Manual - Ibramed
Contents
1. 33 Figure 12 Monopolar Electrode Placement Technique 34 Figure 13 Electrode sizes and current density 34 Figure 14 UP switch for manual stimulation MS 35 FOREWORD This user manual allows the user to efficiently use the NEURODYN PORTABLE TENS FES Electro Stimulator Consult other resources for additional information regarding the uses of electrotherapy 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 SE Sl IBRAMED PRODUCT DESCRIPTION NEURODYN PORTABLE TENS FES transcutaneous neuromuscular stimulator is a two channel stimulator with independent controls for current therapies used in TENS Transcutaneous Electrical Nerve Stimulation and FES Functional Electrical Stimulation Treatment should be administered only under the direct supervision of a health care 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 befo2. FES SYNC FES REC F T RISE T ON DECAY T OFF M STIM Hertz pulses per second Milliampere Volt Ampere Transcutaneous Electrical Nerve Stimulation Modulation of Frequency TENS modulated TENS Acupuncture TENS with Variation Phase Duration Frequency TENS with Variation Frequency Functional Electrical Stimulation Functional Electrical Stimulation Synchronous Functional Electrical Stimulation Reciprocal Frequency Phase Duration Time of Increase Gradient Time of Muscular Contraction Time of Decrease Gradient Time of Muscular Relaxation Manual Stimulation FIGURES GLOSSARY Figure 1 Upper Access Panel ccceccceseeeeeeeeeeeeeeeeress 24 Figure 2 Rear Access Panel anuannnnnnnannnnnnnennnnenneene 24 Figure 3 Front Access Panel raannnnnnnnnnnnnnnennnnenneenn 24 Figure 4 Lower Access Panel raannnnnnnnnnnnnnnennnnenneene 24 Figure 5 NEURODYN PORTABLE TENS FES LCD 25 Figure 6 A Pin cables with banana ends 2 mm and B Conductive rubber electrodes and neutral gel 29 Figure 7 The 9 Volt battery CONNECTION cceeeeeeeeees 29 Figure 8 A MODE switch and caption with the waveforms and parameters B Number 3 Tens Vif changing to number LTE 30 Figure 9 A SET switch B Display showing the flashing po ol EET EE NF SA 30 Figure 10 UP DOWN SwitCh aaunnannnnannnnnnnnnnnnenneenn 31 Figure 11 Bipolar Electrode Placement Technique
3. s Declaration Electromagnetic Immunity The NEURODYN PORTABLE TENS FES is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN PORTABLE TENS FES should assure that it is used in such an environment IEC 60601 Compliance Electromagnetic Environment Guidance Test Level Level Immunity Test Portable and mobile RF communication equipment should not be used no closer to any part of NEURODYN PORTABLE TENS FES including cable than be separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3V d 1 2 VP d 0 35 VP 80 MHz to 800 MHz Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 10 V m d 0 7 VP 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz 10 V m l l l Where p is the maximum output power rating of the transmitter in watts W according to the transmitter 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 ELETROMAGNECTIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The NEURODYN PORTABLE TENS FES is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN PORTABLE TENS FES should assure tha
4. AND CLEANING Installation Instructions 1 Connect the line cord to the back of the NEURODYN PORTABLE TENS FES Electro Stimulator 2 Plug the line cord into a grounded wall outlet 100 240V 50 60 Hz 3 Plug the electrode cables into the electrode cable connections 4 Switch on your equipment GENERAL CARE WITH THE EQUIPMENT Care Instructions with the equipment ENVIRONMENTAL PROTECTION e Avoid areas subject to vibrations The NEURODYN PORTABLE TENS FES is an electronic e Install the equipment on a firm and level surface device and has heavy metals such as lead Thus there are e Do not block ventilation risks of contamination to the environment associated with e Avoid humid hot and dusty environments the disposal of this equipment and its accessories at the end e Make sure the area around the network cable is free of their useful lives The NEURODYN PORTABLE TENS e Do not insert objects into device holes FES 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 N CAUTION CORRECT EQUIPMENT INSTALLATION PREVENTS SECURITY RISKS Cleaning the NEURODYN PORTABLE TENS FES e 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 antimi
