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Instructions Manual

1. gt 95 voltage drops gt 95 voltage drops in U 0 5 by cycle in U by 0 5 cycle Voltage dips short interruptions and 40 U It is advisable that the mains power line is typical It riations 40 U voltage drops DEE voltage Va in 60 U by 5 60 de voltage drops of that in hospital or commercial environments E O 8 in power input ele j in U by 5 cycles If the user of the equipment needs continuous lines functioning during interruptions in the electrical 70 U 30 voltage 70 U feed it is recommended that the equipment is IEC 61000 4 11 drops in 30 voltage drops in fed by a continuous source or battery U by 25 cycles U by 25 cycles 5 LU gt 95 voltage drops in U by 5 seconds lt 5 U gt 95 voltage drops in U_ by 5 seconds If there is image distortion it may be necessary to position the electro medical equipment LYRA Power frequency further away from sources of magnetic fields in the 50 60 Hz frequency of the electrical feed network or install magnetic fild magnetic shielding Power frequency magnetic fields should be at levels characteristic of a IEC 61000 4 8 typical location in a typical commercial or hospital environment NOTE U_ is the A C mains voltage prior to applications of the test level 66 ELECTROMAGNETIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The LYRA is intended for use in the electromagnetic environment
2. Detailed information see interactive MENU INFO key Pre treatment 1 Inform the patient about the techniques and cares 2 Evaluate the phototype and the hair thickness if hair removal and do the pre test in a discreet area 3 Term of consent and information on the technique 4 Instruct the patient to shave the area to be treated on the day previous to the session Preparation for the treatment 1 Confirm if the patient has not been tanning or using medication 2 Shave any residues of hair if there are any on the area to be treated 3 Clean the area and apply a thin layer of transparent gel 4 Position the protection goggles on the patient 5 Select the filter for the treatment 6 Programme the equipment Development of session 1 Put on the operator protective goggles 2 Pick up the handpiece 3 Position the tip of the handpiece on the area to be treated 61 4 Press the footswitch keep it pressed during the entire procedure to release the shots 6 Press the shot control key flash trigger 7 Move the tip over the area at every shot 8 Respect the overlapping of 1 to 2 mm between the tips 9 Perform the traversal re pass in the whole treated area 10 Finalize the programming of the equipment Finalizing the treatment 1 As you finalize the treatment remove the gel and preferably use soothing gel cream over the treated area 2 Clean the tip using a paper towel humidified in alcoho
3. ADDITIONAL CONTRACTUALWARRANTY IBRAMED is not responsible for the transport of the equipment to technical assistance neither is it responsible for any cost and or refund of costs from transport 9 Both in the LEGAL WARRANTY PERIOD and in the ADDITIONAL CONTRACTUAL WARRANTY there is no MAINTENANCE WARRANTY AND TECHNICAL SUPPORT coverage of parts subjected to natural wear and tear such as command switches handles energy cables patient connection cables ultrasound transducer Support brackets cabinets etc A DANGER of the equipment 10 No authorized shop and or technical assistance is authorized No modification whatsoever is authorized to this to alter the conditions mentioned herein or to take responsibility equipment in the name of IBRAMED A non authorized modification may influence the safety TECHNICAL ASSISTANCE of use of this equipment Never carry out any unauthorized repairs under If you have any doubts or functioning problems with your any circumstances equipment contact the IBRAMED post sales department on 55 19 3817 9633 or access the Ibramed webpage www ibramed com br to obtain further information and telephone numbers of authorized technicians A CAUTION MAINTENANCE Company authorization of operation 103 603 1 Technician in Charge Maicon Stringhetta The user must carry out an annual preventive CREA SP 5062850975 inspection not the equipment only at IBRAMED or at other authorized te
4. Make sure the area to be treated is inspected before and after the treatment and interrupted if there is adverse reaction A CAUTION Some patients are more sensitive to IPL and may experience a reaction similar to a skin eruption e g patients who are under medication which increase sensitivity to light BIOCOMPATIBILITY of the materials in contact with the patient ISO10993 1 Ibramed declares that the contact Surface of the handpiece supplied with the equipment does not cause allergic reactions This applicator must be positioned only with the intact surface of the skin respecting a time limit of duration of 24 hours maximum PATIENT PROFILE USER PROFILE AND CONDITIONS OF USE PATIENT PROFILE e Patients with facial and or body aesthetic conditions that are in accordance with the indications of use of the device e Patients must be at least 12 years of age under this age the use of the device must occur only under medical prescription e Patients must weigh more than 35 kg under this weight the use of the device must occur only under medical prescription e Patients their level of consciousness must have preserved USER PROFILE e The equipment must be used only under prescription and supervision of a licensed health professional e The equipment does not require specialized training however the user of the device must read understand and practise the instructions of precaution and operation e The use
5. OPERATING INSTRUCTIONS USING THE MENU KEY TELANGIECTASIA BODY Deposit the tip perpendicular to the skin to avoid compression of the vein Keep the safety pedal pressed to release the shots Next press the shot key located on the handpiece Selecting the key a gt To change the safety password just press the PASSWORD ALTERATION KEY Type the default password on the line Old if there has been a previous alteration type the last programmed key Next type the new password New Repeat the operation to confirm on the line Press SS to return to the INTERACTIVE MENU 423 4J5 6 Figure 41 Step 5 of 5 of application technique General directions Setup Password oa TI General directions Always start programming the device by verifying the light filter indicated for each treatment When you finish using the device remove the filter light and put it away in the transport case sew TTT lala v DUU lelo Figure 43 Safety password alteration screen For treatment of Asian skin select phototype 4 or 5 Do not appy IPL on newly tanned skin Indicate the use of sunscreen Figure 42 General Directions for the use of the equipment 39 OPERATING INSTRUCTIONS USING THE MENU KEY In case the altered password is forgotten on the safety password insertion screen press the finger five times over the word PASSWORD on the screen below The password will be available bel
6. SEELEN OA RAGE 5 50 C 41 122 F Operational temperature range of environment 5 45 C 41 113 OF 24 ACCESSORIES USED Figure 6 Hose with funnel and drainage hose for filling up Figure 4 Handpiece of LYRA the water reservoir The drainage hose can also be used to empty the water reservoir eel SSR A Figure 5 A electrical feed cable and B footswitch pedal 25 ACCESSORIES USED PREPARING THE EQUIPMENT Important the safety goggles must always be worn during IPL treatment A Figure 7 Filter according to the type of treatment available options 480 nm 530 nm e 640 nm B A wa ANA ei Figure 9 A protective goggles for therapist and B protective goggles for patient B C Figure 8 A colorless gel B cuvette and C spatula 26 OPERATING INSTRUCTIONS PREPARING THE EQUIPMENT 1 Connect the electrical feed to the equipment and to the electrical feed source on the wall 2 Position the handpiece on the rack and connect it to the equipment pressing the handpiece connector until it is completely connected 4 Press the ON OFF key to the position ON Observe that the equipment enters the WATER RESERVOIR SUPPLY MODE and that the pump of the cooling system is activated Next press the blinking key with the warning LOW WATER LEVEL IN RESERVOIR Figure 10 se only demineralized water to fill up the reservoir ever fill it up with tap water or
7. Take into account if the patient has a darkened scar in the area of a wound or if she he has a history of keloid or a hypertrophic scar This might indicate a potential for change in pigmentation Keep in mind that the Skin tone of the patient may appear to be darker during the Summer due to a greater exposure to the sun If there are doubts about the real phototype of the skin always treat the patient according to the higher option For example if she he is a phototype 3 or 4 treat her him as a phototype 4 Ask in all the sessions if the patient was exposed to the sun recently Adjust the treatment according to the aspect of the color of the skin in the session For treatment of Asian skin select phototype 4 or 5 Always burns never tans Always burns tans less than average Sometimes burns tans like average Rarely burns tans easily Moderately pigmented always tans Deeply pigmented never burns Figure 64 Adapted Fitzpatrick scale PRE TEST Select one discreet area with the sin tone phototype similar to the area to be treated programme the equipment and apply 1 to 2 shots on the area Observe the reaction immediately after then after 10 to 15 minutes and on the next day The presence of redness on the skin perifollicular edema immediately after the pulse or after 10 to 15 minutes may indicate an excessive dose The darkening burning of the hair can also be an indicative In those cases use a phototype i
8. never burns Step 4 lt gt Figure 26 Step 2 of 6 of programming the equipment Figure 28 Step 4 of 6 of programming the equipment A 35 OPERATING INSTRUCTIONS USING THE MENU KEY Press the key which indicates the wavelength to start Make sure the filter is correct for treatment and if loading the equipment Clean the tip which will be in contact with the skin and the filters using soft cloth or paper towel dampened in alcoholic chlorhexidine at 0 5 it is positioned properly in the applicator gt Figure 29 Step 5 of 6 of programming the equipment OI e Figure 31 Step 1 of 3 of preparing the handpiece Select the correct filter V Eq according to the therapeutic objective Wait for the loading of the equipment Next the equipment will be ready for the application The equipment presents three selective cut filters Loading 480 nm spots and skin tightening 530 nm telangiectasia 640 nm hair removal MENU O O Figure 30 Step 6 of 6 of programming the equipment Figure 32 Step 2 of 3 of preparing the handpiece 36 OPERATING INSTRUCTIONS USING THE MENU KEY Clean the treatment area using alcoholic chlorhexidine at 0 5 Position the filter properly in the indicated place on the handpiece and press it until it is completely locked Protect nevi and skin spots with adhesive or white pencil 4 Figure 33 Step 3 of 3 of preparing the ha
