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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

)

Содержание SONOPULSE III

Страница 1: ...tructions Manual SONOPULSE III Therapeutic Ultrasound 1 and 3 MHz Manufactured by Ibramed Ind stria Brasileira de Equipamentos M dicos EIREILI Made in Brazil ANVISA N 10360310024 3th edition REV_07 20...

Страница 2: ...TIONS 24 SYSTEM SPECIFICATIONS 24 SPECIFICATIONS OF ULTRASOUND 25 NOMENCLATURE 26 CONTROLS INDICATORS AND CONNECTORS 26 DEFINITION OF SYMBOLS 29 ACCESSORIES USED 31 OPERATION INSTRUCTIONS 32 PROGRAMMI...

Страница 3: ...ese symbol and their definitions before operating this equipment Caution Refer to user manual Alternating Current TYPE BF Electrical Equipment Dangerous Voltage CLASS II Electrical equipment Protected...

Страница 4: ...side up Keep away from the rain Stacking up Do not use if the packaging is damaged Manufacturer s name and address Refer to operating instructions for correct product use Limits of temperature for st...

Страница 5: ...igure 3 Frontal view 27 Figure 4 Lower view 27 Figure 5 A Ultrasound transducer with ERA of 7 cm2 B neutral conductor gel 31 Figure 6 A presentation message B standard default SONOPULSE III screen 32...

Страница 6: ...MHz and 3 MHz designed to be usedforaestheticandphysiotherapytreatments SONOPULSE III allows the choice of ERA Effective Radiating Area of 7 cm2 making it possible to select the 1 MHz frequency with t...

Страница 7: ...NOPULSE III stimulator is not designed to prevent the penetration of water and other liquids Penetration of water and other liquids may cause malfunction of the internal components of the system and c...

Страница 8: ...len infected or inflamed areas or on skin eruptions such as phlebitis thrombophlebitis varicose veins etc Ultrasound treatment must not be applied on or next to cancerous lesions Patients with neurost...

Страница 9: ...applicators handles have been developed to allow the professional to protect the hands from ultrasound when performing underwater treatment If a patient complains of deep periosteal pain during ultra...

Страница 10: ...d on ischemic tissues where the blood supply may be incapable of following the increase in metabolic demand and result in necrosis Therapeutic ultrasound must not be applied over bone growth centers U...

Страница 11: ...e CONDITIONS OF USE There are no requisites about a maximum level of education for the intended use Regarding the minimum level of knowledge of the user it is necessary that the user knows the electro...

Страница 12: ...akes 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 ther...

Страница 13: ...e 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 SONOPULSE III was received is s...

Страница 14: ...tem in liquids Cleaning the SONOPULSE III The SONOPULSE III is an electronic device and has heavy metals such as lead Thus there are risks of contamination to the environment associated with the dispo...

Страница 15: ...es indicated by IBRAMED Use a fuse for nominal current of 5 0A operation tension of 250V and snap action model 20AG 50A rupture current SONOPULSE III does not need any type of power stabilizer Never u...

Страница 16: ...Electrical Devices As for the limits of electromagnetic interference SONOPULSE III is an electromagnetic device of Group 1 Class A The simultaneous connection from the patient to SONOPULSE III and to...

Страница 17: ...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 Class...

Страница 18: ...de 2 kV common mode Fast electric transitories pulse train Burst IEC 61000 4 4 The quality of power supply should be that of a hospital environment a or typical commercial building The quality of powe...

Страница 19: ...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 95 of voltage drops in U by 5 seconds The quality of power supply should be tha...

Страница 20: ...ecommended separation distance d 1 2 d 1 2 80 MHz to 800 MHz d 2 4 800 MHz to 2 5 GHz Where P is the maximum nominal output power in watts W according to the transmitter manufacturer and d is the reco...

Страница 21: ...cannot be predicted theoretically with accu racy To assess the electromagnetic environment due to fixed RF transmitters it is recommended an electromag netic inspection on the place If the measure of...

Страница 22: ...he 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 NO...

