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Instructions Manual SONOPULSE III Therapeutic Ultrasound 1 and 3 MHz Manufactured by Ibramed - Indústria Brasileira de Equipamentos Médicos EIREILI. Made in Brazil ANVISA Nº 10360310024 edition (REV_07/2012...
TROUBLESHOOTING ..........71 EQUIPMENT............12 MAINTENANCE, WARRANTY TECHNICAL GENERAL EQUIPMENT CARE........13 SUPPORT.............71 SHIPPING DAMAGE........13 CEFAI – IBRAMED CENTER FOR EDUCATION AND INSTALLATION, CARE AND CLEANING....13 ADVANCED TRAINING.........74 ELECTROMAGNETIC COMPATIBILITY GUIDANCE..16 SPECIFICATIONS..........24 SYSTEM SPECIFICATIONS.......24 SPECIFICATIONS OF ULTRASOUND....25 NOMENCLATURE...........26 CONTROLS, INDICATORS AND CONNECTORS..26 DEFINITION OF SYMBOLS........29 ACCESSORIES USED...........31...
SYMBOL DEFINITIONS Below are the definitions of the symbols used on the equipment and throughout the instructions found in this manual. Understand these symbol and their definitions before operating this equipment. Caution! Refer to user manual. Combined therapy IN. CLASS II Electrical equipment. Off switch.
SYMBOLS DEFINITIONS CARTON Refer operating instructions Fragile. correct product use. This side up. Manufacturer’s name and address. Limits of temperature for storage and packaging in °C (Celsius Degrees). Keep away from the rain. Stacking up. Do not use if the packaging is damaged.
Volt Ampere SONOPULSE III screen..........32 Beam Non-Uniformity Ratio Figure 7. Application technique.........38 Figure 8. A, slot for combined therapy of SONOPULSE III; Minute B, connector cable for combined therapy......40 Figure 9. Application technique for combined therapy..41 Figure 10. Message of selection of language....42...
100 Hz, 48 Hz or 16 Hz, with pulse ratio of 1/2 (50%) or be updated at any time at the manufacturer’s discretion. Visit 1/5 (20%). SONOPULSE III has a PROG key, which allows our web site for updates.
• Check the cables and connectors before each use. infractions that could cause minor to moderate injury or • The SONOPULSE III stimulator is not designed to prevent damage to equipment. the penetration of water and other liquids. Penetration of...
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SAFETY PRECAUTIONS • In order to be protected from the risk of fire, use only spare • Patients with neurostimulation devices or implanted fuses of the same type and class. pacemakers must be distant from any shortwave diathermy, • Make sure the unit is grounded, connecting it to a grounded microwave diathermy, therapeutic ultrasound diathermy, power outlet in conformity with the applicable local and or laser diathermy and must not be treated with these on...
INDICATIONS AND PRECAUTIONS INDICATIONS • Professionals operating the device on a daily basis must not be exposed to therapeutic ultrasound. The applicators handles Therapeutic ultrasound is commonly indicated for: have been developed to allow the professional to protect • Pain relief the hands from ultrasound when performing underwater •...
CONTRA INDICATIONS AND ADVERSE REACTIONS CONTRA INDICATIONS ADVERSE REACTIONS • Therefore, therapeutic ultrasound should not be applied • Therapeutic ultrasound, when applied in continuous circular over the uterus unless specific assurance can be attained movements, may cause a sensation of numbness and/or from the patient that she is not pregnant.
POPULATION AND CONDITIONS OF USE PATIENT POPULATION • Patients over 12 years old, under this age only by medical • There are no admissible deficiencies for the use of the prescription or physiotherapeutic indication; equipment; • Patients over 35 kg, under this weight only by medical •...
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.
SHIPPING DAMAGE INSTALLATION, CARE AND CLEANING Installation Instructions Your SONOPULSE III is shipped complete in one carton. Upon receipt, inspect carton and unit for visible and hidden 1. Connect the line cord to the back of the SONOPULSE damage. In case of damage, keep all shipping materials III.
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ENVIRONMENTAL PROTECTION • Avoid areas subject to vibrations. The SONOPULSE III is an electronic device and has heavy • Install the equipment on a firm and level surface, in open metals such as lead. Thus, there are risks of contamination air.
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• Maintenance and technical assistance of SONOPULSE III must always be performed at unauthorized service, only by In the rear part of SONOPULSE III there is a protection fuse. qualified technicians. To replace it, turn the device off the power supply line...
To prevent electromagnetic interference, we suggest that one • SONOPULSE III equipment is intended for use only by group of power supply line is used for SONOPULSE III and health care professionals. The SONOPULSE III may cause another separate group is used for short wave or microwave radio interference or disrupt equipment operations nearby.
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ELECTROMAGNETIC COMPATIBILITY GUIDANCE Manufacturer’s guidelines and declaration – Electromagnetic emissions SONOPULSE III 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...
