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Instructions for Use ARES CARBOXYTHERAPY 1 Registro ANVISA Nº: 10360310032 Instruções de Uso ARES 1ª edição 12/2009 INSTRUCTIONS FOR USE OF ARES EQUIPMENT MANUFACTED BY IBRAMED ABOUT THE INSTRUCTIONS FOR USE The INSTRUCTIONS FOR USE of ARES were prepared in a synthetic way to facilitate the installation, care and handling of this equipment. WE ASK YOU TO READ THESE INSTRUCTIONS FOR USE BEFORE USING THE EQUIPMENT AND ALWAYS MAKE REFERENCES TO THEM WHENEVER DIFFICULTIES ARISE. In these instructions for use, IBRAMED provides considerations and guidelines of the applications for the use of the treatment modalities offered by ARES for you to make an optimal use of the equipment. 2 Instruções de Uso ARES 1ª edição 12/2009 CONTENTS GENERAL CARE WITH THE EQUIPMENT ......................................................................................... 10 INSTALLATION, CARE AND CLEANING ........................................................................................ 10 SAFETY AND PROTECTION .............................................................................................................. 10 PERSONAL SAFETY ...................................................................................................................... 11 ARES SAFETY ............................................................................................................................... 11 POWER SUPPLY ........................................................................................................................... 11 DESCRIPTION OF ARES .................................................................................................................... 12 ESSENTIAL PERFORMANCE ............................................................................................................. 13 PHYSIOLOGICAL EFFECTS AND INTENDED USE OF ARES CARBOXITHERAPY ................................. 13 PHYSIOLOGICAL EFFECTS EXPECTED “IN LOCO” AFTER THE INFUSION OF CO2............................. 15 GENERAL INDICATIONS FOR ARES CARBOXITHERAPY ................................................................... 15 CONTRAINDICATIONS OF ARES CARBOXITHERAPY ........................................................................ 15 POSSIBLE TRANSITORY SIDE EFFECTS ......................................................................................... 16 REFERENCES .................................................................................................................................... 17 PROFESSIONAL TRAINING ............................................................................................................... 18 CONTROLS, INDICATORS AND CONNECTIONS ............................................................................... 19 OPERATION INSTRUCTIONS ............................................................................................................ 24 PROG./MENU Key ........................................................................................................................... 27 LEAK TESTING .............................................................................................................................. 29 ENVIRONMENTAL PROTECTION ................................................................................................. 30 EQUIPMENT AND ITS ACCESSORIES CLEANING .......................................................................... 31 MAINTENANCE, WARRANTY AND TECHNICAL ASSISTANCE .......................................................... 31 MAINTENANCE............................................................................................................................ 31 WARRANTY ................................................................................................................................. 31 WARRANTY TERM ....................................................................................................................... 32 3 Instruções de Uso ARES 1ª edição 12/2009 TECHNICAL ASSISTANCE ............................................................................................................. 33 TROUBLESHOOTING ................................................................................................................... 33 ELECTROMAGNETIC COMPATIBILITY .............................................................................................. 35 4 Instruções de Uso ARES 1ª edição 12/2009 LIST OF ABBREVIATIONS VA Volt ampéres A Ampéres Mm MilIimeter mL Mililiter mL/min Mililiters per minute V~ Alternating Tension Cm Centimeter Hz Hertz Volts Voltage Min Minutes Kg Kilogram kgf/cm2 Kilogram-power per square centimeter °C Degrees Celsius 5 Instruções de Uso ARES 1ª edição 12/2009 LIST OF FIGURES Figure 1. Upper view of ARES. ................................................................................................................... 19 Figure 2. Rear view of ARES. ...................................................................................................................... 19 Figure 3. Front view of ARES. ..................................................................................................................... 20 Figura 4. Lower view of ARES ..................................................................................................................... 20 Figura 5. Rear view of Ares with cabinet. ................................................................................................... 21 Figura 6. Liquid crystal display of ARES. ..................................................................................................... 24 Figure 7. Sequence of events informed on the liquid crystal display when ARES is connected. .............. 24 Figura 8. Sequence of events informed on the liquid crystal display when drainig ARES equipo. ............ 25 Figure 9. “Default” values of the liquid crystal display to start ARES programming.................................. 25 Figura 10. Illustrative images that indicate the pedal and heating parameters: A, “OFF”, turned off and B “ON”, turned on .......................................................................................................................................... 26 6 Instruções de Uso ARES 1ª edição 12/2009 LIST OF SYMBOLS IN THE EQUIPMENT AND IN THE INSTRUCTIONS FOR USE Observe attentively the instructions for use in the operation manual. It explains the possible effects which security infractions may cause serious injuries and equipment damage. It explains that possible effects of security infractions may cause death or severe injuries. Equipment with applied part of BF type. Dangerous voltage (electric shock risk). CLASS II equipment. Equipment in which the protection against electric shock is not based only on the basic isolation, but it also incorporates additional safety precautions such as double or reinforced isolation which have neither grounded resources for protection, nor installation conditions. IPX0 Equipment not protected against the harmful penetration of water. It indicates the start of the action (START) 7 Instruções de Uso ARES 1ª edição 12/2009 It indicates the end of the action (STOP). It indicates: Off (without Power supply). It indicates: On (with Power supply). V~ ~ line Volts in alternating current. Electric grid in alternating current. 