Pico second laser multiplatform

Pico Toning / Dual Focused Dot /
RuVY Touch+ / Gold Toning+

This guide comprises an outline of the general treatment method for the PicoPlusTM picosecond-domain (ps-domain) Nd:YAG Laser from Lutronic Corporation, and detailed clinical application of this system for specif- ic conditions. The guidelines regarding treatments and parameters are based on advice from experienced users of the PicoPlus, and relevant arti- cles from the peer-reviewed literature. Users are therefore recommended to apply these guidelines as a basic clinical reference. To enhance profi- ciency in the system, understanding of the background and basic science of the ps-domain laser, sufficient training and plenty of experience are required.

The guidelines present a relatively wide range of parameters for each in- dication. Users should always be aware of each patient's skin type, and in addition remember that each patient may have a different skin thickness, age, sensitivity to pain and skin reaction. Furthermore, some character- istics can differ site by site on the same patient. Parameters thus need to be adjusted according to the type of lesion and anatomical site on a case-by-case basis. In general, Caucasian patients and those with a lighter skin phenotype, skin with abundant appendages and thicker skin can be treated with relatively higher parameters than darker skin type patients, so there is a lower chance of side effects such as PIH and scar formation.

After the laser treatment, application of adequate skin cooling and mois- turizing can lower the chance of side effects and downtime. When higher parameters are needed, applying a chilled air cooler or ice pack before and after the laser treatment could alleviate discomfort of patients. 830 nm LED low level light therapy (LED-LLLT) applied optionally before and definitely after laser treatment has also been shown to help wound re- generation. Once the treatment session is finished, it is very important to give patients accurate post-care guidelines and make sure that the pa- tients comply with them.

1. Indications

Tattoo Removal

Black tattoos, Amateur tattoos, Professional tattoos, Traumatic tattoos, Color tattoos

Focus Toning

Skin rejuvenation (Cold rejuvenation). Fine wrinkles, Pores, Scars

Dual Focus Toning

1064nm: Skin rejuvenation (Cold rejuvenation), Wrinkles and scars
532nm: Epidermal pigmented lesions (SK, Lentigines, Café-au-lait, Macules, etc.)

Pico Toning

Melasma, PIH (postinflammatory hyperpigmentation)

Pigment Removal

Epidermal Lesions (ephelides / freckles / seborreheic keratosis / body lentigines / Café-au-lait / Nevus spilus)
Dermal Lesions (Nevus of Ota, ABNOM, Becker's Nevus)

Gold Toning+

Post acne erythema, Acne (esp. for vascular control), melasma (esp. for vascular control), facial flushing, sky blue color tattoo

RuVY Touch+

Epidermal Pigmented Lesions, Green color tattoos

2. Laser Overview

2.1 History

A laser is a device that emits coherent light through a process of optical amplification based on the principle of stimulated emission of electromagnetic radiation. Strictly speaking, “light” should refer only to that portion of the electromagnetic spectrum which is visible to the human eye. Infrared (IR) and ultraviolet (UV) radiation should be referred to as IR and UV energy. However, in these Guidelines, “light” will be used for convenience to describe both visible, UV and IR energy.

The term “LASER” was in its original form the acronym for “light amplification by stimulated emission of radiation”, but is now used in the lower case “laser” to represent both the systems and the energy they emit. The concept behind laser generation was born from Albert Einstein’s 1917 paper on the quantum theory of relativity which postulated that excited atoms can release their excess energy in the form of a photon through a process called “stimulated emission of radiation”.

In the 1950s, a number of scientists and researchers were designing and performing experiments to attempt to turn the theory of stimulated emission into practice. Charles H. Townes of Columbia University made use of microwave frequencies as a medium in a system which he called a MASER, the acronym for microwave amplification by stimulated emission of radiation. The maser, however, showed limited results which prompted Gordon Gould, who was also an alumnus of Columbia University and originally worked with Townes and Townes’ co-researcher and Nobel Laureate Arthur Schawlow, to break away and develop his own ideas for laser. In fact, Gould coined the term “laser” in a publication as early as 1959, and was finally granted 48 patents on his inventions in 1987 in what was known as the “Patlex Action”.