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ELECTROMAGNETIC COMPATIBILITY GUIDANCE Manufacturer’s guidelines and declaration – Electromagnetic immunity SONOPULSE III 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 Test level Conformity level Electromagnetic environment –...
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ELECTROMAGNETIC COMPATIBILITY GUIDANCE Immunity Test level Conformity level Electromagnetic environment -orientations test IEC 60601 < 5% U < 5% U (> 95 % voltage drops (> 95% voltage drops in U ) by 0,5 cycle quality power supply should Voltage drops, in U ) by 0,5 cycle 40% U that...
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ELECTROMAGNETIC COMPATIBILITY GUIDANCE Manufacturer’s guidelines and declaration – Electromagnetic immunity SONOPULSE III 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. Conformity Immunity Test level Electromagnetic environment –...
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To assess the electromagnetic environment due to fixed RF transmitters, it is recommended an electromag- netic inspection on the place. If the measure of field strength at the location SONOPULSE III is used exceeds the conformity level used above, the unit must be observed to see whether the operation is normal. If an abnor- mal performance is observed, additional procedures may be needed, such as reorientation or replacement of the equipment.
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Recommended separation distances between the communication equipment of RF portable and mobile and SONOPULSE III SONOPULSE III 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, SONOPULSE III as recommended below, according to the maximum power of communication equipment.
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ELECTROMAGNETIC COMPATIBILITY GUIDANCE Equipment: Serial number: ANVISA Reg istration ( M.S.): Man ufacturing d ate: Expiratio n date: 5 years Senior engineeer: Mai con String hetta CREA - 5062850975...
SPECIFICATIONS SYSTEM SPECIFICATIONS Range of temperature during transportation and Dimensions storage: 5 - 50°C/ 41- 122°F. Width 10.6 in (27 cm) Depth 10.4 in (26.6 cm) Height 4.9 in (12.5 cm) Range of operational environment temperature: Standard Weight 1.4 kg 5 - 45 °C/ 41- 113 °F.
SPECIFICATIONS SPECIFICATIONS OF ULTRASOUND Frequency 1.1 MHz, ± 10% Note: The equipment in pulsed mode shows values of peak power, average values are 3.3 MHz, ± 10% equivalent to pulsed selected percentage, ex: Effective radiating area (ERA) 7 cm Continuous Mode Selected: Pulsed...
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NOMENCLATURE CONTROLS, INDICATORS AND CONNECTORS 1- ON/OFF switch. 9- Connection for combined therapy with other IBRAMED equipment. 2- Light Indicator of ON condition. 10- Output Connection of transducer to ultrasound. 3- SELECT control keys for selecting parameters. 11- Connection of power cable.
DEFINITION OF SYMBOLS Read and understand these symbols and their definitions before operating the equipment Switch used to start or stop treatment. Always press the center of the switch. Switch with double function: PROG – Selection of pre programmed protocols and private protocols;...
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DEFINITION OF SYMBOLS Read and understand these symbols and their definitions before operating the equipment SELECT: switch for the selection of ultrasound parameters. SET: switch: selection of values of parameters. UP and DOWN: switch: increase or decrease of intensity: 0.1 to 3.0 W/cm...
ACCESSORIES USED 1 and 3 MHz ULTRASOUND: Ultrasound transducer with ERA of 7 cm for frequency of 1 and 3 MHz, with neutral conductor gel. (Figure 5). The screws of the transducer connector must be firmly fixed to the device. Figure 5.
SONOPULSE III screen (Figure 6). Figure 6. A, presentation message; B, standard/default SONOPULSE III screen.
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OPERATION INSTRUCTIONS PREPARING THE EQUIPMENT Selection of parameters Initiating Treatment The SELECT switch allows you to select the parameters Press the START switch to necessary for the treatment. Press SELECT switch up or initiate treatment. down to move the indicating arrow to the next parameter or Stopping Treatment return to the previous parameter.
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TRANSDUCER PROTECTION MESSAGES TEMPERATURE SENSOR Inside the SONOPULSE III transducer there is a temperature sensor which verifies and maintains the work temperature of the piezoelectric crystal, and consequently, the aluminum face of the transducer, which avoids the disagreeable sensation of excessive heat to the patient.
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OPERATION INSTRUCTIONS TRANSDUCER PROTECTION MESSAGES EQUIPMENT WITHOUT TRANSDUCER If the equipment is without its transducer, as the intensity of ultrasound is increased, a protection circuit will be activated and the display will show: Just connect the transducer so that the message disappears and the equipment will return to its original program.
PROGRAMMING THE EQUIPMENT Example: Suppose the clinical practice or literature suggest 3. Press the UP or DOWN buttons to select the ultrasound particular pathology, following parameters: intensity necessary for treatment. 4. Now press the START key to initiate the treatment. After Frequency: 1 MHz press the START key, the transducer figure will appear on the Mode: Pulsed...
