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Radiancy Mistral User Manual

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User Manual
August 2009, Revision 07

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  • Page 1 User Manual August 2009, Revision 07...
  • Page 3 User Manual August 2009, Revision 07...
  • Page 4 Radiancy Inc. LHE is a registered trademark of Radiancy Inc. in the United States and/or in other countries. The Quality Management System of Radiancy Ltd. complies with the Quality Management Standard ISO 13485-2003.

  • Page 5: Table Of Contents

    EMOVAL 4.7. A ................55 REATMENT 4.8. P ..............60 SORIASIS REATMENT 4.9. S .................66 IGHTENING 5. MAINTENANCE 5.1. C .............71 LEANING NSTRUCTIONS 5.2. P & A ...............73 ARTS TTACHMENTS 6. ADVERSE EVENTS REPORT FORM 7. TROUBLESHOOTING 8. MISTRAL SERVICE 9. WARRANTY...
  • Page 6 List of Figures Figure 1: Mistral Main System..............2 Figure 2: Front Panel ...................3 Figure 3: Back Panel..................3 Figure 4: Right Side Panel ................4 Figure 5: Handpiece..................4 Table 1: Handpiece Color Identification............5 Figure 6: Footswitch..................5 Table 2: Technical Specifications ..............6 Table 3: International Standards Labels ............9 Table 4: Additional Labels ............11...
  • Page 7 Figure 26: DB Treatment Mode ..............34 Figure 27: DB Save Treatment Data ............35 Table 6: Energy Level Setting - SR ............42 Table 7: Required Results for Appropriate Energy Setting ......43 Table 8: Energy Level Setting - HR ............49 Table 9: Treatment Course Recommendations ..........53 Table 10: Energy Level Setting - AC ............57 Figure 28: Plaque Psoriasis ...............61 Table 11: Energy Level Setting - PSOR .............64...

  • Page 9: Introduction To The System

    In this manual, the term operator applies to all qualified personnel trained to operate the Mistral system. Important Note – The Mistral user manual is meant as a starting point for treatment, a reference guide of general recommendations. As you gain more experience with the device, you may use your personal expertise to better individualize treatment parameters.

  • Page 10: System Description

    SYSTEM DESCRIPTION This chapter provides a detailed description of the Mistral system; its main components, controls, and technical specifications. Please review this material to familiarize yourself with controls, ports and connectors, as well as the consumable items used during treatment.

  • Page 11: Figure 2: Front Panel

    Main power switch • Fuse drawer • Handpiece cradle • Footswith port • System fan • Air exhaust port • System Fan Handpiece Cradle Power Switch Air Exhaust Port Fuse Drawer Figure 3: Back Panel Power Inlet Mistral User Manual...

  • Page 12: Figure 4: Right Side Panel

    SYSTEM DESCRIPTION Right Side Panel: The Handpiece power and air connections. • Connected Handpiece Handpiece Connections Figure 4: Right Side Panel 2.1.2. Handpieces The Handpieces are connected to the main unit by a spiral cable containing electrical wiring and an air suction hose. The Handpiece consists of an application specific lamp, pulse switch and pulse counter.

  • Page 13: Figure 6: Footswitch

    2.1.3. Footswitch The footswitch arrives connected to the main unit. The system will emit a pulse only if the footswitch and handpiece buttons are pressed simultaneously. Figure 6: Footswitch Mistral User Manual...

  • Page 14: Table 2: Technical Specifications

    SYSTEM DESCRIPTION 2.1.4. Technical Information Table 2: Technical Specifications Technical Specifications Light Source Light & Heat Energy (LHE) Wavelength Range Hair Removal 400-1200 nm Hair Removal V-VI (optional) 550-1200 nm Skin Photo Rejuvenation 400-1200 nm Acne Clearance (optional) 430-1100 nm Psoriasis Care (optional) 350-1100 nm Skin Tightening (optional)

  • Page 15: Major Precautions & Warnings

    CHAPTER 2 2.1.5. Safety Features Many of the Mistral features were built-in to help insure the safety of the user and patient. The following are a few examples: “Ready” indicator lights on the console and handpiece • advise the user when the system is charging or ready to emit a pulse.
  • Page 16 SYSTEM DESCRIPTION Never use flammable substances or harsh chemicals to • clean or disinfect any part of the Mistral system. Always make sure to completely lift the Handpiece off the • patient’s skin between pulses in order to avoid excessive heating of the handpiece or skin.