The first working laser was built, however, by Theodore Maiman of Hughes Research Laboratories in 1960, one year after Gould had coined the term. He made use of a high-voltage helical flash lamp to stimulate chromium atoms using a small-sized tubular synthetic ruby crystal with silver coating on both ends, with the emitting face bearing a scratch. He was able to record a coherent 694.3 nm deep red light which led to the birth of the ruby laser, the first coherent light produced by mankind.

The term coherence embodies the three characteristics of laser energy: the light is monochromatic, meaning it has a precise wavelength; it is collimated, meaning the beam of light is virtually parallel with minimal divergence; and all the photons in the beam are moving together in time and in space, termed as being in phase. It is these characteristics which give laser energy its unique qualities which enable its applications in surgery and medicine.

The following years saw the consecutive development of other kinds of laser: the helium-neon (HeNe) laser (632.8 nm) and neodymium:yttrium aluminum garnet (Nd:YAG) laser (1064 nm) in 1961; the argon laser (488 nm, 514.5 nm) and near-infrared diode laser in 1962; the carbon dioxide laser (10,600 nm) in 1964; the pulsed dye laser in 1969 (580–595 nm); and the excimer laser (172 nm) in 1970.

In the field of dermatology, Dr. Leon Goldman, an American dermatologist and surgeon, was the first scientist to use laser for the treatment of melanoma in 1961. Five years later, he had founded the first laser laboratory and clinic at the University of Cincinnati, Ohio, where he supervised the first laser operation for the removal of a tumor without hemorrhage. He was one of the founders of the American Society for Laser Medicine and Surgery (ASLMS) in 1979 and was inducted as the first president of the organization in 1981. The ASLMS presents a yearly award in his honor, named the Leon Goldman Memorial Award.

The use of laser in medicine and surgery became more prominent in the 1980s with the production of improved versions of the technology. In 1983, the theory of selective photothermolysis was introduced by Dr. R. Rox Anderson and John A. Parrish. This theory was based on the use of pigment-specific and short-pulsed lasers that made it possible to carry out selective treatment of vascular and pigmented lesions with controlled thermal injury to surrounding normal skin. Results showed minimal to almost no scarring. The yellow pulsed dye laser was one of the first lasers to utilize this theory through the treatment of nevus flammeus, more commonly known as the port-wine stain.

Further studies on selective photothermolysis led to the development of the Q-switched laser, mainly indicated for tattoo and pigment removal. In the Q-switching technique, nanosecond pulses of high energy and peak power are generated. The very short pulse width was faster than what was referred to as the thermal relaxation time (TRT) of the target, enabling rapid heating and equally rapid cooling of the target pigment, thus limiting the damage to the target while causing minimal damage to surrounding normal tissues through conducted heat.

Entering the 1990s, a new technology emerged which was referred to as “scanning” particularly applied to CO₂ and Er:YAG lasers. With this technology, the pattern of the laser beams on the target tissue could be controlled by a computer. This technique was further developed in the early 2000s to include fractionation of a laser beam into myriad microbeams which left untreated areas in the injured tissue to minimize downtime and enhance wound healing.

At present, scientists endeavor to expand the use of laser further by aiming for technology that will lessen, if not eradicate, complications and downtime. Moreover, lasers with varying pulsewidths are continuously being developed to improve treatment precision. Recently, picosecond lasers, with pulse widths some orders of magnitude shorter than nanosecond lasers, have been introduced into the market, and which have in an increasing number of indications shown more impressive clinical results than the Q-switched nanosecond lasers, but at a very high price.

