Vascular Treatment Parameters

Vascular Treatment Parameters
PROWAVE 770
Hair Removal
Treatment Guidelines
For use with the ProWave 770 Pulsed Light Handpiece with a wavelength range of 770 to 1100 nm.
Appropriate operator safety eyewear for this device, provided by Cutera, senses the light pulse and
blocks out incoming light. A small amount of light at the beginning of the pulse will be visible.
This eyewear is not for use with the 1064 nm laser handpiece.
The patient should be given the solid, light blocking eyewear also provided by Cutera. Observers of
the procedure may wear the green tinted eyewear provided by Cutera.
© November 2006, D0292 Rev. C
Cutera • 3240 Bayshore Boulevard • Brisbane • California • 94005
PH: 415.657.5500 • www.cutera.com
ProWave 770 Treatment Guidelines
The following guidelines are based on physician feedback from treatments with the ProWave 770 Pulsed
Light Handpiece on patients with Fitzpatrick skin types I–V. Treatment of patients with skin type VI using
the ProWave 770 Pulsed Light Handpiece is not recommended. Additional treatment information is
discussed in the Clinical Presentations CD included with the system.
The ProWave 770 should only be operated by qualified practitioners who have received appropriate
training and have thoroughly read the operator manual. Protective eyewear must be worn by all people in
the treatment room.
Consult the Operator Manual for additional information, including contraindications and possible adverse effects.
PRE-OPERATIVE CONSIDERATIONS:
•
Conduct a patient consultation complete with medical history prior to treatment.
•
Patients should not be treated if they have had significant sun exposure, or artificial (light based or
spray-on) tanning, in the 4 weeks prior to treatment.
•
Patients should be instructed not to pluck or wax prior to treatment as the hair provides the
required chromophore.
•
Clean the skin, including removal of all make-up and other skin care products. Any creams or
products left on the skin can interact with the light and increase the risk of unwanted side effects.
•
Pre-operative photographs should be taken with consistent technique (patient positioning, camera
settings, and room lighting) prior to the initial treatment for general reference. Printed preoperative photos can also be used to compare and duplicate the same patient position when taking
follow-up photos.
•
Shave any hair in the area to be treated.
•
Pigmented lesions should be evaluated for potential skin cancer warning signs prior to treatment.
If these are present, the lesion should not be treated unless diagnosed as benign.
•
These treatments can be tolerated without anesthesia. Topical anesthesia can be used if desired. It
must be completely removed prior to treatment. CAUTION: Toxicity may result with overuse of
topical anesthesia. Consult the manufacturer's labeling.
•
When treating near the mouth, rolled-up gauze can be placed between the lips and teeth to protect
the teeth from discomfort.
•
Do not treat over areas with tattoos.
•
Extreme caution should be used when treating near the eye, taking care to avoid ocular damage
from the light. Patient eye protection appropriate for the given treatment should be used. The light
should always be pointed away from the eye and only applied to the skin outside of the orbital rim.
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.
© November 2006, D0292 Rev. C ProWave 770 Treatment Guidelines
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PROWAVE 770 TREATMENT PARAMETERS:
Treatment of a test area should be performed and observed for the desired response and signs of unwanted
side effects. Settings for full treatment should be based on test area results. A waiting period of 20 to 30
minutes is recommended for most patients. Darker skin types may require 24 to 48 hours to develop.
SKIN TYPE:
I – II
III
IV*
V*
White
White to Light
Brown
Light Brown to
Olive
Moderate to
Dark Brown
Burns easily;
never tans or
tans minimally
Burns
moderately; tans
moderately and
uniformly
Burns
minimally, tans
easily and
moderately
Rarely burns;
tans profusely
No Actinic Bronzing
Fine hair
Program A
25 – 33 J/cm2
Program A
25 – 30 J/cm2
Program B
20 – 25 J/cm2
Program C
10 – 15 J/cm2
No Actinic Bronzing
Coarse hair
Program A
20 – 30 J/cm2
Program B
20 – 25 J/cm2
Program B
15 – 20 J/cm2
Program C
10 – 15 J/cm2
Actinic Bronzing **
Fine hair
Program B
25 – 30 J/cm2
Program B
25 – 30 J/cm2
Program C
20 – 25 J/cm2
Program C
8 – 12 J/cm2
Actinic Bronzing**
Coarse hair
Program B
20 – 25 J/cm2
Program C
20 – 25 J/cm2
Program C
15 – 20 J/cm2
Program C
8 – 12 J/cm2
* In patients with skin types IV and V, treat exposed areas as actinic bronzing.