5. are always thoroughly selected according to the best and latest clinical criteria CEFAI takes into account the personal and professional development of all its partners and customers CEFAI invites both students and professionals in the fields of Physical Rehabilitation Esthetics Physiotherapy Dermatology 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 Special attention is also given to those interested in visiting our structure Whatever your professional development needs we ll be right by your side to provide you with unconditional support We are happy to assist you Contact cefaiQconexaocefai com br www conexaocefai com br 55 19 3808 2348 Thanks IBRAMED A matter of respect f CEFAI cora o avan am IBRAMED JE IBRAMED QUEST O 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
6. 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 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 WARRANTY IBRAMED Industria Brasileira de Equipamentos M dicos EIRELI here identified to the consumer through the following address and telephone number Av Dr Carlos Burgos 2800 Jd Italia 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 39 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 p
7. 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 isometrica do quadriceps Rev fisioter Univ S o 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 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 36 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 ca
8. 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 e Portable powered muscle stimulators should not be used while driving operating machinery or during any activity in which involuntary muscle contractions may put the user at undue risk of injury e Consult with the patient s physician before using this device because the device may cause lethal rhythm disturbances to the heart insusceptible individuals e Apply stimulation only to normal intact clean healthy Skin CONTRA INDICATIONS PRECAUTIONS AND ADVERSE REACTIONS PRECAUTIONS e The safety of electrical stimulation during pregnancy has not been established e Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians e Use caution when the patient has a tendency to bleed internally such as following an injury or fracture e Use caution following recent surgical procedures when stimulation may disrupt the patient s healing process e
9. the battery is low When the conditions to the battery are unsatisfactory low the LCD of the NEURODYN PORTABLE TENS FES will display the low battery message 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 message a O 1 4 00 be AN WARNING Remove the 9 volt battery if the equipment is not used for a long period of the time 32 PROGRAMMING EQUIPMENT Example 1 Suppose that to treat a specific pathology you need to select the following parameters Mode 1 Tens Frequency F 50 Hz Phase Duration T 200 us Time 30 min 1 Press the MODE button until number 1 Tens displays as shown below 1 200 2 Using the SET button select number 2 and number 3 and with UP DOWN buttons scroll through the other parameters and select the value shown in the example 1 Phase Duration T 200 us 2 Frequency F 50 Hz and Time 30 min 1 200 2 50 3 30 s oe ut Td 3 Now adjust the INTENSITY channel in use to select the amount of current needed for the treatment increasing t 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 a
10. voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Class A IEC 61000 3 3 ELETROMAGNECTIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The NEURODYN PORTABLE TENS FES is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN PORTABLE TENS FES 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 TEC 61000 4 5 IEC 60601 Test 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 ELETROMAGNECTIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The NEURODYN PORTABLE TENS FES is intended for u
11. 2 WAY CABLE BLACK 03 13 03028002 or CRYSTAL REEL esm o 03041002 or oven gt 02026024 04 Etectropes SCMX3CM ELECTRODES 5 CM X 3 CM 03040004 og CDUSERMANUAL GEL TUBE CAP 100 GRAMS 03044001 REGISTERED ANVISA No 80122200001 37 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 does mnot 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 the condition of the 9 volt battery on and or work properly 38 MAINTENANCE WARRANTY AND TECHNICAL SUPPORT MAINTENANCE For safe use of the