  • Page 17: Table 3: International Standards Labels

    The table below briefly reviews a number of the internationally recognized symbols that are found on the Mistral main unit and its external package. Table 3: International Standards Labels...
  • Page 18 SYSTEM DESCRIPTION Manufacturer Authorized representitive in the European community Degree of protection against electric shock: Type BF applied part CE mark represents the compliance to the European Medical Device Directive 93/42/EEC, Class IIa device. The number (0344) is of the notifying body, KEMA Notified Body.

  • Page 19: Table 4: Additional Labels

    Label Located on the back of the system this label includes manufacturer details, voltage information, and the system’s serial number. Located on Mistral Handpieces HR Handpieces: Basic and optional XL HR V-VI Handpiece (optional): Basic and SR Handpiece AC Handpiece (optional)
  • Page 20 SYSTEM DESCRIPTION Location and Comments Label On rear panel. This warning appears on all handpiecess, next to opening. Revision 07, August 2009...
  • Page 21 CHAPTER 2 2.2.4. International Standards Compliance The Mistral complies with the following international standards and directives: EMC Standards: IEC 60601-1-2:2001 + A1:2004 Clause 36.201 (Emission); Clause 36.202 (Immunity); Harmonized Standards: Medical Electrical Equipment – Part 1: General Requirements for Safety:...

  • Page 22: Initial Set Up

    Touch Screen Stylus • 3.2. Electrical Requirements Before unpacking Mistral, make sure the work site meets the following electrical requirements. Mistral requires a separate single phase supply line with nominal voltage (according to the local line voltage): Single phase 100-120 VAC ±10%, 10A, 50-60 Hz; or •...

  • Page 23: Installation

    3.3. Installation Mistral is designed for easy installation and does not require any site preparation. Installation is carried out as follows: ♦ Unpack the system and place it in a designated location. It should be placed on a flat, stable surface, such as table, counter or sturdy cart.

  • Page 24: Figure 7: Handpiece Connection

    CHAPTER 3 Figure 7: Handpiece Connection To remove handpiece: a. Push button on back of connector b. Gently pull and pop out connection. Note: Turn the system off when replacing or exchanging handpieces. After the handpiece/s are connected: Plug the system into a designated •...

  • Page 25: Operation And Treatment Protocols

    OPERATION AND TREATMENT PROTOCOLS 4.1. General Guidelines for the Operation of Mistral The general guidelines below are relevant for all Mistral applications. To insure patient safety, attain optimal clinical results and protect device performance, operators should adhere to the following protocols: Activation –...
  • Page 26 CHAPTER 4 Overlapping – No overlapping is necessary. If unavoidable, keep overlapping to a minimum of 5%. Stacking and/or excessive overlapping can cause crusting or blisters which can lead to transient pigmentary changes. Additional Pulses – To trigger the next pulse, wait until charging is completed and the “Ready”...

  • Page 27: Using The Touch Screen Computer

    Pulse Counter Figure 8 - Pulse Counters 4.2. Using the Touch Screen Computer Mistral's touch screen is designed to guide you through the entire treatment process. It is recommended to read this section carefully and to completely Mistral User Manual...

  • Page 28: Figure 9: Password Entry

    CHAPTER 4 familiarize yourself with the computer interface before beginning treatment. You may use the stylus or your finger to gently tap and activate the touch screen pad. Using the stylus is recommended. When treating patients, the operator may choose either direct or data base treatment protocols.

  • Page 29: Figure 10: Home Page

    Gently tap the screen where you wish to go next. Figure 10: Home Page 4. Training (Figure 11) - The tutorial page allows access to a Mistral training video and the help file. Figure 11: Tutorial/Help Page 5.

  • Page 30: Figure 12: Settings Page

    Figure 12: Settings Page a. Export/Import Data Base – using the USB ports found on the front bottom right of Mistral, you may export or import either data base or treatment files from or to an outside source. b. Screen Calibration – Calibration should be performed once every 6 months.
  • Page 31 Trigger the first pulse on the tested area. Apply the pulse by pressing on the footswitch followed by simultaneously pressing the handpiece pulse button. The pulse will not trigger unless the footswitch is depresssed. Lift the handpiece completely away from direct contact with the skin between pulses. Mistral User Manual...
  • Page 32 CHAPTER 4 g. Release footswitch between pulses. h. The next sequence begins after the pulse has been emitted. Repeat steps d-f for the second and third pulse. Place test pulses next to each other to aid in comparison and observation. k.

