SmartXide DOT - Clinical User Manual v.2.2.pdf

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  • 1

    Laser Technologies

    for Dermatology

    & Cosmetic Surgery

    SmartXide DOT

    Clinical User Manual

    Version 2.2 - September 2008

  • 2

  • I

    Index

    1 Disclaimer ............................................................................... 1

    2 Introduction............................................................................. 2

    2.1.1 Traditional Skin Resurfacing ................................................ 2

    2.1.2 Non-Ablative Photorejuvenation ........................................... 3

    2.1.3 Fractional Photothermolysis ................................................ 4

    3 SmartXide DOT Technical Features................................................ 6

    4 Hi-Scan DOT - Technical Features ................................................... 7

    4.1.1 Scanning Areas ................................................................ 8

    4.1.2 Scanning Modes ............................................................... 9

    4.1.3 Smart Pulse Emission........................................................10

    5 Clinical Procedure ....................................................................11

    5.1 Pre Treatment Care..............................................................11

    5.1.1 Patient Examination & Contraindications ................................11

    5.1.2 PIH prevention ...............................................................12

    5.1.3 Infection prevention.........................................................12

    5.2 Anaesthesia Indications..........................................................13

    5.2.1 Anaesthesia Techniques ....................................................13

    5.2.2 Fractional Skin Resurfacing ................................................16

    5.2.3 Traditional Skin Resurfacing ...............................................16

    5.3 Treatment Procedure ............................................................17

    5.3.1 FRACTIONAL MODE : Indications & Clinical Protocol..................17

    I

  • II

    5.3.2 Traditional Skin Resurfacing: Clinical Protocol..........................23

    5.3.3 TRADITIONAL MODE: Indications & Clinical Protocol ...................25

    5.4 Post Treatment care .............................................................28

    6 Clinical Cases ..........................................................................29

    6.1 Fine wrinkles, Textures and Spots .............................................29

    6.2 Wrinkles...........................................................................32

    6.3 Acne Scars ........................................................................34

    6.4 Keloid..............................................................................35

    6.5 Epidermal Linear Nevus.........................................................36

    6.6 Epidermal Pigmented Lesion...................................................36

    6.7 Lentigo Simplex ..................................................................37

    6.8 Beckers Nevus....................................................................37

    6.9 Melasma...........................................................................38

    II

  • 1 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    1 Disclaimer While the information contained in these pages has been compiled from sources believed to

    be current and reliable, DEKA cannot be held responsible for any errors, omissions, defects

    in, or the accuracy, completeness, timeliness or usefulness of, the information supplied to

    users on this document.

    The following materials are presented for educational purposes only. Methods described may

    not be the only or best method in every case. DEKA specifically disclaims any and all liability

    for injury or other damages of any kind for any and all claims that may arise out of the use of

    any drug, device or technique described in these pages, whether such claims are asserted by

    a physician or any other persons.

    Information on this document may contain technical inaccuracies or typographical errors.

    DEKA takes no responsibility for the consequences of error or for any loss or damage suffered

    by users of any of the information published on any of these pages. Such information does not

    form any basis of contract with readers or users of these pages.

    Furthermore, DEKA will not be liable to users of any for any damages, claims, demands or

    causes of action, direct or indirect, special, incidental, consequential or punitive, as a result

    of the use of this document or any information obtained from it.

    Information may be changed or updated without notice. DEKA may also make improvements

    and/or changes in this document at any time without notice.

    All information contained within this document is the property of DEKA. Copyright 2008.

  • 2 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    2 Introduction The natural ageing process together with exposure to the sun and pollution

    leads to a gradual deterioration of the skins structure and function. This is

    mainly evident at the level of the epidermis and the upper papillary dermis,

    with a tissue laxity and skin that appears more lined, often accompanied by

    telangiectasias, wrinkles, and dark spots.

    2.1.1 Traditional Skin Resurfacing

    Resurfacing with pulsed CO2 laser has always been considered the first choice of

    treatment for rhytids and photo-damaged facial skin1-6. However, due to the

    lengthy recovery times and frequent complications7-8, not all patients agree to

    undergo this type of operation9-10.

    Traditional Skin Resurfacing. Skin Healing Process.

  • 3 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    Besides the usual recovery time required for oedema, burning, scabs and

    erythema which may often last for months11-12, there is also a high incidence of

    complications connected with hyper-and hypo-pigmentation, HSV infection,

    outbreaks of acne, milia formation, and dermatitis13-18.

    Cases of HSV infection and outbreaks of acne, after traditional resurfacing with pulsed CO2 laser.