12. Caption with the waveforms Burst on s and parameters Fes Sync O Decay s Fes Rec O Off s Fes sync Vif 8 M Stim Figure 5 NEURODYN PORTABLE TENS FES LCD Fes Rec Vif 4 25 SYMBOL DEFINITIONS SPECIFICATIONS Channel Lead SYSTEM SPECIFICATIONS Fi dl Charnel gt Wire Connectors Dimensions Chonde Land 2 Width 3 0 in 7 8cm Depth 5 8 in 14 8 cm Height 1 9 in 5 cm Standard Weight without accessories 0 240 kg Power Parameters increase Input 100 240V 50 60 Hz Input Power 15 VA Fuses 5A 250V 20AG Electrical Class CLASS II Electrotherapy TYPE BF Regulatory Compliance IEC EN 60601 1 IEC EN 60601 1 2 IEC 60601 2 10 IEC 60601 1 4 Temperature Range During Transport and Storage Intensity InLensily 5 50 C 41 122 F y Environment operating temperature range Parameters decrease 5 45 C 41 113 OF o Na 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 Output Mode Electrodes rn Transcutaneous Electrical Nerve Output Intensity 0 100 mA timulation l l l Frequency F 0 5 250 Hz The Asymmetrical Biphasic waveform has short pulse duration and is capable of strong stimulation of nerve Phase Duration
13. Em Ur Po IBRAMED QUESTAO DE RESPEITO Instruction Manual NEURODYN PORTABLE TENS FES Manufactured by Ibramed Industria Brasileira de Equipamentos M dicos EIRELI Made in Brazil ANVISA N 10360310012 11 edition LAST REV 12 2013 TABLE OF CONTENTS SYMBOL DEFINITTON S Se 3 CARTON EEE EE E al ABREVIATIONS GLOSSARY ccccc cece eee eee e eee eeee eee eeeas 4 FOURES GLOSSAR Luren 5 FOREWORD EEEE E N EEEE EENAA AN AAIEN 6 PRODUC DESCRIPTION erre 6 SAFETY PRECAUTIONS iss ccniwosteusiestawse gues ender ens 7 INDICATIONS havre mans vrnnn era nemne DR 2 9 CONTRA INDICATIONS PRECAUTIONS AND ADVERSE REACTIONS 20000 00 00 ETE 10 POPULATION AND CONDITIONS OF USE 11 RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT sssssusununnnsnanonannunsnannunun nn RD 12 GENERAL CARE WITH THE EQUIPMENT 13 ELECTRICAL FEED s esssusunuununununuen D A 15 ELETROMAGNECTIC COMPATIBILITY ecaa 16 NOMEN CHA FURE genene derre ESANA 24 CONTROLS INDICATORS AND CONNECTIONS 24 SYMBOL DEFINI TIONS sssssssssssssusnnnnnnnnnnsrnrersrerenns 25 SPECIFICATION ev 26 SYSTEM SPELT CAINS pane ago a dna 26 WAVEFORM SPECIFICATIONS ursine 2 ACCESSORIES USED Leda 29 OPERATING INSTRUCTIONSS maisen 29 PROGRAMMING EQUIPMEN Iinsiccdtncxnennadteneaseasorenanns 32 ELECTRODE GUIDELINE scscicactapcconnienccedamnoensewarceaes 33 USING THE MS MANUAL STIMULATION 35 PROGRAMMING USER
14. MANUAL STIMULATION 35 REFERENT 36 ACCESSORIES ACCOMPANYING NEURODYN PORIADES LENS PES under 37 REPLACEMENT ACCESSORIES possprsadeniaanstnnraas 37 TROUBLESHOOT ING ssasasssssssnensnnrnrnnrnnnnnrnrrerenrnne 38 MAINTENANCE WARRANTY AND TECHNICAL E MERE E T 39 CEFAI IBRAMED CENTER FOR EDUCATION AND PUBIC IIDMIESAINING 0cccccescccnceeesseneceesceneeeeses 41 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 Caution Refer to user manual Off switch TYPE BF Electrical equipment g C On switch Dangerous voltage o gt b gt CLASS II Electrical equipment V Voltage in AC Alternating Current IPXO Not protected against the harmful effects of lj Electrical Network in AC water penetration We Alternating Current FE A Sensitivity against electrostatic discharge SYMBOL DEFINITIONS CARTON I i E E a i Ni T Fragile This side up Limits of temperature for storage and packaging in C Celsius Degrees Keep away from the rain Stacking up Do not use if the packaging is damaged Refer to operating instructions for correct product use Manufacturer s name and address ABREVIATIONS GLOSSARY Hz mA VA TENS BURST TENS BURST TENS AC TENS VIF TENS VF FES
15. ORTABLE TENS FES will perform the stimulation following the rise on and decay gradients programmed for FES current types Fes Sync Synchronized Fes Fes Sync The LCD will display the following message VIF Synchronized Fes with Vif Fes Rec Reciprocal Fes or Fes Rec Vif Reciprocal Fes with Vif It is necessary to program the parameters in the LCD of the 8 O E e NEURODYN PORTABLE TENS FES so that the MS key works as a manual stimulation Figure 14 moos ar Now press the UP switch and the MS function will be activated and the display will show ON To use the MS switch select the function number 6 Fes Sync 7 Fes Rec 8 Fes Sync Vif or 9 Fes Rec Vif using the MODE switch After that using the SET switch select function 8 M Stim ON and select the others parameters 4 Rise 5 On 6 Decay and 7 Off using the UP DOWN switch 8 on s Figure 14 UP switch for manual stimulation MS 35 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
