Manual - Ibramed
Contents
1. 32 PROGRAMMING THE EQUIPMENTT 36 DIRECTIONS ON ULTRASOUND 37 TECHNICS OF ULTRASOUND APPLICATION 38 COMBINED THERAPY USING SONOPULSE COMPACT o o o 39 USING THE PROG MENU KEYS 42 CLINICAL RESOURCES LIBRARY CLINICAL MECANICO oE ee EE EEE E 44 IN 57 ACCESSORIES WHICH ACCOMPANY SONOPULSE 59 ING s sssssssasa 61 MAINTENANCE WARRANTY AND TECHNICAL SUPPOR nee ee eee 61 IBRAMED CENTER FOR EDUCATION AND ADVANCED 64 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 COMBINE AY Caution Refer to user manual N Combined therapy IN CLASS II Electrical equipment Off Switch 1 Protected against dripping water On Switch PX7 Protected against the effects of immersion TYPE BF Electrical Equipment VV Stop treatment AN Dangerous Voltage Start treatment Alternating Current lt 1 Transducer SYMBOLS DEFINITIONS CARTON Fragil2. 43 FOREWORD This user manual allows the user to efficiently use the SONOPULSE Compact 1 MHz It also gives suggestions for treatment protocols so that you can use your equipment to its full potential Consult other resources for additional information regarding the uses of ultrasound before attempting any treatment on a patient Users must read understand and follow the information in this manual for each mode of treatment available as well as the indications contra indications warnings and precautions The specifications and instructions in this manual are in effect at the time of its publication These instructions may be updated at any time at the manufacturer s discretion Visit our web site for updates mo IBRAMED PRODUCT DESCRIPTION ESSENTIAL PERFORMANCE SONOPULSE Compact 1 MHz is a therapeutic ultrasound micro controlled device in the frequencies of 1 MHz designed to be used for aesthetic and physiotherapy treatments SONOPULSE Compact 1 MHz allows the choice of ERA Effective Radiating Area of 7 1 MHz frequency with the ERA 7 The average ultrasound output power is 21 Watts for the ERA of 7 cm therefore the maximum intensity is W cm The ultrasound emission mode can be adjusted to continuous or pulsed The pulsed mode has pulse repetition frequencies of 100 Hz 48 Hz or 16 Hz with pulse ratio of 50 1 5 20 or 1 10 10 SONOPULSE Compact 1 MHz also has a PROG key which allow
3. 5 50 C 41 122 F Depth 10 4 in 16 6 cm Height 4 9 in 12 5 cm Standard Weight 1 4 kg Range of operational environment temperature with transducer 5 45 C 41 113 OF Power Input 100 240 50 60 Hz Input power 100 VA Fuses 5A 250 20AG Fast Action Electrical Class CLASS II Electrical Protection TYPE BF Conformity Regulations IEC 60601 1 IEC 60601 1 2 IEC 60601 2 5 IEC 60601 1 4 24 SPECIFICATIONS SPECIFICATIONS OF ULTRASOUND Frequency 1 1 MHz 10 Note The equipment in pulsed mode shows values of peak power average values are Effective radiating area ERA 7 cm equivalent to pulsed selected percentage ex Mode Continuous Pulsed ected otency Work Cycle 20 50 Duty cycle 50 Frequency of pulse repetition 100 Hz 16 Hz 48 Hz Transducer of 7 1 1 MHz 10 Average Power 21 x 0 5 10 5 W Treatment time 1 30 min Output Power Crystal of 7 cm 0 1 a 3 0 W cm2 1 1 MHz Maximum Amplitude 7 21 W 20 BNR Crystal of 7 cm 3 25 Figure 1 Upper view Figure 2 Rear view 26 CONTROLS INDICATORS AND CONNECTORS Figure 3 Frontal view Figure 4 Lower view 2 CONTROLS INDICATORS AND CONNECTORS 1 ON OFF switch 12 General technical information 2 Light Indicator of ON condition 13 Protection fuse 3 SELECT control keys for selecting para
4. 41 USING THE PROG MENU KEYS USING THE MENU BUTTON USING THE PROG BUTTON SELECTION OF LANGUAGE SELECTION OF PROGRAMMED PROTOCOLS The PROG MENU key is used to select the language Turn the equipment on as described above Press briefly the Press the PROG MENU key until you hear three sound PROG key and press SET key to select the PROGRAMMED beeps Select the desired language Portuguese protocols Next the information of the first treatment Spanish or English Press the PROG MENU key protocol of the equipment will appear on the display Use again to define the chosen language figure 8 the SET key to select another protocol See protocols details in section CLINICAL RESOURCES LIBRARY A MENU If the first treatment protocol is the chosen protocol press the PROG key once more The display will show the parameters for the selected protocol including the 4Timer Emission ultrasound intensity Next select the therapy time using gt Mode Cont the SET key and just press the START key YPulse Freq Proceed on the same way to select any of the available protocols Just follow the steps described above Language English Figure 10 Message of selection of language 42 USING THE PROG MENU KEYS PROGRAMMING PARTICULAR PROTOCOLS To program new protocols press briefly the PROG key and press SET key to select the USER protocols Using the SET key choose one of the 20 USER protocols available Adjust the
5. _ B IBRAMED QUEST O DE RESPEITO Instructions Manual SONOPULSE Compact 1 MHz Therapeutic Ultrasound 1 MHz Manufactured by Ibramed Industria Brasileira de Equipamentos M dicos EIREILI Made in Brazil ANVISA N 10360310025 4th edition REV 07 2012 TABLE OF CONTENTS SYMBOL DEFINITION ssa aci irado ca nda raiado 3 CARTON raia 4 ABREVIATIONS GLOSSARY 5 FIGURES GLOSSAR perenne qan 5 PORE VOR 6 PRODUCT DESCRIPTION u uuu a Sakancagupusasaspakuaqa 6 ESSENTIAL PERFORMANCE 6 SAFETY PRECAUTIONS sia INDICATIONS AND PRECAUTIONS 9 CONTRA INDICATIONS AND ADVERSE REACTIONS 10 POPULATION AND CONDITIONS OF USE 11 RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT RR Bode Ess 12 GENERAL EQUIPMENT CARE 13 SMIPPING DAMAGE assinar assada 13 INSTALLATION CARE AND CLEANING 13 ELECTROMAGNETIC COMPATIBILITY GUIDANCE 16 SPECIPICANONS Rr 24 SYSTEM SPECIFICATIONS 24 SPECIFICATIONS OF ULIRASOUND 25 NOMENCLATURFE 26 DEFINITION OF SYMBOLS aa s nn 29 ACCESSORIES USED 31 OPERATION INSTRUCTIONS
