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1. 23 ACCESSORIES teorias Kad TUE 27 USING THE MENU PROG BUTTON cansino 29 OPERATING INSTRUSTONS omnia 30 ELECTRODE GUIDELINE Senos caes 36 USING THE MENU PROG 40 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS 42 RE ne 45 ACCESSORIES ACCOMPANYING NEURODYN II 46 ll e cu IIA MEE 47 RETINENS CCFESSORIES 47 MAINTENANCE WARRANTY AND TECHNICAL SUPPORT 48 CEFAI IBRAMED CENTER FOR EDUCATION AND ADVANCED mu eu mad am eiua n ite 50 SYMBOL DEFINITIONS BELOW ARE THE DEFINITIONS OF THE SYMBOLS USED ON THE EQUIPMENT AND THROUGHOUT THE INSTRUCTIONSFOUNDINTHISMANUAL UNDERSTAND THESE SYMBOLS AND THEIR DEFINITIONS BEFORE OPERATING THIS EQUIPMENT Start treatment Caution Refer to user manual Off switch TYPE BF Electrical equipment On switch V Stop treatment Dangerous voltage j 9 9 Voltage in AC Alternating Current Electrical Network in AC CLASS II Electrical equipment li INC Alternating Current O Not protected against the harmful effects of water penetration Sensitivity against electrostatic discharge gt SYMBOL DEFINITIONS CARTON Fragile This side up n Limits of temperature for storage and packaging in C Celsius Degrees Keep away from the rain Stacking up Do not use if the packaging damaged Refer to
2. Neurodyn ll EL10_V03_Ex Figure 8 A LCD Messages B NEURODYN II Electro Stimulator Default Screen Note that entering the default screen will cause the word TENS to flash The selection cursor parameters will appear in the Current word and now the device can be programmed Edit Waveform Parameter The SELECT buttons allow you to select the parameters required for the treatment Press the cursor keys to move to the next parameter or rewind the cursor back to the previous setting The SET buttons allow you to select the values of each parameter required for the treatment Time Parameters Set the session time using the SELECT and SET keys Using the SELECT key scroll through the parameters until the timer parameter is located Press SET key to select and to choose the timer desired At the end of the scheduled time you will hear a beep indicating that the emission current has been interrupted Press the STOP button the sound signal turns off and the equipment goes back to the programming status Start Treatment START Press the START button to begin therapy Y session Stop Treatment STE Press the STOP button to end therapy session OPERATING INSTRUCTIONS 2 Using the SELECT key scroll through the parameters until Waveform Intensit the desired parameterislocated Press SET key to select and The Waveform Intensity may be increased or decreased at to choose the status of the parameter desir
3. Sync 10 50 Hz Mode Conv Treatment time Timer Intensity 1 120 mA Positioning of electrodes One electrode channel Decay on the dermatome Off corresponding to the pain and the second on the nerve root corresponding to the On the muscular dermatome in which Positioning of electrodes center or on the the pain is localized motor muscular point Burst Frequency Burst freq Rise D 15 min 1 120 mA Treatment time Timer Intensity WUJ e wj e U IIVI Manufacturer does not preset the intensity because it needs to be adjusted by the therapist in accordance to the patient s needs and treatment plan It can be increased or decreased on the appropriate channel by pushing the up and down button 4 UJ CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 5 RUSSIAN Maintaining or Increasing Range of Motion Description Maintaining or increasing range of motion Parameters values Current Russian Mode Burst duration Duty cycle 50 Burst Frequency Burst freq O 8 Intensity 1 to 120 mA On Positioning of electrodes the muscular center or on the motor muscular point UN lt 2 O Manufacturer does not preset the intensity because it needs to be adjusted by the therapist in accordance to the patient s needs and treatment plan It can be increased or decreased on the appropriate channel by pushing the up and down button 44 REFERENCES DeSantana JM Walsh
4. 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m Where p is the maximum output power rating of the IEC 61000 4 3 80 MHz to 2 5 GHz 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 II is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN II should assure that it is used in such an environment IEC 60601 Compliance Electromagnetic Environment Guidance Test Level Level Immunity Test 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 2 Radiated RF 3 V m IEC 61000 4 3 80MHzto2 5GHz WM 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
