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Neurosoft Neuro-MSX Technical Manual

Repetitive magnetic stimulator
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Technical Manual
Neuro-MSX
Repetitive Magnetic Stimulator
TM063.02.001.001
(13.09.2022)

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  • Page 1 Technical Manual Neuro-MSX Repetitive Magnetic Stimulator TM063.02.001.001 (13.09.2022)
  • Page 2 Neurosoft LLC © 2022 5, Voronin str., Ivanovo, 153032, Russia P.O. Box 10, Ivanovo, 153000, Russia Phone: +7 (4932) 95-99-99, (4932) 24-04-34 Fax: (4932) 24-04-35 E-mail: info@neurosoft.com Internet: www.neurosoft.com...
  • Page 3 Contents Introduction ....................... 5 Abbreviations ......................6 Indications for Use ....................7 Intended Audience ....................7 Operator Qualifications .................... 7 Contraindications ..................... 8 Warnings and Precautions ..................9 Possible Side Effects ....................16 Description ....................... 20 1.1. Principle of Operation ................. 20 1.2.
  • Page 4 2.8.2. Equipment Assembly ................69 Proper Use ....................... 75 3.1. Workflow Using the Stimulator ..............75 3.2. Stand-alone Mode ..................76 3.3. USB Control Mode ..................80 3.4. Control Mode via Trigger Input ..............81 3.5. Control Mode via Trigger Output ..............82 3.6.
  • Page 5 You can send your responses and recommendations to the following address: P.O. Box 10, Ivanovo, 153000, Russia or to e-mail: help@neurosoft.com You can find additional information on Neurosoft products in the Internet: www.neurosoft.com or contact us by phone: +7 (4932) 59-21-12 (Service Centre)
  • Page 6 Neuro-MSX (Technical Manual) Abbreviations The following abbreviations are used in this manual: AFEC — angulated figure-of-eight coil DCC — double cone coil EEG — electroencephalography, electroencephalographic EMG — electromyography, electromyographic FEC — figure-of-eight coil ITI — intertrain interval LAN — local area network LCD —...
  • Page 7 Operator Qualifications Neuro-MSX magnetic stimulator is used by prescription only by or under the supervision of a licensed professional trained in the use of Neuro-MSX stimulator. It is recommended that Neuro-MSX magnetic stimulator user be a licensed clinical professional who is approved by the licensed professional who prescribed treatment.
  • Page 8 Neuro-MSX (Technical Manual) Contraindications Every patient must be screened for contraindications prior to perform magnetic stimulation. When deciding on diagnostic TMS or rTMS treatment, the respective contraindications described safety recommendations shall be considered [1], [9]. There are two contraindications for rTMS therapy: 1.
  • Page 9 It is normal to feel temporary mild discomfort at the site of stimulation during and/or shortly after treatment Neuro-MSX has an adverse affects on some devices. Before starting treatment the prescribing physician to screen each patient for the presence of these devices. See Ошибка! Источник...
  • Page 10 Neuro-MSX (Technical Manual) Magnetically activated dental Patient injury implants Aneurysm clips or coils Serious patient injury or death Carotid or cerebral stents Patient injury or death Cochlear, otologic implants Patient injury Cerebral Spinal Fluid (CSF) Patient injury shunt Ferromagnetic ocular...
  • Page 11 Warnings and Precautions cm distance from the operating coil so they are not affected by rTMS as the magnetic field can cause movement, heating or dysfunction of these devices. Before the treatment start the patient should take off and remove from patient area all removable devices and objects that may be affected by magnetic field: adornments (for example earrings), eyeglasses, cell phones, MP3 players, PDA devices, headphones, coins...
  • Page 12 Neuro-MSX (Technical Manual) Seizure Monitoring Warnings and Precautions During rTMC session you must keep watching over the signs of seizure and terminate the treatment session if those signs appear. If patient has taken a medication that may alter the seizure threshold, detect the motor...
  • Page 13 Warnings and Precautions improperly, without following the instructions of this manual; · eliminating faults that require opening the enclosures of the components included in product specification; · performing stimulation if the enclosures of the electronic unit, computer and other devices used together with the stimulator are open.
  • Page 14 Neuro-MSX (Technical Manual) operator must protected from continuous impact of the magnetic field. It is recommended to use a holder for coil fixation. If the coil heats over 41°C, the magnetic stimulator stops the stimulation and indicates the overheating. As far as the coil...
  • Page 15 Warnings and Precautions Table 3. Safety recommendations for intertrain intervals for 10 trains of TMS at < 20 Hz Intertrain Stimulus intensity, % of MT interval, s Safe Safe Safe Insufficient data а Unsafe (3) Unsafe Unsafe (2) Unsafe (2) а...
  • Page 16 Neuro-MSX (Technical Manual) Possible Side Effects The adverse effects of TMS are given in Table 5 according to the data reported in [1], [7], [10]: Table 5. Adverse effects of TMS Adverse effect Single pulse Paired pulse High Theta burst...
  • Page 17 Possible Side Effects Transient acute hypomania induction. The literature data describes some cases of treatment-emergent mania in patients with uni- and bipolar depression following both low- and high-frequency rTMS of the left prefrontal cortex. However, the overall results of a large number of randomized controlled studies show that the risk of this side effect is rather low.
