Manual - Ibramed
Contents
1. IBRAMED QUESTAO DE RESPEITO Instructions Manual SONOFOCUS Focused Ultrasound 1 8 MHz Manufactured by IBRAMED Industria Brasileira de Equipamentos M dicos EIREILI Made in Brazil ANVISA n 10360319004 23 edi o Rev 03 2014 TABLE OF CONTENTS SYMBOL DEFINITIONS ENEE 3 CARTON A FIGURE gt GLOSSAR rreren E 5 ABBREVIATIONS nne 5 FOREWORD N A E E 6 PRODUCT DESCRIPION esanaan aaa puerto dias 6 ESSENTIAL PERFORMANCE a eos 6 SAFETY PRECAUTIONS o AA PRECAUTIONARY DEFINITIONS nena 7 INDICATIONS PRECAUTIONS CONTRA INDICATIONS AND RM 9 POPULATION AND CONDITIONS OF 95 11 ADDITIONAL INFORMATION ABOUT FOCUSED LIPOCAVITATION ono RE RR B 1g ADDITIONAL INFORMATION ABOUT FOCUSED ULTRASOUND ensaia umi ux uU fla eae wd alc N 15 RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT 14 GENERAL EQUIPMENT 6 5 0062 L5 SHIPPING Bauer 15 INSTALLATION CARE AND CLEANING cca 15 CARE WITH YOUR EOUIPMEN sunk sete Rn nett 15 INSTALLATION CARE AND CLEANING 16 ELECTROMAGNETIC COMPATIBILITY GUIDANCE 18 ELECTROMAGNETIC 19 SP ECIPI2. POWER SHOT TIME SHOT TIME START AREA Watts 40 Figure 5 A Ibramed logo B equipment and programming Figure 6 Screen for adjustment of shot time firmware model and C standard default screen 29 OPERATION INSTRUCTIONS Area Before programming the treatment the user must demarcate the area and highlight the application points as shown in steps 2 to 5 in Application Techniques see pages 36 to 37 of this manual To program the treatment area press the AREA key and using the UP DOWN keys adjust the value from 20 to 400 cm rea POWER SHOT TIME gt v4 Figure 7 Screen to adjust the Area START Number of passes To program the number of passes press the key with the arrows the number of passes corresponds to the number of arrows 2 or 3 If you choose 2 passes perform the ultrasound shots in the highlighted points marked horizontally and vertically For 3 passes perform the shots in the highlighted points horizontally vertically and longitudinally 30 Start of therapy After the necessary parameters are adjusted for the therapy press START The power chosen the number of shots and the time of application will appear on the execution screen 2 2 40 Shots Figure 8 Execution screen To start the shots press the pedal only once If you wish to stop the application press the pedal or press STOP In this case the application and the count
3. zl Limits of temperature for storage and packaging e in C Celsius Degrees Keep away from the rain Stacking up Do not use if the packaging is damaged FIGURES GLOSSARY Figure 1 Representative image of flat transducer and focused Figure 20 Step 3 of 11 cessa 35 LRN CU Cel SU 12 Figure 21 Step 4 of 11 mmn 36 Figure 2 Front view of SONOFOCUS 26 Figure 22 Step 5 of Dbi nisso Si 36 Figure 3 Rear view of SONOFOCUS 26 Figure 23 Step 6 of 11 36 Figure 4 A connecting the power cable B connecting the Figure 24 Step 7 of Il 36 pedal C connecting the transducer 298 Figure 25 Step 9 Of WE df 27 Figure 5 A Ibramed logo B equipment and programming Figure 26 Step 9 of 11 sessenta 37 firmware model and C standard default screen 29 Figure 27 Step 10 of 11 eren mmm nnn 37 Figure 6 Screen for adjustment of shot time 29 Figure 28 Step 11 of 11 eren nmm nnn 37 Figure 7 Screen to adjust the 30 Figure 8 Execution screen esee nnn 30 Figure 9 A Active cycle of the transducer and B inactive cycle of the transducer ceeeeeeen n nn 31 ABBREVIATIONS GLOSSARY
4. l Figure 27 Step 10 of 11 Step 10 of 11 Guidelines mter AH pds Ma nm Dr d in Pe Ls BzLu stort bee 24 stats ed Lac Eta co pede ch ser m rrt tte nis 7 Palais die zd ob ra dis Lee scm tr THOS ite bee HESS HH da Heus ree bi nams W dan RT polo n He bu peni Ee hd qu boas Wet el ara FA dade FE perit TH nesta in Hee AXE zb Feil ane d dixe i is lhe rip klim peers me seco perm ST E nmn de vz5 ife POMEL ESE n Ta QquEL ie STC d Da i ft Figure 28 Step 11 de 11 4 LI REFERENCES Khokhlova TD Canney MS Khokhlova VA Sapozhnikov OA Crum LA Bailey MR Controlledtissueemulsification produced by high intensity focused ultrasound shock waves and millisecond boiling J Acoust Soc Am 2011 Nov 130 5 3498 510 Ter Haar G Coussios C High intensity focused ultrasound Physical principles and devices International Journal of Hyperthermia 23 89 104 2007 Ferreira AS Barbieri CH Mazzer N Campos AD Mendonca AC Mensuracao de area de cicatriza o por planimetria ap s aplica o do ultra som de baixa intensidade em pele de rato Revista Brasileira de Fisioterapia Sao Carlos v 12 n 5 p 351 8 set out 2008 Marcelo Araujo Fermin de C Garcia Velasco M todos fisicos utilizados para oclus o de varizes dos membros inferiores Jornal Vascular B
5. 25 NOMENCLATURE CONTROLS INDICATORS AND CONNECTORS UT N Sonofocus Figure 2 Front view of SONOFOCUS Figure 3 Rear view of SONOFOCUS 1 ON OFF key 5 Connections to transducer 2 Light Indicator of equipment on condition 6 Protection fuse 3 Display with touch sensitive screen 7 Electrical feed cable connection 4 Connections to pedal 8 Technical characteristics label and serial number T 26 DEFINITION OF SYMBOLS Read and understand these symbols and their definitions before operating the equipment POWER SHOT TIME 0002 000 POWER key to select the power of the ultrasound from 2 to 30 W SHOT TIME key to select the ultrasound shot time between 1 and 10 seconds AREA key to select the treatment area between 20 and 400 cm The UP DOWN keys allow the adjustment of parameters Key which allows the adjustment of the numbers of passes according to the number of arrows 2 or 3 START key which allows to start the treatment 2 STP MENU 949 99 IDIOMA LANGUAGE STOP Key which allows stopping the treatment MENU key which allows the access to INFO and LANGUAGE keys INFO key which allows the access to information referring to indications contraindications treatment areas and application techniques IDIOMA LANGUAGE key which allows the choice of language PORTUGUES ESPANOL or ENGLISH HOME key which allows at any gi
