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Neuro-MS/D - Caputron Medical

1. Fig 25 The connection of the main unit 1 Mains cable for the main unit 2 Endcap It is prohibited to use the system if the end cap is not fixed by the screws 47 Neuro MS D Technical Manual 3 48 Proper Use 3 1 Operating Order Before the stimulator switching on it is required to perform the assembly and the con nection of the units according to chapter 2 Assembly and Installation All the stimula tor units should be connected to the mains It is required to make sure that the electronic units of the stimulator do not have the visible mechanical failures which can be dangerous The order of operation 1 Connect the coil required for the operation to the stimulator Make sure that the coil connector is inserted firmly and the spring lock is locked In case of incorrect fixation the burning out of the power connector pins is possible If you use the cooling unit connect the cooling agent hoses of the cooled coil to the cooling unit using the input and output quick connect couplings on the front panel of the cool ing system Pay attention to the color marking Using the Mains power switch located on the rear panel of main unit connect the power supply to the magnetic stimulator by turning it to I position At that the Power state indicator located on the front panel will highlight yellow If expansion unit is included in the stimulator delivery set than using
2. During the continuous use of the stimulator the overheating of internal components of the main unit and the expansion unit are possible If any component is overheated Qu imi oe 868 inscription appears of the Amplitude indicator cmi inscription appears on Stimulation parameters indicator during the overheating of the main unit Be during the overheating of the expansion unit and 888 during the overheating of the extra power supply unit Wait for about an hour till the internal components cool down Proper Use 3 2 Troubleshooting The list of stimulator possible troubles is given in Table 10 Table 10 Troubleshooting Trouble Symptom Cause Way of Removal If you use the stimulator The faulty USB cable is used to Replace USB cable It is operating in USB control connect to computer recommended to use the mode the program displays cable included in the the message concerning stimulator delivery set the data exchange error with the stimulator or stimulator missing In stand alone mode the stimulator operates regularly The stimulator is controlled The failure has occurred during Switch off and then on the by Neuro MEP NET or the finishing of operation of Mains power switch located Neuro MS NET program Neuro MEP NET or Neuro on the rear panel manufactured by Neurosoft MS NET program manufactured Ltd via USB After the by Neurosoft Ltd finishing of the operation with the program a
3. 2 2 Room Selection and Placement Before assembly and setting of stimulator it is necessary to select a place for it tak ing into consideration power wiring and protective ground in the room and also to read the following requirements and recommendations Requirements concerning room selection and equipment placement e The device has been designed for indoor use at room temperatures between 10 C and 35 C 80 maximum relative humidity e When placing the electronic unit of stimulator in the immediate vicinity of any elec tronic equipment see the schemes given on Fig 18 and Fig 19 O Mouse Keyboard More than 1 m a al gt 1 5m Fig 18 The scheme drawing of stimulator placement when connecting to digital EMG systems manufac tured by Neurosoft Ltd Assembly and Installation 220 230 V Fig 19 The scheme drawing of stimulator placement when connecting to digital EMG systems produced by other manufacturers The following abbreviations are used on the figures e EMG electronic unit of digital EMG system e C patient chair e M monitor e MS magnetic stimulator e P printer e SU PC system unit e T isolation transformer which corresponds to IEC 60601 1 standard requirements e power cables 220 230 V e gignal cables e To provide the normal cooling of the internal components during the stimulator op eration the stimulator should be placed on a firm surfa
4. Monophasic Power monophasic Paired monophasic The specifications of coils are provided in the technical manual concerning these coils Table 6 Dependence of Maximal Stimulus Amplitude on Stimulation Frequency While Working with without Extra Power Supply Unit with Use of RC 02 150 Big Ring Coil Stimulation Frequency Hz Maximum Power Without Extra Power With Extra Power Supply Unit Supply Unit 5 100 100 10 69 100 15 53 100 20 43 100 25 37 89 30 30 79 Safety and Electromagnetic Compatibility Electromagnetic compatibility EMC is provided by conformance to international standard IEC 60601 1 2 2007 requirements The magnetic stimulator is intended for operation in electromagnetic environment as specified in Appendix 1 As for safety magnetic stimulator satisfies IEC 60601 1 2005 requirements it is re ferred to class and has BF type work parts corresponding to IEC 60601 1 2005 Interpretation of Symbols on Electronic Unit attention consult operational documentation work parts of BF type according to IEC 60601 1 eX rt mark of conformance to Russian standards requirements mark of conformance to 93 42 EEC Concerning Medical Devices directive 0535 mark of conformance to 2002 96 EC On waste electrical and electronic equipment WEEE directive Neuro MS D Technical Manual 1 5 Delivery Set The delivery set includes the
5. The expansion unit contains the charging circuitry intended to charge the high voltage capacitor the system of high voltage electronic switches and the control circuitry De pending on the operation mode the high voltage capacitor of the expansion unit is connected on parallel to the capacitor of the main unit to produce the power pulses or is used to generate the second stimulus in the paired stimulation mode The pulse width in the power mode is extended with approximately 40 relative to the standard mode Description The magnetic stimulator generates the following stimulus waveform e Monophasic stimulus with expansion unit only the stimulus when the current flows through the coil in one direction increasing by sine law and decreasing by ex ponent Fig 3 Coil current Time Fig 3 Monophasic stimulus e Biphasic stimulus the stimulus when the current waveform in the coil is charac terized by one period of damped sinusoid Fig 4 Coil current Time Fig 4 Biphasic stimulus e Biphasic burst stimulus in USB control mode only the biphasic stimulation when the series of the biphasic pulses with high frequency up to 100 Hz and de creasing amplitude are generated instead of single pulse Fig 9 The amplitude of the first pulse is specified for this stimulus After obtaining this stimulus the residual charge of the capacitor is used to generate the next stimulus Coil current Time Fig 5 Biph
6. Small figure of eight coil 50 mm NSFT 058304 005 1 1 1 1 FEC 02 50 Angulated figure of eight coil 100 mm placebo NSFT 058304 009 1 1 1 1 AFEC 02 100 P Figure of eight coil 100 mm placebo NSFT 058304 004 4 4 4 4 FEC 02 10 P Cooled figure of eight coil 100 mm NSFT 058304 010 g 4 1 4 FEC 02 100 C Cooled angulated figure of eight coil 100 mm NSFT 058304 011 1 1 1 placebo AFEC 02 100 C P Cables Control cable for Neuro MS D expansion unit NSFT 058103 034 1 Trig in cable for synchronization via electrical NSFT 014103 032 1 1 1 1 stimulator DIN8 FE DIN5 2409 Trig in cable for synchronization via electrical NSFT 014103 033 1 1 1 1 stimulator DIN8 FE DIN5 1809 Trig in cable DIN8 EBNC NSFT 014103 039 1 1 1 1 Trig out cable DINS gt BNC NSFT 014103 047 1 1 1 1 Holders Flexible arm NSFT 016998 002 4 B 4 4 CH 1 Touchscreen computer holder NSFT 016998 010 1 1 1 1 H 2 FISSO flexible arm NSFT 016998 012 H 3 iha Ba ka Neuro MS D Technical Manual Table 8 Continued Document code or main specifications Quantity pcs Name 1 2 3 Trolleys Trolley with custors for magnetic stimulator NSFT 059201 001 3 shelves T 1 Computer and Electronic Equipment System unit TC 4013 003 1 1 1 1321815802011 e Functional e Elegance e Elite Monitor LCD 19 VESA holder 1 1 1 built in power supply unit Touchscreen computer IEI Afolux 12A 1 1 1 Print
7. 4 Marking 5 Connector for mains supply cable attachment 6 Equipotential connector The connector for the attachment of equipotential cable connecting the cases of units included in the system 33 Neuro MS D Technical Manual 1 7 4 Controls Connectors and Indicators of Extra Power Supply Unit Fig 13 The front panel of extra power supply unit The front panel of extra power supply unit contains Fig 13 1 Power indicator 03 Depending on mode Power indicator lights e Orange standby mode e red blinks overheat e green extra power supply unit is switched on and functions properly Fig 14 The rear panel of extra power supply unit The rear panel of extra power supply unit contains the following Fig 14 1 Connector for mains supply cable attachment 2 Mains power switch 34 Description To connect the mains supply to this unit turn Mains power switch to On I position To disconnect from the mains supply set the Mains power switch to Off 0 position 3 High voltage connector to attach the main unit The high voltage connector is in tended to attach the high voltage cable to the unit and opposite part of this cable is plugged into the main unit 4 Cooling fans output The fans provide the air circulation inside the main stimulator unit The air is sucked through the holes located on the bottom panel and blown out via the cooling fan outlet at the
8. name ae and signature of beginning of end of storage fso torage perso ka responsible for storage Warranty 11 1 The manufacturer guarantees the magnetic stimulator quality conformance to TC 9442 009 13218158 2008 requirements if the rules of operation storage trans portation and mounting prescribed in the operational documentation are observed 11 2 Warranty period is 24 months from the delivery date to the customer chapter 9 There is no warranty for consumables The warranty period can be prolonged for the period from reclamation submission up to repair completion chapters 12 13 11 3 The operation of guarantee commitment is stopped if e the rules of operation storage transportation and mounting prescribed in the operational documentation are not observed e the warranty period is expired e a user brakes the seal without permission of the manufacturer 11 4 The manufacturer is obliged to repair the equipment in case of breakdown dur ing the warranty period free of charge The repair is carried out in the service center of 59 Neuro MS D Technical Manual 12 60 Neurosoft Company 5 Voronin str lvanovo 153032 Russia only if this registration certificate is provided You can also contact SAS Neuromed Company Authorized European Representa tive of Neurosoft Company to Mr Pierre Scholl by the following address Chemin du tomple 84330 Le Barroux France Phone 490 65