16. S FES 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 FES can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the NEURODYN PORTABLE TENS FES as recommended below according to the maximum output power of the communications equipment Separation distance ae to frequency of transmitter Rated maximum power tput of t itt ae 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 COMPATIBILITY Equipment Serial number ANVISA Registration M S Manufacturing date Expiration date 5 years Senior engineeer Maicon Stringhetta CREA 5062850975 23 NOMENCLATURE E 7 Channel 2 m Cd L et EE ae S
17. T 50 500 us fibers in the skin and in muscle Because of its short pulse Burst Frequency 2 Hz duration the patient typically tolerates the current well Modulation of Burst Frequency 250 Hz even at relatively high intensities VF Frequency 7 65 Hz VIF Frequency 7 65 Hz VIF Phase Duration 50 225 us 5 l Current Mode alho E ise Ea Gee Normal Continuous Tens F 0 5 250 Hz T 50 500 us EE RER E Burst Modulation Burst F 250 Hz T 50 500 us pe pa E OE Boe Acupuncture Tens Ac F 8 25 Hz T 175 275 us va uka ra Frequency Phase Duration Variation Dp td a BENS Saks BARS Cia lo St do i 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 2 SPECIFICATIONS FES Function Electrical Stimulation Output Mode Electrodes Functional Electrical Stimulation FES uses low levels of Output Intensity 0 100 mA electrical current to stimulate physical or bodily functions Frequency F 0 5 250 Hz lost through nervous system impairment FES is applied to Phase Duration T Adjustable 50 500 us peripheral nerves that control specific muscles or muscle groups VIF Phase duration 50 225 us VIF Frequency 7 65 Hz Current Mode Synchronous Fes Sync 1 amp 2 channel Reciprocal Fes Rec 1 amp 2 channel
18. Use caution if stimulation is applied over the menstruating or pregnant uterus e Use caution if stimulation is applied over areas of skin that lack normal sensation Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium gel 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 e Do not user this device on patients whose pain syndromes are undiagnosed 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 and 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 POPULATION AND CONDITIONS OF USE PATIENT POPULATION e Patients over 12 years old under this age only by medical prescription or physiotherapeutic indication e Patien
19. a RTS elle ETT ea ra EE TG ee E No ra Electro 3 wS Therapy gt 4 gt ware ai ne 9 11 14 4 00 CO Figure 2 Rear Access Panel da pe F E a Li gt i 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 Manual Stimulation Button 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 Current Mode Tens Tens Vf Tens Vif definitions before operating this equipment Tens Ac Burst Fes Sync Fes Rec Fes Sync Vif Fes Rec Vif Channel 2 vat A Select the parameters Phase Duration T Frequency F Time Rise On Decay Off and Manual Stimulation M Stim w Sw eit ie Boot al TE 2 7 amp 2 Fr ho h f lt T a SP PR PA OT REN a bee pe por bl p l a i a p FAEN g Therapy Button used to start or stop the treatment OD On switch foo GX 0 0a Em ODO Cm 1 2 3 4 5 7 8 9 amp C Off switch Tens T us Tens Vf O F HZ O Tens Vif Time Min i Tens Ac Rise s