  • Page 33: Figure 13: Test Mode 1

    Verify energy level Skin Type Skin Photo Type Figure 13: Test Mode 1 Figure 14: Test Mode 2 3. Direct Treatment: After testing, note results. 4. Data Base: After testing, confirm and save energy levels.(Figure 15) Mistral User Manual...

  • Page 34: Figure 15: Test Mode 3

    CHAPTER 4 Figure 15: Test Mode 3 5. If the test session must be cancelled early, you have the option to save results already obtained. Figure 16: Test Mode 4 4.2.3. Direct Treatment 1. Select application. Only applications that are related to the attached handpieces will be accessible, all other applications will be greyed out.

  • Page 35: Figure 17: Dt Select Application

    Continue treatment using determined protocols from the section of the user manual relevant to the application being used. Set Energy Level here Confirmed Energy Level Confirm Choice here Return to Home Page Mute Button Figure 18: DT Treatment Page Mistral User Manual...
  • Page 36 CHAPTER 4 3. Optimal Pulse Train (OPT) Settings OPT is used during HR and ST treatments. During hair removal, OPT takes advantage of the skin's thermal relaxation time. A pulse train of 3 short bursts with 2 rest periods is delivered.

  • Page 37: Figure 19: Hr Dt Treatment Page

    1 number or character. o To keep the keyboard visible, tap the key twice. o To return to the standard keyboard, tap the key once. 1. From the Home Page, select Data Base Treatment. Mistral User Manual...

  • Page 38: Figure 20: Db Patient Search

    2. From this page, you may search for previously entered patients or create a new profile. (Figure 20) 3. Patient Search – Mistral uses a 'smart search' system to help find your patient quickly and easily. Enter the first few letters or digits into one of the search fields.

  • Page 39: Figure 22: Db Clinical History

    Pigmentation: This refers to the degree of any previous • pigmentation changes that your patient may have experienced with other devices or treatments prior to using Mistral. History: This refers to your patients medical history prior to • using Mistral.

  • Page 40: Figure 24: Db Edit Record

    CHAPTER 4 4. To edit a patient's profile, select Edit Record and change any details as needed. From here you may save changes or remove the patient completely from your data base. Caution: Any changes made to the patients record are permanent. No history will be saved.

  • Page 41: Figure 25: Db Select Application

    The treatment area will be saved to the data base. Refer to the table below for complete treatment area selection options. Table 5: Data Base Application Selection Hair Removal Skin Photo Rejuvenation Acne Clearance Psoriasis Care Skin Tightening Mistral User Manual...

  • Page 42: Figure 26: Db Treatment Mode

    CHAPTER 4 8. For repeat clients, you will be automatically directed to the treatment mode with all the details from the last treatment. You will be able to immediately begin treatment. (Figure 26) 9. When treating your patients, especially for first time, confirm patient details with the treatment log.

  • Page 43: Pre-Treatment Considerations

    Advise the patient that there may be some discomfort, erythema, edema or blistering associated with the treatment and that there is a minimal Mistral User Manual...

  • Page 44: Pre-Treatment Preparations

    Report ( 6). If the effects match any of the criteria found there, copy then fill out the form and send it by FAX or email to your Radiancy Distributor and to Radiancy Ltd. within 48 hours of noticing the effects.
  • Page 45 FITZPATRICK SKIN TYPE CLASSIFICATION Always burns, never tans Always burns, tans less than average III Sometimes burns, tans average IV Rarely burns, tans with ease Moderately pigmented, always tans VI Deeply pigmented, never burns Mistral User Manual...
  • Page 46 CHAPTER 4 4.4.3. Pre-Treatment Test Caution: As some patients may have a delayed reaction to the light • flash, do not perform more than 3 test pulses during the first test session. Wait at least 24 hours before administering the first treatment. For patients with Fitzpatrick Skin Types IV-VI, it is •...
  • Page 47 Using a damp cloth or hygenic wipe, remove any residual anesthesia., then thouroughly clean and dry the entire area before begining any procedure. The above are general guidelines. With any specific topical anesthesia, always follow the manufacturer's instructions. Mistral User Manual...