5. from the self adhesive electrodes pull them by their protective cover Never pull the cord The TENS FES and RUSSIAN currents are depolarized currents and they do not require specific positioning for the cathode and anode electrodes unlike polarized currents The electrodes must be positioned in pairs on the patient in accordance with the colors of each channel orange black blue and green Continuous Current Polarized Charges move always in the same direction it is that in which the continuous flow follows only one direction Unidirectional Alternating Current Depolarized There is the inversion of polarity ate regular time intervals it is that in which the current flows first in one direction then another Bidirectional continuous flow 28 USING THE MENU PROG BUTTON USING THE MENU BUTTON SELECT THE LANGUAGE The MENU PROG button is used to select the language Press MENU PROG until you hear three beeps Select the desired language Portugu s Espafiol or English figure 7 Timer pb Current v Mode Language English Figure 7 LCD displays the selected language 29 OPERATING INSTRUCTIONS PREPARE DEVICE Turn the power switch on LCD displays the message device presentation for a few seconds followed by the software model of the device default screen programming Figure 8 A B IBRAMED Timer type gt Current TENS Y Mode Intensity mA ch1 0 ch3 0 ch2 0 ch4 0
6. muscles Electrodes of similar size are placed over each extremity of the muscle or muscle group The Neurodyn II electrostimulator offers wave for mats for bipolar stimulation Transcutaneous Nervous Elec trical Stimulation TENS Functional Electrical Stimulation FES and Russian Current Russian 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 lager electrode is placed over the painful area The Neurodyn II Electrostimulator offers wave forms for monopolar stimulation Functional Electrical Stimulation FES and Russian Current Russian Figure 9 Bipolar Electrode Placement Technique 37 Figure 10 Monopolar Electrode Placement Technique ELECTRODE GUIDELINE ELECTRODE POSITIONING Positioning of the Electrodes for Foot Drop Positioning of the Electrodes for Foot Drop Positioning of the electrodes on the gastrocnemius muscle Positioning of the electrodes on the posterior tibial muscle motor point on the muscle belly motor point on the muscle belly Figure 11 Positioning of the electrodes on the Figure 12 Positioning of the electrodes on the gastrocnemius muscle posterior tibial muscle 38 ELECTRODE GUIDELINE A WARNING Placement of the electrodes near the chest may increase the
7. operating instructions for correct product use Manufacturer s name and address ABREVIATIONS GLOSSARY VA TENS FES Cont Sync Rec VIF Rise On Decay Off Manual stm Hertz pulses per second Milliampere Volt Ampere Transcutaneous Electrical Nerve Stimulation Functional Electrical Stimulation Continuous Synchronous Reciprocal Variation Phase Duration Frequency Time of Increase Gradient Time of Muscular Contraction Time of Decrease Gradient Time of Muscular Relaxation Manual Stimulation FIGURES GLOSSARY Figure 1 Upper Access 20 Figure 2 Rear Access 20 Figure 3 Front Access 20 Figure 4 Lower Access 20 Figure 5 A Pin cables with banana ends 2 mm and B Self adhesive conductive 27 Figure 6 A the connectors must be affixed to your connection on the panel of the device B the connector screws must be firmly affixed and C put the banana pins cable inside the electrode connector and not forget that the electrodes must be positioned in pairs on the patient in accordance with the colors of each channel eorr see 28 Figure 7 LCD displays the selected language 29 Figure 8 LCD Messages B NEURODYN Electro S
8. 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 Mackler 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 ACCESSORIES ACCOMPANYING NEURODYN II Ibramed NEURODYN II contains accessories designed to meet the requirements of electromagnetic comparability accessories accessories code 03018108 02049011 and 02049031 QUANTITY ITEM DESCRIPTION PART NUMBER Cable PP 2 X 0 75 with 1 50MT Black Plug 1809 NEMA 2P with Plug 1809 FDA Cable 09 Kit for NeuroII Blue Green 2 ways each Cable 38 Electrostimulation Kit Black Orange 2 ways Electrode Valu Trode
9. 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 current density per area of electrode should not exceed 2 mA cm The smallest electrode size that may be used with this device is 25 cm2 We recommend the use of electrodes provided by Axelgaard Manufacturing Co Ltd Fallbrook CA 92028 USA FAX 1 760 723 2356 www axelgaard com 0 0 Figure 13 Electrode sizes and current density 39 USING THE MENU PROG BUTTON USING THE PROG BUTTON SELECT THE PRE PROGRAMMED PROTOCOLS Turn the equipment on as described above Press briefly the PROG button and press the SET button to select the PROGRAMMED protocols Next the information of the first treatment protocol in the equipment will appear on the display Use the SET button to select another protocol See the details in the tables below If this is the chosen protocol press the PROG button once more The display will show the parameters for the selected protocol including or not including the intensity desired Then just press the START button and in case the intensity was not adjusted previously select the intensity of current desired Proceed the same way to select any of the protocols available Just follow the steps above 40 USING THE MENU PROG BUTTON PROGRAMMING USER PROTOCOLS PROGRAMMING THE MANUAL STIMULATION To progra
