Yag Protocol

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030 These guidelines were developed from clinical experience and are subject to change as additional experience is gained. Be sure to inquire with your Candela Sales Representative, Clinical Consultant or visit MyCandela.com regularly for the latest updates and a comprehensive bibliography list of references/published articles. 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 Section 6 of the Operators Manual at the start of each treatment day and when the hand piece is changed. Check the delivery system for any damage (ie: dropped). Discontinue use of your laser delivery system if you suspect a problem.

HAIR REMOVAL/PFB TREATMENT PARAMETERS For Skin Types I-VI PT. SKIN TYPE/ETHNIC ORIGIN

Spot Size

Pulse Duration

(mm)

(ms)

FLUENCE 2

(J/cm )

RETREAT

DCD Spray/Delay Facial: 4-6 weeks

I

8

90-100

Scandinavian

10

70-80

30/20/0

Trunk: 6-8 weeks

II

12

60–70

40/20/0

Leg: 8-12 weeks

Northern European

15

40-44

18

26-30

8

80-90

III

10

50-70

(Dark Caucasian, Light Asian)

12

3, 10, 20

3, 10, 20

15

40–60 24-30

8

60-70 40-50

IV

10

(Mediterranean

12

Asian, Hispanic)

15

20-30

18

14-20

8502-00-0867 Revision E

3, 10, 20

Test small area and wait several minutes to evaluate response prior to treatment. 1.Establish skin type

DCD spray duration and delay may be adjusted to accommodate patient comfort Do not use post laser pulse DCD cooling for hair removal

30-40

18

COMMENTS

(ms)

(Caucasian)

July 2006

COOLING*

DCD settings set too high or too low may cause pigmentary problems. Lower DCD setting on darker skin types

20-46

Candela Corporation Proprietary

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

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.

Page 1 of 10

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030 HAIR REMOVAL/PFB TREATMENT PARAMETERS For Skin Types I-VI (Continued) PT. SKIN TYPE/ETHNIC ORIGIN V (Middle Eastern, Latin, Lighter African-American, Darker Hispanic, Indian, Native AM)

FLUENCE SPOT Pulse 2 SIZE (mm) Duration (J/cm ) (ms) 8 10 12

3, 10, 20

15 18

RETREAT

Facial: 4-6 weeks

30-50

Trunk: 6-8 weeks

18–30

Leg: 8-12 weeks

10-30

30/20/0

6-20

40/20/0

40-50

VI

10

30-40

(Dark AfricanAmerican)

12

18-30

15

6-30

18

6-18

COMMENTS

(ms)

50-60

8 3, 10, 20

COOLING* DCD Spray/Delay

DCD spray duration and delay may be adjusted to accommodate patient comfort Do not use post laser pulse DCD cooling for hair removal

Test small area and wait several minutes to evaluate response prior to treatment. 1.Establish skin type

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

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.

8502-00-0867 Revision E July 2006

Candela Corporation Proprietary

Page 2 of 10

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

VASCULAR TREATMENT PARAMETERS: Lesion

SPOT SIZE (mm)

Pulse Duration (ms)

STARTING

COOLING*

COOLING*

FLUENCES

DCD Spray/Delay

DCD Spray/Delay

(ms)

(ms)

Original Style Handpiece

New Style Handpiece

(J/cm

2)

CLINICAL ENDPOINTS & RETREATMENT

IF CLINICAL ENDPOINT NOT ACHIEVED:

Telangiectasia

Leg Vessels < 0.5mm

1.5

20-40

Start with 360 Single pulse only (No stacking or multiple passes)

< 1 mm

3

40-60

Start with 220 Single pulse only (No stacking or multiple passes)

1.5 mm: -50 ms spray/30 ms delay -10 ms post spray

1.5 mm: -10 ms spray/20 ms delay -10 ms post spray

Clinical endpoint vasoconstriction, vasospasm and/or darkening of vessel contents ----Evaluate/Retreat 8-10 weeks apart

3mm:

3 mm:

-50 ms spray/30 ms delay

-15-20 ms spray/20 ms delay

-10 ms post spray

-10 ms post spray

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

1. Decrease pulse

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

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

.