  • Page 18 Neuro-MSX (Technical Manual) · make a decision on performing TMS only in cases of a favorable risk/benefit ratio in patients with pre-existing noise induced hearing loss, under concurrent treatment with ototoxic medications (such as Amynoglycosides, Cisplatine) and also in young children.
  • Page 19 Possible Side Effects · The effect on the immune system is still studied. In few publications related to the after-effects of rTMS on immune system there are no data that rTMS may impact negatively to immune system. · The effect of rTMS on antonomic functions was reviewed in some studies. Thus, rTMS (500 ms, 20 Hz, 70-90% with maximum intensity) induced a short lasting increase in heart rate and blood pressure (Foerster, 1997).
  • Page 20 Neuro-MSX (Technical Manual) Description 1.1. Principle of Operation The block diagram of the units and their interconnection is shown in Fig. 1.1. The block diagram of the main stimulator unit consists of the control circuit, capacitor, capacitor charging circuit intended for charging the capacitor up to the voltage specified by the control circuit and high-voltage electronic switch.
  • Page 21 Description The principle of operation is based on discharge of the high voltage capacitor (charged up to 1.8 kV) through stimulation coil made of copper wire at the moment of electronic switch opening. this time discharge current (up to 10 kA) generates the magnetic field. This field induces the current in body tissues located near which causes nerve impulse as during usual electrical stimulation.
  • Page 22 Neuro-MSX (Technical Manual) magnetic stimulator generates different pulse sequences depending on the stimulation mode: · single pulse mode — stimulation by single pulses (Fig. 1.3); · train mode — stimulation by trains (Fig. 1.4); · burst mode — stimulation by bursts (Fig. 1.5);...
  • Page 23 USB connector of the personal computer using the removable interface cable included in the delivery set. Under control of digital EMG and/or EEG systems manufactured by Neurosoft. At that, the electronic unit of the stimulator is connected with USB port...
  • Page 24 3 — trolley with castors (4 shelves); 4 — touchscreen computer (is not included in the delivery set); 5 — touchscreen computer holder; 6 — Neuro-MSX main unit; 7 — Neuro-MSX cooling unit; 8 — Neuro-MSX extra power supply unit; 9 — EMG unit.
  • Page 25 Description 1.2.1. Controls, Connectors and Indicators of the Main Unit The front and rear panels of the main unit are shown in Fig. 1.9 and Fig. 1.10 respectively. Fig. 1.9. Front panel of the main unit The front panel of the main unit contains (Fig. 1.9): 1 —...
  • Page 26 Neuro-MSX (Technical Manual) After coil replacement press the “Arm” button to start charging the capacitor up to the specified value. When using the cooled coil, pressing the “Arm” button will also enable the circulation of cooling agent inside the coil.
  • Page 27 Description 6 — “On/Off” button and “Power” indicator. The “On/Off” button switches between the operating mode and standby mode of the stimulator. When the voltage is supplied, the stimulator enters the standby mode. This is indicated by the yellow light of the “Power” indicator.
  • Page 28 See section 3.4 “Control Mode via Trigger Input” for details. Only equipment compliant with IEC 60601-1:2005/A1:2012 (EN 60601- 1:2006/А1:2013) and configured according to IEC 60601-1:2005/A1:2012 (EN 60601-1:2006/А1:2013) can be connected to Neuro-MSX magnetic stimulator. Permissible ranges of signal parameters are listed in section A.1.4.
  • Page 29 Description 13 — Cooling fan outlet. The fans ensure air circulation inside the main unit. The air is drawn through the slots at the bottom panel of the unit and expelled through the fan outlets on the rear panel. 14 — Label (see section 1.6 “Labeling”). 15 —...
  • Page 30 Neuro-MSX (Technical Manual) · NS063201.006-020 cooling unit — features a passive cooling system. This unit can be used to perform most of the treatment protocols at the ambient temperature up to 24°C (see technical manual for the coils). The front panels of the cooling units have the only difference: “Irbis” cooling unit features a logo and a name on its panel while NS063201.006-020 cooling unit does...
  • Page 31 The “Control” connector allows connecting the cooling unit to the main unit using communication cable. 6 — USB connector. The connector is intended to perform unit maintenance (in Neurosoft Service Center). 7 — “Mains power” switch. To turn on power supply of the cooling unit, set power switch to “ON” (I) position.
  • Page 32 Neuro-MSX (Technical Manual) 1.2.3. Controls, Connectors and Indicators of the Extra Power Supply Unit The front and rear panels of the extra power supply unit are shown in Fig. 1.14 and Fig. 1.15 respectively. Fig. 1.14. Front panel of the extra power supply unit 1 —...
  • Page 33 Description 5 — Label (see section 1.6 “Labeling”). 6 — Cooling fan outlet. The fans ensure air circulation inside the main unit. The air is drawn through the slots at the bottom panel of the unit and expelled through the fan outlets on the rear panel.
  • Page 34 Neuro-MSX (Technical Manual) If the stimulator is disarmed, pressing and holding the “Trigger” and “+” buttons enables capacitor charging (the same as pressing the “Arm” button on the stimulator front panel). 4 — High-voltage connector. 5 — Cooling agent hoses.