10. seconds Compliance Level lt 5 U gt 95 voltage drops in U by 0 5 ciclo 40 0 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 0 by 5 seconds 16 Electromagnetic Environment Guidance Mains power quality should be that of a typical commercial or hospital environment If the user of the NEURODYN II requires continued operation during power mains interruptions it is needed that the NEURODYN II 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 s Declaration Electromagnetic Immunity The NEURODYN II is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN II 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 II including cable than be separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 VP d 1 2 VP 80 MHz to 800 MHz d 2 3 VP 800 MHz to 2 5 GHz Conducted RF 3 Vrms 3V IEC
11. that would otherwise serve as a protective mechanism e Effectiveness is highly dependent upon patient selection by a practitioner qualified in the management of pain patients PREACAUTIONS AND ADVERSE REACTIONS PRECAUTIONS e The long term effects of electrical stimulation are un known e Since the effects of stimulation of the brain are unknown stimulation should not be applied across the head and electrodes should not be placed on opposite sides of the head e The safety of electrical stimulation during pregnancy has not been established e Some patients may experience skin irritation or hyper sensitivity due to the electrical stimulation or electrical conductive medium gel e Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians e Patients with suspected or diagnosed epilepsy should fol low 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 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 e Keep this device out of the reach of children 11 e Use this device only with the leads electrodes and accessories recommended b
12. 1 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 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 II is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN II 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 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
13. C Constant Current Available on Channels 1 2 or 4 25 SPECIFICATIONS WAVEFORM SPECIFICATIONS Russian Current Output Mode Electrodes Output Intensity CC O 120 mA peak to peak Current Mode Continuous Russian Cont 1 2 3 amp 4 channel Synchronous Russian Sync 1 2 3 amp 4 channel Reciprocal Russian Rec 1 8 3 2 amp 4 channel Burst Duration Duty cycle 10 20 30 40 or 50 Burst Frequency 10 100 Hz steps of 10 Hz AA E RS Ba af AREA Ramp CC Constant Current Rise Time of Increase Gradient 1 9s On Time of Muscular Contraction 1 60s Decay Time of Decrease Gradient 1 9s Off Time of Muscular Relaxation 1 60 s Treatment Time 1 60 min Set Intensity Individual Channel Intensity Setting Available on Channels 1 2 3 or 4 26 ACCESSORIES USED TENS FES or RUSSIAN pin connector cables with banana ends 2 mm and conductive self adhesive electrodes Figure 5 Figure 5 A Pin cables with banana ends 2 mm and B Self adhesive conductive electrodes 27 ACCESSORIES USED Figure 6 A the connectors must be fixed to your connection on the panel of the device B the connector screws must be firmly fixed and C put the banana pin cable inside the electrode connector and remember that the electrodes must be positioned in pairs on the patient in accordance with the colors of each channel NOTE To remove the banana pins
14. 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 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 Comparacao dos efeitos de dois protocolos de estimulac o el trica neuromuscular sobre a forca muscular isom trica 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 premodulated interferential currents Archives of Physical 45 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
15. Day a E gt IBRAMED QUESTAO DE RESPEITO Instructions Manual NEURODYN II Manufactured by Ibramed Ind stria Brasileira de Equipamentos M dicos EIRELI Made in Brazil 274 edition LASTREV 08 2014 TABLE OF CONTENTS Caution Federal Law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he she practices to use or order the use of this device SYMBOL DEFINLL IONS queima nana apa aaa a Domina 3 CARTON M 4 ABREVIATIONS CGLUOSSARY A FOREWORD 6 PRODUCT DESCRIPTION assis ana adia a 6 SAFETY LLL ER 7 PRECAUTIONARY 7 ELECTROTHERAPY INDICATIONS sescezeveren ssec o sore cos gar 9 CONTRAINDICATIONS WARNINGS AND PRECAUTIONS 10 PREACAUTIONS AND ADVERSE REACTIONS 11 GENERAL CARE WITH THE EQUIPMENT 12 INSTALLATION CARE AND CLEANING 12 ELETROMAGNECTIC 14 20 CONTROLS INDICATORS AND CONNECTIONS 20 SYMBOL DEFINITIONS 21 SP SS BO hoe er EEE E 22 SYSTEM SPECIFICANONS concessus sa ad n vat rones 22 WAVEFORM