** Actinic Bronzing is chronic “tan-like” pigmentation damage resulting from long-term sun exposure.
This is different from recent sun exposure, which should not be treated.
Specific parameters are provided as a guide only. Select parameters depending on color and density of
lentigines, hair density, and actinic bronzing. Observe light-tissue interaction and clinical endpoints to
determine appropriate settings. Patients with skin type V should be treated with caution. Treatment of
patients with skin types VI is not recommended.
•
•
•
•
•
Treatment is not recommended for areas of recent sun exposure or tanning.
Darker skin, especially in exposed areas, and skin with actinic bronzing have a higher risk of
pigmentary changes.
The ProWave 770 has three program modes (A, B, and C) which control the wavelength spectrum,
pulse duration, and epidermal cooling:
o Program A has the shortest wavelength distribution and shortest pulse durations. This
mode is best suited for light skin patients without actinic bronzing.
o Program B has a longer wavelength distribution, longer pulse durations, and provides
greater epidermal cooling. This mode is best suited for light skin type patients with
actinic bronzing or light brown to olive skin patients in areas of minimal exposure.
o Program C has the longest wavelength distribution, longest pulse durations, and
provides greatest epidermal cooling. This mode is best suited for darker skin type patients
with coarse hair.
o Snowflake Mode decreases the window temperature to 5°C to allow more comfort
during treatment.
Prior to treating each patient, the program, the fluence, and the repetition rate settings must be
determined. First select the program based on the table above. If in doubt, it is safest to use the
longer wavelength program of the two choices (i.e. B over A). As there is no single standard for
skin type definition, use the definitions provided above for use with the ProWave 770.
The program should always be entered first, as each time the program is changed, the system will
recall the fluence and repetition rate last used with that particular program.
© November 2006, D0292 Rev. C ProWave 770 Treatment Guidelines
Page 3 of 4
•
Fluence should be adjusted based on epidermal response. Areas with high hair density and/or
coarse dark hairs should be treated at lower fluences than areas with sparser hair. Increasing the
fluence may provide increased efficacy. However, factors such as skin type and actinic bronzing
may limit the maximum useable fluence that does not result in unwanted epidermal damage.
•
Fluence settings should not be based on settings used with other pulsed light devices.
RECOMMENDED TECHNIQUE:
•
Apply a thin layer of clear, non-perfumed mineral oil to the skin for easy gliding of the handpiece.
•
Place the window in full contact with the area to be treated and activate the light pulse.
•
Subsequent pulses should be placed adjacent to one another so that there is no more than 1 mm
overlap between pulses.
•
The appropriate speed to glide the handpiece will be determined by the repetition rate setting.
Users should gain treatment experience at low repetition rates prior to using the faster repetition
rate settings.
•
Epidermal responses of erythema and/or perifollicular edema are common but not required for a
successful treatment.
•
Fluence increases, if indicated, should be performed gradually while watching for epidermal
response. This effect is often delayed
•
Always observe the epidermis during treatment, watching for signs of damage (epidermal
separation or gray coloration). If damage is seen, stop the treatment, cool the area, and adjust the
settings before continuing.
•
Do not “double pulse” or retreat an area within a single visit.
•
Ensure that all surfaces of the window and the adjacent plastic are free of debris during treatment.
POST-OPERATIVE CARE:
•
Ice, chilled gel, or hydro-gel pads may be applied post-treatment as needed for patient comfort.
The treatment window can also be used as an effective post-cooling device.
•
If lentigines darken during treatment, they should be allowed to flake off naturally for best results.
•
Additional treatment may be scheduled as the next growth phase occurs and new hair is visible. A
general guideline is 6 weeks between treatment although this can vary depending on the patient
and the treated area.
•
Localized erythema may also be present and typically resolves within 24 to 48 hours. If prolonged
erythema occurs, future treatments should be performed at a lower fluence.
•
If a wound develops an antibiotic ointment may be recommended.
•
Patients should avoid artificial tanning, or sun exposure without sun protection, between
treatments.
© November 2006, D0292 Rev. C ProWave 770 Treatment Guidelines
Page 4 of 4
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