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 Spot Pulse FLUENCE COOLING* RETREAT COMMENTS
TYPE/ETHNIC Size Duration 2
(J/cm ) DCD Spray/Delay
ORIGIN (mm) (ms) (ms)
I 8 90-100 Facial: 4-6 weeks Test small area and
30/20/0 Trunk: 6-8 weeks wait several minutes
Scandinavian 10 70-80
to evaluate response
II 12 3, 10, 20 60–70 40/20/0 Leg: 8-12 weeks prior to treatment.
Northern 15 40-44 1.Establish skin type
European DCD spray duration and Cold compress
18 26-30 2.Select pulse
(Caucasian) delay may be adjusted or cold gel packs duration
to accommodate patient may be applied short= finer hair
comfort
8 80-90 after treatment long = thicker hair
Do not use post laser to cool skin and
III 10 50-70 pulse DCD cooling for 3. Select fluence
remove heat
(Dark Caucasian, 12 3, 10, 20 40–60 hair removal based upon skin type.
Light Asian) Look for perifollicular
15 30-40
DCD settings set too edema
18 24-30
high or too low may Increase fluence in a
cause pigmentary 2 J/cm2 increment
8 60-70 problems. Lower DCD until this response is
setting on darker skin seen.
IV 10 40-50 types Balance between
(Mediterranean 12 3, 10, 20 20-46 laser heating and
Asian, Hispanic) 15 20-30 DCD cooling is critical.
18 14-20

8502-00-0867 Revision E Candela Corporation Proprietary Page 1 of 10

July 2006
 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 SPOT Pulse FLUENCE COOLING* RETREAT COMMENTS
TYPE/ETHNIC SIZE (mm) Duration 2
(J/cm ) DCD Spray/Delay
ORIGIN (ms)
(ms)
V 8 50-60 Facial: 4-6 weeks Test small area and
Trunk: 6-8 weeks wait several minutes to
(Middle Eastern, 10 30-50
evaluate response
Latin, Lighter Leg: 8-12 weeks
12 3, 10, 20 18–30 prior to treatment.
African-American,
Darker Hispanic, 15 10-30 30/20/0 1.Establish skin type
Indian, Native 18 6-20 40/20/0 Cold compress 2.Select pulse
AM) or cold gel packs duration
DCD spray duration and
8 40-50 delay may be adjusted to may be applied short= finer hair
VI 10 30-40 accommodate patient after treatment to long = thicker hair
comfort cool skin and
(Dark African- 12 3, 10, 20 18-30 3. Select fluence
American) Do not use post laser remove heat
15 6-30 based upon skin type.
pulse DCD cooling for
18 6-18 hair removal Look for perifollicular
edema
Increase fluence in a 2
J/cm2 increment until
this response is seen.

8502-00-0867 Revision E Candela Corporation Proprietary Page 2 of 10

July 2006
 GentleYAG Family of Laser Systems Treatment Guidelines
Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

VASCULAR TREATMENT PARAMETERS:

Lesion SPOT Pulse STARTING COOLING* COOLING* CLINICAL IF CLINICAL
SIZE Duration FLUENCES DCD Spray/Delay DCD Spray/Delay ENDPOINTS & ENDPOINT NOT
(mm) (ms) 2)
RETREATMENT ACHIEVED:
(J/cm (ms) (ms)
Original Style New Style Handpiece
Handpiece

Telangiectasia
Clinical endpoint 1. Decrease pulse
Leg Vessels vasoconstriction, width.
< 0.5mm 1.5 vasospasm and/or 2 Increase fluence
20-40 Start with 360 1.5 mm: 1.5 mm: darkening of vessel incrementally until
contents desired result is
Single pulse only ----- achieved up to a
-50 ms spray/30 ms delay -10 ms spray/20 ms delay
maximum of
(No stacking or -10 ms post spray -10 ms post spray Evaluate/Retreat 2
320J/cm with 3mm
multiple passes) 8-10 weeks apart spot size and up to
2
500J/cm with
1.5mm spot size.
< 1 mm 3 40-60 Start with 220 3mm: 3 mm: Post treatment
Cold compress or
cold gel packs may
Single pulse only -50 ms spray/30 ms delay -15-20 ms spray/20 ms delay be applied after No post spray should
-10 ms post spray -10 ms post spray treatment to cool be used on skin types
(No stacking or skin and remove IV - VI
multiple passes) heat .
.