    2.1.2 Non-Ablative Photorejuvenation

    Over recent years, the market has therefore been orientated towards less

    invasive and less problematic systems and methods. This has led to a wide-scale

    production of a myriad of non-ablative devices for reducing wrinkles and

    improving photo-damaged skin with the consequent passing over from skin

    resurfacing to skin rejuvenation. However, a critical review of the literature

    inherent to these methods has revealed that in terms of efficacy, none of the

    results obtained with these non-ablative methods can be compared with the

    resurfacing results achieved with the CO2 laser19-23. Moreover, these types of

    treatment are usually quite expensive for the patient, the devices themselves

    are also costly for the medical practitioners, and the results obtained are not

    always satisfactory.

  • 4 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    2.1.3 Fractional Photothermolysis

    This situation has stimulated the search for new methods and protocols that are

    more efficient in combining quick recovery and minimal post-op risks with

    greater treatment efficacy. The advent of Fractional Photothermolysis, initially

    introduced with non-ablative methods, has given rise to the development of a

    new method that manages to effectively combine all the needs of both medical

    practitioners and patients, and namely, the Fractional Laser Skin Resurfacing

    with CO2 laser24-28

    .

    Fractional laser treatment allows to

    obtain remarkable results with

    minimal downtime.

    The CO2 laser energy, applied in a

    fractional way, creates very thin and

    spaced columns of thermal damage

    which penetrate deep into the

    dermal skin layer and stimulate a

    new collagen production. The tissue

    between the columns of thermal

    damage is spared, resulting in a faster healing process.

    Various CO2 lasers with fractioned emission are currently available on the market.

    Despite the fact that all these systems are based on the same principles, they present

    significant differences with regard to output power, dwell-time, distance between the

    dots, varying scanner shapes and the laser beam profile. These differences may

    produce clinical results that differ greatly between one device and another.

    1. Manuskiatti W et al. Long-term effectiveness and side effects of carbon dioxide laser resurfacing for photoaged facial skin. J Am Acad Dermatol. 1999;40:401-11.

    2. Fitzpatrick RE et al. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol 1996;132:395402.3.Schwartz RJ et al. Long term assesment of CO2 facial laser resurfacing: Aesthetic results and complications. Plast Reconstr Surg. 1999; 103:592-601.

    4. Lent WM, David LM. Laser resurfacing: a safe and predictable method of skin resurfacing. J Cutan Laser Ther. 1999;1:87-94.

    5. Fitzpatrick RE. Maximizing benefits and minimizing risk with CO2 laser resurfacing. Dermatol Clin. 2002;20:7786.

    6. Hruza GJ, Dover JS. Laser skin resurfacing. Arch Dermatol 1996;132:451455.

  • 5 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    7. Bernstein L et al. The short and long term side effects of carbon dioxide laser resurfacing. Dermatol Surg 1997;23:519525.8.Alster T, Hirsch R. Single-pass CO2 laser skin resurfacing of light and dark skin: Extended experience with 52 patients.J Cosmet Laser Ther 2003;5:3942.

    9. Trelles MA, et al. The origin and role of erythema after carbon dioxide laser resurfacing: a clinical and histologic study. Dermatol Surg. 1998;24:25-30.

    10. Burkhardt BR, Maw R. Are more passes better? safety versus efficacy with the pulsed CO2 laser. Plast Reconstr Surg. 1997;99:1531-1534.

    11. Sullivan SA, Dailey RA. Complications of laser resurfacing and their management. Ophthal Plast Reconstr Surg.2000;16:41726.

    12. Berwald C et al.. Complications of the resurfacing laser: Retrospective study of 749 patients. Ann Chir Plast Esthet. 2004;49:3605.

    13. Alster TS. Cutaneous resurfacing with CO2 and erbium: YAG lasers: preoperative, intraoperative, and postoperative considerations. Plast Reconstr Surg. Feb 1999;103(2):619-32.

    14. Alster TS. Side effects and complications of laser surgery. In Alster TS: Manual of Cutaneous Laser Techniques, ed 2. Philadelphia, Lippinco. 2000;pp 175-187.

    15. Alster TS, Lupton JR. Treatment of complications of laser skin resurfacing. Arch Facial Plast Surg. Oct-Dec 2000;2(4):279-84.

    16. Sriprachya-Anunt S et al. Infections complicating pulsed carbon dioxide laser resurfacing for photoaged facial skin. Dermatol Surg. 1997;23:527-36.

    17. Nanni CA, Alster TS. Complications of carbon dioxide laser resurfacing. An evaluation of 500 patients. Dermatol Surg 1998;24:315320.

