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The document outlines treatment guidelines for a GentleMAX Pro laser system including recommendations for hair removal, vascular lesions, wrinkles treatment and safety precautions.

It provides recommendations for hair removal treatment including spot size, pulse duration, fluence and retreat times based on skin type and area being treated.

The document states that the DCD spray should provide sufficient epidermal cooling and that settings should be adjusted based on skin reaction and patient tolerance. It also warns not to spray into eyes or open wounds and of potential ECG interference.

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
Spot size Pulse Fluence * DCD Spray/delay/ Retreat Comments
(mm) Duration (ms) (J/cm2) post spray (ms)
8 30-40
I - II 10 26-35
(Caucasian red hair,
12 3 26-36
freckles, fair skin, blue
15 20–30 40/40/0 Skin types I-III
eyes)
18 14-20
50/30/0 Test small area and wait several minutes
8 26-40
to evaluate response prior to treating entire
III 10 16-30 50/40/0 area.
(Darker Caucasian, light 12 3 18-30
Asian) 15 16-26
18 10-16 Facial:
8 22-30 4 - 6 weeks
IV 10 16-26 Skin types IV-VI and tanned skin
(Mediterranean Asian, 3 Trunk:
12 16-20 40/30/0
Hispanic) 6 - 8 weeks Pre-treat with prescription strength
15 10-20
18 8-16 40/40/0 hydroquinone for at least 2 weeks prior to
Leg: treatment. Test small area and wait 1-2
V 8 22-26 10 -12 weeks
50/30/0 weeks prior to treating entire area to
(Middle Eastern, 10 16-20 evaluate tissue response. DCD may need
Hispanic, 12 14-20
3 50/40/0 to be adjusted when altering fluence.
Asian, light skinned 15 10-20 Do not treat recently tanned skin.
African American,
Indian, Native American) 18 6-16
Allow tan to fade prior to treatment.
8 22-26
10 16-20 Consider the 1064 nm for hair removal
VI 3 40/40/0
12 10-20 treatment on Type V-VI skin type.
(Dark African American) 50/30/0
15 7-20
18 6-16

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Candela Corporation Proprietary
GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

VASCULAR LESIONS GUIDELINES (755 nm)

Spot Pulse * DCD


Lesion/ Skin Fluence Spray/delay
size Duration Retreat Comments
type (J/cm2) /post spray
(mm) (ms)
(ms)

50/30/0 Pulse each area once. Endpoint is perivascular erythema, subtle


8 3 40 - 50
60/40/0 edema of vessel, or no vessel re-fill.
Telangiectasia

FACE
4-6 weeks
60-80 Skin types I-II
Skin Types for diffuse Consider longer pulse duration within the recommended range for
I - III redness. larger vessels (0.4 to 1.6 mm). Adjust pulse duration and fluence
6 20 - 60 50 /20/0 for desired endpoint:
80-90 Vasoconstriction,
for discrete Vasospasm, and/or
vessels Darkening vessel contents
Telangiectasia
8 3 50-80 Consider longer pulse duration within recommended range for
LEGS
larger vessels (> 0.6 mm). Adjust pulse duration and fluence for
desired endpoint:
Vessels
10-12 weeks Vasoconstriction,
Vasospasm, and/or
Skin Types
6 20-60 85-90 50 /20/0 Darkening vessel contents
I-III

Hemangioma 8 3 60-70 90/80/0 3-4 weeks

40/40/0 Face: 8 weeks Transient graying of skin followed by purpura


Port Wine
8 3 35- 85 50/40/0 Extremities: 12
Stain
60/40/0 weeks

* 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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Candela Corporation Proprietary
GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

WRINKLES TREATMENT GUIDELINES (755 nm)

Spot Pulse
Fluence
* DCD
Skin type size Duration
(J/cm2) Spray/delay/ Retreat Comments
(mm) (ms) post spray (ms)
40/40/0
May apply cold compress or cold gel packs immediately
I–IV 12 3 26-40 2-4 weeks
50/30/0 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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Candela Corporation Proprietary
GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

BENIGN PIGMENTED LESIONS (755 nm)


Spot Pulse
Fluence
Lesion/ Skin type size Duration DCD Retreat Comments
(J/cm2)
(mm) (ms)

Treatment of skin types V or VI is not recommended.


