Cutera Excel V Setup guide

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Clinical Training Guide
Cutera Inc. World Headquarters
3240 Bayshore Boulevard, Brisbane, CA 94005 USA
Tel: [phone]
Fax: [phone]
www.cutera.com

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The following information is supplemental to the excel V Operator Manual. Refer to the Operator Manual for detailed
information, including important cautions and warnings, prior to using the laser system.
The Cutera excel V is a dual wavelength (532 nm and 1064 nm) laser system that can be used with two
interchangeable handpieces.
•The CoolView (532 nm/1064 nm) handpiece with sapphire cooling window is indicated for treatment of
benign vascular, cutaneous and pigmented lesions and mild to moderate inflammatory acne.
•The CoolView handpiece 1064 nm wavelength is also indicated for temporary and permanent hair reduction
on all skin types (Fitzpatrick I – VI), including tanned skin. Permanent hair reduction is defined as long-term,
stable reduction in hair counts observed at 6, 9 and 12 months after the end of a treatment regime.
•The genesis V (1064 nm) non-ablative skin therapy handpiece is indicated for treatment of wrinkles,
rosacea/diffuse redness, scar reduction and Poikiloderma of Civatte.
CoolView Handpiece with Chilled Sapphire Window genesis V Handpiece with Temperature Sensors
MECHANISM OF ACTION
Using the CoolView handpiece, the excel V treats benign vascular, cutaneous and pigmented lesions by selectively
targeting hemoglobin and melanin (selective photothermolysis) without causing thermal damage to the surrounding
tissue.
•For benign vascular lesion treatments, laser light is absorbed by hemoglobin in the veins, and the heat
produced causes photocoagulation. Heat is transferred to the vessel wall, which ultimately destroys the
vessels and prevents recanalization. The laser treats individual veins, but new veins may appear due to an
underlying disorder.
•For benign pigmented lesion treatments, the laser light is absorbed by superficial melanin in the lesion.
Pigmented cells are denatured, darken, rise to the surface, and flake off over a couple of weeks.
Using the genesis V handpiece, the excel V treats wrinkles and diffuse redness (non-ablative skin therapy) by
gently heating the dermis with the 1064 nm wavelength and microsecond pulses, which preferentially heat very fine
vasculature. This treatment can be performed without epidermal cooling.

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USING THESE TREATMENT GUIDELINES
These treatment guidelines are based on physician feedback and
are provided as a guide only. They are not designed to be a
substitute for clinical training. The excel V should only be operated
by qualified practitioners who have received appropriate training
and have thoroughly reviewed the Operator Manual that shipped
with the system. When using the laser, always observe laser-
tissue interaction and clinical endpoints to determine appropriate
settings.
The parameter recommendations in these guidelines are for
patients with Fitzpatrick skin types I-VI with the 1064 nm
wavelength and skin types I-IV (unless otherwise indicated) with
the 532 nm wavelength. In general, longer pulse durations and
lower fluence are recommended for darker skin types and tanned
skin. The increased melanin content in darker skin increases the
risk for side effects.
Test pulses are always advised. Start conservatively, fire a test
pulse, and evaluate tissue response before continuing or adjusting
parameters. Be advised, however, that potential adverse reactions
may take 24-48 hours or longer to appear.
INDICATIONS FOR USE
Refer to the Operator Manual for a complete list of indications for use.
The Cutera excel V is cleared for the treatment of:
•Benign vascular lesions
•Benign pigmented lesions
•Benign cutaneous lesions
•Wrinkles
•Mild to moderate inflammatory acne
•Hair reduction
CONTRAINDICATIONS
•Pregnant patients
•Patients undergoing treatment for skin cancer
WARNINGS
•Do not treat over dysplastic nevi or questionable pigmented lesions.
oOnline Melanoma resources include www.aad.org and www.cancer.org.
•Do not treat over or close to:
otattoos or permanent make-up
ometal or electronic implants
•Hair removal by lasers or intense pulse light sources can cause increased hair growth in some individuals.
Based upon currently available data, the highest risk groups for this response are females of Mediterranean,
Middle Eastern and South Asian heritage treated on the face and neck
PRECAUTIONS
•Do not treat patients who have taken Accutane in the past 6 months.
•Anticoagulants may increase the risk of purpura or bruising.
•Gold therapy may cause blue-gray discoloration.
•Vitiligo may cause de-pigmentation.
•Pre-treatment with an antiviral may be indicated for patients with herpes.
•Use caution when treating patients with a history of keloids or hypertrophic scarring.
•Do not treat over open wounds.
•Only treat over known benign lesions.
•Use caution when treating over hair bearing areas, as the laser energy may affect hair growth.
Refer to the Operator Manual for a complete list of contraindications, warnings, and precautions.