  • Page 48: Skin Photo Rejuvenation

    Fine lines and wrinkles (rhytides) • Skin aging in the form of overall tone and texture • Mistral may be used to treat the face, neck, décolleté, arms and the back of hands. 4.5.2. Contraindications Mistral should not be used on patients who: •...
  • Page 49 • Have been on a steroid regimen (i.e. for asthma) over the last 3 months. • Have an active implant, such as a pacemaker, incontinence device, insulin pump, etc. • Have any other condition which in the practitioner’s opinion would make it unsafe for them to be treated. Mistral User Manual...

  • Page 50: Table 6: Energy Level Setting - Sr

    CHAPTER 4 4.5.3. Pre-Treatment Test – Skin Rejuvenation Applications Table 6: Energy Level Setting - SR Pulse Pulse Pulse Set the energy level for the first pulse according to the table above. For example, if the patient has skin Type III, the energy level for the first test pulse should be set at 40.

  • Page 51: Table 7: Required Results For Appropriate Energy Setting

    Resume treatment only after the skin has completely healed. 4.5.4. Treatment Principles: Pigmentary Lesions (Sun Spots, Age Spots, etc.) Before administering treatment, refer to section 4.1. Carefully • follow the guidelines presented there. Mistral User Manual...
  • Page 52 4.5.5. Treatment Principles: Vascular Lesions Mistral may be used to treat small superficial vascular lesions, up to 0.5 mm diameter, appearing on the face and décolleté only, not on other areas of the body. Results are very individual and often depend on the depth and size of the lesion.
  • Page 53 Before administering treatment, refer to section 4.1. Carefully • follow the guidelines presented there. Set the energy level according to test results. • A full treatment course generally consists of 5-6 sessions • spaced 2-3 weeks apart. Mistral User Manual...
  • Page 54 CHAPTER 4 When treating fine lines, wrinkles, and skin texture treat the • entire face. The appropriate energy level for treatment is one that causes • only mild redness and disappears quickly after the pulse. Perform two passes in a crisscross pattern over the entire face. •...

  • Page 55: Hair Removal

    Side effects were all minor and transient • 4.6.2. Indications The Mistral HR treatment is indicated for patients in good general health, 18 years of age or older with skin types I-VI according to the Fitzpatrick skin type classification. 4.6.3.
  • Page 56 CHAPTER 4 Have tanned by sun or artificial tanning machine within the last • 21 days. Have a tattoo or permanent makeup in the treatment area. • Have abnormal skin conditions due to differnet diseases, • conditions (e.g. diabetes) or medicinal intake. Have a history of skin disorders such as vitiligo or psoriasis in •...

  • Page 57: Table 8: Energy Level Setting - Hr

    The appropriate energy level has been reached if any of the following required reactions are observed immediately following the pulse: • Darkening/burning of the hair • Skin redness around the hair (Perifollicular erythema) - immediately or within 10-15 minutes after pulsing. Mistral User Manual...
  • Page 58 CHAPTER 4 • Note for advanced users: The optimal result is achieved when the hair in the majority of the pulse area has completely disintegrated. If the energy level you're using provides good results but still not optimal, you may attempt to raise the energy level in increments of 2-5 levels with each pulse until most of the hair in the pulse zone is disintegrated.
  • Page 59 Perform maintenance treatments as needed. • 4.6.6. Considerations for Feminine Facial Hair Facial hair is generally obstinate and one of the hardest conditions to treat for successful long term removal. Often caused by chronic or life Mistral User Manual...
  • Page 60 CHAPTER 4 stage hormonal imbalances, it is important to understand that light based treatments do not treat the underlying causes of these imbalances and can at best offer temporary cosmetic relief. Therefore when treating unwanted facial hair it is crucial to correctly set the patient’s expectations and be very clear about anticipated outcomes.

