NEURODYN - Ibramed
Contents
1. Standard Weight without accessories 0 240 kg Power Input 100 240V 50 60 Hz Input Power 15 VA Fuses 5A 250V 20AG Electrical Class CLASS II Electrotherapy TYPE BF Regulatory Compliance IEC 60601 1 IEC 60601 1 2 IEC 60601 2 10 IEC 60601 1 4 Parameters decrease Parameters increase aa Temperature Range During Transport and Storage intensity Intensily 5 E 50 C 41 E 122 F Environment operating temperature range 5 45 C 41 113 OF o o N CAUTION Up or Down Intensity Channels 1 and 2 The device and its consumable parts must be disposed Observe the colors related to channels of at end of life according to the applicable federal and or state and or local regulations 26 SPECIFICATIONS WAVEFORM SPECIFICATIONS TENS Transcutaneous Electrical Nerve Stimulation Output Mode Electrodes The Asymmetrical Biphasic waveform has short pulse duration eat PUL LACES y roe TS and is capable of strong stimulation of nerve fibers in the skin Frequency F 0 5 250 Hz and in muscle Because of its short pulse duration the patient Phase Duration T Adjustable 50 500 us typically tolerates the current well even at relatively high Burst Frequency 2 Hz intensities Modulation of Burst Frequency 250 Hz VF Frequency 7 65 Hz VIF Frequency 7 65 Hz DO A VIF Phase Duration 50 225 us E Ra e GE d E Current Mode 3 SS no o E Normal Continuous Tens F 0 5 250 H2. 0 35 P_ 80 MHz to 800 MHz IEC 61000 4 6 150 kHz to 80 MHz SE ery VEER Where p is the maximum output power rating of the Radiated RF 10 V m transmitter in watts W according to the transmitter IEC 61000 4 3 80 MHz to 2 5 GHz 10 V m manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol WW 20 ELETROMAGNETIC COMPATIBILITY NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in 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 broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength at the location in which the NEURODYN PORTABLE TENS is used exceeds the applicable RF compliance level above the NEURODYN PORTABLE TENS should be observed to verify normal operation If abnormal performance is observed additional measur
3. 5 19 3817 9633 AN DANGER Do not alter this equipment Any unauthorized modification can affect the safety of this equipment Never make unauthorized repairs CEFAI 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 well be right by your side to provide 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 cefaiQconexaocefai 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 IBRAMED A matter of respect CEFAI takes into account the personal and professional de velopment of all its partners and customers CEFAI invites both students and pr
4. BRAMED 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 WARRANTY IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI here identified to the consumer through the following address and telephone number Av Dr Carlos Burgos 2800 Jd It lia Amparo SP Tel 55 19 3817 9633 provides product warranty for eighteen 18 months insofar as the conditions set for warranty terms are followed by the user as mentioned below 37 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 4 The warranty does not cover damage caused to the product resulting from a Failure to follow the specifications and recommendation
5. Em Ur mg S IBRAMED QUESTAO DE RESPEITO Instructions Manual NEURODYN PORTABLE TENS Manufactured by Ibramed Industria Brasileira de Equipamentos M dicos EIRELI Made in Brazil 11 edition LAST REV 12 2013 TABLE OF CONTENTS STMPBUOL DEFINITIONS oasanahodana ee 3 CARTO Norunn nnne EE 4 ABREVIATIONS GLOSSARY sccictnsssieerentesetseseaseenannees a FIGURES GLOSOAR O upanes ao espada oder gt EE Eeer 6 PRODUCT DESCRIPTION cancaacssawservesenssestesences isn NA 6 SAFETY PRECAUTIONS usasse penis a vadia aids ELECTROTHERAPY INDICLATMONS TE 9 CONTRAINDICATIONS PRECAUTIONS AND ADVERSE REACTION KEE 10 PATIENT POPULATION AND CONDITIONS OF USE 11 RESPONSIBILITY FOR USE ELECTROMEDICAL G T LV MR 12 GENERAL CARE WITH THE EQUIPMENT 13 INSTALLATION CARE AND CLEANING 13 ELECTRICAL FEED tccranecnccienssanesennantt ouesn tances eae 15 ELETROMAGNETIC COMPATIBILITY nn 16 NOMENCEA FORE EE 24 CONTROLS INDICATORS AND CONNECTIONS 24 SYMBOL DEFINITIONS EE 25 SPECIFICATIONS EE 26 By SOE She e RL EE 26 WAVEFORM SPECIFICATIONS an 27 RE ER RE 28 EIS EREECHEN 28 OPERATING IN SRC TON E 29 PROGRAMMING EQUIPMENT eee eees 31 ELECIRODE Ee RT DK ER ELECTROTHERAPY PATIENT PREPARATION 32 REFERENCES E 34 ACCESSORIES ACCOMPANYING NEURODYN PORTABLE TEN O areae sa ai sia Un Ena a A a ia as 35 TROUBLESHOOTING EE 36 MAINTENANCE WARRANTY AND TECHNICAL Een 37 CEFAI IBRAMED CEN
