Treatment Guidelines For customers outside of the USA Cutera Inc. World Headquarters 3240 Bayshore Boulevard, Brisbane, CA 94005 USA Tel: +1 415 657 5500 Fax: +1 415 330 2444 www.cutera.com The following treatment parameters were created for the GenesisPlus unit ONLY and are not to be used for the Nd:YAG on the Xeo, CoolGlide or ExcelV systems. April 2013 D1074 Rev. G p. 1
The Cutera GenesisPlus is an Nd:YAG (1064 nm) laser with a patented pulse structure designed for safe and effective treatment on all skin types and tanned skin. It can be safely used on all body parts (excluding the eye and surrounding area). Common indications include: Clearance of nail with Onychomycosis / Nail Fungus Warts Scar reduction: including reduction in hypertrophic and keloid scars Improvement in texture Reduction in pore size Wrinkle reduction Rosacea / Diffuse Redness Poikiloderma of Civatte Morton s Neuromas PREREQUISITE The GenesisPlus device should only be operated by qualified practitioners who have received appropriate training and have thoroughly read the GenesisPlus Operator Manual (shipped with laser) and reviewed the GenesisPlus Training Presentation (found on Cutera VIP website) prior to operating the laser. PATIENT ASSESSMENT This is a medical device. It is important to obtain a complete medical history and signed informed consent. Consult the Operator Manual for additional information, including expected transient events and possible adverse events. Determine ethnicity and skin type by using the attached Fitzpatrick Skin Type scale Contraindications: Pregnancy and patients undergoing treatment for skin cancer Patient Considerations including but not limited to are below: Current Medications (both routine and occasional use) o Accutane do not treat if taken in the last 6 months o Gold Therapy may cause blue-gray discoloration o Anticoagulants may increase risk of purpura or bruising Vitiligo may cause de-pigmentation Herpes pre-treatment with an antiviral may be indicated Open wounds Diabetes may impede wound healing Neuropathies decreased sensation or numbness o Treatment area should be evaluated for numbness or decreased sensation History of keloid or hypertrophic scarring Tan skin and darker skin types have an increased risk of complications and/or pigmentary issues. Parameters may need to be adjusted to help prevent adverse events. No self-tanners, spray tans, etc. for at least 2-4 weeks prior to treatment Do not treat questionable skin lesions. These should be evaluated by a specialist prior to treatment. o Online Melanoma resources include (www.aad.org), (www.cancer.org) April 2013 D1074 Rev. G p. 2
TEMPERATURE MONITORING GenesisPlus features a temperature sensor which monitors average temperature over a larger treatment area when handpiece is approximately 4cm from the tissue The temperature in Celsius will be displayed on the screen with the colored lights on the handpiece corresponding to that temperature Can be used as an indicator of bulk heating o Bulk heating is usually achieved at 39-46 o C (Yellow LEDs) LED Color Green Green Green Yellow Yellow Red Temp Range 26-30 o C 31-34 o C 35-38 o C 39-42 o C 43-46 o C 47-50 o C POSITIONING THE HANDPIECE When performing rejuvenation, scar or Onychomycosis treatments, position the handpiece approximately 4cm above the treatment area maintaining that distance during the entire treatment Ensure that the smaller working distance beam is centered in the larger aiming beam The temperature sensor will not be visible Visible aiming beam Invisible Temperature sensor Visible working distance beam GOGGLES Safety eyewear must be worn by ALL people in the treatment room. o Check the wavelength and optical density (>=6.1 @ 1064nm) marked on all operator goggles o Patients can opt to wear Operator Goggles during off the face treatments Operator Goggles Patient Goggles SELECTING PARAMETERS The recommended parameters are provided as a guide and are based on practitioner feedback. Fluence is the energy measured in J/cm2 o Fluence may need to be lowered for areas with increased target Pulse Duration or Pulse Width is the length of each laser pulse measured in milliseconds (ms) o Shorten pulse duration for more aggressive treatments o Lengthen pulse duration for more conservative treatments Repetition Rate is the number of pulses per second measured in Hz o Repetition rate may need to be lowered for increased patient comfort April 2013 D1074 Rev. G p. 3