8 Instruções de Uso ARES 1ª edição 12/2009 IN THE SHIPPING BOX FRAGILE: The content in this package is fragile and must be transported carefully. THIS SIDE UP: It indicates the correct position to transport the package. 50º C 5º C LIMITS OF TEMPERATURE: It indicates the limits of temperature for transportation and storage of the package. KEEP AWAY FROM THE RAIN: The packaging must not be transported under the rain. DO NOT STACK: This equipment cannot be stacked on top of each other. Do not use if the packaging is damaged. Refer to the instructions for use. This symbol warns the reader to refer to the instructions for use to have the necessary information to the adequate use of the product. It indicates the manufacturer’s name and address 9 Instruções de Uso ARES 1ª edição 12/2009 GENERAL CARE WITH THE EQUIPMENT INSTALLATION, CARE AND CLEANING ARES does not require special care and arrangements to be installed. We only suggest some general care: Avoid places subject to vibrations. Install the equipment on a steady horizontal surface in a place with perfect ventilation. In case of built-in closet, make sure there is circulation of air in the rear part of the equipment. Do not put the equipment on carpets, cushions and other fluffy surfaces that may obstruct ventilation. Avoid humid, hot and dusty places. Place the grid cable so that it is free, in a place where it cannot be stepped on and do not put any piece of furniture on it. Do not insert objects into the holes of the equipment and do not place recipients with liquid on it. Do not use volatile substances (benzine, alcohol, solvents in general) to clean the cabinet, as they may damage its finish. Use only a soft, dry and clean fabric for that. ATTENTION: To prevent electric shock, do not use the plug of the appliance with an extension cord, or other socket unless the terminals fit completely into the receptacle. Disconnect the power plug from the socket when not using the equipment for a long time. FOLLOW THE INSTRUCTIONS FOR USE CORRECTLY WHEN INSTALLING THE CO 2 CYLINDER. SECURITY RISKS MAY OCCUR IF THE EQUIPMENT IS NOT PROPERLY INSTALLED. SAFETY AND PROTECTION ARES corresponds to CLASS II BF type considering safety and protection. It should be operated only by qualified professionals and in medical departments properly authorized. This equipment is not supposed to be used in places where there is a risk of explosion such as in the anesthesia department or in the presence of inflammable anesthetic mixture with air, oxygen or nitrous oxide. NOTE - Potential electromagnetic interference: Regarding the electromagnetic disturbance, ARES is an electromedical equipment which belongs to Group 1 Class A. The short distance operation (1 meter, for example) of a shortwave, radiofrequency or 10 Instruções de Uso ARES 1ª edição 12/2009 microwave therapeutic equipment can produce instability in the output of the equipment. To prevent electromagnetic interference, a group of the electric grid is suggested to be used for ARES and another separate group for the shortwave or microwave equipment. It is also suggested that the patient, ARES and the power cables are installed at least 3 meters from the shortwave, microwave or radiofrequency therapeutic equipment. Communication equipment by radiofrequency, mobile or portable may cause interference and affect the functioning of Ares. PERSONAL SAFETY Before turning ARES on and operating it, read the instructions for use carefully, observing the information contained on it. Also check on : If the equipment was adequately plugged in the local electrical grid. Talk with the patient to know whether he is in a comfortable position during the treatment. If the equipment is working correctly, at regular intervals during the treatment. At regular intervals, ask if the patient feels well and whether the treatment is tolerable. ARES SAFETY The inappropriate installation, operation or maintenance may result in malfunction of the equipment. POWER SUPPLY ARES is a CLASS II monophasic equipment with applied part of BF type of security and protection. ARES operates with voltages ranging from 100 - 240 volts 50/60 Hz. You just need to plug the device and it will automatically select the tension. The power cable is detachable. The equipment uses the power plug as a resource to separate electrically its circuits in relation to the electrical grid in all poles. 11 Instruções de Uso ARES 1ª edição 12/2009 ATTENTION: The protection fuse is in the rear part of ARES. To change it, unplug the power outlet and with the help of a small screwdriver, remove the protection cover, disconnect the fuse, substitute it and put the cover back again. Always use the fuses indicated by IBRAMED: use the 5.0A fuse for nominal current, operating voltage 250V~ and fast action model 20AG (breaking current of 50A). SECURITY RISKS MAY OCCUR IF THE EQUIPMENT IS NOT ADEQUATELY INSTALLED. NOTE: 1- There are dangerous tensions within the equipment. Never open it. Before connecting ARES, make sure: To prevent electric shock, do not use the plug of the device with an extension cable, or any other outlet, unless the terminals are fully inserted into the receptacle. Cleaning and disinfection should always be made with the extension cable unplugged. The maintenance and the technical assistance of ARES should always be made in an authorized service and only by qualified technicians DESCRIPTION OF ARES ARES is an equipment microcontroled for carboxitherapy. It is a CLASS II monophasic equipment with applied part of BF type of security and protection. In carboxitherapy, the carbon dioxide (CO2) is insufflated subcutaneously with specific accessories. The CO2 is injected in a controlled way and the gas infusion is programmed according to the purposes of the treatment and the functions of the resistance found in the human tissues. The use of CO2 USP (United States Pharmacopeia) grade, the use of bacterial filters and the asepsis of the treated area ensure the low risk of the local contamination. CO 2 is nontoxic and introduced through subcutaneous injection with 30 G ½ needles (insulin). ARES controls are operated through a touch keyboard. All information concerning the parameters chosen by the therapist are displayed in the alphanumeric liquid crystal display. 