Guidelines

GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES GentleMAX Pro is a 755 nm and 1064 nm laser system. Single wavelength 755 nm or 1064 nm configurations are also available. You may disregard recommendations for wavelengths not present on your system. These guidelines were developed from clinical experience and are subject to change as additional experience is gained. Be sure to inquire with your Candela Representative or visit Practice360.com regularly for the latest updates. Treatment Guidelines do not take the place of the procedures and instructions found in the Operator’s Manual. FAILURE TO USE THE LASER IN ACCORDANCE WITH SUCH PROCEDURES AND INSTRUCTIONS COULD RESULT IN SERIOUS INJURY TO THE OPERATOR, THE PATIENT AND OTHERS, AS WELL AS DAMAGE TO THE LASER SYSTEM. Follow OSHA and ANSI standards for laser safety. Protective eyewear must be worn by all persons in the treatment room during laser operation. Perform User Verification tests as outlined in the Operators Manual at the start of each treatment day and when the hand piece is changed. Check the delivery system for any damage (i.e. dropped).

HAIR REMOVAL TREATMENT GUIDELINES (755 nm) Lesion/ Skin type I - II (Caucasian red hair, freckles, fair skin, blue eyes)

III (Darker Caucasian, light Asian)

IV (Mediterranean Asian, Hispanic) V (Middle Eastern, Hispanic, Asian, light skinned African American, Indian, Native American) VI (Dark African American)

Spot size (mm) 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 8 10 12 15

Pulse Duration (ms)

3

3

3

3

Fluence (J/cm2) 30-40 26-35 26-36 20–30 14-20 26-40 16-30 18-30 16-26 10-16 22-30 16-26 16-20 10-20 8-16 22-26 16-20 14-20 10-20

18

6-16

8 10 12 15 18

22-26 16-20 10-20 7-20 6-16

3

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* DCD Spray/delay/ post spray (ms)

Retreat

Comments

40/40/0

Skin types I-III

50/30/0

Test small area and wait several minutes to evaluate response prior to treating entire area.

50/40/0

Facial: 4 - 6 weeks 40/30/0 40/40/0 50/30/0 50/40/0

Trunk: 6 - 8 weeks Leg: 10 -12 weeks

Skin types IV-VI and tanned skin Pre-treat with prescription strength hydroquinone for at least 2 weeks prior to treatment. Test small area and wait 1-2 weeks prior to treating entire area to evaluate tissue response. DCD may need to be adjusted when altering fluence. Do not treat recently tanned skin. Allow tan to fade prior to treatment.

40/40/0 50/30/0

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Consider the 1064 nm for hair removal treatment on Type V-VI skin type.

GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

VASCULAR LESIONS GUIDELINES (755 nm)

Lesion/ Skin type

Spot size (mm)

Pulse Duration (ms)

Fluence (J/cm2)

* DCD Spray/delay /post spray (ms)

8

3

40 - 50

50/30/0 60/40/0

Telangiectasia FACE Skin Types I - III

20 - 60

Comments

Pulse each area once. Endpoint is perivascular erythema, subtle edema of vessel, or no vessel re-fill. 4-6 weeks

60-80 for diffuse redness. 6

Retreat

Skin types I-II Consider longer pulse duration within the recommended range for larger vessels (0.4 to 1.6 mm). Adjust pulse duration and fluence for desired endpoint: Vasoconstriction, Vasospasm, and/or Darkening vessel contents

50 /20/0 80-90 for discrete vessels

Telangiectasia 8

LEGS

3

50-80

Vessels

10-12 weeks

Skin Types I-III

6

20-60

85-90

50 /20/0

Hemangioma

8

3

60-70

90/80/0

3-4 weeks

Port Wine Stain

8

3

35- 85

40/40/0 50/40/0 60/40/0

Face: 8 weeks Extremities: 12 weeks

Consider longer pulse duration within recommended range for larger vessels (> 0.6 mm). Adjust pulse duration and fluence for desired endpoint: Vasoconstriction, Vasospasm, and/or Darkening vessel contents

* DCD is an Option. If DCD is not used another form of epidermal cooling should be used.

Transient graying of skin followed by purpura

Skin cooling reduces the rise in temperature in the epidermis, allows for higher tolerated fluences, and provides partial anesthesia. Cool compress or cold gel pack may be applied immediately before treatment to cool skin and after treatment to remove heat.