6. ACCESSORIES WHICH ACCOMPANY SONOFOCUS REPLACEMENT ACCESSORIES e The use of accessories ultrasound transducer and cables The replacement accessories are designed for use with the different from those for which the equipment was designed SONOFOCUS When ordering provide the respective codes may significantly degrade the performance of the emissions description and quantity desired and immunity Therefore DO NOT USE accessories ultrasound transducer and cables from SONOFOCUS equipment in other equipment or electromedical systems he use of accessories cables and transducer other than those designed for this specific equipment may significantly degrade the performance of the emissions and immunity Do not use SONOFOCUS accessories cables and transducer in of use are designed and manufactured by IBRAMED for use other equipment or electromedical system only with the SONOFOCUS equipment e The SONOFOCUS transducer is identified by a serial number each transducer has its unique characteristics e he accessories and cables described in these instructions therefore its replacement must only be performed by IBRAMED Authorized Technical Assistance 40 TROUBLESHOOTING What may initially appear to be a problem not always is really a defect Therefore before turning to technical assistance check the items described in the table below PROBLEMS The equipment does not turn on 1 SOLUTION Is cable connected If i
7. Figure 10 Warning of excess of temperature CN Figure 11 Warning of equipment without transducer 32 MHz Megahertz million pulses 105 by second Figure 12 Interactive 33 W Watts Figure 13 Choice of 8 6 enne 33 Figure 14 INFO 3 Hz us Figure 15 Indications of use of the equipment 34 iL Figure 16 A and B contraindications of use of the nei Centimeter CQUIDMENL 34 cm Square centimeter Figure 17 Suggestion of treatment areas 34 mm Milimetro Figure 18 Step 1 OL Llssossgasapansrassisosassasisacadsaamisgean o 35 VA Volt Amper Figure 19 Step 2 of dA passaro died uia PACO NTE S End 35 min Minute FOREWORD These instructions of use allow the user the efficient use of the high intensity focused ultrasound HIFU SONOFOCUS Consult adequate literature in order to obtain additional information about the therapeutic ultrasound before any treatment on a patient Users 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 con
8. concrete or ceramic If floors are covered with synthetic material the relative humidity should be at least 30 The quality of power supply should be that of a hospital environment a or typical commercial building The quality of power supply should be that of a typical commercial or hospital environment ELECTROMAGNETIC COMPATIBILITY Immunity test Voltage drops Short interruptions and voltage variations in power input lines IEC 61000 4 11 Magnetic field at power frequency 50 60 Hz IEC 61000 4 8 NOTE U Test level IEC 60601 lt 5 U gt 95 voltage drops in U by 0 5 cycle 40 U 60 of voltage drops in U by 5 cycles 70 U 30 of voltage drops in U by 25 cycles lt 5 U gt 95 of voltage drops in U by 5 seconds Conformity level 5 U gt 95 voltage drops in U by 0 5 cycle 40 U 60 of voltage drops in U by 5 cycles 70 U 30 of voltage drops in U by 25 cycles 5 U gt 95 of voltage drops in U by 5 seconds is the C A voltage before applying the test 21 Electromagnetic environment orientations The quality of power supply should be that of a typical commercial or hospital environment If the user s equipment requires continued operation during power failure it is recommended the equipment be powered by an uninterrupted power supply or battery Magnetic fields at power frequency should be at the level of a typical loc
9. e Portable and Mobile Radio Frequency RF communications equipment can affect Medical Electrical Devices 18 POTENTIAL ELECTROMAGNETIC INTERFERENCE As for the limits of electromagnetic interference SONOFOCUS is an electromagnetic device of Group 1 Class A The Simultaneous connection from the patient to SONOFOCUS and to high frequency surgical equipment may result in burns in the ultrasonic transducer application area and possible damage to the device Short distance operation 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 power supply line is used for SONOFOCUS and another separate group is used for short wave or microwave equipment We also suggest that the patient SONOFOCUS e and connection cables are installed at least 3 meters away from short wave and microwave therapy equipment Medical Electrical Devices requires special attention regarding Electromagnetic Compatibility EMC and must be installed and put into service according to the EMC information provided in the following tables LI ELECTROMAGNETIC COMPATIBILITY Manufacturer s guidelines and declaration Electromagnetic emissions SONOFOCUS is destined to be used in the electromagnetic environment specified below The user of the equipment should be sure that it will be used in this environment Emission test Conformity
10. key or return to the default screen using the HOME key Mark the treatment area lt gt Step 2 of 11 After turning the equipment on a suggestion of power and shot time will appear on the display Adjust the number of strokes 2 19 os The adjustment of the area will be detailed in the following screens Step 1 of 11 gt Figure 18 Step 1 of 11 l O Figure 20 Step 3 of 11 35 Measure the area using a measuring tape Calculate the area in cm rea Adjust the equipment to the value obtained Step 3 of 11 USING THE MENU KEY Use the mold to highlight Place the gel in the the area ultrasound transducer Mark the localized spots inside the marked area 1 Step 4 of 11 l Step 6 of 1 Figure 21 Step 4 of 11 Figure 23 Step 6 of 11 gt aN Area with application spots po Po Place the PVC on the transducer Never use more than one layer of PVC film in the transducer because that can cause burns 18 Step 7 of 11 Step 5 11 Figure 22 Step 5 of 11 Figure 24 Step 7 of 11 36 18 t USING THE MENU KEY Transducer ready for application ft Figure 25 Step 8 of 11 Step 8 of 11 Apply conductive gel on the skin 18 gt Step of 11 Figure 26 Step 9 of 11 37 Position the transducer on the skin to start the application A gt