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PATIENT ASSESSMENT
•Obtain a medical history and signed consent prior to
treatment.
•Determine skin type to help guide treatment parameter
selection.
oRe-evaluate patient prior to each treatment.
oSun exposure may increase melanin content of the skin;
treatment settings may need to be adjusted.

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AVOIDING COMPLICATIONS
•Use extreme caution when treating near the eye.
oAlways treat outside the orbital rim of the eye aiming the beam away from the orbit.
oAlways use patient eye protection.
oPoint the sapphire window away from the eye and apply to the skin outside of the orbital rim.
•Sun exposure, tanning beds, and artificial tanning may increase the risk of side effects and adverse events.
oPatients should avoid sun exposure, including tanning beds, and artificial tanning (spray tans, tanning
lotions, etc.) for at least 4 weeks prior to treatment.
oPatients with any residual sun tan in the treatment area have a higher risk of adverse events.
•Remove all traces of make-up prior to treatment.
•Keep top side of sapphire window clear of gel; wipe periodically with 4x4 gauze if necessary.
oExcessive top side gel may affect laser beam output, possibly leading to adverse events.
•Darker skin types have an increased risk of complications and/or pigmentary issues.
•Pre and post cooling helps reduce the risk of complications.
•Reaction to treating over fillers and toxins is unknown.
•Reaction to treating over superficial cosmetic implants or threads is unknown.
•Place moist gauze between the lips and teeth to protect tooth enamel.
•Do not use parameters from other 532 nm or 1064 nm lasers.
PRE-TREATMENT PREPARATION
•Topical anesthetic is optional with CoolView treatments. If used, thoroughly remove before treating.
oCAUTION: Toxicity may result from overuse. Consult the manufacturer’s labeling.
•Do not use topical anesthetic with genesis V procedures. Patient feedback is very important for non-ablative
skin therapy.
•Clean patient’s skin, removing all make-up and/or topical anesthetic.
•Shave the treatment site if there is excessive hair.
•Take photographs prior to the initial treatment for future reference.
•To help prevent condensation of the sapphire window when treating with cooler Window Temperatures,
place one drop of Anti-fog drops on top of the sapphire window prior to and during treatment when
necessary.
SAFETY EYEWEAR
Safety eyewear appropriate for 532 nm and 1064 nm must be worn by ALL people in treatment room.
•The laser ships with opaque stainless steel patient goggles as well as operator goggles.
•Check the wavelength and optical density (OD ≥ 5.89 @ 532 nm and OD ≥5.81 @ 1064 nm) marked on all
operator goggles.
•Apply wet gauze over the eye lid when using metal eye shields.
oCAUTION: Metal eye shields may increase in heat and burn the patient if a protective layer of gauze is
not used.
Operator Goggles
Patient Goggles

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EXCEL V USER INTERFACE
1. Fluence is the energy measured in J/cm2. Press the Up/Down arrows to adjust.
2. Pulse Duration is the length of each pulse measured in milliseconds (ms). Press the UP/Down arrows to adjust.
The pulse duration is set to 0.3 ms and cannot be adjusted when using the genesis V handpiece,
3. Repetition Rate is the number of pulses per second measured in Hz with foot pedal depressed. Press the
Up/Down arrows to adjust.
4. Temperature can be adjusted to 5°C, 10°C, 15°C, or 20°C by selecting the Temperature Icon.The real time
temperature is also displayed. The temperature cannot be adjusted when using the genesis V handpiece.
5. Memory Button saves 3 different settings per wavelength for common indications.
6. Number of Pulses is displayed. Press the reset button to reset.
7. Spot Size is adjustable from 2 - 12 mm. Press –/+ to adjust. The Spot Size cannot be adjusted when using the
genesis V handpiece.
8. Standby/Ready Button – Press to toggle between Standby and Ready Mode. Standby/Ready button is yellow
and the handpiece cannot be fired when in Standby Mode. Standby/Ready button is green when in Ready Mode.
The system will not go into ready mode unless the handpiece is out of the holster. Press the foot pedal to start
the pulse after the “flute” sound indicates system is ready.
9. Wavelength – Chosen wavelength will be displayed. Select either 532 nm or 1064 nm to select wavelength for
treatment. The wavelength cannot be adjusted when using the genesis V handpiece.
10. Information Screen – The Information & Adjustment Screen can be accessed to verify system software version
or adjust the screen brightness, volume level or beam intensity.
NOTE: Treatment parameters are interrelated. Therefore, not all parameter combinations are simultaneously
available. If you attempt to select a treatment setting that is not available, the system emits a distinct audible tone.
Changing one or more of the other parameters may enable you to select the desired treatment setting.
genesis V User Interface
532 nm User Interface
CoolView 1064 nm User Interface
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CoolView 532 nm User Interface
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VASCULAR TREATMENTS WITH 532 NM AND 1064 NM WAVELENGTHS
VASCULAR TREATMENT PROCESS
•The purpose of the treatment is to selectively treat the target of hemoglobin (chromophore) without causing
thermal damage to the surrounding tissue.
•Laser light is absorbed by hemoglobin in the veins and the heat produced causes photocoagulation.
•This heat is transferred to the vessel wall which affects the collagen and ultimately helps to destroy the
vessel and prevent recanalization.
•The laser treats individual veins but new veins may appear due to an underlying disorder
TYPES OF VEINS
Telangiectasia or spider veins – treat with 532 or 1064 nm wavelength
•Up to 1 mm in diameter
•Superficial, small veins; pink to purple in color
Reticular veins or “feeder veins” – treat with 1064 nm wavelength
•1 – 3 mm in diameter
•Superficial collecting veins that are blue green
Varicose veins – usually requires surgery, not appropriate for laser therapy
•Vary in diameter
•Bulging and twisting veins of the lower extremity caused by increased venous pressure as
a result of venous incompetence
•Bulging varicose veins should be evaluated by a vascular surgeon
REFLUXING OR INCOMPETENT VEINS
•Venous reflux or incompetence is a diseased or abnormal valve that is no longer able to close when
subjected to pressure. This failure to close prevents the valve from stopping the backward flow of blood. In
response to gravity, blood pours backward (like a waterfall), overloading the vein with volume and pressure
which leads to the development of varicose veins.
•Duplex ultrasound may be ordered to diagnose possible reflux of the Greater or Lesser Saphenous Vein
which is usually treated surgically.