  • Page 61: Table 9: Treatment Course Recommendations

    2-3 weeks and longer as needed (after 30% regrowth occurs) 4. Maintenance – Performed every 6 months as necessary. 5. Early Termination – Interim treatment results should be evaluated after 4-7 treatments, depending on the case. If the practitioner Mistral User Manual...
  • Page 62 CHAPTER 4 does not observe at least 30% reduction of hair they should consider, together with the patient, the possibility of early termination. 6. Special Note About Vellus Facial Hair – Do not attempt to remove vellus facial hair as induced hair growth may result. Photo History –...

  • Page 63: Acne Treatment

    2 months following the last treatment, reaching a 90% decrease in lesion count from baseline. 4.7.2. Indications The Mistral AC handpiece is intended to provide phototherapeutic light to the body. The Mistral AC handpiece is generally indicated to treat Mistral User Manual...
  • Page 64 Fitzpatrick skin types I-VI. 4.7.3. Contraindications Mistral should not be used for acne treatments on patients who: Are under 12 years of age. • Are pregnant or lactating. •...

  • Page 65: Table 10: Energy Level Setting - Ac

    If the required reaction in the target area is observed, this is the appropriate energy level for treatment. If this required result does not appear increase the energy level according to Table 10 until the Mistral User Manual...
  • Page 66 CHAPTER 4 required result is observed. Typically, it is advisable to wait a minimum of 30 seconds between test pulses to determine the skin’s reaction. Test pulses should be administered on adjacent spots. If the required result is not observed immediately following or within 24 hours after the test, you have not yet reached the optimum level for the treatment area.
  • Page 67 3-4 treatments. This is a natural part of the healing process and will resolve itself within days. Adaptors –The Mistral handpiece has 3 optional adaptors: 2 • Medium size-(13x50/13x35mm) and a Small area- (13x12mm).

  • Page 68: Psoriasis Treatment

    Psoriasis Care Handpiece coagulates the capillaries which feed the psoriatic lesions. Mistral also emits a pulse of heat which reduces swelling and inflammation and relieves pruritus. Thirteen patients participated in a controlled study. Patients received two therapy regimens in parallel;...

  • Page 69: Figure 28: Plaque Psoriasis

    Figure 28: Plaque Psoriasis 4.8.3. Indications The Mistral PSOR handpiece is intended to provide phototherapeutic light to the body. The Mistral PSOR handpiece is generally indicated to treat dermatological conditions and is specifically indicated to treat mild and moderate plaque psoriasis, which includes the treatment of patients with Fitzpatrick skin types I-VI.
  • Page 70 CHAPTER 4 Have used any medications, herbal preparations or chemicals • that cause photosensitivity within the last 6 weeks. These include, but are not limited to, gold therapy, tetracycline or sulfa drugs and certain psychiatric medications. In case of uncertainty regarding photosensitivity side effects, have the patient consult their physician.
  • Page 71 Warning: Do not treat the area around the eyes. Testing Procedure Perform the pre-treatment preparations. Select a section on the treated area and conduct a test by applying 3 different energy levels as explained below. Mistral User Manual...

  • Page 72: Table 11: Energy Level Setting - Psor

    CHAPTER 4 Table 11: Energy Level Setting - PSOR Skin Types I-III Skin Types IV Skin Types V-VI Pulse Pulse Pulse Select energy level for first pulse according to Table 11. • Trigger a pulse on a skin patch in the test site. •...
  • Page 73 (e.g. Aloe Vera) may be used if necessary. Interventions - If blistering occurs, slightly reduce the energy • level. Do not readminister treatment to the same place until the blister has resolved. Salycilic acid should not be applied on iritated skin. • Mistral User Manual...

  • Page 74: Skin Tightening

    Skin Tightening 4.9.1. Indications Mistral ST treatments are indicated for patients in good general health, 18 years of age or older, for the treatment of finelines and wrinkles. Mistral may be used to treat the face, neck, and abdomen. Warning: Do not connect any other handpiece to the system when using the ST handpiece.

