Multiple Aesthetic Treatment System
Contents
1. G The responsibility of DMC regarding the use of the equipment and its consequences is limited to the replacement value of the equipment CHECKLIST 68 WARRANTY TERM USER MANUAL Elite Unit Carrying Case 2 Green safety goggles 1 Safety goggles with elastic patient Warranty Term User Manual AIC Cable AITTE LE TTI AILI TLEL ATTE TLEL TI AILLI TLEL CEE amO DMC EQUIPAMENTOS LTDA Rua Sebasti o de Moraes 831 Jardim Alvorada Sao 5 5 CEP Zip Code 13562 030 CNPJ 02 827 605 0001 86 ANVISA Registration 80030810090 Tech Officer Renaldo Massini Jr CREA 0601706815 Technical Name Multiple Use Aesthetic Laser System Technical Support DMC EQUIPAMENTOS LTDA Telephone 55 16 2107 2323 Fax 55 16 2107 2320 21 113 1 Rev 02 Data de Revis o 06 03 20122. and red and infrared laser diodes with wavelengths of 660 nm and 808 nm respectively ELITE User Manual SAFETY IMPORTANT PRECAUTIONS DANGER Only aesthetic professionals should use this equipment doctors biomedicians technical and postgraduate estheticians and physiotherapists DANGER The use of laser technology implies in protection through the use of safety goggles by all those present where the laser application session is taking place Do not allow the equipment to be submerged Never look directly at the emitted laser light and never direct it to anyone Reflective surfaces may reflect the laser beam towards the eyes Never radiate tumor processes directly The laser can stimulate them Do not radiate the beam on women who are less than three months pregnant equipment should be electrically connected to ground e Place the equipment in a safe place preventing it from being subjected to shock and vibration Do not use abrasive solutions for cleaning CONTRAINDICATIONS WARNING There are no absolute contraindications however the examples below should be considered inappropriate Pregnant women or nursing mothers Patients with an episode of skin cancer in the radiated region Glaucoma patients Cataracts not under medical supervision LIST OF COMPONENTS Elite Unit Carrying case 2 green safety gog
3. depending on the light source LED or Laser Press or to select and confirm by pressing After finishing an application select the next step between the options SELECT OPTION gt gt NEXT AREA NEXT LEVEL CONCLUSION Next Area repeats the same light application Next Level goes to the next light application Conclusion ends the application and returns to the Main Menu Entering OPERATION mode This screen shows the last parameters configured in the Red Laser Infrared Laser Blue LED and Amber LED modes After the end of each cycle the fan in the handpiece will remain on for about 5 minutes to cool the lighting system The unit should only be turned off after the handpiece fan turns off WARNING Only activate the handpiece when directed to the treatment area WARNING In the case of power failure the system will restart automatically returning to stand by state It is necessary to press the handpiece button to activate the light PREVENTIVE MAINTENANCE The unit must be disconnected from the electrical outlet before cleaning it in order to avoid exposing the user to electric shocks Clean the unit with a soft cloth dampened in 70 alcohol Do not allow liquids to flow into the unit through the air inlet outlet holes This may permanently damage the unit STORAGE AND TRANSPORT Store the equipment in a cool and dry place away from dus
4. Aesthetic or Facial Aesthetic Press to confirm SEL OPERATION BLUE LED SEL OPERATION RED LASER SEL OPERATION INFRARED LASER SEL OPERATION AMBER LED SEL OPERATION BODY AESTHETIC SEL OPERATION FACIAL AESTHETIC Red Laser Mode After confirming the Red Laser mode the next screen allows the dosage setting The dosage can be varied between 1 J 2 J or 3 J Press or A to select and to confirm RED LASER SEL DOSE 1J ADJUSTING PARAMETERS After setting the dose the screen will appear as follows RED LASER 0 0 energy counter is shown on the bottom left side and a fluency counter on the bottom right side ELITE User Manual Blue LED Mode After confirming the Blue LED mode the next screen allows the setting of the time The time can be adjusted from 30 seconds to 3 minutes with 30s intervals Press to select and to confirm BLUE LED TIME SEL 1 00 ADJUSTING PARAMETERS After setting the time the screen will appear as follows BLUE LED 470nm 0 30 200mw cm The display shows a countdown timer on the bottom left side and the power density on the bottom right side Infrared Laser Mode After confirming the Infrared Laser mode the next screen allows the dosage setting The dosage can be varied between 1 J 2 J or 3 J Press or to select and to confirm INFRARED LASER SEL DOSE 1J ADJUSTING PARAMETERS After selecting the dose