12 Instruções de Uso ARES 1ª edição 12/2009 ESSENTIAL PERFORMANCE Carboxitherapy is a method widely used in Esthetic Medicine, Dermato-funcional Physiotherapy and by other professionals working in the health area properly licensed to treat cellulite, skin flabbiness, localized fat, stretch marks and anesthetic scars. Other sciences such as Rheumatology, Angelology, Dermatology, and Physiotherapy have also used this resource for treating disorders including peripherical artery diseases, microangiopathy, varicose ulcers, psoriasis, and sports injuries, among others. The therapy consists of subcutaneous applications of controlled concentrations of carbon dioxide (CO2 standard/ USP grade). It is a fast therapy, with very little discomfort and very efficient for most patients. Although Carboxitherapy is a new technique, the use of CO2 for therapeutic purposes began in France around 1932, in Royat thermal station where dry carbon dioxide baths in carbonic water were used to treat patients with peripheral artery diseases, ulcers and wounds. This kind of treatment with transcutaneous CO2 was used for many years. The results encouraged further studies, leading to the increasing indications of new treatments (Corassa et al., 2006). In 1990, Belotti et al., in Rabbi Thermal Institute, whose water has a percentage of carbon similar to Royat, began to study the actual benefits in the treatment of localized fat and cellulite. After the development of new techniques, the application is no longer topical, and the CO 2 has been injected directly into the subcutaneous tissue, ensuring better and faster results. Thus, the term Carboxitherapy was originated, that is, the use of carbon dioxide, CO2, a metabolite normally produced in our body for therapeutic purposes. PHYSIOLOGICAL EFFECTS AND INTENDED USE OF ARES CARBOXITHERAPY Carbon dioxide (CO2) is a gas produced during the cellular metabolism which spreads rapidly from the cells to the capillaries to be transported dissolved in the plasma in the form of biocarbonate ions (HCO3-). It is bound to hemoglobin (hemoglobin-carbamino) and to other carbaminic compounds up to the lungs where it is eliminated to the air (Nardelli et al, 2009, Tortora e Grabowski, 2002; Guyton e Hall, 2011). At rest, with normal ventilation, the human body consumes about 250 mL/min of O2 (transported from the lungs to the tissues) and emits 250 mL/min of CO2 (removed from the tissues and excreted through the alveolar breathing), but may increase this volume by about six times during physical exercises (about 1200/1500 mL/min) (Viegas, 2002; Tortora and Grabowski, 2002; Guyton and Hall, 2011). CO2 is very soluble in the plasma and the dissolved amount is determined by the product of the partial pressure of the gas and its solubility coefficient (α = 0,03 mL/dL of blood/mmHg). It can spread into the bloodstream in amounts up to 100 mL/min without major changes in the partial pressure of CO2 (PaCO2). A slight increase in the concentration of CO2 dissolved in the plasma activates control mechanisms of ventilation which increase the frequency and the depth of breathing allowing greater CO2 exhalation and O2 capturing (Tortora and Grabowski, 2002; Guyton and Hall, 2011). 13 Instruções de Uso ARES 1ª edição 12/2009 One of the main mechanisms for adjusting the pulmonary ventilation is the partial pressure of CO2 (PaCO2), the quantity of CO2 dissolved in the arterial blood. The variations of PaCO2 are noticed by the central and peripheral chemoreceptors and the mechanisms to increase or decrease the ventilation are driven to keep PaCO2 around 35-45 mmHg (Nardelli et al., 2009). During the carboxitherapy, an average from 30 – 100mL/minute of CO2 are administered by subcutaneous assisted infusion. The small rise in CO2 levels is readily solved by a slight increase of the frequency and depth of breathing during and after the treatment without the risk of hypercapnia and respiratory acidosis (Viegas, 2002; Tortora e Grabowski, 2002; Guyton and Hall, 2011; Varlaro et al., 2007). The CO2 (USP standard) used in carboxitherapy is the same used to promote pneumoperitoneum in laparoscopic video surgery (Ochiai et al., 2000; Abu-Rafea et al., 2006) and arteriography (Simão and Guillamoun, 2004). The total volume of insufflated gas under assisted pressure during the pneumoperitoneum may vary from 1 to 4 liters and to calculate the ideal value to be insufflated, variables such as height, weight, body mass index and age should be considered (Abu-Rafea et al., 2006, Mulier et al., 2009). For esthetic/therapeutic use of subcutaneous carboxitherapy, the total volume insufflated per session ranges from 200 to 1200mL, indicated depending on the area to be treated and the purposes of the treatment. The O2 affinity with the hemoglobin is altered by pH, because the acidity stimulates the oxygen release, so in the presence of the carbon dioxide this affinity is reduced. So the presence of high levels of CO2 in the tissues or in the capillaries close to them favors the oxygen release of the hemoglobin creating the Bohn effect. When used as therapeutic method, the excess CO2 is eliminated from the body by physiological mechanisms through the breathing or by the kidneys in the form of hydrogen ions (+H) or bicarbonate (H2CO3). The correct application of carbon dioxide (CO2) does not promote toxicity to the body (Viegas, 2002; Tortora e Grabowski, 2002; Guyton e Hall, 2011). The infusion of CO2 activates the local microcirculation, improves the cell nutrition and eliminates toxins, reduces the inflammation processes improving the tissue quality. It is a technique that may act alone or as an excellent adjunct to conventional therapies. Among the expected results are: improved microcirculation and reduction of edema, improvement of cell nutrition and elimination of toxins, reduction of localized fat, improvement of elasticity and skin tone (smoother and regular), reduction of measures and body remodeling (Brandi et al., 2001., Corassa et al., 2006, Varlaro et al., 2007, Ferreira et al., 2008; Lee, 2010) 14 Instruções de Uso ARES 1ª edição 12/2009 PHYSIOLOGICAL EFFECTS EXPECTED “IN LOCO” AFTER THE INFUSION OF CO2 Arteriovenous vasodilatation; Increasing of volume and speed of the local blood flow; Increasing of the blood and the lymphatic drainage; Promoting the elimination of toxins; Improvement in tissue nutrition; Bohr Effect increase (the increase of local CO2 increases the hemoglobin affinity for CO 2 which will be loaded and decreases the affinity for CO2, released to the tissue. Lipolysis due to the increase of local metabolism. GENERAL INDICATIONS FOR ARES CARBOXITHERAPY Facial Rejuvenation Gynoid Lipodistrophy (cellulite) Localized fat: facial and body Stretch marks Skin flabbiness: body and facial Pre and post operative of lipoaspiration Dark circles Plastic and esthetic surgery (promotes the healing process) Alopecy Psoriasis Varicose ulcers Peripheral arteriopathy Microangiopathy Sports Medicine Erectile dysfunction associated with microangiopathy. CONTRAINDICATIONS OF ARES CARBOXITHERAPY Pregnant women Cardiac or respiratory failure Renal and hepatic failure Diabetics 15 Instruções de Uso ARES 1ª edição 12/2009 Psychological problems Epileptics Hipertensives with decompensated Systemic erithematosis lupus Imunodepressive patients Coagulation disorders Collagen diseases Abnormally increased local circulation o Facial Rosacea o Poikiloderma of Civatte POSSIBLE TRANSITORY SIDE EFFECTS Hyperemia and increased local temperature: these reactions occur due to increased local blood flow and ceases in a few minutes. Local Crepitation: usually a painless sensation which may occur after insufflation and is caused by the presence of gas within the subcutaneous tissue, if the tissue is palpated and it may last approximately one hour. Local discomfort sensation: The patient may experience a feeling of local discomfort and pain, however it is a light feeling and it disappears in 24 hours. Bruising and/or ecchymosis: it may occur if during the puncture there is a split of microvases. Heaviness sensation and local volume increase: temporary sensation caused by infusion that can affect patients in general.. 