  • Page 75: Table 12: Energy Level Setting - St

    • Have any other condition which in the practitioner’s opinion would make it unsafe for them to be treated. 4.9.3. Pre-Treatment Test – Skin Tightening Application Table 12: Energy Level Setting - ST Skin Type Pulse Width Medium Long 1st Pulse 2nd Pulse 3rd pulse Mistral User Manual...
  • Page 76 CHAPTER 4 Set the energy level for the first pulse according to Table 12. For example, if the patient has skin Type III, the pulse width should be set at medium with the energy level set at 30. The appropriate energy level has been reached if any of the following required reactions are observed immediately following the pulse: •...
  • Page 77 Set the energy level according to test results. • You may apply non-humid ice , such as an ice pack , to the • site of the next pulse to enhance patient comfort. Mistral User Manual...
  • Page 78 CHAPTER 4 The appropriate energy level for treatment is one that causes • only mild redness that disappears quickly after the pulse. Perform two passes. Wait a minimum of 5 minutes between • the passes to prevent over heating the skin. Maintenance treatments should be performed as needed.

  • Page 79: Maintenance

    This may affect performance and the life of the lamp. Use the supplied cleaning tool to clean the lamp after each treatment (Figure 29). Tip B Tip A Use this end to clean Use this end to clean between between the lamps the lamps and reflector. Figure 29 Mistral User Manual...

  • Page 80: Figure 30

    CHAPTER 4 Put 2 drops of alcohol on the sponge part of the cleaning tool (Figure 30) Figure 30 2. Use Tip B to gently rub along the length of the lamps between the two lamps until the debris is removed (Figure 31). Figure 31 3.

  • Page 81: Parts & Attachments

    Parts & Attachments 5.2.1. Handpiece Replacement The handpiece must be replaced every 50,000 pulses. Remove the handpiece from the system and return it to your Radiancy representitive for a replacement. 5.2.2. Area Adaptors The Area Adaptors are used when treating different size and shape areas..

  • Page 82: Figure 34: Fuse Location

    CHAPTER 4 5.2.3. Fuse Replacement To replace the fuse and restore the energy after a fuse is blown, turn off the unit and disconnect the system from the electrical outlet. Wait 5 minutes. Pull out the fuse drawer located in the back panel. Replace the fuse and push the drawer back into position.

  • Page 83: Adverse Events Report Form

    In the case of any of the adverse events listed below, please complete this form and send a copy to your distributor and Radiancy Ltd. no longer than 24-48 hours after you learn of the occurance. Retain a copy for your own records.
  • Page 84 Treatment Administration : Date of event: (mm/dd/yy) _______ / _______ / _______ Please specify device used: Device Name: _____________________ Company: _________________________ Serial Number: _____________________ Where was the treatment done? Name of Facility: __________________ Address: ________________________ ________________________ ________________________ Who performed the treatment? Full Name: _______________________ Title: ________________________ Who is preparing and submitting this report?
  • Page 85 ____________________________________________________________ ____________________________________________________________ ____________________________________________________________ Please include any other relevent patient history , including any preexisting medical condition(s): ____________________________________________________________ ____________________________________________________________ ____________________________________________________________ Relation to the Treatment: Event Outcome: Probable Resolved Possible Improved Probably not Unchanged Not related Worsened Mistral User Manual...

  • Page 86: Troubleshooting

    Check the number of pulses The handpiece is worn that were performed with the handpiece. Replace If over 50,000 pulses. Improper locking of Stop system operation. Call lamp into Handpiece caused darkening of Radiancy service immediately contact points Mistral User Manual...

  • Page 87: Mistral Service

    5 Hanagar St., P.O. Box 7329 Tel: 972-9-775-7500 Hod Hasharon, 45240, ISRAEL Fax: 972-9-775-7511 service@radiancy.com Radiancy Radiancy Inc. Toll Free number: North America 40 Ramland Road South, Suite 200 888-661-2220 Orangeburg, NY 10962, USA Tel: 1-845-398-1647 Fax: 1-845-398-1648 info@radiancy.com Mistral User Manual...

  • Page 88: Warranty

    WARRANTY After receiving Mistral and operating it for the first time, please fill out this Warranty Card and send to: Radiancy (Israel) Ltd. 5 Hanagar St., P.O. Box 7329 Hod Hasharon, 45240 Israel Mistral™ Warranty Card: User Information: System Details:...
  • Page 91 RADIANCY INC. 40 Ramland Road South, Orangeburg, Suite 200, New York 10962, USA Tel: +1 845 398 1647 Fax: +1 845 398 1648 Toll Free: +1 888-661-2220 www.radiancy.com RADIANCY INC ▪ RADIANCY LTD © 2007-2009 Radiancy Inc. All Rights Reserved.

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