6. 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 62 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 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
7. and the transducer material that it is made from do not provoke potential irritation on the skin 37 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 38 COMBINED THERAPY USING SONOPULSE COMPACT 1 MHZ The simultaneous therapeutic application of ultrasound and functional electrostimulation may be performed with SONOPULSE Compact 1 MHz using an electro stimulator from the NEURODYN line of Ibramed equipment In this technique the applicator releases ultrasonic energy and becomes an active electrode of the electrostimulation Follow the instructions below to perform combined therapy INSTRUCTIONS FOR COMBINED THERAPY Combined therapy may be performed by any electrostimulator of the NEURODYN line of Ibramed equipment connected to SONOPULSE Compact 1 MHz by a special connection cable black inserted in the combined therapy slot in the frontal part of SONOPULSE Compact 1 MHz This cable presents an alligator pin adaptor which is connected to the black banana pin in the electrostimulation cable in the NEURODYN line The dispersive banana pin red of electrostimulation is connected to a dispersive electrode which is applied to the patient to close the electrical circuit When the electric current output is generated by the stimulator the current flows through the aluminum face of the transducer by means
8. conformity level in each frequency range Interference may occur around the equipment marked with this symbol o 20 ELECTROMAGNETIC COMPATIBILITY GUIDANCE NOTE 1 At 80 MHz 800 MHz it is applied to the higher frequency range NOTE 2 These guidelines may not be applicable to all situations Electromagnetic 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 SONOPULSE Compact 1 MHz 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 10 m 21 ELECTROMAGNETIC COMPATIBILITY GUIDANCE Recommended separation distances between the communication equipment of RF portable and mobile and SONOPULSE Compact 1 MHz SONOPULSE Compact 1 MHz is intended to be used in an electromagnetic environment in which RF
9. disturbances are controlled The user of the electrostimulator can help to prevent the electromagnetic interference by maintaining the minimum distance between the portable communication equipment and mobile RF transmitters and SONOPULSE Compact 1 MHz as recommended below according to the maximum power of communication equipment Maximum rated power output of the transmitter maximum Separation distance a to frequency of transmitter nominal potency of transmitter output 150 kHz in 80 MHz 80 MHz MHz 800 MHz o 2 5 GHz 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 ELECTROMAGNETIC COMPATIBILITY GUIDANCE Equipment Serial number ANVISA Registration M S Mian ufacturing date Expiration date 5 years Senior engineeer Maicon Stringhetta CREA 5062850975 23 SPECIFICATIONS SYSTEM SPECIFICATIONS Range of temperature during transportation and Dimensions storage Width 10 6 in 27
10. e Bazin S 1998 Editora Manole Unsworth J Kaneez S Harris S Ridgway J Fenwick S Chenery D Harrison A Pulsed low intensity ultrasound enhances mineralization in preosteoblast cells Ultrasound Med Biol 2007 33 9 1468 74 Warden S J Fuchs Kessler C K Avin Cardinal R E Stewart R E Ultrasound produced by a conventional therapeutic ultrasound unit accelerates fracture repair Physical Therapy August 2006 86 8 Weichenthal M Mohr P Stegmann W Breitbart EW Low frequency ultrasound treatment of chronic venous ulcers Wound Rep Reg 1997 5 1 18 22 Young S R Dyson M The effect of therapeutic ultrasound on angiogenesis Ultrasound in Medicine and Biology 1990 16 3 pp 261 269 ACCESSORIES WHICH ACCOMPANY SONOPULSE COMPACT 1 MHZ SONOPULSE Compact 1 MHz contains accessories conceived to satisfy the demands of electromagnetic compatibility accessories coded 03017006 and 02049048 CODE DESCRIPTION OF ITEM 03017006 PP FEMALE CABLE IEC 2X0 75X1500MM 03040004 DIGITAL OPERATIONS MANUAL IBRAMED 100511 02049048 SILICONE HEAD KIT WITH NTC 03026009 PROTECTION FUSE CARD 03019012 01 20AG FUSE OF 5A 03026003 01 BAG SAFIRA LINE TUBE OF GEL CAP 100 GRAMS 03044001 01 REGISTER ANVISA N 80122200001 59 ACCESSORIES WHICH ACCOMPANY SONOPULSE COMPACT 1 MHZ The use of accessories ultrasound transducer and cables and electrodes different from the ones for which the dev
11. kVin the feeding lines 1 kV in the input output lines 1 kV diferencial mode 2 kV common mode 18 Electromagnetic environment orientations The floor should be wooden 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 GUIDANCE 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 by 5 seconds Conformity level 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 by 5 seconds is the C A voltage before applying the test 19 Electromagnetic environment orientations The quality of power supply should be that of a typical commercial or hospital environment If the user s equipment requires con
