Home

Manual

1. English Figure 10 Message language selection 40 USING THE MS PROG BUTTON PROGRAMMING USER PROTOCOLS PROGRAMMING THE MANUAL STIMULATION To program new protocols briefly press the key PROG and 1 To program manual stimulation it is necessary to adjust press the SET button to select USER protocols With the SET button choose one of the 20 available USER protocols Enter the parameters according to therapeutic needs and press START The last set parameters will be recorded in the device parameter OFF because it is the therapist who will manually memory To access Protocols saved by the user simply select trigger stimulation the PROG key and the SET key to choose the protocol number 2 When selecting the function EST MANUAL Manual desired the parameters to be used in therapy with Sync Fes Fes Synchronous or Rec Fes Fes Reciprocal modes except the Stimulation the stimulation will be performed manually For this function to be active ON the therapist must select the EST MANUAL mode using the SELECT and SET keys to Timer type select ON gt Current Tens 3 Then press the START button to begin therapy In this T Mode function the device performs the rise on and decay ramp Protocols jthat is its remains off rest for the period that the therapist Programmeed set deems necessary Users set 4 To start stimulation again press the PROG key which a r EE when pressed will
2. 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 ELETROMAGNECTIC COMPATIBILITY Equipment Serial number ANVISA Registration M S Mian ufacturing date Expiration date 5 years Senior engineeer Maicon Stringhetta CREA 5062850975 26 NOMENCLATURE CONTROLS INDICATORS AND CONNECTIONS 1 11 12 Figure 2 Rear Access Panel Figure 1 Upper Access Panel Figure 3 Front Access Panel 27 NOMENCLATURE 1 Power ON OFF Switch 2 Power On Indicator LED 3 SELECT control Key 4 SET control key 5 Alphanumerical LCD display 6 START STOP control key 7 PROG MENU control key PROG selection of pre programmed protocols MENU language selection 8 Light indicators yellow of channels 1 and 4 9 UP and DOWN control keys individual channel intensity 10 Outlet connections cables to patient 11 Protection fuse Figure 4 Lower Access Panel 12 Connection to power cable 13 General technical information 14 Label with technical characteristics 15 Serial number
3. infractions that could cause minor to moderate injury or damage to equipment A WARNING Text with a WARNING indicator refers to potential safety infractions that could cause serious injury and equipment damage Text with a DANGER indicator refers to potential safety infractions that represent immediately life threatening situations that would result in death or serious injury 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 temperatures between 41 F and 122 F 5 C and 50 C Avoid damp and dusty environments Check cables and associated connectors before each use e The NEURODYN Compact 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 an
4. 0 250 mA Frequency R 0 5 250 Hz Current Mode Synchronous Fes Sync 1 amp 2 channel Reciprocal Fes Rec 1 or 2 channel Phase Duration T 50 500 us Frequency Phase Duration Variation VIF VIF Frequency 2 247 Hz VIF Phase duration 50 500 us 32 SPECIFICATIONS RUS Russian Current The Russian current is an alternated current of medium Ramp frequency 2 5 kHz modulated in rectangular bursts with Rise Time of Increase Gradient 149 8 frequency of 50 Hz and work cycle of 50 used to produce On Time of Muscular Contraction 1 60 s muscle strengthening without significant discomfort for the Decay Time of Decrease Gradient 1 95 patient Off Time of Muscular Relaxation 1 60 s Treatment Time 1 60 min Set Intensity Individual channel intensity 1 and 2 Impedance bandwidth of charge for the mentioned parameters 1000 Ohms CEE ERE EEE EEE EEE FEL NET EEE EEE EEE ETE KER ETE EEE KEE EEE EEE P Output Mode Electrodes Output Intensity 0 250 mA Current Mode Continuous Russian Cont 1 amp 2 channel Synchronous Russian Sync 1 amp 2 channel Reciprocal Russian Rec 1 amp 2 channel Burst Duration Duty Cycle 10 20 30 40 e 50 Burst Frequency 10 100 Hz steps of 10 Hz 33 ACCESSORIES USED TENS FES and RUSSIAN CURRENT pin connector cables with banana ends 2 mm and conductive self adhesive electrodes and neutral conductive gel Figure 5 Figura 5 A Pin cables with banana ends 2
5. Compact 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 T ENVIRONMENTAL PROTECTION NEURODYN Compact is an electronic device and has heavy metal parts such as lead So there are risks of contamination to the environment associated with the discharge of this device and its accessories at the end of their service life NEURODYN Compact its parts and the accessories must not be disposed of as urban residues Contact the local distributor to obtain information about norms and laws relative to the elimination of electrical residues electronic equipment and their accessories N WARNING CORRECT EQUIPMENT INSTALLATION PREVENTS SECURITY RISKS A The device and its consumable parts must be eliminated at the end of their shelf life according to the federal norms and or state norms and or local norms of each country 16 ELECTRICAL FEED NEURODYN Compact 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 circ
6. Compact Electro Stimulator It also gives suggestions for treatment protocols so that you can use your equipment to its full potential Consult other resources for additional information regarding the uses of 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 contraindications 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 website for updates A IBRAMED PRODUCT DESCRIPTION ESSENTIAL PERFORMANCE NEURODYN Compact transcutaneous neuromuscular stimulator is a two channel stimulator with independent controls for current therapies used in TENS Transcutaneous Electrical Nerve Stimulation FES Functional Electrical Stimulation and RUSSIAN CURRENT Burst Modulated Medium Frequency 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 before operating this equipment prior to therapy session A CAUTION Text with a CAUTION indicator refers to potential safety