6. Figure 7 The 9 Volt battery connection Type of battery T used with device IEC 6F22 9 Volts battery 28 OPERATING INSTRUCTIONS Turn on the power switch The LCD will display the default screen with the parameters used at the last treatment for example 5l 3 200 Note that the LCD displays the number 3 that indicates Tens Vif Select Waveform Press MODE to select the waveform you want to use for the treatment 1 Tens 2 Tens Vf 3 Tens Vif 4 Tens Ac and 5 Burst Note that a point to the left of the first number will be flashing indicating that the MODE function is ready for programming The numbers related to the waveforms are identified in the caption and should be adjusted via the MODE key for example change number 3 Tens Vif to number 1 Tens Figure 8 A O Tens O T us Tens Vf F Hz Tens Vif Time Min Tens Ac O Burst 29 3200 1 200 Figure 8 A MODE switch and caption with the waveforms and parameters B Number 3 Tens Vif changing to number 1 Tens Edit Waveform Parameters The SET button allows the selection of the parameters required for the treatment 1 T us 2 F Hz and 3 Time min Press SET and note that the point now will be flashing indicating that the SET function is now ready for programming Observe that this time the flashing point is located to the right of the first number giving access to cho
7. ITY Equipment Serial number ANVISA Registration M S Mian ufacturing date Expiration date 5 years Senior engineeer Maicon Stringhetta CREA 5062850975 23 NOMENCLATURE 11 9 14 5 Figure 2 Rear Access Panel T 10 Figure 1 Upper Access Panel Figure 3 Lateral Access Panel Figure 4 Lower Access Panel 1 Power ON OFF Switch 6 UP DOWN Intensity Buttons Channels 1 and 2 11 General Technical Information 2 MODE Button 7 Channel indicator LEDs 12 Battery Placement 3 SET Button 8 Caption witch waveforms and parameters 13 Battery Input 9 V 4 UP DOWN Buttons 9 Channel Lead Wire Connector 14 Serial Number 5 LCD Display 10 Line Cord Connection 24 SYMBOL DEFINITIONS Read and Understand these symbols and their definitions before operating this equipment Current Mode Tens Tens Vf Tens Vif move Tens Ac and Burst Select the parameters Phase Duration T ser Frequency F and Timer e Button used to start or stop the o O treatment e On switch amp C Off switch Figure 5 NEURODYN PORTABLE TENS LCD O Tens T us Tens vf OQ F Hz Caption with the Tens Vif Time Min waveforms and Tens Ac Burst parameters 25 SYMBOL DEFINITIONS SPECIFICATIONS SYSTEM SPECIFICATIONS Channel Lead Dimensions we age 2 Wire Connectors Width 7 8 cm 3 0 in vd i l Channels 1 and 2 Depth 14 8 cm 5 8 in Height 5 cm 1 9 in
8. Level 6 kV by contact 8 kV by air 2 kV for power Supply lines 1 kV for input output lines 1 kV diferencial mode 2 kV common mode Compliance Level 6 kV by contact 8 kV by air 2 kV for power Supply lines 1 kV for input output lines 1 kV diferencial mode 2 kV common mode 18 Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment ELETROMAGNETIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The NEURODYN PORTABLE TENS is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN PORTABLE TENS should assure that it is used in such an environment Immunity Test Voltage dips Short interruptions and voltage variations in power input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic fild IEC 61000 4 8 NOTE U is the A C mains voltage prior to applications of the test level IEC 60601 Test Level lt 5 U gt 95 voltage drops in U 0 5 by cycle 40 U voltage drops in 60 U by 5 cycles 70 U 30 voltage drops in U by 25 cycles lt 5 U gt 95 volta
9. Press the MODE button until number 1 Tens displays the battery is low When the conditions to the battery are unsatisfactory low the LCD of the NEURODYN PORTABLE TENS will display the low battery message 1 200 LB Even with battery low the equipment will operate for an additional time and disconnect automatically when the battery is empty At this time the LCD will display the lt o Wa message 2 Using the SET button select number 2 and number 3 and with UP DOWN buttons scroll through the other Low Battery gt LB parameters and select the value shown in the example 1 1 00 1 Phase Duration T 200 us 2 Frequency F 50 A A Hz and Time 30 min 14 200 2 50 3 30 AN WARNING Ki SE as shown below Remove the 9 volt battery if the equipment is not used for a long period of the time 3 Now adjust the INTENSITY channel in use to select the amount of current needed for the treatment increasing Slowly using the UP DOWN intensity button ELECTRODE GUIDELINE ELECTROTHERAPY PATIENT PREPARATION e Electrode Placement can be achieved using the Bipolar or Monopolar Techniques Proper positioning and contact will insure treatment comfort and efficiency e Examine the skin for any wounds and clean the treatment area by rubbing the skin with medical grade alcohol e Before placing the electrodes clean the area with soft Soap and water to remove oil and possible skin fragm