12. return to normal The equipment will automatically revert the frozen time resuming the original program 34 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 Timer Mode v Pulse Freq Equipment without transducer Just connect the transducer so that the message disappears and the equipment will return to its original program 35 PROGRAMMING THE EQUIPMENT Example Supposethe clinical practice orliterature suggest for a particular pathology the following parameters Mode Pulsed Pulse 100 Hz Duty Cycle 50 Time 10 minutes Ultrasound energy 1 Watt cm 1 Turn on the equipment to initiate the standard program described above Note the cursor on the Mode field Timer Emission gt Mode Cont v Pulse Freq watts watts cm 0 0 2 Using SELECT and SET switches go through the parameters and select the values shown in the example 36 3 Press the UP or DOWN keys to select the ultrasound intensity necessary for treatment 4 Now press the START key to initiate the treatment After press the START key the transducer figure will appear on the display It indicates that the ultrasound energy is activated Now the patient is receiving the ultrasound energy and the
13. unless proper formal claim has been filed by the receiver against the carrier The carton in which your SONOPULSE Compact 1 2 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 13 GENERAL EQUIPMENT CARE SONOPULSE Compact 1 MHz Care Instructions e Avoid areas subject to vibrations e Install the equipment on a firm and level surface in open alr e Do not block ventilation e Avoid humid hot and dusty environments e Make sure the area around the network cable is free e Do not insert objects into device holes CAUTION Proper installation operation and maintenance of the equipment prevents security risks Cleaning the SONOPULSE Compact 1 MHz e Disconnect the system from the power source wipe with a clean lint free cloth moistened with water and mild antibacterial soap e Ifa more sterile cleaning is needed use a cloth moistened with an antimicrobial cleaner e Do not place the system in liquids 14 ENVIRONMENTAL PROTECTION The SONOPULSE Compact 1 MHz is an electronic device and has heavy metals such as lead Thus there are risks of contamination to the environment associated with the disposal of this equipment and its accessories at the end of their useful lives The SONOPULSE Compact 1 MHz parts and accessories must be disposed of as waste Contact your local distributor for information
14. 1 MHz Muscle Parameters values Rhomboid Injury Parameters values Injury Subacute Phase Subacute Phase 1 MHz Frequency 1 MHz Pulsed denis Pulse frequency 100 Hz Pulse frequency 100 Hz Intensity 0 8 W cm Intensity 1 5 W cm Treatment time 1 30 min Treatment time 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 the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 48 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 11 1 MHz Protocol 12 1 MHz Reduction of Muscle Reduction of Muscle Spasm I Parameters values Parameters values Spasm Deltoid Cervical Paraspinal Intensity 0 8 W cm2 Intensity 0 8 W cm2 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 the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 49 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 13 1 MHz Protocol 14 1 MHz Reduction of Muscle Spasm Reduction of Muscle Spasm Parameters values Parameters values Thoracic Paraspinal Lumbar Paraspinal Frequency 1 MHz Frequency 1 MHz The treatment time depends of the size
15. 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 MAINTENANCE WARRANTY AND TECHNICAL SUPPORT 6 The warranty does not cover parts subjected to natural TECHNICAL ASSISTANCE wear such as but not limited to control buttons control keys handles and moving parts cables connectors device cabinets If you have any doubts or problems related to the operation of your equipment please contact our technical department Call 19 3817 9633 7 The selling points are neither authorized to alter the conditions mentioned in this document nor to take any 1 commitment on behalf of IBRAMED Do not alter this equipment Any unauthorized modification can affect the safety of this equipment Never make unauthorized repairs 63 IBRAMED CENTER FOR EDUCATION AND ADVANCED TRAINING IBRAMED Equipment goes beyond technology It also pro Special attention is also given to those interested in visiting vides knowledge Science constitutes our differential value our structure Whatever your professional development and we effectively take advantage of its benefits in order to needs we ll be right by your side to provi
16. 72 302 Doan N Reher P Meghji S Harris M In vitro effects of therapeutic ultrasound on cell proliferation protein syn thesis and cytokine production by human fibroblasts os teoblasts and monocytes Journal of Oral and Maxillofacial Surgery April 1999 57 4 pp 409 419 Drapper D O Prentice W E Ultrassom terap utico In Prentice W Modalidades terap uticas para fisioterapeu tas 2004 29 ed Editora Artmed Gebauer D Mayr E Orthner E Ryaby JP Low intensity pulsed ultrasound Effects on nonunions Ultrasound Med Biol 2005 10 1391 1402 57 Hoogland R Ultrasound Therapy 2005 Delft Holland Enraf Nonius Johannsen F Gam A N Karlsmark T Ultrasound therapy in chronic leg ulceration a meta analysis Wound Rep Reg 1998 6 121 26 Khan Y Laurencin CT Fracture repair with ultrasound clinical and cell based evaluation Journal of bone and Joint surgery feb 2008 90 supplement 1 pp 138 45 Leung MC Ng GY Yip KK Effect of ultrasound on acute inflammation of transected medial collateral ligaments Arch Phys Med Rehabil 2004 85 963 6 Liebano R eGomes A C Autiliza aodaeletrotermofototerapia notratamentodosidosos In Funcionalidadeeenvelhecimento Perracini M R e Fl C M 2009 Rio de Janeiro Editora Guanabara Koogan pp441 479 Mason C P Leung Gabriel Y F Ng and K K Yip Therapeutic ultrasound enhances medial collateral ligament repair in rats Ultrasound in Medicine amp Biolog