7. Frequency R Frequency R 50 Hz Phase duration T 150 us Phase duration T 250 us S intensity 1 250 mA per ss The conductive rubber Decay electrodes that are positioned in at the local to be treated positioned Treatment time 25 min or the desired number around the area to be of muscle contractions stimulated this area Intensity 1 250 mA Should be between the Positioning of electrodes In the muscular centre or on electrodes the motor muscular point Positioning of electrodes The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 43 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 6 FES Increase muscle Increase muscle Parameters values strength in athletes 1 Parameters values strength in athletes 2 Description Stimulation Description Stimulation for conditioned muscle for conditioned muscle initial phase intermediate phase Mode Fes Sync Mode Fes Sync Frequency R 60 Hz Frequency R Phase duration T 350 us Phase duration T Rise Rise 12 s Decay 1s Decay Off 20s Off Treatment eine 25 min or the desired numbe Treatment time 25 min or the desired numbe of muscle contractions of muscle contractions Intensity 1 250 mA Intensity 1 250 mA 1 a In the muscular centre or on Position F el
8. in AC Alternating Current SYMBOL DEFINITIONS v Fragile This side up Refer to operating instructions for correct product USE Manufacturer s name and address in C Celsius Degrees Limits of temperature for storage and packaging P a if A Keep away from the rain Stacking up Do not use if the packaging is damaged ABREVIATIONS GLOSSARY off Rise Decay Hertz Kilohertz Milliampere Milliseconds Minute Second Volt ampaere Time of Muscular Contraction Time of Muscular Relaxation Time of Increase Gradient Time of Decrease Gradient LIST OF FIGURES Figure 1 Upper Access Panelszznznunnnnnnnnnnnunannnunnnunununnn 27 Figure 2 Rear Access Panel aaaaanananan a n n nanana 27 Figure 3 Front Access Panel aaaaaaaaaas s sananarara 27 Figure 4 Lower Access Panel aasaaaaaaas s sananarara 26 Figure 5 A Pin cables with banana ends 2 mm 34 B Self adhesive conductive electrodes 7 35 C neutral conductive gel ssssassvv rea 38 Figure 6 A e B LCD Messages C NEURODYN COMPACT Electro Stimulator Default Screen sx2ansasasasn nanars 38 Figure 7 Bipolar Electrode Placement Technique 39 Figure 8 Monopolar Electrode Placement Technique 40 Figure 9 Electrode sizes and current density 41 FOREWORD This user manual allows the user to efficiently use the NEURODYN
9. mm B Self adhesive conductive electrodes e C neutral conductive gel A CAUTION e The connector screws must be firmly affixed to your connection on the back panel of the device e To remove the banana pins self adhesive electrodes pull them by their protective cover Never pull the cord 34 OPERATING INSTRUCTIONS PREPARE DEVICE Turn the power switch LCD displays the message device presentation for a few seconds followed by the software model of the device default screen programming Figure 6 A IBRAMED Neurodyn Compact EL11 V03 Figure 6 A LCD Messages B NEURODYN Compact Electro Stimulator Default Screen Note that entering the default screen will cause the word TENS to flash This is to do with the selection cursor parameters function which displays whenever the device is being programmed 35 Edit Waveform Param The SELECT button 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 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 Patient preparation Prepare the patient for
10. 26 NOMENCLATURE SYMBOL DEFINITIONS Read and Understand these symbols and their definitions before operating this equipment Before using and operating the NEURODYN Compact Electro Stimulator please read and learn the symbols on the LCD device DA Button used to start or stop the treatment MV Always press the center key CHANNEL 1 CHANNEL 2 STOP Channel Lead Wire Connectors Channel 1 and 2 Double Function Key PROG Selection of pre programmed protocols and private protocols MENU Selection of language Portuguese English or Spanish SELECT key selection of the parameters of ultrasound a ee ee E e g L UP or DOWN Channel 1 and 2 Observe the colors related to channels SET key selection of the values of the parameters 29 SPECIFICATIONS SYSTEM SPECIFICATIONS Dimensions Temperature Range During Transport and Storage i 5 50 C 41 122 F Width 27 cm 10 6 in Depth 26 6 cm 10 4 in Height 12 5 cm 4 9 in Environment operating temperature range Standard Weight without accessories 1 85 kg 5 45 C 41 113 F Power Input 100 240V 50 60 Hz Input Power 85 VA Fuses 5A 250V 20AG Fast Action Rupture capacity 35A Electrical Class CLASS II Electrotherapy TIPE BF Regulatory Compliance IEC 60601 1 IEC 60601 1 2 IEC 60601 1 4 IEC 60601 2 10 30 SPECIFICATIONS WAVEFORM SPECIFICATIONS TENS Transcutaneous Electrical Nerve Stimulation
11. EQUIPMENT SHIPPING DAMAGE Your NEURODYN Compact 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 Compact 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 15 INSTALLATION CARE AND CLEANING Installation Instructions 1 Connect the line cord to the back of the NEURODYN Compact 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 NEURODYN Compact 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
12. Em UV 25 IBRAMED QUESTAO DE RESPEITO Instruction Manual a oft ompact Manufactured by IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI ANVISA n 10360310012 6 edition REV 08 2012 TABLE OF CONTENTS SYMBOL DEPINDITONS saca sas pesscan casa ss sais DA SCE naNS Ri 3 CARTON pane sita nu ie da da ira A ABREVIATIONS GLOSSAR O apacstantarinse sadio saida picadas 5 LIS OF FIGURE soir aa stan g a aaa 5 FOREWORD RR 6 ESSENTIAL PERFORMANCE 2a2a222sssssskksa anana 6 PRODUCT DESCRIPTION cccccccceeesseses n DR i 6 SAFETY PRECAUTIONS 22222 222nsnsna nnnannnnnnr MO 7 INDICATIONS CONTRAINDICATIONS PRECAUTIONS AND ADVERSE REACTIONS 222 2222 22222 ns nsnnannnann nn RR 10 POPULATION AND CONDITIONS OF USE eee 14 GENERAL CARE WITH THE EQUIPMENT 13 SHIPPING DAMAGE corria rod inr ais nadas dado nadas 15 INSTALLATION CARE AND CLEANING 15 ENVIRONMENTAL PROTECTION EA E 16 ELECTRICAL FEED sR nen kak Rasa a a a 17 ELECTROMAGNETIC COMPATIBILITY GUIDANCE 18 ELETROMAGNECTIC COMPATIBILITY aaa 19 NOMENGEATURE arado can dana Ras RENERE RENET sita 27 CONTROLS INDICATORS AND CONNECTIONS 27 SYMBOL DEFINITIONS santa Fadas in O aaa 29 SPECITICAMNONS atenta eis a yaa Lala ts aa dn nim a 30 STS TEM SPECIFICATION S seirinin coesa iara banan ika 30 WAVEFORM SPECIFICATIONS sussa 22 nakka akal 31 ACCESSORIES USE Dissnusi