11. Electromagnetic emissions SONOFOCUS emits RF energy only for its internal functions RF Emissions However its RF emissions are very low and it is unlikely NBR IEC CISPR 11 to cause any interference in nearby electronic equipment IEC CISPR 11 RF Emissions NBR IEC CISPR 11 Class A IEC CISPR 11 Harmonic Emissions SONOFOCUS is suitable to be used in all kinds of places IEC 61000 3 2 Class A other than residential and which are not directly connected to the public distribution of low voltage which supplies the domestic buildings Emissions due to the fluctuation scintillation Class A IEC 61000 3 3 ELECTROMAGNETIC COMPATIBILITY Manufacturer s guidelines and declaration Electromagnetic immunity SONOFOCUS is destined to be used in the electromagnetic environment specified below The user of the equipment should ensure that it is used in such environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Fast electric transitories pulse train Burst IEC 61000 4 4 Outbreaks IEC 61000 4 5 Test level IEC 60601 6 kV by contact 8 kV by air 2 kV in the feeding lines 1 kV in the input output lines 1 kV mode differential 2 kV mode common Conformity level 6 kV by contact 8 kV by air 2 kV in the feeding lines 1 kV in the input output lines 1 kV mode differential 2 kV mode common 20 Electromagnetic environment orientations The floor should be wooden
12. SP 5062850975 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 Special attention is also given to those interested in visiting our structure Whatever 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 conexaoc
13. tissues as well as helping in the permeation of actives through sonophoresis In these modes of treatment low levels of energy are generally used Also with a flat transducer but associated with electro therapeutic currents ultrasound is used in aesthetic treatments including the treatment of cellulitis and localized fat using high intensities of energy up to 3 W cm with the objective of favoring lipolysis tissue drainage and tissue reorganization Focused therapeutic ultrasound HIFU High Intensity Focused Ultrasound was designed for the treatment of tumors by tissue heating and ablation The first research with this therapeutic proposal dates from 1942 however was only described in humans in 1960 The ability of HIFU to reach cellular volumes at controlled depths appeared as an attractive proposal for use in aesthetic treatments as a non invasive modeling of the body contour HIFU for aesthetic use consist of the propagation of ultrasound propagation through the biological tissues without causing damage the ultrasound beams carry the energy which converges inside the volume or focal rea which may cause a local increase cavitation and of temperature in a magnitude ADDITIONAL INFORMATION ABOUT FOCUSED LIPOCAVITATION sufficient to cause lesion of the subcutaneous adipose tissue with consequent lysis of the adipocytes in the treatment area This occurs without damage to the tissue in the area around or subjacent SONOFOCUS fo
14. voltage and or subjected to excessive fluctuation or overcharge c Misuse lack of reasonable care product alterations modifications or repairs undertaken by individuals or entities not authorized by IBRAMED d Removal or adulteration of the equipment serial number e Damage during Transport 5 The legal warranty does not cover expenses incurred during product installation or transport to the plant or sale point labor materials parts and adjustments necessary to the readiness of the premises in view of the installation of the device such as but not limited to electric net masonry hydraulic network grounding system as well as their requirements 6 The warranty does not cover parts subjected to natural wear such as but not limited to control keys contr AA MAINTENANCE WARRANTY AND TECHNICAL SUPPORT keys handles and moving parts cables connectors device cabinets 7 The selling points are neither authorized to alter the conditions mentioned in this document nor to take any commitment on behalf of IBRAMED DANGER Do not alter this equipment Any unauthorized modification can affect the safety of this equipment Never make unauthorized repairs TECHNICAL ASSISTANCE If you have any doubts or problems related to the operation of your equipment please contact our technical department Call 19 3817 9633 Company authorization of operation 103 603 1 Technician in Charge Maicon Stringhetta CREA
15. CA ONO nai USED DIM 26 SYSTEM SPECIFICA ONS unia nana nao as ET peida das 26 SPECIFICATIONS OF ULTRASOQUND 26 N QBN PPP PPP PPP 26 CONTROLS INDICATORS AND CONNECTORS 26 Oi SYMBOLS erem IHHH Hn 2 ORBRALION INSTRUCTIONS 28 ENU KEY eer mnn nm mmn 33 REFERENCES ep rer Na re 38 ACCESSORIES WHICH ACCOMPANY SONOFOCUS 39 5 40 TROVELESBOOQUINO paragens Ade Raia DA Cena 41 MAINTENANCE WARRANTY AND TECHNICAL SUPPORT 41 CEFAI IBRAMED CENTER FOR EDUCATION AND ADVANCED TRAINING asas masi AURA 44 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 Off switch Class I Equipment of protection against electric CLASS I sod TP P 9 On switch Start treatment DXT Protected against dripping water PX7 Protected against the effects of immersion TYPE BF Electrical Equipment AN Dangerous Voltage lt p Transdutor Stop treatment Alternating Current a SYMBOLS DEFINITIONS Refer to operating instructions for correct product use Fragile This side up Manufacturer s name and address E
16. Contact your local distributor for information on rules and laws regarding the disposal of waste electrical electronic equipment and accessories A CAUTION THE DEVICE AND ITS CONSUMABLE PARTS MUST BE DISPOSED OF AT END OF LIFE ACCORDING TO THE APPLICABLE FEDERAL AND OR STATE AND OR LOCAL REGULATIONS INSTALLATION CARE AND CLEANING ELECTRICAL FEED SONOFOCUS is a protective CLASS I device with applied part type BF of safety and protection SONOFOCUS works in power supply tension in the range of 100 240V 50 60 Hz Just connect the device to the power line and it will perform the selection of power tension automatically The connector cable to the power supply line is detachable The device uses the power line plug as a resource to electrically separate its circuits in relation to the power supply line in all poles NOTES In the rear part of SONOFOCUS there is a protection fuse To replace it turn the device off the power supply line and with the help of a screwdriver remove the protection lid disconnect the fuse perform the replacement and reinsert the lid Always use the fuses indicated by IBRAMED Use a fuse for nominal current of 5 0A operation tension of 250V and snap action model 20AG 50A rupture current SONOFOCUS does not need any type of power stabilizer Never use a power stabilizer 17 Before turning on SONOFOCUS make Sure e The tension and frequency of the local power supply line of the establ