    18. Sadick NS. Update on non-ablative light therapy for rejuvenation: A review. Lasers Surg Med. 2003;32:1208.

    19. Nanni CA, Alster TS. Complications of carbon dioxide laser resurfacing. An evaluation of 500 patients. Dermatol Surg 1998;24:315320.

    20. Sadick NS. Update on non-ablative light therapy for rejuvenation: A review. Lasers Surg Med. 2003;32:1208.

    21. Williams EF III, Dahiya R. Review of nonablative laser resurfacing modalities. Facial Plast Surg Clin North Am. 2004;12:30510.

    22. Grema H et al. Facial rhytides subsurfacing or resurfacing? A review. Lasers Surg Med. 2003;32:40512.

    23. Bjerring P. Photorejuvenation an overview. Med LaserAppl. 2004;19:18695.

    24. Le Pillouer-Prost A, Zerbinati N. Fractional laser skin resurfacing with SmartXide DOT. Initial Results. J Cosmc and Laser Ther, 2008;10(2):in press.

    25. Matteo Tretti Clementoni et al. Non sequential fractional ultrapulsed C02 resurfacing of photoaged skin. J Cosmc and Laser Ther, 2007;9(4):21822.

    26. Hantash BM et al. Ex vivo histological characterization of a novel ablative fractional resurfacing device. Laser Surg Med. 2007;39:87-95.

    27. Hantash BM et al. In vivo histological evaluation of a novel ablative fractional device. Laser Surg Med. 2007;39:96-107.

  • 6 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    3 SmartXide DOT Technical Features

    Type of Laser CO2

    Wavelength 10.6 m

    Power to Tissue 30 W (max)

    Repetition Rate from 5 to 100 Hz

    Pulse Length from 0.2 to 80 ms

    Delivery System Articulated Arm with 7 Mirrors

    Aiming Beam Diode Laser, 3 mW@ 635-670 nm

    Scanning Mode Traditional & DOT-Fractional

    User Interface LCD Colour Touch Screen

    Aiming Beam Diode laser 635 nm

    Power Supply 230 Vac / 1.8 A (max) / 50-60 Hz

    Dimensions 48 cm (W) x 55 cm (D) x 120 cm (H)

    Weight 30 Kg

  • 7 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    4 Hi-Scan DOT - Technical Features

    Scanning Area Max: 15 x 15 mm Min: 1 x 4 mm

    Spot Size

    Stimulative Effect

    Ablative Effect

    350 m 120 m

    Scanning Mode Traditional & DOT-Fractional

    Pulse Emission

    Dwell Time from 0.2 to 2 ms (DOT) from 0.2 to 20 ms (Std.)

    DOT Pitch from 200 to 2000 m

  • 8 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    4.1.1 Scanning Areas

  • 9 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    4.1.2 Scanning Modes

    Normal

    Interlaced

  • 10 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    4.1.3 Smart Pulse Emission

    The first part of the pulse has high peak power for few tens of microseconds

    that allows for rapid ablation of the epidermis and the first layers of the derma,

    while the second part of the pulse has low peak power allowing for targeted

    heating of the deeper areas of the skin.

    Smart Pulse Emission

    AAbbllaattiioonn

    PPoowweerr

    PPuullssee DDuurraattiioonn

  • 11 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5 Clinical Procedure

    5.1 Pre Treatment Care

    5.1.1 Patient Examination & Contraindications

    First of all it is important to proceed with the visit and the anamnesis of the

    patient.

    A persons history should be compiled by establishing the following:

    Sun and UV lamp exposure: avoid them before (at least 1 month), during and after treatment. Apply SPF50 sunblock before and after the treatment.

    Make sure that the patient is not taking incompatible drugs as: o Anticoagulants (as acetylsalicylic acid, heparin, etc),

    o Retinoids these drugs can cause problems in the healing process with possible scar results - (as isotretinoin, etc),

    o Photo-sensitizers (as tetracycline [antibiotic], naproxen [NSAD], auranofin [antirheumatic], estrogens and progestins [oral

    contraceptive], cloroquine [antimalarial], etc.)

    Suspend the administration according to the specific drug so that its effect is

    expired before the treatment.

    Recent exfoliation treatment (peels, scrubs, retin-A) and surgical treatment (as lifting, etc.).

    Past skin disorders. History of herpes virus infection. In order to ensure a positive outcome with laser treatment, the patient must

    strictly follow a pre-operative protocol to help prevent the two main possible

    complications: Post-inflammatory Hyperpigmentation (PIH) and infection.

  • 12 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.1.2 PIH prevention

    Especially with darker phototypes (III, IV, V and VI) and Asian phototypes, it is

    recommended to apply a topical cream every day for four weeks before the

    treatment for inhibiting melanin production.