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GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

WRINKLES TREATMENT GUIDELINES (755 nm)

Skin type

Spot size (mm)

Pulse Duration (ms)

Fluence (J/cm2)

I–IV

12

3

26-40

* DCD Spray/delay/ post spray (ms) 40/40/0 50/30/0

Retreat

Comments

2-4 weeks

May apply cold compress or cold gel packs immediately after treatment to cool skin and remove heat.

* DCD is an Option. If DCD is not used another form of epidermal cooling should be used.

Skin cooling reduces the rise in temperature in the epidermis, allows for higher tolerated fluences, and provides partial anesthesia. Cool compress or cold gel pack may be applied immediately before treatment to cool skin and after treatment to remove heat.

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GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

BENIGN PIGMENTED LESIONS (755 nm) Lesion/ Skin type

Spot size (mm)

Pulse Duration (ms)

Fluence (J/cm2)

DCD

Retreat

Treatment of skin types V or VI is not recommended.

SEBORRHEIC KERATOSES 8

3

80 - 100

SOLAR LENGTIGINES, Lentigines, dyspigmentation, ephelides, solar Melanocytic BENIGN MELANOCYTIC NEVI

10

3

30 - 60

Skin Types I-IV

12

SOLAR LENGTIGINES, Lentigines, dyspigmentation, ephelides, solar Melanocytic BENIGN MELANOCYTIC NEVI

12, 15

Start at lowest fluence for treatment one and observe tissue response. Start by treating darkest lesions, which require lower fluences. Lighter spots may require higher fluence

Skin Types I-IV

Skin Types I-III

Comments

off

18

3

3

3

30 - 40

12 - 30

12 - 20

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Clinical endpoint: Darkening of the lesion and/or peri-lesional erythema

4 weeks

The DCD is generally not used for the treatment of benign pigmented lesions. For some patients, some cryogen may be beneficial. A cooling method such as cool gel pack or cold compress for brief pre and post laser epidermal cooling may be used. Endpoint: Typically, slight popping of the skin and slight whiteto-gray discoloration immediately post laser pulse, followed by slight erythema. For use of the 18mm Refer to Candela Clinical Bulletin No. 19 or Candela Clinical Educator. The distance of the handpiece to the skin should be varied dependent upon the laser-tissue interaction observed, start at 1–2 cm off of the skin.

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GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES 1064 nm HAIR REMOVAL/PFB TREATMENT PARAMETERS (1064 nm) PT. SKIN TYPE/ETHNIC ORIGIN I Scandinavian II Northern European (Caucasian) III (Darker Caucasian, Light Asian) IV (Mediterranean Asian, Hispanic) V (Middle Eastern, Lighter African American, Darker Hispanic, Indian, Native American) VI (Dark African American)

Spot size (mm) 8 10 12

Pulse Duration (ms)

3, 10, 20

40–44

18 8 10 12 15 18 8 10 12 15

26-30 80-90 50-70 40-60 30-40 24-30 60-70 40-50 20-46 20-30

3, 10, 20

18

14-20

8 10 12

50-60 30-50 18-30

3, 10, 20

15

10-30

18 8 10 12 15 18

6-20 40-50 30-40 18-30 7-30 6-18

3, 10, 20

Retreat

Comments

90-100 70-80 60-70

15

3, 10, 20

* DCD Spray/delay/ post spray (ms)

Fluence (J/cm2)

30/20/0 40/20/0 DCD spray duration and delay may be adjusted to accommodate patient comfort Do not use post laser pulse DCD cooling for hair removal DCD settings set too high or too low may cause pigmentary problems. Lower DCD setting on darker skin types

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Facial: 4 - 6 weeks Trunk: 6 - 8 weeks Leg: 8 -12 weeks Cold compress or cold gel packs may be applied after treatment to cool skin and remove heat

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Consider the 755 nm laser for hair removal treatment on Type I skin type. Test small area and wait several minutes to evaluate response prior to treatment. 1.Establish skin type 2.Select pulse duration; short= finer hair long = thicker hair 3. Select fluence based upon skin type. Look for perifollicular edema Increase fluence in a 2 J/cm2 increment until this response is seen. Balance between laser heating and DCD cooling is critical.

GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES VASCULAR TREATMENT PARAMETERS (1064 nm)

Lesion

Spot size (mm)

Pulse Duration (ms)

STARTING Fluence (J/cm2) Single pulse only (No stacking or multiple passes)

Telangiectasia

Leg Vessels

Start with 360 1.5

COOLING* DCD Spray/delay/post spray (ms)

-10 ms spray/20 ms delay

20-40 -10 ms post spray

< 0.5mm

CLINICAL ENDPOINTS & RETREATMENT Vasoconstriction, vasospasm and/or darkening of vessel contents ----Evaluate/Retreat 8-10 weeks apart

IF CLINICAL ENDPOINT NOT ACHIEVED:

1. Decrease pulse duration. 2. Increase fluence incrementally until desired result is achieved up to a 2 maximum of 320J/cm with 3mm spot 2 size and up to 500J/cm with 1.5mm spot size.

Post treatment Leg Vessels < 1 mm

3

40 - 60

Start with 220

-15-20 ms spray/20 ms delay -10 ms post spray

Leg Vessels < 1.5 mm

40-60

Start with 200

Cold compress or cold gel packs may be applied after treatment to cool skin and remove heat

Increase fluence incrementally until desired result is achieved up to a 2 maximum of 280 J/cm

-15 ms spray/20 ms delay -10 ms post spray

3

Leg Vessels 1.5-3.0 mm

60

Start with 180

-15 ms spray/20 ms delay -10 ms post spray

< 0.5 mm

Leg Vessels 0.5 – 1.5 mm

Vasoconstriction, vasospasm and/or darkening of vessel contents Evaluate/Retreat 8-12 weeks apart

Leg Vessels 20-30

3x10 30-50

180

160

40 ms spray / 20 ms delay / 0 post spray

Cold compress or cold gel packs may be applied after treatment to cool skin and remove heat

Leg Vessels 1.5-3.0 mm

60

140

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No post spray should be used on skin types IV - VI

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No post spray should be used on skin types IV - VI Increase fluence incrementally until desired result is achieved up to a 2 maximum of 260J/cm No post spray should be used on skin types IV - VI

Increase fluence incrementally until desired result is achieved.

GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

VASCULAR TREATMENT PARAMETERS (1064 nm)

Lesion

Spot size (mm)

Pulse Duration (ms)

STARTING Fluence (J/cm2) Single pulse only (No stacking or multiple passes)

COOLING* DCD Spray/delay/post spray (ms)

CLINICAL ENDPOINTS & RETREATMENT

Clinical endpoint Vasoconstriction, vasospasm, and/or darkening vessel contents

Telangiectasia

Facial Vessels <.5 mm

Start with 340 1.5

20

-10 ms/20 ms delay -10 ms post spray

Telangiectasia

Facial Vessels <1 mm

130 3

30

- 40ms spray/30 ms delay

Evaluate/Retreat 6-8 weeks Cold compress or cold gel packs may be applied after treatment to cool skin and remove heat Vasoconstriction, vasospasm and/or darkening of vessel contents ----Evaluate/Retreat 8-10 weeks apart Post treatment Cold compress or cold gel packs may be applied after treatment to cool skin and remove heat

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IF CLINICAL ENDPOINT NOT ACHIEVED:

Increase fluence incrementally until desired result is achieved up to a 2 maximum of 400J/cm No post spray should be used on skin types IV – VI

No post spray should be used on skin types IV - VI

GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

WRINKLES TREATMENT GUIDELINES (1064 nm) Area

Face & Neck Forehead

Spot Size (mm)

Pulse Duration (ms)

Fluence (J/cm2)

DCD (ms)

10

50

50

40/20/0

Retreat Comments

4-5 TX performed monthly 10

50

40-50

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40/20/0

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GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES Pre-Treatment Preparation Patient selection should be based upon the physician’s assessment of the individual patient, including a detailed medical history. The treatment protocol should be discussed in detail including risks and benefits, side effects, and expected results, alternative or concurrent therapies and follow up care. The physician should set proper expectations based upon their clinical experience. Informed consent and photographs should be obtained. Individual patient characteristics such as skin condition and type, sex, age and medications may influence the response to and efficacy associated with treatment. The response to treatment may vary on subsequent visits and the skin reaction must be carefully assessed on each visit. These guidelines are intended for use by providers who are knowledgeable in laser tissue interactions. Contra-indications and Precautions •

Accutane: Wait 6 months after the completion of Accutane therapy

•

Tattoos: Do not treat tattooed skin, including decorative, permanent makeup and radiation port tattoos.

•

Photosensitivity: History of photosensitivity to 755 nm or 1064 nm light.

•

Pregnancy: Refer to Candela Corporation Policy Number 0920-23-0814.

•

Seizure disorders: Do not treat patients with a history of light-triggered seizures.

•

Medications: Patients taking daily anticoagulation therapy, iron supplements, herbal supplements such as ginko, ginseng or garlic may bruise more readily.