10. RIES ACCOMPANYING NEURODYN PORTABLE TENS NEURODYN PORTABLE TENS contains accessories REPLACEMENT ACCESSORIES designed to meet the requirements of electromagnetic comparability accessories accessories code 03049001 03049009 and 03049008 This list of replacement accessories are designed for use with the NEURODYN PORTABLE TENS Electro Stimulator When ordering provide the respective part numbers description and quantity desired PART QUANTITY ITEM The use of accessories cables and electrodes other than those NUMBER DESCRIPTION intended for this specific equipment may significantly degrade POWER CABLE KIT NEURODYN the performance of the emissions and immunity DO NOT PORTABLE USE accessories cables and electrodes from NEURODYN 03049009 o ELECTROSTING aug PORTABLE TENS equipment on other equipment or medical CABLE ORANGE 03 13 electro systems 03049008 ot tos A CABLE BLACK 03 13 03026042 ot EE 03041002 o Jop 03026024 04 ee SCMX3CM ELECTRODES 5 CM X 3 CM 03040004 or CDUSERMANUAL GEL TUBE CAP 100 GRAMS 03044001 REGISTERED ANVISA N 80122200001 35 TROUBLESHOOTING What may initially look like a problem is rarely a defect Before calling customer support please check the items described below PROBLEMS SOLUTIONS The equipment does not e Is the power cable properly connected turn on 1 If not connect it Also check the wall socket e Have you checked the safety fuse The equipment doe
11. TER FOR EDUCATION AND EE Te EAR EE 39 SYMBOL DEFINITIONS BELOW ARE THE DEFINITIONS OF THE SYMBOLS USED ON THE EQUIPMENT AND THROUGHOUT THE INSTRUCTIONS FOUND IN THIS MANUAL UNDERSTAND THESE SYMBOLS AND THEIR DEFINITIONS BEFORE OPERATING THIS EQUIPMENT A Caution Refer to user manual e Off switch amp O CLASS II Electrical equipment C On swith PXO Not protected against the harmful effects of j m Voltage in AC Alternating Current water penetration Electrical Network in AC AR Sensitivity against electrostatic discharge ey line Alternating Current TYPE BF Electrical equipment AN Dangerous voltage SYMBOL DEFINITIONS ABREVIATIONS GLOSSARY CARTON Hz Hertz pulses per second Fragile mA Milliamper VA Volt Amper ee TENS Transcutaneous Electrical Nerve Stimulation This side up BURST Modulation of Frequency air o TENS BURST TENS modulated in Burst Limits of temperature for storage and packaging in C Celsius Degrees TENS AC TENS Acupunture TENS VIF Variation Phase Duration Frequency TENS Keep away from the rain TENS VF TENS with Variation Frequency F Frequency T Phase Duration Stacking up Q Do not use if the packaging is damaged Refer to operating instructions for correct product use Manufacturer s name and address FIGURES GLOSSARY Figure 1 Upper Access Panel 24 Figure 2 Rear Access Panel 24 Figure 3 Front Access Panel 24 Figure 4 Lower Acc
12. analgesic effects of interferential therapy on two experimental pain models cold and mechanically induced pain Physiotherapy 2006 92 2 95 102 Ozcan J Ward AR Robertson VJ A comparison of true and 34 premodulated interferential currents Archives of Physical Medicine and Rehabilitation 2004 85 3 409 415 Robertson VJ Ward AR Use of electrical stimulation to strengthen the vastus medialis muscle following a lateral patellar retinacular release Journal of Orthopaedic and Sports Physical Therapy 2002 32 9 437 446 Selkowitz DM High frequency electrical stimulation in muscle strengthening A review and discussion Am J Sports Med 1989 17 1 103 111 Shanahan C Ward AR Robertson VJ A Comparison of the analgesic efficacy of interferential therapy and TENS Physiotherapy 2006 92 4 247 253 Snyder Mackle L Garrett M Roberts M A comparison of torque generating capabilities of three different electrical stimulating currents J Orthop Sports Phys Ther 1989 10 8 297 301 Snyder Mackler L Delitto A Stralka SW Bailey SL Use of electrical stimulation to enhance recovery of quadriceps femoris muscle force production in patients following anterior cruciate ligament reconstruction Phys Ther 1994 74 10 901 907 ST Pierre D Taylor AW Lavoie M et al Effects of 2500 Hz Sinusoidal current on fibre area and strength of quadriceps femoris J Sports Med Phys Fitness 1986 26 1 60 66 d ACCESSO
13. ble for the delivery of the unit All 50 60 Hz claims relating to damage during transport should be filed e Plug the electrode cables into the electrode cable directly with them The manufacturer will not be liable for any connections damage during shipping nor allow for adjustments unless e Switch on your equipment proper formal claim has been filed by the receiver against the carrier The carton in which your NEURODYN PORTABLE TENS Electro Stimulator 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 CARE WITH THE EQUIPMENT NEURODYN PORTABLE TENS Electro Stimulator 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 N CAUTION CORRECT EQUIPMENT INSTALLATION PREVENTS SECURITY RISKS Cleaning the NEURODYN PORTABLE TENS Electro Stimulator Disconnect the system from the power source wipe with a clean lint free cloth moistened with water and mild antibacterial soap If a more sterile cleaning is needed use a cloth moistened with an antimicrobial cleaner Do not place the system in liquids 14 ENVIRONMENTAL PROTECTION The NEURODYN PORTABLE TENS is an e