9. s Le 5 Fig 10 The rear panel of the expansion unit The rear panel of the expansion unit contains the following Fig 10 1 Connector for mains supply cable attachment 2 Mains power switch To connect the mains supply to the expansion unit turn Mains power switch to On I position To disconnect from the mains supply set the Mains power switch to Off 0 position 3 Control connector Ct Control connector is intended to attach the communication cable to main unit and cooling unit 4 High voltage connector to attach the main unit The high voltage connector is in tended to attach the high voltage communication cable to the main unit 5 Cooling fans output The fans provide the air circulation inside the main stimulator unit The air is sucked through the holes located on the bottom panel and blown out via the cooling fan outlet at the rear panel 6 Marking 7 USB connector The connector is intended to attach the stimulator to the computer using USB cable 8 Equipotential connector The connector for the attachment of equipotential cable connecting the cases of units included in the system 31 Neuro MS D Technical Manual 1 7 3 32 Controls Connectors and Indicators of Cooling Unit EN m2 n3 r4 7 5 Fig 11 The front panel of the cooling unit The front panel of the cooling unit contains the following Fig 11 1 2 5 6 Quick conn
10. 45 Neuro MS D Technical Manual 2 4 7 46 Assembly and Connection of Main Unit and Extra Power Supply If you use the main unit and extra power supply unit the placement of these units is carried out according to Fig 1 The main unit is placed on extra power supply unit In case you use the trolley for magnetic stimulator the units are placed on the different shelves in the same order The units are connected with the use of the connecting cables Fig 24 and are at tached to the mains by mains cable Main unit 4 Ca ag Extra power supply unit Vamaamasano Fig 24 The connection of main unit and extra power supply unit 1 Equipotential cable 2 Mains supply cable for main unit 3 Mains supply cable for extra power supply unit 4 HV cable The connected cables should be fixed by the specified screws It is prohibited to use the system if the connection cables are not fixed It is prohibited to use cooled coils that are not connected to cooling system or if the cooling system does not function Assembly and Installation 2 4 8 Assembly and Connection of Main Unit If you use the trolley for the magnetic stimulator the main unit is placed on the top shelf The unit is connected to the mains with the mains cable The end cap is placed on HV connector located on the rear panel of the case and is fixed by the screws Main unit
11. To adjust the pause use Stimulation parameters knob If you press Pulse button in this mode you will run the repetitive stimulation The Session button will start blinking green and Stimulation parameters indicator will display the time left before the stimulation stop 18 Frequency button If the mode is disabled the button is not highlighted In case you press Frequency button the stimulator will switch to the repetitive stimulation frequency setting mode At that the button will highlight green In this mode Stimulation parameters indicator displays the current frequency of the repetitive stimulation To adjust the frequency use Stimulation parameters knob If you press Pulse button in this mode you will run the repetitive stimulation The Session button will start blinking green and Stimulation parameters indicator will display the time left before the stimulation stop i kolelsiz ls Le 5 Fig 8 The rear panel of main unit The rear panel of main unit contains Fig 8 1 Connector for mains supply cable attachment 2 Mains power switch 27 Neuro MS D Technical Manual To connect the mains supply to the magnetic stimulator turn Mains power switch to On I position To disconnect from the mains supply set the Mains power switch to Off 0 position 3 USB connector ote The connector is intended to att
12. contraindications for the stimulator application severe arterial hypotension systemic blood diseases bleeding propensity thrombophlebitis recurrent thromboembolism fractures before immobilization diffuse goiter Ill stage acute inflammatory purulent processes abscesses and phlegmons before lancing and draining of cavities cholelithiasis epilepsy febrile states and also transcranial magnetic stimulation of patients suffering from the arterial hypertension Ill stage the diagnosis is confirmed Neuro MS D Technical Manual 1 3 Warnings and Precautions gt 1M Do not start working with stimulator before you have read this document The stimulator must be used by the qualified medical personnel trained to operate on it and knowledgeable of magnetic stimulation application During the work on the stimulator it is required to observe the working regulations concerning the safety rules while operating on electrical installations High voltages 1500V are presented within the stimulator To provide safety measures and exclude the hazard of medical staff s or patient s electric shock the medical staff is PROHIBITED e to use the stimulator which was mounted and installed incorrectly without following this manual instructions e to eliminate faults connected with opening of the compo nents included in the delivery set e to work with the stimulator when the electronic unit box computer or other devices u
13. electronic units with the set of coils and cables The de livery set of the stimulator corresponds to Table 7 and Table 8 The figures in Quantity pcs column of Table 7 and Table 8 indicate 1 Neuro MS D magnetic stimulator delivery set variant 1 diagnostic 2 Neuro MS D magnetic stimulator delivery set variant 2 therapeutic 3 Neuro MS D magnetic stimulator delivery set variant 3 advanced therapeutic 4 Neuro MS D magnetic stimulator delivery set variant 4 advanced research The complete delivery set of the stimulator delivery set variant 4 is given on Fig 1 Fig 1 The external view of assembled magnetic stimulator with NSFT 058201 001 main unit 14 Description 1 Cooled angulated figure of eight coil 100 mm AFEC 02 100 C the cooled coil is used together with the cooling unit 2 Coil holder 3 Trolley with custors for magnetic stimulator 4 shelves 4 Touchscreen computer 5 Touchscreen computer holder 6 Main unit 7 Expansion unit 8 Cooling unit 9 Extra power supply unit 10 Neuro MEP Micro digital EMG system Neuro EMG MS delivery set Table 7 Base Delivery Set Name Document name or main specifications Quantity pcs Main unit NSFT 058201 005 Expansion unit NSFT 058201 002 Cooling unit NSFT 058201 003 NSFT 058201 007 Extra power supply unit NSFT 058201 004 NSFT 058201 011 Neuro MEP Micro Ne
14. field It is recommended to use the holder to fix the coil STOP If the coil heats over 41 C the magnetic stimulator stops the stimulation and indicates the overheating As far as the coil hare temperature on its surface still grows even after the stimulation stop owing to the thermal lag it is required to remove immediately the coil from the patient surface to avoid the patient s burn and discomfort To protect a patient from excessive impact by the electromagnetic field generate the minimal required number of pulses The general principles of safety regulations are stated in e Risk and safety of repetitive transcranial magnetic stimulation report and suggest ed guidelines from the International Workshop on the safety of repetitive magnetic stimulation June 5 7 1996 by Eric M Wassermann accepted for publication 23 May 1997 Neuro MS D Technical Manual 10 e Safety of different inter train intervals for repetitive transcranial magnetic stimula tion and recommendations for safe ranges of stimulation parameters by Robert Chen Christian Gerloff Joseph Classen Eric M Wassermann Mark Hallet Leo nardo G Cohen accepted for publication 23 May 1997 The information in Table 1 and Table 2 is related to recommended train parameters while performing the repetitive transcranial magnetic stimulation and cited from Safe ty of different inter train intervals for repetitive transcranial magnetic stimulati
15. is not set the button does not highlight In case you press the button the current amplitude value is taken as 100 and it is displayed on Amplitude indicator The button and MT indicator are highlighted green 8 Amplitude indicator Depending on the stimulator state it indicates e the stimulus amplitude in percents from the maximal value or from MT After the stimulator switching off the current amplitude is stored in the memory and is indi cated at the next switching on The amplitude adjust is performed with the use of Amplitude knob e information concerning the fault presence e information concerning the overheating Description 9 MT icon MT icon is intended to indicate the mode of amplitude detection of the motor threshold MT It is highlighted green in the active mode 10 On Off button and Power indicator On Off button toggles the operational mode of the stimulator On initial application of mains power the stimulator enters the standby mode This is indicated by the yellow light of Power indicator Pushing the On Off button in the standby mode will set the stimulator into the operational mode This is indicated by green light of the Power indicator All indicators and symbols will illuminate within a period of 3 seconds After the expiring of 3 seconds the stimulator switches to the single pulse mode At the end of the session the stimulator ca
16. rear panel 5 Marking 6 Equipotential connector The connector for the attachment of equipotential cable connecting the cases of units included in the system 1 7 5 Coil Controls Connectors and Indicators Fig 15 Cooled coil The cooled coil contains the following Fig 15 1 Coil power connector 2 Quick connect couplings for cooling unit connection 3 Hoses to connect to the cooling unit 4 Ready indicator duplicating the Ready indicator located on the front panel of the main unit 35 Neuro MS D Technical Manual 5 The Pulse button functioning is analogous to the Pulse button on the front panel of the main unit 1 8 Synchronization The Trig in out connector is used for stimulator synchronization with other EMG equipment It is located on the rear panel of stimulator The pinout is given on the Fig 16 and the functions of these pins are described in the table Table 9 Fig 16 The pinout Table 9 Pin Name Function Note number 1 5 V Output 5 V GROUND Ground 4 TRIG IN Trigger input Application of a signal TTL CMOS logical level of either polarity see POLARITY pin to TRIG IN input will result in the stimulation being triggered This signal must be active for at least 200 us The trigger pulses are ignored by the stimulator e in USB control mode e if there are some faults e if the coil is overheated e if the internal components of
17. that this button is highlighted green In this mode Stimulation parameters indicator displays the current session duration To adjust the session duration the Stimulation parameters knob is used If you press Pulse button in the mode you will start the repetitive stimulation the Session button will start blinking green and the Stimulation parameters indicator will show the time left before the stimulation stop 16 Pause button MN If the mode is disabled the button is not highlighted In case you press Pause button the stimulator will switch to pause duration setting mode You can set pauses between the trains during the repetitive stimulation and the button will highlight green In this mode Stimulation parameters indicator displays the current value of pause between trains To adjust the Description pause use Stimulation parameters knob If you press Pulse button in this mode you will run the repetitive stimulation The Session button will start blinking green and Stimulation parameters indicator will display the time left before the stimulation stop 17 Train button NE If the mode is disabled the button is not highlighted In case you press Train button the stimulator will switch to train duration setting mode At that the button will highlight green In this mode Stimulation parameters indicator displays the current train duration
