Download Treatment Guidelines

Treatment Guidelines
Cutera Inc. World Headquarters
3240 Bayshore Boulevard, Brisbane, CA 94005 USA
Tel: +1 415 657 5500
Fax: +1 415 330 2444
www.cutera.com
D1471 Rev C June, 2013
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The Cutera, Inc. Prowave LX handpiece is indicated for the removal of unwanted hair, and to effect stable, longterm, or permanent, hair reduction
PREREQUISITE
The Prowave LX handpiece should only be operated by qualified practitioners who have received appropriate
training and have thoroughly reviewed the Operator Manual prior to operating the Prowave LX handpiece.
SPECIFICATIONS
 Spot size: 1x3 cm
 Wavelength: 680 nm to 1100 nm
o Automatically set by Program Mode
 Fluence: 5 to 35 J/cm²
o Operator selects
 Rep Rate: 0 to 2.0 Hz
o Operator selects
LASER HAIR REMOVAL PROCESS
 The purpose of the treatment is to selectively treat the hair follicle without causing thermal damage to the
surrounding tissue.
o The sapphire window provides epidermal cooling and protection.
 Permanent hair reduction is achieved by using heat to disable the hair follicle and prevent re-growth
o The bulb and bulge of the hair follicle, which are responsible for hair re-growth, are targeted by the
Prowave LX.
o Because the bulb and bulge of the hair follicle must be present, do not pluck or wax targeted hair in
between treatment sessions.
 The Prowave LX targets the melanin in the hair bulb and bulge; therefore hair must be brown or black.
o The Prowave LX does not target and cannot be absorbed by white, gray, red or light-blond hair.
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HAIR GROWTH PHASES
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Anagen - Active Phase
o The laser light is absorbed by the melanin in the hair shaft reaching bulb and disabling the hair
follicle
Catagen - Transitional Phase
o Hair bulge & bulb are beginning to disengage from the hair shaft and treatment is not effective
Telogen - Resting Phase
o Hair bulge and bulb are disengaged from the hair shaft and treatment is not effective
TREATMENT INTERVALS
 Only the hair follicle in the anagen growth phase can be effectively targeted and disabled
 Multiple treatments are required to achieve sufficient reduction in hair growth because each hair goes
through 3 growth phases (anagen, catagen and telogen) independent of the neighboring hairs so not all
hairs will be in the same phase at the same time, thus multiple treatments are required
 Treatment Interval recommendations are a general guideline only and are a compilation of intervals used by
successful operators
o Facial hair: 6-8 week intervals between treatments
o Body hair: 8-10 week intervals between treatments
o Back or Leg hair: 10-12 week intervals between treatments
 Hormones, diseases, medication or other factors can affect the treatment outcome
 Treatments that are spaced too close together may appear to be more successful within the first few
treatments but a smaller percentage of anagen hair may be available as a target thus more treatment
sessions may be required for the desired final outcome
 Patients should be assessed before each treatment to determine treatment intervals and settings
o Hair may grow back lighter and finer and settings may need to be adjusted to target this new hair
 If the patient returns for treatment and there is minimal hair, it may be in a transitional or resting phase
o Wait until hair is actively growing to resume treatment cycle
 Facial skin has significantly more hair follicles at per cm2 than the body which is why you can see results
within the first three to four treatments with shorter interval times
 When in doubt, it is better to space the treatments farther apart than closer together
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PATIENT ASSESSMENT
Contraindications: Pregnancy and Skin Cancer
This is a medical device. It is important to obtain a complete medical history and signed informed consent
Determine ethnicity and skin type by using the attached Fitzpatrick Skin Type scale
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
History of keloid or hypertrophic scarring
Patients with Hormone disorders (i.e.Polycystic Ovarian Syndrome) may not see effective hair reduction
Only treat over known benign lesions
Do not treat over dysplastic nevi or questionable pigmented lesions
o Online Melanoma resources include (www.aad.org), (www.cancer.org)
AVOIDING COMPLICATIONS
 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 should be always be used.
o The treatment window should be pointed away from the eye and applied to the skin outside of the
orbital rim.
o Skin at the edge of the orbital rim can be treated by pulling it away from the eye while
simultaneously holding the goggles in place, so treatment is kept outside of the orbital rim.
 Do not treat over or close to tattoos or permanent make-up
 Shave treatment area
 Sun exposure, tanning beds or artificial tanning may increase risk of side effects and adverse events
 No self-tanners or sun-tanning for at least 4 weeks prior to treatment
o Includes spray tans, tanning lotions, tanning beds, sun exposure, etc.
o Self-tanners need to be completely sloughed and this can take up to 4 weeks
o Patient should have no residual suntan (sun/tanning booth) prior to treatment
o Sun tan should be faded but keep in mind that any residual tan is a target for the laser
 All traces of make-up must be removed
 Be aware of implants and threads
 Stay at least 6 inches away when treating near a Pacemaker
 Reaction to fillers unknown
 Pigmented lesions may darken. Allow these to slough off naturally.