20. crobial cleaner Do not place the system in liquids 14 ELECTRICAL FEED NEURODYN PORTABLE TENS FES is monophasic equipment and it may be connected to mains voltage in the range of 100 to 240v 50 60 Hz Just connect the equipment to the power supply line and it will perform the of selection mains voltage automatically The connecting cable to the power line is detachable The equipment uses a mains plug as a resource to electrically separate its circuits in relation to the mains power in all the poles NEURODYN PORTABLE TENS FES does not need any type of current stabilizer Never use power stabilizers 15 Before turning on NEURODYN PORTABLE TENS FES make sure e The tension and frequency of the local mains voltage is equal to the one described on the label of power line and tension characteristics located in the rear part of the equipment e To prevent electrical shock do not use the plug in the equipment as an extension cable or other types of plugs except the terminals fit completely in the receptacle e Cleansing and disinfection must be performed with the power plug disconnected from the mains voltage e Maintenance and technical assistance of NEURODYN PORTABLE TENS FES must always be performed at an authorized technical service only by qualified technicians N CAUTION There are dangerous tensions inside the equipment Never open the equipment ELETROMAGNECTIC COMPATIBILITY Electromagnetic Compatibil
21. ical Stimulation TENS Figure 11 Bipolar Electrode Placement Technique Monopolar Electrode Placement Technique The Monopolar Electrode Placement Technique has been found to be especially useful for muscle stimulation of the upper extremities and small muscle groups The smaller electrode is placed over the muscle motor point and the larger electrode is placed over the painful area Monopolar Techniques may be used with the waveforms nica Biphasic and Low Frequency ELECTRODE GUIDELINE The NEURODYN PORTABLE TENS FES Electro Stimulator Electrode Sizes and Current Density offerswaveformsoftheFunctionalElectricalStimulation FES The size of the electrodes and the energy density used during therapy must comply with IEC 60601 2 10 i e the current density per area of electrode should not exceed 2 mA cm w7 nin Figure 13 Electrode sizes and current density Figure 12 Monopolar Electrode Placement Technique Placement of the electrodes near the chest may increase the risk of cardiac fibrillation 34 USING THE MS MANUAL STIMULATION PROGRAMMING USER MANUAL STIMULATION Manual Stimulation MS is a switch that allows for the stimulation to be manually performed by the user When this switch is activated the equipment will execute the rise on decay and stop gradients this means that it will remain in off for the period that the operator considers necessary Each time this switch is activated NEURODYN P
22. irements 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 TECHNICAL ASSISTANCE If you have any doubts or problems related to the operation of your equipment please contact our technical department Call 55 19 3817 9633 1 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 provides knowledge Science constitutes our differential value and we effectively take advantage of its benefits in order to ensure patient safety and thereby maximize results IBRAMED develops products with scientific support of the most recent medical studies published in major scientific journals in the areas of biological health and exact Access to the knowledge database is guaranteed by CEFAI IBRAMED Center for Education and Advanced Training whose goal is to provide technical and scientific support as well as current literature on therapies and their applicability while our treatment choices
23. ity Guidance AX 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 Industria Brasileira de Equipamentos M dicos EIRELI as replacement parts for internal or external components may result in increased emission or decreased immunity of the NEURODYN PORTABLE TENS FES Electro Stimulator ELETROMAGNECTIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Emissions The NEURODYN PORTABLE TENS FES is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN PORTABLE TENS FES should ensure that it is used in such an environment Emission Test Compliance Electromagnetic environment Guidance The NEURODYN PORTABLE TENS FES must emit RF Emissions a Group 1 electromagnetic energy in order to perform it s intend CISPR 11 function Nearby electronic equipment may be affected RF Emissions Class A CISPR 11 Harmonic The NEURODYN PORTABLE TENS FES is suitable for use Emissions Class A in all establishments other than domestic those directly IEC 61000 3 2 connected to the public low