13. Frequency Phase Duration Variation VIF VIF Frequency 2 247 Hz The Symmetrical Biphasic waveform has a short pulse VIF Phase Duration 50 500 us duration and is capable of strong stimulation of nerve fibers in the skin and in muscle TENS is a classic current used for Current Mode treatment of pain by sensorial stimulation and the patient Normal Continuous Tens Conv R 0 5 250 Hz typically tolerates the current well even at relatively high T 50 500 us intensities Burst Modulation Tens Burst R 250 Hz T 50 500 us Treatment Time 1 60 min Set Intensity Individual channel intensities 1 and 2 Impedance bandwidth of charge for the mentioned parameters 1000 Ohms Output Mode Electrodes Output Intensity 0 250 mA Frequency R 0 5 250 Hz Phase Duration T Adjustable 50 500 us Burst Frequency 2 Hz Modulation of Burst Frequency 250 Hz 31 SPECIFICATIONS FES Function Electrical Stimulation Functional Electrical Stimulation FES uses low levels of Ramp electrical current to stimulate physical or bodily functions Rise Time of Increase Gradient 1 9 s lost through nervous system impairment On Time of Muscular Contraction 1 60 s Decay Time of Decrease Gradient 1 9 s Off Time of Muscular Relaxation 1 60 s Treatment Time 1 60 min Set Intensity Individual channel intensity setting 1 and 2 Impedance bandwidth of charge for the mentioned parameters 1000 Ohms L Output Mode Electrodes Output Intensity
14. URODYN Compact is suitable for use in all Emissions Class A establishments other than domestic those directly connected IEC 61000 3 2 to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions IEC 61000 3 3 een ELETROMAGNECTIC COMPATIBILITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The NEURODYN COMPACT is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN COMPACT should assure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast Transitories burst IEC 61000 4 4 Surge IEC 61000 4 5 IEC 60601 Test 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 21 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 Immunit
15. 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 63 4 The warranty does not cover damage caused to the product resulting from a Failure to follow the specifications and recommendations detailed in these instructions for use during installation or use of the product b Accidents or acts of God connections to electrical system with inappropriate voltage and or subjected to excessive fluctuation or overcharge c Misuse lack of reasonable care product alterations modifications or repairs undertaken by individuals or entities not authorized by IBRAMED d Removal or adulteration of the equipment serial number e Damage during Transport 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 ofthe device such as but not limited to electric net masonry hydraulic network grounding system as well as their requirements MAINTENANCE WARRANTY AND TECHNICAL SUPPORT TECHNICAL SUPPORT 6 The warranty does not cover parts subjected to natural If you have
16. alues Spasticity control 1 Parameters values Description Reduction of muscle spasticity in patients with central nervous system higher motoneuronal lesions Description Increase of strength and muscular facilitation in patients with stroke for use in subluxated Shoulder advanced a Frequency R 40 Hz Frequency R 50 Hz Phase duration T 300 us Phase duration T 300 us I 15 min or the desired number Treatment time 30 min of muscle contractions Intensit 1 250 mA tento BTT On the centers of the Positioning of electrodes supraspinal muscle and medial On the muscle centre oron the deltoid fibers to be moved Positioning of electrodes motor muscular point of the during functional activit opposite muscle in relation to the spastic muscle The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 51 PROTOCOLOS PRE PROGRAMADOS Spasticity control 2 Parameters values Spasticity control 3 Parameters values Description Reduction of muscle spasticity in patients with centralnervoussystem higher motoneuronallesions Description Reduction of muscle spasticity in patients withcentralnervoussystem higher motoneuronallesions intermediate phase advanced phase Frequency R SO Hz Frequency R 50 Hz Phase duration T 300 us Phase dur
17. any doubts or problems related to the operation wear such as but not limited to control buttons control of your equipment please contact keys handles and moving parts radiofrequency applicators Telephone 55 19 3817 9633 cooling applicator cables connectors device cabinets pedal infrared thermometer 7 The selling points are neither authorized to alter the A conditions mentioned in this document nor take any commitment on behalf of IBRAMED Do not alter this equipment Any unauthorized modification can affect the safety of this equipment Never make unauthorized repairs 64 CEFAI IBRAMED Center for Education and Advanced Training IBRAMED Equipment goes beyond technology It also Special attention is also given to those interested in visiting provides knowledge Science constitutes our differential our structure Whatever your professional development value and we effectively take advantage of its benefits needs we ll be right by your side to provide you with in order to ensure patient safety and thereby maximize unconditional support results We are happy to assist you IBRAMED develops products with scientific support of the most recent medical studies published in major scientific Contact cefai conexaocefal com br journals in the areas of biological health and exact www conexaocefai com br 55 19 3808 2348 Access to the knowledge database is guaranteed by CEFAI IBRAMED Center for Education and Advanc
18. ation T 300 us t Treatment tine 15 min orthe desired number Treatment tine 15 min orthe desired number of muscle contractions of muscle contractions Intensity 1 250 mA Intensity 1 250 mA On the muscle centre or onthe On the muscle centre or onthe motor muscular point of the Positioning of electrodes motor muscular point of the opposite muscle in relation to opposite muscle in relation to the spastic muscle the spastic muscle The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 4 52 Positioning of electrodes CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 24 FES Increase of local muscular resistance 2 Parameters values Increase of local muscular resistance 1 Parameters values Description Increase Description Increase of the localized muscle of the localized muscle Na resistance intermediate resistance initial phase phase Frequency R 20 Hz Frequency R 20 Hz Phase duration T 300 us Phase duration T 300 us Rise Rise n 25 s n 35s Decay 2S Off 50 s 40 min 3 times per day Treatment time Intensity 1 250 mA Decay 2S Off 45 s Treatment time 40 min 3 times per day Intensity 1 250 mA Positioning of electrodes On the muscular cantaron on the motor muscular point M On the muscular center o