17. E SENSOR EQUIPMENT WITHOUT TRANSDUCER Integrated to the ultrasound transducer of SONOFOCUS there If the equipment is without transducer when pressing the is a temperature sensor which verifies the work temperature START key the following image will appear of the piezoelectric crystal and consequently the one in the aluminum face It is a safety mechanism which avoids the N overheating of the transducer In case the transducer reaches the temperature of 41 degrees Celsius the equipment Power W interrupts the ultrasound emission and the timer for 10 seconds The professional must keep the transducer coupled because after 10 seconds the equipment will automatically continue to emit ultrasound Shots STOP Timer V Figure 11 Warning of equipment without transducer Just connect the transducer and the message will disappear and the equipment will go back to the program conditions Figure 10 Warning of excess of temperature 32 USING THE MENU KEY After pressing the MENU key the following screen will appear which will allow the options INFO or LANGUAGE MENU IDIOMA LANGUAGE Figure 12 Interactive MENU USING THE LANGUAGE KEY The LANGUAGE key allows the choice PORTUGU S ESPANOL or ENGLISH as shown in the screen below Sonofocus PORTUGU S ESPANOL ENGLISH ale IBRAMED Figure 13 Choice of language After selecting the language the equipment will return to the Standard defa
18. agnetic propagation is affected by absorption and reflection from structures objects and people Field strengths set by fixed transmitters such as radio base stations telephone cellular cordless telephones and land mobile radios amateur radio AM FM radio and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters it is recommended an electromagnetic inspection on the place If the measure of field strength at the location SONOFOCUS is used exceeds the conformity level used above the unit must be observed to see whether the operation is normal If an abnormal performance is observed additional procedures may be needed such as reorientation or replacement of the equipment Over the frequency range from 150 kHz to 80 MHz the field strength must be less than 3 V m 23 ELECTROMAGNETIC COMPATIBILITY Recommended separation distances between the communication equipment of RF portable and mobile and SONOFOCUS SONOFOCUS is intended to be used in an electromagnetic environment in which RF disturbances are controlled The user of the electro stimulator can help to prevent the electromagnetic interference by maintaining the minimum distance between the portable communication equipment and mobile RF transmitters and SONOFOCUS as recommended below according to the maximum power of communication equipment Maximum rated pet Separation distance pr din
19. ation in a typical commercial or hospital environment ELECTROMAGNETIC COMPATIBILITY Manufacturer s guidelines and declaration Electromagnetic immunity SONOFOCUS is destined to be used in the electromagnetic environment specified below The user of the equipment should ensure that it is used in such environment imunidade IEC 60601 de Conformidade EquipamenCommunication equipment of RF portable and mobile should not be used near any part of SONOFOCUS including cable with separation distances smaller than the recommended calculated from the equation applicable to the transmitter frequency Recommended separation distance d 1 2 JP 3V d 1 2 VP 80 MHz to 800 MHz d 2 3 JP 800 MHz to 2 5 GHz RF Conducted 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Where P is the maximum nominal output power in watts W according to the transmitter manufacturer and d is RF Radiated 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz 3 V m the recommended separation distance in meters m It is recommended that the field intensity established by the RF transmitter as determined by an electromagnetic inspection on the local smaller than the conformity level in each frequency range Interference may occur around the equipment marked with this symbol t 2 2 ELECTROMAGNETIC COMPATIBILITY NOTE 1 At 80 MHz and 800 MHz it is applied to the higher frequency range NOTE 2 These guidelines may not be applicable to all situations Electrom
20. cused lipocavitation has principles similar to those in therapeutic ultrasound and in HIFU Its transducer was designed to accumulate energy at a depth of 13 3 mm and it works in the frequency of 1 8 MHz 10 and maximum power of 30 W When the adipose tissue in the focal area receives these massive doses of energy a strong cavitation associated to acoustic shock waves is produced This combination of mechanic effect associated to the thermal effects produces emulsification of the fat contained in the adipocytes without Significantly affecting the adjacent structures This mixture of mechanic and thermal stress triggers in the adipose cells a cascade of events which induces apoptosis or programmed cell death Cells of the inflammatory process neutrophils and macrophages are activated and absorb and digest by liberation of enzymes part of the lipids liberated and the debris rests of the dead cells in the treated area This inflammatory process is subclinical and generally asymptomatic The rest of the lipids liberated in the process are dispersed to the interstitial space and diffused to the lymphatic circulation and blood circulation where theoretically they are processed 13 by the liver by endogenous lipases and cleaved in free fatty acids and glycerol or form lipoprotein complexes and are liberated in the blood circulation where afterwards they can be used as a source of energy by the cellular metabolism The increases of circulatin