    It is possible to use cream containing hydroquinone or, as alternative lighteners,

    arbutin, azelaic acid, kojic acid or stabilized vitamin C.

    This procedure is highly recommended with darker and Asian skin types, while

    for photo type I and II it is just a suggestion.

    5.1.3 Infection prevention

    The drugs used fall into two main categories:

    antiviral drugs (aciclovir, valaciclovir, etc) It is suggested to start the antiviral prophylaxis 6 days before the treatment

    in subjects with a positive anamnesis of herpes virus infections history.

    The antiviral treatment can start 2 days before the treatment in subjects

    without previous experience of herpes infections.

    It is recommended to continue the antiviral drugs at routine doses for 5-15

    days after the intervention.

    antibiotic drugs (macrolides, cephalosporins, etc) The doctor may consider prescribing antibiotic drugs as well, starting 6 or 1

    days before the treatment (according to the patient anamnesis) and

    continuing for 7-8 days after the procedure.

    Remark: It is not necessary to prescribe antibiotic drugs in all cases. It is

    often enough the application of a topical antibiotic cream or ointment (like

    gentamicin) after the procedure.

  • 13 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.2 Anaesthesia Indications

    Dermal treatments with laser may give rise to a painful sensation described as

    similar to an elastic band being pinged against the skin, or the pain caused by

    burns.

    The anaesthetic protection for CO2 laser skin therapies becomes necessary in specific cases,

    such as:

    Traditional CO2 laser skin resurfacing; The treatment of extensive skin areas; The treatment of deep lesions;

    Patients with a low pain threshold; Non-compliant patients; Paediatric patients.

    5.2.1 Anaesthesia Techniques

    Irrespective of the anaesthetic method used, several indispensable precautions are necessary:

    A careful clinical assessment (if an anaesthetist is necessary this will be their exclusive responsibility), with particular attention to cardiovascular, pulmonary, and neurological

    pathologies, hypertension, diabetes, allergic phenomena and/or any idiosyncratic

    reactions to the medicinal products to be administered;

    Instrumental assessment (ECG, chest X-ray, etc.) wherever indicated; Detailed indications regarding the administration, modification or discontinuation of

    therapies in progress (in the current condition and in relation to the type of

    intervention/treatment, the assessment will mainly concern the anticoagulant therapy);

    Pre-op fasting (6 hours for solids, 2 hours for liquids); Informed consent; Outpatient safety devices;

  • 14 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    Preventive insertion of peripheral venous cannula.

    The following anaesthesia techniques may be used:

    Transdermal anaesthesia;

    Infiltrative anaesthesia; Peripheral blocks;

    Locoregional blocks; Local anaesthesia techniques associated with sedative analgesia; General anaesthesia.

    Transdermal Anaesthesia (Topical Anaesthesia) A number of local anaesthetics are available for topical use in various types of preparation

    that usually all provide efficacious analgesia albeit of brief duration. Among the various

    preparations, a product which is marketed worldwide, namely EMLA (containing lidocaine

    2.5% + prilocaine 2.5%), has to be applied 1 hour before the treatment.

    Infiltrative Anaesthesia

    While the use of this type of anaesthetic does not necessarily require the presence of the

    anaesthetist, monitoring of the vital parameters is obligatory, as well as the presence of all

    the aids for coping with possible emergency situations. Any type of local anaesthetic may be

    used for the infiltration. The onset of the action is extremely rapid with nearly all agents,

    irrespective of whether used intradermically or subcutaneously. Epinephrine considerably

    prolongs the duration of the block via infiltration.

    Both intradermal and subcutaneous infiltration may be painful, above all due to the acid pH

    that characterises all local anaesthetics. The problem can be attenuated with suitable

    administration techniques and the addition of NaHCO3 in a 10-15% ratio.

    The intradermal and subcutaneous infiltration techniques foresee the use of fine needles (30

    G) for the initial pomphus, after which larger gauge needles can be used (25-23 G) for

    achieving an optimal anaesthesia in the area to be treated, and by always taking care to

    inject the preselected solution very slowly.

  • 15 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    Peripheral nerve blocks

    Whereas with transdermal and infiltrative anaesthesia techniques the presence of the

    anaesthetist is not considered indispensable - except in the case of elderly patients (when

    sedative methods are required) or those with psycho-pathological problems their presence

    will be necessary for performing peripheral nerve blocks. In the majority of cases it will be

    the anaesthetist who personally performs the block, and they must always be present for

    correct intra and perioperative assistance.

    The blocks used in the cervico-facial district consist of:

    TRIGEMINAL Central blocks:

    - ophthalmic bundle-branch

    - maxillary bundle-branch

    - mandibular bundle-branch

    Peripheral blocks:

    - supraorbital nerve

    - infraorbital nerve

    - mental nerve

    The local anaesthetics used for peripheral nerve blocks are the same as those used for the

    infiltrative techniques.