8502-00-0867 Revision E July 2006

Candela Corporation Proprietary

Page 3 of 10

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

VASCULAR TREATMENT PARAMETERS: (continued) Lesion

SPOT SIZE (mm)

Pulse Duration (ms)

STARTING

COOLING*

COOLING*

FLUENCES

DCD Spray/Delay

DCD Spray/Delay

(ms)

(ms)

Original Style Handpiece

New Style Handpiece

(J/cm

2)

Telangiectasia

Leg Vessels

3

40-60

Start with 200

3mm:

3mm:

< 1.5 mm Single pulse only

-50 ms spray/30 ms delay

-15 ms spray/20 ms delay

(No stacking or multiple passes)

-10 ms post spray

-10 ms post spray

CLINICAL ENDPOINTS & RETREATMENT

Clinical endpoint vasoconstriction, vasospasm and/or darkening of vessel contents Evaluate/Retreat

July 2006

Candela Corporation Proprietary

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

8-12 weeks apart Cold compress or cold gel packs may be applied after treatment to cool skin and remove heat

8502-00-0867 Revision E

IF CLINICAL ENDPOINT NOT ACHIEVED:

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

Page 4 of 10

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

VASCULAR TREATMENT PARAMETERS: (continued) Lesion

SPOT SIZE (mm)

Pulse Duration (ms)

STARTING

COOLING*

COOLING*

FLUENCES

DCD Spray/Delay

DCD Spray/Delay

(ms)

(ms)

Original Style Handpiece

New Style Handpiece

(J/cm

2)

Telangiectasia

Leg

Vessels

3

60

Start with 180

3mm:

3mm:

1.5-3.0 mm Single pulse only

-50 ms spray/30 ms delay

-15ms spray/20ms delay

(No stacking or multiple passes)

-10 ms post spray

-10 ms post spray

CLINICAL ENDPOINTS & RETREATMENT

Clinical endpoint vasoconstriction, vasospasm and/or darkening of vessel contents Evaluate/Retreat

July 2006

Candela Corporation Proprietary

Increase fluence incrementally until desired result is achieved up to a maximum of 2 260J/cm

8-12 weeks Cold compress or cold gel packs may be applied after treatment to cool skin and remove heat

8502-00-0867 Revision E

IF CLINICAL ENDPOINT NOT ACHIEVED:

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

Page 5 of 10

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

VASCULAR TREATMENT PARAMETERS: For skin types I-IV only (continued) Lesion

SPOT SIZE (mm)

Pulse Width (ms)

STARTING

COOLING*

COOLING*

FLUENCES

DCD Spray/Delay

DCD Spray/Delay

(ms)

(ms)

Original Style Handpiece

New Style Handpiece

(J/cm

2)

CLINICAL ENDPOINTS & RETREATMENT

IF CLINICAL ENDPOINT NOT ACHIEVED:

Clinical endpoint vasoconstriction, vasospasm, and/or

Do Not Use 3 mm spot size on the face

Telangiectasia

Facial Vessels <.5 mm

1.5

20

Start with 340 Single pulse only (No stacking or multiple passes)

1.5 mm

1.5 mm:

-50 ms spray/30 ms delay

-10 ms/20 ms delay

-10 ms post spray

-10 ms post spray

darkening vessel contents Evaluate/Retreat 6-8 weeks

0.5-1.0 mm

1.5

40

Start with 250 Single pulse only (No stacking or multiple passes)

8502-00-0867 Revision E July 2006

Increase fluence incrementally until desired result is achieved up to a maximum of 2 400J/cm

Candela Corporation Proprietary

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

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

Page 6 of 10

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

Skin Tightening/Wrinkle Reduction Spot Size (mm)

Area

Pulse Duration

Fluence

DCD

(J/cm2)

(ms)

Retreat

Comments

(ms)

Face & Neck

10

50

50

40/20/0

4-5 TX performed monthly

see below

Forehead

10

50

40-50

40/20/0

4-5 TX performed monthly

see below

•

Single pulsing with minimal overlap (= 20%).