21. efai com br www conexaocefai com br 55 19 3808 2348 Thanks IBRAMED Matter of respect 75 CEFAI O51 IBRAMED UV n IBRAMED QUEST O DE RESPEITO IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI Av Dr Carlos Burgos 2800 Jd It lia 13901 080 Amparo SP Brasil 55 19 3817 9633 www ibramed com br ibramed ibramed com br
22. ermission from IBRAMED MAINTENANCE WARRANTY AND TECHNICAL SUPPORT WARRANTY IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI here identified to the consumer through the following address and telephone number Av Dr Carlos Burgos 2800 Jd It lia Amparo SP Tel 55 19 3817 9633 provides product warranty for eighteen 18 months insofar as the conditions set for warranty terms are followed by the user as mentioned below WARRANTY TERMS 1 IBRAMED warrants that this product is free of manufacturing defects for eighteen 18 continuous months provided the set terms presented in these instructions for use are followed 2 The warranty period takes effect from the date of purchase and applies to the original purchaser only even in the event of a product being transferred to a third party The warranty covers the replacement of component parts and labor required to repair defects whenever the presence of such manufacturing defects can be determined 3 Customer Service during the warranty period will be provided exclusively at IBRAMED sale points by IBRAMED itself or another agent designated by the manufacturer 42 4 The warranty does not cover damage caused to the product resulting from a Failure to follow the specifications and recommendations detailed in these instructions for use during installation or use of the product b Accidents or acts of God connections to electrical system with inappropriate
23. g plasmatic lipids are considered non Significant and mechanisms of maintenance of homeostasis are activated promoting their subsequent normalization In order to enhance the results we recommend aerobic physical activities after the treatment with SONOFOCUS 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 14 GENERAL EQUIPMENT CARE SHIPPING DAMAGE Your SONOFOCUS is shipped complete in one carton Upon receipt inspect carton and unit for visible and hidden damage In case of damage keep all shipping materials including carton and contact the shipping agent responsible for the delivery of the unit All claims relating to damage during transport should be filed directly w
24. he instructions of use are read carefully and all the instructions are understood before the use of the device e There are no admissible deficiencies for the use of the equipment e Regarding the frequency of use this device is used according to clinical needs up to several times a day and is reusable e Regarding mobility this device is considered a portable device ADDITIONAL INFORMATION ABOUT FOCUSED LIPOCAVITATION Since the introduction of focused ultrasound as a therapeutic resource over 50 years ago its biological actions have been investigated Therapeutic ultrasound is a mode of longitudinal sound energy which when transmitted to the biological tissues is capable of producing cellular alterations by mechanical and thermal means Therapeutic ultrasound comprehends a range of frequency which varies from 20 kHz to 5 MHz and its current applicabilities vary according to its frequency power and the form of transducer The transducer can be flat non focused or curved focused as demonstrated in figure 1 Focused Transducer Transducer ee NES QUE GENERO te OP EE ee RS 6 Skin ta Fat Fal area W Muscle Figure 1 Representative image of flat transducer and focused transducer 12 Therapeutic flat ultrasound is a commonly used resource in physiotherapy for physical rehabilitation and uses its mechanic and thermal feats to promote repair and regeneration in bone muscle and tegmental
25. hol thinner and solvents in general to clean the cabinet because they may damage the finish Use only a smooth cloth dry and clean e The equipment does not need to be used in armored places e The equipment must not be used very near or stack over other devices T INSTALLATION CARE AND CLEANING e SONOFOCUS must not be used without the coupling mean gel e Avoid places subject to vibration Install the device on a flat and firm surface e Do not block ventilation e Avoid humid hot and dusty environments e Make sure the area around the power cable is free e Do not introduce objects in the orifices in the device A CAUTION CORRECT EQUIPMENT INSTALLATION PREVENTS SECURITY RISKS CLEANING THE SONOFOCUS e Disconnect the system from the power source wipe with a clean lint free cloth moistened with water and mild antibacterial soap e If a more sterile cleaning is needed use a cloth moistened with an antimicrobial cleaner e Do not place the system in liquids CAUTION THE EQUIPMENT MAY SUFFER IRREVERSIBLE DAMAGE IF IT WORKS WITHOUT THE ADEQUATE COUPLING MEAN ENVIRONMENTAL PROTECTION The SONOFOCUS is an electronic device and has heavy met als such as lead Thus there are risks of contamination to the environment associated with the disposal of this equip ment and its accessories at the end of their useful lives The SONOFOCUS parts and accessories must be disposed of as waste