2.2 Laser Safety

As much as the laser has proven to be beneficial to clinicians and patients alike, the use of this technology is not without risks. It must be remembered that surgical lasers are potentially dangerous systems designed to cause damage. Accidental injuries to the eye and skin are the major concerns. Thus, standards focusing on risk management have been drawn up for all those who will come in contact with lasers, including operators, ancillary staff, the patient and the institute where the laser is being used. The International Electrotechnical Commission (IEC) serves to formulate global standards for laser safety involving manufacturers, physicians, and other practitioners. Standards set by countries base theirs on those from the IEC, such as the American National Standard (ANSI Z136.3) in the United States and the AS/NZ in Australia. Practitioners and manufacturers have developed a consensus to abide by these standards, many of which have become mandatory rather than optional. There are clear legal regulations governing how lasers are used, and prosecution will result if these rules are not followed.

Most of the laser safety standards are based on a theoretical approach, especially mathematical calculations. Although all those involved in the use of lasers should have appropriate technical knowledge such as the limits of exposure, wavelength-related hazard areas, optical density levels, laser classification, and so on, a laser safety officer (LSO) must be present to oversee and ensure compliance with all the standards and rules.

In line with these standards, laser systems have been classified according to the hazard they represent in terms of output power, wavelength, and pulse duration. Moreover, the safety precautions vary for each class which include “eye protection, flammability, reflection, and administrative control measures.” The latest classifications provided by the IEC 60825-1:07-2015 for laser products are given below:

Laser Classifications

Class 1: This class of laser does not normally produce harmful radiation levels during normal operation and is excluded from control measures. Examples: lasers found on printers, supermarket scanners, CD players.

Class 1M: Safe under normal operation, but harm may come when the beam is viewed using optical instruments. Lasers in fiber optic communication systems fall under this category.

Class 1C: This classification covers laser systems used for various skin procedures such as hair removal, wrinkle reduction, tattoo removal, and acne treatment.

Class 2: Emit visible radiation not exceeding 1 mW of power. Damage is unlikely unless direct visualization of the beam is attempted. Example: simple laser pointers.

Class 2M: Emit visible beams (400–700 nm) that are widened or divergent. Hazardous when viewed with optical instruments (binoculars/telescopes).

Class 3R: Emit a visible beam 5 times the limit of Class 2. Require less safety measures than Class 3B or 4, but can still cause injury with direct or prolonged exposure.

Class 3B: Emit up to 500 mW in continuous mode. Eye damage is likely if viewed directly, but diffuse reflections are usually safe. Examples: therapy lasers, some research lasers.

Class 4: High-powered systems that can cause serious harm to eyes and skin, create fire hazards, toxic fumes, and plasma formation. Used in surgery, industrial cutting, welding.

Important rules for safe medical laser use:

• All medical staff operating a laser system must complete training and know the location and operation of the emergency stop button.
• The system should be in standby mode by default; it should only switch to ready mode when the operator is ready to fire.
• Strict rules regarding care of laser keys:
  1. Only authorized staff should access keys.
  2. Keys must be removed when device is not in use.
  3. Keys should not be inserted unless a Laser Safety Officer (LSO) is present.

Ultimately, safety with medical lasers is everyone’s responsibility, and common sense must never be ignored.

2.3 Contraindications

• Pregnancy
• Breastfeeding
• Suntan within a month
• Sun-sensitizing drugs such as retinoids and tetracyclines
• Photophobia
• Epilepsy
• Blood coagulation disorders
• Skin prone to develop keloids
• Patients with unrealistic expectations

2.4 Complications

• Skin abrasions such as blisters and scars which may take 10 or more days to heal
• Appearance of bruises on the treatment area which may last 5–15 days; discoloration in brown skin may take up to 3 months
• Change in pigmentation such as hyper- and/or hypopigmentation
• Scarring (especially in those prone to keloids)
• Skin infection in the treatment area (herpes virus may be reactivated)
• Pain
• Urticaria
• Edema
• Inflammation

Note: Always perform consultation prior to laser treatment. Consider patient’s age, medical history, and skin condition.