  • Page 35 Description Fig. 1.18. Bottom panel Designations shown in Fig. 1.18: 1 — “1–” — touch-proof input for connecting the negative electrode of the first channel (black); 2 — “1+” — touch-proof input for connecting the positive electrode of the first channel (red);...
  • Page 36 The connector is intended to ensure operation in synchronization mode. Only equipment compliant with IEC 60601-1:2005/A1:2012 (EN 60601- 1:2006/А1:2013) and configured according to IEC 60601-1:2005/A1:2012 (EN 60601-1:2006/А1:2013) can be connected to Neuro-MSX magnetic stimulator. Permissible ranges of signal parameters are listed in section A.1.4.
  • Page 37 Description Fig. 1.21. Rear panel of the electrical stimulator unit The following elements are located on the unit rear panel: 4 — trig out connector. The connector is intended to ensure stimulator operation in synchronization mode. 5 — USB port. The port is intended to connect the electrical stimulator unit to a computer using USB cable.
  • Page 38 Neuro-MSX (Technical Manual) Fig. 1.22. Workflow using the stimulator in stand-alone mode If necessary, you can edit treatment protocol parameters. To do it, select the protocol in the “Treatment” screen by pressing and holding the “Stimulation parameters” knob against the desired protocol (Fig. 1.22). After that, the list of parameters available for the selected protocol will appear on the screen.
  • Page 39 2 — Coil temperature in Celsius degrees. 3 — “USB control” indicator. If this symbol is displayed, it means the stimulator is connected to a computer via USB and is controlled by the related Neurosoft software. 4 — “Mode” indicator. Single pulse mode is enabled.
  • Page 40 Neuro-MSX (Technical Manual) · “Discharging” — the stimulator is switched on, high voltage is delivered, the capacitor is being discharged, the stimulator cannot deliver pulses. 8 — “Coil type” indicator shows the coil type code. The detailed information on coil types and their specifications is provided in the respective technical manual.
  • Page 41 Description 1.3.2. “Treatment” Screen The “Treatment” screen is shown in Fig. 1.24. To switch to this screen, follow the steps described in section 1.3 “Stimulator Interface”. Fig. 1.24. Selecting predefined treatment protocol The following information is shown on the main unit display (Fig. 1.24): 1 —...
  • Page 42 Neuro-MSX (Technical Manual) Perform the steps described in section 1.3 “Stimulator Interface” to open the list of parameters available for the particular protocol. The following information is shown on the protocol parameters screen (Fig. 1.25): 1 — treatment protocol name. The parameters can be edited using Neuro-MS.NET software via USB interface or over Wi-Fi via Web interface;...
  • Page 43 Description 1.3.3.1. “Train” Mode Parameters The following parameters are available in the “Train” mode (Table 6). Table 6. “Train” mode parameters Parameter Graphical representation Parameter description of the parameter Frequency Pulse frequency per train Pulses per train Number of pulses per train Train duration Rated pulse train duration Interval between pulse trains...
  • Page 44 Neuro-MSX (Technical Manual) 1.3.3.2. “Burst” Mode Parameters The following parameters are available in the “Burst” mode (Table 7). Table 7. “Burst” mode parameters Parameter Graphical representation Parameter description of the parameter Frequency in Frequency of pulses per burst burst Pulses per burst...
  • Page 45 Description 1.3.3.3. “Ramp” Mode Parameters The following parameters are available in the “Ramp” mode (Table 8). Table 8. “Ramp” mode parameters Parameter Graphical representation Parameter description of the parameter Frequency Frequency of pulses per train Ramp up Amplitude ramp up time in train A period when pulses in train are Plateau delivered with the same amplitude...
  • Page 46 Neuro-MSX (Technical Manual) 1.3.3.4. “Sweep” Mode Parameters The following parameters are available in the “Sweep” mode (Table 9). Table 9. “Sweep” mode parameters Parameter Graphical representation Parameter description of the parameter Minimum pulse frequency at the Lowest frequency beginning (end) of the train...
  • Page 47 Description 1.3.4. Repetitive Mode The stimulator display in the repetitive stimulation mode is shown in Fig. 1.26. Follow the steps described in section 1.3 “Stimulator Interface” to switch to the “Repetitive mode” screen. Fig. 1.26. Repetitive mode The following elements are shown on the main unit display in this mode: 1 —...
  • Page 48 Neuro-MSX (Technical Manual) 3 — Name of the selected treatment protocol. 4 — “Intensity” indicator. The indicator shows pulse intensity in percent of the maximum intensity value or in percent of MT depending on the selected mode. 5 — MT (if available).
  • Page 49 Description 1.4. Stimulator Setup The stimulator settings can be viewed and changed in the “SETTINGS” menu (Fig. 1.27). To open the menu, press the On/Off button while pressing and holding the “Stimulator parameters” knob (in the standby mode). Fig. 1.27. “SETTINGS” menu The following information is shown on display: 1 —...