26. ing of the shots will stop To restart the application just press the pedal once again To return to the programming screen press STOP OPERATION INSTRUCTIONS The equipment presents an automaticsequenceofshots During the shots the image of the active transducer programmed shot time or the image of the inactive transducer fixed intervals at 2 seconds will appear as shown in the pictures below 2 21 40 Shots 2 4 40 Shots Figure 9 A Active cycle of the transducer and B inactive cycle of the transducer 31 After the end of each shot the equipment will emit a sound Signal at that moment the transducer must be dislocated 1 cm over the treatment area This dislocation must occur after each sound signal until the end of the programmed number of shots When the counting of the shots and the application time is finalized the equipment will emit another sound signal CAUTION Before starting the therapy using SONOFOCUS the cavity of the ultrasound transducer must be completely fulfilled with coupling gel The volume of gel should be even with the edge of the transducer Avoid the formation of air bubbles in the gel when filling the transducer CAUTION Never use more than one layer of PVC film in the transducer because that interferes in the passage of ultrasonic energy leaving it more superficial can cause burns OPERATING INSTRUCTONS TRANSDUCER PROTECTION MESSAGES TEMPERATUR
27. ishment where the device is installed are equal to the one described on the label describing characteristics of tension and power located at the rear part of the device e To prevent electrical shock do not use the plug in the device with extension cables or any other types of sockets except the terminals connect perfectly in the receptacle e Cleansing and disinfection must always be performed with the power plug off of the power supply line e Maintenance and technical assistance of SONOFOCUS must always be performed at unauthorized service only by qualified technicians A CAUTION INSIDE THE DEVICE THERE ARE DANGEROUS TENSIONS NEVER OPEN THE DEVICE ELECTROMAGNETIC COMPATIBILITY GUIDANCE e This unit is not designed to be used where there is explosion hazard such as anesthesia departments or in the presence of an anesthetic flammable when mixed with air oxygen or nitrous oxide e Using cables electrodes and other accessories from other manufacturers and or different from those specified in this manual as well as the replacement of internal components SONOFOCUS may result in increased emissions or decreased immunity of the equipment e SONOFOCUS equipment is intended for use only by health care professionals The SONOFOCUS may cause radio interference or disrupt equipment operations nearby It may be necessary to adopt mitigation procedures such as reorienting or relocating the equipment or shielding of the site
28. ith them The manufacturer will not be liable for any damage during shipping nor allow for adjustments unless proper formal claim has been filed by the receiver against the carrier The carton in which your SONOFOCUS was received is specially designed to protect the unit during Shipping Please keep all shipping materials in case you need to return your unit for servicing Installation Instructions 1 Connect the line cord to the back of the SONOFOCUS 2 Plug the line cord into a grounded wall outlet 100 240V 50 60 Hz 3 Plug the ultrasound cables into the correct connections 4 Switch on your equipment INSTALLATION CARE AND CLEANING CARE WITH YOUR EQUIPMENT e Avoid places subject to vibration e Install the device on a firm horizontal surface in a place with perfect ventilation e In the case of fitted cabinet make sure there is no obstacle to the free circulation of air in the rear part of the device e Do not place the device over rugs mats cushions or smooth surfaces which obstruct ventilation e Avoid humid hot or dusty places This device is not protected against the harmful penetration of water e Position the power cable in such a manner that it is free out of places where it could be treated on and do not place any piece of furniture over it e Do not introduce objects in the orifices in the equipment and do not place recipients containing liquids over it e Do not use volatile substances benzene alco
29. on N CAUTION Text with a CAUTION indicator refers to potential safety infractions that could cause minor to moderate injury or damage to equipment WARNING Text with a WARNING indicator refers to potential safety infractions that could cause serious injury and equipment damage Text with a DANGER indicator refers to potential safety infractions that represent immediately life threatening situations that would result in death or serious injury e Read comprehend and practice the precaution and operation instructions Know the limitations and dangers associated with the use of any electrical stimulation Observe the precaution and operation labels placed on this unit e Do not operate this unit in an environment where other devices intentionally radiate electromagnetic energy in an unprotected manner e Check the cables and connectors before each use e The SONOFOCUS stimulator is not designed to prevent the penetration of water and other liquids e Penetration of water and other liquids may cause malfunction of the internal components of the system and consequently promote risk of injure to the patient e Disconnect the plug from the power outlet when the device is not used for long periods of time e he applicator should be operated only by the handle to avoid exposure to unwanted emission of ultrasound SAFETY PRECAUTIONS e In order to be protected from the risk of fire use only spare fu
30. oxygen or nitrous oxide Equipment is not the AP or APG category INDICATIONS PRECAUTIONS CONTRA INDICATIONS AND ADVERSE REACTIONS INDICATIONS SONOFOCUS supplies the high intensity focused ultrasound energy and must be used with coupling gel High intensity focused ultrasound is commonly indicated for aesthetic treatments for a non invasive modeling of the body contour PRECAUTIONS e Ultrasound must not be applied over sensitive areas or areas with reduced circulation or on anesthetic areas The patients with reduced sensitivity are not able to warn the professional in case there is any discomfort during treatment and in patients with compromised circulation there might be an accumulation of excessive heat in the treatment area e Care must be taken in the therapeutic ultrasound treatment of patients with hemorrhagic diathesis or hemorrhagic disturbances e Operators must not be routinely exposed to therapeutic ultrasound e If a patient complains about deep periosteal pain during an ultrasound treatment the intensity must be reduced to a comfortable level e Heating in the acute or sub acute phase of arthritis must be avoided e Other treatments with electronic devices which may come into contact with the patient during the treatment with therapeutic ultrasound must be properly tested to guarantee the safety of the operation CONTRA INDICACOES e Focused ultrasound must not be applied in areas with Subcutaneous adipo