•

Multiple passes (2-3) are required at above settings to achieve collagen contraction.

•

Treat face in sections (for example; first, three passes on the left cheek, then the right cheek, then the forehead ).

General Guidelines for all Laser treaments: Consult the Clinical In-service Manual for additional information, including contraindications and possible adverse affects. Conduct a patient consultation complete with medical history prior to treatment. Skin Preparation •

Clean and dry the skin thoroughly including removing all topic agents prior to treatment.

•

Shave area to be treated thoroughly prior to treatment,

•

Do not treat long hair, external hair may act as a heat sink and possibly burn the skin.

•

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

8502-00-0867 Revision E July 2006

Candela Corporation Proprietary

Page 7 of 10

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

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.

Treatment Considerations: •

Ensure that proper protective eyewear is in position prior to treatment.

•

Do not treat skin within the orbital rim.

•

The distance gauge should be held at a perpendicular angle to the skin (90 degrees).

•

The distance gauge rim should be in contact with the skin.

•

Apply single pulses without overlap.

•

Perform 3 consecutive passes.

•

Perform a consecutive vertical, horizontal then diagonal pass to treat confluently and avoid “skip” areas.

•

40 J/cm2 may be used on the forehead if 50 J/cm2 is not tolerated.

•

The use of epidermal cooling reduces the rise in temperature in the epidermis, allows for higher tolerated fluences, and provides partial anesthesia. Candela recommends the use of the Dynamic Cooling Device which delivers doses of cryogen selected by the user. 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.

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.

8502-00-0867 Revision E July 2006

Candela Corporation Proprietary

Page 8 of 10

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030 •

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 may be applied to decrease edema and discomfort.

•

A moisturizing SPF 30+ sunblock should be applied before the patient leaves the office.

•

Avoid irritation of the treatment area.

•

Resume usual topical agents when irritation resolves.

Expected Responses: Laser Hair Removal: •

Perifollicular edema/erythema, uticaria

•

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 laser hair reduction (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.

Untoward Responses •

LHR and Vascular lesions:

•

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

•

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

•

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

Determining the end of treatment •

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

8502-00-0867 Revision E July 2006

Candela Corporation Proprietary

Page 9 of 10

GentleYAG Family of Laser Systems Treatment Guidelines Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030 •

The provider’s judgement 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 laser mask to reduce breathing plume.

•

Keep room well ventilated to disperse hair odor.

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. 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. Increasing cryogen spray durations does not equate to increased epidural protection in all skin types, especially darker skin types.

WARNING When treating patients with the GentleYAG laser and using the Dynamic Cooling Device (DCD) in conjunction with 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 during extended tr eatments. Wipe the distance gauge with a warm moist cloth to prevent accumulation of frost.

CAUTION If crescent shaped marks, welts or wheals are noted during treatment, the fluence and 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 user verification test section of the Operator’s Manual. CRYOGEN REORDER - Replacement canisters of cryogen are ordered by the part number. Candela GentleCool

tm

canisters sizes are available in 1000 grams

only for this product: 12 canisters/case #1600-00-0212

CAUTION Do not use Flammable products on the skin or in the vicinity of the laser.

8502-00-0867 Revision E July 2006

Candela Corporation Proprietary

Page 10 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

Approval of Clinical Parameters By Dr.Robin Stones In Compliance With Standard P1.1 For Prescribed Techniques and Prescribed Technology Dealing With Contradictions And Complications For Candela VBEAM PEERFECT And Candela GentleLaserscope Class VI – Lyra and Aura Lasers

Revision :As per published protocols Issue date: October 2007 Review Date: September 2009 Issued by: Alex Zarneh (unless laser software / hardware is upgraded or clinical reasons justify amendment)

8502-00-0891 Revision 07

Candela Proprietary

Sheet 1 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

Lesion

Spot size (mm)

Pulse Duration (ms)

Fluence (J/cm2)

5 7 10 3x10

6,10,20 6,10,20 6,10,20 10

7.5-12 7-12 5.5-7.5 11-14

DCD Spray / Delay

Retreat (weeks)