8502-00-0867 Revision E Candela Corporation Proprietary Page 3 of 10

July 2006
 GentleYAG Family of Laser Systems Treatment Guidelines
Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

VASCULAR TREATMENT PARAMETERS: (continued)

Lesion SPOT Pulse STARTING COOLING* COOLING* CLINICAL IF CLINICAL

SIZE Duration FLUENCES DCD Spray/Delay DCD Spray/Delay ENDPOINTS & ENDPOINT NOT
(mm) (ms) 2)
RETREATMENT ACHIEVED:
(J/cm (ms) (ms)
Original Style New Style Handpiece
Handpiece

Telangiectasia Clinical endpoint

vasoconstriction, Increase fluence
vasospasm and/or incrementally until
Leg Vessels 3 40-60 Start with 200 3mm: 3mm: darkening of vessel desired result is
contents achieved up to a
< 1.5 mm
Single pulse only -50 ms spray/30 ms delay -15 ms spray/20 ms delay maximum of 280
2
Evaluate/Retreat J/cm
-10 ms post spray -10 ms post spray
(No stacking or
8-12 weeks apart
multiple passes)

Cold compress or No post spray

cold gel packs may should be used on
be applied after skin types IV - VI
treatment to cool
skin and remove
heat

8502-00-0867 Revision E Candela Corporation Proprietary Page 4 of 10

July 2006
 GentleYAG Family of Laser Systems Treatment Guidelines
Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

VASCULAR TREATMENT PARAMETERS: (continued)

Lesion SPOT SIZE Pulse STARTING COOLING* COOLING* CLINICAL IF CLINICAL
(mm) Duration FLUENCES DCD Spray/Delay DCD Spray/Delay ENDPOINTS & ENDPOINT NOT
(ms) 2)
RETREATMENT ACHIEVED:
(J/cm (ms) (ms)
Original Style New Style Handpiece
Handpiece

Telangiectasia Clinical endpoint

vasoconstriction, Increase fluence
vasospasm and/or
Leg Vessels
3 60 Start with 180 3mm: 3mm: darkening of vessel
incrementally until
desired result is
contents achieved up to a
1.5-3.0 mm
Single pulse only -50 ms spray/30 ms delay -15ms spray/20ms delay maximum of
2
Evaluate/Retreat 260J/cm
-10 ms post spray -10 ms post spray
(No stacking or
8-12 weeks
multiple passes)

Cold compress or
cold gel packs may No post spray
be applied after should be used on
treatment to cool skin types IV - VI
skin and remove
heat

8502-00-0867 Revision E Candela Corporation Proprietary Page 5 of 10

July 2006
 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 Pulse STARTING COOLING* COOLING* CLINICAL IF CLINICAL
SIZE Width FLUENCES DCD Spray/Delay DCD Spray/Delay ENDPOINTS & ENDPOINT NOT
(mm) (ms) 2)
RETREATMENT ACHIEVED:
(J/cm (ms) (ms)
Original Style New Style Handpiece
Handpiece

Telangiectasia
Clinical endpoint Do Not Use 3 mm
Facial Vessels 1.5 20 Start with 340 1.5 mm vasoconstriction, spot size on the face
<.5 mm 1.5 mm: vasospasm, and/or
darkening vessel
Single pulse only -50 ms spray/30 ms delay Increase fluence
-10 ms/20 ms delay contents
incrementally until
(No stacking or -10 ms post spray -10 ms post spray desired result is
multiple passes) achieved up to a
Evaluate/Retreat
maximum of
6-8 weeks 400J/cm
2