17. PULSE Compact 1 MHz there is Compact 1 MHz mustalways be performed at unauthorized a protection fuse To replace it turn the device off the service only by qualified technicians 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 A CAUTION nominal current of 5 0A operation tension of 250V and snap action model 20AG 50A rupture current NOTES Inside the device there are dangerous tensions SONOPULSE Compact 1 MHz does not need any type of Never open the device power stabilizer Never use a power stabilizer 15 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 SONOPULSE Compact 1 MHz may result in increased emissions or decreased immunity of the equipment e SONOPULSE Compact 1 MHz equipment is intended for use only by health care professionals The SONOPULSE Compact 1 MHz may cause radio interference or disrupt equipment operations nearby It may be necessary to adopt mitigation procedures such as reorienting o
18. al 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 12 GENERAL EQUIPMENT CARE SHIPPING DAMAGE INSTALLATION CARE AND CLEANING Your SONOPULSE Compact 1 MHz is shipped complete in Installation Instructions one carton Upon receipt inspect carton and unit for visible 1 Connect the line cord to the back of the SONOPULSE and hidden damage In case of damage keep all shipping Compact 1 MHz materials including carton and contact the shipping agent 2 Plug the line cord into a grounded wall outlet 100 240V 50 60 Hz responsible for the delivery of the unit All claims relating 3 Plug the ultrasound cables into the correct connections to damage during transport should be filed directly with 4 Switch on your equipment them The manufacturer will not be liable for any damage during shipping nor allow for adjustments
19. col 19 1 MHz Protocol 20 1 MHz Reduction of Muscle Parameler values Trochanteric Bursitis Parameters values Spasm Rectus Femoris Acute Phase O Pulse frequency 100 Hz Treatment time 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 the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 53 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 21 1 MHz Protocol 22 1 MHz Trochanteric Bursitis Gluteus Medius Tendinopathy Parameters values Chronic Phase Acute Phase Parameters values Pulse frequency 100 Hz The treatment time depends of the size of the treatment area and ERA Effective Radiating Area of the transducer 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 selected for the treatment 54 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 23 1 MHz Protocol 24 1 MHz Supraspinal Tendinopathy Gluteus Medius Tendinopathy Parameters values Parameters values Acute Phase Chronic Phase Frequency 1 MHz Pulse frequency 100 Hz i Treatment time 1 30 min Intensity 1 8 W cm2 Treatment time 1 30 min The treatment time depends of the size of the treatment area and the ERA Ef
20. de you with ensure patient safety and thereby maximize results unconditional support IBRAMED develops products with scientific support of the We are happy to assist you most recent medical studies published in major scientific journals in the areas of biological health and exact Contact cefai conexaocefai com br www conexaocefai com br Access to the knowledge database is guaranteed by CEFAI 55 19 3808 2348 IBRAMED Center for Education and Advanced Training whose goal is to provide technical and scientific support Thanks as well as current literature on therapies and their appli cability while our treatment choices are always thoroughly selected according to the best and latest clinical criteria CEFAI takes into account the personal and professional de velopment of all its partners and customers IBRAMED A matter of respect CEFAI invites both students and professionals in the fields of Physical Rehabilitation Esthetics Physiotherapy Derma tology 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 gt CEFAI rorma ao avan am IBRAMED 64 Em Z n O IBRAMED QUEST O DE RESPEITO IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI Av Dr Carlos Burgos 2800 29 It lia 13901 080 Amparo SP Brasil 19 3817 9633 www ibramed com br ibramed ibramed com br
21. display will show watts watts cm 7 0 1 5 At the end of the time the emission of ultrasound is interrupted and a sound beep will be emitted at the end of the treatment 6 Press the STOP key to stop the sound beep The equipment can now be turned off the same program can be performed or a new program may be programmed DIRECTIONS ON ULTRASOUND PATIENT PREPARATION e Examine the skin for any wounds and clean the treatment area rubbing the skin with medical use alcohol e Before applying the ultrasound clean the area with and soap and water to remove the oil and possible skin fragments thus reducing the difficulty of passage of the ultrasound through the skin e Clean the applicator with soap and water before each therapy session e Apply conductor gel over the patient s treatment area e Move the ultrasound transducer constantly during the session in circular moves Examine the skin again after treatment e 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 There is no risk of harmful effects to the cells nor is there any allergic reaction or of sensitivity The gel and the transducer The gel