16 Instruções de Uso ARES 1ª edição 12/2009 REFERENCES ABU-RAFEA, B.; VILOS, G.A.; VILOS, A.G.; HON, B.S. HOLLETT-CAINES, J.; AL-OMRAN, M. Effect of body habitus and parity on insufflated CO2 volume at various intraabdominal pressures during laparoscopic access in women. Journal of Minimally Invasive Gynecology (2006) 13, 205–210. BRANDI, C.; D’ANIELLO, C.; GRIMALDI, L.; BOSI, B.; DEI, I.; LATTRULO, P. Carbon dioxide therapy in the treatment of localized adiposities: clinical study and histopathologocial correlations. Aesthetic Plast Surg. 2001; 25:170-174. CORASSA, J.M.; PEREIRA, F.L.C.; PENHA, R.M.; CORASSA, M.P. Uso da carboxiterapia no tratamento de distúrbios vasculares: resultados preliminares. Revista de Angiologia e Cirurgia Vascular, n 5, 2006. FERREIRA, J.C.; HADDAD, A., TAVARES, S. Increase in collagen turnover induced by intradermal injection of carbon dioxide in rats. J Drugs and Dermatology. 2008; 7 201-206. GUYTON, A.C.; HALL, J.E. Tratado de Fisiologia Médica, 12ª ed, Guanabara- Koogan, 2011, Rio de Janeiro RJ. MULIER, J.; DILLEMANS, B.; CROMBACH, M.; MISSANT, C.; SELS, A. On the abdominal pressure volume relationship. The Internet Journal of Anesthesiology. 2009 : 21( 1). NARDELLI, L.; ROCCO, P.R.M.; GARCIA, C.S.N.B. Controvérsias acerca da acidose hipercápnica na síndrome do desconforto respiratório agudo. Rev Bras Ter Intensiva. 2009; 21 (4):404-415. OCHIAI R.; TAKEDA, J.; NOGUCHI, J.; OHGAMI, M.; ISHII, S. Subcutaneous Carbon Dioxide Insufflation Does Not Cause Hypercarbia During Endoscopic Thyroidectomy. Anesth Analg 2000; 90:760–2. SIMÃO, J.R.; GUILLAMOUN, T. Estudo angiográfico de fístula arteriovenosa utilizando gás carbônico como meio de contraste*. Radiol Bras. 2004, 37: 397-403. TORTORA, G.J. ; GRABOWSKI, S.R. Princípios de Anatomia e Fisiologia. 9ed. Rio de Janeiro: Guanabara Koogan, 2002. VIEGAS, C.A. Gasometria arterial. J Pneumol 28(Supl 3) – 2002 S233-S238. 17 Instruções de Uso ARES 1ª edição 12/2009 RESPONSABILITY FOR USING ELECTROMEDICAL EQUIPMENT The use of electromedical equipment is restricted to a physician or someone under his /her supervision, to physiotherapists and other health care professionals appropriately licensed. This professional will be responsible for the use and operation of the equipment. IBRAMED makes no representation concerning laws and federal, state or local law which can be applied to the use and operation of any electromedical equipment. The physician or someone under his/her supervision, even the physiotherapist or any other licensed health care professional assumes full and total commitment to get in contact with the local certifying agencies to determine any credential required by law for the clinical use and operation of this equipment. PROFESSIONAL TRAINING ARES was developed to be operated by trained professionals regarding their handling and their clinical applications. Physicians, technical personnel and other team members of the medical clinic and nurses, physiotherapists, biomedical or other appropriately licensed health professionals are included. IBRAMED offers training for ARES. At the end of this training, the participants will be able to operate the equipment. 18 Instruções de Uso ARES 1ª edição 12/2009 CONTROLS, INDICATORS AND CONNECTIONS Figure 1. Upper view of ARES. Figure 2. Rear view of ARES. 19 Instruções de Uso ARES 1ª edição 12/2009 Figure 3. Front view of ARES. Figure 4. Lower View of ARES 20 Instruções de Uso ARES 1ª edição 12/2009 Figure 5. Rear view of ARES with cabinet. 1- On/off power switch. 2- Luminous indicator showing that the equipment is “turned on”. 3- BACK and NEXT control keys. 4- SET+ and SET- control keys. 5- Alpha numerical liquid crystal display. 6- The same key has two functions: START – start the treatment. STOP – stop the treatment. 7- PROG/MENU control keys – this key has two functions: program selection (treatment protocols) and menu. Thus, according to the function, we can call it PROG. key or MENU key. 8- Gas CO2 flow control. 21 Instruções de Uso ARES 1ª edição 12/2009 9- Luminous indicator (yellow) of gas output. 10- Connection to plug in the pedal. 11- CO2 input connection. 12- CO2 output connection. 13- Power cable connection to be connected to the local power grid. See chapter ARES – Electrical feed. 14- Fuse rack – See chapter ARES – Electrical feed. 15- Tag with the characteristics of the line voltage. 16- Tag with the technical characteristics of ARES. 17- Serial number tag. 18- Caution tag. 19- Cabinet (wheeled cart) of ARES equipment for the CO² cylinder to be fastened. Gabinete (carrinho) do equipamento ARES para fixação do cilindro de CO2. 20- CO2 cylinder (must be acquired separately). 21- CO2 gas flow regulator. 22- CO2 cylinder pressure regulator. Set Volume: Choice parameter for CO2 volume, in mL per point. Adjustable from 5 to 200 mL or “free” mode in which the gas is released in a continuous way, according to the flow velocity chosen in FLOW parameter. Flow: CO2 flow velocity during the infusion, adjustable from 5 to 200 mL/min. Volume: Total volume of gas meter, in mL, used during the session. 22 Instruções de Uso ARES 1ª edição 12/2009 Pedal: Choice parameter to turn on (ON) or turn off (OFF) the activation of CO2 releasing by the equipment (it replaces the START/STOP key). We suggest that you always use the pedal; that avoids the operator hands to be in contact with the equipment panel during the application, thus preventing contamination risks. Heating: option parameter to turn on (ON) or turn off (OFF) heating. We always recommend you to turn on the gas heating; it minimizes the discomfort and improves patient adherence to treatment, besides favoring vasodilatation which improves the results. Timer: CO2 release time progressive meter. It also allows a reference regarding the time duration of session. START and STOP: Key used for: START – start the treatment. STOP – stop the treatment. It is a dual function key and is also used to zero the parameters values used in the previous session, for that, press the key for 3 seconds. Always press the center of the key. BACK and NEXT: Control keys are used to select the necessary parameters to the treatment. When pressing the NEXT key you will forward to the other parameter. When pressing the BACK key you will return to the previous parameter. Note that whenever a selection is made through the BACK and NEXT keys, the selected parameter will start flashing. SET + and SET - : Keys used to the choice of the values of each parameter necessary to the therapy. SET + growing values. SET decreasing values. PROG./MENU: Dual function key: program selection from 1 to 10 (records of treatment particular protocols) and menu function. 