  • Page 50 Neuro-MSX (Technical Manual) · “Language” — allows selecting the stimulator interface language. · “Auto discharge” — automatic discharge time when the stimulator enables discharge if its controls were inactive while the stimulator was in the “Armed” state. · “Serial num.:” — serial number of the stimulator.
  • Page 51 Description 1.4.4. “TRIGGER” Submenu The settings available in the “TRIGGER” submenu are shown in Fig. 1.31. Fig. 1.31. “TRIGGER” submenu · “Trigger Out” — trigger output control: o Off — trigger pulse is not generated at the trigger output during the stimulation.
  • Page 52 Neuro-MSX (Technical Manual) · “Delay Output” — allows adjusting pulse delay relative to trig-out signal (Fig. 1.33). Fig. 1.33. Pulse delay relative to trig-out signal The permissible ranges are given in Annex 1 “Specifications”. 1.4.5. “WIFI” Submenu The settings available in “WIFI” submenu are shown in Fig. 1.34.
  • Page 53 Description 1.4.6. “OPTIONS LIST” Submenu The “OPTIONS LIST” submenu (Fig. 1.35) includes the complete list of options and shows if an option is available for the particular stimulator. Fig. 1.35. “OPTIONS LIST” submenu · “Train up to 30Hz” — allows performing stimulation by trains up to 30 Hz frequency.
  • Page 54 Neuro-MSX (Technical Manual) · selecting stimulation mode; · displaying stimulation status — stimulation progress, intensity, parameters and coil temperature. To enable operation over W-Fi (see section 1.4.5 “WIFI” Submenu”) activate “Web Mode” in the stimulator settings (Fig. 1.36). Fig. 1.36. Wi-Fi settings In this mode, the stimulator works as an access point, creating a local Wi-Fi network with the network name and password specified in the settings.
  • Page 55 Description The stimulator web interface is similar to the interface of the main stimulator unit (see section 1.3 “Stimulator Interface”): · “Stimulation” page shows current state of the stimulator and the stimulation progress (Fig. 1.38). Fig. 1.38. “Stimulation” page · “Protocols”...
  • Page 56 Neuro-MSX (Technical Manual) 1.6. Labeling The example of the label for the stimulator unit is shown in Fig. 1.41. Fig. 1.41. The example of the label for the stimulator unit Interpretation of label symbols: — catalogue number according to ISO 15223-1.
  • Page 57 Description The device is identified with GS1-128 barcode that includes GTIN code and serial number (Fig. 1.42). Fig. 1.42. GS1-128 barcode 1 — device identifier GTIN. 2 — indicator digit. 3 — company prefix. 4 — item reference number. 5 — check digit. 6 —...
  • Page 58 Neuro-MSX (Technical Manual) Assembly and Connection 2.1. Personnel Requirements The stimulator should be installed by a person authorized by the manufacturer or the technical personnel of the medical facility which is going to use it. It is necessary to know that safety and quality of operation depend on the proper assembly of the magnetic stimulator.
  • Page 59 Assembly and Connection 2.3. Room Selection and Placement Before assembly and installation of the stimulator, select a place for it considering electrical wiring and protective ground in the room, and make sure to read the following requirements and recommendations. In the selected place, an access to multiple mains socket outlets should be ensured.
  • Page 60 EN 60601-1 requirements. If Neuro-MSX is used together with computer equipment, it is allowed to use only computer equipment that complies with EN 60601-1 safety requirements. The safety level of computer equipment connected without the use of isolation devices is insufficient for the patient’s environment.
  • Page 61 Assembly and Connection Fig. 2.2. Example of equipment placement when using a notebook with a medical power supply and optionally connected to LAN that does not comply with safety requirements for medical electrical equipment and systems Fig. 2.3. Example of equipment placement when using a notebook and printer that are powered using an isolation transformer and optionally connected to LAN that does not comply with safety requirements for medical electrical equipment and systems...
  • Page 62 Neuro-MSX (Technical Manual) Fig. 2.4. Example of equipment placement when using a desktop PC and printer that are powered using an isolation transformer and optionally connected to LAN that does not comply with safety requirements for medical electrical equipment and systems AC power adapter compliant with EN 60601-1 shall be used as a medical power supply unit.
  • Page 63 Assembly and Connection The equipment placement options and connection to mains are shown in Fig. 2.5 — Fig. 2.9. Equipment placement Equipment connection Fig. 2.5. Stimulator configuration — therapeutic, stand-alone mode...
  • Page 64 Neuro-MSX (Technical Manual) Equipment placement Equipment connection Fig. 2.6. Stimulator configuration — therapeutic, connected to PC...
  • Page 65 Assembly and Connection Equipment placement Equipment connection Fig. 2.7. Stimulator configuration — diagnostic, using EMG system...
  • Page 66 Fig. 2.8. Stimulator configuration — diagnostic, using medical devices of the third-party manufacturer Only equipment compliant with IEC 60601-1:2005/A1:2012 (EN 60601- 1:2006/А1:2013) and configured according to IEC 60601-1:2005/A1:2012 (EN 60601-1:2006/А1:2013) can be connected to Neuro-MSX. Permissible ranges of signal parameters are listed in section A.1.4.
  • Page 67 Assembly and Connection Equipment placement Fig. 2.9. Stimulator configuration — therapeutic, placebo...