9. of the connection plug of the water entrance Water Supply and of the exit connections Water Vent and Water Drain 1 To remove the plug or plugs use one hand to press the ring against the connector and with the other hand simultaneously pull the plug until its complete removal Figure 12 T OPERATING INTRAUCTIONS Figure 12 Removal of the connection plug Figure 13 Connection of hose 2 To connect the hoses just press them against the connection until you feel the resistance Figure 13 3 To remove the hoses use one hand to press the ring against the connector and simultaneously with the other hand pull the hose until its complete removal Figure 14 4 Replace the plug or plugs at the end of the procedure inserting it or them into the connection until you feel resistance Figure 14 Removal of connection hose 29 OPERATING INSTRUCTIONS Supply of the water reservoir Position of the supply hoses and periodical replacement once a month of demineralized water of the reservoir XA L AA SE ee B wie gt lt a es e a k i E a SN 4 Za CIO a K Figure 15 Supply and periodical replacementof demineralized water of the tip cooling system reservoir 30 Drainage of water reservoir The water flowing offis necessary for the monthly replacement of water and can be necessary when the system is removed or transported Place a recipient under the drainage co
10. reactions gt Programming the equipment gt Preparing the handpiece gt Preparing the patient gt Application technique gt General directions Figure 20 Interactive menu Figure 21 INFO summary Select the desired key or press O to return to the treatment Indications selection screen y Indications Hair removal Permanent reduction of hair Selecting the key y Treatment of acneic skin To obtain access just press the INFO key and you will Treatment of vascular lesions telangiectasia have access to the summary with the following information Rosacea treatment indications contraindications possible adverse reaction programming the equipment preparation of the handpiece preparation of patient application techniques and general directions Figure 21 Treatment of benign pigmentary lesions spots Cutaneous photoaging skin tightening Figure 22 Indications of use of equipment 33 OPERATING INTRUCTIONS USING THE MENU KEY Contraindications Contraindications Recent tanning up to 4 weeks before treatment Pregnancy Over areas with suspected neoplastic areas Over tattoos or permanent make up Application directed to eyes or over the eyes Presence of implanted electronic device Ex cardiac pacemaker Possible adverse reactions Potential Adverse Reaction Dischromy Pruritus Burns Erythema Edema Purpura KE gt ez Figure 24 Possible adverse reaction wh
11. rear view of LYRA 21 Figure 3 A handpiece of LYRA B frontal view of handpiece and rear view of NANAPIECE cccceeeeeueeueuceuvensaueunenees 22 Figure 4 Handpiece of LYRA 25 Figure 5 A electrical feed cable and B footswitch p edal rasaseceacs 25 Figure 6 Hose with funnel and drainage hose for filling up the water reservoir The drainage hose can also be used to empty the water eServoOll ccccceccccucuessucucesuuuveneueveneue 25 Figure 7 Filter according to the type of treatment Available options 480 nm 530 nm and 660 nm 26 Figure 8 A colorless gel B cuvette and C spatula 26 Figure 9 A protective goggles for therapist and B protective goggles for patient cccccesseceeueeeeueeueeneuuenns 26 Figure 10 Warning of low level of water of supply MOC sas ipa ad a ada Sa nd neces Sac odiar 28 Figure 11 Instruction screen about the supply mode of the water Feel spas seas didi died asas e id sds da 28 Figure 12 Removal of connection plug 29 Figure 13 Connection of bose cece ee eens 29 Figure 14 Removal of connection hose 29 Figure 15 Supply and periodical substitution of demineralized water of the tip cooling water 30 LIST OF FIGURES Figure 17 Figures A and B show the introductory message Of LYRA muiasaiacentadarasis assis iidianeada diria sd ad 31 Figure 18 Screen for insertion of safety password 32 Fig
12. set by fixed transmitters such as radio base stations telephone cellular cordless telephones and land mobile radios amateur radio AM FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength at the location in which the LYRA is used exceeds the applicable RF compliance level above the LYRA should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorientation or relocating the LYRA b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 68 ELECTROMAGNETIC COMPATIBILITY Recommended separation distances between the mobile RF communication equipment and LYRA The LYRA is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the LYRA can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the LYRA as recommended below according to the maximum output power of the communications equipment Rated maximum power output of transmitter Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 VP d 1 2 VP d 2 3 VP
13. supply network that supplies buildings used for domestic Voltage fluctuations REES flicker emissions IEC 61000 3 3 In accordance ELECTROMAGNETIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The LYRA is intended for use in the electromagnetic environment specified below The user of LYRA guarantees that it is used in such environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast Transitories burst IEC 61000 4 4 Surge TEC 61000 4 5 IEC 60601 Test Level 6 kV by contact 8 kV by air 2 kV for power Supply lines 1 kV for input output lines 1 kV diferencial mode 2 kV common mode Compliance Level 6 kV by contact 8 kV by air 2 kV for power supply lines 1 kV for input output lines 1 kV diferencial mode 2 kV common mode 65 Electromagnetic Environment Guidance It is advisable that floors are made of wood concrete or ceramic If the floors are covered by synthetic material it is convenient that relative humidity is at least 30 It is advisable that the quality of power line feed is typical of a hospital or commercial environment It is advisable that the quality of power line feed is typical of a hospital or commercial environment ELECTROMAGNETIC COMPATIBILITY IEC 60601 Compliance Level Immunity Test Test Level Electromagnetic Environment Guidance lt 5 We lt 5 U
14. times the flash lamp is shot during the application Between shots it is necessary to wait for 3 seconds for the After the loading of the equipment is complete and the lamp is energized in case the equipment remains in disuse skin phototype longer than 5 minutes it will automatically turn off the lamp and return to the parameter adjustment screen condition available Shot Energy CIC oO Figure 52 A system loading of LYRA B screen with the selected parameter of Example 4 and the energy which will be used in the treatment 48 OPERATING INSTRUCTIONS EMERGENCY STOP BUTTON In case of intercurrence immediately press the emergency B stop button to stop the equipment The equipment will emit a sound beep and display the screen shown in figure 53 B Emergency Emergency button Lyra Figure 53 A emergency button and B emergency screen When the emergency situation is solved just turn the button clockwise to restart the system AS C 49 OPERATING INSTRUCTIONS PROTECTION WARNINGS OF THE EQUIPMENT Integrated to LYRA equipment there are sensors which a message indicating the procedure to be carried out Figure verify inadequate situations This is a safety mechanism to 35 Carry out the procedure and press The system will be avoid damage to the equipment and risks to the patient restarted automatically In case it persists repeat the operation If it still pers
15. tone Press the corresponding key Figure 49A On the next screen after checking if the correct filter is used press the key Figure 49B Next wait for the complete loading of the equipment After that the equipment will be ready for use indicating the Figure 49 A screen for selecting parameters and B filter energy J which will be used in the treatment check warning 480 nm 45 T OPERATING INSTRUCTIONS After that keep the footswitch pedal press to release the energy position the tip of the handpiece on the area and press the shot button on the handpiece Keep the footswitch pedal pressed during the entire treatment After the end of the treatment or if you want to return to the programming condition press The icon Shots stores the number of times the flash lamp is shot during the application Between shots it is necessary to wait for 3 seconds for the loading of the capacitor banks After the loading of the equipment is complete and the lamp is energized in case the equipment remains in disuse longer than 5 minutes it will automatically turn off the lamp and return to the parameter adjustment screen condition available Skin phototype ces ES EB Shot Energy fo C Figure 50 A LYRA system loading and B screen with parameter of Example 3 selected and the energy which will be used in the treatment 46 OPERATING INSTRUCTIONS PROGRAMMING THE EQUIPMENT Example 4 Sp
16. warning persists contact IBRAMED technical assistance 53 OPERATING INSTRUCTIONS PROTECTION WARNINGS OF THE EQUIPMENT Problems in the system hardware Warning of problems in the system hardware Figure 62 Step 1 Turn off the device Step 2 Look for authorized service Figure 63 Instructions on problems in the system hardware Figure 62 Warning of problems in the system hardware Press the image and another screen will appear indicating the procedure to be performed Figure 63 The equipment must be turned off and sentto IBRAMED technical assistance in order to avoid damage to the equipment or risk to the patient 54 PREPARATION FOR IPL THERAPY CARES PRIOR TO TREATMENT e During the first visit the professional must evaluate the areas to be treated record the clinical background and determine the cutaneous sensitivity and the phototype of the patient e The background of the patient must include information on any previous similar problem habits or previous depilation and inquire if the patient commonly suffers from irritation when shaving if the patient has any reaction to wax or if the skin is generally sensitive to creams or lotions It is also necessary to determine if the patient has any history of keloids or hypertrophic scarring Patients with history of such problems must be treated less aggressively e The professional must explain to the patient about the treatment pr