23 Instruções de Uso ARES 1ª edição 12/2009 INTENSITY: When the application starts this key allows the increase or reduction of the gas flow velocity in real-time. CO2 OUTPUT: luminous indicator of gas output. When the indicator is lit, it shows the effective flow output of CO2 from the system. OPERATION INSTRUCTIONS All the parameters are programmed by touch keyboard and indicated on liquid crystal display (Figure 6). Below follows the description and the necessary steps to operate the equipment. Figure 6. Liquid crystal display of ARES. 1st STEP: Connect ARES into the on/off power switch. Right after the equipment is connected, the presentation will appear (figure 7). Figure 7. Sequence of events displayed on the liquid crystal display when ARES is connected. Next, the following question appears on the liquid crystal display: “DRAIN SYSTEM?” YES or NO (Figure 8). 24 Instruções de Uso ARES 1ª edição 12/2009 Figure 8. Option of system drainage offered by ARES. This question will be displayed every time the equipment is connected. For YES press the BACK key. This procedure should be made whenever the gas cylinder is installed for the first time, when gas refilling is done or by any other reason which had been necessary to disconnect the equipment from the gas cylinder. Draining the system means to replace all the ambient gas from the system by medical CO2 contained in the cylinder; thus, avoiding operational mistake. Draining the system only once is enough to assure the replacement; then, whenever you connect the equipment again and the question is displayed, just answer NO by pressing the NEXT key. 2nd STEP: Next, the second question is displayed “DRAIN HOSE?” (Figure 9). This question should be answered YES by pressing the BACK key, whenever you replace the hose, i.e., when starting the treatment with a new patient. The drainage of the hose is the removal of the ambient air contained inside the tube and its replacement for CO2, this way, avoiding application mistakes. All the programmed data in the equipment, including the CO2 volume used in the session and the gas effective emission time are zeroed. After this procedure, ARES is effectively ready to the next treatment session. Figure 9. Sequence of events displayed on the liquid crystal display when draining ARES hose. If you have finished draining the system, also answer NO by pressing the NEXT key. If, for any reason, you have interrupted the treatment, by disconnecting the equipment and then decide to continue the treatment with the same patient, answer NO by pressing the NEXT key. 25 Instruções de Uso ARES 1ª edição 12/2009 If the choice is YES, (press BACK) the accumulated volume (VOLUME) and the gas infusion time (TIMER) will be zeroed. If the choice is NO, the following question will appear on the display: “ZERO OUT VOLUME?”, if the answer is NO (press NEXT), the values are kept the same and the functions return to the previous condition so that the treatment in progress can be continued. Note: For system drainage and/or hose drainage, the needle should not be connected to the hose. 3rd STEP: The treatment parameters are programmed by touch keyboard and shown on the alphanumerical liquid crystal display (Figure 10). Observe that the cursor remains “flashing” when the parameter is active, i.e., ready to be programmed. The control keys BACK and NEXT are used to forward and return through parameters and the control keys SET+ and SET- are used to increase or reduce values or to connect or disconnect the functions of the pedal and the equipment gas heating. Figure 10. “Default” values which are shown on the liquid crystal display to start ARES programming. 4th STEP: Enable the parameters, Pedal (ON) and the parameter Heating (ON) (Figure 11). A B OFF OFF ON ON Figure 11. Illustrative images that indicate the pedal and heating parameters: A, “OFF”, turned off and B, “ON”, turned on. 5th STEP: Insert the desired values for the therapy in the fields SET VOLUME and FLOW necessary to the therapy. 26 Instruções de Uso ARES 1ª edição 12/2009 6th STEP: The key START/STOP has dual function, when the equipment is programmed, just press the key to start the gas output of ARES system and by pressing the key again when using the equipment, it stops the gas emission. If preferred by the operator, the pedal can be used instead of the key. Thus, when activating the key START or PEDAL (when the pedal function is turned on), the process of releasing or stopping the gas flow will be started. Right after the release of CO2 by the equipment is started, the luminous indicator of CO2 gas OUTPUT will light up; that means the effective CO2 flow output of the system. In the function INTENSITY, the UP and DOWN keys allow to increase (UP) or reduce (DOWN) the gas flow velocity in mL/min in real-time, i.e., during the infusion procedure, without the need to stop the system to correct (increase or reduce) this parameter. Note: We suggest that the procedure to prepare the patient should be done before turning on and program the equipment. PROG./MENU Key The control key PROG./MENU has dual functions: program selection (treatment particular protocols) and menu. Therefore, according to its function, we can call it PROG key or MENU key. The first is displayed when we briefly press the key. This way, we have access to a system of parameters programming record, i.e., ARES carboxytherapy system allows to record protocols called particular protocols. The second is activated when we press the key for 3 seconds, in this case, the following language option is offered: Portuguese, Spanish and English. 1- Functioning as PROG key This PROG key is used to select treatment protocols, i.e., ready programs which are memorized in the equipment. To program the protocols, after pressing the key briefly, select one of the particular protocols from 1 to 10, go back to the previous key (pressing PROG/MENU again); enter the values in the parameters set volume and flow and press START/STOP. The selected parameters will be recorded in the system and can be accessed whenever it is necessary. ARES can store up to 10 particular treatment protocols. Whenever a protocol is accessed and its parameters have been altered, the key START/STOP should be pressed so that the last entered data is stored in the equipment memory when it is turned off. This way, for example, it is possible to build up personalized protocols and use them whenever is appropriate. 2- Functioning as MENU key This MENU key is used to select the language of the text which is shown on the liquid crystal display. There are three options of languages: Portuguese, English or Spanish. After selecting the language through the keys SET+ and SET-, just press the key PROG/MENU again so that the selection is registered. 