Страница 23: ...23 ELECTROMAGNETIC COMPATIBILITY GUIDANCE Equipment Serial number ANVISA Registration M S Manufacturing date Expiration date 5 years Senior engineeer Maicon Stringhetta CREA 5062850975...

Страница 24: ...STEM SPECIFICATIONS Dimensions Power 10 6 in 27 cm 10 4 in 26 6 cm 4 9 in 12 5 cm 1 4 kg Width Depth Height Standard Weight with transducer IEC 60601 1 IEC 60601 1 2 IEC 60601 2 5 IEC 60601 1 4 Range...

Страница 25: ...m2 BNR Crystal of 7 cm2 1 1 MHz 10 3 3 MHz 10 7 cm2 Continuous Pulsed 20 50 100 Hz 16 Hz 48 Hz 1 1 MHz 10 3 3 MHz 10 1 30 min 0 1 to 3 0 W cm 1 1 MHz e 3 3 MHz 21 W 20 3 Note The equipment in pulsed m...

Страница 26: ...26 NOMENCLATURE CONTROLS INDICATORS AND CONNECTORS Figure 1 Upper view Figure 2 Rear view...

Страница 27: ...27 NOMENCLATURE CONTROLS INDICATORS AND CONNECTORS Figure 3 Frontal view Figure 4 Lower view...

Страница 28: ...crease ultrasound intensity 8 Control keys PROG MENU PROG Selection of pre programmed protocols MENU Selection of language NOMENCLATURE CONTROLS INDICATORS AND CONNECTORS 9 Connection for combined the...

Страница 29: ...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 priva...

Страница 30: ...nd 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...

Страница 31: ...r with ERA of 7 cm2 B neutral conductor gel 1 and 3 MHz ULTRASOUND Ultrasound transducer with ERA of 7 cm2 for frequency of 1 and 3 MHz with neutral conductor gel Figure 5 A B B The screws of the tran...

Страница 32: ...ndicates the word Output This arrow indicates the parameter to be programmed B A Check if the power cable is connected to the power supply on the wall Press the ON OFF switch to the ON position The di...

Страница 33: ...rs Programming treatment time The intensity of ultrasound may be increased or decreased at any time during the session After pressing the START key press the UP or DOWN switch up or down respectively...

Страница 34: ...xceeds41 C During treatment particularly when the couplant gel used is not of superior quality the temperature may rise above 41 C When that happens the equipment will freeze the programmed time and t...

Страница 35: ...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...

Страница 36: ...own in the example 3 Press the UP or DOWN buttons to select the ultrasound intensity necessary for treatment 4 Now press the START key to initiate the treatment After press the START key the transduce...

Страница 37: ...tly 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 transduce...

Страница 38: ...38 TECHNICS OF ULTRASOUND APPLICATION Position of the ultrasound transducer for the application with ERA of 7 cm2 figure 7 Figure 7 Application technique with ERA of 7 cm2...

Страница 39: ...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...

Страница 40: ...combined therapy Press the START key in SONOPULSE III and in the electrostimulator to initiate the treatment The intensity of electrostimulation is adjusted in the electrostimulator whereas the intens...

Страница 41: ...USING SONOPULSE III Position of the ultrasound transducer and the electrostimulation electrode for combined therapy Figure 10 Figure 9 Application technique for combined therapy APPLICATION TECHNIQUE...

Страница 42: ...Next the information of the first treatment protocol of the equipment will appear on the display Use the SET key to select another protocol See protocols details in section CLINICAL RESOURCES LIBRARY...

Страница 43: ...protocols available Adjust the parameters according to the therapeutic needs and press START The last parameters defined will be recorded in the memory of the device To access the protocols saved by...

Страница 44: ...ent time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 2 1 MHz Rectus Femoris Injury Acute Phase Parameters values Frequency 1 MHz Mode P...

Страница 45: ...tment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 3 1 MHz Anterior Tibial Injury Acute Phase Parameters values Frequency 1 MHz Mod...

Страница 46: ...tment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 5 1 MHz Rhomboid Injury Acute Phase Parameters values Frequ ncia 1 MHz Mode Puls...

Страница 47: ...ent time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 7 1 MHz Femoral Biceps Injury Subacute Phase Parameters values Frequency 1 MHz Mod...