ONYCHOMYCOSIS / NAIL FUNGUS PERFORMING THE PROCEDURE Avoiding Complications Anesthetics or nerve blocks are not recommended as patient feedback is required Patients with neuropathy may not be able to provide feedback o Increased risk of adverse events Do not treat over or close to tattoos Implants o Reaction to metal implants is unknown o Pacemaker - stay at least 6 inches away from implant Prepping the Patient Remove nail polish and clean toes/fingers Remove or cover any jewelry (including toe rings) Clean all nails thoroughly Shave the treatment area if there is excessive hair Topical anesthetic should not be used as patient feedback is required If nail is thicker than 2mm, the nail may be debrided o Smoke evacuator & laser plume mask filtered to 0.1 microns are recommended when debriding Nail may be notched with a file to assess growth of clear nail Pre-treatment photographs should be taken prior to the initial treatment for future reference Safety eyewear must be worn by ALL people in the treatment room Recommend that laser operator follow Universal Precautions (gloves, masks, etc.) Smoke Evacuator and/or laser plume masks filtered to 0.1 microns are optional during laser treatment Selecting Treatment Parameters Start with slow repetition rate for patient comfort and adjust to patient tolerance Spot Size Skin Type 5mm Fluence Pulse Duration Repetition Rate # Treatments I-IV 14-18 J/cm2 0.3 ms 2 3 Hz 1-5 V-VI 12-16 J/cm2 0.3 ms 2 3 Hz 1-5 100+ pulses per toe using multiple passes 600+ pulses using multiple passes May need additional pulses for severely infected or larger nails. Target Minimum Total Pulses Hallux/Thumb Toes/Fingers 400+ pulses using multiple passes Toes 1,000+ per foot 600+ 100+ per toe Fingers 1,200+ per hand 400+ 200+ per finger 200+ pulses per finger using multiple passes April 2013 D1074 Rev. G p. 4
Performing the Treatment Gel is not used Nerve blocks are not recommended as patient feedback is required Treat the entire nail bed, matrix and lateral folds, extending approximately 2mm Matrix or past the nail Proximal nail fold Hold the handpiece perpendicular to the nail s surface o Ensure the distance beam is centered in the aiming beam (approximately 3-4 cm from target) Treatment Technique: o Pulses should be adjacent Adjacent pulses should be of the larger aiming beam, NOT the smaller distance beam o Do not stack pulses (one pulse directly on top of another with no cooling time) or overlap pulses o Alternate between vertical and horizontal passes with each pass o Movement should be controlled and Repetition Rate adjusted according to the Incorrect Technique patient s tolerance Treatment Steps: o Start treatment on the hallux (big toe) or thumb moving onto adjacent toes/fingers o Use multiple passes until the recommended number of pulses has been delivered o Repeat either sequence until the recommended number of pulses have been delivered Correct Technique Treat each toe/finger to point of discomfort, then move to the adjacent toe/finger OR Treat hallux/thumb with 50-75 pulses at a time then move to smaller toes/fingers with 25 pulses per digit at a time. o The number of passes may change from patient to patient depending on patient tolerance Distance Laser Beam o It should be noted that the pain tolerance lowers with each pass Beam (treatment area) o Pause treatment for 5-10 seconds in between passes for patient comfort o White flashes or sparks can occur during treatment It is recommended that all 10 toes/fingers be treated Endpoint for treatment is number of pulses o Though the goal temperature is NOT the endpoint, it can help indicate if enough heat is being delivered to the tissue. Post Operative Care To help prevent re-infection: o Wear clean shoes/socks home after treatment o Wash sheets, disinfect shower/bath and vacuum carpets day of treatment o Apply anti-fungal cream 2X per day for approximately 2 weeks to 3+ months depending severity of the infection o Apply anti-fungal powder to all shoes at least 1x per week for at least 1+ month o Keep nails trimmed and cleaned (disinfecting instruments after each use) o Do not walk barefoot in public places (pool, gym, etc.) Nail polish may be applied 24 hours after treatment Number of treatments will depend on severity of the Onychomycosis / Toenail Fungus o The average time interval between treatments is 4-6 weeks Due to slow nail growth, results may not be noticeable for 3+ months o Toenails may take 9-12+ months and fingernails may take 6-9+ months to grow out Severely infected nails may take longer If a blister develops, treat as a wound Cold gel packs or cool compresses may be applied post-treatment on hot spots April 2013 D1074 Rev. G p. 5