18. the stimulator are overheated 5 TRIG OUT Trigger output The TRIG OUT supplies a synchronization signal to the external EMG equipment A TTL CMOS logical level pulse width and polarity are user defined see POLARITY pin is provided at this output whenever the stimulator is discharged on every pulse 8 POLARITY Input of polarity With POLARITY being connected to the selection Ground or being not connected the stimulator requires a rising edge trigger pulse and produces a falling edge trigger output pulse wherever it is discharged With POLARITY being connected to 5V the stimulator requires a falling edge trigger pulse and produces a rising edge trigger output pulse wherever it is discharged 36 Description You can set the duration of trigger pulses within the range from 10 us up to 50 ms for more details see chapter 1 9 1 9 Main Unit Service Menu Main unit service menu is meant for the control of service functions such as trigger pulse duration turn on off the cooling unit control Exit Fig 17 Main unit service menu 1 To open the service menu press and hold Stimulation frequency button and press On Off button located on the front panel when the stimulator is in stand by mode 2 The trigger pulse duration setup mode is activated The u92 symbol appears on Amplitude indicator and the trigger pulse width in ms from O to 50 O position correspond to 10
19. unit is not connected Check the type of the control cable it should be NSFT 058103 070 or NSFT 058103 071 If you use NSFT 058201 003 cooling unit disable the cooling unit control interface see chapter 2 4 2 BEE 43 Invalid data from the cooling unit Check the connection of control cable to the control cable for the cooling unit is not connected 52 Only for NSFT 058201 005 main unit the expansion unit and the cooling unit Check the type of the control cable it should be NSFT 058103 070 or NSFT 058103 071 If you use NSFT 058201 003 cooling unit disable the cooling unit control interface see chapter 2 4 2 Proper Use 3 3 Operation in Stand alone Mode In stand alone mode of operation the stimulator can produce e the single pulses e perform the repetitive stimulation by trains After the power supply switch on the stimulator stands in the Single stimulation mode at that the Single pulse button highlights green If you press Single pulse button the stimulator will switch to the setting mode of repetitive stimulation frequen cy At that the Single pulse button does not illuminate and Frequency button is highlighted green The next pressing of Single pulse button switches the stimulator to single pulse mode While operating with digital EMG and EP system the delay of the capacitor charge start is provided in single pulse mode to exclude the noise impac
20. us pulse duration is displayed on Stimulation parameters indicator The duration is set by Stimulation parameters knob 3 To activate the cooling unit control mode press Stimulation frequency button once more The at E a Amplitude indicator displays WI and Stimulation parameters indicator displays setting state UOD eee control is on EE control is off To change the state use Stimulation parameters knob If you use the stimulator with NSFT 058201 003 cooling unit change ace setting to OFF If you use the stimulator with NSFT mi D 058201 007 cooling unit change setting to We position 4 To return into the mode of trigger pulse duration setup press Stimulation frequency button once more To save settings and quit the service menu press On off button on the front panel of the main unit 37 Neuro MS D Technical Manual 2 38 Assembly and Installation 2 1 Requirements to Personnel Conducting Stimulator Assembly and Installation The stimulator should be installed by the person who is authorized by the manufactur er or the technical personnel of the medical institution which is going to use it It is necessary to know that safety and quality of operation depend on the proper assem bly of the magnetic stimulator Further assembly and installation requirements which define the product safety will be marked by bold and italic font in the text
21. 0 470 622 748 384 Fax 490 650 470 E mail bscholl orange fr Reclamation Data 12 1 In case of system breakdown or faultiness in the period of warranty and also product defect detected when primary acceptance the consumer should send written notification to Neurosoft Ltd authorized European representative or nearest distribu tor The actual list of Neurosoft Ltd distributors is represented on the web site http www neurosoft ru eng useful links aspx This notification should contain the fol lowing information the consumer s name and the address the serial number of the system see chapter 7 of the present manual or the system marking the copy of chapter 9 of this manual or the number and the date of the invoice or other document confirming the system purchase the detailed description of failures If it is possible indicate the reasons and circum stances preceding the fault detection in addition it is recommended to add the test report the exam data photos and other materials allowing to solve the problem as soon as possible 12 2 In case of system return to the service center for the repair or the replacement the following rules should be observed it should be packed so to exclude the possibility of its damage during the transporta tion the notice see item 12 1 and the present manual must be added to the system being returned Reclamation Data 12 3 All the reclamations its description and take
22. Error indication mode the error code 25 Neuro MS D Technical Manual 26 e in Stimulator overheating mode the information concerning the overheated component The parameters can be changed using Stimulation parameters knob 14 13 Delay icon The icon is highlighted green in the single pulse mode At that the Stimulation parameters indicator displays the delay for stimulator capacitor charge and the Stimulation parameters knob is used to change this delay 14 Stimulation parameters knob The Stimulation parameters knob is intended to set the stimulation parameters The selection of the specified parameter is carried out by pressing the corre sponding button Single pulse Frequency Train Pause or Session and allows to specify the following e in Single pulse mode the delay for stimulator capacitor charge e in Stimulation frequency setting mode the stimulation frequency e in Train duration setting mode the train duration e in Pause setting mode the pause duration e in Session duration setting mode the session duration The value of the changed parameter is displayed on Stimulation parameters indica tor 12 15 Session button If the mode is disabled the button is not highlighted In case you press Session button the stimulator switches to the session duration setting mode for the repetitive stimulation At
23. F communications equipment and magnetic stimulator The magnetic stimulator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the magnetic stimulator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the magnetic stimulator as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz up to 80 MHz outside ISM bands 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 17VP d 117VP d 2 23 P 0 01 0 117 0 117 0 233 0 1 0 369 0 369 0 738 1 1 167 1 167 2 333 10 3 689 3 689 7 379 100 11 667 11 667 23 333 Notes 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Refere
24. Parts and Accessories Quick connect coupling NS 4D42006 3 8 1 1 1 Software on CD i without complementary _ Neuro MS NET software modules 1 1 Operational Documentation Neuro MS D technical manual TM 058 01 002 001 1 1 1 Coils for Magnetic Stimulator technical manual TM 058 02 001 001 1 1 1 Neuro MS NET user manual UM 058 01 003 000 1 1 Package Cardboard package set 1 1 1 Note 1 Depending on the customer requests either figure of eight coil 100 mm FEC 02 100 or an gulated figure of eight coil 100 mm AFEC 02 100 can be included in the base delivery set 2 NSFT 058201 035 and NSFT 058201 036 cables are supplied with NSFT 058201 001 main unit 3 NSFT 058201 070 and NSFT 058201 071 cables are supplied with NSFT 058201 005 main unit Description Table 8 Additional Equipment Accessories and Software Document code or f main specifications Quantity pcs Name 1 2 3 4 Neuro EMG MS digital neurophysiological system NSFT 034999 004 4 4 4 for EMG Trigger unit NSFT 990201 007 1 1 1 1 TU 2 Coils Cooled big ring coil 150 mm NSFT 058304 003 7 4 4 1 RC 02 150 C Bia ring coil 150 mm NSFT 058304 002 1 1 1 g ring RC 02 150 NSFT 058304 001 1 1 1 Small ring coil 100 mm RC 02 100 oe 1 NSFT 058304 013 1 1 1 Figure of eight coil 100 mm FEC 02 100 Angulated figure of eight coil 100 mm NSFT 058304 014 i 4 i i AFEC 02 100
25. SFT 058201 005 units are identical The front panel of the main unit contains the following Fig 7 1 Coil connector high voltage connector intended for the coil attachment 2 Coil change button combined with High voltage indicator A The High voltage indicator highlights yellow when the stimulator is switched on and 1500 V high voltage is supplied inside the stimulator As far as the high 9 voltage is supplied to coil connector at the moment of stimulus delivery it is dangerous to disconnect the coil To replace the coil press Coil change button which switches off the internal high voltage power supply and discharges instantly the high voltage capacitor to the safe voltage After that the High voltage indicator stops illuminating If you press the button again the high voltage power supply switches on and the capacitor charging up to the specified voltage is started The High voltage indicator highlights yellow In case you press the Coil change button during the repetitive stimulation the stimulator will stop the stimulation After the coil replacement the next pressing of this button will resume the stimulation from the stop moment The given function is used to replace the overheated coil to the cool one to continue the repetitive stimulation 3 Coil temperature indicator Coil temperature indicator Fig 7 is a 5 segment three colored temperature scale The seg
26. Technical Manual Neuro MS D Magnetic Stimulator TM058 01 003 000 17 09 2013 Neurosoft Ltd 2014 5 Voronin str lvanovo 153032 Russia P O Box 10 Ivanovo 153000 Russia Phone 7 4932 24 04 34 Fax 7 4932 24 04 35 E mail com neurosoft ru Internet www neurosoft ru Contents Contents iranan aa nanai ainan ALKAA AAAA ERALA AA AAAA NENEA A AAAA ERALA A E AAA EANNA 3 ahirete a iTo p aae E T E E 5 Ta Desripti Nn iistiid AA aaa nasama 6 Te FUNCION Sera nana a E E Aaah Aa nanana 6 Dee ela NAA PAD ANON 7 1 3 Warnings and Precautions paka KAGALAKAN 8 1 4 Main Specifications aa NA a naa pA KNA kauna nG khan aaa aa nG ka eR a 11 1 5 PAA AA AA ean ecacaiea wa Geared Coen ve coat uan tee ve dena 14 1 6 Structure and OpPEaN0 Nama ANA AN AA AG 18 1 7 Description of Controls Connectors and Indicators 7 munaananananan 23 1 7 1 Controls Connectors and Indicators of Main Uhnit 23 1 7 2 Controls Connectors and Indicators of Expansion Uhit 29 1 7 3 Controls Connectors and Indicators of Cooling Unit 32 1 7 4 Controls Connectors and Indicators of Extra Power Supply Unit 34 1 7 5 Coil Controls Connectors and INdiCators cccccceseeeeeeeeeeeeeeeeees 35 TEBE SYMCMFOMIZ ALON tede cath debra es cancel n a et ghee INL EE oh chad ta choees 36 1 9 Main Unit Service Menu aa otecctdiieesnteotaeeheneudole adem en aceon 37 2 Assem