Страница 48: ...t time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocolo 9 1 MHz Anterior Tibial Injury Subacute Phase Parameters values Frequency 1 MHz Mod...

Страница 49: ...nt time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 11 1 MHz Rhomboid Injury Subacute Phase Parameters values Frequency 1 MHz Mode Puls...

Страница 50: ...or must calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 13 1 MHz Reduction of Muscle Spasm Deltoid Parameters...

Страница 51: ...t calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 15 1 MHz Reduction of Mus cle Spasm Thoracic Paraspinal Para...

Страница 52: ...calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocolo 17 1 MHz Reduction of the Muscle Spasm Rhomboid Parameters v...

Страница 53: ...ust calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 19 1 MHz Reduction of the Muscle Spasm Gastrocnemius Param...

Страница 54: ...late the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 21 1 MHz Reduction of the Muscle Spasm Rectus Femoris Parameters va...

Страница 55: ...calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocolo 23 3 MHz Plantar Fasciitis Chronic Phase Parameters values Fr...

Страница 56: ...lculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 25 3 MHz Iliotibial Syndrome Chronic Phase Parameters values Fre...

Страница 57: ...calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 27 1 MHz Trochanteric Bursitis Chronic Phase Parameters value...

Страница 58: ...treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 29 3 MHz Elbow Injury Acute Phase Parameters values Frequency 3 MHz Mode Pu...

Страница 59: ...cording to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 31 3 MHz Interphalangeal Joint Injury Acute Phase Parameters values Frequency 3 MHz Mode Puls...

Страница 60: ...time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 33 1 MHz Gluteus Medius Tendinopathy Acute Phase Parameters values Frequency 1 MHz Mo...

Страница 61: ...alculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocolo 35 3 MHz Ant Tibial Patellar Calcaneus Tendonitis Chronic Phas...

Страница 62: ...he operator must calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocolo 37 1 MHz Supraspinal Tendinopathy Chronic Ph...

Страница 63: ...ucer The operator must calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 39 3 MHz Elbow Joint Stiffness Paramete...

Страница 64: ...tor must calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocol 41 3 MHz Interphalangeal Joint Stiffness Parameters v...

Страница 65: ...ator must calculate the treatment time according to the size value of the treatment area divided by the value of the ERA of the transducer Protocolo 43 3 MHz Immediate Postoperative Parameters values...

Страница 66: ...th of the target tissue The treatment time depends of the size of the treatment area and the ERA Effective Radiating Area of the transducer The operator must calculate the treatment time according to...

Страница 67: ...Orthner E Ryaby JP Low intensity pulsed ultrasound Effects on nonunions Ultrasound Med Biol 2005 10 1391 1402 REFERENCES Mizrahi N Seliktar D Kimmel E Ultrasound Induced Angiogenic Response in Endothe...

Страница 68: ...oltani A and Roy R A Cavitational mechanisms in ultrasound accelerated fibrinolysis Ultrasound in Med Biol 2007 Vol 33 No 6 pp 924 933 ter Haar G Princ pios eletrof sicos In Eletroterapia de Clayton 1...

Страница 69: ...TION OF ITEM 03017006 01 PP FEMALE CABLE IEC 2X0 75X1500MM 03019012 01 DIGITAL OPERATIONS MANUAL IBRAMED 100511 03026009 01 SILICONE HEAD KIT WITH NTC 03040004 01 PROTECTION FUSE CARD 03019012 01 20AG...

Страница 70: ...in these instructions of use and manufactured by IBRAMED are for the sole use with SONOPULSE III equipment ACCESSORIES WHICH ACCOMPANY SONOPULSE III The replacement accessories are designed for use w...

Страница 71: ...curity 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...

Страница 72: ...over 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...

Страница 73: ...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 plea...

Страница 74: ...rapies 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 deve...

Страница 75: ...75 IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI Av Dr Carlos Burgos 2800 Jd It lia 13901 080 Amparo SP Brasil 19 3817 9633 www ibramed com br ibramed ibramed com br...

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