  • Page 68 Neuro-MSX (Technical Manual) 2.7. Selecting the Coil The coil is selected depending on the given application. The detailed description of the available coils is provided in the particular technical manual. A typical approach to coil selection is given in Table 11.
  • Page 69 Assembly and Connection 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 (“0” position of the power switch). If you use the main stimulator unit together with extra power supply unit and/or with cooling unit, it is recommended to use a trolley for the magnetic stimulator, which will ensure reliable mounting of the units and allow smooth equipment relocating.
  • Page 70 Neuro-MSX (Technical Manual) Place the unused coil in K-8 holder (Fig. 2.11). Fig. 2.11. Placement of coil on the holder Fill the cooling agent into the cooling unit tank (Fig. 2.12) as described in Annex 4 “Preparing Cooling Unit for Use”.
  • Page 71 Assembly and Connection · configuration 3 (advanced therapeutic) — see section A5.3 “Connection Diagram for Configuration 3 (advanced therapeutic)”. Plug the HV socket of the coil cable into the main unit (Fig. 2.13). Fig. 2.13. Coil connection to the main unit Plug the cooled coil hoses into the cooling unit (Fig.
  • Page 72 Neuro-MSX (Technical Manual) Place the medical chair and the trolley with the stimulator in the desired area and make sure that the “Mains power” switch on the rear panel of the units is in “0” position. Plug the stimulator into a power outlet.
  • Page 73 Assembly and Connection Fig. 2.17. Fixing K-9 flexible arm to the medical chair 11. Position and secure the selected coil in the flexible arm (Fig. 2.18) (see technical manual for the flexible arm). Fig. 2.18. Coil positioning 12. Place PC near the stimulator following recommendations of section 2.3 “Room Selection and Placement”.
  • Page 74 The “New hardware wizard” will perform the stimulator installation and the dialog box notifying on installation completion will appear. 17. Click “Finish”. Now the stimulator is ready for use. The operation of Neurosoft EMG/EEG systems using Neuro-MS.NET software is described in the related user manuals.
  • Page 75 2. Under control of Neuro-MS.NET software via USB. 3. Under control of Neuro-MEP.NET software supplied with Neurosoft digital EMG and EP systems or Neuron-Spectrum.NET software supplied with Neurosoft digital EEG and EP systems (via USB).
  • Page 76 Neuro-MSX (Technical Manual) If the trouble occurs during the stimulator operation, the error code will appear on the stimulator display. The error indication is accompanied by the sound notification. In this case refer to section 3.8 “Troubleshooting”. Switch the stimulator off using “On/Off”...
  • Page 77 Proper Use The workflow using the stimulator is shown in Fig. 3.1 and includes the following steps: Searching MT in the single-pulse mode. Selecting treatment protocol for repetitive stimulation. Performing repetitive stimulation — progress monitoring. Fig. 3.1. Workflow using the stimulator Step-by-step description: Toggle “Mains power”...
  • Page 78 Neuro-MSX (Technical Manual) · 30% pulse intensity. If necessary, specify another pulse intensity value using the “Stimulation parameters” knob (see sections 1.2 “Controls, Connectors and Indicators” and 1.4 “Stimulator Setup”). · Coil state — coil type and temperature. Fig. 3.3. Stimulator display before pulse delivery To charge the stimulator press “Arm”...
  • Page 79 Proper Use prevent accidental stimulation after long-term time-out. To charge the stimulator press “Arm” button. To open the list of the predefined protocols Press the “Stimulation parameters” knob . Then select the required protocol from the list by rotating the same knob (Fig.
  • Page 80 15. Set “Mains power” switch on the rear panel of the stimulator unit to Off (0) position. 3.3. USB Control Mode The stimulator can operate under the control of Neurosoft EMG and/or EEG systems, and Neuro-MS.NET software. In this mode the stimulator is connected to PC via USB and controlled by the corresponding software.
  • Page 81 Proper Use The stimulator can be controlled by the third-party manufacturer equipment via USB using the provided software libraries. Contact Neurosoft for details. 3.4. Control Mode via Trigger Input The stimulator trigger input is used for synchronization with EMG and/or EEG systems of the third-party manufacturer.
  • Page 82 BNC connector for this purpose. In this case you may use NS063103.009 cable (Fig. 3.10). Only equipment compliant with IEC 60601-1:2005/A1:2012 (EN 60601- 1:2006/А1:2013) and configured according to IEC 60601-1:2005/A1:2012 (EN 60601-1:2006/А1:2013) can be connected to Neuro-MSX. Permissible ranges of signal parameters are listed in section A.1.4.
  • Page 83 Acquisition of Evoked Potentials Refer to section 3.3 “USB Control Mode” if you use the stimulator together with Neurosoft digital EMG and/or EEG systems. If the stimulator is used together with the third-party manufacture equipment, see sections 3.4 “Control Mode via Trigger Input”...
  • Page 84 Neuro-MSX (Technical Manual) · place the coil and HV cable as far as possible from recording electrodes; · use recording electrodes with minimum cable length; · use shielded cables, if there are no such cables, twist the active recording and reference electrodes;...
