Compliance for each emission and immunity standard ............19 Description of the Device ..................23 Front Panel ........................ 23 The Rear Panel ......................24 Assembly of the Magnetic Stimulator ................. 26 Stimulation Coils ......................26 Configuration and assembly ..................30 DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Maintenance, Cleaning and Disinfection ............77 Troubleshooting ....................77 Replacing fuses ......................78 Changing the power cable ..................78 Specifications....................79 Disposal of the product ..................82 Consumables ....................84 Clinical Recommendations and Literature ............. 86 DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
DuoMAG TMS technical description and instructions for use 1. Identification of the Product Manufacturer DEYMED Diagnostic s.r.o Kudrnacova 533 Hronov 549 31 Czech Republic Tel.: +420 491 481 298 e-mail: obchod@deymed.com Web: www.deymed.com IČO: 25284584 DIČ: CZ25284584 Product type designation DuoMAG comes in two types.
Safety classification for Magnetic Stimulator: IP 20 (protected from touch by fingers, not protected from liquids). The device is designed for continuous operation in non-explosive environments without anaesthetics. Classification of the Stimulation Coils Patient electrical isolation classification: BF. Safety classification for stimulation coils: IP 20 DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
The shelf life of the Stimulation Coils 100R, 125R, 50BF, 50BFT, 70BF, 70BFP, 70BF- Cool, 70BFP-Cool and 120BFV is 5 years. Production labels Labeling of the DuoMAG Magnetic Stimulator Patterns of magnetic stimulator DuoMAG XT and MP labels DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
DuoMAG TMS technical description and instructions for use Labeling of the magnetic stimulator DuoMAG Sample DuoMAG type XT System label. Sample DuoMAG type MP System label. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
DuoMAG TMS technical description and instructions for use Labeling of the Stimulation Coil The 100R, 125R, 50BF, 50BFT, 70BF, 70BFP, 70BF-Cool, 70BFP-Cool and 120BFV Stimulation Coil labels: DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Disposal of the product Other definitions Supplier = Manufacturer or its Authorized Representative. Control PC / Control Software = Software in an external PC, laptop or similar device which controls the Magnetic Stimulator and displays its current state. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
It is a ferromagnetic or metal bone or joint implants, intravascular implants (stents, venous filters), metallic valve replacement, ventricular brain drainage, metal fragments, splinters, also implanted electronic devices that are formed from metallic or ferromagnetic materials. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Another magnetic stimulation contraindication is the presence of implants (cochlear, ocular, stents, clamps) and also for rTMS, electrically conductive ink tattoos placed near the stimulated position. Proximity means distance up to about 20 cm from the coil centre. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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If during stimulation the Stimulation Coil emits sounds noticeably different than you are used to, gives off any strange smell, changes its color, shape, or starts to overheat such that when touched, it burns the skin, discontinue use of the Coil and contact your supplier. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Please pay attention to these potentially misleading situations: Video equipment is often equipped with the same type of connector and connects using the same or very similar cables (BNC connectors and cables). If you accidentally connect DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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The RJ45 connector placed on the back of the Magnetic Stimulator is intended for use only with Deymed EEG/EMG devices. As with the previously mentioned BNC connectors, this connector is also designed for synchronization and starting the stimulation. If you connect a standard network UTP cable to this connector, it should probably not lead to the damage of the network components or the Magnetic Stimulator.
4. implants (cochlear, ocular, stents, clamps) and electrically conductive ink tattoos placed near the stimulated position (approx. 20 cm) Relative: 1. gravidity, 2. childhood - risk acceptance should be considered in connection with not fully developed hearing. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Use a separate electrical circuit wiring for the device. Do not mechanically or thermally stress the power cable. Keep the cable leading directly from the socket to the device and do not conflict it with other cables. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
During stimulation at this distance from another electronic medical device, there is real risk of data loss, disturbance or interruptions of communication, failure or the restarting of the system, etc. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Quasi-peak value Mean value 0,15 – 0,50 0,5 – 5 5 – 30 Radiated emissions (distance 10 meters) according to ČSN EN 55011 Limit value dB [µV/m] Frequency range MHz Quasi-peak value 230 - 1000 DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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ČSN EN 61000-4-3 ed. 3: 2006 + A1: 2008 + Z1: 2010 + A2: 2011 Intensity Frequency of Frequency Polarization of field modulation 80 MHz - 2.7 GHz 1 kHz Horizontal 80 MHz - 2.7 GHz 1 kHz Vertical DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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AM at 1kHz Magnetic field of network frequency according to ČSN EN 61000-4-8 ed. 2:2010 test level of immunity of the magnetic field of the network frequency (50/60 Hz): • 30 A/m 50 or 60 Hz DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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• 0 % UT, 1 cycle; • 70 % UT, 25/30 cycle; • Single phase: at 0°. test level of immunity, voltage interruptions: • 0 % UT, 250/300 cycle Standards have been applied without any deviations. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
FULL CHARGE - lights up when the unit is ready for stimulation (charged to a preset intensity). Green indicator READY - lights when the unit is in operation and ready for use. Main switch O = OFF, I = ON DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
BNC connector TTL IN provides external synchronized control of stimulation, see technical data. RJ45 connector Connect a cable to the I/O port of the Deymed USB Adapter, see technical data. BNC connector BNC connector TTL OUT used to output the synchronization trigger, see technical data.