17. with any other type of liquid REPLACE THE DEMINERALIZED WATER MONTHLY OPERATING INSTRUCTIONS Figure 10 Warning of low level of water of the supply mode Follow the instructions described on the screen Figure 11 or described below To remove the plugs use of hand to press the ring against the connector and with the other hand simultaneously pull the plug until it is totally removed Figure 12 Connect the hose with the funnel to the water entrance Water Supply and the drain hose to the water exit connector Water Vent Position a recipient under the end of the drain hose to collect the excess of water during refill When the water overflows through the exit connector Water Vent the filling up will be complete Remove the hose and close the connections Press to restart the system The equipment will be ready for use In case the system identifies low level of water redo the process adding water 26 Remove both plugs of the supply conectors Connect the hoses to the Water Supply entrance and to the wather output Water Vent Fill up the reservoir with demineralized water 4 liters of water until it overflows through the output conector Water Vent next remove the hoses and close the conectors Figure 11 Instruction screen about the supply mode of the water reservoir Details about the connection and disconnection of the supply hoses and water drainage of LYRA Instructions about the removal
18. Em UV Po IBRAMED QUESTAO DE RESPEITO Instructions Manual E LYRA Manufactured by Ibramed Ind stria Brasileira de Equipamentos M dicos EIRELI Made in Brazil ANVISA n 10360319005 2 edition 02 2015 TABLE OF CONTENTS SMe Ok DEPENDILONO aomiaador seas nad die Dan ir dies 3 ON TRE EQUIPMEN H EE 4 CARTON EE 5 LIST elef ETGEN EI KETTER 6 LIS OF FIGURE E 6 LIS Or TABLE sessions acoes das Asas tno pasa E TERE 8 Mee 9 PRODUCT DESCRIPTION 0000000000 Ea eo 9 ESSENTIAL PERFORMANCE ERR 9 SAFETY PRECAUTIONS xxx NNN Neuen TT 10 INFORMATION ON INTENSE PULSED LIGHT 12 RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT 15 INDICATIONS CONTRAINDICATIONS AND PRECAUTIONS 16 PRECAUTIONS AND ADVERSE REACTIONS 17 PATIENT PROFILE USER PROFILE AND CONDITIONS OF USE 18 GENERAL CARE WITH THE EQUIPMENT 19 TRANSPORT DAMAGE 0 Mies ime ME Be of 19 CARES WITH THE EQUIPMENT cc cee eee eee eens 19 INSTALLATION CARE AND CLEANING cc ceeeee cece eee eee 20 INSTALLATION INSTRUCTIONS aa 20 CLEANING E 20 CLEANING THE HANDPIECE AND FILTERS 20 GOGGLES CARE AND CLEANSING sseseserernnnnnna 20 NOMENCLANORE EE 21 EE Ee 24 ACCESSORIES VSED atuais nana Anda ima a dat 25 Bi EA RECETTE 2 PREPARING THE EOUIDMENT soro 2 USING TRE EQUIPMEN e erer deene 31 USING TRE MENU KEY
19. For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 80 MHz to 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ENVIRONMENTAL INFLUENCES LYRA is an electronic piece of equipment and has heavy metals such a lead Therefore there are risks of contamination to the environment associated with the elimination of this equipment and its accessories at the end of their useful shelf life LYRA its parts and accessories must not be eliminated as urban residues Contact the local distributor to get further information on the norms and laws regarding the elimination of electrical residues electronic equipment and their accessories ENVIRONMENTAL INFLUENCES LYRA must not come into contact with biological material which may suffer degradation from the influence of bacteria plants animals and the like LYRA must undergo annual maintenance calibration as specified by the manufacturer in these instructions of use to minimize wear and tear or corrosion which may reduce its mechanical properties in its
20. GE key allows altering the o language Portuguese Spanish or English Key for confirmation Key indicating IPL is on STAND BY condition condition For emission just press the trigger on the handpiece C Key indicating IPL is on AVAILABLE 23 SPECIFICATIONS SYSTEM HANDPIECE Dimensions Handpiece with 3 interchangeable cut off filters Width 40 cm 15 7 in 5 480 nm Filter 480 nm 1200 nm 10 Depth 47 cm 18 5 in 5 530 nm Filter 530 nm 1200 nm 10 Height 120 cm 47 2 in 5 640 nm Filter 640 nm 1200 nm 10 Net weight with accessories 47 kg 5 Dimension of handpiece tip 7 5 cm 1 5 x 50 mm 10 Gross weight with packaging 55 kg 5 Water reservoir of tip cooling system empty Operating radius of handpiece cable 1 5 m 10 Energy emitted maximum 95 J 10 Electrical Characteristics Fluency of tip 12 6 J cm2 10 Input 127 240 V 50 60 Hz Pulse mode per shot simple or double Inout Power 800 VA Duration of pulse 1 to 60 ms 10 Fuses 10A 20AG Snap action Electrical Class CLASS I REFRIGERATION Electrical Safety TYPE BF Handpiece cooling Peltier and water thermoelectric i method ReguISsOry COMTORIKLEY Stored Volume 4 liters of demineralized water IEC 60601 1 IEC 60601 1 2 LAMP IEC 60601 1 4 Spectrum 400 a 1200 nm 10 IEC 60601 1 6 Composition Xenon gas Useful life 1 000 000 10 sm Temperature range during transport and storage
21. It indicates Off no electric voltage It indicates On with electric voltage V Alternating Current eed line Electric network in Alternating Current Dangerous Voltage CLASSI CLASS 1 equipment It has grounding resources for protection IPXO Equipment not protected against harmful water penetration AR Sensitivity to electrostatic discharge SYMBOL DEFINITIONS ON THE EQUIPMENT Do not step on the equipment surface Do not sit on the equipment Non ionizing radiation Refer to the instructions manual brochure Note follow the instructions of use SYMBOL DEFINITIONS CARTON FRAGILE The content in this package is fragile E ran Sd TA i and must be transported carefully raid Brazilian certification seal eru Gompulsorio inmerro This side up S N serial number Limits of temperature for storage and packaging in C Degrees Celsius Keep away from the rain Do not stack up damaged Check the operating instructions Indication of the maufacturer s name and address Q Do not use if the packaging is LIST OF ABBREVIATIONS LIP TRT J cm2 J s nm cm Intense Pulsed Light Thermal relaxation time TRT Joule Joule per square centimeter Joule per second Watt Energy Fluency Nanometer Millisecond Square centimeter LIST OF FIGURES Figure 1 Absorption spectrum of main skin chrom ODNO e 14 Figure 2 A frontal view and B
22. N KEN ENN ENN EN ENN EEN KEN ENN ENN 50 Figure 56 Warning of problems in the water cooling of Man GIICCe El epeen Cds da cds ana ida nd dad 51 Figure 57 Instructions on the problems in the water cooling system of handpiece D A ENNEN EEN NK ENN NN EN DY Figure 58 Warning of equipment without handpiece 52 Figure 59 Instructions on the connection procedure of the handpiece aka NNN KEEN E Eu un ee 52 Figure 60 Warning of problems in the cooling system pump of the handpieCe s sssesesessssssssnsnnnsnnnsnnnsnsnnana 53 Figure 61 Instructions on the procedure for problems in the pump of the handpiece tip cooling system 53 Figure 62 Warning of problems in the system ha POU WO0C ss anna aa SR O SEU 54 Figure 63 Instructions on problems in the system hard MATO canas ee ee 54 Figure 64 Adapted Fitzpatrick scale cece 56 Figure 65 Opening the LYRA fuse Dbox 73 Figure 66 Removal of the fuse box drawer 73 Figure 67 Repositioning of the fuse box drawer 73 LIST OF TABLES Table 2 Detailing of doses for telangiectasia treatment Observe the duration of the interval between the pulses highlighted in ParenthesiS ccccsessececsccsneceeseusareensauaueenss 59 Table 3 Pre programmed doses for Skin Tigtening Observe the duration of the interval between pulses highlighted in et enge TT E 59 Table 4 Pre programmed doses for Spots Skin Observe the duration of the inte
23. PROTECTION WARNINGS OF THE EQUIPMENT Equipment without handpiece If the equipment is without the handpiece or if it has any problems recognizing the connection as you turn on the equipment the following screen will appear Figure 58 Step 1 Turn off the device Step 2 Connect the handpiece to the device Figure 59 Instructions on the connection procedure of the handpiece Figure 58 Warning of equipment without handpiece Press the image A and another screen will appear with the message indicating the procedure to be carried out Figure 59 The equipment must be turned off and the connection of the handpiece must be adequately performed In case the warning persists contact IBRAMED technical assistance 52 OPERATING INSTRUCTIONS PROTECTION WARNINGS OF THE EQUIPMENT Cooling system pump of the handpiece If the equipment presents problems in the pump of the cooling system the following screen will appear Figure 60 Step 1 Turn off the device Step 2 Look for authorized service Figure 61 Instructions on the procedure for problems in the pump of the handpiece tip cooling system Figure 60 Warning of problems in the cooling system pump of the handpiece Press the image AY and another screen will appear with a message indicating the procedure to be carried out Figure 61 The equipment must be turned off and its connection must be performed Just turn on the equipment again In case the
24. R All maintenance must follow the precautions for IP exposure to radiation WARRANTY TERM 1 Your IBRAMED product is guaranteed against manufacturing defects ifconsideredthe conditions established by this manual 18 consecutive months exception of the handpiece Check section C divided as follows a 03 first three months Legal Warranty b 15 fifteen remaining months Additional warranty provided by IBRAMED CONTRACTUAL WARRANTY c The handpiece has a warranty of 1 million shots or 18 months according to sections A and B whichever occurs first 2 The warranty period will start counting from the date of purchase date in which the sale invoice is issued even if the purchaser later on transfers the equipment to a third party The warranty will comprehend the replacement of parts and the labor costs in the repair of the defects found as being derived from manufacturing T MAINTENANCE WARRANTY AND TECHNICAL SUPPORT 3 The LEGAL WARRANTY and the ADDITIONAL CONTRACTUAL WARRANTY will cease to be valid in the cases specified below e When the identification number serial number of the equipment is removed or altered e When itis determined that the equipment and or its accessories have suffered fall contact with water or misuse e When it is determined that the equipment seal was violated or if it is characterized that the equipment has suffered alterations modifications or repairs by other technicians oth