19. cation area and possible damage to the equipment Operation at short distance 1 meter for example from short wave therapy equipment may induce instability in the outlet of the equipment To prevent electromagnetic interference we suggest that one group of mains voltage is used for NEURODYN Compact and another separate group is used for the other Short wave or microwave equipment We suggest that the patient NEURODYN Compact and connection cables are installed at least 3 meters away from the short wave or microwave equipment A CAUTION Portable and Mobile Radio Frequency RF communications equipment can affect Medical Electrical Devices 19 ELETROMAGNECTIC COMPATIBILITY The electromedical devices demand special attention regarding electromagnetic compatibility EMC and must be installed and operated according to the EMC information provided as follows Guidance and Manufacturer s Declaration Electromagnetic Emissions The NEURODYN Compact is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN Compact should ensure that it is used in such an environment Emission Test Compliance Electromagnetic environment Guidance The NEURODYN Compact must emit electromagnetic RF Emissions energy in order to perform it s intend function Nearby NBR IEC CISPR 11 electronic equipment may be affected IEC CISPR 11 RF Emissions NBR IEC CISPR 11 Class A IEC CISPR 11 Harmonic The NE
20. d ratings e Be sure the unit is grounded by connecting itto 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 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
21. e duration T 300 ps On On 35S 15s 15s Off 20 s Treatment time 35 min Treatment time 30 min Intensity 1 250 mA Intensity 1 250 mA In the muscular centre or on the motor muscular point of Bo i osi ao dos eletrodos Posic o dos eletrodos the rectus femoris muscles GRE vastus lateralis and vastus medialis The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys a 48 In the muscular centre of the CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 16 FES Increase of muscular E i Increase of muscular Parameters values arameters values strength after PNL 2 strength after PNL 3 Description Increase of Description Increase musclestrengthin patients of muscle strength in with peripheral nerve patients with peripheral lesions intermediate nerve lesions advanced phase phase Frequency R 65 Hz Frequency R 65 Hz Phase duration T 300 us Phase duration T 300 us Off 18s 18 s A Treatment time 30 min Treatment time 30 min Intensity 1 250 mA Intensity 1 250 mA In the muscular centre of the Positioning of electrodes In the muscular centre of the Positioning of electrodes denervated muscles denervated muscles The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by th
22. e therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 49 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 17 FES Prog 18 FES Increase of muscular Increase of muscular Parameters values Parameters values strength after stroke 1 strength after stroke 2 Descri o Aumento da Descri o Aumento da for a e facilita o mus for a e facilita o mus cular em pacientes com cular em pacientes com AVC para uso no ombro AVC para uso no ombro subluxado fase interme subluxado fase inicial di ria Frequency R 40 Hz Frequency R 40 Hz Phase duration T 300 us Phase duration T 300 us On 8s 10s On de a ad Treatment time 30 min Treatment time 30 min Intensity 1 250 mA Intensity 1 250 mA On the centers of the On the centers of the Positioning of electrodes Supraspinal muscle and medial Positioning of electrodes supraspinal muscle and medial deltoid fibers to be moved deltoid fibers to be moved during functional activit during functional activit The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 50 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 19 FES Prog 20 FES Increase of muscular strength after stroke 3 Parameters v
23. e with the prescriptions and directions provided by a health professional e Neuromuscular stimulators must be kept out of the reach of children e Neuromuscular stimulators must be used only with those conductor wires and electrodes recommended by the manufacturer 12 ADVERSE REACTIONS e Patients may feel skin irritation and burning under the stimulation electrodes e Patients may feel headache or other painful sensations during or after electrical stimulation next to the eyes on the head or face e Patients must stop to use the device and consult with a health professional if they feel adverse reactions after the use of the device RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT The use of electromedical equipment is restricted to a physician or under his command the physical therapists or health professionals properly licensed The professional will be responsible for properly licensed use and operation of the equipment IBRAMED makes no representations regarding laws and federal state or local laws that may apply to the use and operation of any electromedical equipment The physician or under his command also the physical therapist or other professional health care licensed assumes total and full commitment to contact the local certifying agencies to determine any credential required by law for clinical use and operation of this equipment The use of electromedical equipment must comply with the local state and federal co
24. ectrod In the muscular centre or on ositioning of electrodes ositioning of electrodes 9 the motor muscular point the motor muscular point The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 44 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 7 FES Increase muscle strength in athletes 3 Description Stimulation for conditioned muscle advanced phase Mode Frequency R Phase duration T Rise Decay Off Treatment time Intensity Positioning of electrodes Prog 8 FES Increase of muscle strength Parameters values after ACL injury 1 Parameters values Description Increase of muscle strength in patients with LCA lesion with or without ligamentoplasty Fes Sync 60 Hz 350 us 18s 50 Hz Frequency R Phase duration T n Positioning of electrodes 1s 18 s 12s 25 min or the desired numbe of muscle contractions 1 250 mA 25 min 1 250 mA In the muscular centre or on the motor muscular point of the rectus femoris muscles vastus lateralis and vastus medialis No ventre muscular ou sobre o ponto motor The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The in
25. ed Training Thanks whose goal is to provide technical and scientific support as well as current literature on therapies and their applicability while our treatment choices are always thoroughly selected according to the best and latest clinical criteria CEFAI takes into account the personal and professional development of all its partners and customers IBRAMED A matter of respect CEFAI invites both students and professionals in the fields of Physical Rehabilitation Esthetics Physiotherapy 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 CEFAI rormacho avan am IBRAMED 65 Fe DC IBRAMED QUEST O DE RESPEITO IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI Av Dr Carlos Burgos 2800 Jd It lia 13901 080 Amparo SP Brasil 55 19 3817 9633 www ibramed com br ibramed ibramed com br