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DuoMAG TMS technical description and instructions for use Fuses Fuse housing of supply for the external DuoMAG Touch-screen Control PC (T1, 25A), see technical data AC OUT AC OUT 110/230V max 100 VA for power supply to DuoMAG Touch Screen Control PC. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
USB cable but the Stimulator is still able to work without the Control PC, albeit with only single pulses. Stimulation Coils Stimulation Coil DuoMAG 100R Typical use: Stimulation of peripheral nerves or shallow cortical stimulation. Stimulation Coil DuoMAG 125R Typical use: Spinal stimulation. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Very focused cortical stimulation, mainly for rTMS. Paired pulse stimulation with twin coil configuration due to smaller size. Coil handle oriented perpendicular to the coil plane. Stimulation Coil DuoMAG 70BF Typical use: Focused cortical stimulation, mainly for rTMS. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Focused long-term cortical stimulation, mainly for rTMS. Can be used with the counterweight balanced coil-holder. on MagTower Configuration. Stimulation Coil DuoMAG 70BFP-Cool (70BFP1-Cool, 70BFP2-Cool) Typical use: For blinded studies. Can be used with the counterweight balanced coil-holder. on MagTower Configuration. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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DuoMAG TMS technical description and instructions for use Stimulation Coil DuoMAG 120BFV Typical use: Deep cortical stimulation. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Before unbraking the cart it is necessary to put the arms as close to the cart as possible and lock it. Release all the wheel brakes to move the Magnetic Stimulator cart. Before using the Magnetic Stimulator on the cart reapply all the wheel brakes. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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MEP visualisation with EMG module. It is not allowed to put on the arms any devices except the ones specified by the manufacturer (typically EMG headbox, All-In-One PC, Stimulation coil) DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Release all the wheel brakes to move the Magnetic Stimulator cart. Before using the Magnetic Stimulator on the cart reapply all the wheel brakes. DuoMAG , type MP Desktop Configuration The DuoMAG MP or DuoMAG MP-Dual can be placed on a desktop or similar in a compact space. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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DuoMAG MP-Dual Configuration on cart The MP-Dual with Cart is a flexible configuration for advanced research and clinical uses of two or more of Deymed’s Mono-phasic stimulators. This configuration allows the user to perform paired-pulse mono-phasic stimulation with full control of all stimulation parameters at the touch of the screen.
Magnetic Stimulator on the cart reapply all the wheel brakes. Use in Conjunction with EMG / EP, EEG device or neuronavigation The DuoMAG system can be used in conjunction with Deymed TruScan EEG, Deymed TruTrace EMG, Brainsight TMS Neuronavigation. All devices that you intend to connect, either via BNC connectors or the USB interface, must meet the standards of ČSN EN 60601-1 The minimum distance from the Stimulation...