0.5-1.0 mm 1.5 40 Start with 250

Cold compress or No post spray should
cold gel packs may be used on skin types
Single pulse only be applied after IV - VI
treatment to cool
(No stacking or
skin and remove
multiple passes)
heat

8502-00-0867 Revision E Candela Corporation Proprietary Page 6 of 10

July 2006
 GentleYAG Family of Laser Systems Treatment Guidelines
Models: 9914-0950, 9914-0960, 9914-1020 and 9914-1030

Skin Tightening/Wrinkle Reduction

Spot Pulse Fluence DCD Retreat Comments

Size Duration (J/cm2) (ms)
Area (mm) (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 Candela Corporation Proprietary Page 7 of 10

July 2006
 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 Candela Corporation Proprietary Page 8 of 10

July 2006
 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 Candela Corporation Proprietary Page 9 of 10

July 2006
 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.

tm
CRYOGEN REORDER - Replacement canisters of cryogen are ordered by the part number. Candela GentleCool 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 Candela Corporation Proprietary Page 10 of 10

July 2006
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 Pulse Fluence DCD Retreat Comments

size Duration (J/cm2) Spray / Delay (weeks)
(mm) (ms) (ms)
Telangiectasia Double or triple pulse
5 6,10,20 7.5-12 medium depending on the refill of
Facial 7 6,10,20 7-12 30/20 the vessel.
10 6,10,20 5.5-7.5 Use 3x10 on linear vessels.
3x10 10 11-14 For vessels which do not
4-6 clear immediately: treat first
with the round spot followed
by the 3x10 spot.
5, 7 40 8-12 Use of shorter pulse
Nasal 10 6.5-7.5 durations will induce
3x10 10-12 purpura but may clear
vessels faster.

Leg 10,20,30, 11-18 medium

30/20 Select longer pulse
3x10 ---------- ------------ ------------- durations to decrease
high 8-12 purpura.
40 15-25 40/20

Telangectatic 7 10,20,30 11-15 medium 6-10 Larger spot size may

Matting 30/20 improve results.
10 6-7 Expect erythema.

8502-00-0891 Revision 07 Candela Proprietary Sheet 2 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

Photo- Treat full face with one

Rejuvenation pass using dyschromia
parameters followed by an
Wrinkles additional pass using
7 10 7 medium 4–6 wrinkles/diffuse redness
10 6 6 30/20 parameters.
Diffuse vessels/background
blush:may treat the entire
---------- --------- ----------- cosmetic unit w/ 50%
Diffuse Facial overlap using a larger spot.
Telangiectasia 7 6,10,20 8-11 Shorter pulse durations and
Rosacea 10 5.0 -7 higher fluences may induce
purpura.
Vessels may be pulsed 2-3
12 40 5-7 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.
Dyschromia
Benign 7 10 7-8 ---------------------------------------------
Press the lens firmly onto the skin
Epidermal
until the skin turns pale.
Pigmented 10 5-7
Lesions
--------- ----------- ------------- OFF Clinical endpoint = darkening or
color change at the treatment site-
observe tissue response..Always
start with the lowest fluence and
7PL 1.5 7-10 observe the lesion for several
10PL 5.5-8 minutes before adjusting
fluence.Darker lesions may require
lower fluences.

Peri-lesional erythema may occur.

Poikiloderma of Always perform test spots

Civatte laterally. Apply pulses
10 10 5-6.5 medium 4-6 close to one another to
30/20 minimize uneven pattern.
Feather edge(decrease
fluence by 1-2 J/cm2 @
periphery) to minimize
sharp line of demarcation.
Expect erythema
Cherry 3 1.5 12 medium 4-6 Use white, moist template
Angioma; 5 10 30/20 to isolate lesion. Double
Spider 7 8-11.5 pulse center of angioma
Angioma 10 5-10 first, then treat peripheral
vessels.Clinical
endpoint=purpura.