26. 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 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 INDICATIONS CONTRAINDICATIONS PRECAUTIONS AND ADVERSE REACTIONS INDICATIONS FOR USE Indications for the currents Russian and FES e Prevention or treatment of atrophy for disuse e Increase in local blood circulation e Muscle reeducation e Maintenance or increase in amplitude of movement e Relaxation of spasmodic muscles Indications for TENS current e Symptomatic relief and treatment of chronic pain e Increase in local blood circulation e Symptomatic relief of acute post traumatic pain e Acute postoperative pain 10 CONTRAINDICATIONS e Do not use
27. ency R Phase duration T Rise On Decay Off Treatment time Intensity Positioning of electrodes Parameters values Fes Sync 40 Hz 250 us 5S 6s 2S 15s 35 min 1 250 mA In the muscular centre or on the motor muscular point of the rectus femoris muscles vastus lateralis and vastus medialis Increase of muscular strength knee surgery prosthesis 2 Description Increase of muscle strength in patients Subject to surgery for knee prosthetics intermediate phase Parameters values Frequency R 40 Hz 2s Treatment time Intensity Positioning of electrodes 35 min 1 250 mA In the muscular centre or on the motor muscular point of the rectus femoris muscles vastus lateralis and vastus medialis The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 4 47 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 14 FES Increase of muscular M Increase of muscular strength knee arameters values strength after PNL 1 Parameters values surgery prosthesis 3 Description Increase Description Increase of muscle strength in of muscle strength in ap oF eae patients with peripheral prosthetics advanced nerve lesions initial Frequency R 40 Hz Frequency R 65 Hz Phase duration T 250 us Phas
28. ensity 1 250 mA Intensity Positioning of electrodes Positioning of electrodes The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys T 55 PROTOCOLOS PRE PROGRAMADOS Prog 29 RUSSIAN Prog 30 RUSSIAN Original Russian current for Original Russian current for Parameters values flaccidity 3 IIa Fibers flaccidity 1 IIb Fibers Description Increase of muscular strength emphasis on type Ila fibers advanced phase 15 min Intensity 1 250 mA Intensity 1 250 mA Positioning of electrodes Positioning of electrodes Bipolar Parameters values Description Increase of muscular strength emphasis on type IIb fibers initial phase GW OV UW Ninlnly n The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys T 56 PROTOCOLOS PRE PROGRAMADOS Prog 31 RUSSIAN Prog 32 RUSSIAN Original Russian current for Original Russian current for flaccidity 2 IIb Fibers Parameters values flaccidity 3 IIb Fibers Description Increase of muscular strength emphasis on type IIb fibers intermediate phase Parameters values Description I
29. ent and after the START key is pressed an increase in intensity will gradually occur until it reaches the amount of current preset by the operator If during the gradual increase in intensity the operator realizes that the previously set amount of current is above the limit tolerable by the patient press the DOWN key to decrease the amount of current until it reaches the amount of current to the ideal to the patient 5 At the end of the programmed time the emission current is interrupted and an 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 37 ELECTRODE GUIDELINE ELECTROTHERAPY PATIENT PREPARATION e Electrode Placement can be achieved using the Bipolar or Monopolar Techniques Proper positioning and contact will insure treatment comfort and efficiency e Examine the skin for any wounds and clean the treament 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 e Electrode Biocompatibility ISO 10993 Ibramed declares that the electrodes supplied with the equipment do
30. iated with neuromuscular electrical stimulation in healthy individuals Am J Phys Med Rehabil 2011 90 5 399 406 Ward AR Lucas Toumbourou S McCarthy B Acomparison of the analgesic efficacy of medium frequency alternating current and TENS Physiotherapy 2009 95 4 280 288 59 ACCESSORIES ACCOMPANYING NEURODYN COMPACT Ibramed NEURODYN COMPACT contains accessories designed to meet the requirements of electromagnetic comparability accessories PARI QUANTITY ITEM DESCRIPTION NUMBER 03017006 PLUG LINE CORD LENGTH 1 5 M 03049006 KIT ELECTROTHERAPY LEAD WIRE BANANA PLUG 03026025 CONDUCTIVE RUBBER ELECTRODE 5CM X 5 CM 03019012 PROTECTION FUSE 20AG 2A 03026009 PROTECTION FUSE CHART 03044001 GEL TUBE 100GRAMS ANVISA REGISTRATION NUMBER 80122200001 MANUFACTURER GEL CL NICO 03026003 oq EE BAG SAPPHIRE LINE 03040004 DIGITAL OPERATIONAL MANUAL IBRAMED 100511 01 01 60 ACCESSORIES ACCOMPANYING NEURODYN COMPACT REPLACEMENT ACCESSORIES This list of replacement accessories are designed for use with the NEURODYN COMPACT 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 COMPACT equipment on other equipment or medical elec
31. irs without prior explicit turned on but does the equipment as mentioned in the not emit current instructions written permission from IBRAMED to patient 1 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 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 is turned on but does not emit current to patient 2 The equipment e Check if the amount of gel is does not turn enough on and or work e Check if the electrodes are worn properly properly 62 MAINTENANCE WARRANTY AND TECHNICAL SUPPORT 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 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 WARRANTY TERMS 1 IBRAMED warrantsthatthis productis free of manufacturing defects for eighteen 18 continuous months provided the set terms presented in these instructions for use are followed 2 The warranty period takes effect from the date of purchase and applies to the original purchaser only even in the event of a product being transferred to
