You are on page 1of 9

03-JUL-19

Quick Reference Guide

1. Before You Start


This document serves as guidance to clinicians treating with the Vbeam Prima system for the indications specified
herein. The following 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 https://portal.candelamedical.com/
regularly for the latest updates.
These Treatment Guidelines do not take the place of the procedures and instructions found in the operator’s manual,
nor are they meant to supplant clinical decision making by individual operators.
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 local and state regulatory 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 operator’s manual at the start of each treatment day and when the
handpiece is changed. Check the delivery system for any damage before each treatment.

Warning
• When using the Contact Cooling handpiece, always apply a thin layer of water-based ultrasound
coupling gel.
• When using the 1064 nm wavelength, never stack pulses or double-pulse.
• When using the 1064 nm wavelength, a distance of twice the spot size must be maintained between
spots when treating linear vessels.

©2019 Candela Corporation. All rights reserved. This material contains registered trademarks, tradenames and brand names of Candela Corporation and its affiliates,
including Candela, Vbeam and Vbeam Prima. All other trademarks are the property of their respective owners. 8505-10-0391, Revision C, June 2019
2. Treatment Parameters
03-JUL-19
Wavelength Spot Size Pulse Width Fluence DCD Contact
Treatment Comments
[nm] [mm] [ms] [J/cm2] [ms] Cooling
CATEGORY: VASCULAR / RED
3 11 – 14

Cherry 5 8 – 10
Angiomas 7 8 – 12 30 / 20
10 5 – 10
5 8 – 10 • Use a white, moist template to isolate the lesion.
Angiomas Hemangiomas 7 1.5 6 – 10 • Clinical endpoint: purpura.
40 / 20 • CAUTION: Use caution and lower fluences for infants.
10 5–6
3 11 – 12
Spider 5 8 – 10
Angiomas 7 8 – 11.5
10 5 – 10
5 8 – 15
7 8 – 15
595 Coldest
Facial 10 0.45 – 1.5 7 – 10
12 5–9 30 / 20
15 3–6 40 / 20
7 1.5 8 – 12
10 5–7 • Use lower fluences on neck and extremities.
Neck, Head
Port Wine Stains 12 0.45 – 1.5 4–7 • Recommend starting with larger spot sizes
15 3 – 6.5 (>5 mm).

5 6 – 12
Trunk,
7 6 – 7.5
Extremities
10 5–7
1.5
5 10 – 15
Hypertrophic 7 10 – 15 40 / 20
10 10

Page 2
Wavelength Spot Size Pulse Width Fluence DCD Contact
Treatment Comments
03-JUL-19 [nm] [mm] [ms] [J/cm2] [ms] Cooling
CATEGORY: VASCULAR / RED (Continued)
Linear Vessels 3x10 10 – 40 10 – 15 Coldest • Fluence and pulse duration will be adjusted based on
7 8 – 11 chromophore.
6 / 10 • Shorter pulse durations and higher energies may
Rosacea Diffuse 10
5–7 Colder induce purpura.
Redness 12 3/6/10 • Depending on patient's expectation treating to
15 3/6/10 6.25 – 6.75 purpura gives faster clearance.
30 / 20
Leg 595
3x10 10 – 20 10 – 18 30 / 10 • Recommend using 3x10 spot on linear vessels.
Matting
• For vessels which do not clear immediately: treat first
7 10 – 13 with the 3x10 followed by the round spot.
Red Telangiectasia Facial 10 / 20 Coldest
10 6 – 10 • Use of shorter pulse widths may induce purpura with
the 595 nm wavelength.
3x10 10 – 15
Nasal / Alar 10 / 20
10 6 – 8.5

Wavelength Spot Size Pulse Width Fluence DCD Contact


Treatment Comments
[nm] [mm] [ms] [J/cm2] [ms] Cooling
CATEGORY: VASCULAR / PIGMENT (RED / BROWN)
Always perform test spots laterally. Apply pulses close to
10 one another to minimize uneven pattern. Feather edge
Poikiloderma of Civatte 3/6 5 – 6.5 30 / 20 Cold
(decrease fluence by 1-2 J/cm2 @ periphery) to minimize
15 sharp line of demarcation.