 Avoid treatments that may irritate the skin for 1-2 weeks prior to treatment (depilatories, harsh chemicals,
etc.)
 Ensure the entire sapphire crystal is in full contact with the skin during the treatment.
 Cold gel packs or cool compresses can be used post-treatment for patient comfort. Ice should not be
applied directly to a suspected burn as it may cause unwanted side effects.
 Ensure treatments are not spaced too close together as this will decrease efficacy of treatment
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PREPARING THE PATIENT
 Clean skin removing all make-up and/or topical anesthetic.
 Ensure treatment area is clean shaven.
 Pre-operative photographs should be taken prior to the initial treatment for future reference.
 Treatment of a test area should be performed and observed prior to treatment. Potential adverse reactions
may take 24-72 hours to appear.
o Foot-printing is usually evident 24-72 hours post treatment and is not a desirable result; indicates
over-treatment. If this occurs, settings should be lowered for desired results.
o Patients with actinic bronzing have a higher risk of developing foot-printing.
o Test spots should be done on the same area being treated (i.e. don’t test spot on arm when treating
the face)
o Tests spots are recommended prior to subsequent treatments
 Test spots should include 3-4 adjacent pulses to help gauge skin’s reaction to bulk heating
 Topical anesthetic is optional and must be removed before treating
o CAUTION: Toxicity may result from overuse. Consult the manufacturer’s labeling.
 Safety eyewear must be worn by ALL people in the treatment room.
o Use eyewear appropriate for Intense Pulsed Light devices (520-1100 nm)
Shutter Operator Goggles
Operator Goggles
Patient Goggles
Disposable Patient Eye shield
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PROWAVE LX USER INTERFACE
1. Fluence is the energy measured in J/cm2. The lighter the
chromophore, the more energy (fluence) is needed. Press the
Up/Down arrows to adjust.
2. Pulse Duration is the length of each pulse measured in
milliseconds (ms). Automatically selected by program.
2
3. Repetition Rate is the number of pulses per second
measured in Hz. Repetition Rate should only be used by
advanced users. Slowing down the Repetition Rate can help
with patient comfort. Press the Up/Down arrows to adjust.
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1
4
6
7
8
Snowflake Mode ON
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4. Program Selection – press the icon underneath the Program
Icon to select the appropriate Program Mode.
5. Snowflake Mode is recommended for epidermal protection
and patient comfort. Snowflake Mode lowers the treatment
window temperature of all Program Modes to 5°C and should be
turned on for all treatments.
6. Standby Button – press yellow icon to go into Standby Mode.
The handpiece cannot be fired when in Standby Mode. Screen
background is yellow.
Snowflake Mode OFF
7. Ready Button – press the green icon to go into Ready Mode
to begin treatment. Start the pulse after the “flute” sound
indicates system is ready. Screen background is green.
8. Number of Pluses is displayed. Press the icon to reset.
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PARAMETER SELECTION
The following parameters are provided as a guide only and are based on practitioner feedback. Observe lasertissue interaction and clinical endpoints to determine appropriate settings.
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Short Pulse Duration Mode - most aggressive
o Patients with lighter skin types and lighter colored or finer hair
Medium Pulse Duration Mode – mid-range program
o Patients with medium skin types (Skin Types II or III) and medium hair color & thickness
Long Pulse Duration Mode – least aggressive
o Patients with darker skin types (Skin Type III or IV) or actinic bronzing and dark or coarse hair
This device is not intended for patients with Skin Type V or VI
Actinic Bronzing Patients
 Actinic bronzing is chronic “tan-like” pigmentation damage resulting from long-term sun exposure
 *Caution! Short Mode is not recommended for any patients with actinic bronzing in the treatment area as
this short pulse duration mode can remove background pigment
 Patients with actinic bronzing are at high risks for crusting, foot-printing and adverse events
 Treating patients with actinic bronzing carries more risks when using the shorter pulse duration modes over
the longer pulse duration modes
Program Modes
 Short Mode – Short Pulse Duration Mode
 Medium Mode – Medium Pulse Duration Mode
 Long Mode – Long Pulse Duration Mode
Short Mode Medium Mode Long Mode
Repetition Rate
 Repetition rate should always be adjusted according to patient tolerance and operator expertise
 Single pulses are recommended when treating on the face or on contoured area because the crystal must
maintain contact with the skin at all times
 Single pulses are recommended on areas where additional cooling is desired (higher energy settings, sun
exposed areas, etc.)