32. lied when the patient is sleeping e Stimulation must not be applied when the patient is driving operating machines or during any activity in which electrical stimulation may put the patient in risk of lesion e Stimulation with polarized current must not be applied over areas with metal implants 11 PRECAUTIONS e Stimulation must be applied only on normal intact clean healthy skin e Consult with a doctor before using this device because the device may cause lethal disturbances in cardiac patients e The long term effects of chronic electrical stimulations are not known e The safety of neuromuscular stimulators for use during pregnancy has not been established e Extreme care must be taken with patients with suspicion of cardiac problems or diagnosed cardiac problems e Extreme care must be taken with stimulation treatment in the presence of the following a When there is a tendency of hemorrhage after acute trauma or fracture b Subsequently to recent surgical procedures when the muscle contraction may disturb the wound healing process c During the menstruating uterus or pregnancy d Over areas of the skin which lack normal sensitivity INDICATIONS CONTRAINDICATIONS PRECAUTIONS AND ADVERSE REACTIONS e Some patients present skin irritation or hypersensitivity caused by electrical stimulation or electrical conducting medium e The electrode placement and the stimulation configurations must be in accordanc
33. ncrease of muscular strength emphasis on type IIb fibers advanced phase Burst Frequency Burst Frequency i CERTA ECO Day 58 o 55 or 0 yr E Treatment time Treatment time Intensity 1 250 mA Intensity 1 250 mA Positioning of electrodes Positioning of electrodes Prog 1 to 20 User Protocols The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 57 T REFERENCES DeSantana JM Walsh DM Vance C Rakel BA Sluka KA Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain Curr Rheumatol Rep 2008 10 6 492 9 Delitto A Rose SJ McKowen JM et al Electrical stimulation versus voluntary exercise in strengthening thigh musculature after anterior cruciate ligament surgery Phys Ther 1988 68 5 660 663 Gersh MR Wolf SL Applications of Transcutaneous Electrical Nerve Stimulation in the management of patients with pain Phys Ther 1985 65 3 314 336 Guirro R Nunes CV Davini R Compara o dos efeitos de dois protocolos de estimulacao el trica neuromuscular sobre a for a muscular isom trica do quadriceps Rev fisioterUniv Sao Paulo 2000 7 1 2 10 15 Laufer Y Ries JD Leininger PM Alon G Quadriceps femoris muscle torques produced and fatigue generated by neuromu
34. netic Compatibility The purpose of this standard is e Ensure that the level of spurious signals generated by the equipment and irradiated to the environment are below the limits specified in IEC CISPR 11 Group 1 Class A radiated emission e Ensure the equipment immunity to electrostatic discharges by contact and through the air from the accumulation of Static electric charges acquired by the body Electrostatic Discharge IEC 61000 4 2 e Ensure the immunity of equipment when subjected to an electromagnetic field incident from external sources Radiated RF Immunity IEC 61000 4 3 A 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 18 The use of accessories other than those listed except when supplied or sold by Ibramed Industria Brasileita de Equipamentos M dicos EIRELI as replacement parts for internal or external components may result in increased emission or decreased immunity of the NEURODYN Compact Electro Stimulator ELETROMAGNECTIC COMPATIBILITY POTENTIAL ELECTROMAGNETIC INTERFERENCE As for the limits for electromagnetic disturbances NEURODYN Compact is electromagnetic equipment which belongs to Group 1 Class A The simultaneous connection of the patient to NEURODYN Compact and surgical HF equipment may result in burns on the appli
35. 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 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 The symmetrical waveforms of the Biphasic Medium Frequency and Bipolar Interferential Premodulated are usually applied to the body using the Bipolar Technique The NEURODYN COMPACT Electro Stimulator offers waveforms of the Nervous Transcutaneous Electrical Stimulation TENS Functional Electrical Stimulation FES and Russian Current RUS Figure 7 Bipolar Electrode Placement Technique 38 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 Symmetrical Biphasic Medium Frequency and Bipolar Interferential Premodulated The NEURODYN COMPACT Electro Stimulator offers Waveforms of the Nervous Transcutaneous Electrical Stimulation TENS Functional Elect
36. perform the stimulation It is necessary to press the PROG key aech time for a new stimulation Figure 11 Display to select the programmed and user 5 The manual stimulation mode is active until the end of the protocols programmed time of treatment To cancel the therapist must trigger the STOP button 41 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 1 TENS Trigger points pain control Parameters values Description Modulation of trigger points pain Mode Tens Conv Frequency R Phase duration T 500 us Intensity 1 250 mA One electrode on the muscular trigger point and the other 7 cm away from the main electrode Positioning of electrodes Prog 2 TENS Parameters values Acute pain treatment Description Modulation of acute pain Frequency R 170 Hz Phase duration T Treatment time Intensity 1 250 mA Positioning of electrodes On the painful area The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 3 TENS Prog 4 FES Motor recovery after Chronic pain treatment Parameters values surgery Description Post Description Modulation of Surgery Stimulation chronic pain for functional motion recovery Parameters values
37. r on Positioning of electrodes the motor muscular point The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 53 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 26 RUSSIAN muscular resistance 3 Description Muscular Description Increase stimulation through of the localized muscle resistance advanced Russian Current On Off Phase duration T Burst Frequency 50 Hz F of E 16 s Treatment time 40 min 3 times per day Treatment time 25 min Intensity 1 250 mA Intensity 1 250 mA On the muscular center or on e On the muscular center or on Positioning of electrodes Positioning of electrodes the motor muscular point the motor muscular point The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist T according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys 54 PROTOCOLOS PRE PROGRAMADOS Prog 27 RUSSIAN Prog 28 RUSSIAN Original Russian current for Original Russian current for na Parameters values Description Increase of Description Increase of muscular strength emphasis on muscular strength emphasis type Ila fibers initial phase on type Ila fibers intermediate phase Int