595 7 7 – 10 • 595 nm wavelength has absorption to melanin.


10 N/A • Caution when treating Skin Types IV or V.
Dyschromia 10 5–7 Cold • Not recommended with tanned skin.
• Caution with higher fluences.
15 3 / 6 / 10 5 – 6.75 20 / 10 • For underlying vasculature, lengthen pulse duration.

Page 3
Wavelength Spot Size Pulse Fluence DCD Contact
Treatment Comments
[nm] [mm] Width [ms] [J/cm2] [ms] Cooling
03-JUL-19 CATEGORY: PIGMENT (BROWN)

5 • 595 nm wavelength has absorption to melanin.


• Caution when treating Skin Types IV or V.
• Not recommended with tanned skin.
Benign Pigmented Lesions 595 7 6 – 10 8.5 – 11 N/A Cold • Caution with higher fluences.
• For underlying vasculature, lengthen pulse duration.
• Adjust spot size based on size of lesion.
10 • Treatment for Skin Types I - III without a tan.

Wavelength Spot Size Pulse Fluence DCD Contact


Treatment Comments
[nm] [mm] Width [ms] [J/cm2] [ms] Cooling
CATEGORY: VASCULAR (BLUE VEINS)
Reticular Leg 1.5 200 – 360
10 – 20
Veins < 0.5 mm 3 280 – 340
Reticular Leg 3 x 10 80 – 130
20 – 30 • Consider contact cooling for 1064 nm wavelength.
Veins 0.5-1 mm 3 240 – 300
• Ice immediately after or in between pulses.
3 x 10 80 – 130 30 / 20 / 10
Reticular Leg • No post spray should be used on skin types
Leg Veins 20 – 40 or
Veins 1-2 mm 3 200 – 260 IV-VI.
40 / 20 / 10
1064 3 x 10 80 – 110 • For Skin Types I and II, may consider DCD of 15 / 20 /
Reticular Leg
10 for fine leg veins.
Veins 2-3 mm 3 160 – 240 Coldest
40 – 60
Reticular Leg 3 x 10 70 – 100
Veins > 3 mm 6 140 – 150

Alar 40 / 30 • Facial vessels with 1064 nm is for advanced users.


Facial Veins 1.5 10 – 40 200 – 280 • Consider using longer pulse durations for telangiectasia
Facial 30 / 20 1.5-3 mm with the 1064 nm wavelength.
595 7 1.5 7 – 10
Venous Lakes Venous Lakes 30 / 20 N/A
1064 5 20 – 50 70 – 120

Page 4
Wavelength Spot Size Pulse Fluence DCD Contact
Treatment Comments
[nm] [mm] Width [ms] [J/cm2] [ms] Cooling
03-JUL-19 CATEGORY: BENIGN CUTANEOUS LESIONS
Ecchymosis 595 10 6 6 – 7.5 30 / 20 Coldest Consider second pass for clinical endpoint (darkening)
10 4.5 – 6 Slight redness and light purpura may be experienced,
Inflammatory Acne Vulgaris 595 3/6 30 / 20 N/A
15 5.5 – 6.75 observe closely.

7 7–8 • Newer, more vascular scars may respond better than


older, atrophic scars.
Scars 595 10 1.5 – 6 4–7 30 / 20 Colder • Range of clinical endpoint from purpuric to
subpurpuric depending on age and vascularity of the
15 4 – 6.75 scar.
Newer, more vascular striae may respond better than
Red Striae 595 10 1.5 / 3 4–7 30 / 20
older, atrophic striae.
Facial 595 5 1.5 9 – 9.5 30 / 20 CAUTION: Single pulses only. Observe tissue response.
Use DCD for facial warts.
5
• Prepare thick warts before treatment. Cryogen may be
Warts 595 1.5 9 – 15 Off sprayed pre- and post-laser to cool area. Topical or
Non-Facial 7 injected anesthetic may be utilized.
• Recommend starting treatment with 595 nm
1064 3 10 – 20 140 – 180 30 / 20 wavelength.
N/A
Face & Neck • For painting technique: 5-7 Hz, three to four passes for
10 20 35 40 / 20 face. Three passes for Neck. Lift 2 mm off of skin for
Forehead
1064 painting technique.
Painting • For stamping technique: 3 – 4 passes for face, and up
8 – 10 0.5 8 – 12 Off
Wrinkles Technique to 3 for neck per patient tolerance.
7 10 7
Face 595 10 6 30 / 20 N/A
6
12 5