27. USB Control Mode ssssssssseneesnenesssernrrrnrrsssrrrrnrrnnresserrrrrrnn 54 3 5 Operation in Control Mode via Trig in sssssssessssesenerrneresserrrerrnrresserrrrrrnn 54 3 6 Operation in Syncronization Mode with External Device via Trig out 55 3 7 Actions in the Emergency aaa ANA AA hk 55 A SEN aaa ARA AGA AN 55 4 1 General Requirements ccccceeeeeeeeeceeeeeeeeeeeeeeesaeaeeeeeeeeeeenessaaaeeeeeees 55 4 2 Maintenance BENG aan cata erie de eae aaa ates 56 4 3 CONSOIV ATOM akma aaa a ankas 56 A BIAG AA NA NAA NAA AO 56 Neuro MS D Technical Manual 5 Packing and Transportation nnna 56 6 Utiliza O n a e eedt AA AA ee ee PAM PAA PR 57 7 Delivery Set and Package Data 000 000mnunamamununuauaaaaaaaananassanannnnanaaaana 57 8 Acceptance Certificate la AINA AKA NAMANA ANN 58 9 Delivery Certificate maa ANGARA 58 10 Storage Regulallons aaa AA AA 58 DI Waray AA al el eels a PA PAGA Aa 59 T2 Reclamation Dalan NAA taliina 60 Se Kepal Dala aaa ka aaa kaaa AGA Gagana nA Aa O 62 Appendix 1 Electromagnetic Emissions and Immunity sseeeeeees 63 Referentes a tee eects enero crt settee acl 67 Introduction Introduction This technical manual hereinafter referred to as manual is the combined document describing operation and servicing of Neuro MS D magnetic stimulator hereinafter re ferred to as stimulator This m
28. ach the stimulator to the computer using USB cable 4 High voltage connector for the expansion unit The high voltage connector is in tended to attach the high voltage communication cable to the expansion unit If you use the main unit without the expansion one plug in and fix the end cap on this connector using two screws 5 Cooling fans output The fans provide the air circulation inside the main stimulator unit The air is sucked through the holes located on the bottom panel and blown out via the cooling fan outlet at the rear panel 6 Marking 7 Trig in out connector Ce Trig in out connector is intended to synchronize the stimulator with other devices see chapter 1 8 Synchronization 8 Control connector Ctrl Control connector is intended to attach the communication cable to expansion unit and cooling unit 9 The connector for the attachment of mains cable for cooling unit When you switch on the operational mode using On Off button the mains voltage is sup plied to this connector 10 Equipotential connector The connector for the attachment of equipotential cable connecting the cases of units included in the system 28 Description 1 7 2 Controls Connectors and Indicators of Expansion Unit Fig 9 The front panel of expansion unit The front panel of the expansion unit contains the following Fig 9 1 Ready indicator v Ready indicator
29. agent circulates The cooling process occurs in the cooling unit The cooling unit provides the forced circulation of cooling agent and heat rejection us ing the cooling elements Thermoelectric Cooler The control system regulates the temperature of the cooling agent and switches off the cooling at the temperature de crease to exclude the condensate formation on the coil surface Description Neuro MS D Technical Manual 20 220V USB Synchronization 220V Ty y npa Capacitor Capacitor additional fam lt gt ircui ircui lt gt CG LO aaa TO charging circuitry Control circuitry le tp Control circuitry Sa charging circuitry ul tt i Indication Capacitor saa Indication and control Capacitor Electronic switch gt Electronic switch a aaaaa Extra power supply unit Main unit Expansion unit Coil po 4 l y Cooling unit Cooling eens TEE Pump Indication Control circuitry A A Power supply Power supply ma Control High voltage 220 V Cooling agent Fig 2 Neuro MS D block diagram To expand the number of the base stimulator functions the expansion unit can be used It allows increasing the stimulus intensity and obtaining the additional stimulus waveforms and stimulation modes
30. anual is the document which certifies the stimulator specifications guaranteed by the manufacturer Do not start working with stimulator before you have read this document You can send your responses and recommendations to Neurosoft Company by the following address P O Box 10 Ivanovo 153000 Russia or by e mail help neurosoft ru You can find additional information on Neurosoft products in the Internet www neurosoft ru or ask questions by phones 7 4932 24 04 37 Service department 7 4932 24 04 34 You can also contact SAS Neuromed Company Authorized European Representa tive of Neurosoft Company to Mr Pierre Scholl by the following address Chemin du tomple 84330 Le Barroux France Phone 490 650 470 622 748 384 Fax 490 650 470 E mail bscholl orange fr Neuro MS D Technical Manual 1 Description 1 1 Function The stimulator is intended for diagnostic together with digital EMG systems and therapeutic impacts by magnetic pulses to motor zone of cerebral cortex and periph eral nervous system The stimulator uses the magnetic pulses of short duration which can easily penetrate through clothes cranium bones and soft tissues They exert influence upon deep pe ripheral nerves cerebrum and spinal cord which are inaccessible for other kinds of stimulation The stimulator can be applied in psychiatry neurology epileptology pulmonology pediatrics ophthalmology traumato
31. asic burst stimulus 21 Neuro MS D Technical Manual e Paired monophasic stimulus with expansion unit only two stimuli with the specified interpulse interval and amplitude specified for each stimulus independent ly Fig 6 Coil current Time Fig 6 Paired monophasic stimulus The magnetic stimulator can operate in several modes 1 Stand alone mode e single pulse of the specified amplitude e in repetitive stimulation mode the series of stimulation trains and pulses during some period of time session time These trains have certain duration and speci fied pauses between them 2 Under control of digital EMG and EP systems manufactured by Neurosoft Ltd At that the electronic unit of the stimulator is connected with USB port of the per sonal computer using the removable interface cable included in the delivery set 3 Under control of digital EMG systems produced by other manufacturers via the trigger in out 4 Under control of specialized Neuro MS NET software allowing to perform the therapeutic medical procedures At that the electronic unit of the stimulator is connected with USB connector of the personal computer using the removable in terface cable included in the delivery set 22 Description 1 7 Description of Controls Connectors and Indicators 1 7 1 Controls Connectors and Indicators of Main Unit Fig 7 The front panel of the main unit The control layout of NSFT 058201 001 and N
32. bly and Installation ccssssseeeeeeeeeeeeseeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeeeeeeeeeees 38 2 1 Requirements to Personnel Conducting Stimulator Assembly and maalanONam nakapaa baa awe skate Se ceba ge acces nb leas ge dared neeiares 38 2 2 Room Selection and Placement cccceeeeseeseceeeeeeeeeeeeeseeeeeeeeeeeeeeas 38 2 3 Unpacking and Delivery Set Check 000070700000aaananannnnnaaaaaanananasananasnann 40 2 4 Assembly and Connection of Stimulator cece ceeeeeeeeee eres eeeeeneeeeeeeeeeeeee 40 2 4 1 General Requirements to Assembly ceceeeeeeeeeeeeetteeeeeeeeeeeeeee 40 2 4 2 Preparation of Cooling Unit to Operation aaananawnanawaaana 41 2 4 3 Assembly and Connection of Main Unit Expansion Unit and GOOlING UN E R ANAN AA E AE eee 41 2 4 4 Assembly and Connection of Main Unit Extra Power Supply Unit and Cooling Unit AA AR 43 2 4 5 Assembly and Connection of Main Unit and Cooling Unit 44 2 4 6 Assembly and Connection of Main Unit and Expansion Unit 45 2 4 7 Assembly and Connection of Main Unit and Extra Power Supply 46 2 4 8 Assembly and Connection of Main Unit ee eeeeeeeeeeeeeeeeee 47 ic AA ee ee eee eee eer ener 48 3 1 Operating Orde ama akan Ga Ga NA AA 48 3 2 TOUDISSMOOHING scanere e a sok A a EE 51 3 3 Operation in Stand alone MOde cccceeeeeeseeeceeeeeeeeeeeeeeeaeeeeeeeeeeeeeeae 53 3 4 Operation in
33. ce The clearance from the cooling fan output up to the wall not less than 50 mm should be provided The fans provide the air circulation inside the main stimulator unit The air is sucked through the holes located on the bottom panel and blown out via the cooling fan outlet at the rear panel e The patient environment within 1 5 meters should contain only the electron ic units being the medical device with the required safety level The fact is that the safety level of the computer equipment is insufficient for the use in the patient environment Hence a patient must not contact with the metal parts of computer equipment cases and the personnel must not touch simul taneously these parts and patient body The computer equipment used in the 39 Neuro MS D Technical Manual system should correspond to IEC 60601 1 or be connected via the isolation transformer specialized power supply unit for notebook PC corresponding to above mentioned requirements Requirements to mains 2 3 If To avoid electrical shock magnetic stimulator mains plug must only be in serted in an appropriate mains socket outlet provided with a protective earth ground contact The use of multi socket electric mains extenders without additional protective actions is prohibited The fact is that the probable break of the protective ground circuit of the multi socket electric mains extender can lead to summa tion of leakage current in all connected unit
34. chieved intensity of magnetic field depends on stimulation frequency and decreases with its increase This dependence is caused by limited capability of capac itor charge circuit to charge the capacitor to required voltage during the pause be tween stimuli If you set higher stimulus amplitude than stimulator can deliver at speci fied stimulation frequency the first train stimulus series of stimuli can be delivered with the specified amplitude the amplitudes of next stimuli will decrease to maximal achieved one at stated frequency Extra power supply unit is intended for joint use with main unit and allows obtaining maximal stimulus amplitude with 100 intensity at higher stimulation frequency see Table 6 The current flowing through the coil provokes its heating The higher is the stimulus in tensity and stimulation frequency the quicker is the heating of the operating surface of the coil The contact with this heated surface can evoke the hyperaemia or burn To control the temperature the coils are equipped with the temperature sensors The in dications of these sensors are controlled by the stimulator control system In case the coil heats up to 41 C the stimulation is stopped and the stimulator notifies a user about it The use of coils with the force cooling allows to increase the time of the continuous operation without overheating In this type of coils the coil winding is made of copper tube where the cooling liquid cooling