•

Photosensitizing medications: Medications that induce photosensitivity within or above the 755 nm or 1064 nm wavelength range. Refer to Candela Corporation Drugs That May Cause Photosensitivity, Part Number 0920-23-0011. Stop the medication if possible for 3-5 days prior to treatment.

•

Herpes Simplex Virus (HSV) 1 & 2: Do not treat if active lesion(s) are present within the intended treatment area. Patients with a known history of frequent HSV 1&2 lesions should begin prophylaxis prior to treatment as prescribed by their physician.

•

Poorly controlled medical conditions: These patients should be carefully evaluated by their physician for medical clearance.

•

Active skin infection: Avoid treatment of open wounds and skin that is actively infected.

•

Cold sensitivity: Use caution when treating patients with Raynaud phenomenon.

•

Keloid scarring: Perform test spots prior to treating larger areas.

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GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES •

Implanted medical devices: Pacemakers, cardioverters, and other implantable devices or fillers, consult a physician.

•

Minimize overlapping: Divots or 1/8 inch (3 mm) moon hypopigmentation or hyperpigmentation may occur if overlap is greater than 30%.

•

Tanned skin: Do not treat recently tanned skin. Blisters and hypopigmentation or hyperpigmentation may occur. Allow tan to fade prior to treatment. When in doubt, compare treatment area with limited sun exposure area. Skin Preparation for Treatment

•

Topical anesthetics may be used prior to laser hair removal (LHR) per anesthetic manufacturer’s directions. HOWEVER, the topical anesthetics should be removed from the skin prior to treatment.

•

Skin must be clean and dry; remove all lotions, perfumes, make-up, deodorant, self tanners, etc.

•

When cleaning the skin with alcohol, make sure the alcohol is completely removed and the area rinsed prior to treatment.

•

Shave area to be treated immediately before treatment. DO NOT leave any stubble on skin.

•

DO NOT treat long hair, as the external hair acts as a heat sink and may burn the skin.

•

Patients should not tweeze, wax, or have electrolysis 6 weeks before treatment. Test Areas

•

Perform test areas when a concern exists regarding the potential response to treatment.

•

Select a small area in the anticipated treatment site.

•

Apply a series of pulses with several fluences.

•

Evaluate the sites in 2 weeks.

•

Treatment may proceed when the expected treatment response is noted. Laser Treatment Considerations

•

Perform User Verification Tests prior to each treatment session. This test procedure is outlined in the Operator’s Manual.

•

Position patient comfortably and confirm that the patient and everyone in the treatment room are wearing the correct protective eyewear.

•

Always hold the laser handpiece perpendicular, flat/flush and in contact to the skin to apply laser energy, otherwise an uneven application of cryogen and energy may occur and an untoward skin reaction may occur.

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GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES •

The aiming beam and laser beam are dimensionally identical, so the aiming beam can be used to accurately define the treatment area. The spot should be absolutely circular if the handpiece is held at the appropriate 90 degree angle.

•

Τo prevent debris build up on the inside of the distance gauge and maintain good visibility, follow the procedures in The Cleaning and Disinfecting Policy outlined in the Operator’s Manual.

•

Always observe the epidermal response throughout the treatment and adjust the fluence and epidermal cooling (DCD or Air) as needed. Measures to prevent untoward effects and decrease discomfort

•

Cool compress or cold gel packs may be applied immediately after treatment to decrease discomfort.

•

Large areas that are divided into sections need to be cooled just prior to treatment.

•

After each laser pulse, a gentle rub of the area with a dry gauze pad or gentle rub with a gloved hand may minimize discomfort. Treating Specific Body Areas

•

CANDELA DOES NOT recommend treating the area within the orbital rim as ocular damage may occur.

•

Insert moistened white gauze cotton in nose or ears during treatment to prevent laser absorption by unintended targets.

•

Patients with dental work may experience sensitivity when the laser pulse is administered in the perioral area; place moistened dental roll or moistened white gauze between the teeth and the inside of the lip during treatment to prevent damage to the teeth or oral mucosa.

•

Cover any area requiring shielding with moistened white gauze or a moistened white card to prevent absorption of light.

•

Before treating a full beard or scalp, be sure the patient wants this area to remain free of hair, and has signed an informed consent.

•

Use a white makeup pencil for drawing in a treatment area grid.

•

When treating anal area, place wet gauze over the anus first. Methane gas is flammable. Post-Treatment Care

•

Cool compresses or cold gel packs or chilled aloe vera gel may be applied after treatment.