24. lini lit Frequency Phase Duration Variation Vif PORRA PRESA eaten foodie fatale F 7 65 Hz T 50 225 us Ramp Rise Time of Increase Gradient 1 9 s ver kund a soe Heine pesos On Time of Muscular Contraction 1 30 s e a U U Decay Time of Decrease Gradient 1 9 s an a Off Time of Muscular Relaxation 1 30 s Set Intensity Individual Channel Intensity Setting Available on Channels 1 or 2 Timer 1 60 min 28 ACCESSORIES USED TENS or FES pin connector cables with banana ends 2 mm and rubber conductive electrodes Figure 6 Figure 6 A Pin cables with banana ends 2 mm and B Conductive rubber electrodes and neutral gel The connector screws must be firmly affixed to your connection on the back panel of the device To remove the banana pins self adhesive electrodes pull them by their protective cover never pull the cord OPERATING INSTRUCTIONS Prepare Device The NEURODYN PORTABLE TENS FES can be used with power cable or with battery In case the use of battery the IEC 6F22 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 Figure 7 NEW LEADER Figure 7 Type of battery used with device IEC 6F22 9
25. nd 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 fragments thus reducing the resistance to the passage of the electrical current Rinse and dry the area well before placing the electrodes e Distribute the conductive gel onto the surface of the rubber which will be in contact with the skin e When using the self adhesive electrode remove it from the protective backing and apply it on 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 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 55 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 FES Electro Stimulator offers waveforms of the Functional Electrical Stimulation FES and Nervous Transcutaneous Electr
26. ompliant 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 current 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
27. pabilities 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 t ACCESSORIES ACCOMPANYING NEURODYN PORTABLE TENS FES NEURODYN PORTABLE TENS FES contains accessories REPLACEMENT ACCESSORIES designed to meet the requirements of electromagnetic comparability accessories 03049001 03049008 This list of replacement accessories are designed for use and 03049009 with the NEURODYN PORTABLE TENS FES Electro Stimulator When ordering provide the respective part numbers description and quantity desired PRE QUANTITY a The use of accessories cables and electrodes other than ERAM ERES DES CR those intended for this specific equipment may significantly 03049001 POWER CABLE KIT NEURODYN degrade the performance of the emissions and immunity PORTABLE DO NOT USE accessories cables and electrodes from 03049009 mL JE ELECTROSTIMULATION 2 WAY NEURODYN PORTABLE TENS FES equipment on other CABLE ORANGE 03 13 equipment or medical electro systems 03049008 ELECTROSTIMULATION
28. ramming Observe that this time the flashing point is located to the right of the first number giving access to choose the parameters Figure 9 A B S Ga 3 200 s Figure9 A SET switch B Displayshowingtheflashing point t OPERATING INSTRUCTIONS The figure below shows an example of waveform and parameter adjustment according to the text above Tens O T us f Q Tens vf O F Hz Figure 10 UP DOWN switch O Tens Vif O Time Min Ti A Rise s de E pi Time Parameters Fes Sync O Decay s Fes Rec Off s At the end of the scheduled application time the yellow Fes Sync Vif MStim Fes Rec Vif 3200 3200 luminous indicator of the presence of output current intensity will be turned off indicating the end of the treatment The current intensity will be stopped The LCD will display 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 about setting Figure 10 the use of electrodes t 31 OPERATING INSTRUCTIONS Waveform Intensity The Waveform Intensity may be increased or decreased at any time during the session Press the INTENSITY button up or down Low Battery The equipment has a protection against safety risks if
29. re 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 N WARNING Text with a WARNING indicator refers to potential safety infractions that could cause serious injury and equipment A DANGER 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 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 FES Electro Stimulator is not designed to prevent the infiltration of water or other liquids The infiltration of water or other liquids 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 Be sure the unit is grounded by connecting it to a grounded electrical outlet c