35. citor charge start is provided in the single pulse mode when you work with the digital EMG system It is done to exclude the noise impact from power supply unit during the response acquisition The delay time is specified in the software for the corresponding digital system the procedure of working with the program is de scribed in User Manual for the corresponding digital system 3 5 Operation in Control Mode via Trig in The stimulator trigger input is used for synchronization with digital EMG systems produced by third party manufacturers The principle of operation in this mode is analogous to the stand alone operation in single pulse mode see chapter 3 3 Operation in Stand alone Mode The only dif ference is that the stimulus start is performed by the external device via trig in To do that the pin TRIG IN see chapter 1 8 Synchronization in Trig in out connector is used Often the electrical stimulator of digital EMG system provides the synchro signal for that purpose Neuro MS D stimulator is connected to output of electrical stimulator of digital EMG system using the special communication cable The cable connects Trig in out con nector of the magnetic stimulator to output of electrical stimulator of digital EMG sys tem On digital EMG system set the following stimulus parameters electrical current 10 mA and pulse width 200 us The stimulus is produced in 100 200 us after the electri cal s
36. e coil or the stimulator case during the stimula tion the session will be stopped The use of the expansion unit allows producing the additional pulse types To do this select the required pulse type by pressing the corresponding button on the expansion unit When you select Paired stimulation mode the amplitude of the first stimulus is set on the main unit The amplitude of the second stimulus and interpulse interval is set on the expansion unit The Ready indicator shows the readiness to the stimulus pro ducing of the specified amplitude The paired stimulation is available in the single pulse mode only 53 Neuro MS D Technical Manual 54 3 4 Operation in USB Control Mode The stimulator can operate under control of digital EMG and EP systems manufac tured by Neurosoft Ltd and also under control of Neuro MS NET software In this mode the stimulator is connected to PC via USB and controlled by the corresponding software The order of the stimulator connection to PC and the process of software in stallation are described in the chapter 2 Assembly and Installation In USB control mode the Amplitude knob allows to adjust the required amplitude value and all the rest stimulation parameters are set in the software The stimulus producing is invoked by the pressing of Pulse button on the coil or on the stimulator case or by specifying menu command in the digital system software The delay of capa
37. e silicone oil polydimethylsiloxane 5 cSt is used as a cooling agent for the cooling unit The use of other liquids is prohibited NSFT 058201 005 main unit has the communications interface with NSFT 058201 007 cooling unit It controls the cooling unit pump in different modes and to display messages about cooling unit malfunctions on the main unit You can switch cooling unit control on off use service menu commands for more de tails see chapter 1 9 2 4 3 Assembly and Connection of Main Unit Expansion Unit and Cooling Unit If you use the main unit the expansion unit and cooling unit the placement of these units is carried out on the different shelves of the trolley according to Fig 1 The units are connected with the use of the connecting cables Fig 20 and are at tached to the mains by mains cables 41 Neuro MS D Technical Manual Main unit Fig 20 The connection of the main unit expansion unit and cooling unit 1 Control cable 2 HV cable 3 Equipotential cable 4 Mains supply cable for the main unit 5 Mains supply cable for the expansion unit 6 Mains supply cable for cooling unit The connected cables should be fixed by the specified screws It is prohibited to use the system if the connection cables are not fixed 42 2 4 4 Assembly and Installation Assembly and Connection of Main Unit Extra P
38. ect coupling of cooling agent input for coil connection Quick connect coupling of cooling agent output for coil connection Measuring tube to indicate the cooling agent level with minimum min and maxi mum max marks Cooling indicator The indicator highlights when the cooling elements are switched on and blinks when they are off Coil is not connected indicator It is highlight red if the coil is not connected or the cooling agent does not circulate Fault indicator It blinks red if the fault is detected during the operation ki It does not illuminate if the system is in working order It highlights red if after the switching on the self diagnosis system detected a fault Description 6 5 4 Fig 12 The rear panel of the cooling unit The rear panel of the cooling unit contains the following Fig 12 1 Mains power switch I position To disconnect from the mains supply set the Mains power switch to To connect the mains supply to the cooling unit turn Mains power switch to On Off 0 position 2 Control connector Chl Control connector is intended to attach the communication cable to main tr unit and expansion unit 3 Cooling fans output The fans provide the air circulation inside the main stimulator unit The air is sucked through the holes located on the bottom panel and blown out via the cooling fan outlet at the rear panel
39. er Laser or jet 1 1 1 Software on CD Neuro MS NET software without complementary modules Operational Documentation Trigger unit TU 2 technical manual TM990 01 001 000 1 1 1 Note 1 Depending on the customer requests either figure of eight coil 100 mm FEC 02 100 or an gulated figure of eight coil 100 mm AFEC 02 100 can be included in the base delivery set 2 All the computer equipment must comply with CISPR 22 for B class 3 It is allowed to supply system with another PC which specifications are not lower that stated in the user manual for magnetic stimulator software 1 6 Structure and Operation The block diagram of the units included in the stimulator complex and their connec tions are represented on Fig 2 The block diagram of the main unit of the magnetic stimulator Fig 2 consists of the control circuitry capacitor capacitor charging circuit ry intended for the capacitor charge up to achieving the voltage specified by the con trol circuitry and the high voltage electronic switch Magnetic stimulator principle of operation is based on discharge of high voltage ca pacitor 1 5 kV through stimulation coil made of copper wire at the moment of elec tronic switch opening At this time the discharge current up to 8 kA generates the magnetic field This field induces the current in body tissues located near which caus es nerve impulse as during usual electrical stimulation Maximum a
40. he Pulse button is pressed YEE 2 The coil is not connected or is Check if the coil connector is attached connected incorrectly properly eR Incorrect connection of the power Check the connection to the power cable end cap of the main unit connector located on the rear panel of the main unit depends on the system delivery set e if the expansion unit is not connected the end cap should be fixed e if the expansion unit is used the power cable connected to the expansion unit should be at tached HER 9 Incorrect connection of the power Check HV cable connection to the cable of the expansion unit expansion unit and main unit HEC 30 Data loss while transferring via It can happen when the faulty USB cable USB is used Only the cable supplied together with the stimulator should be used HEF 31 USB disconnection during the It is not recommended to disconnect the operation USB connector from the computer during the operation BE 40 Invalid control data the control Check the connection of control cable to cable to the expansion unit is not the expansion unit and the main unit connected HEC 41 Missing data from the expansion Check the connection of control cable to unit the control cable for the the expansion unit and the main unit expansion unit is not connected HEC 42 Missing data from the cooling unit Check the connection of control cable to the control cable for the cooling unit the expansion unit and the cooling
41. he corresponding devices 40 Assembly and Installation If you purchase the stimulator together with the personal computer PC it is supplied with the installed and configured program If you purchase the stimulator separately install the software from the compact disk included to the delivery set The software must be installed before the first connection of stimulator to PC Read carefully the corresponding chapter of the user manual Placement of the units performing of inter unit connection and connection to the mains is carried out only when the Mains power switch of all units is switched off O position of the power switch If you use the main unit together with the expansion unit and or cooling unit it is rec ommended to use the trolley for the magnetic stimulator allowing to provide the stable fixation of the units and facilitating the system move 2 4 2 Preparation of Cooling Unit to Operation The liquid level for the normal operation of the cooling unit should be within minimum min and maximum max marks The filler for the cooling agent filling is located in the recess on the top cover of the unit in the left back corner The lid should be screwed tightly before the transportation and the operation If the level of the cooling agent is below the min mark screw off the lid and add the cooling agent up to the max level not more using the funnel The lid should be screwed tightly Th
42. highlights green when the unit is charged up to the specified level 2 Amplitude knob HEY Amplitude knob allows increasing decreasing the current amplitude value of the second stimulus in the paired stimulation mode by rotating the knob clockwise and counterclockwise correspondingly 3 The Amplitude indicator The Amplitude indicator represents the current value of the amplitude of the second stimulus in percents from the maximal value or relative to MT in the paired stimulation mode After the stimulator switching off the current amplitude is stored in the memory and is indicated at the next switching on The amplitude adjust is performed with the use of Amplitude knob 4 MT icon qc MT icon is intended to display the mode of motor threshold MT fixation If MT is fixed it is highlighted green 5 Power indicator The Power indicator lights yellow in the stand by mode and green in the operating mode The stimulator switches from the stand by mode to the operating one and back if you press On off button on the main unit 6 Interpulse interval displays the current value of the interpulse interval in the paired stimulation mode 29 Neuro MS D Technical Manual 30 7 Interpulse interval knob Eh It specifies the interpulse interval in the paired stimulation mode in ms 8 Paired stimulation button AA If you press this button the stim
43. ig 26 appears after magnetic stimulator connection to computer press button without inserting the installation disk Found New Hardware Wizard Welcome to the Found New Hardware Wizard This wizard helps you install software for Neurosoft Magnetic Stimulator 3 If your hardware came with an installation CD 3 or floppy disk insert it now What do you want the wizard to do Install the software automatically Recommended Install from a list or specific location Advanced Click Next to continue l Next gt Cancel Fig 26 Found New Hardware Wizard dialog box New hardware wizard will perform the stimulator installation After the installation completion the dialog box given on the Fig 27 will appear on the screen Press the Completing the Found New Hardware Wizard The wizard has finished installing the software for 2 Neurosoft Magnetic Stimulator Click Finish to close the wizard Fig 27 Found New Hardware Wizard dialog box after the installation completion The stimulator on off and setting of the stimulation parameters is performed using the corresponding program As soon as you finish pass to p 11 9 Press On Off button to switch on the stimulator At that the Power state indi cator of the main unit and expansion unit will glow green 49 Neuro MS D Technical Manual 50 10 All the indicators highlight for 3 seconds which allows controlling it