22. e SA Refer to operating instructions for correct product use This side up Manufacturer s name and address sa Limits of temperature for storage and packaging in C Celsius Degrees a Keep away from the rain Stacking up Do not use if the packaging is damaged ABREVIATIONS GLOSSARY FIGURES GLOSSARY MHz Megahertz million pulses 10 by second Figure 1 Upper 26 ERA Effective Radiating Area Figure 2 Rear 26 W Watt 5 Figure Frontal VieW ccccceceseeeeeeseeeeeeeeeeeteeneeenags 27 W cm Watt s per square centimeter Figure 4 Lower vieWw 27 cm2 Square centimeter Figure 5 A Ultrasound transducer with ERA of 7 B VA Volt Ampere neutral conductor gel 31 BNR Beam Non Uniformity Ratio Figure 6 A presentation message B standard default Min Minute SONOPULSE Compact 1 MHZ 32 Figure 7 ApplicationtechniquewithERAof7cm 38 Figure 8 A slot for combined therapy of SONOPULSE Compact 1 MHz connector cable for combined therapy 2 39 Figure 9 Applicationtechniqueforcombinedtherapy 41 Figure 10 42 Figure11 Programmed and User protocols display
23. fective Radiating Area of the transducer 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 selected for the treatment 55 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 25 1 MHz Protocol 26 1 MHz Supraspinal Tendinopathy EE chronic Phase Parameters values Sonophoresis Rehabilitation Parameters values Intensity 1 8 W cm2 Duty cycle Pulse frequency 100 Hz ii Treatment time 1 30 min Prog 1 to 20 User Protocols 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 the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 56 REFERENCES Amirez A Schwane J A McFarland C Starcher B The effect of ultrasound on collagen synthesis and fibro blast proliferationin vitro Medicine amp Science in Sports amp Exercise 1997 29 3 326 332 Bailey R Khokhlova V O A Sapozhnikov S Kargl and L A Crum Physical Mechanisms of the Thera peutic Effect of Ultrasound A Review Acoustical Physics 2003 49 4 pp 369 388 From Akusticheski I Zhurnal 2003 49 4 437 464 Cameron M Ultrasound In Cameron M Physical Agents in Rehabilitation 1999 Philadelphia W B Saunders Com pany pp 2
24. ice was designed may significantly degrade the performance of emissions and immunity Therefore DO NOT USE accessories ultrasound transducer cables and electrodes of SONOPULSE Compact 1 MHz 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 Compact 1 MHz equipment REPLACEMENT ACCESSORIES The replacement accessories are designed for use with SONOPULSE Compact 1 MHz As you order them provide the respective codes description and quantity desired The use of accessories cables and transducer Other than the ones destined for this specific equipment may degrade significantly the performance and immunity Do not use accessories cables and transducer of SONOPULSE Compact 1 MHz in other equipment or electromedical systems 60 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 PROBLEMAS SOLU O power cable properly The equipment does not connected turn on 1 If it is not connect it Also check the power outlet on the wall Have you checked the protection fuse Check if they are properly connected Check also if the value is in accordance with the indicated in the operation instructions Have you followed the recommendations The equipment is on ins
25. makers 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 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 oxygen or nitrous oxide Equipment is not the AP or APG category INDICATIONS AND PRECAUTIONS INDICATIONS Therapeutic ultrasound is commonly indicated for e Pain relief e Reduction of muscle spasm Localized increase in blood flow e Increase in range of motion in contracted joints using heat associated with stretch techniques Relief of pain muscle spasms and contracted joints may be associated with e Adhesive capsulitis Bursitis with mild calcification Myositis e Lesion of soft tissues Post lesion shortening of tendons and scar Relief of chronic pain and muscle contracture may result from e Capsular tension e Capsular scar PRECAUTIONS Ultrasound treatment must be avoided over the stellate ganglion spinal cord after laminectomy when great tissue resections have been performed under subcutaneous majo
26. meters 14 Label with technical characteristics and serial number 4 SET control keys increasing or decreasing parameter values 15 Federal Law warning only for the USA 5 Alphanumerical liquid crystal display 16 General technical information 6 START STOP control keys to start or stop treatment 7 UP and DOWN control keys increase or decrease ultrasound intensity 8 Control keys PROG MENU PROG Selection of preprogrammed protocols MENU Selection of language 9 Connection for combined therapy with other IBRAMED equipment 10 Output Connection of transducer to ultrasound 11 Connection of power cable 26 DEFINITION OF SYMBOLS 4Timer Emission Mode Cont v Pulse Freq watts watts cm 0 0 0 0 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 MENU Selection of language Portuguese English or Spanish 29 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 30 ACCESSORIES USED 1 MHz ULTRASOUND Ultrasound transducer with ERA of 7 cm with neutral conductor gel Figure 5 A The screws of the transd