31. pplied with the equipment do not cause allergic reactions The transducer and the gel must only be put in contact with the intact skin surface respecting the limit of time of the duration of this contact which is 24 hours There are no risks of harmful effects to the cells nor allergic or sensitivity reactions The gel and the transducer material with which it is manufactured do not cause skin irritation 10 POPULATION AND CONDITIONS OF USE PATIENT POPULATION e Patients over 12 years old under this age only by medical prescription or physiotherapeutic indication e Patients over 35 kg under this weight only by medical prescription or physiotherapeutic indication e There are no restrictions as of nationality e Patients with preserved level of conscience and sensitivity CONDITIONS OF USE e There are no requisites about a maximum level of education for the intended use e Regarding the minimum level of knowledge of the user it is necessary that the user knows the electro physical agents and their therapeutical effects The user must know physiology anatomy and the basic sciences chemistry physics and biology The user is supposed to have studied or be presently studying physiology and anatomy e A maximum level of knowledge is not required from the user e The instructions of use are available in Portuguese Spanish and English 11 e Regarding the minimum level of experience of the user it is necessary that t
32. rasileiro Vol 5 2006 Melo RM Gouv a CMCP Silva AL Efeito do ultra som na preven o da hernia incisional mediana no rato Acta Cirurgica Brasileira 2005 20 100 108 Jesus GS Ferreira AS Mendonca AC Fonoforese x permeacao cutanea Fisioterapia em Movimento 2006 19 4 83 88 Fodor PB Smoller BR Stecco KA et al Biochemical changes in adipocytes and lipid metabolism secondary to the use of high intensity focused ultrasound for non invasive body sculpting Presented at the Annual Meeting of the American Society of Aesthetic Plastic Surgery April 2006 Orlando FL Conselho Federal de Medicina Resolu o N 1 711 de 10 de Dezembro de 2003 Dispon vel em http www portalmedico org br resolucoes cfm 2003 1711 2003 htm Fatemi A High Intensity Focused Ultrasound Effectively Reduces Adipose Tissue Seminar in Cutaneous Medicine and Surgery 28 257 262 2009 Coleman KM Coleman III WP Benchetrit A Non Invasive External Ultrasonic Lipolysis Seminar in Cutaneous Medicine and Surgery 28 263 267 2009 ACCESSORIES WHICH ACCOMPANY SONOFOCUS SONOFOCUS contains accessories designed to satisfy the demands of electromagnetic compatibility CODE QUANTITY DESCRIPTION OF ITEM 03017007 LE C 3 X 0 75 X 1500 mm PP FEMALE CABLE SONOFOCUS METALLIC RACK 02039229 PEDAL 02039534 SONOFOCUS APPLICATOR PVC FILM FUSE 20AG 054 PROTECTION FUSE CARD DIGITAL OPERATION MANUAL IBRAMED SONOFOCUS 39
33. se layer thinner than 1 5 cm e Focused ultrasound must not be applied on pregnant women or over the potentially pregnant uterus e Focused ultrasound must not be applied over neoplastic areas or over areas where a tumor has been removed e Focused ultrasound must not be applied over the eyes e Focused ultrasound must not be used over ischemic areas where the blood supply may be unable to fulfill the metabolic demand and result in necrosis e Focused ultrasound must not be applied over bone epiphyses still in growth e It is recommended that any patient with implanted electronic device e g pace maker deep brain stimulation device is not subjected to focused ultrasound therapy e Focused ultrasound must not be applied over the cardiac area e The focused ultrasound must not be applied over abdominal LI INDICATIONS PRECAUTIONS CONTRA INDICATIONS AND ADVERSE REACTIONS CONTRA INDICATIONS hernia or diastasis of the rectum muscle in patients being treated on the abdomen e Focused ultrasound must not be applied in cases of healing deficit e The focused ultrasound must not be applied in individuals with metabolic and hepatic diseases which compromise the metabolism of fat ADVERSE REACTIONS e Focused ultrasound may cause a tingling sensation and or uncomfortable heat e BIOCOMPATIBILITY of the materials in contact with the patient ISO 10993 1 IBRAMED declares that the ultrasound transducer and the coupling gel su
34. ses of the same type and class e Make sure the unit is grounded connecting it to a grounded power outlet in conformity with the applicable local and national electrical codes e Before treating the patient it is necessary to know the operational procedures for each treatment mode available as well as the indications contra indications warnings and precautions Refer to other sources to obtain additional information on electrotherapy applications e To avoid electrical shock turn the device off the power supply line before any maintenance procedure e The ultrasound treatment must not be applied on swollen infected or inflamed areas or on skin eruptions such as phlebitis thrombophlebitis varicose veins etc e Ultrasound treatment must not be applied on or next to cancerous lesions e Patients with neurostimulation devices or implanted pacemakers must be distant from any shortwave diathermy microwave diathermy therapeutic ultrasound diathermy or laser diathermy and must not be treated with these on any part of their bodies The diathermy energy shortwave microwave ultrasound and laser may be transferred through the implanted neurostimulation system and it may cause damage to the tissues and result in serious injury or death e Damage injury and death may occur during diathermy therapy even if the implanted system is turned off e Equipment not suitable for use in the presence of a flammable anesthetic mixture with air
