treatment for permanent removal of discrete white hair Terminal hair not vellous short fine light colored hairs Lumenis does not r...

Страница 72: ...pper Lip 16 Weeks 6 Weeks Eyebrows 4 8 Weeks 3 Months Ear 4 8 Weeks 3 Months Legs 24 Weeks 16 Weeks Arms 18 Weeks 13 Weeks Axilla 4 Months 3 Months Pubic 3 Months 4 Months Richards Meharg Table Note O...

Страница 73: ...ns History of livedo reticularis an autoimmune vascular disease Hypersensitivity at the treatment site to any agents solutions or gel used in the treatment if no alternative exists Use of anticoagulan...

Страница 74: ...ssion disorders Tattoos at the treatment sites stay more than inch away from tattoo border Significant concurrent skin conditions affecting areas to be treated or any inflammatory skin conditions Acti...

Страница 75: ...e waxing plucking tweezing or electrolysis in the treatment area within the preceding 6 weeks Chronic or cutaneous viral fungal or bacterial infections in the treatment area Photosensitivity disorder...

Страница 76: ...es in a few months fluence and skin type dependent Irritation itching burning sensation or discomfort during or following treatment may occur Superficial erosions of the treated area may be visible af...

Страница 77: ...sure to moderately intense heat of infrared radiation Pruritis may occur in rare cases Contact dermatitis or irritant dermatitis may occur in some cases Infection at the treatment site Mild to moderat...

Страница 78: ...any of the listed contraindications In the event of adverse outcomes CONTACT LUMENIS In the US 1 877 LUMENIS 586 3647 Outside the US contact your local Customer Support Sales and Service representativ...

Страница 79: ...ted or vaporized Singed hair on skin or in disposable tip HS only Gel becomes brownish from singed hairs ET only Odor of singed hair present Perifollicular edema and erythema May be Mild HS hp to Mode...

Страница 80: ...Positive Clinical End Points Perifollicular erythema Initial redness from ChillTip and pressure Erythema around treated hair increases after a few minutes LS ET Results 80...

Страница 81: ...Perifollicular edema Swelling around the follicle bumps several minutes after treatment Positive Clinical End Points LS ET Results 81...

Страница 82: ...hromophores is minimized Therefore LightSheer HS tissue response i e edema and erythema may be mild in comparison to the patient s previous experience Proactively counsel patients to expect milder res...

Страница 83: ...LightSheer ET hp 34 38j cm2 auto 30ms LightSheer HS hp 8 11 j cm2 custom Immediate Reaction Courtesy of Girish Munavalli MD MHS FAAD L R Comparison of Clinical Endpoints LS HS LS ET 83...

Страница 84: ...action throughout treatment adjust if and as needed Since no two patients are exactly alike do not rely solely on written parameters Clinical end points that indicate fluence and or pulse width must b...

Страница 85: ...ses soothing cream or gel i e aloe vera Crusty spots may occur Clean area 2 x daily with mild soap Sunscreen for 6 weeks on treatment area May experience singed hair and shedding process in days follo...

Страница 86: ...The Treatment of Pseudofolliculitis Barbae...

Страница 87: ...FB Commonly referred to as razor bumps Medical term for persistent irritation due to shaving Problematic for men of African descent others with curly hair Inflammatory foreign body response to a sharp...

Страница 88: ...Photos courtesy of Fran E Cook Bolden MD Before Treatment After Treatment LightSheer Treatment of PFB LightSheer ET Results Shown Skin Types IV VI 88...

Страница 89: ...Lumenis You A Partnership for Success...

Страница 90: ...ced training with preceptors workshops and Webinars Lumenis is Committed to Your Practice Success Lumenis Physician Portal for information and practice building tools with easy access http aestheticpo...

Страница 91: ...aining Discussions Physician Portal Customers go to http aestheticportal lumenis com Register Create a New Account Download practice marketing tools access training Join discussion forums of interest...

Страница 92: ...Consumer Site www skinandhealth com raises consumer awareness Lumenis customers register for free referral service Doctor Finder helps patients Find a Practitioner Help Patients Find Your Practice 92...

Страница 93: ...Any Questions Contact Us 93...

Страница 94: ...anned skin Primary Procedures Hair removal permanent hair reduction Secondary Procedures Treatment of benign vascular lesions leg veins Treatment of pseudofolliculitis barbae PFB Treatment of benign p...

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