SEBORRHEIC KERATOSES
8 3 80 - 100 Start at lowest fluence for treatment one and observe tissue
Skin Types I-IV response.
Start by treating darkest lesions, which require lower fluences.
Lighter spots may require higher fluence

Clinical endpoint:
4 weeks
SOLAR 10 3 30 - 60 Darkening of the lesion and/or peri-lesional erythema
LENGTIGINES,
Lentigines, dyspigmentation,
ephelides, solar Melanocytic The DCD is generally not used for the treatment of benign
BENIGN MELANOCYTIC NEVI off pigmented lesions. For some patients, some cryogen may be
beneficial. A cooling method such as cool gel pack or cold
Skin Types I-IV 12 3 30 - 40 compress for brief pre and post laser epidermal cooling may be
used.

Endpoint: Typically, slight popping of the skin and slight white-


SOLAR 12, 15 to-gray discoloration immediately post laser pulse, followed by
3 12 - 30
LENGTIGINES, slight erythema.
Lentigines, dyspigmentation,
ephelides, solar Melanocytic For use of the 18mm Refer to Candela Clinical Bulletin No. 19
BENIGN MELANOCYTIC NEVI or Candela Clinical Educator. The distance of the handpiece to
18 3 12 - 20 the skin should be varied dependent upon the laser-tissue
Skin Types I-III interaction observed, start at 1–2 cm off of the skin.

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Candela Corporation Proprietary
GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

1064 nm
HAIR REMOVAL/PFB TREATMENT PARAMETERS (1064 nm)
PT. SKIN Spot Pulse
Fluence * DCD
TYPE/ETHNIC size Duration Spray/delay/ Retreat Comments
(J/cm2)
ORIGIN (mm) (ms) post spray (ms)
I 8 90-100
Scandinavian 10 70-80
12 3, 10, 20 60-70
II
Northern European 15 40–44
30/20/0
(Caucasian) 18 26-30 Consider the 755 nm laser for hair removal treatment
40/20/0
8 80-90 on Type I skin type.
III Facial:
10 50-70 DCD spray duration 4 - 6 weeks
12 3, 10, 20 40-60 Test small area and wait several minutes to evaluate
(Darker Caucasian, and delay may be
response prior to treatment.
Light Asian) 15 30-40 adjusted to Trunk:
18 24-30 accommodate 6 - 8 weeks
1.Establish skin type
8 60-70 patient comfort
2.Select pulse duration;
IV 10 40-50 Leg:
short= finer hair
12 20-46 Do not use post 8 -12 weeks
3, 10, 20 long = thicker hair
(Mediterranean 15 20-30 laser pulse DCD
3. Select fluence based upon skin type.
Asian, Hispanic) cooling for hair
18 14-20 removal Cold compress
Look for perifollicular edema
8 50-60 or cold gel
V
10 30-50 DCD settings set packs may be
(Middle Eastern, Increase fluence in a 2 J/cm2 increment until this
12 18-30 too high or too low applied after
Lighter African response is seen.
3, 10, 20 may cause treatment to
American, Darker pigmentary cool skin and
15 10-30 Balance between laser heating and DCD cooling is
Hispanic, Indian, problems. Lower remove heat
Native American) 18 6-20 critical.
DCD setting on
VI 8 40-50 darker skin types
10 30-40
3, 10, 20
(Dark African 12 18-30
American) 15 7-30
18 6-18

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Candela Corporation Proprietary
GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

VASCULAR TREATMENT PARAMETERS (1064 nm)