Page 5
zzzzzzzzzzzzzzzzzzzzzzzzzzzzz

3. Indications for Use


03-JUL-19
595 nm Wavelength
• General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
• Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg
telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, poikiloderma of Civatte and
benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of wrinkles.
• Treatment of Benign Epidermal Pigmented Lesions.
• Treatment of Inflammatory Acne Vulgaris.
• Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
• Podiatry: Treatment of benign cutaneous lesions, such as warts.

1064 nm Wavelength
The Vbeam Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but
not limited to, port-wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lakes, leg veins, spider veins,
poikiloderma of Civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar
lentigos (sun spots), café-au-lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags and keratoses. The
laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

4. Pre-Treatment Preparation
Pre-Treatment Visit
Patient selection should be based upon the provider’s assessment of the individual patient, including a detailed medical
and medication history. The treatment protocol should be discussed in detail including risks and benefits, possible side
effects and expected results, alternative or concurrent therapies and follow-up care. The provider should set proper
expectations based upon his/her clinical experience. Informed consent and photographs should be obtained. Individual
patient characteristics such as skin condition and type, gender, age and medications may influence the response to and
efficacy associated with the 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 practitioners who are knowledgeable in
laser tissue interactions.

Contraindications and Precautions


• Accutane: wait 12 months after the completion of Accutane therapy.
• Tattoos: do not treat tattooed skin, including decorative, permanent makeup and radiation port tattoos.
• History of photosensitivity to 595- or 1064-nm light.
• Pregnancy: refer to Candela’s policy # 0920-23-0814.
• Seizure disorders: do not treat patients with a history of light-triggered seizures.
• Medications: daily anticoagulation therapy, iron supplements, vitamin E, fish oil, herbal supplements such as ginkgo,
ginseng or garlic may interfere with the Treatment.
• Photosensitizing medications: medications that induce photosensitivity or medications within or above the 595 nm
wavelength. Refer to Candela’s list of Drugs That May Cause Photosensitivity. Stop the medication if possible, for 3-5
days prior to treatment.
• Topical medications and skin care products: stop 72 hours pre- and post-treatment. Self-tanning products must be
removed.
• 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.
• Active skin infection: avoid treatment of open wounds and skin that is actively infected.

Page 6
zzzzzzzzzzzzzzzzzzzzzzzzzzzzz

• Cold sensitivity: use caution when treating patients with Raynaud’s phenomenon.
03-JUL-19
• Keloid scarring: perform test spots prior to treating larger areas.
• Implanted medical devices: pacemakers, cardioverters and other implantable devices or fillers: consult with your
physician prior to treatment.
• Use caution when treating recently tanned skin. Blisters and hyper/hypopigmentation may occur, allow tan to fade
prior to treatment to reduce this risk. When in doubt, perform test spots on tanned and un-tanned areas for
comparison before proceeding.
• Treatment of warts may result in hypopigmentation or a scar.

Skin Preparation for Treatment


• Topical anesthetics may be used prior to laser treatment per manufacturers’ directions. HOWEVER, 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.
• 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.
• Shave hair-bearing areas prior to treatment.

Test Areas
• Perform test spots in areas where 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.
• Evaluate the sites in two weeks.
• Treatment may proceed when the expected treatment response is noted.

5. Procedure for Establishing the Purpura – Free Threshold


• Select spot size, pulse duration, fluence and DCD settings.
• Apply escalating fluences until purpura appears, then reduce the energy by 0.25-0.50 J/cm2.
• 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.