MORTON S NEUROMA PERFORMING THE PROCEDURE Treatment Description GenesisPlus can be used to relieve the symptoms of Morton s Neuromas, a painful and often chronic condition with limited options for pain management. Avoiding Complications Topical anesthetics or local anesthetics should not be used as patient feedback is required Patients with neuropathy may not be able to provide feedback o Increased risk of adverse events Do not treat over or close to tattoos Possible hair loss may occur Reaction to metal implants and fillers is unknown Prepping the Patient Clean entire treatment area (including in between toes) ensuring any lotion, lint, dirt, etc. is removed Shave the treatment area if there is excessive hair Remove or cover any jewelry in treatment area such as toe rings Pre-treatment ultrasound can be conducted prior to the initial treatment for future reference Recommend that laser operator follow Universal Precautions (gloves, masks, etc.) Safety eyewear must be worn by ALL people in the treatment room o Check the wavelength and optical density (>=6.1 @ 1064nm) marked on all operator goggles Selecting Treatment Parameters Start with low fluence and slow repetition rate to observe laser-tissue interaction Adjust fluence and repetition rate to patient tolerance Sensitive areas, darker skin types, areas of dense hair or recent sun exposure may require lower fluence or slower repetition rates Skin Type Spot Size Fluence Pulse Width Repetition Rate Number of Treatments I-IV 5 mm 14-18 J/cm 2 0.3 ms 5 10 Hz 2-10 V-VI 5 mm 12-16 J/cm 2 0.3 ms 5 8 Hz 2-10 Dorsal delivery of 300-500 pulses followed by Plantar delivery of 400-500 pulses is typical April 2013 D1074 Rev. G p. 6
Treatment Technique Gel is not used Topical anesthetics should not be used as patient feedback is required o Patients should experience heating to a warm to hot, but not painful level Hold the handpiece approximately 3-4 cm from the skin s surface o Ensure the distance beam is centered in the aiming beam Plan to treat in a line over the neuroma starting from between the toes on either side of the neuroma extending distally to 2-3 cm beyond the neuroma The handpiece should be moved continuously with an even distribution of pulses o Movement should be controlled with the speed adjusted according to the repetition rate and patient s tolerance The handpiece should be moved in a paintbrush style backwards and forth along the treatment line first over the neuroma and then extending slightly to either side of the neuroma Pause treatment after every 3 to 5 passes, when the temperature peaks between 42 C - 46 C or when the patient reports moderate discomfort and massage neuroma for 5-10 seconds o If needed, slow the repetition rate for patient comfort o Continue until the desired numbers of pulses have been delivered The temperature indicator should be monitored during treatment to ensure that optimal temperatures are achieved, however; the endpoint is determined by the total number of pulses delivered not intraoperative treatment temperature Depending on the user setting, the laser emits a distinct water drop sound every 25, 100 and 500 pulses or every 100, 1000 and 5000 pulses o These sounds can help keep track of treatment progress without looking at the screen Dark skin, scars or hot spots may require cooling or more pauses during the treatment Post-Operative Care No special post-operative care is typically required Erythema is normal and expected and resolves with time Edema is a normal reaction Average treatment protocol is 6 to 10 treatments, weekly or twice a week depending on severity. While some patients have reported improvement and relief after 1 treatment, most will typically begin to feel relief after 2 to 3 treatments If a blister develops, treat as a wound Cold gel packs or cool compresses may be applied post-treatment on hot spots It is recommended that patients avoid tight shoes, high heels, running and high impact aerobics during their treatment regimen Markings showing typical treatment area for a patient with a neuroma Correct Handpiece Technique Massaging treatment area April 2013 D1074 Rev. G p. 7
WARTS PERFORMING THE PROCEDURE Avoiding Complications Deep tissue injury and prolonged wound healing may occur o Diseases such as Diabetes may impede wound healing Do not treat over or close to tattoos or permanent make-up Possible hair loss may occur Implants o Reaction to metal implants or fillers is unknown o Pacemaker - stay at least 6 inches away from implant Prepping the Patient Clean treatment area Shave the treatment area if there is excessive hair Anesthetics may be used for patient comfort o Local anesthesia (lidocaine without epinephrine) is optional Recommend that laser operator follow Universal Precautions (gloves, masks, etc.) A smoke evacuator is recommended o Laser plume masks filtered to 0.1 microns optional Pre-treatment photographs should be taken prior to the initial treatment for future reference Safety eyewear must be worn by ALL people in the treatment room o Check the wavelength and optical density (>=6.1 @ 1064nm) marked on all operator goggles Selecting Treatment Parameters Start with low fluence and longer pulse duration and adjust to epidermal response The target chromophore for the wart is the vascular component Parameters need to be adjusted according to location, size and/or color of