25. RLESS GEL TUBE CAP 1 KG REGISTERED AT ANVISA N 80122200001 SPATULA FOR GEL CUVETTE 200 ML 71 ACCESSORIES WHICH ACCOMPANY LYRA TROUBLESHOOTING REPLACEMENT ACCESSORIES What may initially look like a problem is rarely a defect The replacement accessories are designed to be used with Before calling customer support please check the items LYRA When you order them provide the respective codes described below description and desired quantity The use of accessories not PROBLEMS SOLUTION designed for this specific equipment may significantly degrade the performance of the emissions and immunity Do not use The equipment Is the power cable properly LYRA accessories in other electromedical systems does not turn connected on 1 If it is not it is necessary to connect it Also check the socket on the wall The equipment Have you checked the safety fuse does not turn on Check if there is a bad contact Check 2 if the value is correct as stated in the instructions The power is Have you followed the on but does recommendations of the instructions not perform the to use the equipment correctly Check function them and repeat the steps in the controllers indications and operation section TROBLESHOOTING REPLACING THE PROTECTION FUSE On the rear part of LYRA there is the protection fuse To replace it make sure the equipment is de energized and using a small screwdriver remove the protective lid and
26. aaa radeon uai as 33 PROGRAMMING THE EQUIPMENT 41 EMERGENCY STOP BUI ON usas asa aaa na o 49 PROTECTION WARNINGS OF THE EQUIPMENT 50 PREPARATION FOR IPL THERAPY EEN 55 CARES PRIOR TO TREATMENT ccccceeeeeeeeeeeeeees 55 BEFORE STARTING THE TREATMENT 55 SRU GO d EE 56 CT ee ee ee rer 56 SUGGESTION OF INTERVAL AND NUMBER OF SESSIONS 56 PREQUENSEORAMIMED DCH sek ek N NN ENKEN RN EEN KEEN 57 APPLICAMHBINMINECHINIQUE cccccccesseceessssccneererssssecneeees 61 ee SEQUENCE ER 61 RERERENCES TTT 62 ELECTROMAGNETIC COMPATIBILITY GUIDANCE 63 POTENTIAL ELECTROMGNETIC INTERFERENCE 63 ELECTROMAGNETIC COMPATIBILITY cccceeeeeeeeeeeeeee 64 ENVIRONMENTAL INFLUENGCER ccc ccceeeee seen eee eeeee eens 70 ACCESSORIES WHICH ACCOMPANY LYRA 71 REPLACEMENT ACCESSORIES 72 TROUBLE SHOOTING saias td tao iria 72 REPLACING THE PROTECTION FUSE 73 MAINTENANCE WARRANTY AND TECHNICAL SUPPORT 74 CEFAI IBRAMED CENTER FOR EDUCATION AND ADVAN RR A EE 7 SYMBOL DEFINITIONS BELOW ARE THE DEFINITIONS OF THE SYMBOLS USED ON THE EQUIPMENT AND THROUGHOUT THE INSTRUCTIONS FOUND IN THIS MANUAL UNDERSTAND THESE SYMBOLS AND THEIR DEFINITIONS BEFORE OPERATING THIS EQUIPMENT A Caution Refer to user manual A Symbol danger caution radiation 1 Equipment with applied part of BF type O
27. banks passes through the xenon gas contained in the lamp so that the bright light is emitted therefore the electric light is converted into optical energy Using filters itis possible to select wavelengths according to the depth of the structure intended to be reached The IPL emission spectrum varies from 450 to 1200 nm and for example when a 640 nm filter is used the emission occurs only in the 640 to1200 nm spectrum blocking the emission of shorter wavelengths The first generation of IPL devices emitted part of the infrared spectrum which led to predominantly epithelial damage and an elevated incidence 12 of secondary effects in the second generation of IPL devices however cut filters were incorporated in the infrared portion and also cooling techniques significantly reducing the side effects Energy Energy is a concept which allows quantifying the interactions between quite different phenomena its official unit is the Joule Power on the other hand is measured in Watts 1 W 1J s and the energy represents the quantity of light which comes out of the optical conductor divided by the duration of this energy Fluency It is the quantity of energy applied in the tissue in relation to the area over which the energy is applied The measurement unit is J cm2 Joule per square centimeter Duration of flash The duration of pulse is the time it takes to emit energy For a better understanding of the relation between the
28. chnical centers IBRAMED Should not be held responsible for maintenance repairs or modifications which have been performed by agents or companies not expressly authorized CEFAI IBRAMED CENTER FOR EDUCATION AND ADVANCED TRAINING IBRAMED Equipment goes beyond technology It also provides knowledge Science constitutes our differential value and we effectively take advantage of its benefits in order to ensure patient safety and thereby maximize results IBRAMED develops products with scientific support of the most recent medical studies published in major scientific journals in the areas of biological health and exact Access to the knowledge database is guaranteed by CEFAI IBRAMED Center for Education and Advanced Training whose goal is to provide technical and scientific support as well as current literature on therapies and their applicability while our treatment choices are always thoroughly selected according to the best and latest clinical criteria CEFAI takes into account the personal and professional development of all its partners and customers CEFAI invites both students and professionals in the fields of Physical Rehabilitation Esthetics Physiotherapy Dermatology and Esthetic Medicine to take part in free courses workshops and the best Postgraduate Lato Sensu courses in the areas of physical rehabilitation and esthetics 7 Special attention is also given to those interested in visiting our structure Whatever
29. disconnect the fuse Perform the replacement and reposition the lid in place Remember that the spare fuse is stored internally in the same compartment where the fuse is Figures 65 66 and 67 Figure 66 Removal of the fuse box drawer Figure 65 Opening the LYRA fuse box CAUTION There are dangerous tensions inside the equipment Never open the equipment Figure 67 Repositioning of the fuse box drawer 73 T MAINTENANCE WARRANTY AND TECHNICAL SUPPORT MAINTENANCE For the safe use of the equipment we recommended to have it inspected and undergo preventive maintenance at IBRAMED or an authorized technical center every 12 months IBRAMED manufacturer only assumes liability for the technical features and equipment safety provided the unit is used according to the instructions for use contained in the manual when maintenance repairs and modifications are undertaken solely by the factory or authorized agents and in the event of a breakdown when the components that can cause a security risk to the appliance are replaced by original spare parts If requested IBRAMED will provide technical documentation circuit diagrams lists of parts and components etc necessary for the repair of any equipment That however does not imply in a repair authorization We do not take responsibility for repairs performed without our explicit written authorization This equipment has a shelf life of 5 years 4 A DANGE
30. duration of exposure of the structure to light and the confinement of heat a very useful theoretical concept is used called Thermal Relaxation Time TRT The TRT of a structure is defined as the time required for the heat generated by the absorbed light within the target chromophore to cool to half of the INFORMATION ON INTENSE PULSED LIGHT original value immediately after the emission of the light pulse The pulse duration must be smaller than the TRT of the target tissue for in lengthy exposures a uniform heating of the adjacent tissues consequent lesion occur Some ILP devices emit light in fractioned pulses in subpulses This is the concept which most contributed to the success of the IPL technique The fractioning of pulses in double or triple pulses allows the epidermis and thin vessels to cool in the intervals between the pulses while the thicker vessels and hairs remain heated Handpiece Applicator The handpiece or applicator is essentially composed of e A flash tube which transforms the electric energy which comes into its terminals into intensely bright white light This tube is made of quartz to support the strong thermal and mechanical limitations Normally it is filled up with xenon a rare type of gas which allows good performance e A reflector whose objective is to resend the maximum amount of light to the optical tube These reflectors may be of either golden metal or reflexive white material e An optical f
31. e of 1 000 000 shots which allows for linear and functional performance SAFETY PRECAUTIONS DEFINITIONS OF PRECAUTIONS the precautions instructions found in this section and throughout these instructions of use are indicated by specific Symbols It is necessary that you understand these symbols and their definitions before starting to operate this equipment and before the therapy session A CAUTION Text with indication Attention refers to potential safety infractions in potential which may cause minor to moderate lesions or damage to the equipment Text with indication Warning refers to potential safety infraction in potential which may cause serious injury and damage to the equipment A DANGER Text with indication Danger refers to potential safety infractions which represent immediate threat to life and result in death or serious injury 10 e Read understand and practise the precaution and operation instructions Know the limitations and dangers associated with the use of any electro stimulation Observe the precaution and operation labels placed on the unit e Do not operate this unit in an environment where other devices intentionally propagate electromagnetic energy in an unprotected manner e This unit must be transported and stored at temperatures between 5 C and 50 C 41 F and 122 F Avoid humid and dusty environments The equipment must not be stacked and or placed next to oth