16. Model VL4545 four electrode 03018108 02049011 02049031 03026031 pkg 03040008 03019012 46 ACCESSORIES ACCOMPANYING NEURODYN II REPLACEMENT ACCESSORIES This list of replacement accessories are designed for use with the NEURODYN II Electro Stimulator When ordering provide the respective part numbers description and quantity desired The use of accessories cables and electrodes other than those intended for this specific equipment may significantly degrade the performance of the emissions and immunity DO NOT USE accessories cables and electrodes from NEURODYN II equipment on other equipment or medical electro systems TROUBLESHOOTING 000000099000000000000900000099090000009000000090000900000000900000000900000900000909000009000000000009000090000009000000000000090000009090000000900000900000909000000000000900000000000000000000000000000000000909000092900009909099 What may initially look like a problem is rarely a defect Before calling customer support please check the items described below PROBLEMS The equipment does not turn on 1 The equipment does not turn on 2 The equipment is turned on but does not emit current to patient 1 The equipment is turned on but does not emit current to patient 2 The equipment does not turn on and or work properly TROUBLESHOOTING SOLUTIONS e s the power cable properly connected If not connect it Also check the wall socket e Have
17. arity inversion 0 2 milliseconds For TENS and FES currents the frequency can be adjusted by the user therefore the polarity varies according to the frequency The frequency may be adjusted between 0 5 to 250 Hz which represents a period from 2s to 4 milliseconds so the inversion of polarity may vary between 1 second to 2 milliseconds Minimum TENS and FES Frequency minimum 0 5 Hz period 2 seconds polarity inversion 1 second Maximum TENS and FES Frequency maximum 250 Hz period 4 milliseconds polarity inversion 2 milliseconds 23 Between the minimum and maximum frequency the polarity changes by 1 second to 2 milliseconds for TENS FES and 0 2 milliseconds for Russian For example Frequency 250Hz Period 1 Frequency Period 1 250 Period 4 milliseconds Inversion Polarity Period 2 Inversion Polarity 4 2 Inversion Polarity 2millisec onds The polarity changes through the type of current chosen i e Russian TENS or FES and frequency chosen There is no direct option to control the polarity The rate charge depends on the frequency set by the User There are no specific modes the user can choose to change the polarity SPECIFICATIONS WAVEFORM SPECIFICATIONS TENS Symmetrical Biphasic TENS and FES Current Output Mode Electrodes Output Intensity CC 0 120 mA peak to peak Frequency 0 5 250 Hz Phase Duration Adjustable 50 500 us Burst Frequency 2 Hz Modulation of Bur
18. audible alarm will signal the treatment end 6 Press the STOP button to stop the alarm The equipment can now be switched off repeat the same programming task or undertake a new programming task 36 ELECTRODE GUIDELINE PATIENT PREPARATION Prepare the patient for therapy as described and read about the use of electrodes 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 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 ELECTRODE BIOCOMPATIBILITY ISO 10995 IBRAMED declares that the electrodes supplied with the equipment do not cause allergic reactions These electrodes must only be put in contact with the integral surface of the skin respecting the time limit of the duration of this contact of up to 24 hours ELECTRODE GUIDELINE ELECTRODE POSITIONING Bipolar Electrode Placement Technique The technique of positioning the bipolar electrodes is used to provide stimulation of the large groups of muscles such as the quadriceps or ischiotibial
19. 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 to the correct electrode size consult a licensed practitioner prior to therapy session SAFETY PRECAUTIONS 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 Equipment not suitable for use in the presence of a flammable anesthetic mixture
20. d or subjected to excessive fluctuation or overcharge MAINTENANCE WARRANTY AND TECHNICAL SUPPORT C Misuse lack of reasonable care product TECHNICAL SUPPORT alterations modifications or repairs undertaken by individuals or entities not authorized by IBRAMED d Removal or adulteration of the equipment serial If you have any doubts or problems related to the operation of your equipment please contact number IBRAMED USA REPRESENTATIVE e Damage during Transport QS Health 223 E Flager Street Suite 402 5 Thelegal warranty does not cover expenses incurred Miami FL 33131 during product installation or transport to the plant or sale Sales 1 888 275 0025 x 2 point labor materials parts and adjustments necessary to Phone 1 786 254 7723 the readiness of the premises in view of the installation of Fax 786 358 6072 the device such as but not limited to electric net masonry hydraulic network grounding system as well as their requirements Email sales qs health com Website www ibramed us 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 N DANGER applicators cooling applicator cables connectors device cabinets pedal infrared thermometer Do not alter this equipment Any unauthorized modification can affect the safety of this 7 selling points are neither authorized to alter equipment t