6. Laser Treatment Considerations


• Perform verification tests prior to each treatment session. This test procedure is outlined in the operator’s manual.
• Position the patient comfortably and confirm that the patient and everyone in the treatment room are wearing the
correct laser-protective eyewear.
• Always hold the laser handpiece perpendicular to the skin to apply laser energy, otherwise an uneven application of
cryogen and energy may occur, resulting in an adverse skin reaction.
• The aiming beam and laser beam are dimensionally identical, so the aiming beam can be used to accurately define
the treatment area. The spot will be circular if the handpiece is held at the appropriate 90° angle.
• Always observe the epidermal response throughout the treatment and adjust the fluence and DCD as required.
• Measures to Prevent Adverse Effects and Decrease Discomfort:
 Cool compress or cold gel packs may be applied immediately after treatment to decrease patient discomfort.
 After each laser pulse, a gentle rub of the area with a gloved hand may minimize discomfort.

Page 7
zzzzzzzzzzzzzzzzzzzzzzzzzzzzz

• Treating Specific Body Areas


03-JUL-19
 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;
place 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.
 If desired, a white makeup pencil may be used to draw a treatment area grid.
 When treating the anal area, place wet gauze over the anus first; methane gas is flammable.
• Refer to the operator’s manual for cleaning and disinfecting instructions. Follow the procedures outlined in the
distance gauge cleaning protocol to prevent a buildup of debris on the distance gauge, and to maintain good visibility.

7. Post-Treatment Care
• Cool compresses, cold gel packs or chilled aloe Vera gel may be applied after treatment.
• Prolonged exposure to the sun should be avoided; a moisturizing sunblock of at least SPF30+ should be applied per
manufacturer’s instructions at all times throughout the course of treatment.
• Clean the area gently and avoid irritation from friction or rubbing.
• Resume use of usual topical agents when any irritation resolves.

8. Expected Responses
• Purpuric Treatment: purpura, edema, minimal to moderate discomfort relieved by cold compress or cool gel pack.
• Non-Purpuric treatment: edema, slight to moderate erythema, and a tight sensation with minimal discomfort.

9. Possible Adverse 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).

10. 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 and patient result have been achieved.
• Maintenance treatments may be required to maintain the desired result.

Page 8
zzzzzzzzzzzzzzzzzzzzzzzzzzzzz

11. Warnings & Precautions Concerning the Use of Cryogen


03-JUL-19
• 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 to offset the heat
generated by 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 add to the patient’s comfort.
• When using the Vbeam laser with multiple pulses, the user should monitor the distance gauge condition and wipe the
distance gauge as required. After approximately 30 pulses, check the condition of the distance gauge for hair,
cryogen buildup, etc. Wipe if necessary before continuing treatment.
• Special Considerations When the Vbeam System Is Not Equipped with the Dynamic Cooling Device (DCD):
Ø If the DCD option is not installed and cooling is desired, another method of cooling (air cooling or contact cooling,
etc.) should be utilized.
Ø Several applications including non-facial warts and benign epidermal pigmented lesions are treated without DCD
cryogen spray. Application of a cool compress post-treatment may enhance patient comfort.

Special Considerations When Using DCD Cryogen Spray


• 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.
• Select the default, Medium setting (30/20).
• Adjust based upon epidermal response and patient comfort.

12. Additional Warnings and Precautions


• 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.
• If crescent shaped marks, welts or wheals are noted during treatment, the fluence and or DCD settings should be
adjusted immediately. Failure to adjust these parameters can result in subsequent crusting, blistering, or other
adverse reactions. Crescents may result from not holding the distance gauge properly. If the problem persists,
discontinue treatment and refer to the User Verification test section in the operator’s manual.
• Do not use flammable products on the skin or in the vicinity of the laser.
• When using the Vbeam laser with the Dynamic Cooling Device (DCD), in conjunction with an ECG monitoring device,
interference with the ECG monitoring device may result.
• Oxygen will accelerate combustion of any flammable material. Oxygen should never be directed towards or over the
laser field, and 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.
• Treatment to areas bearing hair may cause the hair to be singed and may cause it to ignite. A fire extinguisher should
be available.

Page 9

You might also like