44. logy and orthopedy and other areas of medicine for e noninvasive diagnostics of demyelinating diseases of nervous system vascular diseases of brain traumatic injuries of spinal cord injures of cranial nerves motor neuron diseases myelo and radiculopathies Parkinson disease Alzheimer s dis ease mental diseases epilepsy migraine neurourological disorders localization of speech center e treatment motor skills disorders depression spasticity pain syndromes Parkinson diseases auditory hallucinations obsessive compulsive disorders schizophrenia exacerbation genetic degenerative diseases The stimulator can be used in patient care institutions diagnostics centers neurosur gical clinics experimental laboratories of scientific and research institutes Description 1 2 Contraindications In each individual case if the harm risk caused by the stimulator use exceeds the possible positive effect the medical personnel should make an independent decision concerning the reasonability of its application It is prohibited to apply the device for the stimulation of head neck and abdomen of pregnant woman It is prohibited to apply the device for the stimulation of patients with implanted pace makers cochlear implants and other electronic implants as far as the electromagnetic field emitted by the stimulator can disable them A Repetitive transcranial stimulation can provoke the epileptic seizures The general
45. ments of this scale highlight one by one after achieving the following temperature 23 Neuro MS D Technical Manual 24 First green segment at less than 30 C temperature Second green segment at coil temperature from 30 up to 34 C First yellow segment at coil temperature from 34 up to 38 C Second yellow segment at coil temperature from 38 up to 41 C Red segment if the coil temperature exceeds 41 C at that Start button and stimulus delivery commands from all the external devices are disabled 4 Coil indicator Coil indicator glows green when the coil is connected and ready for operation When the coil is overheated it starts blinking red 5 Pulse button combined with Ready indicator D Ready indicator highlights green if the stimulator is ready to produce the pulse of the specified amplitude The single pressing of Pulse button activates the single or repetitive stimulation depending on the current operation mode To stop the repetitive stimulation press Pulse button again This button is duplicated with Pulse button located on the coil 6 Amplitude knob Amplitude knob allows increasing decreasing the current value of the amplitude by rotating the knob clockwise or counterclockwise correspondingly 7 MT detection button MT detection button is intended to fix the amplitude of motor threshold MT If the threshold
46. mulation Parameters Peak magnetic field at 100 output depends on coil 0 4 0T Pulse duration e standard biphasic 250 330 us e power biphasic 360 450 us Maximum frequency at maximum power e without extra power unit 5 Hz e with extra power supply unit 20 Hz Power Supply Supply voltage 220 22 230 23 V 50 or 60 Hz Maximum power consumption during the stimulation e main unit lt 1000 V A e expansion unit s1000 V A e cooling unit s1000 V A e extra power supply unit s2400 V A Trig in out Trig in TTL CMOS Trig out TTL CMOS Trig in pulse width 2 200 us Stimulus delay relative to trig in signal 100 200 us Trig out pulse width user defined 10 us 50 ms General Specifications and Parameters Interface USB Safety I Work parts BF type Cooling unit tank volume while filling up to the maximal level 3 5 Type of cooling agent Silicone oil 5 cSt Ingress protection IP20 Operation temperature 10 35 C Relative air humidity lt 80 Depends on coil type the data is given for RC 02 150 coil Neuro MS D Technical Manual Table 3 Continued Parameters Values Dimensions e main unit NSFT 058201 005 NSFT 058201 001 e expansion unit e cooling unit e extra power supply unit 460x215x520 mm 360x170x520 mm 460x215x520 mm 470x215x520 mm 360x170x520 mm Weight e main unit e expansion unit e cooling unit filled with cooling agent e extra power supply unit not more than 24 kg not more than 15 kg n
47. mulator _ main unit serial number L expansion unit serial number LI cooling unit serial number L extra power supply unit serial number is collected and packed according to TC 9442 009 13218158 2008 Package report number Package report date The detailed information about the delivery set is described in the package report which is an integral part of the present document and should be kept along with it Utilization 57 Neuro MS D Technical Manual 8 10 58 Acceptance Certificate The magnetic stimulator corresponds to TC 9442 009 13218158 2008 and is ready for operation DC representative signature Delivery Certificate The magnetic stimulator is delivered to a customer date System was handed signature System was accepted signature Storage Regulations The magnetic stimulator should be stored in the manufacturer package in an enclosed room at from 5 up to 40 C and 80 maximum relative humidity measured at 25 C temperature The room air should be free from any dust acid vapors alkali vapors corrosive gases and other injurous admixtures which can cause the corrosion The magnetic stimulator should be put on the shelves not more than in four lines Information about the magnetic stimulator storage before and in the process of opera tion is registered in Table 12 11 Warranty Table 12 Storage Data Date of Storage conditions Position
48. n be returned to its standby condition by pushing the On Off button 11 Single pulse button After the power supply switching on the stimulator stands in the Single pulse mode at that Single pulse button and Delay icon are highlighted green In this mode the Stimulation parameters indicator displays the current delay for the beginning of the stimulator charge process after each stimulation To adjust the delay use the Stimulation parameters knob In this mode press Pulse button to produce the single pulse After the stimulus obtaining the pushing of this button once again is ignored during the period of the capacitor charge delay If you press Single pulse button the stimulator switches to the repetitive stimulation mode in the specification of repetitive stimulation frequency at that Single pulse button does not illuminate and Frequency button and icon highlight green In case you press Single pulse button again you will switch to the single pulse mode 12 Stimulation parameters indicator Depending on the stimulator operation mode the indicator displays e in Single pulse mode the delay for stimulator capacitor charge e in Stimulation frequency setting mode the stimulation frequency e in Train duration setting mode the train duration e in Pause setting mode the pause duration e in Session duration setting mode the session duration e in
49. n measures should be registered in Table 13 Table 13 Reclamation Data The date of Brief description of The date of Taken measures Note failure or the trouble reclamation trouble sending appearance 61 Neuro MS D Technical Manual 13 Repair Data Table 14 Repair Data Name and code of faulty unit Degree of imperfec tion Date comple tion of repair arrival Name of repair works Position name signature of person Carried out the repair Accepted after the repair 62 Appendix 1 Electromagnetic Emissions and Immunity Appendix 1 Electromagnetic Emissions and Immunity Guidance and manufacturer s declaration electromagnetic emissions The magnetic stimulator is intended for use in the electromagnetic environment specified below The customer or the user of the magnetic stimulator should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 2 The magnetic stimulator uses RF energy only for CISPR 11 its internal function Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment RF emissions Class B The magnetic stimulator is suitable for use in all CISPR 11 establishments including domestic HER establishments and those directly connected to Harmonic emissions Class A the public l
50. nces References 1 Chen R Gerloff C Classen J Wassermann E M Hallett M and Cohen L G Safety of different inter train intervals for repetitive transcranial magnetic stimula tion and recommendations for safe ranges of stimulation parameters accepted for publication 23 May 1997 2 Chen R Classen J Gerloff C Celnik P Wassermann E M Hallett M and Co hen L G Depression of motor cortex excitability by low frequency transcranial magnetic stimulation Neurology 1997a 48 1398 1403 3 Pascual Leone A Houser C M Reese K Shotland L I Grafman J Sato S Valls Sole J Brasil Neto J P Wassermann E M Cohen L G and Hallett M Safety of rapid rate transcranial magnetic stimulation in normal volunteers Elec troencephalogr Clin Neurophysiol 1993 89 120 130 4 Wassermann E M Grafman J Berry C Holnagel C Wild K Clark K and Hallett M Use and safety of a new repetitive transcranial magnetic stimulator Electroencephalogr Clin Neurophysiol 1996b 101 412 417 5 Wassermann E M Risk and safety of repetitive transcranial magnetic stimulation report and suggested guidelines from the International Workshop on the safety of repetitive transcranial magnetic stimulation June 5 7 1996 accepted for publi cation 23 May 1997 67
51. nd its closing USb inscription still illuminates on Stimulation parameters indicator The stimulator is equipped with self diagnosis system which controls the operability of the main elements while power switching on and during the operation In case the fault is detected the stimulator stops the stimulation initiates the beep and indicates the fault type on Amplitude indicator and fault code on Parameters indicator The faults detected by the stimulator are divided into two groups e User emerging in the result of incorrect connection of the stimulator or incorrect tt actions of the personnel and indicated as BEE The given faults can be removed by a user e Service emerging when the electronic components of the stimulator break down The given type of errors is indicated as SEr If this fault emerges address to ser vice center of Neurosoft Ltd The list of possible troubles is given in Table 11 In case you can not eliminate the trouble by yourself you should address to service center of Neurosoft Ltd 5 Voro nin str lvanovo 153032 Russia 51 Neuro MS D Technical Manual Table 11 Troubleshooting Code Cause Way of Removal HE 1 The Pulse button is pressed fora 1 Check the Pulse buttons located on long time button sticking stimulator case and on the coil These buttons should switch on off without any sticking 2 The coil is placed so t