2.5 References

1. https://www.britannica.com/technology/laser
2. Laser Physics and Skin Anatomy_Brighlans_Slidenote.pdf
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3799025/
4. http://www.iitb.ac.in/safety/sites/default/files/Laser%20Safety_0_0.pdf
5. https://www.laserworld.com/en/show-laser-light-faq/laser-safety-faq/2964-laser-classes.html
6. http://ehs.uky.edu/radiation/laser_fs.html
7. http://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/Standard%20Laser%20Safety.pdf
8. https://www.howtorelief.com/laser-indication-contra-indication-effect-dangers/
9. https://www.healthline.com/health/laser-therapy#uses
10. https://www.laser-medica.eu/indications-to-laser-treatments/

3. General Operation Guidelines

Glossary

Wavelength (nm)
Physicians should select the appropriate wavelength depending on each individual lesion and each patient’s characteristics.

Spot Size (mm)
Spot size refers to a selectable beam diameter that should be chosen according to the size of a targeted lesion and according to instructions for the indicated procedure.

Fluence (J/cm²)
The fluence, or selectable energy density, is the amount of energy delivered to the surface of the skin per unit area. It refers to the intensity of the energy applied to the tissue, with higher intensity generating stronger reactions. The fluence range can differ according to spot size and pulse width.

Pulse Width (ps / ns)
The pulse width refers to the length of time that the laser energy is incident on the skin per shot. Increasing the pulse width results in a longer irradiation time and a greater volume of affected tissue.

Pulse Rate (Hz)
The pulse rate, or repetition rate, refers to the number of times per second that pulses of laser energy are emitted. A setting of 1 Hz will deliver a single pulse per second as long as the footswitch is pressed, and 10 Hz will deliver 10 pulses per second. It is recommended that lower pulse rates are selected at first until the clinician becomes comfortable with that rate, and then the pulse rate can be increased. When selecting the pulse rate, therefore, the clinician must carefully consider the level of their skill, and the procedure time. The range of selectable pulse rates can differ according to a number of variables.

General Pre-treatment Procedure (applies across indications)

1. Ask the patient to inform the doctor if he/she is taking or applying any medication that might be associated with an increased risk of photosensitization.
2. Thoroughly cleanse the treatment area.
3. Apply anesthetic cream and occlude it for 20–30 minutes. Remove all excess anesthetic cream before treatment. This step can be skipped if the patient has a high pain threshold and can tolerate treatment without anesthesia.
4. Cover the eyes of the patient with an eyeshield. Likewise, the physician and other clinical staff must wear suitable protective eyewear corresponding to the wavelength used.
5. Set the parameters appropriate for the skin condition, including wavelength, spot size, fluence, pulse duration, pulse repetition rate, number of passes.
6. Once parameters are selected, press the Ready button.

Note:

• Always clean the handpiece tip before and after treatment.
• Ensure that the handpiece tip is held flat and in full contact with the skin surface to avoid excessive local reactions.
• Inform patients in advance that some handpieces may produce louder sounds (photoacoustic effect).

General Post-treatment Procedure

1. Apply steroid ointment or prescribe oral antihistamines for 1–2 days to decrease the chance of mild skin reactions such as folliculitis.
2. Optionally, apply antibiotic cream and cover with a dressing.
3. Advise patients not to use functional cosmetics containing Retinol or AHA for 48 hours after treatment unless cleared by physician.
4. Avoid exercise, sauna, or alcohol consumption for the first week after treatment to reduce risk of redness or inflammation.
5. Avoid cosmetics containing alcohol for at least 1 week. A mild moisturizing lotion may be used.
6. Apply a UVA/B sunblock with SPF 30+ and use hats, umbrellas, or other protection when outdoors for at least 30 days post-treatment.
7. Instruct patient to report immediately if water blisters appear in the treated area.