5. E fb nt QMO oyna Elite Multiple Aesthetic Treatment System User Manual ST al orl a Please read this manual completely and follow the instructions carefully The words DANGER WARNING and NOTICE have special meanings and should be read carefully DANGER The safety and or health of the patient user or third parties are at risk Observe this warning in order to avoid lesions to the patient user or third parties A WARNING Information related to the purpose of this device or accessory Information the maintenance of the device or accessory SYMBOLS Scroll through the options Aa Scroll through the options Select A See user manual Type B equipment INDICATIONS The Elite is an equipment used in the treatment of Acne Alopecia Bio stimulation Lymphatic drain age Cinderella effect Expression wrinkles Dark spot Dark circles under the eyes Hydration Illu mination Collagen stimulation Postoperative Cellulitis Stretch marks Localized fat and Micropig mentation This equipment provides energy by means of blue and amber LEDs with wavelengths of 470 nm and 590 nm respectively
6. the surface tension of the skin with esthetic effect of tissue expansion reducing eventual skin folds and expression wrinkles The expansion of the tissues by stimulation of the presence of water helps prevent agglutination of pigments with the ability to absorb light optimizing the whitening esthetic effect since the carbon compounds will be more spaced favoring the reflection of light with whitening effect In another way the stimulation of the presence of water also favors the esthetic whitening effect since it is known that substances solubilized in water absorb less light and reflect more PROGRAMMING THE NUMBER OF SESSIONS 6 8 sessions from the chosen protocol and one maintenance session every 60 90 days is recommended OPERATING INSTRUCTIONS Installation This unit has a full range power supply 90 240VAC To turn the unit on use the on off switch located on the back panel ELITE User Manual PREMILINARY PROCEDURES After turning the unit on a self test is conducted in order for the equipment to check all its internal software configurations Then the initial screens will appear with name of the equipment version serial number and time of use The following screen will be shown Press 4 or D to change the current selection and to confirm MAIN MENU OPERATION SETUP Entering SETUP mode After entering the SETUP mode press or A to select between Blue LED Red Laser Infrared Laser Amber LED Body
7. gles 1 safety goggles with elastic patient User manual and warranty term A C Cable FRONT PANEL Figure 1 Buttons v and used to scroll through the options of the program Button confirms the selected options Handpiece El it has eight amber Leds and two infrared lasers This handpiece will be identified as Amber LED Infrared Laser Handpiece has eight blue leds and two red lasers This handpiece will be identified as Blue LED Red Laser BACK PANEL Location of air outlet must not be obstructed AIC Inlet Location of A C cable inlet On Off Button Turns the unit on and off Figure 2 Back Panel ELITE User Manual ACNE VULGARIS Acne acne vulgaris is an inflammatory disease of the pilosebaceous unit which consists of hair and the sebaceous gland It appears on the face and upper part of the thorax regions where the seba ceous gland is more active Comedones blackheads papules and pustules pimples and nodules internal pimples There are many factors responsible for acne One of them is the individual predisposition which may or may not be inherited from the parents With the production of sexual hormones especially male hormones the sebaceous gland increases its production This sebum binds with keratin in the skin hair orifice forming a compact mass the comedone whic
8. h is sometimes invisible to the naked eye Some bacteria that inhabit the skin especially Propionibacterium acnes multiply due to the abun dant supply of sebum causing an inflammatory response that leads to the formation of pimples and acne nodules As a normal part of the metabolism process the bacteria Propionibacterium acnes produces porphy rin especially photoporphyrin and photosensitive coporphyrin Photosensitivity is a property of the molecules that absorb energy in the form of light in a certain region of the spectrum This energy is used to cause chemical reactions in cells and tissues Several treatments are proposed to prevent this disease The most conventional ones soaps gels with exfoliating and drying substances and oral antibiotics control the disease but after its suspen sion there is a great chance of the symptoms returning Phototherapy with Low Power Laser is gaining an important space among these treatments because it does not cause side effects SPOTS AND DARK CIRCLES The skin has carbon molecules in its composition These molecules are bound together sequentially in bivalent bonds with Hydrogen molecules to form long spirals grouped according to electrical affinity The agglutination of these carbon structures form chromophores energy absorbing substances and cause the esthetic aspect of darkening or spots in the region of higher incidence Despite the existence of chromophores sensitive to other wavelengths t