27. n diseases in Therapeuticultrasound mustnot be appliedfor undiagnosed which for general medical purposes it is advisable to pain suppress heat and fever e Therapeutic ultrasound must not be applied over neoplastic areas or over areas from which tumors have been removed ADVERSE REACTIONS Therapeutic ultrasound must not be applied over the eyes e Therapeutic ultrasound must not be applied on ischemic tissues where the blood supply may be incapable of following the increase in metabolic demand and result in necrosis e Therapeutic ultrasound must not be applied over bone growth centers e Ultrasound therapy is not recommended for patients with implanted electronic devices cardiac pacemakers deep prain stimulation devices Do not apply ultrasound over areas previously treated with radiotherapy Ultrasound must not be applied over the testes to avoid increases in temperatures e Ultrasound must not be applied over the heart Therapeutic ultrasound must not be applied over areas of thrombophlebitis deep vein thrombosis emboli and severe atherosclerosis 10 Therapeutic ultrasound when applied in continuous circular movements may cause a sensation of numbness and or heat If however the applicator is kept over the same place for more than a few seconds in high energies it may become uncomfortable POPULATION AND CONDITIONS OF USE PATIENT POPULATION e Patients over 12 years old under this age onl
28. nectors before each use e The SONOPULSE Compact 1 MHz 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 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 The 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 fuses 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 pace
29. o the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 45 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 5 1 MHz Protocol 6 1 MHz Rhomboid Injury Femoral Biceps Injury Acute Phase Parameters Valles Subacute Phase Mode Mode Parameters values ay Er O mea Pulse frequency 100 Hz Pulse frequency 100 Hz Intensity 1 5 W cm Intensity 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 the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 46 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 7 1 MHz Protocol 8 1 MHz Rectus Femoris Injury Anterior Tibial Parameters values Subacute Phase VAES Injury Subacute Phase Pulse frequency 100 Hz Pulse frequency 100 Hz Intensity 1 5 W cm Intensity 0 8 W cm Treatment time Treatment time 1 30 min 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 the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 47 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 9 1 MHz Protocol 10
30. of the treatment area and the ERA Effective Radiating Area of the transducer 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 selected for the treatment 50 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 15 1 MHz Protocol 16 1 MHz Reduction of Muscle Parameters values or Muscle Parameters valui Spasm Rhomboid Biceps or Triceps Brachii di Mode Intensity Intensity 0 8 W cm2 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 the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 51 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 17 1 MHz Protocol 18 1 MHz Reduction of Muscle Parameters values Reduction Parameters values Spasm Gastrocnemius Spasm Biceps Femoris Treatment time Treatment time 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 the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 52 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Proto
31. of this connection figure 9 39 COMBINED THERAPY USING SONOPULSE COMPACT 1MHZ Combined Therapy IN Figure 8 A slot for combined therapy of SONOPULSE Compact 1 MHz B connector cable for combined therapy Reread all the precautions for neuromuscular electrical stimulation and the contra indications in the instructions of use of the electrostimulation equipment of the NEURODYN line before proceeding to the combined therapy The SONOPULSE Compact 1 MHz 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 Compact 1 MHz and in the electrostimulator to initiate the treatment The intensity of electrostimulation is adjusted in the electrostimulator whereas the intensity of ultrasound is adjusted in the SONOPULSE Compact 1 MHz At the end of the programmed time the emissions of ultrasound and electrical stimulation are interrupted and a sound beep will be emitted at the end of the treatment Press the STOP key to stop the sound beep The equipment may now be turned off or perform the same program or record a new Programa 40 COMBINED THERAPY USING SONOPULSE COMPACT 1 MHZ APPLICATION TECNIQUE FOR COMBINED THERAPY Position of the ultrasound transducer and the electrostimulation electrode for combined therapy Figure 10 HK Figure 9 Application technique for combined therapy
32. 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 GENERAL EQUIPMENT CARE ELECTRICAL FEED SONOPULSE Compact 1 MHz is a protective CLASS II Before turning on SONOPULSE Compact 1 MHz make device with applied part type BF of safety and protection sure SONOPULSE Compact 1 MHz works in power supply e The tension and frequency of the local power supply line of tension in the range of 100 240V 50 60 Hz Just connect the establishment where the device is installed are equal to the device to the power line and it will perform the selection the one described on the label describing characteristics of of power tension automatically The connector cable to the tension and power located at the rear part of the device power supply line is detachable The device uses the power e To prevent electrical shock do not use the plug in the line plug as a resource to electrically separate its circuits device with extension cables or any other types of sockets in relation to the power supply line in all poles 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 SONOPULSE In the rear part of SONO