(ms)

Telangiectasia Facial

medium 30/20

4-6

Nasal

5, 7 10 3x10

Leg 3x10

Telangectatic Matting

7 10

8502-00-0891 Revision 07

Comments

40

8-12 6.5-7.5 10-12

10,20,30,

11-18

----------

------------

40

15-25

10,20,30

11-15

medium 30/20 ------------high 40/20

medium 30/20

6-7

Candela Proprietary

8-12

6-10

Double or triple pulse depending on the refill of the vessel. Use 3x10 on linear vessels. For vessels which do not clear immediately: treat first with the round spot followed by the 3x10 spot. Use of shorter pulse durations will induce purpura but may clear vessels faster.

Select longer pulse durations to decrease purpura.

Larger spot size may improve results. Expect erythema.

Sheet 2 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

PhotoRejuvenation Wrinkles

Diffuse Facial Telangiectasia Rosacea

7 10

10 6

7 6

----------

---------

-----------

7 10

6,10,20

8-11 5.0 -7

12 ---------

Dyschromia Benign Epidermal Pigmented Lesions

7

40

10

4–6

5-7

------------

10

medium 30/20

-------------

--------------

--------------------------------------------Press the lens firmly onto the skin until the skin turns pale.

7-8 5-7

---------

-----------

-------------

7PL 10PL

1.5

7-10 5.5-8

Treat full face with one pass using dyschromia parameters followed by an additional pass using wrinkles/diffuse redness parameters. Diffuse vessels/background blush:may treat the entire cosmetic unit w/ 50% overlap using a larger spot. Shorter pulse durations and higher fluences may induce purpura. Vessels may be pulsed 2-3 times to obtain transient intravascular purpura, which will disappear and become bluish pink”dusky erythema.” May use 10-12mm spot then retreat larger vessels immediately with smaller spot size.

Clinical endpoint = darkening or color change at the treatment siteobserve tissue response..Always start with the lowest fluence and observe the lesion for several minutes before adjusting fluence.Darker lesions may require lower fluences.

OFF

Peri-lesional erythema may occur.

Poikiloderma of Civatte

Cherry Angioma; Spider Angioma

10

10

5-6.5

medium 30/20

4-6

3 5 7 10

1.5

12 10 8-11.5 5-10

medium 30/20

4-6

8502-00-0891 Revision 07

Candela Proprietary

Always perform test spots laterally. Apply pulses close to one another to minimize uneven pattern. Feather edge(decrease fluence by 1-2 J/cm2 @ periphery) to minimize sharp line of demarcation. Expect erythema Use white, moist template to isolate lesion. Double pulse center of angioma first, then treat peripheral vessels.Clinical endpoint=purpura.

Sheet 3 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

Hemangiomas

5

1.5

8-10 medium 30/20

7 6-10

10

5-6

high 40/20 for larger, thicker lesions

2 weeks (neonate and Infant) 8-12 weeks (Adult)

Venous Lake 7 Port Wine Stains

5 7

1.5

7-10

medium 30/20

4-6

0.45

10-15

medium 30/20

8-12

1.5

8-12 4-7.5

Facial Neck, Head

Trunk, Extremities

Hypertrophic PWS

7 10

5 7 10 5 7 10

1.5

6-12 6-7.5 5-7

1.5

10-15 10-15 10

Use lower fluences on neck and extremities.

medium 30/20

Ectatic vessels associated with hypertrophic PWS may be double pulsed.

high 40/20

Warts

Non- Facial

----------------------

Facial

Inflammatory Acne Vulgaris

Scars

5 7

1.5

12-15

0

----------

----------

------------

----------

5

1.5

9-9.5

medium 30/20

3

4.5

10

7 -------10

8502-00-0891 Revision 07

7-8 ----------.45, 1.5

2-3

medium 30/20

4

medium 30/20

4-6

4-5

Candela Proprietary

Use caution and lower fluences for neonates and infants. Treat proliferative hemangiomas every two weeks.Improper treatment may cause scars. Refer to specialist if not within your typical practice.Clinical endpoint=purpura. Two treatments may be required. Clinical endpoint=purpura. Use caution lower fluences and DCD for neonates and infants. Clinical endpoint= purpura