wart o Pulse Duration measures in milliseconds (ms), Smaller, lighter target = Shorter pulse duration Recommended when treating over bottom of foot or over calloused area More aggressive treatment Larger, darker target/skin = Longer pulse duration Recommended when treating over bony areas, near joints or cuticles Less aggressive treatment o Fluence measured in J/cm2 Smaller, lighter target = Higher fluence Recommended when treating over bottom of foot or over calloused area More aggressive treatment Larger, darker target/skin = Lower fluence Recommended when treating over bony areas, near joints or cuticles Less aggressive treatment Size Skin Type Fluence Pulse Width Repetition Rate # Treatments # of Pulses Wart I-VI 160-190J/cm 2 8 15 ms N/A 1+ 1+ Select the back button icon the upper left side of the Genesis screen to access Wart screen. Repetition Rate and Temperature will not be displayed. April 2013 D1074 Rev. G p. 8
Performing the Treatment Handpiece should be 2 cm away from skin instead of the 4cm recommended for Scar or Onychomycosis treatment o Only the larger aiming beam will be visible o The smaller working distance beam and the temperature readout will not be activated Warts may need to be debrided prior to treatment Gel is not used Wart may spark when treated Some warts may require more than one pulse o Do NOT stack pulses (Stacking pulses is placing one pulse directly on top of another with no cooling time) o Pause for a few seconds between pulses o Cool with ice/frozen gel pack in between pulses Individual Warts Treatment Steps Pulse over the wart Do not treat outside the wart border Cool treatment area in between pulses If wart is smaller than laser beam: o Assess surrounding tissue before placing additional pulses to avoid overtreatment of normal tissue If wart is larger than laser beam: o Use less aggressive parameters o May require multiple treatments (treat small sections over multiple visits) o Place pulses with approx. 10%-50% overlap Lighter/Smaller Warts = more overlap Larger/Darker Warts = less overlap Mosaic Wart Treatment Steps Usually require multiple treatments Use less aggressive parameters Do NOT treat entire area of mosaic wart in one session o Only treat the darker/thicker area; usually near center of wart o Do NOT overlap pulses; pulses should be placed adjacent or spaced out o Cool treatment area in between pulses At each subsequent visit, repeat treatment steps End Point Check for end point after first pulse Desired endpoint is a slight ashen color that should occur immediately after pulse o Can be a subtle color change o If surrounding skin becomes white or edematous, it was probably overtreated and should be treated as a wound If endpoint not reached: o Increase fluence by 5J and shorten pulse duration by minimum until you reach end point o Cool treatment area prior to next pulse o Repeat Treatment Steps Immediate post cooling with cold gel pack, Zimmer, etc. may be used for patient comfort Post Operative Care Warts usually have a black or crusty appearance within 24 hours after treatment May apply ointment of choice and non-stick dressing for patient comfort If a blister develops, treat as a wound Treated tissue usually sloughs within 1-4 weeks Deep tissue injury and prolonged wound healing may occur More then 1 treatment may be necessary (4-6 weeks apart) Cold gel packs or cool compresses may be applied post-treatment on hot spots April 2013 D1074 Rev. G p. 9
SCARS AND SKIN REJUVENATION PERFORMING THE PROCEDURE Avoiding Complications Topical anesthetics or local anesthetics should not be used as patient feedback is required Patients with neuropathy may not be able to provide feedback o Increased risk of adverse events Check with surgeon before starting treatment on fresh scars Extreme caution should be used when treating near the eye o Always treat outside the orbital rim of the eye aiming the beam away from the orbit o Patient eye protection is required to avoid ocular damage o The laser beam should ALWAYS be pointed away from the eye and only applied to the skin outside of the orbital rim o Distance from the orbit can often be increased by pulling the skin away from the eye for treatment Do not treat over or close to tattoos or permanent make-up Possible hair loss may occur The Nd:YAG may affect a tooth if exposed o Moist gauze may be placed between the lips and teeth Implants o Reaction to metal implants is unknown o Pacemaker - stay at least 6 inches away from implant o Reaction to fillers is unknown Prepping the Patient Clean skin removing all make-up Shave the treatment area if there is excessive hair A white eyeliner pencil can be used to divide the treatment area into smaller grids if necessary Treatment of a test area should be performed and observed prior to the treatment Topical anesthetic should not be used as patient