21. ed With SELECT any time during the session Press the INTENSITY button key press the arrow down or up to move to the next input UP or DOWN Continue in this manner until all parameters are chosen PROGRAMMING EQUIPMENT A zu hele status gt VIF On v Frequency Example 1 TENS Suppose the clinical practice or literature to suggest certain pathology TENS current type with automatic variation of intensity and frequency VIF ON and the treatment time of 40 min Intensity mA 1 Connect the equipment to start programming the pattern ch1 0 ch3 O described above Using the SELECT key scroll through the ch2 O ch4 O parameters until appear Current After this press SET key to select and to choose the status TENS Note the blinking cursor in the TENS field as shown in the figure below 2 4Manual stm min Timer 40 v Current 4Timer type pb Current TENS v Mode Intensity mA Intensity mA ch1 O ch3 0 ch1 ch2 0 ch4 O ch2 0 ch4 O 31 OPERATING INSTRUCTIONS PROGRAMMING EQUIPMENT A Example 2 FES Suppose the clinical practice or literature to suggest certain pathology FES current type synchronous 50 Hz 200 us ramp Rise 2 s On 10 s Decay 2 s Off 10 s Manual stm and the treatment time of 15 min 4 Current status gt Mode Sync v VIF Intensity mA 1 Connect the equipment to start programming the pattern ch1 O ch3 0 described above Using the SELECT key scroll
22. he conditions mentioned in this document nor take any Never make unauthorized repairs commitment on behalf of IBRAMED 49 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 we ll 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 IBRAMED A matter of respect selected according to the best and latest clinical criteria CEFAI takes into account the personal and professional de velopment of all its partners and customers CEFAI invites both students and professionals in the fields of Physical Rehabil
23. ing 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 NOMENCLATURE 5 4 7 5 _ k e son Er a a Figure 4 Lower Access Panel 2 Figure 1 Upper Access Panel Figure 3 Front Access Panel 1 Power ON OFF Switch 7 PROG MENU Button PROG Select 11 Fuse 2 Power On Indicator LED Protocols Clinical Resources Library and 12 Line Cord Connection MENU L 3 BACK NEXT Buttons 13 General Characteristics Label 8 Channel indicator LEDs 4 SET SET Buttons 2 14 Current output label characteristics 9 UP DOWN Intensity Buttons Ch 11 2 5 LED Display A 15 Caution Federal Law USA 4 6 START STOP ane 16 Serial Number 10 Channel Lead Wire Connectors 20 NOMENCLATURE SYMBOL DEFINITIONS Read and Understand these symbols and their definitions before operating this equipment Before using and operating the NEURODYN II please read and learn the symbols on the LCD device START VA Switch used to start or stop treatment Wo Always press the center of the switch CHANNEL CHANNEL 2 B CHANNEL 3 M CHANNEL STOP Channel Lead Wire Connecto
24. ings 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 website for updates la zi LXI IBRAMED 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 A CAUTION Text with a CAUTION indicator refers to potential safety infractions that could cause minor to moderate injury or damage to equipment AN WARNING Text with a WARNING indicator refers to potential safety infractions that could cause serious injury and equipment damage N 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 Observe 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 This unit should be operated transported and stored at
25. itation 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 CEFAI rormacho avan ava IBRAMED 50 y YE 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 us ibramed ibramed com br
26. m new protocols press the PROG key briefly and In order to program the manual stimulation it is necessary to press the SET button to select the USER protocols With the adjust the parameters which will be used in the Therapy with SET button choose one of the 20 USER protocols available the FES Sync Synchronized FES or FES Rec Adjust the parameters according to the therapeutic needs FES motes me because it is the press START The last parameters defined will be recorded in therapist who will trigger the stimulation manually When the equipment memory To access the protocols saved by the the Manual stm function Manual Stimulation is selected user just select the PROG button and use the SET buttons to the Sta don iS peliermed manually For this function to choose the number of the desired protocol be active ON the therapist must select the Manual stm mode using the SELECT buttons and with the SET buttons choose the Status ON After that press the START button to start the therapy In this function the equipment will 4Timer execute the rise on and decay ramps and stop that is Current remain in off rest for the time the therapist considers Y Mode necessary To start the stimulation again it is necessary Protocols to press PROG button which once pressed will make the equipment execute the stimulation again following the rise on and decay ramps programmed for the type of current FES Sy