33. 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 the user just select the PROG key and use the SET key to choose the number of the desired protocol gt 4Timer Emission Cont vPulse Freq Protocols Programmed set 4 Users setv Figure 11 Programmed and User protocols display 43 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 1 1 MHz Protocol 2 1 MHz Femoral Biceps Injury Rectus Femoris Injury Parameters values Parameters values Acute Phase Acute Phase Frequency Frequency Mode Mode Duty cycle Duty cycle Pulse frequency 100 Hz Pulse frequency 100 Hz 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 the size value of the treatment area divided by the value of the ERA of the transducer selected for the treatment 44 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Protocol 3 1 MHz Protocol 4 1 MHz Anterior Tibial Deltoid Muscle i Parameters values i Parameters values Injury Acute Phase Injury Acute Phase Intensity 0 8 W cm Intensity 0 8 W cm 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 t
34. r down to select the values Programming treatment time Intensity of ultrasound Program the desired session time At the end of the The intensity of ultrasound may be increased or decreased programmed time you will hear a sound beep indicating at any time during the session After pressing the START that the treatment session has been finalized Press the key press the UP or DOWN switch up or down respectively STOP switch so that the sound beep is discontinued The equipment will return to the programming status 33 OPERATION INSTRUCTIONS TRANSDUCER PROTECTION MESSAGES TEMPERATURE SENSOR Inside the SONOPULSE Compact 1 MHz 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 This sensor is programmed so that the temperature in the aluminum never exceeds 41 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 turn off the emission of ultrasound At that moment a sound beep will be emitted and the display will show A Timer Emisson al ele Cont Pulse Overtemperature The professional should continue to move the transducer because after a few seconds the temperature will
35. r nerves and the cranium Ultrasound must not be applied in areas of reduced sensation or circulation or over anesthetic areas Patients with reduced sensation are not capable of warning the professional in case there is discomfort and in patients with compromised circulation there may be an excessive buildup of heat in the treated area Patients with hemorrhagic diastheses or hemorrhagic disorders must be treated with care Professionals operating the device on a daily basis must not be exposed to therapeutic ultrasound The 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 ultrasound treatment the intensity should be reduced to a comfortable level Heating must be avoided during the acute or sub acute phase of arthritis Other treatments with electronic devices or hydro massage devices which may come into contact with the patient during ultrasound therapeutic treatment must be appropriately tested to assure the safety of the operation The operator should manipulate the applicator only by handle during the application CONTRA INDICATIONS AND ADVERSE REACTIONS CONTRA INDICATIONS Therapeutic ultrasound must not be applied over the e Therapeutic ultrasound must not be applied in case of pregnant uterus or potentially pregnant uterus Suspected serious infectious disease and i
36. r relocating the equipment or shielding of the site e Portable and Mobile Radio Frequency RF communications equipment can affect Medical Electrical Devices 16 POTENTIAL ELECTROMAGNETIC INTERFERENCE Asforthelimitsofelectromagneticinterference SONOPULSE Compact 1 MHz is an electromagnetic device of Group 1 Class A The simultaneous connection from the patient to SONOPULSE Compact 1 MHz 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 SONOPULSE Compact 1 MHz and another separate group is used for short wave or microwave equipment We also suggest that the patient SONOPULSE Compact 1 MHz 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 ELECTROMAGNETIC COMPATIBILITY GUIDANCE Manufacturer s guidelines and declaration Electromagnetic emissions SONOPULSE Compact 1 MHz is destined to be used in the electromagnetic environment
37. s the choice of pre programmed treatment programs recorded on the memory of the device SONOPULSE Compact 1 MHz must be used with complaint gel The wavelength of 1 MHz penetrates to a depth of approximately 5 cm This device must be used only under prescription and Supervision of a licensed 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 op erating this equipment prior to therapy session A CAUTION Text with a CAUTION indicator refers to potential safety infractions that could cause minor to moderate injury or damage to equipment A 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 eRead 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 con