  • Page 85 Proper Use Fig. 3.12. Disposable electrode placement close to the coil front edge in the hairless area Fig. 3.13. Cup electrode placement in the hairy area Please remember that neither the electrodes nor their cables shall be located under the coil! Place the loudspeaker on the stand at the coil height and as close to the coil as possible.
  • Page 86 The faults detected by the stimulator are divided into two groups: · Service (Fig. 3.14) — occurs in case of stimulator electronic components failure. Error message includes the error code. If this fault occurs, contact Neurosoft Service Center.
  • Page 87 Check the cooled coil connection to the hydraulic unit adapters on the cooling unit front panel If it is hard to fix an error, contact Neurosoft service center (5, Voronin str., Ivanovo, 153032, Russia, phone +7 (4932) 59-21-12, +7 (4932) 24-04-37, e-mail: help@neurosoft.com).
  • Page 88 When detecting a trouble, please refer to the information given in section 3.8 “Troubleshooting”. If the trouble cannot be eliminated, contact Neurosoft service center. The magnetic stimulator is subject to user maintenance. The volume of the user maintenance is specified in section 4.2 “User Maintenance”.
  • Page 89 Perform visual inspection of the units and their components for signs of damage or wear. Contact Neurosoft service center if you notice any damage or signs of wear. Clean the electronic units with a wrung cloth dampened in any normal dishwashing solution.
  • Page 90 Neuro-MSX (Technical Manual) 4.5. Lifetime The average stimulator lifetime is not less than 5 years from the shipment date. The lifetime of the coils included in the product delivery set is specified in the technical manual for the coils. The manufacturer is obliged to provide technical service of the stimulator and coils throughout its life time.
  • Page 91 Delivery Set and Package Data Delivery Set and Package Data The Neuro-MSX repetitive magnetic stimulator is collected, packed and ready for operation. Packed by ___________________ signature The detailed information on the delivery set is provided in the packing report which...
  • Page 92 8.4. The manufacturer is obliged to repair the stimulator in case of its failure within the warranty period free of charge. The repair is carried out in the Neurosoft Service Center (5, Voronin str., Ivanovo, 153032, Russia) according to procedure described in section 9 “Reclamations”.
  • Page 93 Reclamations · detailed description of faults. If possible state the reasons and circumstances preceding fault detection (in addition it is recommended to attach test report, exam data, photos and other materials that allow solving the problem as soon as possible). 9.2.
  • Page 94 Neuro-MSX (Technical Manual) Annex 1. Specifications A.1.1. Main Specifications Main specifications of the magnetic stimulator are given in Table 14. Table 14. Main specifications of the magnetic stimulator Parameter Value Stimulation Parameters Pulse waveform biphasic Pulse duration range 240…410 µs Peak magnetic field 2.5 T...
  • Page 95 Annex 1. Specifications Table 14 (continued) Parameters Values Weight: · main unit (30.2 ± 0.5) kg · Irbis cooling unit (29.5 ± 0.5) kg · cooling unit (25 ± 0.5) kg · (18.6 ± 0.5) kg extra power supply unit Weight of the stimulator with accessories in package (225 ±...
  • Page 96 Neuro-MSX (Technical Manual) A.1.2. Stimulation Parameters Stimulation parameters and modes are described in Table 15. Table 15. Stimulation parameters Parameter Value Pulse amplitude 0 – 100% Adjustment step for pulse amplitude Intensity in % of MT 0 – 150% Adjustment step for intensity in % of MT Automatic stimulator discharge time 1 –...
  • Page 97 Annex 1. Specifications Table 15(continued) Parameter Value Burst frequency in train 0.1 – 100 Hz Permissible relative deviation of burst frequency in train ± 5% Adjustment step for burst frequency in train: 0.1 Hz · in the range 0.1 – 30 Hz 1 Hz ·...
  • Page 98 Neuro-MSX (Technical Manual) Table 15 (continued) Parameter Value Number of trains per session from 1 to 1000 Adjustment step for the number of trains per session Sweep Mode · Maximum pulse frequency in train 1 – 30 Hz · 1 – 100 Hz (option) Permissible relative deviation of the maximum pulse ±...
  • Page 99 Annex 1. Specifications Depending on the stimulation frequency, the maximum magnetic field amplitude when not using extra power supply unit should correspond to the values listed in Table 16 with the permissible relative deviation of ± 5%. Table 16. The dependence of the maximum amplitude of magnetic field of the pulse on the stimulation frequency when not using extra power supply unit Amplitude, in % of the maximum possible amplitude of 100 % 100 23...
  • Page 100 Neuro-MSX (Technical Manual) Depending on the frequency of stimulation, the maximum amplitude of the magnetic field when using extra power supply unit, should correspond to the values listed in Table 17 with the permissible relative deviation of ± 5%. Table 17. Dependence of the maximum amplitude of the magnetic field of the conventional biphasic...
  • Page 101 Annex 1. Specifications A.1.3. Cooling Unit Main specifications of the cooling unit are given in Table 18. Table 18. Main specifications of the cooling unit Parameter Value Volume of the tank when it is filled up to the “max” 2.5 l PDMS-5 (polymethylsiloxane of 5 сST Cooling agent...