14. d to the head and face and e Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the device PATIENT POPULATION AND CONDITIONS OF USE PATIENT POPULATION e Patients over 12 years old under this age only by medical prescription or physiotherapeutic indication e Patients over 35 kg under this weight only by medical prescription or physiotherapeutic indication e There are no restrictions as of nationality e Patients with preserved level of conscience and sensitivity CONDITIONS OF USE e There are no requisites about a maximum level of education for the intended use e Regarding the minimum level of knowledge of the user it is necessary that the user knows the electro physical agents and their therapeutical effects The user must know physiology anatomy and the basic sciences chemistry physics and biology The user is supposed to have studied or be presently studying physiology and anatomy e A maximum level of knowledge is not required from the user e The instructions of use are available in Portuguese Spanish and English 11 e Regarding the minimum level of experience of the user it is necessary that the instructions of use are read carefully and all the instructions are understood before the use of the device e There are no admissible deficiencies for the use of the equipment e Regarding the frequency of use this device is used accordin
15. decreased immunity of the NEURODYN PORTABLE TENS Electro Stimulator ELETROMAGNETIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Emissions The NEURODYN PORTABLE TENS is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN PORTABLE TENS should ensure that it is used in such an environment Emission Test Compliance Electromagnetic environment Guidance The NEURODYN PORTABLE TENS must emit RF Emissions l ro Group 1 electromagnetic energy in order to perform it s intend CISPR 11 l function Nearby electronic equipment may be affected RF Emissions Class A CISPR 11 Harmonic The NEURODYN PORTABLE TENS is suitable for use Emissions Class A in all establishments other than domestic those directly IEC 61000 3 2 connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Class A IEC 61000 3 3 ELETROMAGNETIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The NEURODYN PORTABLE TENS is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN PORTABLE TENS should assure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast Transitories burst IEC 61000 4 4 Surge IEC 61000 4 5 IEC 60601 Test
16. ds could cause malfunction of internal components of the system and therefore create a risk of injury to the patient e Disconnect the power plug from the outlet when left unused for long periods of time SAFETY PRECAUTIONS e To protect against the risk of fire only use replacement fuses of the same types and ratings e Be sure the unit is grounded by connecting it to a grounded electrical outlet compliant with the applicable national and local electrical codes e Powered muscle stimulators should be used only with the lead wires and electrodes recommended for use by the manufacturer e Prior to patient treatment become familiar with the operating procedures for each mode of treatment available as well as the indications contra indications warnings and precautions Consult other resources for additional information regarding the applications of Electrotherapy e To prevent electrical shock disconnect the unit from the power source before performing any maintenance task e Keep electrodes separated during treatment Electrodes in contact with each other could result in improper stimulation or skin burns e Stimulation should not be applied over the anterior neck or mouth e Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause breathing difficulties e Stimulation should not be applied transthoracically to avoid the introduction of electrical cu
17. ents thus reducing the resistance to the passage of the electrical current Rinse and dry the area well before placing the electrodes e Remove the self adhesive electrodes from the protective backing and apply to the treatment area as prescribed e Ensure the entire electrode surface is in contact with patient skin by pressing into place e Check the electrode contact regularly during treatment e Examine the skin again after the treatment 32 ELECTRODE POSITIONING Bipolar Electrode Placement Technique Bipolar Electrode Placement Techniques should be used to provide stimulation to larger muscle groups such as the quadriceps or the hamstrings Equal size electrodes are placed at each end of the muscle or muscle group For another application are used equal size electrodes placed at each painful area with this area between the electrodes This is used for control pain The symmetrical waveforms of the Biphasic and Low Frequency are usually applied to the body using the Bipolar Technique The NEURODYN PORTABLE TENS Electro Stimulator offers waveforms of the Nervous Transcutaneous Electrical Stimulation TENS Figure 11 Bipolar Electrode Placement Technique ELECTRODE GUIDELINE Placement of the electrodes near the chest may increase the risk of cardiac fibrillation Electrode Sizes and Current Density The size of the electrodes and the energy density used during therapy must comply with IEC 60601 2 10 i e the c