    Anaesthesia techniques associated with sedative analgesia

    The aim is to reach a level of sedation in which the patient is calm and relaxed while still

    continuing to be responsive to the team carrying out the procedure. Sedative analgesic

    techniques are normally used in association with locoregional methods. Ample multicentre

    studies have demonstrated that while the sedative techniques are very safe if performed by

    expert anaesthetists, they could be hazardous in inexperienced hands, especially if performed

    without adequate monitoring systems.

    The drugs used for these methods are:

    CERVICAL PLEXUS

    Superficial C.P.

    Deep C.P.

  • 16 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    SEDATIVES:

    Benzodiazepine

    Ketamine

    Major sedatives

    Hypnotics

    General anaesthesia

    The indications for general anaesthesia are restricted to paediatric and non-compliant

    patients. The presence of the anaesthetist is indispensable, and the anaesthetic may be

    performed in authorised structures including outpatients.

    5.2.2 Fractional Skin Resurfacing

    In case of fractional resurfacing with SmartXide DOT it is usually enough to

    apply a topical anaesthetic 1 hour before the treatment.

    In case of quite superficial action, to use the SmartCryo skin cooling system

    during the treatment can be a possible alternative to the topical anaesthetic.

    5.2.3 Traditional Skin Resurfacing

    Patient discomfort can vary widely in case of traditional laser skin resurfacing.

    Many patients find the topical application applied one or two hours prior to the

    treatment and combined with regional nerve blocks provides appropriate

    analgesia.

    Other patients prefer to undergo intravenous sedation because they find laser

    resurfacing to be uncomfortable.

    ANALGESICS:

    Ketorolac

    Tramadol

    Opiates

    Anaesthetics

  • 17 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.3 Treatment Procedure

    The face is divided into five aesthetic

    units: right malar, perioral, left malar,

    forehead and periorbital-nasal areas. In

    case of laser skin resurfacing (both

    fractional and traditional) full face

    treatment is performed on each aesthetic

    unit sequentially, with care being taken

    to avoid overlapping.

    5.3.1 FRACTIONAL MODE : Indications & Clinical Protocol

    Topical anaesthetic has to be removed just before the treatment.

    Set the SmartXide DOT system in DOT mode according to patient phototype, the

    area to be treated and the application.

    Usually we recommend performing a full-face and single passage treatment to

    obtain a better colour and texture uniformity.

    SmartXide DOT offers the possibility to adapt the procedure according to the

    expectation of the patient: more or less aggressive treatment corresponds to

    longer or shorter down time after every session.

  • 18 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    The quantity of fluence (density of energy measured in J/cm2) delivered with

    the scanner is correlated with the effect provoked on the skin. The following

    formula allows to calculate the fluence level delivered in DOT mode:

    As a simple result of the formula above, reducing the Power and/or the Dwell

    Time and/or increasing the Spacing, it is possible to reduce the fluence and to

    control the thermal effect on the skin.

    5.3.1.1 Skin Resurfacing

    Phototype Power (W) Dwell Time (s)

    Spacing (m)

    Nr. of Sessions

    Nr. of Passages

    I 30 2000 750 2 1

    II 30 2000 1000 3 1

    III 30 2000 1200 3 1

    IV 25 2000 1200 3 1

    V-VI 25 1500 1200 3 1

    Fluence (J/cm2) =

    Power (W) * Dwell Time (ms) * 105

    [ Spacing (m) + 350 ]2

  • 19 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.3.1.2 Chronoaging

    Phototype Power (W) Dwell Time (s)

    Spacing (m)

    Nr. of Sessions

    Nr. of Passages

    I 30 1000 750 4 1

    II 30 1000 1000 6 1

    III 30 1000 1200 6 1

    IV 25 1000 1200 6 1

    V-VI 25 750 1200 6 1

    Fair Asian Skin type

    30 300 300 3 1

    Dark Asian Skin Type

    25 300 350 3 1

    5.3.1.3 Acne Scars & Hypertrophic Scars

    Phototype Power (W) Dwell Time (s)

    Spacing (m)

    Nr. of Sessions

    Nr. of Passages

    I 30 2000 1000 2-3 2

    II 30 1500 1000 3 2

    III 30 1000 1000 3-4 2

    IV-VI 30 750 1000 3-4 2

    Fair Asian Skin type

    30 800 800 3 2

    Dark Asian Skin Type

    25 800 800 3 2

  • 20 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.3.1.4 Keloid

    Phototype Power (W) Dwell Time (s)