27 Instruções de Uso ARES 1ª edição 12/2009 After this procedure, the equipment will restart automatically. Whenever ARES is connected, the last selected language will be executed. CO2 CYLINDER INSTALLATION To acquire your gas cylinder call: White Martins 0800- 709-9000 (ideal weight for ARES cabinet: 4,5 kg). After acquiring the cylinder, prepare the cylinder and CO2 regulating valve installation. ARES cabinet has a compartment to store both the cylinder and the regulating valve. Prepare the gas cylinder and the pressure regulating valve as follows: Remove the cylinder protection cap and keep it in a safe place; thus, whenever it is necessary to refill the gas, the company responsible for the service will only transport the cylinder with the cap. Get the sealing ring and put it between the pressure regulator and the cylinder gas output. Screw the regulating valve nut to the cylinder gas output screw thread with both hands. Next, check if the manometer is in a position which favors the daily visualization of its indicator needle and finally with the aid of a spanner tighten one to the other firmly. Now connect the cylinder gas conductive hose to the equipment; to do this just press firmly one of the ends of the hose into the connector of the adapter gas output which is fixed to the pressure regulator valve. This connector, as well as the equipment gas input connector has fast-coupling system. If it is necessary to uncouple the hose, just press the blue ring towards the connector and turn the hose simultaneously in the opposite direction, this way it is released. Attention: never pull the hose from the fast-coupling system strongly without pressing the ring in order to avoid permanent damages to its locks. Open the cabinet rear door and remove it. Place the cylinder together with the regulator inside the cabinet. Attach the cylinder with the fixation belts, keep the door open until you finish all the installation, including the leak testing and valve opening of the cylinder gas output. To finish ARES assembling, place the device on the cabinet, pull the hose through the upper hole of the cabinet rear cover and connect the hose against the gas input connector in the equipment. Connect the pedal and the detachable power cable in their respective connections. 28 Instruções de Uso ARES 1ª edição 12/2009 Now, just open the gas cylinder valve turning it anti-clockwise until one turn is fully completed. For safety reasons, the cylinder gas output valve should be always closed at the end of the work day and opened again when necessary. LEAK TESTING Make the leak testing right after the gas cylinder installation and also periodically. Check if the cylinder register is opened and if the hoses are connected. With brush, water and soap, check if there is not leaking in the system. For that, just apply the foam that was formed on the tip of the brush over the connectors and the cylinder valve; observe if there is formation of gas bubbles. If it occurs, press the blue hose connectors again with your hands and the pressure valve nut with the spanner. Check again if there is leaking. After the procedure, dry the connections with paper towel. Close the cabinet rear door and finally plug the equipment into the local power grid. ARES is bivolt. Thus, it commutes the voltage automatically. After that, just press the on/off key to connect the equipment. So, your ARES carboxytherapy system is ready to be programed. Cylinder refill The cylinder manometer does not work as a symmetrical gas meter, i.e., every time the gas is consumed the indicator needle goes down; it keeps constant whenever there is CO2 in liquefied form. When the CO2 in liquefied form finishes, and there is only CO2 in gaseous form left, the cylinder will start to depressurize and manometer indicator needle will go down quickly. When the indicator needle is at 40 kgf/cm2, it is necessary to change the cylinder. 29 Instruções de Uso ARES 1ª edição 12/2009 ACCESSORIES ACCOMPANYING ARES The accessories and cables used with ARES are in conformity with the electromagnetic compatibility prescriptions for emissions and immunity. THE ACQUISITION OF GAS CYLINDER, AS WELL AS ITS PERIODIC REFILLING WITH MEDICAL CO2, ALSO KNOWN AS GRADE OR USP PATTERN, NECESSARY TO ARES FUNCTIONING, SHOULD BE MADE THROUGH SPECIALIZED COMPANIES. FOR SUGGESTIONS OF COMPANIES, PLEASE, SEE THE INSTRUCTIONS FOR USE OF YOUR EQUIPMENT. The use of accessories and cables different from the ones for which the equipment was designed can significantly damage the performance of emissions and immunity. List of accessories, cable and its length, designed with ARES equipment, to meet the requirements of electromagnetic compatibility: Code Quantity Product C-015 K-784 01 01 Detachable power cable Pedal for remote activation List of the other accessories that do not affect the requirements of electromagnetic compatibility: Code Quantity Product No code G-072 No code R-161 E-252 01 01 01 01 10 Gas cylinder connection hose of the equipment Cabinet Instructions for use CD Pressure regulating valve Detachable hoses for CO2 application The use of accessories and cables different from the ones for which the equipment was designed can significantly damage the performance of emissions and immunity. Thus, DO NOT USE accessories and cables of ARES equipment in other equipment or electromedical systems. The accessories and cables described in these instructions for use are designed and manufactured by IBRAMED to be used only with ARES equipment. ENVIRONMENTAL PROTECTION 30 Instruções de Uso ARES 1ª edição 12/2009 ARES is an electronic equipment and contains heavy metal like lead. So, there are contamination risks to the environment associated with the elimination of this equipment and accessories at the end of their useful lives. ARES, its parts and accessories should not be eliminated as urban waste. Contact the local distributor to have information about rules and laws regarding the elimination of electrical wastes, electronic equipment and their accessories. EQUIPMENT AND ITS ACCESSORIES CLEANING To clean the cabinet and its parts, use only soft, dry and clean fabric. Do not use volatile substances (benzene, alcohol, thinner and solvents in general) to clean the cabinet as they may damage its finishing. After using the applicators, clean them with running water. If it is necessary to disinfect them use only cotton moistened with gluconate chrorhexidine 0,5%. MAINTENANCE, WARRANTY AND TECHNICAL ASSISTANCE MAINTENANCE We suggest that the user makes an inspection and a preventive maintenance in IBRAMED or in our technical authorized service centers every 12 months of equipment utilization. As a manufacturer, IBRAMED is responsible for the technical characteristics and safety of the equipment only when the unit was used according to the usage instructions contained in the owner’s manual, where maintenance, repairs and modifications have been made by the manufacturer or expressly authorized service centers. In case of components which can cause safety and operation risks to the equipment we are only responsible to the ones that have been changed by original spare parts. If required, IBRAMED can provide technical documentation (circuit diagrams, manufacturer parts and components list, etc.) necessary to possible repair of the equipment. We will not be held liable for repairs made without our prior explicit written authorization. WARRANTY IBRAMED, Medical Equipment Brazilian Industry Ltd., here identified to the consumer through the following address and telephone number: Av. Dr. Carlos Burgos, 2800, Jd Itália, Amparo/SP; tel.: (19) 3817 9633 gives a product-warranty for eighteen (18) months, since the conditions of warranty terms are followed by the user as follows below. 