18. es may be necessary such as reorientation or relocating the NEURODYN PORTABLE TENS b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m 21 ELETROMAGNETIC COMPATIBILITY The NEURODYN PORTABLE TENS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the NEURODYN PORTABLE TENS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the NEURODYN PORTABLE TENS as recommended below according to the maximum output power of the communications equipment Separation distance uo to frequency of transmitter Rated maximum power tput of t itt A a e 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 VP d 0 35 VP d 0 7 VP 100 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 80 MHz to 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ELECTROMAGNETIC COMPATIBIL
19. ess banel 24 Figure 5 NEURODYN PORTABLE TENS LCD 25 Figure 6 A pin cables with banana ends 2 mm and B conductive rubber electrodes and neutral gel 28 Figure 7 The 9 Volt battery Conpechton eee 28 Figure 8 A MODE switch and caption with the waveforms and parameters B Number 3 Tens Vif changing to number Be CNG DEE 29 Figure 9 A SET switch B Display showing the flashing oo RR O wee 29 Figure 10 UP DOWN cwrtch e 30 Figure 11 Bipolar Electrode Placement Technique 32 Figure 12 Electrode sizes and current density 33 FOREWORD PRODUCT DESCRIPTION This user manual allows the user to efficiently use the NEURODYN PORTABLE TENS transcutaneous NEURODYN PORTABLE TENS Electro Stimulator neuromuscular stimulator is a two channel stimulator with independent controls for current therapies used in Consult other resources for additional information TENS Transcutaneous Electrical Nerve Stimulation regarding the uses of electrotherapy before attempting any treatment on a patient Users must read understand Treatment should be administered only under the and follow the information in this manual for each direct supervision of a health care professional mode of treatment available as well as the indications contraindications warnings and precautions The specifications and instructions in this manual are in effect at the time of its publication These instr
20. g 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 physical therapists or health professionals properly licensed The professional will be responsible for properly licensed use and operation of the equipment IBRAMED makes no representations regarding laws and federal state or local laws that may apply to the use and operation of any electromedical equipment The physician or under his command also the physical therapist or other professional health care licensed assumes total and full commitment to contact the local certifying agencies to determine any credential required by law for clinical use and operation of this equipment The use of electromedical equipment must comply with the local state and federal country 12 GENERAL CARE WITH THE EQUIPMENT SHIPPING DAMAGE INSTALLATION CARE AND CLEANING Your NEURODYN PORTABLE TENS Electro Stimulator is Installation Instructions shipped complete in one carton Upon receipt inspect carton e Connect the line cord to the back of the NEURODYN and unit for visible and hidden damage In case of damage PORTABLE TENS Electro Stimulator keep all shipping materials including carton and contact the e Plug the line cord into a grounded wall outlet 100 240V shipping agent responsi
21. ge drops in U by 5 seconds Compliance Level lt 5 U gt 95 voltage drops in U by 0 5 cycle 40 U 60 de voltage drops in U by 5 cycles 70 U 30 voltage drops in U by 25 cycles lt SORN gt 95 voltage drops in U by 5 seconds 19 Electromagnetic Environment Guidance Mains power quality should be that of a typical commercial or hospital environment If the user of the NEURODYN PORTABLE TENS requires continued operation during power mains interruptions it is needed that the NEURODYN PORTABLE TENS be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment ELETROMAGNETIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The NEURODYN PORTABLE TENS is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN PORTABLE TENS should assure that it is used in such an environment li Immunity Test FER QUO sompuanes Electromagnetic Environment Guidance Test Level Level Portable and mobile RF communication equipment should not be used no closer to any part of NEURODYN PORTABLE TENS including cable than be separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P EES SEN 3 V d