35. t is not connect it Also check the power outlet on the wall properly power Have you checked the protection fuse Check ifthey are properly connected Check also if the value is in accordance with the indicated in the operation instructions The equipment does not turn on 2 The equipment is on but does notperform the function Have you followed the recommendations and instructions in the operation manual correctly Check and go over the steps indicated in the item about controls indicators and connections and in the item operation instructions 41 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 We assume no responsibility for repairs without prior explicit written p
36. tained in these instructions of use are valid on the date of their publication These instructions may be updated at any given time at the manufacturer s criteria Visit our website for updates 1 IBRAMED PRODUCT DESCRIPTION ESSENTIAL PERFORMANCE SONOFOCUS is microcontrolled high intensity focused ultrasound equipment HIFU in the frequency of 1 8 MHz 10 Designed for use in aesthetic treatment it allows a non invasive modeling of the body contour The thermal and mechanical cavitational energy produced by SONOFOCUS is transferred to the adipose tissue through a curved transducer coupled to the skin with the use of neutral gel This energy is concentrated in the focal area at a controlled depth 13 3mm in the subcutaneous adipose tissue being capable of inducing lipolysis and promoting by the increase ofintracellular tension discreet rupture in the adipocyte membrane and emulsification of the fat contained in it The shot time can be adjusted from 1 to 10 seconds with maximum output power of 30 W 20 with adjustment of 2 to 30 W The equipment must be used only under prescription and supervision of a properly licensed health professional SAFETY PRECAUTIONS PRECAUTIONARY DEFINITIONS The precautionary instructions found in this section and throughout this manual are indicated by specific symbols Understand these symbols and their definitions before operating this equipment prior to therapy sessi
37. to frequency of transmitter output of the transmitter maximum nominal potency of output 150 kHz to 80 MHz 80 MHz is MHz 800 MHz to 2 5 GHz d 1 2 JP d 1 2 d 2 3 4P For transmitters with a maximum nominal output power not listed above the recommended separation distance in meters m can be determined by using the equation applicable to the frequency of the transmitter where P is the maximum rated output in watts W According to the transmitter manufacturer NOTE 1 80 MHz to 800 MHz applies to the distance of separation for the higher frequency range NOTE 2 These guidelines may not be applicable in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people SPECIFICATIONS SYSTEM SPECIFICATIONS Range of temperature during transportation and Dimensions storage 5 50 C 41 122 F Width 30 cm 11 8 in Depth 30 cm 11 8 in Height 11 cm 4 3 in Range of operational environment temperature Standard Weight 6 kg 5 45 C 41 113 F with transducer Power Input 100 240V 50 60 Hz Input power 250 VA Fuses SA 250 20AG Fast Action 50A SPECIFICATIONS OF ULTRASOUND Electrical Class CLASS I eque 1 8 MHz 10 Electrical Protection TYPE BF Control mode PWM PWM Frequency 31 kHz Shot time 1 to 10 seconds Output Power Maximum 30 W 20 Conformity Regulations Adjustable de 2 a 30 W IEC 60601 1 IEC 60601 1 2 IEC 60601 1 4 IEC 60601 1 6
38. ult screen USING THE INFO KEY Using the INFO key the user will have access to the following information indications contraindications treatment areas and application techniques Indications dp Contraindications Treatment areas Application techniques MENU e o0 eo A Figure 14 INFO key 33 USING THE MENU KEY Next are the screens corresponding to each item B Contraindications Indications Metabolic or hepatic diseases which compromise the fat Indications metabolism Over abdominal hernia or diathesis of abdominal muscles Localized fat treatment Over bone epiphisys Over cardiac area Healing deficit if Figure 16 A and B contraindications of use of the l Q equipment Figure 15 Indications of use of the equipment Noninvasive body contouring Treatment Area Contra Indications A Contraindications Over subcutaneous adipose layer thinner than 1 5 cm Pregnancy or over the gravid uterus Implantable electronic device Over neoplasic areas Over the eye area Over ischemic areas Page 1 Of 2 Figure 17 Suggestion of treatment areas 34 USING THE MENU KEY Application Techniques Screens The Application Techniques present 11 steps To follow the step by step the user must use the arrows which appear in the right bottom corner to advance or return At any given moment the user can return to the MENU using the INFO
39. ven time to return to the standard default programming screen OPERATION INSTRUCTIONS PREPARING THE EQUIPMENT C Connect the power cable to the rear part of the equipment figure 4A and then to the electric power Press the ON OFF key to the position ON Connect the pedal according to figure 4B until you hear a click To disconnect just press the button on the top part of the connector and pull To connect the ultrasound transducer introduce according to the socket figure 4C and turn clockwise until you check its locking Figure 4 A connecting the power cable B connecting the pedal C connecting the transducer PROGRAMMING THE EQUIPMENT As you turn on SONOFOCUS the equipment introduction screens will appear in a sequence Figure 5A and 5B followed by the standard default screen of SONOFOCUS Figure 5C A Mv E C3 IBRAMED T 28 OPERATION INSTRUCTIONS PROGRAMMING EQUIPMENT Power To select the power the user must press the POWER key and a suggestion of 22 W power will appear on the screen as Shown in Figure 5C Using the UP and DOWN keys this value ATAF Il can be adjusted between 2 and 30 W To adjust power during Ono ocus application it is necessary to interrupt the emission pressing Free goon the pedal Shot Time Press the SHOT TIME key and using the UP DOWN adjust the value between 1 and 10 seconds mm ln m um L E Lim Power Shot time POWER
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