27. nc Synchronized FES or FES Rec Reciprocal FES E The manual stimulation mode will be active until the end of the programmed treatment time To cancel it the therapist must press the STOP button Programmed set 4 User set v Figure 14 LCD displays the selection of Programmed and User protocols 41 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 1 TENS Post traumatic Acute Pain Parameters values 1 to 120 mA On the painful area Description Modulation Post traumatic acute pain Current Mode Frequency Phase duration Pulse Treatment time Timer Intensity Positioning of electrodes Prog 2 TENS Post surgical Acute Pain Description Modulation of mE post surgical acute pain 150 Hz Phase duration Pulse 75 HS 1 to 120 mA Treatment time Timer Intensity Positioning of electrodes On the painful area Manufacturer does not preset the intensity because it needs to be adjusted by the therapist in accordance to the patient s needs and treatment plan It can be increased or decreased on the appropriate channel by pushing the up and down button CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 3 TENS Chronic Intractable Pain Description Modulation of chronic intractable pain Prog 4 RUSSIAN Muscle re education Parameters values Description Muscle re education Current Russian Mode Burst duration Duty cycle
28. ormation provided in the following tables Portable and Mobile Radio Frequency communications equipment can affect Medical Electrical Devices 13 ELETROMAGNECTIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Emissions The NEURODYN II is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN II should ensure that it is used in such an environment Emission Test Compliance Electromagnetic environment guidance The NEURODYN II must emit electromagnetic energy RF Emissions Ro Group 1 in order to perform it s intend function Nearby electronic CISPR 11 equipment may be affected RF Emissions Class A CISPR 11 Harmonic The NEURODYN II is suitable for use in all establishments Emissions Class A other than domestic those directly connected to the public IEC 61000 3 2 low 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 II is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN II 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 6060
29. ot apply stimulation across the patient s chest because the introduction of electrical current into the chest may cause rhythm disturbances to the patient s heart which could be lethal e Do not apply stimulation over open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins e Do notapply 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 10 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 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 and healthy skin PRECAUTIONS e ENS is not effective for pain of central origin including headache e TENS is not a substitute for pain medications and other pain management therapies e TENS devices have no curative value e TENS is a symptomatic treatment and as such suppresses the sensation of pain
30. 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 II is used exceeds the applicable RF compliance level above the NEURODYN II should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorientation or relocating the NEURODYN II Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ELETROMAGNECTIC COMPATIBILITY The NEURODYN II is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the NEURODYN II can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the NEURODYN II as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum power DUM CORN 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 VP d 1 2 MM 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 rat
31. rs Channel 1 2 3 and 4 Switch with double function PROG Selection of pre programmed protocols and private protocols CML MENU Selection of language Portuguese ES 3 English or Spanish 3 E SELECT switch for the selection of parameters E UP or DOWN Intensity Channel 1 2 3 and 4 Observe the colors related to channels SET switch for selection of values of the parameters 21 SPECIFICATIONS SYSTEM SPECIFICATIONS Dimensions Width 6 89 in 17 5 cm Depth 10 83 in 27 5 cm Height 4 53 in 11 5 cm Standard Weight without accessories 1 3 kg Power Input 100 240V 50 60 Hz Input Power 85 VA Fuses 250V 20AG Electrical Class CLASS II Electrotherapy TYPE BF Regulatory Compliance IEC 60601 1 IEC 60601 1 2 IEC 60601 1 4 IEC 60601 2 10 Temperature Range During Transport and Storage Between 59 and 104 F Environment operating temperature range 5 459C 41 113 OF 22 SPECIFICATIONS WAVEFORM SPECIFICATIONS The frequency for Russian is fixed therefore the rate of inversion of polarity is also fixed The frequency is 2500 Hz which represent a period of 0 4 milliseconds so this inversion of polarity occurs at every 0 2 milliseconds Minimum Russian Fixed in 2500 Hz period 0 4 milliseconds polarity inversion 0 2 milliseconds Maximum Russian Fixed in 2500 Hz period 0 4 milliseconds pol
