Download Treatment Guidelines

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:
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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:
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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
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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
Temp Range
Green
Green
Green
Yellow
Yellow
Red
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
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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
Invisible
Temperature
sensor
Visible working
distance beam
Visible aiming
beam
GOGGLES
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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
Patient
Goggles
Operator Goggles
SELECTING PARAMETERS
The recommended parameters are provided as a guide and are based on practitioner feedback.
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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
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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
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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
#
Pulse
Repetition
Spot Size Skin Type
Fluence
Treatments
Duration
Rate
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
5mm
100+ pulses
per toe
using multiple
passes
600+ pulses using
multiple passes
May need additional pulses for severely infected or larger nails.
Toes/Fingers
Target
Minimum Total Pulses
Hallux/Thumb
Toes
1,000+ per foot
600+
100+ per toe
Fingers
1,200+ per hand
400+
200+ per finger
April 2013 D1074 Rev. G
400+ pulses
using multiple passes
200+ pulses per finger
using multiple passes
p. 4
Performing the Treatment
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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
Correct Technique
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
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
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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
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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
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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
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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
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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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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
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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
Markings showing typical
treatment area for a patient
with a neuroma
Post-Operative Care
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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
Correct Handpiece
Technique
Massaging treatment area
April 2013 D1074 Rev. G
p. 7
WARTS – PERFORMING THE PROCEDURE
Avoiding Complications
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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
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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
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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.
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
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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
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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

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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
Large Area
(face, neck, or
chest)
I-IV
12-18 J/cm2
0.3 ms
7 – 10 Hz
4-6
V-VI
8-14 J/cm2
0.3 ms
5 – 8 Hz
4-6
I-IV
12-16 J/cm2
0.3 ms
4 – 8 Hz
2-6
500 – 1,000
2-6
Depending on the
size of the scar
Small Area
(scars)
April 2013 D1074 Rev. G
V-VI
8-12 J/cm2
# of Pulses
8,000 – 12,000
0.3 ms
4 – 8 Hz
p. 10
Treatment Technique
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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
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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?
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
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
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00-07
08-16
17-25
25-30
30-40
April 2013 D1074 Rev. G
points
points
points
points
points
=
=
=
=
=
Skin
Skin
Skin
Skin
Skin
type
type
type
type
type
I
II
III
IV
V & VI
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