38. specified below The user of the equipment should be sure that it will be used in this environment Emission test Conformity Electromagnetic emissions SONOPULSE Compact 1 MHz emits RF energy RF Emissions only for its internal functions However its RF NBR IEC CISPR 11 Group 1 emissions are very low and it is unlikely to cause IEC CISPR 11 any interference in nearby electronic equipment RF Emissions NBR IEC CISPR 11 Class A IEC CISPR 11 Harmonic Emissions SONOPULSE Compact 1 MHz is suitable to be used in 61000 3 2 Class A 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 Emissions due to the fluctuation scintillation Class A IEC 61000 3 3 ELECTROMAGNETIC COMPATIBILITY GUIDANCE Manufacturer s guidelines and declaration Electromagnetic immunity SONOPULSE Compact 1 MHz 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 level Immunity Test Test level Electrostatic discharge ESD IEC 61000 4 2 Fast electric transitories pulse train Burst IEC 61000 4 4 Outbreaks IEC 61000 4 5 IEC 60601 6 kV by contact 8 kV by air 2 kVin the feeding lines 1 kV in input output lines 1 kV diferencial mode 2 kV common mode 6 kV by contact 8 kV by air 2
39. tinued operation during power failure it is recommended the equipment be powered by uninterruptedly power supply or battery Magnetic fields at power frequency should be at the level of a typical location in a typical commercial or hospital environment ELECTROMAGNETIC COMPATIBILITY GUIDANCE Manufacturer s guidelines and declaration Electromagnetic immunity SONOPULSE Compact 1 MHz 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 level Conformity i Electromagnetic environment guidelines test IEC 60601 level Communication equipment of RF portable and mobile should not be used near any part of SONOPULSE Compact 1 MHz including cable with separation distances smaller than the recommended calculated from the equation applicable to the transmitter frequency Recommended separation distance d 1 2 3 V d 1 2 VP 80 MHz to 800 MHz d 2 4 VP 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 be smaller than the
40. tructions in the operation manual but does not perform correctly Check and go over the steps indicated the item about controls indicators and connections and in the item operation instructions The equipment does not turn on 2 61 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 15 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 permission 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
41. ucer connector must be firmly fixed to the device Figure 5 A Ultrasound transducer with ERA of 7 cm B neutral conductor gel 31 OPERATION INSTRUCTIONS PREPARING THE EQUIPMENT Check if the power cable is connected to the power supply on the wall Press the ON OFF switch to the ON position The display will show for a few seconds the presentation message which includes the model of the device and the programming software followed by the standard SONOPULSE Compact 1 MHz screen Figure 6 IBRAMED Timer Emission f Cont v Pulse Freq no o watts watts cm Sonopulse Compact 0 0 0 0 1 MHz US06 VOS Figure 6 A presentation message standard default SONOPULSE Compact 1 MHz screen Note that as the standard default screen is shown an arrow indicates the Mode This arrow indicates the parameter to be programmed 32 OPERATION INSTRUCTIONS PREPARING THE EQUIPMENT Selection of parameters The SELECT switch allows you to select the parameters Initiating Treatment necessary for the treatment Press SELECT switch Press the START switch to up or down to move the indicating arrow to the START initiate treatment next parameter or return to the previous parameter Stopping Treatment Press the STOP switch to finalize The SET switch allows the selection of values of STOP therapy each para meter necessary for treatment Press the SET switch up o
42. y March 2006 32 3 pp 449 452 Merrick M A Mihalyov M R Roethemeier J L Cordova M L Ingersoll C D A Comparison of Intramuscular Temperatures During Ultrasound Treatments With Coupling Gel or Gel Pads J Orthop Sports Phys Ther May 2002 32 5 REFERENCES Mizrahi N Seliktar D Kimmel E Ultrasound Induced Angiogenic Response in Endothelial Cells Ultrasound in Medicine and Biology November 2007 33 11 pp 1818 1829 Mortimer A J and Dyson M The effect of therapeutic ultrasound on calcium uptake in fibroblasts Ultrasound in Medicine amp Biology Volume 14 Issue 6 1988 Pages 499 506 OZGONENEL L AYTEKIN E and OGLU G D A double blind trial of clinical effects of therapeutic ultrasound in knee osteoarthritis Ultrasound in Med amp Biol 2009 35 1 pp 44 49 Peschen M Weichenthal M Schopf E Vanscheidt W Low frequency ultrasound treatment of chronic venous leg ulcers in an outpatient therapy Acta Derm Venereol 1997 77 4 311 14 Poltawski and Watson T Relative transmissivity of ultrasound coupling agents commonly used by therapists in the UK Ultrasound in Med amp Biol 2007 33 1 pp 120 128 Soltani and Roy R A Cavitational mechanisms in ultrasound accelerated fibrinolysis Ultrasound in Med amp Biol 2007 Vol 33 No 6 pp 924 933 58 ter Haar Princ pios eletrof sicos In Eletroterapia de Clayton 10 ed Kitchen S
43. y 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 maximum level of knowledge is not required from the user e The instructions of use are available in Portuguese Spanish and English e Regarding the minimum level of experience of the user it is necessary that the instructions of use are read carefully and all the instructions are understood before the use of the device 11 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 RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT The use of electromedical equipment is restricted to a physician or under his command the physic
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