    Spacing (m)

    Nr. of Sessions

    Nr. of Passages

    I 30 2000 800 2-3 1

    II 30 1500 800 3 1

    III 30 1000 800 3-4 1

    IV-VI 25 1000 800 3-4 1

    Fair Asian Skin type

    30 800 700 3 1

    Dark Asian Skin Type

    25 800 700 3 1

    5.3.1.5 Superficial Pigmented lesions

    Phototype Power (W) Dwell Time (s)

    Spacing (m)

    Nr. of Sessions

    Nr. of Passages

    I 30 500 500 1-2 1

    II 30 400 500 1-2 1

    III 30 300 500 1-2 1

    IV 25 300 600 1-2 1

    V 20 300 800 1-2 1

    Fair Asian Skin type

    25 300 650 1-2 1

    Dark Asian Skin Type

    20 250 650 1-2 1

  • 21 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.3.1.6 Melasma

    Phototype Power (W) Dwell Time (s)

    Spacing (m)

    Nr. of Sessions

    Nr. of Passages

    I 20 500 500 4 1

    II 20 400 500 4 1

    III 20 300 500 5 1

    IV 15 400 500 5 1

    Fair Asian Skin type

    20 400 500 4 1

    Dark Asian Skin Type

    20 300 500 4 1

    5.3.1.7 Special Care: Periocular Area

    This area is very delicate. A common side effect is to have swelling and oedema. It is recommended

    to decrease the fluence 30% less.

    Dwell Time

  • 22 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.3.1.8 Special Care: Perinasal & Perimandibular Areas

    In the perinasal area (where there are many sebaceous glands) and in the submandibular area

    (where there are few sebaceous glands) the risk

    of post treatment scars is higher. It is

    recommended to decrease the fluence 20% less.

    Dwell Time

    5.3.1.9 Special Care: Neck Area & Dcolletage

    In the neck area and in the dcolletage the skin is thinner. It is recommended to decrease the

    fluence 30% less.

    Power Dwell Time

  • 23 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.3.2 Traditional Skin Resurfacing: Clinical Protocol

    Each aesthetic unit has to be treated in its entirety avoiding overlap.

    Set the Hi-Scan unit in DOT OFF mode. Choose the appropriate shape and size

    of the scanning area. Set Power and Dwell Time according to the area to be

    treated. Please remember that with darker (III, IV, V and VI) and Asian

    phototypes, fractional skin resurfacing is strongly recommended.

    Moist saline-soaked gauzes are used to remove debris during the procedure.

    This should be done gently to minimize additional tissue trauma. Debris removal

    is necessary to avoid a heat-sink phenomenon, which results in more thermal

    irritation of tissues.

    Most areas are treated with a second pass. Approximately 30% of the time, a

    third pass is employed, a fourth is used in less than 5% of patients.

    The endpoint of treatment is gauged to be ablation of wrinkles or visual

    estimation to have reached the basal layer.

    Skilled surgeons could use more power and more dwell times than recommended

    in the protocol, avoiding multiple passes. In this case, please remember that

    skin removal is not proportional to the power increase whereas thermal damage

    is.

    The neck

    As in phenol-based exfoliation, the neck is not treated. The pilosebaceous

    density in the neck is such that deep vaporization can lead to scarring.

    However, the perimeter can be treated with a single pass at the mandibular

    margin to avoid a frank line of demarcation between laser-resurfaced and non-

    resurfaced skin.

  • 24 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    Malar areas

    For these areas the suggested setting is: Power= 17 W and Dwell Time= 400 s. Normally a second laser pass is used to treat the malar area, this should be done

    transversely with respect to the previous one.

    Perioral Area

    In the perioral area, laser resurfacing is carried on to the vermilion border.

    Great care is taken to avoid allowing the laser beam to strike teeth. Some

    surgeons prefer to use a protective mouth-piece. Be careful because it could

    distort the perioral tissue. Initial parameters should be: Power=13 W and Dwell

    Time= 400 s. Forehead

    When treating the forehead area, the hair is moistened and metal shields or

    moist towels are used to protect the eyes. Care is taken to avoid lasering the

    hairline or eyebrows. Initial parameters are: Power= 15 W and Dwell time= 400

    s. Periorbital area

    Because the eyelid tissue is so delicate, reduced fluence is used: Power=10 W

    and Dwell Time= 400 s. The eye to be treated is anaesthetized with two drops of tetracaine. A glass or metal eye shield is inserted under the lid to protect the

    globe. It is better to use a spherical protector to be sure that the surface is

    smooth and free of any irregularities. Resurfacing is carried no closer than 3 to 4

    mm from the ciliary margin to minimize oedema and possible thermal irritation

    to the meibomian glands in the eyelid area. Multiple passes may be used to

    treat deep wrinkles in the lateral canthal area. For the upper eyelid, treatment

    is carried down to the superior tarsal fold.