4. Focus Toning Treatment

4.1 Introduction

Scars are formed during the wound repair process when some problem occurs with collagen formation resulting in a build-up of fibrotic or immature collagen, sometimes associated with a reduction in blood supply at the site of the wound. Scars can be either raised (hypertrophic) or crater-like (atrophic). People often get frustrated at the appearance of scars especially on the face, such as scarring post-acne, since the scar can remain as permanent damage in the skin. These lumps or craters on the skin may fade over time but it is often the case that they will never completely resolve. [19]

PicoPlus Focused Dots handpiece is especially designed to address scars and other pigmentation problems. It uses the 1064 nm wavelength associated with a strong photoacoustic effect coupled with a photothermal effect, leading to a more effective treatment of problem areas. The treatment of indications such as traumatic scars, mature scars, and mottled scars using the Focused Dots handpiece has been clinically proven to show impressive results and has been recommended by clinicians using this handpiece. Furthermore, the focus toning treatment has been effective in solving issues with wrinkles and enlarged pores, thereby expanding the scope of clinical practice to include skin rejuvenation.

The 1064 nm Focused Dots handpiece is a first generation technology from which the new-generation Dual Focus Toning technology was derived (Refer to the chapter on "Dual Focus Toning treatment"). It has a 7.4 mm × 7.4 mm scan size with 81 focused microbeams in a 9 × 9 matrix. The picosecond laser technology makes it possible to deliver improved clearance of pigmentation and healing of the target tissues following scar revision.

4.2 Indications

• Skin rejuvenation (Cold rejuvenation)
• Fine wrinkles
• Enlarged pores
• Scars

4.3 Pre-treatment Procedure

1. Ask the patient to inform the doctor if he/she is taking or applying any medication that might be associated with an increased risk of photosensitization.
2. Thoroughly cleanse the treatment area.
3. Apply anesthetic cream and occlude it for 20 to 30 minutes, then carefully remove any excess anesthetic cream. This step can be skipped if it is known that the patient has a high pain threshold, and can endure the discomfort during treatment.
4. Cover the eyes of the patient with an eyeshield. Likewise, the physician and other clinical staff must wear suitable protective eyewear.
5. Set the parameters appropriate for the skin condition, for example:
   • Determine the target areas for the laser treatment.
   • Set the fluence, pulse duration, pulse repetition, no. of passes, etc.
   • Once everything has been set, press the “Ready” button.

NOTE:

• Clean the Focused Dots handpiece window and tip before & after the treatment.
• Make sure the handpiece tip is held in complete contact with, and horizontal to the skin. If not, a more aggressive skin reaction might occur than anticipated.
• Due to the high power density of the microbeams, the treatment process may generate a louder sound than usual (photoacoustic effect). In addition to the clinician’s being aware of this, it is recommended to inform patients about this beforehand.

4.4 Treatment Parameters

(Refer to treatment protocol tables in the original document for specific settings.)

4.5 Clinical Endpoint and Immediate Skin Reaction

The treatment settings mentioned above were based on a previous study. It is highly recommended to adjust the treatment parameters according to each patient’s needs, special circumstances, and treatment history. Erythema, petechiae, and edema may occur after treatment.

4.6 Post-treatment Procedure

1. Apply steroid ointment or prescribe oral antihistamines for 1–2 days to decrease the chance of causing mild skin problems such as folliculitis.
2. Apply antibiotic cream on the treated area and cover with a dressing. However, this is optional.
3. Advise the patient not to use functional cosmetics which contain Retinol or AHA as active ingredients for 48 hours after treatment unless prior permission is given by your doctor.
4. The patient should avoid exercising for the first week post-treatment or until initial healing has occurred. Increased redness may result from any activity that increases blood flow or body temperature (e.g., alcohol consumption, exercise, and sauna).
5. Advise the patient to avoid using cosmetics containing alcohol for at least 1 week after the treatment. You may use a mild type of skin moisturizing lotion.
6. The patient should apply a UVA/B sun block with an SPF of more than 30 PA++ and use an umbrella, cap, or any available protection against sunlight when outdoors for at least 30 days after treatment.
7. Ask the patient to notify the clinician immediately when any water blister occurs in the treatment area.