32. edure Should be performed whenever necessary Ibramed suggests weekly cleaning of the equipment CLEANING THE HANDPIECE AND FILTERS Humidity grease and dust are the main factors of filter damage Constantly cleaning these items increases their useful life significantly After each use and its complete cooling the handpiece optical filters must be cleaned using gauze or paper towel damped in alcoholic chlorhexidine Cotton residues and paper fibers must be removed using a paintbrush Cleaning the filter is necessary since the residues accumulated in it or in the metallic part may damage the 20 applicator and expose the patient to the risk of burns due to the evaporation of the filter film due to the high temperature it can reach in the places where residues accumulate GOGGLES CARE AND CLEANSING Carry out a visual inspection of your goggles checking if the lens is not damaged If it is dirty wash it carefully with water and soap so that it does not get scratched Also check the frames It must be ventilated and fit comfortably to the face If necessary take it to an optician to be adjusted At the end of the treatment put it away inside the transport case Do not place any weight over the goggles A CAUTION The correct installation operation and mainte nance of the equipment prevent safety risks WARNING To avoid risk of electrical shock this equipment must be connected only to a mains power line with protective groundi
33. er equipment e Check the cables and connectors before each use e Do not use sharp objects such as a pencil or pen to operate the buttons on the operator interface as it can damage it e Hold the applicator carefully Improper use of the applicator may adversely affect its characteristics e LYRA was not designed to avoid water penetration or infiltration of any other liquids The infiltration of water or other liquids may cause malfunction of the internal components of the system and consequently pose risk to the patient e Disconnect the plug from the outlet when the device is not in use for long periods of time T SAFETY PRECAUTIONS e To protect against the risk of fire use only replacement fuses of the same type and classification e Certify that the unit is grounded connecting it to an outlet grounded according to the national and local applicable codes e Before treating the patient it is necessary to know the operational procedures for each mode of treatment available as well as the indications contraindications warnings and precautions Refer to other resources to obtain additional information about the applications the LYRA eTo avoid electric shock turn the equipment off from the electrical feed before performing any maintenance procedure 11 e Patients with neurostimulation devices or implanted pacemakers must not be treated or must be distant from any short wave diathermy microwave diathermy ultras
34. er than the ones certified by IBRAMED e When the installation or use of the equipment does not observe the specifications and recommendations of the instructions of use contained in this manual e Due to defects caused by accidents or natural agents atmospheric discharges for example e When the equipment is connected to an electrical system with inappropriate voltage and or subjected to excessive fluctuation or overcharge e In cases of transport accidents 4 in the LEGAL WARRANTY period first three months starting on the purchase date IBRAMED is responsible for the transport of the equipment to the technical assistance in case of manufacturing defects however there is need of a previous contact with the company post sales department which in turn 75 will give directions to the Customer about the best manner to Ship the product the location to which it must be shipped and will issue an authorization for transport 5 In case no defect is found in the equipment sent to technical assistance in the LEGAL WARRANTY period all the expenses of the transport of that equipment will be charged to the Customer 6 COVERAGE WITHIN THE LEGAL WARRANTY 03 MONTHS e Manufacturing defects of the equipment and its accessories e Transport of the equipment for repair following previous authorization by IBRAMED 7 COVERAGE WITHIN THE ADDITIONAL CONTRACTUAL 15 MONTHS e Manufacturing defects of the equipment 8 Intheperiodof
35. ich may occur in Contraindications case of excessive dose Patients with photosensitive epilepsy Concomitant use of photosensitizing medicine Patients with pathologies related to photosensitivity Patients with keloid history Patients with healing deficit due to Diabetes Mellitus or other pathologies MENU O 0 Figure 23 A and B contraindications of the use of the equipment 34 OPERATING INSTRUCTIONS USING THE MENU KEY Programming the equipment As you turn on the equipment insert the safety default password 1234 Soe lnm according to the Fitzpatrick classification and the color of Skin Phototype the skin at the moment of we the treatment In the first DEEN FS SSES LE CE session or if there is doubt Halt thickness Ge about the real phototype edi Medium Thick mm make an adjustment to the immediately superior one E CH Password For further information on the safety password refer to IOLL the instructions of use For hair removal adjust the thickness of the hair Next press the stand by key gt MENU 0 O Figure 25 Step 1 of 6 of programming the equipment Select the desired treatment according to the therapeutic obectve skin Tightening usonm reent Always burns tans less than average 1 Always burns never tans Sometimes burns tans as average MENU 0 ee Rarely burns tans easily Moderately pigmented always tans Deeply pigmented
36. ilter for each application the absorption filters being the ones with the best performance e An optical conductor very transparent whose role is to transfer filtered luminous beams to the skin to be treated The principle is the same of that of an optical fiber which 13 conducts light e And also electrical components such as control buttons for the flashes among others Interaction with the tissue Similarly to laser in IPL devices the basic principle is the absorption of photons by endogenous or exogenous chromophores inside the skin and the transfer of energy to these chromophores This transference generates heat which subsequently destroys the target structure The absorption of light is not linked to the coherence of light the so called photobiological reaction occurs independently of the heating source Besides the chromophores in the human skin hemoglobin melanin water show wide spectra of absorption therefore the monochromaticity is not a requisite for photothermolysis As the IPL emit a spectrum of wavelength the three chromophores can be activated with a single exposure to light This versatility implies a reduced selectivity the skin type and the skin condition of the patient determines the choice of suitable cut off filters and therefore the spectrum of the wavelengths to be emitted INFORMATION ON INTENSE PULSED LIGHT Figure 1 Absorption spectrum of main skin chromophores P
37. ing of treatment doses for telangiectasia Observe the duration of the interval between pulses highlighted in parenthesis Filter 530 1200 nm DOUBLE PULSE Telangiectasia Phototype 1 Phototype 2 Duration of Pulse ms Energy J Energy J 26 10 20 10 55 10 28 10 20 10 50 10 Phototype 3 Phototype 4 Duration of Pulse ms Energy J Duration of Pulse ms Energy J 30 10 30 10 45 10 32 10 30 10 40 10 Table 3 Pre programmed doses for Skin Tightennig Observe the duration of the interval between pulses highlighted in parenthesis Filter 480 1200 nm DOUBLE PULSE Skin Tightening Duration of Pulse ms Energy J Duration of Pulse ms Energy J Duration of Pulse ms Energy J Duration of Pulse ms Energy J 24 10 30 10 30 10 32 10 30 10 25 10 59 PRE PROGRAMMED DOSES DIRECTIONS ON PRE PROGRAMMED DOSES Table 4 Pre programmed doses for Spot Skin Observe the duration of the interval between pulses highlighted in parenthesis Filter 480 1200 nm DOUBLE PULSE Phototype 1 Phototype 2 Duration of Pulse ms Energy J Duration of Pulse ms Energy J 12 10 10 10 50 10 A Yo 45 10 Phototype 3 ER 4 Duration of Pulse ms Energy J Duration of Pulse ms Energy J 24 10 30 10 40 10 32 10 30 10 35 10 60 APPLICATION TECHNIQUE SIMPLIFIED SEQUENCE
38. ists contact IBRAMED technical assistance Reservoir of the handpiece tip cooling system supply conectors Remove both plugs of the gt gt 4 Warning that the level of the water reservoir of the handpiece Connect the hoses to the tip cooling is below the adequate level Figure 54 RA and to the wather output Water Vent Fill up the reservoir with demineralized water 4 liters of water until it overflows through the output conector Water Vent next remove the hoses and close the conectors Figure 55 Instructions on the filling up procedure of water reservoir Figure 54 Warning that the water reservoir is below level Press the image A and another screen will appear with 50 OPERATING INSTRUCTIONS PROTECTION WARNINGS OF THE EQUIPMENT Problems in the cooling system of the handpiece tip Warning of problems in the handpiece tip cooling system Figure 56 Step 1 Turn off the device Step 2 Look for authorized service Figure 57 Instructions on the problems in the water cooling system of handpiece tip Figure 56 Warning of problems in the water cooling of handpiece tip Press the image A and another screen will appear with a message indicating the procedure to be carried out Figure 57 The equipment must be turned off and sent to IBRAMED technical assistance in order to avoid damage to the equipment or risk to the patient 51 OPERATING INSTRUCTIONS
39. l chlorhexidine at 0 5 3 Observe the aspect of the skin again 4 Reinforce the instructions and cares REFERENCES Babilas P Schreml S Szeimies RM Landthaler M Intense pulsed light IPL A Review Lasers Surg Med 2010 Feb 42 2 93 104 Dover JS Arndt KA New approaches to the treatment of vascular lesions Lasers Surg Med 2000 26 2 158 63 Elsaie ML Lloyd HW Latest Laser and Light Based Advances for Ethnic Skin Rejuvenation Indian Journal of Dermatology 2008 53 2 49 53 Fan X Xing YZ Liu LH Liu C Wang DD Yang RY Lapidoth M Effects of 420 nm intense pulsed light in an acne animal model J Eur Acad Dermatol Venereol 2012 Feb 25 Gold MH Foster A Biron JA Low Energy Intense Pulsed Light for Hair Removal at Home J Clin Aesthet Dermatol 2010 Feb 3 2 48 53 Goldberg DJ Current trends in intense pulsed light J Clin Aesthet Dermatol 2012 Jun 5 6 45 53 Goldman MP1 Weiss RA Weiss MA Intense pulsed light as a nonablative approach to photoaging Dermatol Surg 2005 Sep 31 9 Pt 2 1179 87 62 Hong S Lee JR Lim T Pigment deposition of cosmetic contact lenses on the cornea after intense pulsed light treatment Korean J Ophthalmol 2010 Dec 24 6 367 70 Kalil CLPV Laser e outras formas de luz na dermatologia C lia Persen Vitello Kalil Rio de Janeiro Elsevier 2011 Laury D Intense pulsed light technology and its improvement on skin aging from the patients perspective using phot