  • Page 102 Neuro-MSX (Technical Manual) Table 19 (continued) Parameter Value Permissible relative deviation of input voltage: · in the range 20 – 100 µV ± 15% · in the range 0.1 – 50 mV ± 5% ≥ 200 MΩ Input impedance ≤ 30 pF Input capacitance ≤...
  • Page 103 Annex 1. Specifications A.1.6. Electrical Stimulator Main specifications of the electrical stimulator are given in Table 21. Table 21. Main specifications of the electrical stimulator Parameter Value Electrical Stimulator Channel Number of channels Pulse type electrical current Pulse waveform rectangular (monophasic, biphasic) Pulse polarity positive, negative...
  • Page 104 Neuro-MSX (Technical Manual) A.1.7. Footswitch Unit The footswitch unit is shown in Fig. A1.1. Fig. A1.1. Footswitch unit Specifications of the footswitch unit are given in Table 22. Table 22. Specifications of the footswitch unit Parameter Value Dimensions 360×180×48 mm Cable length (2.8 ±...
  • Page 105 Annex 1. Specifications Specifications of the patient button are given in Table 23. Table 23. Specifications of the patient button Parameter Value Dimensions (100×48×25) mm Cable length (3 ± 0.05) m Weight (0.12 ± 0.01) kg Interface A.1.9. Footswitch The footswitch is shown in Fig. A1.3. Fig.
  • Page 106 Neuro-MSX magnetic stimulator (diagnostic) Neuro-MSX magnetic stimulator (therapeutic) Neuro-MSX magnetic stimulator (advanced therapeutic) I Neuro-MSX repetitive magnetic stimulator (advanced therapeutic) II Depending on configuration, the magnetic stimulator specification shall comply with the data provided in Table 26. Table 26. Magnetic stimulator specification...
  • Page 107 Annex 2. Product Specification Table 26 (continued) Quantity, Order Code or Name pcs. Image Main Specification AFEC-03-100-C coil NS063209.019 – positioning tool Silicone oil (container, 3 l) NS058998.005 – Coils RC-03-100 small ring coil, NS063304.001 – – – 100 mm RC-03-125 big ring coil, NS063304.002 –...
  • Page 108 Neuro-MSX (Technical Manual) Table 26 (continued) Quantity, Order Code or Name pcs. Image Main Specification K-8 coil holder (trolley/wall NS059998.004 mounted) Trolley T-4/A trolley NS059998.009 – Spare Parts and Accessories – Funnel – L-shape hex key hexahedron – Measuring reel –...
  • Page 109 Annex 2. Product Specification Table 26 (continued) Quantity, Order Code or Name pcs. Image Main Specification Package Cardboard package (set) – Neuro-MSX main unit NS063901.002 package Neuro-MSX cooling unit NS063901.002 – package Neuro-MSX extra power NS063901.001 – – supply unit package...
  • Page 110 Neuro-MSX (Technical Manual) Table 26 (continued) Quantity, Order Code or Name pcs. Image Main Specification DCC-02-125 double cone NS058304.017 coil, 125 mm Cooled coils RC-03-125-С cooled big NS063304.003 ring coil, 125 mm RC-02-150-С cooled big NS058304.026 ring coil, 150 mm FEC-02-100-С...
  • Page 111 NS058214.005 couplings Cooling agent hose NS058214.004 AFEC-02-100-C coil NS058209.021 positioning tool FEC-03-100-C coil NS063209.020 positioning tool EMG equipment and accessories Neuro-MSX EMG unit NS034201.011-020 Neuro-MSX electrical NS061201.012-20 stimulator USB-hub KM-7-2 NS042201.013-020 electronic unit Technical Manual “KМ-7, ТМ042.01.004.000 KM-7-2”...
  • Page 112 Neuro-MSX (Technical Manual) Table 26 (continued) Quantity, Image Order Code or Name pcs. Main Specification USB cable (A→B) NS007103.005 USB cable (A→B) NS007103.005-01 SH-1S small holder NS016201.039 Mounting bracket NS034221.001 ground electrode with Ground electrode with cable TP-DIN, 400 cable (adult)
  • Page 113 Annex 2. Product Specification Table 26 (continued) Quantity, Order Code or pcs. Name Image Main Specification Cup electrode with cable, NS990106.028-02.10 green breathable and perforated, Medical tape transparent, not less than 1 cm wide intended use: reliable Electrode adhesive paste contact and fixation of electrodes to skin intended use:...
  • Page 114 Neuro-MSX (Technical Manual) Table 26 (continued) Quantity, Order Code or Name pcs. Image Main Specification Isolation transformer NS036201.004 TM-630 220 V, 10 А, L=1,8 m, Monitor-computer cable (220 V, 1.8 m, 3×0.75) (3G×0.75 mm 220/230 V, 10 А, not Powercom SCUT adapter more than 1 m long (3G×0.75 mm...
  • Page 115 Annex 3. Emissions and Immunity Annex 3. 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 —...
  • Page 116 Neuro-MSX (Technical Manual) 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.
  • Page 117 Annex 3. 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 level Compliance...
  • Page 118 Neuro-MSX (Technical Manual) Recommended separation distances between portable and mobile RF 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...