  • 25 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.3.3 TRADITIONAL MODE: Indications & Clinical Protocol

    Set the SmartXide DOT system according to the patient phototype, the area to

    be treated and the application.

    TREATMENT EMISSION

    MODE

    LEVEL* FREQUENCY

    (Hz)

    REMARKS

    Acne Scar PW 0.5-3 10-20 DOT treatment suggested. Topical anaesthesia.

    Actinic Cheilitis PW 0.5-5 10-20 Topical anaesthesia.

    Actinic Keratosis (superficial)

    PW 1.5 10 Topical anaesthesia. Spiral movements starting from the edges to the centre.

    Actinic Keratosis (tick)

    PW 5 50

    Angiokeratoma PW 1.5-5 10-20 Topical anaesthesia.

    Balanitis Xerotic Obliterans

    PW 2.5 20 Topical or infiltrative anaesthesia according to the lesion size.

    Basal Cell Carcinoma

    PW 0.5-8 10-50 Indications: Nodular carcinoma with

  • 26 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    TREATMENT EMISSION

    MODE

    LEVEL* FREQUENCY

    (Hz)

    REMARKS

    Haemangioma PW 4-10 80 Not elective treatment. High risk of scar results. It is better to use a vascular laser as Dye laser.

    Hidrocystoma Apocrine

    PW 0.5-2 10

    Hypertrophic Scar PW 0.5-3 10-20 DOT treatment suggested. Topical anaesthesia.

    Keloid PW 0.5-3 10-20 DOT treatment suggested. Topical anaesthesia.

    PW 0.5-3 10-20 Topical anaesthesia. Keratosis (Seborrheic Keratosis) PW 0.5-2 10

    Lentigo Maligna PW 0.5-3 10-20 Perform the incisional biopsy.Infiltrative anaesthesia.

    Leukoplakia PW 0.5-5 10-50 Perform the incisional biopsy.

    Lymphangioma PW 0.5-3 10-20 Only circumscribed lesion.

    Molluscum Fibroma PW 0.5-3 10-20 Topical anaesthesia.

    Neurofibroma PW 0.5-2.5 10-20 Infiltrative anaesthesia (in case of big size).

    Nevus Sebaceus PW 1.5-10 10-20 Infiltrative anaesthesia.

    Pagets Disease PW 0.5-3 10-50 Infiltrative anaesthesia. Perform the incisional biopsy.

    Queyrats Disease** PW 2 20 Infiltrative anaesthesia. Perform the incisional biopsy.

    Rhinophyma 1 PW 2.5-10 50-100 Rough-shape phase. Infiltrative anaesthesia.

    Rhinophyma 2 PW 2.5-5 20 Finishing phase. Infiltrative anaesthesia.

    Sebaceous Adenoma*

    PW 1.5-2.5 10-20 Topical anaesthesia.

    Spider Nevus PW 3-8 80 Not elective treatment. High risk of scar results. It is better to use a vascular laser as Nd:YAG.

    Spinocellular Carcinoma

    PW 2.5-8 20-50 Only selected cases. Perform the incisional biopsy. Infiltrative anaesthesia.

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    TREATMENT EMISSION

    MODE

    LEVEL* FREQUENCY

    (Hz)

    REMARKS

    Superficial Pigmented Lesions**

    PW 1.5 10 DOT treatment suggested.

    Syringoma PW 0.5-2.5 10-20 Infiltrative anaesthesia.

    Trichoepitelioma PW 0.5-5 10-50 Infiltrative anaesthesia.

    Tuberous Angioma PW 4-7 50-80 Better if used in combination with Nd:YAG or Dye laser. Infiltrative anaesthesia.

    Verruca 1 (Verruca Vulgaris)

    PW 4-15 10-100 Topical anaesthesia.

    Verruca 2

    (Verruca Plana)

    PW 0.5-2 10-20 Infiltrative anaesthesia.

    Verruca Pedis** CW 8-10 Watt

    Infiltrative anaesthesia.

    Xanthelasma PW 0.5-3 10-20 Infiltrative anaesthesia.

    Zoon Balanitis** PW 1-2 10-20 Topical or infiltrative anaesthesia according to the lesion size.

    *: In the LEVEL column the suggested ranges for the level setting are shown.

    Consider that usually, the procedure starts setting higher level value (which

    corresponds to a deeper skin ablation effect) for the rough-shape phase. At

    the end of the procedure the level value is reduced to perform more precise

    final touches.