feedback is required Pre-treatment photographs should be taken prior to the initial treatment for future reference Recommend that laser operator follow Universal Precautions (gloves, masks, etc.) Safety eyewear must be worn by ALL people in the treatment room o Check the wavelength and optical density (>=6.1 @ 1064nm) marked on all operator goggles Selecting Treatment Parameters Start with low fluence and slow repetition rate to observe laser-tissue interaction. Adjust to patient tolerance and epidermal response Sensitive areas, darker skin types, highly vascular scars and areas of dense hair or recent sun exposure may require lower fluences or lower repetition rates Size Skin Type Fluence Large Area (face, neck, or chest) Pulse Width Repetition Rate # Treatments I-IV 12-18 J/cm 2 0.3 ms 7 10 Hz 4-6 V-VI 8-14 J/cm 2 0.3 ms 5 8 Hz 4-6 # of Pulses 8,000 12,000 Small Area (scars) I-IV 12-16 J/cm 2 0.3 ms 4 8 Hz 2-6 500 1,000 Depending on the V-VI 8-12 J/cm 2 0.3 ms 4 8 Hz 2-6 size of the scar April 2013 D1074 Rev. G p. 10
Treatment Technique Gel is not used Topical anesthetics should not be used as patient feedback is required Hold the handpiece approximately 3-4 cm from the skin s surface o Ensure the distance beam is centered in the aiming beam. o The handpiece should be continuously moved in a zig-zag motion with even distribution of pulses o Movement should be controlled and speed adjusted according to the patient s tolerance o Treat each region to point of discomfort and erythema (example shown), then move to adjacent regions using multiple passes Depending on the user setting, the laser emits a distinct water drop sound every 25, 100 and 500 pulses (scars) or every 100, 1000 and 5000 pulses (skin rejuvenation). o These sounds can help keep track of treatment progress without looking at the screen Dark skin, scars or hot spots may need cooling or a short break during treatment Treating Scars o Check with surgeon before starting treatment on fresh scars o Always include the tissue surrounding the scar observing for erythema of the scar as endpoint Scar will absorb more energy than surrounding skin Do not rely on heat in surrounding skin as an endpoint Decreased sensation of scar increases risk of burn o Treat in a zig-zag movement across the scar Do not treat linearly o Pausing and/or cooling with an ice/frozen gel pack during treatment may be necessary o Several treatments may be necessary Skin Rejuvenation To ensure bulk heating, divide the face into multiple regions (example shown) o Forehead divide in half o Periocular Do NOT treat upper lids o Cheeks divide into 2-3 sections o Perioral areas The vermillion border may be treated The Nd:YAG may harm a tooth if exposed Moist gauze may be placed between lips and teeth Extreme caution should be used when treating near the eye o Patient eye protection is required to avoid ocular damage o The laser beam should ALWAYS be pointed away from the eye and only applied to the skin outside of the orbital rim o Distance from the orbit can often be increased by pulling the skin away from the eye for treatment Post Operative Care No special post operative care is typically required Erythema is normal and expected and resolves with time Edema is a normal reaction The average time interval between treatments is 2-4 weeks If a blister develops, treat as a wound Cold gel packs or cool compresses may be applied post-treatment on hot spots April 2013 D1074 Rev. G p. 11
Fitzpatrick Classification Questionnaire SCORE 0 1 2 3 4 What is the natural color of your hair? Sandy red Blond Chestnut, dark blond Dark brown Black What is the eye color? Light blue, Gray, Green Blue, Gray, Green Blue Dark Brown Brownish Black What is the color of sun unexposed skin areas? Reddish Very pale Pale with beige tint Light brown Dark brown How many freckles on unexposed skin areas? What happens when you are in the sun TOO long without sunblock? Many Several Few Incidental None Painful redness, blistering, peeling Blistering followed by peeling Burns, sometimes followed by peeling Rarely burns Never had a problem How well do you turn brown? Hardly or not at all Light color tan Reasonable tan Tan very easily Turn dark very quickly Do you turn brown within one day of sun exposure? Never Seldom Sometimes Often Always How does your face respond to the sun? Very sensitive Sensitive Normal Very resistant Never had a problem When did you last expose yourself to the sun or artificial sun treatments? More than 3 months ago 2-3 month ago 1-2 months ago Less than 1 month ago Less than 2 weeks ago Do you expose the area to be treated to the sun? Never Hardly ever Sometimes Often Always TOTAL 00-07 points = Skin type I 08-16 points = Skin type II 17-25 points = Skin type III 25-30 points = Skin type IV 30-40 points = Skin type V & VI April 2013 D1074 Rev. G p. 12