32. st Frequency 250 Hz VIF Frequency 2 247 Hz Note The TENS FES and Russian are depolarized currents VIF Phase Duration 50 500 us The Russian current has a fixed frequency of 2 5 kHz rate of reversal and TENS and FES current frequency can be adjusted from 0 5 250 Hz reversal rate Current Mode Conventional Normal TENS R 0 5 250 Hz T 50 500 us The user chooses the frequency rate reversal for the su 5 FES 0 5 250 Hz modes according to the l Treatment Time 1 60 min desired treatment l m Set Intensity Individual channel intensity The TENS FES and Russian presents automatic polarity reversal according to the frequency Seng durer Ores CC Constant Current 24 SPECIFICATIONS WAVEFORM SPECIFICATIONS FES Functional Electrical Stimulation Output Mode Electrodes Output Intensity CC O 120 mA peak to peak Current Mode Synchronous FES Sync 1 2 3 amp 4 channel Reciprocal FES Rec 1 amp 3 2 4 channel Frequency Phase Duration Variation VIF R 2 247 Hz T 50 500 us Frequency 0 5 250 Hz Phase Duration Pulse 50 500 us VIF Frequency 2 247 Hz VIF Phase duration 50 500 us Ramp Rise Time of Increase Gradient 1 9s On Time of Muscular Contraction 1 6065 Decay Time of Decrease Gradient 1 9s Off Time of Muscular Relaxation 1 60 s Treatment Time 1 60 min Set Intensity Individual Channel Intensity Setting C
33. temperatures between 419 and 1229 59 and 509 Avoid damp and dusty environments e Check cables and associated connectors before each use e The NEURODYN II 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 To protect against the risk of fire only use replacement fuses of the same types and ratings e Be surethe unitis 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 contraindications 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
34. through the ch2 0 ch4 O parameters until appear Current After this press SET key to select and to choose the status FES Note the blinking cursor in the FES field as shown in the figure below B VIF gt Frequency 4 Timer type vPulse Current FES v Mode Intensity mA ch1 O ch3 O Intensity MA ch2 O Ch4 ch1 0 ch3 O ch2 O ch4 O C 4Frequency us 2 Using the SELECT key scroll through the parameters until Pulse 200 the desired parameter is located Press SET key to select and vRise to choose the status of the parameter desired With SELECT Intensity mA key press the arrow down or up to move to the next input Continue in this manner until all parameters are chosen ch1 O ch3 O ch2 O ch4 O 32 OPERATING INSTRUCTIONS D G E H F 22 OPERATING INSTRUCTIONS PROGRAMMING EQUIPMENT 2 Using the SELECT key scroll through the parameters until thedesired parameterislocated Press SET keytoselectand to choosethe status of the parameter desired With SELECT key press the arrow down or up to move to the next input Continue in this manner until all parameters are chosen Example 3 Russian Suppose the clinical practice or literature to suggest certain pathology Russian current type synchronous 50 Hz 50 ramp Rise 2 s On 10 s Decay 2 s Off 10 s and the treatment time of 15 min A 4Current status 1 Connect the equipment to start programming the pattern gt Mode S
35. timulator Default 5 30 Figure 9 Bipolar Electrode Placement Technique 7 Figure 10 Monopolar Electrode Placement Technique 37 Figure 11 Positioning of the electrodes on the gastrocnemius 38 Figure 12 Positioning of the electrodes on the posterior tibial MUS 38 Figure 13 Electrode sizes and current density 39 Figure 14 LCD displays the selection of Programmed and DLOLOCOIS cess vasa re ao RUM ERE EH P 41 FOREWORD PRODUCT DESCRIPTION This user manual allows the user to efficiently use the NEURODYN IItranscutaneousneuromuscularstimulator NEURODYN II Electro Stimulator It also gives suggestions is a four channels stimulator with independent controls for treatment protocols so that you can use your equipment for current therapies used in TENS Transcutaneous to its full potential Electrical Nerve Stimulation FES Functional Electrical Consult other resources for additional information regarding Stimulation and Russian Current Burst Modulated the uses of electrotherapy before attempting any treatment Medium Frequency on a patient Users must read understand and follow the information in this manual for each mode of treatment The equipment is to be used only under the prescription available as well as the indications contraindications and supervision of a licensed practioner warn