38. 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 COMPACT is used exceeds the applicable RF compliance level above the NEURODYN COMPACT should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorientation or relocating the NEURODYN COMPACT b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m b 24 ELETROMAGNECTIC COMPATIBILITY Recommended separation distances between the mobile RF communication equipment and NEURODYN The NEURODYN Compact is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the NEURODYN Compact can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the NEURODYN Compact as recommended below according to the maximum output power of the communications equipment Rated maximum power Separation distance according to frequency of transmitter output of transmitter m d 1 2 P d 0 35 P d 0 7P E For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters
39. rical Stimulation FES and Russian Current RUS rR Figure 8 Monopolar Electrode Placement Technique ELECTRODE GUIDELINE WARNING Placement of the electrodes near the chest may increase the risk of cardiac fibrillation Electrode Sizes and Current Density The size of the electrodes and the energy density used during therapy must comply with IEC 60601 2 10 i e the current density per area of electrode should not exceed 2 mA cm Follow the manufacturer s instructions Figure 9 Electrode sizes and current density 39 USING THE MS PROG BUTTON SELECT THE LANGUAGE USING THE PROG BUTTON The MS PROG button is used to select the language Press MS PROG until you hear three beeps Select the desired Connect the equipment as described above Briefly press language Portugu s Espanol or English Short press MS PROG and the following information will appear on the LCD PROG to set the chosen language This is the first equipment to offer a choice of Treatment Protocols Use the SET SET buttons to select another protocol If this is the protocol chosen press the PROG key Timer Type once again The LCD displays the parameters of the equipment Current Tens scheduled for the selected protocol Then simply press the Mode START button and select the desired current density Proceed the same way to select any of the protocols available Language Simply follow the steps above
40. scular electrical stimulation with three different waveforms Phys Ther 2001 81 7 1307 1316 McManus FJ analgesic effects of experimental pain models induced pain Physiotherapy 2006 92 2 Ward AR Robertson VJ The interferential therapy on two cold and mechanically 95 102 58 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 an terior 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 REFERENCES Ward AR Shkuratova N Russian electrical stimulation the early experiments Phys Ther 2002 82 10 1019 1030 Ward AR Laufer Y Tausher H Esh R Sensory transcutaneous electrical stimulation fails to decrease discomfort assoc
41. snsdssnanabandinnstu biaa udau ba again inun 34 OPERATING INSTRUCTIONS apropriados ainda dd sino 35 PREPARE DEVICE 171561 170h a con inE ERA ba a ban a 35 PROGRAMMING EQUIPMENT sspasagana passa nado 36 ELECTROTHERAPY PATIENT PREPARATION 37 EFLECLR EBSEGUIDELINE 2 ain2ininisnnnssssnanununnanannnnnnnnana 37 USING THE MS PROG BUTTON cccccseceeeeeeesenenensnsens 40 CERs HE LANGUAGE cccceceessesseneeeeesssesees 40 C NGENE PROG BUTTON 22 222nanansnssannn nananunnuvna 40 PROGRAMMING USER PROTOCOLS 41 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS 42 REFERENCES essas sarap Epa Reinado REDE PRADO Rad dos an 58 ACCESSORIES ACCOMPANYING NEURODYN COMPACT 60 REPLACEMENT ACCESSORIES cussaisassesbsusn ssdmeiais 61 TROUBLES HOO UIN Grcsienteconsaneteecensenisanee Sasak danan a 62 MAINTENANCE WARRANTY AND TECHNICAL SUPPORT 62 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 Sensitivity against electrostatic discharge Start treatment TYPE BF Electrical equipment Stop treatment Dangerous voltage O Off switch CLASS II Electrical equipment On swith ol gt bl gt IDXO Not protected against the harmful effects of water penetration y Voltage
42. sure that it is used in such an environment Compliance Immunity Test BAR p Electromagnetic Environment Guidance Test Level Level Portable and mobile RF communication equipment should hot be used no closer to any part of NEURODYN Compact including cable than be separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 YP 3 V d 0 35 VP 80 MHz to 800 MHz d 0 7 VP 800 MHz to 2 5 GHz Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz 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 a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol p Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz 3 V m 23 ELETROMAGNECTIC COMPATIBILITY NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths set by fixed transmitters such as radio base stations telephone cellular cordless telephones and land mobile radios amateur radio AM FM
43. tensity should be adjusted using the Up and Down keys 45 T CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 9 FES Prog 10 FES Increase of muscle E Strength values after AC Parameters values Parameters values Description Increase of muscle strength in patients with LCA lesion with or without ligamentoplasty advanced Frequency R 50 Hz Frequency R 60 Hz Phase duration T 250 us Phase duration T 300 us F F Treatment time 25 min Treatment time 25 min Intensity 1 250 mA Intensity 1 250 mA In the muscular centre or on In the muscular centre or on the motor muscular point of o the motor muscular point of Positioning of electrodes the rectus femoris muscles Positioning of electrodes the rectus femoris muscles vastus lateralis and vastus vastus lateralis and vastus medialis medialis The manufacturer does not indicate the necessary intensity in the protocol because it should be adjusted by the therapist according to the clinical needs of each patient The intensity should be adjusted using the Up and Down keys a 46 Description Increase of muscle strength in patients with LCA lesion with or without ligamentoplasty intermediate phase CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS Prog 11 FES Increase of muscular strength knee surgery prosthesis 1 Description Increase of muscle strength in patients subject to surgery for knee prosthetics implant initial Mode Frequ