STARTING
Spot Pulse Fluence (J/cm2) COOLING* DCD
CLINICAL ENDPOINTS & IF CLINICAL ENDPOINT NOT
Lesion size Duration Single pulse only Spray/delay/post
RETREATMENT ACHIEVED:
(mm) (ms) (No stacking or spray (ms)
multiple passes)
Telangiectasia Vasoconstriction, vasospasm
-10 ms spray/20 and/or darkening of vessel 1. Decrease pulse duration.
Leg Vessels Start with 360 ms delay contents 2. Increase fluence incrementally until
1.5 20-40 ----- desired result is achieved up to a
2
-10 ms post spray Evaluate/Retreat maximum of 320J/cm with 3mm spot
< 0.5mm 2
8-10 weeks apart size and up to 500J/cm with 1.5mm spot
size.
Post treatment
-15-20 ms
Leg Vessels spray/20 ms delay Cold compress or cold gel No post spray should be used on skin
3 40 - 60 Start with 220
< 1 mm packs may be applied after types IV - VI
-10 ms post spray treatment to cool skin and
remove heat
Increase fluence incrementally until
Leg Vessels desired result is achieved up to a
< 1.5 mm -15 ms spray/20 2
maximum of 280 J/cm
40-60 Start with 200 ms delay
-10 ms post spray
No post spray should be used on skin
3 types IV - VI
Increase fluence incrementally until
Leg Vessels Vasoconstriction, vasospasm desired result is achieved up to a
1.5-3.0 mm -15 ms spray/20 and/or darkening of vessel 2
maximum of 260J/cm
60 Start with 180 ms delay contents
-10 ms post spray
No post spray should be used on skin
Evaluate/Retreat types IV - VI
8-12 weeks apart
Leg Vessels
< 0.5 mm Cold compress or cold gel
20-30 180
packs may be applied after
treatment to cool skin and
40 ms spray / 20
Leg Vessels remove heat
3x10 ms delay / 0 post Increase fluence incrementally until
0.5 – 1.5 mm 160
30-50 spray desired result is achieved.

Leg Vessels
1.5-3.0 mm 60 140

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Candela Corporation Proprietary
GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

VASCULAR TREATMENT PARAMETERS (1064 nm)


STARTING
Fluence (J/cm2)
Spot Pulse COOLING* DCD
Single pulse CLINICAL ENDPOINTS & IF CLINICAL ENDPOINT NOT
Lesion size Duration Spray/delay/post
only RETREATMENT ACHIEVED:
(mm) (ms) spray (ms)
(No stacking or
multiple passes)
Telangiectasia Clinical endpoint
Vasoconstriction, vasospasm,
Facial and/or
Increase fluence incrementally until
Vessels darkening vessel contents
desired result is achieved up to a
<.5 mm 2
Start with 340 -10 ms/20 ms maximum of 400J/cm
Evaluate/Retreat
1.5 20 delay
6-8 weeks
-10 ms post spray No post spray should be used on skin
types IV – VI
Cold compress or cold gel
packs may be applied after
treatment to cool skin and
remove heat
Telangiectasia Vasoconstriction, vasospasm
and/or darkening of vessel
Facial contents
Vessels -----
<1 mm Evaluate/Retreat
130 8-10 weeks apart
- 40ms spray/30 No post spray should be used on skin
3 30
ms delay types IV - VI
Post treatment

Cold compress or cold gel


packs may be applied after
treatment to cool skin and
remove heat

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Candela Corporation Proprietary
GENTLEMAXPRO™ LASER SYSTEM TREATMENT GUIDELINES

WRINKLES TREATMENT GUIDELINES (1064 nm)


Area Spot Size Pulse Fluence DCD Retreat
(mm) Duration (J/cm2) (ms) Comments
(ms)
Face & Neck
10 50 50 40/20/0
4-5 TX performed monthly
Forehead
10 50 40-50 40/20/0

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Candela Corporation Proprietary
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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Candela Corporation Proprietary
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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Candela Corporation Proprietary
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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Candela Corporation Proprietary
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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Candela Corporation Proprietary
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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Candela Corporation Proprietary
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 0920-23-
0814).

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

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Candela Corporation Proprietary

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