  • Page 119 If the cooling agent level is below minimum after that, add the oil. If the oil level decreases independently from changing the coil, inspect the unit carefully for signs of cracks or leakage. In case of leakage, stop using the unit and contact Neurosoft service center or your local distributor.
  • Page 120 Neuro-MSX (Technical Manual) Connect the coil to the cooling unit (Fig. A4.3). Fig. A4.3. Connecting the coil to the cooling unit Unscrew the cap of the cooling agent tank (Fig. A4.4). Fig. A4.4. Cooling agent tank Place the funnel into the tank filler neck and pour the cooling agent into the tank (Fig.
  • Page 121 Annex 4. Preparing Cooling Unit for Use When filling the tank, make sure to pour the oil up to the “MAX” level (Fig. A4.6). Fig. A4.6. Range limits for cooling agent Holding service button, switch the cooling unit on using the “Mains switch” on its rear panel (Fig.
  • Page 122 Neuro-MSX (Technical Manual) Check the oil level in the tank without switching the unit off. Add oil up to the “MAX” level if necessary (Fig. A4.9). Fig. A4.9. Checking oil level 10. Toggle the “Mains switch” first on and then off.
  • Page 123 Annex 4. Preparing Cooling Unit for Use 12. Connect protective earth conductor to the terminal (Fig. A4.11). Fig. A4.11. Restoring protective earthing 13. Place the top cover back on the unit and fix it by 4 screws.
  • Page 124 Neuro-MSX (Technical Manual) Annex 5. Magnetic Stimulator Configurations A5.1. Connection Diagram for Configuration 1 (diagnostic) The connection diagram for this configuration is shown in Fig. A5.1. Do not connect the main unit to the mains and PC. The cables shall be fixed by the screws if it is provided.
  • Page 125 Annex 5. Magnetic Stimulator Configurations A5.2. Connection Diagram for Configuration 2 (therapeutic) Connect the units as shown in Fig. A5.3. Do not connect them to the mains and PC. The cables shall be fixed by the screws if it is provided. Fig.
  • Page 126 Neuro-MSX (Technical Manual) 5 — control cable; 6 — equipotential cable; 7 — end cap; 8 — footswitch. If this configuration of the magnetic stimulator is used, the end cap (7) should be fixed in the high-voltage connector intended for extra power supply unit. To fix the cap, align the marks as shown in Fig.
  • Page 127 Annex 5. Magnetic Stimulator Configurations Fig. A5.5. Connection diagram for configuration 3 (advanced therapeutic) Designations shown in Fig. A5.5: 1 — main unit; 2 — cooling unit; 3 — extra power supply unit; 4 — USB cable; 5 — mains cable; 6 —...
  • Page 128 Neuro-MSX (Technical Manual) Fig. A5.6. Connecting HV cable...
  • Page 129 Annex 6. Preparing Cooling Unit for Transportation Annex 6. Preparing Cooling Unit for Transportation Prior to cooling unit transportation, empty the cooling unit tank. Take a clean container not less than 5l volume for cooling agent and a hose (NS058214.004) with quick- connect fitting.
  • Page 130 Neuro-MSX (Technical Manual) Connect the hose to the outlet fitting (marked blue) (Fig. A6.3). Fig. A6.3. Connecting the hose Unscrew the cap of the cooling agent tank (Fig. A6.4). Fig. A6.4. Opening cooling agent tank...
  • Page 131 Annex 6. Preparing Cooling Unit for Transportation Holding service button, switch the cooling unit on using the “Mains switch” on its rear panel (Fig. A6.5). Fig. A6.5. Switching the cooling unit on Wait until the tank is empty and there are no air bubbles (Fig. A6.6). Fig.
  • Page 132 Neuro-MSX (Technical Manual) Connect protective earth conductor to the terminal (Fig. A6.8). Fig. A6.8. Restoring protective earthing 10. Place the top cover back on the unit and fix it by 4 screws.
  • Page 133 Annex 7. Coil Positioning during Diagnostic TMS Annex 7. Coil Positioning during Diagnostic TMS For recording lower or upper limb motor responses, RC-03-125 or RC-02-150 ring coils of large diameter are recommended. These coils ensure deep enough motor cortex stimulation and at the same time do not require precise positioning. When focused stimulation is required, FEC-03-100, FEC-02-100 figure-of-eight coils or AFEC-03-100, AFEC-02-100 angulated figure-of-eight coils.
  • Page 134 Neuro-MSX (Technical Manual) Fig. A7.2. Coil position when recording motor response from the lower limb Refer to publication [5] for detailed information on coil positioning during TMS.
  • Page 135 References References Suponeva N.A., Bakulin I.S., Poydasheva A.G., Piradov M.A. Safety of transcranial magnetic stimulation: review of international guidelines and new findings. Neuromuscular Diseases. 2017;7(2):21-36. Allen C.H., Kluger B.M., Buard I. Safety of transcranial magnetic stimulation in children: a systematic review of the literature. Pediatr Neurol 2017;68:3–17. DOI: 10.1016/j.pediatrneurol.2016.12.009.
  • Page 136 Neuro-MSX (Technical Manual) 11. 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 publication: 23 May 1997).
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