22. ilizers 15 Before turning on NEURODYN PORTABLE TENS make sure e That the frequency tension of the local mains power of the premises where the equipment will be installed is equal to the one described on the tension and power line characteristics label located on the rear part of the equipment e To avoid electric shock do not use the plug of the device with an extension cable nor with other types of cables unless the terminals connect completely to the receptacle e Cleansing and disinfection must be carried out with the mains power plug off the electrical source outlet plug e Maintenance and technical assistance of NEURODYN PORTABLE TENS must always be performed by authorized personnel and in authorized service centers A CAUTION There are dangerous tensions inside the equipment Never open the equipment ELETROMAGNETIC COMPATIBILITY N CAUTION Medical Electrical Devices require special attention regarding Electromagnetic Compatibility EMC and must be installed and put into service according to the EMC information provided in the following tables Portable and Mobile Radio Frequency RF communications equipment can affect Medical Electrical Devices 16 AN WARNING The use of accessories other than those listed except when supplied or sold by Ibramed Ind stria Brasileira de Equipamentos M dicos EIRELI as replacement parts for internal or external components may result in increased emission or
23. insusceptible individuals and e Increase local blood circulation e Apply stimulation only to normal intact clean healthy skin e Post traumatic acute pain e Post surgical acute pain WARNINGS e Do not apply stimulation in the brain region e Do not apply stimulation over open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions eg phlebitis thrombophlebitis varicose veins e Do not apply stimulation over or in proximity to cancerous lesions e Do not apply stimulation in the presence of electronic monitoring equipment e g cardiac monitors ECG alarms which may not operate properly when the electrical stimulation device is in use e Do not apply stimulation when the patient is in the bath or shower e Do not apply stimulation while the patient is sleeping e Do not apply stimulation while the patient is driving operating machinery or during any activity in which electrical stimulation can put the patient at risk of injury CONTRAINDICATIONS PRECAUTIONS AND ADVERSE REACTIONS PRECAUTIONS e The safety of electrical stimulation during pregnancy has not been established e One should be careful with patients with suspected heart problems or already diagnosed problems e Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians e Caution should be used in the presence of the following a When there is a tendency to hemorrhage followi
24. lectronic device and has heavy metals such as lead Thus there are risks of contamination to the environment associated with the dis posal of this equipment and its accessories at the end of their useful lives The NEURODYN PORTABLE TENS parts and accessories must be disposed of as waste Contact your local distributor for information on rules and laws regarding the disposal of waste electrical electronic equipment and accessories ELECTRICAL FEED NEURODYN PORTABLE TENS is mono phasic equipment which can be connected to power supply lines I the range from 100 240V 50 60 Hz Just connect the device to the power line and it will automatically select the mains power The connection cable to the mains power is detachable The equipment uses a power line plug as a resource to electrically separate its circuits in relation to the mains power in all poles NEURODYN PORTABLE TENS requires no type of surge protector Never use stabilizers energy NOTES On the rear part of NEURODYN PORTABLE TENS there is the protection fuse To replace it turn the equipment off the mains power and using a screwdriver remove the protective lid disconnect the fuse make the replacement and put the lid back Always use the fuses indicated by IBRAMED Use the fuse for nominal current of 5 0 A operation tension 250 V and Snap action model 20AG and rupturing capacity of 50A NEURODYN PORTABLE TENS does not need any power stabilizer Never use power stab
25. ng acute trauma or fracture b Following recent surgical procedures when muscle contraction may disrupt the healing process c Over a menstruating or pregnant uterus d Over areas of the skin which lack normal sensation e Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium The irritation can usually be reduced by using an alternative conductive medium or an alternative electrode placement e The long term effects of electrical unknown e Keep this device out of the reach of children e Use this device only with the leads electrodes and accessories recommended by the manufacturer stimulation are 10 CONTRA INDICATIONS e Do not use this device on patients who have a cardiac pacemaker implanted defibrillator or other implanted metallic or electronic device because this may cause electric shock burns electrical interference or death Do not user this device on patients whose pain syndromes are undiagnosed e Other contraindications are patients suspected of carrying serious infectious disease and disease where it is advisable for general medical purposes to suppress heat or fevers ADVERSE REACTIONS e Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin e Patients may experience headache and other painful sensations during or following the application of electrical stimulation near the eyes an