Non-Facial Warts: Pare thick warts before treatment. Cryogen may be sprayed pre and post laser to cool area. Topical or injected anesthetic may be utilized. Pulse stack (1-3 pulses) if tolerated. Clinical endpoint= purpura. Treat a 1-2 mm margin of uninvolved skin with single pulses at the periphery of the wart. Use of home topical therapy may increase efficacy. Facial Warts:CAUTION: Single pulses only Observe tissue response Use DCD

Slight redness and light purpura may be experienced, observe closely. Treatment may begin after suture removal. Newer more vascular scars may respond better than older,atrophic scars. Clinical endpoint=erythemapurpura.

Sheet 4 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

Striae

10

0 .45

3-7

medium 30/20

4-6

Benign Cutaneous Vascular Gynecological Lesions including Vulvodynia Psoriasis

7

0.45

5-6

medium 30/20

8

0.45,1.5

6-8 4-8 3-8

optional, may use 30/20 for patient comfort

Newer more vascular striae may respond better than older, atrophic striae. Clinical endpoint=erythemapurpura Clinical endpoint is light purpura,

2-4 5 7 10

May require several treatments. Remove scale prior to treatment.Clinical response =purpura.

BOLD SETTINGS ARE DISPLAY SCREEN DEFAULT PARAMETERS FOR: Vbeam Perfecta, Platinum, Aesthetica SPECIAL CONSIDERATIONS WHEN USING DCD CRYOGEN SPRAY:

SELECT MEDIUM (30/20) DEFAULT SETTING ADJUST BASED UPON EPIDERMAL RESPONSE AND PATIENT COMFORT. 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. Do NOT Spray Cryogen into the eyes or into an open wound. The DCD spray should be sufficient to cover the treatment area and provide epidermal cooling in opposition to the heat generated from the laser. It is important to maintain both skin protection and patient comfort. Begin with suggested guidelines and increase or decrease settings based on the skin reaction and the patient’s tolerance. Darker skin types do not tolerate excessive amounts of DCD spray. Use caution when increasing DCD spray time on darker skin types. Pre and post cooling with a cold compress may be beneficial. SPECIAL CONSIDERATIONS WHEN DCD CRYOGEN SPRAY IS OMITTED: If the Dynamic Cooling Device Option is not utilized and cooling is desired, another method of cooling (air cooling or contact cooling, etc) should be utilized. Several applications ( non-facial warts, benign epidermal pigmented lesions) are treated without DCD cryogen spray. Application of a cool compress following the treatment may be desired in this situation.

8502-00-0891 Revision 07

Candela Proprietary

Sheet 5 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

A.

Pre Treatment Preparation 1.

Pretreatment visit Patient selection should be based upon the physician’s assessment of the individual patient. including a detailed medical and medication history. The treatment protocol should be discussed in detail including risks & 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.

2. Contraindications and Precautions a.

Accutane: Wait 6 months after the completion of Accutane therapy

b.

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

c.

History of photosensitivity to 595 nm light

d.

Pregnancy: Refer to Candela Corporation policy # 0920-23-0814.

e.

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

f.

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

g.

Photosensitizing Medications: Medications that induce photosensitivity or medications within or above the 595 wavelengths. Refer to Candela Corporation Drugs That May Cause Photosensitivity. Stop the medication if possible for 3-5 days prior to treatment.

h

Topical Medications and skin care products: Stop 72 hours pre and post. Self tanning products must be removed.

i.

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.

j.

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

k.

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

l.

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

m.

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

n.

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

o.

Sunburn: Postpone treatment for 10-14 days after acute unprotected sun exposure.

8502-00-0891 Revision 07

Candela Proprietary

Sheet 6 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

3.

Skin Preparation for Treatment a.

Topical anesthetics may be used prior to laser treatment per manufacturers’ directions. HOWEVER, the topical anesthetics should be removed from the skin prior to treatment.

b.

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

c.