52. nd suggested guidelines from the International Workshop on the safety of repetitive magnetic stimulation by Eric M Wassermann 5 page 10 Table 2 Safety recommendations for inter train intervals for 10 trains of rTMS at lt 20 Hz Inter train Stimulus intensity of MT ee 100 105960 1109 120 5 Safe Safe Safe Insufficient data 1 Unsafe 3 Unsafe Unsafe 2 Unsafe 2 0 25 Unsafe Unsafe Unsafe 2 Unsafe 3 3 These stimulus parameters are considered unsafe because adverse events occurred with stimulation of lower intensity or longer inter train interval but no adverse event was observed with these parameters The minimum number of trains that caused spread of excitation or post TMS EMG ac tivity are indicated in the parentheses The maximum duration number of pulses for individual rTMS trains at each stimulus intensity should not exceed that listed in Ta Description ble 2 Stimulus parameters produced by reducing a set of parameters that is consid ered safe reduction in stimulus intensity train duration or increase in inter train inter val is also considered safe rTMS at 25 Hz 120 of MT 0 4 s duration is unsafe at inter train intervals of 1 s or less The safety of longer inter train intervals at 25 Hz has not been determined 1 4 Main Specifications Table 3 Main Specifications of Stimulator Parameters Values Sti
53. nsulation disturbance of any component included in the magnetic stimulator set which causes the emergency fire mechanical failure flood medical staff evacuation and threat of patient or staff electrical shock it is necessary to de energize the magnetic stimulator completely Servicing 4 1 General Requirements Safety measures when magnetic stimulator servicing conforms to the ones described in the chapter 3 Proper Use Servicing 55 Neuro MS D Technical Manual 56 Qualification requirements to the medical staff are listed in chapter 2 1 Requirements to Personnel Conducting Stimulator Assembly and Installation Servicing of the bought articles included in the magnetic stimulator delivery set is con ducted according to user and technical manuals or typical rules When detecting the troubles it is recommended to use the information given in Trou bleshooting section If the troubles can t be eliminated using magnetic stimulator con trol units or by restart it should be switched off and checked by the specialist Type volume and periodicity of the servicing except specified in this chapter are not determined The delivery set should correspond to the packing list of the medical equipment 4 2 Maintenance Service Magnetic stimulator servicing in the process of operation includes the external exami nation check of connectors and cables setting removal of contaminations from the units surface using
54. o 2 5 GHz 80 MHz to 800 MHz d 2 33VP 800 MHz to 2 5 GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol o 1 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the magnetic stimulator is used exceeds the applicable RF compliance level above the magnetic stimulator should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the magnetic stimulator 2 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Notes 1 At 80 MHz and 800 MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 65 Neuro MS D Technical Manual 66 Recommended separation distances between portable and mobile R
55. of the main unit and is fixed by the screws Main unit Cooling unit LET Fig 22 The connection of the main unit and cooling unit 1 Control cable 2 End cap 3 Equipotential cable 4 Mains supply cable for the main unit 5 Mains supply cable for cooling unit The connected cables should be fixed by the specified screws It is prohibited to use the system if the end cap is not fixed by the screws 2 4 6 Assembly and Installation Assembly and Connection of Main Unit and Expansion Unit If you use the main unit and expansion unit the placement of these units is carried out according to Fig 1 The main unit is placed on the expansion unit In case you use the trolley for the magnetic stimulator the units are placed on the different shelves in the same order The units are connected with the use of the connecting cables Fig 23 and are at tached to the mains by mains cable Main unit Expansion unit Smee eee Fig 23 The connection of main unit and expansion unit 1 Control cable 2 HV cable 3 Equipotential cable 4 Mains supply cable for the main unit 5 Mains supply cable for the expansion unit The connected cables should be fixed by the specified screws It is prohibited to use the system if the connection cables are not fixed
56. on and recommendations for safe ranges of stimulation parameters 1 Table 1 Table of safe train duration s number of pulses for single trains of rTMS in normal volunteers currently in use at NINDS Frequency rTMS intensity of motor threshold Hz 100 110 120 130 140 150 160 170 180 190 200 210 220 1 gt 270 270 gt 270 270 180 180 50 50 50 50 50 50 50 50 20 20 8 8 8 8 6 6 5 5 4 4 5 10 50 10 50 10 50 10 50 5 7 28 3 9 19 2 7 13 1 95 9 1 8 9 1 2 6 1 1 5 1 2 6 0 9 4 10 5 50 5 50 3 2 32 2 2 22 1 0 10 0 6 6 0 7 7 0 6 6 0 4 4 0 5 5 0 3 3 0 2 2 0 2 2 20 1 5 30 1 2 24 0 8 16 0 4 8 0 3 6 0 2 4 0 2 4 0 1 2 0 2 4 0 2 4 0 2 4 0 1 2 0 1 2 25 1 0 25 0 7 17 0 3 7 0 2 5 0 2 5 0 2 5 0 2 5 0 1 2 0 1 2 0 1 2 0 1 2 0 1 2 0 1 2 3 Based on Chen et al 1997 2 9 Based on Wassermann et al 1996 4 No spread of excitation or post TMS EMG activity was observed at these train durations Based on Pascual Leone et al 1993 3 The safe train duration in seconds and the number of stimuli in the single train while performing the repetitive transcranial magnetic stimulation are provided in the Table 1 The maximum safe train duration s is shown followed by the number of pulses See also the table in Risk and safety of repetitive transcranial magnetic stimulation report a
57. ot more than 27 kg not more than 12 kg Cooling agent pressure in coil while cooling unit operating not more than 0 15 MPa Number of coil fills at complete filling of cooling unit Table 4 Range of Controlled Parameters and Frequency Step Parameter Range of Permissible Values 2 Frequency Step Stimulation Parameters Stimulation frequency in repetitive stimulation 0 1 30 Hz 0 1 Hz 0 1 9 9 Hz mode 1 Hz 10 30 Hz Stimulation frequency in burst mode 100 Hz 1 Hz Train duration 0 5 100 s 0 5s Intertrain interval pause 0 5 300 s 0 5s Session duration 0 5 30 min 0 5 min Interpulse interval at paired stimulation 2 990 ms 1 ms Capacitor Charge Control Delay for the capacitor charge start analysis epoch 0 9 90 s 0 01 s 0 0 99 s 0 1 s 1 00 9 90 Trig out Trig out pulse width The burst mode is available only if you use Neuro MS NET software 10 us 1 ms 50 ms 1 ms To avoid the noise impact from the power supply while joint operation with EMG equipment during the response acquisition the delay of capacitor charge start is provided in single pulse mode Table 5 Stimulation Modes Stimulus Type Only Main Unit Main Unit with Expansion Unit Biphasic E Biphasic burst Power biphasic Description Table 5 Continued Stimulus Type Only Main Unit Main Unit with Expansion Unit Power biphasic burst
58. ow voltage power supply network that IEC 61000 3 2 supplies buildings used for domestic purposes Voltage fluctuations flicker Complies emissions IEC 61000 3 3 63 Neuro MS D Technical Manual 64 Guidance and manufacturer s declaration electromagnetic immunity The magnetic stimulator is intended for use in the electromagnetic environment specified below The customer or the user of the magnetic stimulator should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge Floors should be wood concrete ESD 6 kV contact 6 kV or ceramic tile If floors are IEC 61000 4 2 covered with synthetic material the relative humidity should be at least 30 8 kV air 8 kV Electrical fast Mains power quality should be transient burst 2 kV for power 2 kV that of a typical commercial or IEC 61000 4 4 supply lines hospital environment 1 kV for input output lines 1 kV Surge Mains power quality should be IEC 61000 4 5 1 kV differential 1 kV that of a typical commercial or mode hospital environment 2 kV common mode 2 kV Voltage dips short Mains power quality should be interruptions and voltage lt 5 Ur 20 ms that of a typical commercial or variations on power supply gt 95 dip in Ur for hospital environment If the input lines 0 5 and 1cycle user of the magne
59. ower Supply Unit and Cooling Unit If you use the main unit the extra power unit and cooling unit the placement of these units is carried out on the different shelves of the trolley according to Fig 1 The units are connected with the use of the connecting cables Fig 21 and are at tached to the mains by mains cables Main unit Extra power supply unit NGA HIN sy S 5 oNS bk Fig 21 The connection of main unit extra power supply unit and cooling unit 1 2 5 6 Control cable HV cable Equipotential cable Mains supply cable for the main unit Mains supply cable for the cooling unit Mains supply cable for extra power supply unit The connected cables should be fixed by the specified screws It is prohibited to use the system if the end cap is not fixed by the screws 43 Neuro MS D Technical Manual 2 4 5 44 Assembly and Connection of Main Unit and Cooling Unit If you use main unit and cooling unit the placement of these units is carried out ac cording to Fig 1 The main unit is placed on the cooling unit In case you use the trol ley for the magnetic stimulator the units are placed on the different shelves in the same order The units are connected with the use of the connecting cables Fig 22 and are attached to the mains by mains cable The end cap is placed on the HV con nector located on the rear panel
60. s on their metal parts to danger ous values Before the magnetic stimulator placement the electrician must check the quality of standard tripolar sockets and the integrity of the protective ground circuit In case the stimulator components are connected to several tripolar sockets make sure they are grounded to the same protective ground circuit Other wise there is a danger of several tens of Ampers leveling current leakage through the system connecting cables that leads to the equipment break down Any interruption to the protective ground conductor inside or outside the de vice is likely to make the device dangerous Intentional interruption is prohib ited The protective ground conductor should be checked regularly Unpacking and Delivery Set Check the box with the stimulator was under conditions of the excessive moisture or low temperature which differs sharply from working conditions it is necessary to place it in the room and leave for 24 hours in normal conditions Unpack the box and extract the stimulator components The delivery set should corre spond to the packing report list Check visually the stimulator components to make sure that there is no visible dam age 2 4 2 4 1 Assembly and Connection of Stimulator General Requirements to Assembly Place desktop PC based system and magnetic stimulator according to the composed plan and connect computer equipment according to operational documentation for t
61. s operability During this period the stimulator is in self diagnosis mode After that period the stimulator switches to the single biphasic stimulation mode 11 If during the self diagnosis the fault is detected UEC or SEC inscription ap pears on Amplitude indicator of the main unit and the error code displays on the Stimulation parameters indicator The error indication is accompanied with the beep In this case a user should refer to 3 2 Troubleshooting chapter The stim ulator should be switched off using On Off button 12 After the end of operation switch off the stimulator using On Off button 13 Using Power switches located on the rear panels of the main unit the expan sion unit and the cooling unit switch off power supply of these the units If during the stimulation the red segment of Coil temperature indicator lights up it means that the coil has overheated and the stimulation start is impossible You should wait till the coil cools down or replace it To replace the coil press Coil change button and wait till the indicator goes out Af ter that you can replace the coil The next pressing of Coil change button will switch the stimulator to the previous mode set before If the repetitive stimulation is per formed the session will continue from the moment it was stopped It is prohibited to disconnect the coil from the stimulator being in the oper ating mode