26. ofessionals 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 A CENTRO DE ESTUDOS E FORMA O AVAN ADA B R A ME D 39 B else IBRAMED QUESTAO DE RESPEITO Manufactured by IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI Av Dr Carlos Burgos 2800 Jd It lia 13901 080 Amparo SP Brazil Phone 55 19 3817 9633 www ibramed com br ibramed ibramed com br
27. ose the parameters Figure 9 3 200 ww se Figure 9 A SET switch B Display showing the flashing point OPERATING INSTRUCTIONS The figure below shows an example of waveform and parameter adjustment according to the text above O Tens O T us Figure 10 UP DOWN switch Q Tens Vf O F Hz O Tens Vif Time Min Time Parameters Tens Ac At the end of the scheduled application time the yellow Burst luminous indicator of the presence of output current intensity will be turned off indicating the end of the j treatment The current intensity will be stopped The LCD will display 2200 3 200 The UP DOWN buttons allow the selection of the values of each parameter required for the treatment Press the UP button to increase the value of the parameter Prepare and Install Patient Electrodes Press the DOWN button to move back to the previous Prepare the patient for therapy as described and read setting Figure 10 about the use of electrodes 30 OPERATING INSTRUCTIONS PROGRAMMING EQUIPMENT Waveform Intensity Example 1 uppose that to treat a specific pathology you The Waveform Intensity may be increased or decreased need to select the following parameters at any time during the session Press the INTENSITY Mode 1 Tens button up or down Frequency F 50 Hz Phase Duration T 200 us Low Battery Time 30 min The equipment has a protection against safety risks if 1
28. rrent into the heart which may cause cardiac arrhythmia e Stimulation should not be applied over swollen infected and inflamed areas or skin eruptions such as phlebitis thrombophlebitis varicose veins etc e Stimulation should not be applied on or near cancerous lesions e Output current density depends on the electrode size Improper application may result in patient injury For any question related to the correct electrode size consult a licensed practitioner prior to therapy session DANGERS e Patients with an implanted neurostimulation device must not be treated with or be in close range of any shortwave diathermy microwave diathermy therapeutic ultrasound diathermy or laser diathermy anywhere on their body Energy from diathermy shortwave microwave ultrasound and laser can be transferred through the implanted neurostimulation system can cause tissue damage and can result in severe injury or death Injury damage or death can occur during diathermy therapy even if the implanted neurostimulation system is powered off e Equipment not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR OXYGEN or NITROUS OXIDE d ELECTROTHERAPY INDICATIONS INDICATIONS FOR USE Indications for TENS waveform e Consult with the patient s physician before using this device because the device may cause lethal rhythm disturbances to e Symptomatic relief and management of chronic pain the heart
29. s 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 T MAINTENANCE WARRANTY AND TECHNICAL SUPPORT C Misuse lack of reasonable care product alterations modifications or repairs undertaken by individuals or entities not authorized by IBRAMED d Removal or adulteration of the equipment serial number e Damage during Transport 5 The legal warranty does not cover expenses incurred during product installation or transport to the plant or sale point labor materials parts and adjustments necessary to the readiness of the premises in view of the installation of the device such as but not limited to electric net masonry hydraulic network grounding system as well as their requirements 6 The warranty does not cover parts subjected to natural wear such as but not limited to control buttons control keys handles and moving parts radiofrequency applicators cooling applicator cables connectors device cabinets pedal infrared thermometer 7 The selling points are neither authorized to alter the conditions mentioned in this document nor take any commitment on behalf of IBRAMED 38 TECHNICAL ASSISTANCE If you have any doubts or problems related to the operation of your equipment please contact our technical department in Brazil Call 5