31 Instruções de Uso ARES 1ª edição 12/2009 WARRANTY TERM 1) Your IBRAMED product is guaranteed against manufacturing defects for 18 continuous months, whenever the established conditions presented in these instructions for use are considered. 2) The warranty period starts on the date of purchase only to the first consumer purchaser, even if the product is transferred to a third party. The warranty will cover the replacement of component parts and labor to repair defects whenever it is possible to determine the presence of manufacturing defect. 3) The customer service during the warranty period will be made exclusively at IBRAMED sale point, by IBRAMED itself or another one designated by the manufacturer. 4) The warranty will not cover damages caused to the product resulting from: a) Failure to follow the specifications and recommendations of these instructions for use during installation or use of the product. b) Accidents or natural agents, connections to electrical system with inappropriate voltage and/or subject to excessive fluctuation or overcharge. c) The equipment had suffered bad use, lack of care, or also alterations, modifications or repair made by people or entities not authorized by IBRAMED. d) Removal or adulteration of the serial number of the equipment. e) Transport acidentes. 5) The legal warranty does not cover: expenses with the installation of the product, transport of the product to the plant or sale point, expenses with labor, materials, pieces and adaptations necessary to the preparation of the local to the installation of the device, such as electric net, masonry, hydraulic network, grounding system, as well as their adaptations. 6) The warranty does not cover pieces subjected to natural wear, such as control buttons, control keys, handles and moving parts, crystal peeling pen and its tips, diamond peeling pen and its sandpaper, body suction cup applicators, face and body glass suction cup applicators, cabinets of the device. 7) The selling points are neither authorized to alter the conditions mentioned in this document nor take any commitment on behalf of IBRAMED. 32 Instruções de Uso ARES 1ª edição 12/2009 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 - Modifications in this equipment are not allowed. Unauthorized modification may affect the safe operation of this equipment. - Never make any unauthorized repairs under any circumstances. TROUBLESHOOTING What initially seems like a problem is not actually a defect. So, before calling the technical assistance, check the items described in the table below: Problems The equipment does not turn on 1. Solution Is the Power cable properly connected? If it is not, it is necessary to connect it. Also check the socket on the wall. The equipment does not turn on 2. Have you checked the safety fuse? Check if there is not a bad contact. Also check if the value is correct as stated in the operating manual. The equipment is connected, but it does Have you followed the recommendations and instructions of not emit gas to the patient 1. the manual correctly? Check them and repeat the steps indicated in the item about controls, indicators and instructions for use. The equipment is connected, but it does Have you checked the gas cylinder connections? not emit gas to the patient 2. Check if the gas cylinder is not empty. 33 Instruções de Uso ARES 1ª edição 12/2009 TECHNICAL CHARACTERISTICS ARES is an equipment designed for continuous operation mode. It uses technology which assures accuracy of the shown values. ARES is CLASS II monophasic equipment with applied part type BF of security and protection. The equipment is not protected against dripping water (classification IPX0). Power: 100 - 240 volts 50/60 Hz. Input power - Consume (max.): 40 VA Temperature for transportation and storage: 5oC a 50 oC Work environment temperature: 5 oC a 45 oC Possible volumes and flow velocity: Volume (mL) Flow velocity (mL/min) Free 5 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 5 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 -----34 Instruções de Uso ARES 1ª edição 12/2009 Dimensions (mm): 265 x 275 x 115 (W x D x H) Weight (approximately without accessories): 1,4 kg Maximum stacking: 5 boxes Note: The device and its features may change without previous notice. ELECTROMAGNETIC COMPATIBILITY ARES was developed to meet the requirements on the IEC 60601-1-2 standard of electromagnetic compatibility. The purpose of this standard is: To ensure that the level of spurious signals generated by the equipment and radiated to the environment are below the limits specified on the IEC CISPR 11 standard, group 1, class A (Radiated emission). To ensure the equipment immunity against the electrostatic discharge by contact and by air, resulting from the accumulation of electrostatic charges obtained by the body. (Electrostatic Discharge - IEC 61000-4-2 To ensure the immunity of the equipment when subjected to an electromagnetic field incident from external sources (RF Radiated immunity - IEC 61000-4-3). Precautions: ARES complies with technical standards on electromagnetic compatibility and must be installed according to the information provided in this instruction manual. The short distance operation (1 meter, for example) of a therapy device for short waves or microwaves can produce instability in the output of the device. ARES complies with technical standards on electromagnetic compatibility when used with cables and other accessories provided by IBRAMED, as described in these instructions for use (chapter: Accessories accompanying ARES). The use of cables and other accessories from other manufacturers and/or different from those specified in these instructions for use, as well as the replacement of internal components of ARES may result in increase of emissions or reduction of immunity of the equipment. Radiofrequency communication equipment, mobile or portable, can cause interference and affect the functioning of ARES. Always install this equipment as described in these instructions for use. ARES should not be used adjacently or stacked onto other equipment 35 Instruções de Uso ARES 1ª edição 12/2009 Manufacturer’s guidelines and declaration – electromagnetic emissions ARES 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 such an environment. Emission test Conformity RF emissions NBR IEC CISPR 11 IEC CISPR 11 Group 1 Electromagnetic environment - guidelines ARES emits RF energy only for its internal functions. However, its RF emissions are very low and it is not likely to cause any interference in nearby electronic equipment. RF emissions NBR IEC CISPR 11 IEC CISPR 11 Class A Harmonic emissions Class A IEC 61000-3-2 Emissions due