9. he action of Blue Light is directly related to the oxidation of porphyrins wavelength of 415 nm it is therefore considered a non melanin action These extremely reactive substances remove electrons from the molecules of the Hydrogen bridges breaking the carbon conjugation and producing simple compounds with smaller structures These compounds with smaller carbon chains their energy Light absorption capacity reduced and consequently have their capacity to reflect Light increased creating the esthetic effect of whit ening It is important to emphasize that the method is biological of known physiology uses light within the visible spectrum and does not cause loss of substance or exfoliation of the region There is no permanent change of the tissue structure and the presence of heat is not enough to cause burns or any discomfort EXPRESSION MARKS As the region chosen receives the incidence of Blue Light 470 nm the production of free radicals is stimulated reactive oxygen species from melanin compounds These reactive Oxygen species have affinity for the Hydrogen molecule present in water Therefore the free Oxygen reacts with Hydrogen from the water to produce hydrolysis water break and con sequent formation of free ions that will adhere to the wall of the cytoplasmic membrane of tissues These free ions will notably bond with Oxygen molecules and stimulate the presence of water in the region creating a change in
10. t moist chemical products and cleaning agents TECHNICAL SPECIFICATIONS Electrical Characteristics Operating Voltage 90 V to 240 V Blue LED Emitter Wavelength 470 nm Amber LED Emitter Wavelength 590 nm Infrared Laser Diode Wavelength 808 nm Power 100 mW Red Laser Diode Wavelength 660 nm Power 100 mW Electrical Power 60 W User WARRANTY Manual A The equipments manufactured and or sold by DMC have a warranty of 24 twenty four months as from the date of purchase against manufacturing effects B The warranty covers only manufacturing defects or defects of materials used in the manufacture of the products Th e warranty does NOT cover shipment expenses C The warranty is automatically canceled in the case of electrical abuse physical abuse if the parts are changed or in developed the occurrence of applications different from those for which the equipment was D In the case of equipment repaired outside the warranty period it will only be extended to the replaced components E The most common causes of defects resulting from physical shocks to the equipment cases where the warranty is can celed F DMC is not responsible for personal or material damages resulting from the undue use of the equipments it prod to avoid such occu uces and or sells and the user is responsible for providing safety measures in order rrences
11. the screen will appear as follows INFRA LASER 0 0J energy counter is shown on the bottom left side and a fluency counter on the bottom right side Amber LED Mode After confirming the Amber LED mode the unit display will show the following screen AMBER LED 590nm 5 TIMES OF MINUTE Press Creed to confirm Press the button located on the Amber LED Infrared Laser handpiece to activate the light The screen will appear as follows AMBER LED 590nm PHASE 1 5 CONTINUOUS 0 00 To interrupt the application cycle press the button on the Amber LED Infrared Laser handpiece Body Aesthetic or Facial Aesthetic Confirming this function allows the selection of the following pre programmed therapies Acne Alo pecia Bio stimulation Lymphatic drainage Cinderella effect Expression wrinkles Dark spot Dark circles under the eyes Hydration Illumination Collagen stimulation Postoperative Cellulitis Stretch marks Localized fat and Micropigmentation Press 0 or to scroll through the therapy options Press to confirm the selection To cancel and return to the previous menu select the Return option and press The Body Aesthetic screen can be seen below BODY AESTHETIC ACNE ELITE User Manual Press or to scroll through the therapy information Press to confirm the selection After confirming the therapy select the dosage or the time of operation
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