 Faster repetition rates of 0.8-1.2 Hz are recommended only for experienced practitioners when treating
larger areas such as legs, back, arms, etc.
o Lower fluences are recommended when treating with faster repetition rates to help prevent heat buildup
and potential adverse reactions
 User slow repetition rate when treating areas of coarse, dense hair
Hair Type
Fine Hair
Medium Hair
Skin Type I-II
Short Mode *
20-33 J/cm²
Short Mode *
15-24 J/cm²
Short Mode *
10-18 J/cm²
Short Mode *
20-31 J/cm²
Medium Mode
20-34 J/cm²
Medium Mode
16-23 J/cm²
Skin Type III
Skin Type IV
Coarse Hair
Low Density
Medium Mode
23-33 J/cm²
Medium Mode
21-31 J/cm²
Long Mode
16-28 J/cm²
Coarse Hair
High Density
Medium Mode
21-30 J/cm²
Medium Mode
18-28 J/cm²
Long Mode
14-22 J/cm²
Selecting Treatment Parameters
 Always start with a low fluence and assess patient’s skin reaction to determine proper settings
o Test spots are important to determine proper settings
 Treatment ranges are wide due to significant variations in patient response
o Caution! Sun exposed areas have a higher risk of adverse events
o Important to also assess hair color to determine proper settings
o Darker Hair Color = Lower Fluence range
o Lighter Hair Color = Higher Fluence range
o Men’s beards should be treated with lower fluence
 Pigment and moles in the treatment area may be affected
 Patients should be re-assessed prior to each treatment to determine sun exposure and hair’s density and
coarseness
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TREATMENT TECHNIQUE
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Verify that Snowflake Mode is turned ON (blue) to ensure epidermal protection and patient comfort
Hair should be clean shaven
Inspect the handpiece to ensure the crystal surface is free of debris and ejected hair prior to and during
treatment
Apply a thin layer of ultrasound gel for increased epidermal protection and easy gliding of the handpiece to
determine placement of adjacent rows
Crystal must be in full contact with skin during treatment
o Pay particular attention when treating rounded/bony areas
Pulses should be placed adjacent to one another with no overlap
Common endpoints are mild to moderate erythema and/or peri-follicular edema, though these endpoints are
not required for a successful treatment and are usually delayed
o If treated area darkens or develops significant erythema or edema, the fluence should be
decreased or switch to longer pulse duration mode (i.e. from Short Mode to Medium Mode or from
Medium Mode to Long Mode)
If desired clinical endpoint is not achieved, consider increasing fluence or move to a more aggressive pulse
duration mode
Always observe the epidermis during the treatment, watching for signs of damage (epidermal separation or
gray coloration)
o If damage is seen, stop the treatment and cool the skin and evaluate area for possible
complications and wound care
Areas of different density may require adjusting settings during the same treatment
o Use caution on men’s neck as the hair line is approached
Be extra cautions when treating unusual areas (i.e. scalp hair, knuckles, men’s genitalia, ears, inside nose,
etc.)
o Provide extra cooling with handpiece and/or frozen gel pack
 Higher hair density may absorb more heat
 Thinner skin is more easily damaged
o Insert damp cotton ball inside ear canal
o Pull skin away from testes to treat
Do not “double-pulse” or retreat an area within a single visit
When treating near the mouth, rolled-up gauze can be placed between the lips and teeth to protect teeth
from discomfort
Correct Technique
Incorrect Techniques
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POST TREATMENT CARE
For best results, ensure patient adheres to post-care instructions:
 Avoid sun exposure and use a broad spectrum (UVA/UVB) sunscreen
 Redness and peri-follicular edema (looks like a rash/bug bites) are common and resolve with time
 Bruising and swelling are less common but may occur and will resolve with time
 Hair may take up to 2 weeks to fall out
 Avoid heat – hot tubs, saunas, etc. for 1-2 days
 Avoid skin irritants (examples below) a few days post-treatment
o Products containing tretinoin, retinol, benzoyl peroxide, glycolic/salicylic acids, astringents, etc.
 Do not wax or pluck between treatments
SAFETY & SYSTEM MAINTENANCE
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Log on to the Clinical & Training section of the Cutera website’s Education tab (www.cutera.com)
for important information on Laser Safety and Laser Physics
o These presentations review light-tissue interaction and safe laser practices
It is important to properly maintain your system. Failure to do so may affect the life of your laser.
Review the Operator Manual thoroughly for detailed instructions
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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?
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
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
Light brown Dark brown
TOTAL
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00-07
08-16
17-25
25-30
30-40
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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