30. s not Check if there is a bad contact Check if the value is correct as stated in turn on 2 the instructions The equipment is turned on e Have you followed the recommendations for correct use the equipment but does not emit current to as mentioned in the instructions patient 1 Check and repeat the steps in the controllers indications and operation section The equipment is turned on e Have you checked the electrodes and the connecting cables to the but does not emit current to patient patient 2 Check if the cable plug is adequately inserted in the equipment Check if the electrodes are adequately placed on the patient s body The equipment does notturn e Check if the amount of gel is enough on and or work properly e Check if the electrodes are worn properly 36 MAINTENANCE WARRANTY AND TECHNICAL SUPPORT MAINTENANCE For safe use of the equipment it is recommended to have it inspected and undergo preventive maintenance at IBRAMED or an authorized technical center every 12 months The manufacturer IBRAMED only assumes liability for the technical features and equipment safety provided the unit is used according to the instructions for use contained in the manual when maintenance repairs and modifications are undertaken solely by the factory or authorized agents and in the event of a breakdown when the components that can cause a security risk to the appliance are replaced by original spare parts If requested I
31. uctions may be updated at any time at the manufacturer s discretion Visit our website for updates SAFETY PRECAUTIONS PRECAUTIONARY DEFINITIONS The precautionary instructions found in this section and throughout this manual are indicated by specific symbols Understand these symbols and their definitions before operating this equipment prior to therapy session N 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 A DANGER Text with a DANGER indicator refers to potential safety infractions that represent immediately life threatening situations that would result in death or serious injury e Read understand and practice the precautionary and operating instructions Know the limitations and hazards associated with the use of any electrical stimulation Note the precautionary and operational labels placed on the unit e DO NOT operate this unit in an environment where other devices intentionally radiate electromagnetic energy in an unshielded manner e Check cables and associated connectors before each use e The NEURODYN PORTABLE TENS Electro Stimulator is not designed to prevent the infiltration of water or other liquids The infiltration of water or other liqui
32. urrent density per area of electrode should not exceed 2 mA cm 2 The smallest electrode size that may be used with this device is 25 cm2 Follow the manufacturer s instructions We recommend the use of electrodes provided by Axelgaard Manufacturing Co Ltd Fallbrook CA 92028 USA FAX 1 760 723 2356 www axelgaard com iE a i Figure 12 Electrode sizes and current density 33 REFERENCES DeSantana JM Walsh DM Vance C Rakel BA Sluka KA Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain Curr Rheumatol Rep 2008 10 6 492 9 Delitto A Rose SJ McKowen JM et al Electrical stimulation versus voluntary exercise in strengthening thigh musculature after anterior cruciate ligament surgery Phys Ther 1988 68 5 660 663 Gersh MR Wolf SL Applications of Transcutaneous Electrical Nerve Stimulation in the management of patients with pain Phys Ther 1985 65 3 314 336 Guirro R Nunes CV Davini R Compara o dos efeitos de dois protocolos de estimula o el trica neuromuscular sobre a for a muscular isom trica do quadriceps Rev fisioter Univ Sao Paulo 2000 7 1 2 10 15 Laufer Y Ries JD Leininger PM Alon G Quadriceps femoris muscle torques produced and fatigue generated by neuromuscular electrical stimulation with three different waveforms Phys Ther 2001 81 7 1307 1316 McManus FJ Ward AR Robertson VJ The
33. z hd T 50 500 ys IEY ga ga EEY Burst Modulation Burst F 250 Hz ER dt T 50 500 us 3 d a g fteg Acupuncture Tens Ac F 8 25 Hz T 175 275 us Frequency Phase Duration Variation Tens Vif F 7 65 Hz T 50 225 us Frequency Variation Tens Vf F 7 65 Hz T 50 500 us Set Intensity Individual Channel Intensity Setting Available on channels 1 or 2 Timer 1 60 min T 27 ACCESSORIES USED OPERATING INSTRUCTIONS Prepare Device The NEURODYN PORTABLE TENS can be used with power cable or with battery In case of use of battery the IEC 6F22 TENS pin connector cables with banana ends 2 mm and conductive rubber electrodes Figure 6 type use 9 volt battery as accessory to the equipment battery not include Replace battery Remove the protection packing and connect the battery to the connector within the compartment Close the compartment cover The battery connector within the compartment is special and does not allow incorrect placement Use only 9V DC Alkaline Ensure battery door Figure 6 A pin cables with banana ends 2 mm and is in place before starting treatment Remove battery from B conductive rubber electrodes and neutral gel unit when not in use Figure 7 The connector screws must be firmly affixed to your connection on the back panel of the device INEW LEADER To remove the banana pins self adhesive electrodes pull them by their protective cover Never pull the cord
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