to tension fluctuation/ scintillation ARES is suitable to be used in all kinds of places other than residential and which are not directly connected to the public distribution of low voltage which supplies the domestic buildings. Class A IEC 61000-3-3 36 Instruções de Uso ARES 1ª edição 12/2009 Manufacturer’s guidelines and declaration – Electromagnetic immunity ARES is destined to be used in the electromagnetic environment specified below. The user of the equipment should ensure that it is used in such an environment. Test Level IEC 60601 Immunity test Electrostatic discharge (ESD) Conformity Level 6 kV by contact 6 kV by contact 8 kV by air 8 kV by air 2 kV in the feeding lines 2 kV in the feeding lines 1 kV in the input / 1 kV in the input / output lines output lines Electromagnetic environment – guidelines Floor should be wooden, concrete or ceramic. If floors are covered with synthetic material, the relative humidity should be at least 30%. IEC 61000-4-2 Fast electric transitory / pulse train (Burst) The quality of power supply should be that of a typical hospital or commercial environment. IEC 61000-4-4 1 Outbreaks kV differential mode IEC 61000-4-5 2 kV common mode 1 kV differential mode 2 kV common mode The quality of power supply should be that of a typical hospital or commercial environment. 37 Instruções de Uso ARES 1ª edição 12/2009 Test Level IEC 60601 Immunity test < 5% U T (> 95% voltage drops in U T ) by 0,5 cycle 40% U T Voltage drops, short interruptions and voltage variations in power input lines (60% voltage drops in IEC 61000-4-11 (30% voltage drops in U T ) by 5 cycles 70% U T U T ) by 25 cycles < 5% U T (> 95% voltage drops in U T ) by 5 seconds Magnetic field at power frequency (50/60 Hz) 3 A/m Conformity Level Electromagnetic Environment Guidelines < 5% U T (> 95% voltage drops in U T ) by 0,5 cycle 40% U T (60% voltage drops in U T ) by 5 cycles 70% U T (30% voltage drops in U T ) by 25 cycles The quality of power supply should be that of a typical hospital or commercial environment. If the user's equipment requires continued operation during power failure, it is recommended the equipment be powered by an uninterruptible power supply or battery. < 5% U T (> 95% voltage drops in U T ) by 5 seconds 3 A/m IEC 61000-4-8 Magnetic fields at power frequency should be at levels characteristic of a typical location in a typical hospital or commercial environment. NOTE: U T is the c.a. supply voltage c.a. before applying the test level 38 Instruções de Uso ARES 1ª edição 12/2009 Manufacturer’s guidelines and declaration – Electromagnetic immunity ARES is destined to be used in the electromagnetic environment specified below. The user of the equipment should ensure that it is used in such an environment. Immunity Test Test Level IEC 60601 Electromagnetic environment Guidelines Conformity Leval Communication equipment of RF portable and mobile should not be used near any part of ARES, including cables with separation distances smaller than the recommended, calculated from the equation applicable to the transmitter frequency. Recommended separation distance: d = 1,2 d = 0,35 Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3V Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2,5 GHz 10 V/m d = 0,7 P P 80 MHz to 800 MHz P 800 MHz to 2,5 GHz Where P is the transmitter maximum nominal output power in watts (W) according to the transmitter manufacturer and d is 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, a be smaller b than the conformity level in each frequency range . Interference, marked with the following symbol, may occur around the equipment: NOTE 1: At 80 MHz and 800 MHz the higher frequency range is applied. NOTE 2: These guidelines may not be applicable to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths set by fixed transmitters, such as radio base stations, telephone (cellular / cordless) 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 intensity at the location where ARES 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 intensity must be less than 10 V / m. b b Over the frequency range from 150 kHz to 80 MHz, the field strength should be less than 10 V/m. 39 Instruções de Uso ARES 1ª edição 12/2009 Recommended separation distances between the communication equipment of RF portable and mobile and ARES ARES is destined to be used in electromagnetic environment in which RF disturbances are controlled. The user of the electrostimulator can help to prevent the electromagnetic interference by maintaining the minimum distance between the portable and mobile RF communication equipment (transmitters) and ARES, as recommended below, according to the maximum power of the communication equipment. Separation distance according to the frequency of the transmitter in m Maximum nominal power output of the transmitter W 150 KHz to 80 MHz d = 1,2 P 80 MHz to 800 MHz d = 0,35 P 800 MHz to 2,5 GHz d = 0,7 0,01 0,12 0,035 0,07 0,1 0,38 0,11 0,22 1 1,2 0,35 0,7 10 3,8 1,1 2,2 100 12 3,5 7 P For transmitters with a maximum nominal power output 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. Device: Serial number: ANVISA Registration (M.S.): Manufacturing date: Expiration date: 5 years Senior engineer: Maicon Stringhetta CREA - 5062850975 40 Instruções de Uso ARES 1ª edição 12/2009 CEFAI – IBRAMED CENTER FOR EDUCATION AND ADVANCED TRAINING IBRAMED equipment provides more than technology, it provides knowledge! Science is the differential value; it is effectively to take advantage of the benefits, to ensure the patient’s safety and thereby to maximize results. Accessing this knowledge is guaranteed via CEFAI (IBRAMED Center for Education and Advanced Training) whose goal is to provide technical and scientific support and up-to-date literature on the therapies and their applicability, always respecting the clinical criteria of the treatment choices. IBRAMED Scientific Committee acts in order to create scientific support for the development of new products and services and thus, all our equipment and actions are supported by the most recent studies published in major scientific journals in biology, health and science areas. CEFAI takes into account the personal and professional development of all its partners and customers and through the concept of "HOLD my HAND" invites students and professionals in the fields of physical rehabilitation, esthetics, dermatofunctional physiotherapy, and esthetic medicine to participate of its free courses, workshops, and the best Postgraduate Lato Sensu courses in the physical rehabilitation and esthetics areas. Special attention is given to those interested in visiting our structure. We'll be by your side to unconditional support for your professional development. We are happy to serve you! Contact – [email protected] 55 19 3817. 9633 Thanks, IBRAMED – A matter of respect! 41 Instruções de Uso ARES 1ª edição 12/2009 www.ibramed.com.br [email protected] (19) 3817-9633 IBRAMED - Indústria Brasileira de Equipamentos Médicos Ltda. Av. Dr. Carlos Burgos, 2800 - Jd. Itália - CEP 13901-080 - Amparo - SP Instruções de Uso ARES 1ª edição 12/2009 42