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The size of the induced voltage in practical terms does not depend on the impedance of the stimulated tissue. In this way, stimulation using a magnetic stimulator is not unlike using a voltage stimulator. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
When the Red LED indicator goes off and the Green LED indicator is still on, the user may then set the desired stimulation level and start again to stimulate. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Stimulator and minimizes the risk of unwanted stimulation. If you do not plan to use the Stimulator for a long time, turn off the main switch, thereby further increasing the service life of the Stimulator. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Stimulation Coil cable integrity and proper connection of the Stimulation Coil into the Magnetic Stimulator. Turning off the Magnetic Stimulator Turn the power switch to the OFF position (O)(7). The display and all the color LEDs will turn off. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
1. Application initialization, 2. EMG USB adapter connection check, 3. Magnetic Stimulator connection check, 4. Loading configuration, 5. Loading the patient database. If one of the steps is not finished correctly, it is not checked. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
The Main Patient Screen is the first screen that is visible when the user turns on the DuoMAG rTMS Control PC. The Patient information, including session information, is entered and displayed here. A Touch-screen may be used to navigate as well as a connected mouse. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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When a session is grayed out (not black) it indicates the protocol was interrupted or did not come to the end of the session. Information about who or what stopped the session, is indicated on the top bar of the Patient screen. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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This window is not clickable or selectable, as it is only to display data as the user types. Select Patient Button Once the correct patient has been selected on the screen, use this Patient Select button to enter the Stimulation Control Screen. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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MEP or Therapy session is selected. The Quick Controls settings button on the right side of the tab allow the user to preset which features should be visible on the tab. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
TAB button on your computer keyboard. You can make quick entry of information without using the mouse. Patient ID number Motor Threshold saved for Patient Medical Data Remove Patient Card Standard Patient Data DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Set RMT or Set AMT button is pressed in the MEP screen. Remove Patient Card The Delete Patient button will delete all the data of the selected patient. The Patient Card as well as all the session data will be permanently removed. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
The Protocol Setup Screen gives the options needed to configure any standard Repetitive or Burst protocol. The Burst protocol is available only when used with DuoMAG XT-100 Magnetic Stimulator. Protocol Settings Protocol Design Area EMG Display Settings Protocol List Controls Protocol List Repeated / Burst Protocol Selection DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Controls to work with the protocol list allows to: 1. Add New protocol, 2. Delete selected protocol, 3. Rename selected protocol, 4. Duplicate selected protocol, 5. Import protocol from file, 6. Export protocol to file. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Burst protocol. On the right side of the screen displays adjustable parameters corresponding to the selected protocol type. To see more about this function, go to the Burst Protocol Setup (for DuoMAG XT-100 only) section of this user guide. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
NOT be changed or adjusted on the Therapy/Protocol Screen However, the number of trains may be limited by stopping the protocol manually. To do so, click the STOP button on the Therapy/ Protocol Screen before the protocol comes to its end. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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The Protocol Preview area shows a graphical representation of the protocol to help the user visually recognize the protocol design. This display shows only one cycle of a single train in the protocol. All following cycles are the same. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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(not just a single Train or cycle). Listed at the top right of this area is the Total Time which gives the total running time of the entire protocol, from start to finish. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
[2], system will warn user. In this case the user should make a responsible decision whether to use this protocol or not. The settings on the figure below describe how a Burst protocol is configured. Burst Protocol Settings Stimulation Protocol Preview DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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System Configuration. If the mode RMT + AMT is selected in the System Configuration, then the control is available and the user can select whether the protocol is RMT or AMT. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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(not just a single Train or cycle). Listed at the top right of this area is the Total Time which gives the total running time of the entire protocol, from start to finish. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Pre-Stim Alert Settings Main Signal Display Settings Signal Display Zoom MEP Display settings Channel Selection Choose the number of EMG channels to display, by selecting either 1CH, 2CH or both (button will be Orange when selected). DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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• Time Base: 1, 2, 5, 10, 20 ms per division. • Sensitivity: Various incremental steps from 20 µV to 30 mV. • Filter: High Pass in steps from 0.5 Hz to 200 Hz. Low Pass in steps from 40 Hz to 5 kHz. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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The Enable Zoom button will allows the user to enlarge the selected signal window to full screen. Double-tap / click to the selected window to enlarge it. Double-tap / click again to get back to the standard layout. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Motor Threshold (MT). The user may also view the EMG live signal and MEP signal. All controls can be manipulated via the Touch Screen interface or via a connected mouse. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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The Coil Information shows the connected Coil type and its temperature. Presence of the Coil type information depends on the Stimulator firmware. If the Stimulator and the Coil allows this feature, the current connected Coil type will be displayed. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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MEP Table results. Auto-markers will generally appear when the MEP is found by the system. It may not however place the markers where you would like them to be. You should manually adjust DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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MEP response. If the Peak-to-peak value exceeds the predefined value Screen, item 3, MEP p-p threshold) it is highlighted in green. „Int" (see Display Setup indicates the current intensity of stimulation during which the MEP was recorded. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Disable button to set the Stimulator to sleep mode and discharged the capacitors. If the Enabled Stimulator is not Active for a while (a time predefined in the System Configuration Screen, item 6), it will Disable automatically. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Screen interface or via a connected mouse. Selected Patient Information Patient List / Protocol Setups Live EMG signal Pause Protocol Preview Stimulation Intensity Coil Information Stimulation Controls Headbox Battery Charge Indicator Remaining time / pulses DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Coil temperature again drops below the alert level. Headbox Battery Charge Indicator The Headbox Battery indicator shows in percentage the battery level of the connected EMG Headbox. When the battery is below 10 %, it should be recharged. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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If not, the user is warned and must confirm whether to run the protocol or not. The Start Stimulation button will be activated only after first selecting the Enable button. Once activated, the user can click on Start Stimulation, which starts the protocol stimulation. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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The Remaining Pulses is used when the protocol is running and displays the number of stimulations remaining in the currently running protocol. The Time Remaining is used when the protocol is running and displays the actual time to the end of the currently running protocol. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
Color Scheme Translation Notch Filter Frequency Serial Numbers Show Cursor Reboot MEP Adapter Use On-screen Keyboard Reboot Stimulator Show Interrupted Protocols System Idle Time Show advanced settings Motor Threshold Mode Close the System Configuration Window DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Resting and Active. The system then shows both protocol types (RMT and AMT). When a new protocol is created in this MT Mode, the user should set whether the protocol will use RMT or AMT. Selected protocol can be used for stimulating the DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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The Cancel button closes the System Configuration window without saving any changes made to the settings. If the button Close rTMS is available, it will close the DuoMAG rTMS software without turning off the All-In-One PC. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
NOTE: Changes to any setting in Windows should only be performed by a trained service technician. Advanced System Configuration Screen Configuration Codes Manager Stimulator Recharge Delay Active Motor Threshold Settings Research Mode GDT Settings Configuration Codes Manager This button opens the Config Codes Manager. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Fixed Extension is an option to use a fixed extension for GDT (.gdt) or iterativly changing extension. Stimulator Recharge Delay An option to delay the recharge of the capacitors for use in combination with EEG. The value can be set from 0 ms to 600 ms. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Stimulation Coil. The protocol must be selected and the Stimulator Activated. When the Coil button is pressed again during the stimulation, the protocol is paused immediately. A second click on the coil button will start the protocol from the position where it was paused. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
The ID column contains ID of the code in the list. The Code contains information on the connected device, time validity and particular software features. The Expiration column shows the expiration date. The State column shows if the code is in use. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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All changes will take effect after the software restart. If the user does not restart the software immediately, the changes will take effect on the next start of the system. Cancel: This button closes the configuration codes manager without saving any changes. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
PC (described in more detail in chapters Patient screen Add / Edit Patient). After the patient selection window, move to the single stimulation screen (see MEP/MT Single Pulse Screen). Here it is possible to perform a single stimulation. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
System Configuration Screen, item 5) then the protocol can be started using the Coil button if the Stimulator is activated. If the protocol is currently running, it can be paused by pressing the Coil button. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
In the case of the XT system with the Control PC If the control PC cannot be switched on but the Magnetic Stimulator still works, check the power cable to the PC. If is OK, check the fuses. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
The power cable must be long enough and end with the C19 connector for connecting to the Magnetic Stimulator. Replace the supply cable when the appliance is switched off. Ensure that the power cable is not mechanically stressed. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
• Model XT-100:22 Hz (100% intensity), 86 Hz (50%), maximum 100 Hz • Model XT-35: 13 Hz (100% intensity), 35 Hz (50%), maximum 35 Hz • Model XT-10: 5 Hz (100% intensity), 10 Hz (50%), maximum 10 Hz DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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DuoMAG MP: 49 cm x 38 cm x 11 cm DuoMAG XT: 49 cm x 38 cm x 16 cm Weight: DuoMAG MP: 14.5 kg net (without Stimulation Coil) DuoMAG XT: 15 kg net (without Stimulation Coil) DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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Stimulation Coil electrical contact cleanness, integrity of the coil cable, integrity of the power cable to the device, integrity of the Stimulation Coil and the typical sound of the Coil during stimulation. The device contains no parts serviceable at the installation site, except fuses and power cable. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
EC Directive 2006/66. If batteries are not properly disposed of, these substances can cause harm to human health or the environment. To protect natural resources and to promote material reuse, please separate DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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DuoMAG TMS technical description and instructions for use batteries from other types of waste and recycle them through your local, free battery return system. As a result of an incorrect waste disposal procedure, penalties may be imposed in accordance with national rules. DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
12. Consumables DuoMAG MEP Starter Kit (in case of the system with EMG) Cable for Disposable EMG Surface Electrode (1,5 m) Ground electrode 1.5 x 25 cm (2 m) Deymed Self-Adhesive Disposable Electrodes (12 pieces) DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
[5] Jean-Pascal Lefaucheur, Nathalie André-Obadia, Andrea Antal, Samar S. Ayache, Chris Baeken, David H. Benninger, Roberto M. Cantello, Massimo Cincotta, Mamede de Carvalho, Dirk de Ridder et al. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clinical Neurophysiology [online]. 2014 DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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DuoMAG TMS technical description and instructions for use DEYMED Diagnostic s.r.o. Version: DM004-IFU1902EN...
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