    **: Treatment not included in the Treatment Menu of SmartXide DOT system.

  • 28 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    5.4 Post Treatment care

    Operations carried out with CO2 laser devices generate abrasion or ablation of

    the skin which makes daily care of the wound essential.

    The aim is to achieve healing, preventing the formation of scabs in the middle

    and on the inner edges of the area treated, and thus guaranteeing an adequate

    cleanliness and softness (above all with regard to the skin site).

    In order to reduce the oedema and the inflammation that may occur after the procedure, we recommend applying on the skin, just after the treatment,

    cool compression or wet gauzes cooled using the SmartCryo air jet.

    As post-treatment care, we suggest open-type medication with accurate gentle skin cleansing, cold packs compression which must always be carried

    out with sterile gauze and physiological solution. We recommend that the

    patient re-applies every time emollient and/or antibiotic and enzymatic

    ointments, especially after cleaning and showers. This procedure has to be

    performed 3-4 times per day until the clinical healing is observed (4-7 days).

    After this time, apply a normal skin-care moisturizer and a sunblock

    protection (for 2-5 months according to the skin phototype and the

    environmental conditions).

    It is suggested to wait for 1 day before having a shower (avoid hot water on the treated area until healing is complete).

    Avoid topical exfoliation for at least 4 weeks. The use of active Vitamin C-based creams, useful for maintaining the

    uniformity and compactness of the new tissue and reducing any possible

    deterioration, may be continued for unlimited time.

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    6 Clinical Cases

    6.1 Fine wrinkles, Textures and Spots

    Before and after 4 sessions. Courtesy of Dr Anne Le Pillouer-Prost Marseille France.

    Before and after 3 sessions. Courtesy of Dr Anne Le Pillouer-Prost Marseille France.

  • 30 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    Before and after 3 sessions. Courtesy of Dr Anne Le Pillouer-Prost Marseille France.

    Before and after 2 sessions. Courtesy of Dr Nicola Zerbinati Pavia Italy.

  • 31 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    Before and 21 days after 1 session. Courtesy of Dr C. William Hanke Indianapolis, IN USA.

    Before and 17 days after 1 session. Courtesy of Dr C. William Hanke Indianapolis, IN USA.

  • 32 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    6.2 Wrinkles

    Before and after 2 sessions. Courtesy of Dr Anne Le Pillouer-Prost Marseille France.

    Before and after 2 sessions. Courtesy of Dr Anne Le Pillouer-Prost Marseille France.

  • 33 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    Before and after 1 session. Courtesy of Dr Patrick Treacy Dublin - Ireland.

    Before and 6 days after 1 session. Courtesy of Dr Hee-Jin Han Seoul - Korea.

    Before and 14 days after 1 session. Courtesy of Dr C. William Hanke Indianapolis, IN - USA.

  • 34 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    6.3 Acne Scars

    Before and after 1 session. Courtesy of Dr Nicola Zerbinati Pavia Italy.

    Before and after 2 sessions. Courtesy of Dr Jahanara Ferdous Khan - Dhaka Bangladesh.

  • 35 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    Before and after 1 session. Courtesy of Dr Hee-Jin Han Seoul - Korea.

    6.4 Keloid

    Before and after 2 sessions. Courtesy of Dr Nicola Zerbinati Pavia Italy.

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    6.5 Epidermal Linear Nevus

    Before and after 1 session. Courtesy of Dr Nicola Zerbinati Pavia Italy.

    6.6 Epidermal Pigmented Lesion

    Before and after 1 session. Courtesy of Dr Nicola Zerbinati Pavia Italy.

  • 37 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    6.7 Lentigo Simplex

    Before and after 2 sessions. Courtesy of Dr Jahanara Ferdous Khan - Dhaka Bangladesh.

    6.8 Beckers Nevus

    Before and after 2 sessions. Courtesy of Dr Jahanara Ferdous Khan - Dhaka Bangladesh.

  • 38 SmartXide DOT Clinical User Manual- Version 2.2 - September 2008

    6.9 Melasma

    Before and after 2 sessions. Courtesy of Dr Jahanara Ferdous Khan - Dhaka Bangladesh.

    Before and after 5 sessions. Courtesy of Dr Nicola Zerbinati Pavia Italy.

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    Deka M.E.L.A. srl, 2008

    All rights reserved. All other brands and product names are trademarks or registered

    trademarks of their respective holders.

    DEKA M.E.L.A. s.r.l.

    Via Baldanzese, 17 50041 Calenzano (FI) Italy

    Tel +39 055 8874942 - Fax +39 055 8832884

    e-mail: [email protected]

    web: www.dekalaser.com