Candela does not recommend the use of alcohol to clean the skin prior to treatment. Rinse the treatment area thoroughly with water after cleaning with soap (or similar mild cleanser) and water.

d.

4.

Shave hair-bearing areas prior to treatment.

Test Areas a.

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 1-3 pulses with several incremental increased fluences.

b.

Evaluate the sites in 2 weeks

c.

Treatment may proceed when the expected treatment response is noted.

B. Procedure for establishing the Purpura – Free Threshold 1.

Select spot size, pulse duration, fluence and DCD settings.

2.

Apply escalating fluences until purpura appears, then reduce the energy by 0.25- 0.50 J/cm2.

3.

Optimum parameters may be achieved by matching pulse duration to vessel size.

Note: Treatment at sub-purpuric fluences may necessitate additional treatments for complete clearance of vessels on the face.

C

Laser Treatment Considerations 1.

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

2.

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

3

Always hold the laser handpiece perpendicular 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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Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

4.

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.

5.

Always observe the epidermal response throughout the treatment and adjust the fluence and DCD as needed.

6.

Measures to prevent untoward effects and decrease discomfort Cool compress or cold gel packs may be applied immediately before, during and 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 gloved hand may minimize discomfort.

7.

Treating Specific Body Areas Upper and lower eyelids may only be treated following the insertion of intraocular corneal eye shields. 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; a moistened dental roll or moistened white gauze between the teeth during treatment to prevent unintentional treatment of adjacent tissue.. Cover any area requiring shielding with moistened white gauze or a moistened white card to prevent absorption of light. Refer to the Laser Accessory Vendor sheet for additional product information. 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.

8.

The Cleaning and Disinfecting Policy is outlined in Section 6 of the Operator’s Manual. Follow the procedures outlined in the distance gauge cleaning protocol to prevent build up of debris on the distance gauge and to maintain good visibility. The Compression Handpiece Distance Gauge Cleaning and Disinfecting Policy is located in Section 6.

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Candela Proprietary

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Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

D.

Post-treatment care 1.

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

2.

A moisturizing SPF 30+ sunblock should be applied per manufacturer’s instructions to sun-exposed areas prior to the next treatment.

E.

F.

3.

Clean the area gently and avoid irriation from friction or rubbing.

4.

Resume use of usual topical agents when any irritation resolves.

Expected Responses 1.

Purpuric Treatment: purpura, edema, minimal to moderate discomfort relieved by cold compress or cool gel pack.

2.

Non-Purpuric treatment: edema, erythema, and a tight sensation with minimal discomfort.

Untoward Effects Itching(hive-like response) Burning, blistering, scabbing, crusting, color and/or texture changes Herpes simplex activation Hyperpigmentation( darkening of the skin, transient or long term) Hypopigmentation( lightening of the skin; transient, long term or possibly permanent) If hypo- or hyperpigmentation occurs treatment should not be performed until pigmentation returns to normal. Scarring (rare, possibly permanent)

G.

Determining the end of treatment 1.

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

2.

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

3.

H.

Maintenance treatments may be required to maintain the desired response .

Additional Warnings and Precautions

CAUTION A buildup of frost may occur on the distance gauge during extended treatments. Wipe the distance gauge with a warm moist cloth to prevent accumulation of frost

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Candela Proprietary

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Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

CAUTION If crescent shaped marks, welts or wheals are noted during treatment, the fluence and 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 user verification test section of the Operator’s Manual. CAUTION Do not use Flammable products on the skin or in the vicinity of the laser. Warning When using the Vbeam laser with the Dynamic Cooling Device (DCD) in use in conjunction with an ECG monitoring device interference with the ECG monitoring device may result. Warning Oxygen will accelerate combustion of any flammable material. Never direct oxygen (with or without gasses) toward or over the laser field. Extreme caution should be used. When oxygen is in use, gauze, sponges, and hair near the treatment area should be moistened with water. Be aware that hairspray, gel, deodorants, and other grooming products may contain flammable substances. Caution Treatment to areas bearing hair may cause the hair to be singe and may cause it to ignite. A fire extinguisher should be available.

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Candela Proprietary

Sheet 10 of 10