40. lteration screen 39 Figure 44 Language selection screen 40 Figure 45 A parameter selection key and B warning of verification of 640 nm fiIter eee ccccseeeeeeeeeeeeeeeeneaes 41 Figure 46 A system loading of LYRA and B screen with selected parameters of Example land the energy which will be used in the treatMent ccsecccceesseueueeseueeuenseuuenns 42 Figure 47 A screen for selecting the parameters and B filter check warning 530 nm EEN EEN 43 Figure 48 A system loading of LYRA and B screen with the selected parameter of Example 2 and the energy which will be used in the treatment cccvscsecevescueveccucueusucueceucuvesauavens 44 Figure 49 A screen for selecting parameters and B filter check warning 480 mm EEN 45 Figure 50 A system loading of LYRA and B screen with the selected parameter of Example 3 and the energy which will be used in the treatm E Os ia eee ies sau RN IA SL eee eae ene 46 Figure 51 A screen for selecting parameters and B filter check warning 480 mm 47 Figure 52 A system loading of LYRA and B screen with the selected parameter of Example 4 and the energy which will be IESELEN 48 Figure 53 A emergency button and B emergency s LIST OF FIGURES CIO ee de EE PMPA REA ANT DAE tase 49 Figure 54 Warning that the water reservoir is below lev S id ee eee ee dad ad nda ere 50 Figure 55 Instructions on the filling up procedure of water FeSeGPVOIE nn KANN KE
41. mmediately superior to the one selected and or for hair removal and increase the thickness SUGGESTION OF INTERVAL AND NUMBER OF SESSIONS AREA INTERVAL NUMBER Hair Removal 4 to 8 weeks 6 to 8 Telangiectasia 3 to 6 weeks 6 to 8 Skin Tightening 3 to 6 weeks 4 to 6 Spots Skin 3 to 6 weeks 4 to 6 Rosacea 3 to 6 weeks 4 to 6 Acne 3 to 6 weeks 4 to 6 The number of sessions may vary according to the area and the response to treatment For hair removal annual maintenance sessions are suggested T PRE PROGRAMMED DOSES DIRECTIONS ON PRE PROGRAMMED DOSES The doses fluences are shown on the display in decreasing order from left to right therefore higher phototypes use lower doses Skin Phototype Hair Thickness K 8 o O Telangiectasia 530nm 1200NnM Skin Phototype Skin Phototype O 3 O PRE PROGRAMMED DOSES DIRECTIONS ON PRE PROGRAMMED DOSES Table 1 Detailing of pre programmed doses for hair removal Filter 640 1200 nm SINGLE PULSE Hair thickness Duration of Pulse ms Energy J Duration of Pulse ms Energy J Medium Medium Thick 75 10 Duration of Pulse ms Energy J 24 10 75 10 26 10 65 10 in Medi 30 10 70 10 32 10 60 10 5 5 Duration of Pulse ms Energy J 45 10 Phototype 5 Duration of Pulse ms Energy J Medium 42 10 50 10 Medium Thick 58 PRE PROGRAMMED DOSES DIRECTIONS ON PRE PROGRAMMED DOSES Table 2 Detail
42. mplete loading of the equipment After that the equipment is ready for use indicating the energy J which will be used in the treatment Hair Removal 640nmM 1200nNmM Skin Phototype ke E Hair Thickness Make sure the filter is correct for treatment and if it is positioned properly in the applicator 640NM 1200NM Figure 45 A parameter selection key and B warning of T verification of 640 nm filter OPERATING INSTRUCTIONS PROGRAMMING THE EQUIPMENT After that keep the footswitch pedal pressed to release the energy position the tip of the handpiece on the area and press the shot button on the handpiece Keep the footswitch pedal pressed during the entire treatment After the end of the treatment or if you want to return to the Load ng programming conditions press CG The icon Shots stores the number of times the flash lamp is shot during the application Between shots it is necessary to wait for 3 seconds for the Hair Removal 640nm 1200nmM loading of the capacitor banks Skin phototype After the loading of the equipment is complete and the RE EE ERR lamp is energized in case the equipment remains in disuse longer than 5 minutes it will automatically turn off the lamp Hair Thickness and return to the parameter adjustment screen condition E available Figure 46 A system loading LYRA and B screen with the parameters of example 1 selected and the energy which will be u
43. ndpiece Figure 35 Step 2 of 3 of patient preparation Patient preparation For hair removal perform the trichotomy previously Put protection goggles on the patient Apply neutral colorless gel For skin tightening spots and over the treatment area telangiectasia in areas with greater presence of hair perform previous trichotomy The therapist must wear the Lyra protection goggles during the entire application MENU ry lt gt oo TT 0 Figure 34 Step 1 of 3 of patient preparation Figure 36 Step 3 of 3 of patient preparation 37 OPERATING INSTRUCTIONS USING THE MENU KEY Application technique Perform a pre test on the area to be treated to evaluate the reaction of the skin to the selected parameters HAIR REMOVAL Position the tip perpendicular to the skin with moderate pressure Keep the pedal pressed to release of the shots Then press the shot key located on the handpiece 4 SKIN TIGHTENING Position the tip perpendicular to the skin with light pressure Keep the pedal pressed to release of shots Next press the shot key located on the handpiece TELANGIECTASIA FACE Deposit the tip perpendicular to the skin to avoid compression of the vein Keep the safety pedal pressed to release the shots Next press the shot key located on the handpiece 4 Figure 38 Step 2 of 5 of application technique Figure 40 Step 4 of 5 of application technique 38
44. ng NOMENCLATURE B E 1 On off key E 2 Output connection of handpiece al 3 Handpiece rack 4 Ouput connection of the footswitch 7 5 Touchscreen 6 Quick connection for the hose and funnel of the water reservoir Water Supply ey 7 Quick connection for the hose Water Vent 8 Quick connection for the hose Water Drain 9 Electrical feed connector 10 Protection fuse box 11 Emergency stop button Figura 2 A frontal view and B rear view of LYRA 21 NOMENCLATURE HANDPIECE CONTROL AND CONNECTIONS 17 qe 12 Figure 3 A handpiece of LYRA B frontal view of handpiece and C rear view of handpiece a 15 12 Handpiece connector 13 Lamp shot counter 0 14 Cooling tip d 15 Upper switch for flash emission control 16 Lower switch for flash emission control 17 Aperture for insertion of filter 18 Handpiece cord 22 NOMENCLATURE READ AND UNDERSTAND THESE SYMBOLS AND THEIR DEFINITION BEFORE OPERATING THE EQUIPMENT gt HOME key allows access to treatment election ATTENTION Alert warning MENU 20 Key which gives access to INFO SAFETY PASSWORD and LANGUAGE O Q S ue Key which allows returning to the previous PASSWORD ALTERATION key allows aon altering the safety password Key which allows advancing to the next screen Tecla ALTERACAO DE SENHA permite alterar a senha de seguranca LANGUA
45. nnection Water Drain Remove the connection plugs of connections Water Vent and Water Drain Let all the water flow off and replace the lids on the connections The monthly replacement of water is recommended In long periods when the equipment is not used drain the reservoir Figure 16 Drainage of the water reservoir OPERATING INSTRUCTIONS USING THE EQUIPMENT Check if the electrical feed cable is connected to the energy source Press the ON OFF key to the position ON The display will show the introduction messages for a few seconds Figure 17 A and B followed by the password insertion screen of LYRA Figure 18 A B AW Selz Lut IBRAMED Figure 17 Figures A and B show the introduction messages of LYRA Firmware PLO1 Vol 31 OPERATING INSTRUCTIONS USING THE EQUIPMENT Type the default safety password 1234 Figure 18 to enter the treatment programming mode Figure 19 Figure 19 Treatment selection screen Figure 18 Screen for insertion of safety password Before using the equipment for the first time we suggest the use of key it is used to access the tutorial and obtain information about the use of the equipment alter the safety password or select the desired language Portuguese English or Spanish To alter the default password consult the directions on page 40 32 OPERATING INSTRUCTIONS gt Indications gt contraindications gt Potential adverse
46. ocedure the expected results the possibility of potential adverse reaction and the importance of completing the entire treatment e Warn the patient that she he might feel a certain discomfort erythema edema and blisters as a consequence of the treatment and that there is a minimal risk of adverse reaction as the change in the texture of the skin hypopigmentation or hyperpigmentation e These effects are generally transitory and are solved ina few months e No type of anesthetic is necessary D95 BEFORE STARTING THE TREATMENT e It is recommended that before the treatment the patient signs a term of consent which indicates the full understanding of the procedure and its side effects and that she he accepts to be submitted to it e It is very important to keep a copy on paper of all the records of the patient including photographs taken previously to the treatment e The treatment area must be perfectly clean with water and soap to degrease the skin and to remove any residue of cream make up or topic anesthetics e make sure the area is totally dry e The spots and marks on the skin must be covered with white Adhesive tape or white pencil FACIAL TREATMENT e Tie and protect the hair e Clean the skin removing residues of make up e The patient must wear the protective goggles PREPARING THE PATIENT FOR IPL THERAPY SKIN PHOTOTYPE To evaluate the skin of the patient use the Fitzpatrick classification Figure 64
47. orejuvenation parameters Dermatol Online J 2003 Feb 9 1 5 Lee HI Rho YK Kim BJ Kim MN A Case of Faun Tail Naevus Treated by Intense Pulsed Light Ann Dermatol 2009 May 21 2 147 9 Li YH Wu Y Chen JZ Zhu X Xu YY Chen J Dong GH Gao XH Chen HD A split face study of intense pulsed light on photoaging skin in Chinese population Lasers Surg Med 2010 Feb 42 2 185 91 ELECTROMAGNETIC COMPATIBILITY GUIDANCE e The use of this unit is not predicted in places where there is risk of explosion such as anesthetic departments or in the presence of anesthetic mixture inflammable when in contact with air oxygen or nitrous oxide e The use of cables or other accessories from other manufacturers and or different from those specified in this manual as well as the replacement of internal components of LYRA may result in increase of emissions or decrease of immunity of the equipment e LYRA is designed for use only by professionals in the health field LYRA may cause radio interference or interrupt equipment operation nearby It might be necessary to adopt mitigating procedures such as redirecting relocation of equipment or armoring of a place for the exclusive use of LYRA e Mobile or Portable radiofrequency equipment may cause interference and affect the functioning of LYRA 63 POTENTIAL ELECTROMGNETIC INTERFER ENCE Regarding the limits of electromagnetic disturbance LYRA is electromagnetic equipment which belongs