•

A moisturizing SPF 30-plus sunblock should be applied prior to the next treatment.

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GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES •

Avoid irritation.

•

Resume use of usual topical agents when irritation resolves. Expected Responses

Laser Hair Removal: •

Perifollicular edema/erythema, urticaria.

•

The appearance of perifollicular edema and erythema may be altered if a topical anesthetic is used, as the topical may cause vasoconstriction or erythema.

•

After LHR the treated hair may not shed for several weeks. Patient should be reassured that the hair will eventually exfoliate.

•

Approximately 20% reduction of hair growth noted 4-8 weeks following each procedure.

Vascular lesions: •

Vasoconstriction of facial and leg veins, transient urticaria.

•

Gradual fading over several weeks to months.

•

Purpura may occur and commonly resolves within 14 days.

•

Additional treatments may be performed to achieve desired vessel response.

Benign Pigmented Lesions: •

Immediate (tan to brown) darkening of the lesion.

•

Slight peri-lesional erythema and urticaria.

•

Formation of superficial red-brown scale which resolves within 7-14 days.

•

Gradual fading over 4-6 weeks.

Wrinkles •

Immediate erythema and erythema which subsides within several hours.

•

Improvement noted following a series of 4-5 treatments performed one month apart. Untoward Responses

Laser Hair Removal and Vascular Lesions: •

Burning, blistering, scabbing, crusting, hyperpigmentation, hypopigmentation, purpura and/or herpes simplex activation, in rare cases, scarring may result.

•

Hypopigmentation or hyperpigmentation may not appear for 1-2 weeks and in rare cases may last for months or longer.

•

If hypopigmentation or hyperpigmentation occurs treatment should not be performed until pigmentation returns to normal.

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GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES Determining the end of treatment •

Multiple treatments over a period of several months may be required.

•

The provider’s judgment will determine the end of treatment. Treatment should cease when the desired clinical endpoint has been achieved.

•

Maintenance treatments may be required to maintain the desired response.

Reduction of Plume and Hair Odor in Treatment Room •

Use a smoke evacuator during treatment especially for treatment of larger areas.

•

Wear a mask to reduce breathing plume.

•

Keep room well ventilated to disperse hair odor. EPIDERMAL COOLING

The use of epidermal cooling is strongly recommended. Cooling reduces the rise in temperature in the epidermis, allows for higher tolerated fluences, and provides partial anesthesia. Candela recommends the use of it’s patented Dynamic Cooling Device™ (purchased separately) which consistently delivers doses of cryogen selected by the user. The treatment parameters above suggest recommended settings. The Dynamic Cooling Device (DCD™) also contains an optional Post Spray feature. This feature provides additional cooling and may enhance patient comfort if needed. When using the Post Spray feature, the user should start at low settings, observe patient response, and adjust if needed. SPECIAL CONSIDERATIONS WHEN USING DCD CRYOGEN SPRAY: DO NOT spray cryogen into the eyes or into an open wound. The DCD spray should be sufficient to cover the spot on the skin and provide epidermal cooling in opposition to the heat generated from the laser system. It is important to maintain both skin protection and patient comfort, so adjust the spray parameters accordingly, keeping in mind the patient’s skin type. Begin with suggested guidelines and increase or decrease settings based on the skin reaction and the patient’s tolerance.

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GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES WARNING When treating patients with the laser system and using the Dynamic Cooling Device (DCD) in conjunction with an ECG monitoring device attached to the patient, interference with the ECG monitoring device may result. CAUTION A buildup of frost may occur on the distance gauge or cryogen nozzle during extended treatments. Wipe the distance gauge or cryogen nozzle (with alcohol-soaked gauze) to prevent accumulation of frost. CAUTION If crescent shaped marks, welts or wheals are noted during treatment, the fluence or DCD settings should be adjusted immediately. Not making such an adjustment can result in subsequent crusting, blistering, and other adverse reactions. Crescents may result from not holding the distance gauge properly. If problem persists, discontinue treatment and refer to the user verification test section of the Operator’s Manual. CRYOGEN REORDER Replacement canisters of cryogen are available for order by part number. The Candela GentleCool™ canisters are only available as 2.2 lbs (1000 g) canisters: 12 canisters/case #1600-00-0212 WARNING Refer to Candela Policy for Pregnancy and the use of Lasers (Policy Number 0920-230814). CAUTION Do not use flammable products on the skin or in the vicinity of the laser system.

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