Treatment Guidelines

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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

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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)

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Visible aiming beam Visible working distance beam Invisible Temperature sensor Operator Goggles 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)

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

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

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

LED Color Temp Range

Green 26-30 o_C Green 31-34 o_C Green 35-38 o_C Yellow 39-42 o_C Yellow 43-46 o_C Red 47-50 o_C Patient Goggles

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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 Fluence Pulse Duration Repetition Rate # Treatments 5mm 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

May need additional pulses for severely infected or larger nails.

Target Minimum Total Pulses Hallux/Thumb Toes/Fingers

Toes 1,000+ per foot 600+ 100+ per toe

Fingers 1,200+ per hand 400+ 200+ per finger

400+ pulses using multiple passes

200+ pulses per finger using multiple passes

600+ pulses using multiple passes 100+ pulses per toe using multiple passes

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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 past the nail

 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 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

 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

o It should be noted that the pain tolerance lowers with each pass

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

Matrix or Proximal nail fold

Incorrect Technique Correct Technique Distance Beam Laser Beam (treatment area)

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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

 Clean entire treatment area (including in between toes) ensuring any lotion, lint, dirt, etc. is removed

 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

 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/cm2 0.3 ms 5 – 10 Hz 2 - 10 V-VI 5 mm 12-16 J/cm2 0.3 ms 5 – 8 Hz 2 - 10

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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

 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

Correct Handpiece Technique

Massaging treatment area Markings showing typical treatment area for a patient

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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

 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

 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/cm2 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.

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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 over-treatment 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 over-treated and should be over-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

 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

 Treated tissue usually sloughs within 1-4 weeks

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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

 Clean skin removing all make-up

 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

 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 Pulse Width Repetition Rate # Treatments # of Pulses Large Area (face, neck, or chest) I-IV 12-18 J/cm2 0.3 ms 7 – 10 Hz 4-6 8,000 – 12,000 V-VI 8-14 J/cm2 0.3 ms 5 – 8 Hz 4-6 Small Area (scars) I-IV 12-16 J/cm2 0.3 ms 4 – 8 Hz 2-6 _{500 – 1,000} Depending on the size of the scar

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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

 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

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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? _{Gray, Green}Light blue, 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 _{unexposed skin areas?}How many freckles on Many Several Few Incidental None

What happens when you are in the sun TOO long

without sunblock? 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 _{one day of sun exposure?}Do you turn brown within 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

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Treatment Guidelines