48. ots Skin Suppose that by clinical evaluation it was observed Skin phototype 1 e em ALWAYS start the programming by the selection of filter Insert the 480nm filter in the handpiece and using the touchscreen select the treatment Spots skin D n 200m as shown below Skin Phototype in the figure below Evaluate on the patient the skin tone of WE FER the area to be treated Hair Removal 640nm 1200nmM O Telangiectasia 530nm 1200nmM Make sure the filter is correct for treatment and if it is positioned properly in the applicator Select on the screen the SKIN PHOTOTYPE The fluence emitted decreases according to the increase of the skin tone Press the corresponding key Figure 51A On the next screen after checking if the correct filter is used press the key Figure 51B Next wait for the complete loading of the equipment After that the equipment will be ready for use indicating the Figure 51 A screen for selecting parameters and B filter energy J which will be used in the treatment check warning 480 nm 47 T OPERATING INSTRUCTIONS After that keep the footswitch pedal press to release the energy position the tip of the handpiece on the area and press the shot button on the handpiece Keep the footswitch pedal pressed during the entire treatment After the end of the treatment or if you want to return to the Load i ng programming condition press C The icon Shots stores the number of
49. ound diathermy or Intense Pulsed Light diathermy on any part of their bodies The diathermy energy shortwave microwave ultrasound and IPL may be transferred though the implanted neurostimulation system and it may cause damage to the tissues resulting in serious injuries or even death Damage wounds and death may occur during Therapy with diathermy even if the implanted system is turned off e Equipment that is not adequate for use in the presence of an ANESTHETIC MIXTURE FLAMMABLE WHEN IN CONTACT WITH AIR OXYGEN OR NITROUS OXIDE Equipment is not AP or APG category INFORMATION ON INTENSE PULSED LIGHT INTENSE PULSED LIGHT IPL The use of polychromatic light was first described in 1976 by Muhlbauer et al for the treatment of vascular malformations The photothermolysis of pigmented structures cells and organelles by selective absorption of pulsed radiation has been described in detail since 1983 In 1990 Goldman and Eckhouse described a new high intensity flash lamp as an adequate tool to treat vascular lesions Intense Pulsed Light IPL was commercially launched as a medical device in 1994 In the following years several technical modifications allowed easy handling the increase in safety and the widened spectrum of potential indications Flash lamp and filters LIP devices use flash lamps and microcontrolled capacitor banks to generate high intensity polychromatic pulsed light The electric energy stored in the capacitor
50. ow the insertion field Just insert it in the proper field to enter the programming screen Password EEE The LANGUAGE key allows the choice of PORTUGUESE SPANISH or ENGLISH Press the desired language then the System will be restarted in the selected language Figure 44 MENU In case you do not wish to change the language press so to return to the INTERACTIVE MENU PORTUGU S ESPANOL ENGLISH Es Za slo IBRAMED Figure 44 Language selection screen OPERATING INSTRUCTIONS PROGRAMMING THE EQUIPMENT Example 1 Hair removal Suppose that by clinical evaluation it was observed Skin phototype 4 and medium Hair Thickness ALWAYS start the programming by the selection of filter Insert the 640 nm filter in the handpiece and using the touchscreen select the treatment as shown in the figure below Evaluate on the patient at the time of the session the skin tone and the thickness of the hair on the area to be treated Hair Removal 640nmM 1200nm Telangiectasia 530nm 1200nmM MENU 00 00 Select on the screen the SKIN PHOTOTYPE and the corresponding HAIR THICKNESS The fluence emitted decreases according to the increase of the skin tone and the thickness of hair When the thickness of hair is large select the thickness by the largest hair Press the corresponding keys Figure 45A On the next screen after checking if the filter used is correct press the key Figure 45 B Then wait for the co
51. r must know the aspects relative to IPL Therapy and their interaction with the soft tissues e The user must know the limitations and dangers associated with the use of any IPL device and observe the precaution and operation labels placed on the unit e The user must follow the information contained in these 18 instructions of use for each mode of treatment available as well as the indications contraindications warnings possible adverse reaction and precautions e The user must have his cognitive functions intact e The user must have the necessary motor skills to handle the equipment e Regarding mobility this equipment is considered Portable equipment PART OF THE BODY ON WHICH IT IS APPLIED OR WITH WHICH IT INTERACTS Areas of the trunk face neck upper and lower limbs Polychromatic light interacts with the skin of the treated area GENERAL CARE WITH THE EQUIPMENT TRANSPORT DAMAGE LYRA is shipped complete to the cliente inside a box Upon receiving it inspect the box and the equipment to visualize any possible damage In case of damage keep all the transport materials including the packaging and contact the agents in charge for the delivery of the unit All complaints regarding damage during transport must be presented directly to them The manufacturer will not be responsible for any damage during transport will not perform adjustments unless a formal complaint is presented by the receiver against the transpo
52. rt agent The box in which your LYRA was delivered was especially designed to protect the equipment during transport Keep the transport packaging in case you need to return your equipment for maintenance Keep the transport packaging in case you need to return your equipment for maintenance 19 CARES WITH THE EQUIPMENT e Avoid places subject to vibration e Do not place it on top of rugs cushions or other smooth Surfaces which obstruct ventilation e Avoid damp warm and dusty places e This equipment is not protected against harmful water penetration e Make sure that the area around the electrical feed cable is free e Do not insert objects in the orifices of the device e Temperature range during transport and storage 5 50 C 41 122 F INSTALLATION CARE AND CLEANING INSTALLATION INSTRUCTIONS 1 Connect the energy cable to the rear part of LYRA 2 Connect the energy cable to an outlet 127 240 V 50 60 Hz 3 Connect the handpiece to the equipment 4 Turn on your equipment CLEANING LYRA The equipment must be cleaned daily or in case there is need immediately after its use Do not immerse the equipment in liquids Do not use volatile substances benzene alcohol thinner or solvents in general to clean the cabinet because they may damage the finishing Turn the equipment off of the electrical feed source clean it using a cloth humidified with water and soft antibacterial soap The cleaning proc
53. rval between pulses highlighted in ET St 7717 EE 60 PREFACE These instructions of use allow the user the efficient use of LYRA Consult appropriate literature to obtain additional information about the uses of the oscillating vibration impact technique Before stating any treatment on a patient the user must read understand and follow the information in these instructions of use for each mode of treatment available as well as the indications contraindications warnings and precautions The specifications and instructions contained in these instructions of use are in effect on the date of their publication These instructions may be updated at any given moment at the manufacturer s discretion Visit our website for updates PRODUCT DESCRIPTION ESSENTIAL PERFORMANCE LYRA is Intense Pulsed Light IPL micro controlled equipment designed for use in aesthetics dermato functional aesthetic biomedicine and other fields of aesthetics LYRA has a handpiece with the possibility of interchange of three selective cut filters with wavelengths of 480 nm 530 nm and 640 nm which allow the professional to choose the most adequate spectrum of light radiation for each treatment LYRA has a peltier and water cooling system which cools the tip of the handpiece crioprotection making the treatment safer and more comfortable The fractioning of pulse produced by LYRA minimizes even more the risk of lesions O LYRA has a lamp with useful lif
54. sed in the treatment 42 OPERATING INSTRUCTIONS PROGRAMMING THE EQUIPMENT Example 2 Telangiectasia used in the treatment Suppose that by the clinical evaluation it was observed Telangiectasia 530nm 1200nmM Skin phototype 3 ALWAYS start the programming by the selection of filter Insert the 530 nm filter in the handpiece and using the touchscreen select the treatment EAN as shown below Skin Phototype in the figure below Evaluate on the patient the skin tone of the area to be treated 3 WS Hair Removal 640nmM 1200nm Telangiectasia 530nm 1200NM Make sure the filter is correct for treatment and if it is positioned properly in the applicator Select on the screen the SKIN PHOTOTYPE The fluence emitted decreases according to the increase of the skin tone Press the corresponding key Figure 47A On the next screen after checking if the correct filter is used press the key Figure 47B Next wait for the A 530nm 1200NM complete loading of the equipment After that the equipment Figure 47 A parameter selection screen and B warning of T will be ready for use indicating the energy J which will be verification of 530 nm filter 43 OPERATING INSTRUCTIONS After that keep the footswitch pedal press to release the energy position the tip of the handpiece on the area and press the shot button on the handpiece Keep the footswitch pedal pressed during the entire treatmen
55. specified below The customer or the user of the LYRA Should assure that it is used in such an environment C li e f Immunity Test ITE 0009S AM PEAN Electromagnetic Environment Guidance Test Level Level It is not advisable that mobile or Portable RF communication equipment is used at shorter distances from any part of LYRA including cables than the distance of separation recommended calculated by the equation applicable to the frequency of the transmitter Distance of separation recommended d 1 2 p 150 KHz to 80 MHz 3 Vrms d 1 2 JP 80 MHz to 800 MHz d 2 3 jp 800 MHz to 2 5 GHz Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Where pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz 3 V m a an electromagnetic site survey a should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol te 67 ELECTROMAGNETIC COMPATIBILITY NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths
56. t After the end of the treatment or if you want to return to the programming condition press The icon Shots stores the number of times the flash lamp is shot during the application Between shots it is necessary to wait for 3 seconds for the B Telangiectasia 530nm 1200nm loading of the capacitor banks After the loading of the equipment is complete and the lamp is energized in case the equipment remains in disuse longer than 5 minutes it will automatically turn off the lamp and return to the parameter adjustment screen condition available Skin Phototype ae Shot Energy J Figure 48 A LYRA system loading and B screen with parameter of Example 2 selected and the energy which will be used in the treatment 44 OPERATING INSTRUCTIONS PROGRAMMING THE EQUIPMENT Example 3 Skin Tightening Suppose that by the clinical evaluation it was observed ALWAYS start the programming by the selection of filter Insert the 480nm filter in the handpiece and using the touchscreen select the treatment skin Tightening a8onm 200nm as shown below skin Phototype in the figure below Evaluate on the patient the skin tone of ae i the area to be treated Hair Removal 640nm 1200nNnmM o Make sure the filter is correct for treatment and if it is positioned properly in the applicator Select on the screen the SKIN PHOTOTYPE The fluence emitted decreases according to the increase of the skin
57. telangiectasia e Treatment of rosacea e Treatment of benign pigmentary lesions e Cutaneous photoaging rejuvenation CONTRAINDICATIONS e If the patient is undergoing natural or artificial tanning processes up to 4 weeks prior to the treatment e Pregnant women e In areas with suspected spots or which have potentially cancerous tissue e Treatment area with tattoos or permanent make up e Pointing directly at people s or animal s ayes e Presence of implanted electronic device e g cardiac pacemaker e Patients with photosensitive epilepsy e Concomitant use of photosensitizing medicine e Patients presenting particular sensitivity to solar irradiation or conditions related with photosensitivity e g porphyria polymorphic light eruption solar urticaria lupus and other 16 autoimmune conditions e Patients with healing deficit due to Diabetes Mellitus or other pathologies PRECAUTIONS e Avoid solar exposure of the treated areas for at least 5 days after the application the use sunscreen FP60 is strongly recommended e A medical evaluation previous to the IPL treatment is strongly recommended in those cases in which the patient presents any skin pathology e Do not perform ILP treatment when the patient is being treated with antibiotics ingesting vitamin A supplements and or other melanin stimulating substances e In the hair removal treatments the use of other depilatory practices must be avoided in the
58. to the Group I Class A The operation at a short distance 1 meter for example of short wave or microwave Therapy equipment may produce instability in the output of the device To prevent electromagnetic interference we suggest that one group of the mains power line is used for LYRA and another separate group for the shortwave and microwave equipment We also suggest that the patient LYRA and the connection cables are installed at least 3 meters away from shortwave or microwave therapy equipment ELECTROMAGNETIC COMPATIBILITY LYRA is Group 1 Class A electromedical equipment The electromedical devices demand special attention regarding electromag netic compatibility EMC and must be installed and operated according to the EMC information provided as follows Manufacturer s guidelines and declaration Electromagnetic emissions The LYRA is intended for use in the electromagnetic environment specified below It is strongly advised that the purchaser or user of LYRA guarantees that it is used in such environment Emission Test Compliance Electromagnetic environment guidance The LYRA must emit electromagnetic energy in order to perform RF Emissions it s intend function Nearby electronic equipment may be CISPR 11 Group 1 affected RF Emissions CISPR 11 Class A Harmonic Emissions The LYRA is suitable for use in all establishments other than IEC 61000 3 2 Class A domestic those directly connected to the public lowvoltage power
59. two weeks prior and subsequent to the application of IPL Only shave the hair e Skin of high phototype dark or deeply tanned requires closer attention as to the prescription of dosage for IPL application e Soon after the application slight erythema and or transitory edema may occur they will disappear in up to 3 hours after the application The use of soothing lotions and or cold patches over the treated areas may minimize such effects e Rarely may appear more intense erythema which will disappear between 2 and 7 days after the application viro PRECAUTIONS AND ADVERSE REACTIONS PRECAUTIONS the need for additional treatment However if desired the use of soothing products such as gel creams or specific ointments may hasten the recovery process e All the treated areas must be cleaned with water and neutral Soap POSSIBLE ADVERSE REACTIONS There are no significant records of more serious adverse reactions transitory or permanent stemming from the use of IPL Therapy provided that the applications are adequate to the patient However the following may occur e Transitory hyperpigmentation resolved without adjuvant treatments in up to 6 months after the application e Dyschromia e Itching e Burns e Erythema or local edema from 30 minutes to 72 hours e Purpura 17 PREVENTION OF ADVERSE REACTIONS e Make sure the conditions of the area to be treated and the real phototype are evaluated at each session e
60. ulse duration can be adjusted at relatively wide intervals depending on the device in the millisecond range The combination of particular wavelengths pulse durations pulse intervals and fluences facilitates the treatment of a wide spectrum of skin conditions such as acne vulgaris pigmented lesions vascular lesions unwanted hair growth photodamaged skin scars and angiokeratoma 14 RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT The use of electromedical equipment is restricted to a physician or under his command the physical therapists or health professionals properly licensed The professional will be responsible for properly licensed use and operation of the equipment IBRAMED makes no representations regarding laws and federal state or local laws that may apply to the use and operation of any electromedical equipment The physician or under his command also the physical therapist or other professional health care licensed assumes total and full commitment to contact the local certifying agencies to determine any credential required by law for clinical use and operation of this equipment The use of electromedical equipment must comply with the local state and federal country 15 INDICATIONS CONTRAINDICATIONS AND PRECAUTIONS INDICATIONS IPL is commonly indicated in the treatment of the following conditions e Hair removal e Permanent reduction of hairs e Treatment of acneic skin e Treatment of lesions
61. ure 19 Treatment selection screen 32 Figure 20 Interactive menu 33 Figure 21 INFO Gummar ccc cccc cece eee eeee eee eeeeneeeeees 33 Figure 22 Indications of use of equipment 33 Figure 23 A and B contraindications of use of equipment 34 Figure 24 Possible adverse reaction which may occur in case of EXCESSIVE OOeg xxx NNN Ku EENEG 34 Figure 25 Step 1 of 6 of programming the equipment 35 Figure 26 Step 2 of 6 of programming the equipment 35 Figure 27 Step 3 of 6 of programming the equipment 35 Figure 28 Step 4 of 6 of programming the equipment 35 Figure 29 Step 5 of 6 of programming the equipment 36 Figure 30 Step 6 of 6 of programming the equipment 36 Figure 31 Step 1 of 3 of preparing the handpiece 36 Figure 32 Step 2 of 3 of preparing the handpiece 36 Figure 33 Step 3 of 3 of preparing the handpiece ES Figure 34 Step 1 of 3 of preparing the patient 37 Figure 35 Step 2 of 3 preparing the patient 37 Figure 36 Step 3 of 3 preparing the patient 57 Figure 37 Step 1 of 5 of application technique 38 Figure 38 Step 2 of 5 of application technique 38 Figure 39 Step 3 of 5 of application technique 38 Figure 40 Step 4 of 5 of application technique 38 Figure 41 Step 5 of 5 of application technique 39 Figure 42 General Directions for the use of the equipment 39 Figure 43 Safety password a
62. useful fife The useful life period of LYRA depends on the care by the user and the manner in which the equipment is handled The user must respect the instructions regarding cleaning and storage of the equipment cables and electrodes contained in these instructions of use A CAUTION A CAUTION CALIBRATION The correct installation of the equipment prevents safety risks The equipment must undergo periodic annual The device and its consumable parts must be eliminated at the end of its useful life according to the local and or state and or federal norms of each country maintenance to minimize the wear and tear or corrosion which may reduce its mechanical properties in its useful fife ACCESSORIES WHICH ACCOMPANY LYRA LYRA has accessories which were designed to satisfy the requirements of electromagnetic compatibility accessories of codes 03017007 and 02037920 CODE QUANTITY DESCRIPTION OF ITEM 03017007 02037920 03026102 03026101 03026100 03038188 03026104 02059229 03040015 03015118 02039617 02039717 03026112 03044016 03026096 03026095 FEMALE PP CABLE IEC 3X0 75X1500MM APPLICATOR IPL 7 5 CM2 FILER FOR IPL 640 NM FILTER FOR IPL 530 NM FILTER FOR IPL 480 NM OPERATOR PROTECTIVE GOGGLES PATIENT PROTECTIVE GOGGLES FOOTSWITCH PEDAL LYRA DIGITAL OPERATION MANUAL PLUG FOR PUSH IN 8MM 20 AG OF 10A FUSE LYRA FUNNEL AND DRAIN FOR WATER RESERVOIR SUPPLY PLASTIC FIN SMALL CRYSTAL ROSE LYRA COLO
63. your professional development needs we ll be right by your side to provide you with unconditional support We are happy to assist you Contact cefai conexaocefai com br www conexaocefai com br 55 19 3808 2348 Thanks IBRAMED A matter of respect f CEFAI ora o avan am IBRAMED Em Ur Po S IBRAMED QUESTAO DE RESPEITO IBRAMED Industria Brasileira de Equipamentos M dicos EIRELI Av Dr Carlos Burgos 2800 Jd Italia 13901 080 Amparo SP Brazil Telefone 55 19 3817 9633 www ibramed com br ibramed ibramed com br

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