36. ulator e Plug the line cord into a grounded wall outlet 100 240V 50 60 Hz e Plug the electrode cables into the electrode cable connections e Switch on your equipment 12 NEURODYN II Electro Stimulator Care Instructions e Avoid areas subject to vibrations e Install the equipment on a firm and level surface in open air 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 Cleaning the NEURODYN II 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 AN CAUTION CORRECT EQUIPMENT INSTALLATION PREVENTS SECURITY RISKS GENERAL CARE WITH THE EQUIPMENT Electromagnetic Compatibility Guidance AN CAUTION WARNING Medical Electrical Devices require special attention regarding Electromagnetic Compatibility EMC and must be installed and put into service according The use of accessories other than those listed except when supplied or sold by Ibramed Ind stria Brasileira de Equipamentos M dicos Ltda as replacement parts for internal or external components may result in increased emission or decreased immunity of the RF NEURODYN II Electro Stimulator to the EMC inf
37. with air oxygen or nitrous oxide ELECTROTHERAPY INDICATIONS INDICATIONS FOR USE Indications for Russian waveform e Temporary relaxation of muscle spasms e Prevention or retardation of disuse atrophy in post injury type conditions e Increase local blood circulation e Muscle re education e Maintaining or increasing range of motion Indications for FES waveform e Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexion of the foot thus improving the patient s gait Indications for TENS waveform e Symptomatic relief of chronic long term intractable pain e Symptomatic relief of post traumatic acute pain and post surgical acute pain Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions CONTRAINDICATIONS WARNINGS AND PRECAUTIONS CONTRAINDICATIONS 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 WARNINGS e Do not apply stimulation over the patient s neck because this could cause severe muscle spasms resulting in closure of the airway difficulty in breathing or adverse effects on heart rhythm or blood pressure e Do n
38. without prior explicit written permission from IBRAMED WARRANTY IBRAMED Ind stria Brasileira de Equipamentos M dicos here identified to the consumer through the following address and telephone number Av Dr Carlos Burgos 2800 Jd It lia Amparo SP Brazil Phone 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 48 WARRANTY TERMS 1 IBRAMED warrants that this product is free of manufacturing defectsforeighteen 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 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 an
39. y the manufacturer e Use this device only under the continued supervision of a licensed practitioner 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 e Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the device GENERAL CARE WITH THE EQUIPMENT SHIPPING DAMAGE Your NEURODYN II 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 II 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 INSTALLATION CARE AND CLEANING Installation Instructions e Connect the line cord to the back of the NEURODYN II Electro Stim
40. ync described above Using the SELECT key scroll through the v VIF parameters until appear Current After this press SET key ERE to select and to choose the status Russian Note the blinking cursor in the Russian field as shown in the figure below i RE en l ch2 O ch4 O B 4Timer type pb Current Russian v Mode VIF gt Burst freq v Duty cycle Intensity mA Intensity mA ch1 O rod a PC THE 0 ch2 O ch4 O ch1 O ch3 O ch2 O ch4 O 34 OPERATING INSTRUCTIONS C F D G H 35 OPERATING INSTRUCTIONS 3 Once all parameter are chosen press the START button to begin treatment 4 Press the UP or DOWN channel in use to select the amount of current needed to treat Note The intensity adjustment may be made before or after pressing the START button In order to make the intensity adjustment before pressing START the operator must adjust the quantity of current necessary for a particular patient and after pressing the START button a gradual increase in intensity will occur until the quantity of current previously adjusted is reached In case during the gradual increase in intensity the operator notices that the intensity of current is above the tolerable limit for the patient press the DOWN button so that there is decrease in the quantity of current until the ideal quantity of current for the patient is reached 5 At the end of the programmed time the emission current is interrupted and an
41. you checked the safety fuse Check if there is a bad contact Check if the value is correct as stated in the instructions e Have you followed the recommendations for correct use the equipment as mentioned in the instructions Check and repeat the steps in the controllers indications and operation section e Have you checked the electrodes and the connecting cables to the patient Checkifthecableplugisadequately inserted in the equipment Check if the electrodes are adequately placed on the patient s body e Check if the amount of gel is enough e Check if the electrodes are worn properly 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 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

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