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SELECTING TREATMENT PARAMETERS FOR VASCULAR TREATMENTS
Select parameters in the order listed below. Always start with the least aggressive settings for a specific vessel.
Observe laser-tissue interaction and clinical response to determine appropriate settings for each patient.
1. Wavelength is measured in nanometers (nm). Selection is based on vessel depth and color.
•superficial vessel (fine to moderate size, pink to red) = 532 nm
•larger, deeper vessel (very dark red, blue to purple) = 1064 nm
2. Spot Size is measured in millimeters (mm). Selection is based on treatment type and vessel depth.
•linear vessels, superficial = smaller spot size
•linear vessels, deeper = larger spot size
•area treatments/diffuse redness = larger spot size
•larger spot sizes penetrate deeper with the 1064 nm wavelength and are typically more uncomfortable.
3. Fluence is the energy, measured in J/cm2. Selection is based on vessel size, depth, and skin type.
•532 nm: smaller vessels = lower fluence; larger vessels = higher fluence
•1064 nm: smaller vessels = higher fluence; larger vessels = lower fluence
•darker skin types or tan skin = lower fluence
4. Pulse Duration is the length of each pulse, measured in milliseconds (ms). Selection is based on vessel size
and
color.
•smaller diameter, lighter vessel = shorter pulse duration
•larger diameter, darker vessel = longer pulse duration
•darker skin types or tan skin = longer pulse duration
•Pulse durations shorter than 10 ms increase the likelihood of purpura when treating vascular lesions.
5. Window Temperature is measured in o Celsius. Four options are available: 5o, 10o, 15o, and 20o C.
•5oor 10oC is recommended for vascular indications for increased epidermal protection and patient comfort.
•5oC is recommended for larger, darker vessels and vascular birthmarks (more hemoglobin).
•Use the lowest window temperature in which the desired clinical endpoint can be achieved.
6. Repetition Rate is the number of pulses per second, measured in Hz, with foot pedal depressed.
•For increased epidermal safety, use single pulses (0.0 Hz) with pre and post cooling.
•Low to Moderate Repetition Rate is recommended for the large area Global Treatment.
7. Contact Cooling – Sapphire window provides pre, parallel, and post cooling.
•Pre-cooling protects the epidermis by reducing initial skin temperature.
•Parallel cooling during the laser pulse protects the epidermis while the laser is firing.
•Post-cooling extracts heat from tissue to help prevent epidermal injury.
•Longer pre and post cooling is recommended when treating larger, darker vessels, darker skin types and tan
skin.
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+
Spot Size
Linear vessels
Superficial vessels
Area treatments
Deeper vessels
Fluence
532 nm: Smaller vessels
1064 nm: Larger vessels
532 nm: Larger vessels
1064 nm: Smaller vessels
Pulse Duration
Smaller vessels
Larger vessels
Darker skin types
Tan skin
+
+
-
-