30. se in the electromagnetic environment specified below The customer or the user of the NEURODYN PORTABLE TENS FES 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 field 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 voltage drops in U by 5 seconds Compliance Level lt 5 ie 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 5 U 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 FES requires continued operation during power mains interruptions it is needed that the NEURODYN PORTABLE TENS FES 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 ELETROMAGNECTIC COMPATIBILITY Guidance and Manufacturer
31. sional 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 Your NEURODYN PORTABLE TENS FES Electro Stimulator is shipped complete in one carton Upon receipt inspect carton and unit for visible and hidden damage In case of damage keep all shipping materials including carton and contact the shipping agent responsible for the delivery of the unit All claims relating to damage during transport Should be filed directly with them The manufacturer will not be liable for any damage during shipping nor allow for adjustments unless proper formal claim has been filed by the receiver against the carrier The carton in which your NEURODYN PORTABLE TENS FES 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 INSTALLATION CARE
32. t Volts battery OPERATING INSTRUCTIONS Turn on the power switch The LCD will display the default screen with the parameters used at the last treatment for example ale 3 200 NotethattheLCDdisplaysthenumberSthatindicates TensVif 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 5 Burst 6 Fes Sync 7 Fes Rec 8 Fes Sync Vif and 9 Fes Rec Vif 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 Tens T us Tens Vf O F HZ OQ Tens Vif O Time Min Tens Ac Rise s Burst on s O Fes Sync Decay s OQ Fes Rec off s Fes sync Vif O M Stim O Fes Rec Vif 30 3 200 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 3 Time min 4 Rise s 5 On s 6 Decay s 7 Off s and 8 MStim Press SET and note that the point now will be flashing indicating that the SET function is now ready for prog
33. t it is used in such an environment IEC 60601 Compliance Immunity Test Test Level Level Electromagnetic Environment Guidance Conducted RF 3 Vrms IEC 610002446 150 kHz to 80 MHz 3 V Interference may occur in the vicinity of equipment marked with the following symbol t Radiated RF 10 V m IEC 61000 4 3 80 MHz to 2 5 GHz vm 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 FES is used exceeds the applicable RF compliance level above the NEURODYN PORTABLE TENS FES should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorientation or relocating the NEURODYN PORTABLE TENS FES Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m ELETROMAGNECTIC COMPATIBILITY The NEURODYN PORTABLE TEN
34. to the correct electrode size consult a licensed practitioner prior to therapy session 1 DANGER 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 Equipment is not the AP or APG category INDICATIONS INDICATIONS FOR USE Indications for FES waveform e Prevention or treatment of disuse atrophy e Increase local blood circulation e muscle reeducation e Maintaining or increasing range of motion e Relaxation of muscle spasm Indications for TENS waveform e Symptomatic relief and management of chronic pain e Increase local blood circulation e Post traumatic acute pain e Post surgical acute pain WARNINGS e Do not apply stimulation over open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions such as phlebitis thrombophlebitis varicose veins e Do not apply stimulation
35. ts 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 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 physical therapists or health professionals properly licensed The profes
36. urchase 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 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 MAINTENANCE WARRANTY AND TECHNICAL SUPPORT 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 requ
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