8502-00-0891 Revision 07 Candela Proprietary Sheet 3 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

Hemangiomas 5 1.5 8-10 2 weeks Use caution and lower

medium (neonate fluences for neonates and
30/20 and infants.
Infant) Treat proliferative
7 8-12 hemangiomas every two
6-10 high 40/20 weeks weeks.Improper treatment
for larger, (Adult) may cause scars. Refer to
thicker specialist if not within your
10 5-6 lesions typical practice.Clinical
endpoint=purpura.
Venous Lake Two treatments may be
7 1.5 7-10 medium 4-6 required.
30/20 Clinical endpoint=purpura.
Port Wine Use caution lower
Stains 5 fluences and DCD for
7 0.45 10-15 medium 8-12 neonates and infants.
Facial 30/20 Clinical endpoint=
7 1.5 8-12 purpura
Neck, Head 10 4-7.5

Use lower fluences on neck

Trunk, 5 6-12 medium and extremities.
Extremities 7 1.5 6-7.5 30/20
10 5-7
Ectatic vessels associated
5 10-15 with hypertrophic PWS may
Hypertrophic 7 1.5 10-15 high be double pulsed.
PWS 10 10 40/20

Warts Non-Facial Warts:

Pare thick warts before treatment.
Cryogen may be sprayed pre and
5 post laser to cool area. Topical or
Non- Facial 7 1.5 12-15 0 injected anesthetic may be utilized.
Pulse stack (1-3 pulses) if
tolerated. Clinical endpoint=
purpura. Treat a 1-2 mm margin
---------------------- ---------- ---------- ------------ ---------- 2-3 of uninvolved skin with single
pulses at the periphery of the wart.
medium Use of home topical therapy may
increase efficacy.
Facial 5 1.5 9-9.5 30/20
Facial Warts:CAUTION:
Single pulses only
Observe tissue response
Use DCD
Inflammatory Slight redness and light
Acne Vulgaris 10 3 4.5 medium 4 purpura may be
30/20 experienced, observe
closely.
Scars 7 7-8 medium 4-6 Treatment may begin after
-------- ----------- 30/20 suture removal.
Newer more vascular scars
10 4-5 may respond better than
.45, 1.5
older,atrophic scars.
Clinical
endpoint=erythema-
purpura.

8502-00-0891 Revision 07 Candela Proprietary Sheet 4 of 10

Candela Vbeam Perfecta, Platinum, Aesthetica Treatment Guidelines

Striae 10 0 .45 3-7 medium 4-6 Newer more vascular striae

30/20 may respond better than
older, atrophic striae.
Clinical
endpoint=erythema-
purpura
Benign 7 0.45 5-6 medium 8 Clinical endpoint is light
Cutaneous 30/20 purpura,
Vascular
Gynecological
Lesions
including
Vulvodynia
Psoriasis 2-4 May require several
5 6-8 optional, treatments. Remove scale
7 0.45,1.5 4-8 may use prior to treatment.Clinical
10 3-8 30/20 response =purpura.
for patient
comfort

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. Shave hair-bearing areas prior to treatment.

4. 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.

8502-00-0891 Revision 07 Candela Proprietary Sheet 7 of 10

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.

8502-00-0891 Revision 07 Candela Proprietary Sheet 8 of 10

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.
3. Clean the area gently and avoid irriation from friction or rubbing.
4. Resume use of usual topical agents when any irritation resolves.

E. 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.

F. 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. Maintenance treatments may be required to maintain the desired response .

H. 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

8502-00-0891 Revision 07 Candela Proprietary Sheet 9 of 10

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.

8502-00-0891 Revision 07 Candela Proprietary Sheet 10 of 10