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TREATMENT PARAMETERS – 532 NM VASCULAR WITH COOLVIEW HANDPIECE
These parameters are provided as a guide only for skin types I-IV, unless otherwise stated. Observe laser-tissue
interaction and clinical endpoints to determine appropriate settings. 532 nm is NOT recommended for the treatment
of unwanted periorbital veins, venous lakes, reticular leg veins, or purple/nodular port wine stains. For these
indications, 1064 nm is the preferred wavelength.Darker III and IV skin types, such as Asian, Latino, and
Mediterranean, have a higher risk of PIH and other adverse events and should be treated with more conservative
settings.
Example Picture
Vessel Type
Temp
Spot Size
Fluence
Pulse Duration
Facial
Telangiectasia
< 2 mm
5° 5 mm 8 – 10 J/cm² 8 – 12 ms
> 2 mm 5° 7 mm 7.4 – 9 J/cm² 10 – 20 ms
Fine Leg
Telangiectasia
* Skin Types I-III only
5° 5 mm 8.4 – 11 J/cm² 8 – 15 ms
Matting
(Face or Nose)/
Rosacea
(Global Treatment)
5°
5°
5°
7 mm
10 mm
12 mm
8 – 10 J/cm²
6 – 9 J/cm²
5 – 8 J/cm²
8 – 15 ms
8 – 15 ms
8 – 15 ms
Matting
(Neck or Chest)
5°
5°
10 mm
12 mm
6 – 8 J/cm²
5 – 7.4 J/cm²
10 – 20 ms
10 – 20 ms
Diffuse Redness
(Face)
5°
5°
10 mm
12 mm
6 – 9 J/cm²
5 – 8 J/cm²
7 – 11 ms
8 – 12 ms
Cherry or Spider
Angiomas
10°
10°
3 mm
5 mm
10 – 14 J/cm²
8 – 12 J/cm²
6 – 12 ms
8 – 15 ms
Skin Tags or
Sebaceous
Hyperplasia
15°- 20°
15°- 20°
2 mm
3 mm
16 – 20 J/cm²
14 – 18 J/cm²
4 – 10 ms
4 – 10 ms

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TREATMENT TECHNIQUE – 532 NM VASCULAR WITH COOLVIEW HANDPIECE
•WARNING: The red diode aiming beam in the sapphire window should be in full contact with the skin before,
during, and after the laser pulse.
oPay close attention when treating over the nose or curved areas to ensure full contact with the
sapphire window where the red aiming beam is present.
oConsider using a smaller spot size if you cannot ensure full contact with the sapphire window.
•Technique:
oApply a thin layer of clear gel (such as ultrasound gel) for increased
epidermal protection and patient comfort and seat the sapphire window
gently on the skin.
oEnsure that no large bubbles are present under the aiming beam.
oDo not apply too much pressure on the skin with the handpiece while
treating vessels to avoid compressing the target.
oCreate suction by gently lifting the handpiece slightly while maintaining
contact.
oPre-cool area with sapphire window, depress the foot pedal to fire a
pulse, then glide handpiece to next treatment area and repeat.
oEnsure that handpiece has complete contact with skin during each pulse.
•Always observe the epidermis during the treatment, watching for signs of damage (blanching or gray
coloration).
oIf damage is seen, stop the treatment and apply a cool compress and evaluate the area for possible
complications and wound care.
•Common endpoints are transient or persistent color change within the vessel, vessel disappearance or
constriction, erythema, or purpura.
oIf the clinical endpoint is not reached, shorten the pulse duration or increase the fluence.
oA second pulse may be delivered after allowing the skin to fully cool.
•Treating small vessels
oPlace the treatment pulses sequentially with a slight overlap.
oDo not stack pulses or double pulse.
•Treating diffuse redness/matting
o10 – 12 mm spot size (Global Treatment) recommended.
oOverlap pulses by no more than 10-20%.
oOnly 1 pass recommended.
•Treatment of Diffuse Redness with Discreet Vessels –
oIf a patient wants fewer treatments with more downtime:
Option 1: Combine small and large spot sizes.
−Use a 3 - 5mm spot size to trace smaller vessels
−Follow with 10 – 12 mm spot size treatment
covering the entire area (Global Treatment).
oOverlap pulses by no more than 10-20%.
oOnly 1 pass recommended.
−The risk of edema is high.
−Fewer treatments may be required.
−Lowering the fluence can decrease downtime but
increases number of treatments
Option 2: Use large spot size only.
−Treat the entire area with large 10 – 12 mm spot
size (Global Treatment)
oOverlap pulses by no more than 10-20%.
−Follow with additional pulses on areas that did not
respond with the same spot size.
oIt is not recommended to do a full second
pass with the 10 – 12 mm spot size.
−The risk of edema is high.
−Fewer treatments are usually required.
−Lowering the fluence can decrease downtime but
increase number of treatments
oIf a patient wants more treatments with less downtime per treatment:
Treat discreet vessels with 3 – 5 mm spot size.
Follow with genesis V to treat the diffuse redness.
The 3 – 5 mm spot size may cause localized edema.
More treatments may be required with this technique.
Ensure full contact of sapphire window
Global Treatment Example
Global Treatment Endpoint