62. sed together with the stimula tor are open Always check the stimulator and coils for the absence of cracks and other defects Before the stimulation make sure that there are no patient cables or electrodes connected to a patient and also metal parts contacting with a patient in impact area within 5 cm and less from the coil as far as the electromagnetic field can create the electrical current leaking through a patient Do not allow the coil to come into close proximity less than 1 meter with electronic equipment monitor computer etc and also the magnetic carriers credit cards floppy disks etc The magnetic field emitted by the coil can result in its damage and information loss Description It is prohibited to immerse the coil in water ice or refrigerate to cool it off It is prohibited to use cooled coils without cooling unit It can cause coil surface overheating even after the stimulation stop patient s burn and magnetic stimulator damage It is recommended to use the ear tips to protect from the acoustic mex noise when delivering more than 10000 stimuli per day gt 10000 The stimulus evoked by the stimulator generates a loud click that can frighten a patient Tell a patient about the stimulation beginning or give her him the ear tips The stimulator must not be used together with the anaesthetic gases as far as it can inflame The operator must be protected from the continuous impact of the magnetic
63. t from the power supply during the response acquisition The delay value is displayed on Stimulation parameters indicator To adjust the delay use Stimulation parameters knob Each time you press Pulse button on the coil or the stimulator case the stimulus will be generated The Ready indicator shows the readiness to the next stimulus After the stimulus producing the Pulse button is ignored for the time being equal to the delay for capacitor charge start The parameters of the repetitive stimulation are specified before the stimulation be ginning To do this press Session Pause Train or Frequency button to select the corresponding mode To adjust the corresponding parameter use Stimulation pa rameters knob This current value will be displayed on Stimulation parameters indi cator The range of the specified values and the frequency step are given in chapter 1 4 Main Specifications If you press Pulse button on the coil or on the stimulator case when one of the but tons Frequency Train Pause or Session is highlighted the repetitive stimula tion will be run During the repetitive stimulation Session button and min indicator blink The Stimulation parameters indicator displays the countdown of the session duration When the session time is expired the stimulation is stopped In case you press Pulse button on th
64. the Mains power switch located on the rear panel of this unit connect the power supply to the magnetic stimulator by turning it to I position At that the Power state indi cator located on the front panel will highlight yellow If extra power supply unit is included in the stimulator delivery set than using the Mains power switch located on the rear panel of this unit connect the power supply to the magnetic stimulator by turning it to I position At that the Power state indicator located on the front panel will highlight yellow If cooling unit is included in the system connect the power supply to the cooling unit by turning it to I position using the Mains power switch located on the rear panel of the cooling unit If the stimulator is used together with the digital EMG and EP systems manufac tured by Neurosoft Ltd connect the corresponding equipment to the computer according to the technical manual recommendations If the stimulator is used with EMG devices produced by third party manufacturers the connection of the corresponding equipment should be performed according to the requirements described in chapter 1 8 Synchronization If the stimulator is used with Neuro MS NET software the program must be in stalled before the first connection of the stimulator to the computer Connect the Proper Use main unit to the computer using the USB cable If the window represented on F
65. tic stimulator IEC 61000 4 11 requires continued operation during power mains interruptions it is 5 ETP recommended that the 40 Ur 60 dip in 100 ms magnetic stimulator be Ur for 5 cycles powered from an uninterruptible power supply or a battery 70 Ur 30 dip in 500 ms Ur for 25 cycles 120 Ur 20 dip in Ur for 25 cycles 500 ms lt 5 Ur gt 95 dip in Ur for 5000 ms 5s Power frequency Power frequency magnetic magnetic field 3 A m 3 A m fields should be that of a IEC 61000 4 8 typical commercial or hospital environment Note Ur is the a c mains voltage prior to application of the test level Appendix 1 Electromagnetic Emissions and Immunity Guidance and manufacturer s declaration electromagnetic immunity The magnetic stimulator is intended for use in the electromagnetic environment specified below The customer or the user of the magnetic stimulator should assure that it is used in such an environment Immunity test IEC 60601 test Compliance level Electromagnetic environment level guidance Portable and mobile RF communications equipment should be used no closer to any part of the magnetic stimulator including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms 150 kHz to 3V IEC 61000 4 6 80 MHz outside d 1 17VP ISM bands Radiated RF 3 V m 3 V m d 1 17VP IEC 61000 4 3 80 MHz t
66. timulus start To acquire the responses on digital EMG system EMG software is used typically 4 Typical schematic for the stimulator connection to digital EMG system via the electri cal stimulator output is given on Fig 28 Plug XP1 view from the pinout side D a cir ar 8 2 I and EP system 3 Plug XP2 view from the pinout side 2 4 5 oo 1l0 o 0 3 obo MAS 8100S 7 8 to digital EMG to Neuro MS DN 5M2 240 Fig 28 Trigger cable schematic for the stimulator connection to digital EMG system via the electrical stimulator 3 6 Operation in Syncronization Mode with External Device via Trig out The stimulator trigger out can be used for synchronization with digital EMG systems produced by third party manufacturers see chapter 1 8 Synchronization The principle of operation in this mode is analogous to the operation in stand alone mode with single pulse stimulation see chapter 3 3 Operation in Stand alone Mode In this operation mode the stimulator trigger output is connected to trigger input of EMG device using the special communication cable The stimulus is producedd by the pressing of Pulse button located on the coil or on the stimulator case At that the Trig out signal in Trig in out connector is generated for each stimulus see chapter 1 8 Synchronization 3 7 Actions in the Emergency In the cases of electrical i
67. ulator will switch to the paired stimulation mode When you press Pulse button on the main unit the stimulator produces two stimuli with the specified interpulse interval and specified amplitude for each stimulus in this mode The interpulse interval is set using the Interpulse interval knob and this current value is displayed on Interpulse interval indicator The amplitude of the first stimulus is set on the main unit the one of the second stimulus is specified on the expansion unit The amplitude setting is carried out with the use of Amplitude knob and is displayed on Amplitude indicator on the corresponding unit The switch to the paired stimulation mode is possible only in case the single pulse mode is set on the main unit 9 Standard monophasic button If you press this button the stimulator will switch to the standard monophasic stimulation mode The switch to this mode is possible only in the single or repetitive stimulation mode 10 Power monophasic button If you press this button the stimulator will switch to the power monophasic stimulation mode The switch to this mode is possible only in the single or repetitive stimulation mode 11 Power biphasic button If you press this button the stimulator will switch to the power biphasic stimulation mode The switch to this mode is possible only in the single or repetitive stimulation mode Description 8 7
68. uro EMG MS delivery set NSFT 034999 004 Coil holder NSFT 058998 003 a Il CH 5 End cap NSFT 058105 001 1 1 Coils Big ring coil 150 mm NSFT 058304 002 B RC 02 150 Small ring coil 100 mm NSFT 058304 001 B _ RC 02 100 Figure of eight coil 100 mm NSFT 058304 013 m 7 FEC 02 100 Cooled angulated figure of eight coil 100 mm NSFT 058304 012 4 4 AFEC 02 100 C Cables HV high voltage cable for Neuro MS D expansion unit connection NSFT 058103 033 Control cable for Neuro MS D cooling unit NSFT 058103 035 NSFT 058103 070 Neuro MS D Technical Manual Table 7 Continued Document name or Name main specifications Quantity pes 1 2 3 Control cable for Neuro MS D cooling and NSFT 058103 036 z E expansion units NSFT 058103 071 HV cable for extra power supply unit connection to B Neuro MS D NSFT 058103 058 1 Equipotential cable NSFT 058103 032 050 1 2 IEC C13 IEC C14 mains supply cable 220 V 10 A 1 8m K 4 4 to connect cooling unit 3Gx0 75 sq mm CEE 7 7 IEC C13 mains supply cable 220 V 10 A 1 8 m 4 4 2 3Gx0 75 sq mm USB A B cable 3m 1 1 1 Holders FISSO flexible arm NSFT 016998 012 B ing 4 H 3 Flexible arm NSFT 016998 002 B 4 B CH 1 Trolleys Trolley with custors for magnetic stimulator NSFT 059998 002 B 1 1 4 shelves T 2 Spare
69. wet fabric 4 3 Conservation The magnetic stimulator components including accessories and operational documen tation should be packed in separate plastic sachets and then placed in a manufacturer package 4 4 Life Time The stimulator life time is 5 years starting from the shipment date to a user The life time of coils included in the delivery set is 1 year starting from the shipment date to a user The manufacturer is obliged to provide the technical service of a stimulator and coils during its life time Packing and Transportation The package should conform to the accepted one when manufacturing and delivering In case the factory package is damaged but the long term stimulator storage and transportation is expected respect the following recommendations e The stimulator with operational documentation should be packed in plastic sachets and cardboard boxes e The cardboard boxes should be covered by the paper tape or pressure sensitive adhesive tape The stimulators can be transported by all kinds of covered carries except non heated airplane pods according to rules of goods transportation for each mode of transport at temperature varying from 50 up to 50 C Utilization The device utilization is performed according to the current legislation of the area where the equipment is used Special requirements to device utilization are not pro vided by the manufacturer Delivery Set and Package Data Neuro MS D magnetic sti

Neuro-MS/D - Caputron Medical

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