44. therapy as described and read about the use of electrodes Start Treatment START Press the START button to begin therapy VS session STOP Stop Treatment Press the STOP button to end therapy session T OPERATING INSTRUCTIONS Waveform Intensit The Waveform Intensity may be increased or decreased at 2 With the SELECT and SET keys scroll through the other any time during the session Press the INTENSITY button parameters and select the values shown in the example UP or DOWN A Mode status PROGRAMMING EQUIPMENT gt VIF On Example 1 Suppose the clinical practice or literature to Y Frequency suggest certain pathology TENS current type with automatic Intensity ma variation of intensity and frequency VIF ON and the 0 0 treatment time of 40 minutes ch1 ch2 1 Connect the equipment to start programming the pattern described above Note the blinking cursor in the CURRENT TYPE field K 4 Manual stm min b gt Timer 40 v Current A Timer Type Intensity mA 0 0 b gt Current Tens v Mode ch1 ch2 Intensity ma 0 0 ch1 ch2 o am OPERATING INSTRUCTIONS 3 Press the UP or DOWN channel in use to select the amount of current needed to treat 4 Now press the START button to start treatment Note The intensity adjustment can be done before or after pressing the START key To adjust the intensity before pressing the START the operator must adjust the amount of current required for a given pati
45. 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 This device must not be used for the relief of local symptomatic pain without known etiology unless a pain syndrome is diagnosed e The stimulation must not be applied in patients with Suspicion of transmittable infectious diseases and or diseases in which it is advisable for medical purposes to Suppress heat or fever e Stimulation must not be applied on the nerves of the carotid Sheath particularly in patients with altered sensitivity to reflex of the carotid sinus e Stimulation must not be applied over the neck or mouth Spasms of the larynx and pharynx muscles may occur and the contractions may cause the closure of the upper airways or cause respiratory difficulties e Stimulation must not be applied over the cardiac area because it might cause cardiac arrhythmia e Stimulation must not be applied over the brain area e Stimulation must not be applied over swollen infected or inflamed areas neither over skin eruptions such as phlebitis thrombophlebitis varicosis etc T INDICATIONS CONTRAINDICATIONS PRECAUTIONS AND ADVERSE REACTIONS e Stimulation must not be applied over or next to cancerous lesions e Stimulation must not be applied when the patient is in the Shower or bathtub e Stimulation must not be app
46. tro systems 61 MAINTENANCE WARRANTY AND PRADA A TECHNICAL SUPPORT What may initially seem like a technical failure is not always a 4 4 4 MAINTENANCE failure Therefore before asking for technical assistance check the steps described in the table below For safe use of the equipment it is recommended to have it inspected and undergo preventive maintenance at IBRAMED PROBEEMS SUN or an authorized technical center every 12 months e Is the power cable properly The manufacturer IBRAMED only assumes liability for the connected technical features and equipment safety provided the unit If not connect it Also check the wall Socket 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 The equipment does not turn on 1 e Have you checked the safety fuse The equipment Check if there is a bad contact does not turn on 2 Check if the value is correct as stated can cause a security risk to the appliance are replaced by in the instructions original spare parts If requested IBRAMED will provide technical documentation circuit diagrams lists of parts and l i o Have you followed the components etc necessary for the repair of any equipment The equipment is recommendations for correct use We assume no responsibility for repa
47. uits in relation to the mains power in all the poles NOTES In the rear part of NEURODYN Compact there is a protection fuse To replace it turn the equipment off of the mains voltage line and with a screwdriver remove the protection lid disconnect the fuse and perform the replacement then replace the protection lid Always use the fuses indicated by Ibramed Use the fuse for the nominal current of 5 0A operation tension 250V and snap action model 20AG rupture current of 50A NEURODYN Compact does not need any type of current Stabilizer Never use power stabilizers 17 Before turning on NEURODYN Compact make sure 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 o 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 o Cleansing and disinfection must be performed with the power plug disconnected from the mains voltage Maintenance and technical assistance of NEURODYN Compact must always be performed at an authorized technical service only by qualified technicians There are dangerous tensions inside the equipment Never open the equipment ELECTROMAGNETIC COMPATIBILITY GUIDANCE NEURODYN Compact was developed to meet the requirements in IEC 60601 1 2 Electromag
48. untry 13 POPULATION AND CONDITIONS OF USE PATIENT POPULATION e Patients over 12 years old under this age only by medical prescription or physiotherapeutic indication e Patients over 35 kg under this weight only by medical prescription or physiotherapeutic indication e There are no restrictions as of nationality e Patients with preserved level of conscience and sensitivity CONDITIONS OF USE e There are no requisites about a maximum level of education for the intended use e Regarding the minimum level of knowledge of the user it is necessary that the user knows the electro physical agents and their therapeutical effects The user must know physiology anatomy and the basic sciences chemistry physics and biology The user is supposed to have studied or be presently studying physiology and anatomy e A maximum level of knowledge is not required from the user e The instructions of use are available in Portuguese Spanish and English 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 14 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 GENERAL CARE WITH THE
49. y Test Voltage dips short interruptions and voltage variations in power input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic fild IEC 61000 4 8 NOTA 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 cyclo 40 U 60 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 Compliance Level lt 5 U gt 95 voltage drops in U by 0 5 cycle 40 U 60 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 22 Electromagnetic Environment Guidance Mains power quality should be that of a typical commercial or hospital environment If the user of the NEURODYN Compact requires continued operation during power mains interruptions it is needed that the NEURODYN Compact be bowered 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 Compact is intended for use in the electromagnetic environment specified below The customer or the user of the NEURODYN Compact should as

Manual

Contents

Download Pdf Manuals

Related Search

Related Contents