• Move the ultrasound transducer constantly during the session in circular moves. Examine the skin again after treatment. • BIOCOMPATIBILITY of the materials in contact with the patient (ISO 10993-1): A IBRAMED states that the ultrasound transducer and coupling gel provided with the equipment do not provoke allergic reactions. The transducer and gel must be only be placed in contact with intact surface of the skin, respecting duration limit time of this contact of 24 hours.
TECHNICS OF ULTRASOUND APPLICATION Position of the ultrasound transducer for the application with ERA of 7 cm (figure 7). Figure 7. Application technique with ERA of 7 cm...
Combined therapy may be performed by any electrostimulator of the NEURODYN line of IBRAMED equipment connected to SONOPULSE III by a special connection cable (black) inserted in the combined therapy slot in the frontal part of SONOPULSE III. This cable presents an alligator pin adaptor which is connected to the black banana pin in the electrostimulation cable in the NEURODYN line.
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NEURODYN line before proceeding to the combined therapy. The SONOPULSE III timer will control the time of ultrasound therapy, however, the same therapy time must be adjusted in the electrostimulator for the combined therapy. Press the START key in SONOPULSE III and in the electrostimulator to initiate the treatment.
COMBINED THERAPY USING SONOPULSE III APPLICATION TECHNIQUE FOR COMBINED THERAPY Position of the ultrasound transducer and the electrostimulation electrode for combined therapy (Figure 10) Figure 9. Application technique for combined therapy.
USING THE PROG/MENU KEYS USING THE MENU KEY USING THE PROG KEY SELECTION OF LANGUAGE SELECTION OF PROGRAMMED PROTOCOLS The MENU key is used to select the language. Press the Turn equipment described above. Press briefly the PROG key and press SET key to select the MENU key until you hear three sound beeps.
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USING THE PROG/MENU KEYS PROGRAMMING USER PROTOCOLS To program new protocols, press briefly the PROG button and press SET button to select the USER protocols. Using the SET button choose one of the 20 USER protocols available. Adjust the parameters according to the therapeutic needs and press START.
REFERENCES Amirez, A.; Schwane, J. A.; McFarland, C.; Starcher, B. The Mizrahi, N. Seliktar, D. Kimmel, E. Ultrasound-Induced effect of ultrasound on collagen synthesis and fibroblast Angiogenic Response in Endothelial Cells, Ultrasound in proliferationin vitro. Medicine & Science in Sports & Exercise Medicine and Biology November 2007;...
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REFERENCES Mortimer A.J. and Dyson, M. The effect of therapeutic Unsworth J, Kaneez S, Harris S, Ridgway J, Fenwick S, Chenery ultrasound on calcium uptake in fibroblasts. Ultrasound in D, Harrison A. Pulsed low intensity ultrasound enhances Medicine & Biology, Volume 14, Issue 6, 1988, Pages 499- mineralization in preosteoblast cells.
ACCESSORIES WHICH ACCOMPANY SONOPULSE III SONOPULSE III contains accessories conceived to satisfy the demands of electromagnetic compatibility - accessories coded 03017006 and 02049048. CODE QUANTITY DESCRIPTION OF ITEM 03017006 PP FEMALE CABLE IEC-2X0,75X1500MM 03019012 DIGITAL OPERATIONS MANUAL IBRAMED 100511 03026009...
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Therefore, DO NOT USE accessories, ultrasound transducer, cables and electrodes of SONOPULSE III in other equipment or electromedical systems. The accessories, electrodes and cables described in these instructions of use and manufactured by IBRAMED are for the sole use with SONOPULSE III equipment.
Therefore, before turning to technical assistance, For the safe use of the equipment, we recommended to have check the items described in the table below. it inspected and undergo preventive maintenance at IBRAMED or an authorized technical center every 12 months. PROBLEM...
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Removal or adulteration of the equipment serial number. e) Damage during Transport. 1) IBRAMED warrants that this product is free of manufacturing defects for eighteen (18) continuous months provided the set 5) The legal warranty does not cover: expenses incurred terms presented in these instructions for use are followed.
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7) The selling points are neither authorized to alter the conditions mentioned in this document nor to take any commitment on behalf of IBRAMED. TECHNICAL ASSISTANCE If you have any doubts or problems related to the operation of your equipment please contact our technical department.
CEFAI – IBRAMED Center for Education and Advanced Training IBRAMED Equipment goes beyond technology. It also provides Special attention is also given to those interested in visiting our knowledge! Science constitutes our differential value and we structure. Whatever your professional development needs, effectively take advantage of its benefits in order to ensure we’ll be right by your side to provide you with unconditional...
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IBRAMED Indústria Brasileira de Equipamentos Médicos EIRELI. Av. Dr. Carlos Burgos, 2800 - Jd. Itália 13901-080 - Amparo - SP - Brasil 19 3817 9633 www.ibramed.com.br ibramed@ibramed.com.br...